NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY … Working Group/_Quality... · SUPPLEMENT 1S-1 Supplementary Requirements for Organization 1 GENERAL This Supplement provides

NQA-1 SIDE-BY-SIDE ANALYSIS OF REQUIREMENT EQUIVALENCY NQA-1-1994-1 NQA-1-2008 Additional Information

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BASIC REQUIREMENT 1 ORGANIZATION

REQUIREMENT 1 ORGANIZATION

100 Basic The organizational structure, functional responsibilities, levels of authority, and lines of communication for activities affecting quality shall be documented.

Responsibilities for the establishment and implementation of the quality assurance program shall be defined. The organizational structure, functional responsibilities, levels of authority, and lines of communications for activities affecting quality shall be documented.

Persons or organizations responsible for assuring that an appropriate quality assurance program has been established and verifying that activities affecting quality have been correctly performed shall have sufficient authority, access to work areas, and organizational freedom to:

Those responsible for verifying quality achievement have sufficient authority, direct access to management, organizational freedom and access to work to perform their function.” (Req 1, 201d, 1)

(a) identify quality problems; The organization shall establish and implement processes to detect and correct quality problems.” (Req 2, 100,9)

(b) initiate, recommend, or provide solutions to quality problems through designated channels;

The organization shall establish and implement processes to detect and correct quality problems. (Req. 2, 100,9)

(c) verify implementation of solutions; and Completion of corrective actions shall be verified. (Req. 16, 100, 4)

(d) assure that further processing, delivery, installation, or use is controlled until proper disposition of a nonconformance, deficiency, or unsatisfactory condition has occurred.

Further processing, delivery, installation, or use of a nonconforming item shall be controlled pending the evaluation and an approved disposition by authorized personnel.(Req.15, 401,2)

Such persons or organizations shall have direct access to responsible management at a level where appropriate action can be effected.

Those responsible for verifying quality achievement have sufficient authority, direct access to management, organizational freedom and access to work to perform their function. (Req.1, 201d, 1)

Such persons or organizations shall report to a management level such that required authority and organizational freedom are provided, including sufficient independence from cost and schedule considerations.

Those responsible for verifying quality achievement have sufficient authority, direct access to management, organizational freedom and access to work to perform their function. (Req.1,201d,1)


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SUPPLEMENT 1S-1 Supplementary Requirements for Organization

1 GENERAL This Supplement provides amplified requirements for organization.

It supplements the requirements of Basic Requirement 1 of this Part (Part I) and shall be used in conjunction with that Basic Requirement when and to the extent specified by the organization invoking this Part (Part I).

2 RESPONSIBILITY 200 STRUCTURE AND RESPONSIBILITY 2.1 Purpose 201 General The organizational structure and the responsibility assignments shall be such that:

The organizational structure and responsibility assignments shall be such that

(a) senior management establishes overall expectations for effective implementation of the quality assurance program and is responsible for obtaining the desired end result

(a) quality is achieved and maintained by those who have been assigned responsibility for performing work; and

(b) quality is achieved and maintained by those assigned responsibility for performing work

(b) quality achievement is verified by persons or organizations not directly responsible for performing the work.

(c) quality achievement is verified by those not directly responsible for performing the work

(d) those responsible for assuring that an appropriate quality assurance program has been established and those verifying activities affecting quality have sufficient authority, direct access to responsible levels of management, organizational freedom, and access to work to perform this function, including sufficient independence from cost and schedule when opposed to safety function considerations. These verification functions include the following: (1) identifying quality problems (2) initiating, recommending, or providing solutions to quality problems through designated channels (3) verifying implementation of solutions


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(4) assuring that further processing, delivery, installation, or use is controlled until proper disposition of a nonconformance, deficiency, or unsatisfactory condition has occurred.

2.2 Delegation of Work 202 Delegation of Work The individual(s) or organization(s) responsible for establishing and executing a quality assurance program under this Standard may delegate any or all of the work to others but shall retain responsibility therefore.

The individual (s) or organization (s) responsible for establishing and executing a quality assurance program under this Standard may delegate any or all of the work to others but shall retain responsibility therefor.

2.3 Nonconforming Items Responsibility for the control of further processing, delivery, installation, or operation of nonconforming items shall be designated in writing.

Responsibility for the control of further processing, delivery, installation, or use of nonconforming items shall be designated in writing. (Req. 15, 402,2)

3 MULTIPLE ORGANIZATIONS 300 INTERFACE CONTROL 3.1 Responsibility Where more than one organization is involved in the execution of activities covered by this Part (Part I), the responsibility and authority of each organization shall be clearly established and documented.

Where more than one organization is involved in the execution of activities, the responsibilities, interfaces, and authority of each organization shall be clearly defined and documented.

3.2 Interface Control

3.2.1 The external interfaces between organizations and the internal interfaces between organizational units, and changes thereto, shall be documented.

The external interfaces between organizations and the internal interfaces between organizational units, and changes thereto, shall be documented.

3.2.2 Interface responsibilities shall be defined and documented.

Where more than one organization is involved in the execution of activities, the responsibilities, interfaces, and authority of each organization shall be clearly defined and documented. (Req. 1, 300, 1)


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Basic Requirement 2 Quality Assurance Program

Requirement 2 Quality Assurance Program

100 BASIC

A documented quality assurance program shall be planned, implemented, and maintained in accordance with this Part (Part I), or portions thereof.

(a) A documented quality assurance program shall be planned, implemented, and maintained in accordance with this Part ( Part I), or portions thereof.

The program shall identify the activities and items to which it applies.

The program shall identify the activities and items to which it applies.

The establishment of the program shall include consideration of the technical aspects of the activities affecting quality.

The program shall provide control over activities affecting quality to an extent consistent with their importance.

The program shall include monitoring activities against acceptance criteria in a manner sufficient to provide assurance that the activities affecting quality are performed satisfactorily. (Req. 2, 100, 4)



The program shall include monitoring activities against acceptance criteria in a manner sufficient to provide assurance that the activities affecting quality are performed satisfactorily.

The program shall be established at the earliest time consistent with the schedule for accomplishing the activities.

The program shall be established at the earliest time consistent with the schedule for accomplishing the activities.

The program shall provide for the planning and accomplishment of activities affecting quality under suitably controlled conditions.

The program shall provide for the planning and accomplishment of activities affecting quality under suitably controlled conditions.

Controlled conditions include the use of appropriate equipment, suitable environmental conditions for accomplishing the activity, and assurance that prerequisites for the given activity have been satisfied.

Controlled conditions include the use of appropriate equipment, suitable environmental conditions for accomplishing the activity, and assurance that prerequisites for the given activity have been satisfied.

The program shall provide for any special controls, processes, test equipment, tools, and skills to attain the required quality and for verification of quality.

The program shall provide for any special controls, processes, test equipment, tools, and skills to attain the required quality of activities and items and for verification of that quality.

The organization shall establish and implement processes to detect and correct quality problems.


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The program shall provide for indoctrination and training, as necessary, of personnel performing activities affecting quality to assure that suitable proficiency is achieved and maintained.

(b) The program shall provide for indoctrination, training, and qualification as necessary of personnel performing or managing activities affecting quality to ensure that suitable proficiency is achieved and maintained.

Management of those organizations implementing the quality assurance program, or portions thereof, shall regularly assess the adequacy of that part of the program for which they are responsible and shall assure its effective implementation.

(c) Management shall regularly assess the adequacy and effective implementation of the quality assurance program.

SUPPLEMENT 2S-1 Supplementary Requirements for the Qualification Of Inspection and Test Personnel

1 GENERAL This Supplement provides amplified requirements for the qualification of personnel who perform inspection and testing to verify conformance to specified requirements for the purpose of acceptability.

It supplements the requirements of Basic Requirement 2 of this Part (Part I) and shall be used in conjunction with that Basic Requirement when and to the extent specified by the organization invoking this Part (Part I)

Supplement do not apply to the qualification of personnel for performance of nondestructive examination.

2 CERTIFICATION 2.1 Qualification Requirements The responsible organization shall designate those activities that require qualified inspection and test personnel and the minimum requirements for such personnel.

The responsible organization shall designate those activities that require qualification of personnel and the minimum requirements for such personnel. (Req.2, 300, 1)

Further, the responsible organization shall establish written procedures for the qualification of inspection and test personnel, and for the assurance that only those personnel who meet the requirements of this Supplement are permitted to perform inspection and test activities.

The responsible organization shall establish written procedures for the qualification of personnel, and for the assurance that only those personnel who meet the requirements are permitted to perform these activities. (Req. 2, 300, 2)


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When a single inspection or test requires implementation by a team or a group, personnel not meeting the requirements of this Part (Part I) may be used in data-taking assignments or in plant or equipment operation, provided they are supervised or overseen by a qualified individual.

2.2 Personnel Selection Personnel selected for performing inspection and test activities shall have the experience or training commensurate with the scope, complexity, or special nature of the activities.

Indoctrination and training shall be commensurate with scope, complexity, importance of activities, and the education, experience, and proficiency of the person. (Req. 2,200,1) The responsible organization shall designate those activities that require qualification of personnel and the minimum requirements for such personnel. (Req. 2, 300, 1)

200 INDOCTRINATION AND TRAINING Indoctrination and training shall be commensurate

with scope, complexity, importance of the activities, and the education, experience, and proficiency of the person.

2.3 Indoctrination 201 Indoctrination Provisions shall be made for the indoctrination of personnel as to the technical objectives and requirements of the applicable codes and standards, and the quality assurance program elements that are to be employed.

Personnel performing or managing activities affecting quality shall receive indoctrination in their job responsibilities and authority that includes general criteria, technical objectives, requirements of applicable codes and standards, regulatory commitments, company procedures, and quality assurance program requirements.

2.4 Training 202 Training The need for a formal training program shall be determined, and such training activities shall be conducted as required to qualify personnel who perform inspections and tests.

The need for a formal training program for personnel performing or managing activities affecting quality shall be determined.

Training shall be provided, if needed, to achieve initial proficiency, maintain proficiency, and adapt to changes in technology, methods, or job responsibilities.

On-the-job training shall be used if direct hands-on applications or experience is needed to achieve and maintain proficiency.

On-the-job training (including mentoring) is an effective training method and should be documented as well as classroom training. (P-III, 2A-1,600,2,2)


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2.5 Determination of Initial Capability The capabilities of a candidate for certification shall be initially determined by a suitable evaluation of the candidate's education, experience, training, and either test results or capability demonstration.

The initial capabilities of a candidate shall be determined by an evaluation of the candidate’s education, experience, training, and either test results or capability demonstration. (Req. 2, 302,1)

2.6 Evaluation of Performance The job performance of inspection and test personnel shall be reevaluated at periodic intervals not to exceed 3 years.

The job performance of inspection and test personnel shall be reevaluated at periodic intervals not to exceed three years. (Req. 2,302,2)

Reevaluation shall be by evidence of continued satisfactory performance or redetermination of capability in accordance with the requirements of para. 2.5 above.

Reevaluation shall be by evidence of continued satisfactory performance or redetermination of capability in accordance with the requirements of 200 above. (Req. 2,302,3)

If during this evaluation or at any other time, it is determined by the responsible organization that the capabilities of an individual are not in accordance with the qualification requirements specified for the job, that person shall be removed from that activity until such time as the required capability has been demonstrated.

If during this evaluation or at any other time, it is determined by the responsible organization that the capabilities of an individual are not in accordance with qualification requirements specified for the job, that person shall be removed from that activity until such time as the required capability has been demonstrated. (Req. 2, 302, 4)

Any person who has not performed inspection or testing activities in his qualified area for a period of 1 year shall be reevaluated by a redetermination of required capability in accordance with the requirements of para. 2.5 above.

Any person who has not performed inspection or testing activities in the qualified area for a period of 1 year shall be reevaluated. (Req. 2,302,5)

2.7 Certificate of Qualification The qualification of personnel shall be certified in writing in an appropriate form, including the following information:

The qualification of inspection, test and lead auditor personnel shall be certified in writing and include the following information: (Req. 2,400a)

(a) employer's name; Employer’s name (Req. 2, 400a1) (b) identification of person being certified; Identification of person being certified (Req. 2,

400a2) (c) activities certified to perform; Activities certified to perform (Req. 2,400a3) (d) basis used for certification, which includes such factors as:

Basis of qualification (Req. 2,400a4)

(1) education, experience, indoctrination, and training

education, experience, indoctrination, and training (Req. 2,400a4a)

(2) test results, where applicable test results, where applicable (Req. 2,400a4b)


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(3) results of capability demonstration capability demonstration (Req. 2,400a4c) (e) results of periodic evaluation; Results of periodic evaluation (Req. 2,400a5) (f) results of physical examinations, when required;

Results of physical examinations, when required (Req. 2,400a6)

(g) signature of employer's designated representative who is responsible for such certification;

Signature of employer’s designated representative who is responsible for such certification (Req. 2,400a7)

(h) date of certification and date of certification expiration.

Date of certification or recertification and certification expiration. (Req. 2,400a8)

2.8 Physical The responsible organization shall identify any special physical characteristics needed in the performance of each activity, including the need for initial and subsequent physical examination.

The responsible Organization shall identify any special physical characteristics needed in the performance of each activity, including the need for initial and subsequent physical examination. (Req. 2,400b,1)

3 RECORDS 3.1 Record Files Records of personnel qualification shall be established and maintained by the employer. These records shall include the information required by para. 2.7 above.

Records of qualification, including requalification for auditors and lead auditors, and for inspection and test personnel shall be established and maintained by the employer and for indoctrination and training. (Req. 2,500,2)

300 Qualification Requirements The responsible organization shall designate those

activities that require qualification of personnel and the minimum requirements for such personnel.

The responsible organization shall establish written procedures for the qualification of personnel, and for the assurance that only those personnel who meet the requirements are permitted to perform these activities..

Specific qualification requirements for personnel performing nondestructive examination inspection and tests to verify quality and auditing are specified in paras. 301 through 304 of this Requirement.


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SUPPLEMENT 2S-2 Supplementary Requirements for the Qualification of Nondestructive Examination Personnel

301 Nondestructive Examination (NDE)

1 GENERAL This Supplement provides amplified requirements for the qualification of personnel who perform radiographic (RT), magnetic particle (MT), ultrasonic (UT), liquid penetrant (PT), eddy current (ET), neutron radiographic (NRT), leak testing (LT), acoustic emission (AE), and visual testing (VT) [hereinafter referred to as nondestructive examination (NDE)] to verify conformance to specified requirements.

This section specifies requirements for the qualification of personnel who perform radiographic (RT), magnetic particle (MP), ultrasonic (UT), liquid penetrant (PT), electromagnetic (ET), neutron radiographic (NR), leak testing (LT), acoustic emission (AE), and visual testing (VT) to verify conformance to the specified requirements.


2 CERTIFICATION 2.1 Applicable Documents The American Society of Nondestructive Testing Recommended Practice No. SNT-TC-1A, December 1980 Edition, and its applicable supplements shall apply as requirements to NDE personnel covered by this Supplement.

The American Society of Nondestructive Testing (ASNT) Recommended Practices or Standards provide acceptable qualification requirements for NDE personnel. Applicable Codes and Standards or design criteria controlling the qualification of NDE personnel shall be utilized to establish the applicable ASNT qualification requirement and edition or to specify an equivalent alternative requirement.

302 Inspection and Test The initial capabilities of a candidate shall be

determined by an evaluation of the candidate’s education, experience, training, and either test results or capability demonstration.

The job performance of inspection and test personnel shall be reevaluated at periodic intervals not to exceed 3 years. of section 200 of this Requirement.

Reevaluation shall be by evidence of continued satisfactory performance or redetermination of capability in accordance with the requirements


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If during this evaluation or at any other time, it is determined by the responsible organization that the capabilities of an individual are not in accordance with the qualification requirements specified for the job, that person shall be removed from that activity until such time as the required capability has been demonstrated.

Any person who has not performed inspection or testing activities in the qualified area for a period of 1 year shall be reevaluated.

2.2 Program The responsible organization shall establish written procedures for the control and administration of NDE personnel training, examination, and certification.

The responsible organization shall establish written procedures for the qualification of personnel, and for the assurance that only those personnel who meet the requirements are permitted to perform these activities. (Req. 2,300,2)

2.3 Records Records of personnel qualification shall be established and maintained by the employer.

Records of qualification, including requalification, for auditors and lead auditors, and for inspection and test personnel shall be established and maintained by the employer and for indoctrination and training. (Req.2,500,2)

SUPPLEMENT 2S-3 Supplementary Requirements for the Qualification of Quality Assurance Program Audit Personnel

303 Lead Auditor

1 GENERAL This Supplement provides amplified requirements for the qualification of an audit team leader, henceforth identified as a Lead Auditor, who organizes and directs audits, reports audit findings, and evaluates corrective action.

This Supplement also provides amplified requirements for the qualifications of individuals, henceforth referred to as Auditors, who participate in an audit, such as technical specialists, management representatives, and auditors-in-training.

Auditors participate in an audit. (Req.2,304,1)


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2 QUALIFICATION OF AUDITORS 2.1 Responsibility of Auditing Organization . The responsible auditing organization shall establish the audit personnel qualifications and the requirements for the use of technical specialists to accomplish the auditing of quality assurance programs.

The responsible organization shall designate those activities that require qualification of personnel and the minimum requirements for such personnel. (Req. 2,300,1)

Personnel selected for quality assurance auditing assignments shall have experience or training commensurate with the scope, complexity, or special nature of the activities to be audited.

The responsible organization shall designate those activities that require qualification of personnel and the minimum requirements for such personnel. (Req. 2,300,1)

Auditors shall have, or be given, appropriate training or orientation to develop their competence for performing required audits.

Auditors shall have, or be given appropriate training or orientation to develop their competence for performing required audits. (Req. 2,304,2)

Competence of personnel for performance of the various auditing functions shall be developed by one or more of the methods given in (a) through (c) below:

Competence of personnel for performance of the various auditing functions shall be developed by one or more of the following methods. (Req.2,304,3)

(a) orientation to provide a working knowledge and understanding of this Part (Part I) and the auditing organization's procedures for implementing audits and reporting results;

(a) Orientation to provide a working knowledge and understanding of this Standard and the auditing organization’s procedures for implementing audits and reporting results. (Req. 2,304,4)

(b) training programs to provide general and specialized training in audit performance.

(b) General and specialized training in audit performance where the general training shall include fundamentals, objectives, characteristics, organization, performance, and results of quality auditing and the specialized training shall include methods of examining, questioning, evaluating, and documenting specific audit items and methods of closing out audit findings. (Req.2,304,5)

General training shall include fundamentals, objectives, characteristics, organization, performance, and results of quality auditing.

(b) General and specialized training in audit performance where the general training shall include fundamentals, objectives, characteristics, organization, performance, and results of quality auditing and the specialized training shall include


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methods of examining, questioning, evaluating, and documenting specific audit items and methods of closing out audit findings.(Req. 2,304,5)

Specialized training shall include methods of examining, questioning, evaluating, and documenting specific audit items and methods of closing out audit findings.

(b) General and specialized training in audit performance where the general training shall include fundamentals, objectives, characteristics, organization, performance, and results of quality auditing and the specialized training shall include methods of examining, questioning, evaluating, and documenting specific audit items and methods of closing out audit findings.(Req. 2,304,5)

(c) on-the-job training, guidance, and counseling under the direct supervision of a Lead Auditor.

(c) (On-the-job training, guidance, and counseling under the direct supervision of a Lead Auditor. Such training shall include planning, performing, reporting, and follow-up action involved in conducting audits. (Req.2,304,6)

Such training shall include planning, performing, reporting, and follow-up action involved in conducting audits.

(c) On-the-job training, guidance, and counseling under the direct supervision of a Lead Auditor. Such training shall include planning, performing, reporting, and follow-up action involved in conducting audits. (Req.2,304,6).

3 QUALIFICATION OF LEAD AUDITORS 303 Lead Auditor The Lead Auditor organizes and directs audits,

reports audit findings, and evaluates corrective action.

An individual shall meet the requirements of paras. 3.1 through 3.4 below prior to being designated a Lead Auditor.

An individual shall meet the requirements of paras. 303.1 through 303.6 of this Requirement prior to being designated a Lead Auditor.

3.1 Communication Skills 303.1 Communication Skills The prospective Lead Auditor shall have the capability to communicate effectively, both in writing and orally.

The prospective Lead Auditor shall be capable of communicating effectively, both in writing and orally.

These skills shall be attested to in writing by the Lead Auditor's employer.

These skills shall be attested to in writing by the Lead Auditor’s employer.

3.2 Training 303.2 Training Prospective Lead Auditors shall have training to the extent necessary to assure their competence in auditing skills.

Prospective Lead Auditors shall receive training to the extent necessary to assure auditing competence including

Training in the following areas shall be given based upon management evaluation of the particular needs of each prospective Lead Auditor.

(a) knowledge and understanding of this Standard and other nuclear-related codes, standards, regulations, and regulatory guides, as applicable


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3.2.1 Knowledge and understanding of this Part (Part I) and other nuclear-related codes, standards, regulations, and regulatory guides, as applicable.

(b) general structure of quality assurance programs as a whole and applicable elements as defined in this Standard

3.2.2 General structure of quality assurance programs as a whole and applicable elements as defined in this Part (Part I).

(c) auditing techniques of examining, questioning, evaluating, and reporting; methods of identifying and following up on corrective action items; and closing out audit findings

3.2.3 Auditing techniques of examining, questioning, evaluating, and reporting; methods of identifying and following up on corrective action items; and closing out audit findings.

(d) planning audits of activities affecting quality

3.2.4 Audit planning in the quality-related functions for the following activities: siting, designing, purchasing, fabricating, handling, shipping, receiving, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, modifying, and decommissioning of nuclear facilities or associated components, and safety aspects of the nuclear facility.

Activities affecting quality include siting, designing, procuring, fabricating, handling, shipping, receiving, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, modifying, and decommissioning. (Part 1,Introduction,200)

3.2.5 On-the-job training to include applicable elements of the audit program.

(e) on-the-job training to include applicable elements of the audit program

3.3 Audit Participation 303.3 Audit Participation The prospective Lead Auditor shall have participated in a minimum of five (5) quality assurance audits within a period of time not to exceed 3 years prior to the date of qualification, one audit of which shall be a nuclear quality assurance audit within the year prior to his qualification.

Prospective Lead Auditors shall participate in a minimum of five quality assurance audits within a period of time not to exceed 3 years prior to the date of qualification, one audit of which shall be a nuclear quality assurance audit within the year prior to qualification.

Participation in independent assessments including team assessment activities such as operations readiness reviews and regulatory inspections/surveys may be used to satisfy up to four of the five required quality assurance audits, provided that the activities can demonstrate the following:


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(a) independence from the functional areas being assessed (b) planning that establishes the scope of the activities and associated evaluation criteria (c) performance by technically qualified and experienced personnel (d) results that are documented and reported to management (e) appropriate corrective action initiated and tracked to resolution Such participation shall be subject to review and acceptance by the organization responsible for quality assurance audits and/or the certifying authority prior to their use for qualification.

3.4 Examination 303.4 Examination The prospective Lead Auditor shall pass an examination which shall evaluate his comprehension of and ability to apply the body of knowledge identified in para. 3.2 above.

Prospective Lead Auditors shall pass an examination that shall evaluate comprehension of and ability to apply the body of knowledge identified above.

The examination may be oral, written, practical, or any combination of the three types.

The examination may be oral, written, practical, or any combination thereof.

The development and administration of the examination shall be in accordance with Section 5 of this Supplement.

Note: Refer to (2,400) for development and administration of the examination.

4 MAINTENANCE OF QUALIFICATION 4.1 Maintenance of Proficiency 303.5 Maintenance of Proficiency Lead Auditors shall maintain their proficiency through one or more of the following: regular and active participation in the audit process; review and study of codes, standards, procedures, instructions, and other documents related to quality assurance program and program auditing; or participation in training program(s).

Lead Auditors shall maintain their proficiency through one or more of the following: (a) regular and active participation in the audit process (b) review and study of codes, standards, procedures, instructions, and other documents related to quality assurance program and program auditing (c) participation in training program(s)

Based on annual assessment, management may extend the qualification, require retraining, or require requalification.

Based on annual assessment, management may extend the qualification, require retraining, or require requalification.


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These evaluations shall be documented. Records of qualification, including requalification, for auditors and lead auditors, and for inspection and test personnel shall be established and maintained by the employer for indoctrination and training. (Req. 2,500,2)

4.2 Requalification 303.6 Requalification Lead Auditors who fail to maintain their proficiency for a period of 2 years or more shall require requalification.

Lead Auditors who fail to maintain their proficiency for a period of 2 years or more shall require requalification.

Requalification shall include retraining in accordance with the requirements of para. 3.2 above, reexamination in accordance with para. 3.4 above, and participation as an Auditor in at least one nuclear quality assurance audit.

Requalification shall include retraining in accordance with the requirements of para. 303.2 of this Requirement, reexamination in accordance with para. 303.4 of this Requirement, and participation as an Auditor in at least one nuclear quality assurance audit.

5 ADMINISTRATION 5.1 Organization Responsibility . Training of auditors shall be the responsibility of the employer.

The program shall provide for indoctrination, training, and qualification as necessary, of personnel performing or managing activities affecting quality to assure that suitability proficiency is achieved and maintained. (Req. 2,100b, 1)

The responsible auditing organization shall select and assign personnel who are independent of any direct responsibility for performance of the activities which they will audit.

These audits shall be performed in accordance with written procedures or checklists by personnel who do not have direct responsibility for performing the activities being audited (Req. 18,100,2)

The Lead Auditor shall, prior to commencing the audit, concur that assigned personnel collectively have experience or training commensurate with the scope, complexity, or special nature of the activities to be audited.

Indoctrination and training shall be commensurate with scope, complexity, importance of the activities, and the education, experience, and proficiency of the person. (Req. 2,200,1)

5.2 Qualification Examination The development and administration of the examination for a Lead Auditor required by para. 3.4 above is the responsibility of the employer.

(7) Signature of employer’s designated representative who is responsible for such certification; (Req. 2, 400,7)

The employer may delegate this activity to an independent certifying agency, but shall retain responsibility for conformance of the examination and its administration to this Part (Part I).

The employer may delegate qualification examination activities to an independent certifying agency, but shall retain responsibility for conformance of the examination and its administration. (Req. 2,400b,2)


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Integrity of the examination shall be maintained by the employer or certifying agency through appropriate confidentiality of files and, where applicable, proctoring of examinations.

Integrity of the examination shall be maintained by the employer or certifying agency through appropriate confidentiality of files and, where applicable, proctoring of examinations. (Req. 2,400b,3)

Copies of the objective evidence regarding the type(s) and content of the examination(s) shall be retained by the employer in accordance with the requirements of Section 6 below.

Copies of the objective evidence regarding the type(s) and content of the examination(s) shall be retained by the employer in accordance with the requirements of 500 below. (Req. .2,400b,4)

6 RECORDS 6.1 General Records of personnel qualifications for Auditors and Lead Auditors performing audits shall be established and maintained by the employer.

Records of qualification, including requalification, for auditors and lead auditors, and for inspection and test personnel shall be established and maintained by the employer and for indoctrination and training. (Req. 2,500,2)

6.2 Certification of Qualification Each Lead Auditor shall be certified by his employer as being qualified to lead audits.

The qualification of inspection, test and lead auditor personnel shall be certified in writing and include the following information: (Req. 2,400a,1)

This certification shall, as a minimum, document the following:

The qualification of inspection, test and lead auditor personnel shall be certified in writing and include the following information: (Req. 2,400a,1)

(a) employer's name: (1) Employer’s name; (Req. 2,400a,1) (b) Lead Auditor's name; (2) Identification of person being certified (Req.

2,400a,2) (c) date of certification or recertification; (8) Date of certification or recertification and

certification expiration. (Req. 2,400a) (d) basis of qualification (i.e., education, experience, communication skills, training, examination, etc.);

(4) Basis of qualification a) education, experience, indoctrination, and training b) test results, where applicable c) capability demonstration results (Req. 2,400a)

(e) signature of employer's designated representative who is responsible for such certification.

(7) Signature of employer’s designated representative who is responsible for such certification. (Req. 2,400a)


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6.3 Updating of Lead Auditors' Records Records for each Lead Auditor shall be maintained and updated annually.

Based on annual assessment, management may extend the qualification, require retraining, or require requalification.(Req. 2,303.5,2) and Records of qualification, including requalification, for auditors and lead auditors, and for inspection and test personnel shall be established and maintained by the employer and for indoctrination and training. (Req. 2, 500, 2)

304 Auditors Auditors are participants in an audit. Auditors shall have, or be given, appropriate training

or orientation to develop their competence for performing audits.

Competence of personnel for performance of the various auditing functions shall be developed by one or more of the following methods:

(a) orientation to provide a working knowledge and understanding of this Standard and the auditing organization’s procedures for implementing audits and reporting results.

(b) general and specialized training in audit performance where the general training shall include fundamentals, objectives, characteristics, organization, performance, and results of quality auditing and the specialized training shall include methods of examining, questioning, evaluating, and documenting specific audit items and methods of closing out audit findings.

(c) on-the-job training, guidance, and counseling under the direct supervision of a Lead Auditor.

Such training shall include planning, performing, reporting, and follow-up action involved in conducting audits.

305 Technical Specialists The responsible auditing organization shall establish

the qualifications and requirements for use of technical specialists to accomplish the auditing of quality assurance programs.

400 RECORDS OF QUALIFICATION (a) The qualification of inspection, test, and Lead

Auditor personnel shall be certified in writing and


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include the following information: (1) employer’s name (2) identification of person being certified (3) activities certified to perform (4) basis of qualification (a) education, experience, indoctrination, and training (b) test results, where applicable (c) capability demonstration results (5) results of periodic evaluation (6) results of physical examinations, when required (7) signature of employer ís designated representative

who is responsible for such certification

(8) date of certification or recertification and certification expiration

(b) The responsible organization shall identify any special physical characteristics needed in the performance of each activity, including the need for initial and subsequent physical examination.

The employer may delegate qualification examination activities to an independent certifying agency, but shall retain responsibility for conformance of the examination and its administration.

Integrity of the examination shall be maintained by the employer or certifying agency through appropriate confidentiality of files and, where applicable, proctoring of examinations.

Copies of the objective evidence regarding the type(s) and content of the examination(s) shall be retained by the employer in accordance with the requirements of section 500 of this Requirement.

500 RECORDS Records of the implementation for indoctrination and

training may take the form of attendance sheets, training logs, or personnel training records.

Records of indoctrination and training shall include one or more of the following:

(a) attendance sheets (b) training logs (c) personnel training records

The employer shall establish and maintain records for indoctrination and training; Auditor and Lead Auditor


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qualification and requalification; and inspection and test personnel qualification and requalification.

SUPPLEMENT 2S-4 Supplementary Requirements for Personnel Indoctrination and Training

1 GENERAL This Supplement provides amplified requirements for the indoctrination and training of personnel performing or managing activities affecting quality.


2 APPLICABILITY This Supplement applies to personnel performing or managing activities affecting quality.

Personnel to be indoctrinated or trained shall be identified.

“The need for a formal training program for personnel performing or managing activities affecting quality shall be determined.” (Req. 2,202,1)

The extent of indoctrination and training shall be commensurate with the following:

“Indoctrination and training shall be commensurate with scope, complexity, importance of the activities, and the education, experience, and proficiency of the person.” (Req. 2,200)

(a) the scope, complexity, and nature of the activity; and

Note: Included in previous paragraph (Req. 2,200).

(b) the education, experience, and proficiency of the person.


Activities affecting quality include siting, designing, purchasing, fabricating, handling, shipping, receiving, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, modifying, and decommissioning.

Activities affecting quality include siting, designing, procuring, fabricating, handling, shipping, receiving, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, modifying, and decommissioning. (Part 1,Introduction, 200)

3 INDOCTRINATION Personnel shall be indoctrinated in the following subjects as they relate to a

“Personnel performing or managing activities affecting quality shall receive indoctrination in their


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particular function: job responsibilities and authority; general criteria, including applicable codes and standards, regulatory commitments, company procedures, and quality assurance program requirements.” (Req. 2,201)

(a) general criteria, including applicable codes, standards, and company procedures;


(b) applicable quality assurance program elements; and

Note: Included in previous paragraph (Req 2,201).

(c) job responsibilities and authority. Note: Included in previous paragraph (Req 2,201). 4 TRAINING Training shall be provided, if needed, to: “Training shall be provided, if needed, to achieve

initial proficiency, maintain proficiency, and adapt to changes in technology, methods or job responsibilities. (Req. 2,202,2)

(a) achieve initial proficiency; Note: Included in previous paragraph (2,202,2). (b) maintain proficiency; and Note: Included in previous paragraph (2,202,2). (c) adapt to changes in technology, methods, or job responsibilities.

Note: Included in previous paragraph (2,202,2).

5 RECORDS Records of the implementation of indoctrination and training may take the form of:

“Records of the implementation for indoctrination and training may take the form of attendance sheets, training logs, or personnel training records.” (Req. 2,500,1)

(a) attendance sheets; Note: Included in previous paragraph (2,500,1). (b) training logs; or Note: Included in previous paragraph (2,500,1).

(c) personnel training records. Note: Included in previous paragraph (2,500,1).

BASIC REQUIREMENT 3

DESIGN CONTROL REQUIREMENT 3

DESIGN CONTROL

100 BASIC The design shall be defined, controlled, and verified.

The design shall be defined, controlled, and verified.

Applicable design inputs shall be appropriately specified on a timely basis and correctly translated into design documents.

Design inputs shall be specified on a timely basis and translated into design documents.

Design interfaces shall be identified and controlled.

Design interfaces shall be identified and controlled.

Design adequacy shall be verified by persons other than those who designed the item.

Design adequacy shall be verified by individuals other than those who designed the item or computer program.


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Design changes, including field changes, shall be governed by control measures commensurate with those applied to the original design.

Design changes shall be governed by control measures commensurate with those applied to the original design.

SUPPLEMENT 3S-1 SUPPLEMENTARY REQUIREMENTS FOR DESIGN CONTROL

1 GENERAL This Supplement provides amplified requirements for design control.

It supplements the requirements of Basic Requirement 3 of this Part and shall be used in conjunction with that Basic Requirement when and to the extent specified by the organization invoking this Part.

2 DESIGN INPUT 200 DESIGN INPUT Applicable design inputs, such as design bases, performance requirements, regulatory requirements, codes, and standards, shall be identified and documented, and their selection reviewed and approved by the responsible design organization.

Applicable design inputs shall be identified and documented, and their selection reviewed and approved.

Note: A listing of design inputs "the nuclear industry has found desirable to consider…" is included in Appendix 3A-1, 200, Design Input.

The design input shall be specified and approved on a timely basis and to the level of detail necessary to permit the design activity to be carried out in a correct manner and to provide a consistent basis for making design decisions, accomplishing design verification measures, and evaluating design changes.

The design input shall be specified to the level of detail necessary to permit the design activities to be carried out in a correct manner and to provide a consistent basis for making design decisions, accomplishing design verification measures, and evaluating design changes.

Changes to Appendix 3A-1, 200 Design Input Design inputs include many characteristics and functions of an item or system. These inputs vary depending on the application; however, the nuclear industry has found it desirable to consider at least the following listed inputs as they apply to specific items or systems: ( a) basic functions of each structure, system, and component ( b) performance requirements such as capacity, rating, and system output (c) regulatory requirements and commitments or responses to federal, state, and local regulations. For example, these may include, but not be limited to ( 1) safety analysis report ( 2) NRC’s Safety Evaluation Report and supplements thereto


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( 3) environmental report ( 4) NRC’s environmental statement and supplements thereto ( 5) technical specifications ( 6) regulatory guides ( 7) code of federal regulations ( 8) NRC bulletins, circulars, notices, and generic letters

( 9) commitments in correspondence with NRC (d) codes and standards. For example these may include, but not be limited to: (1) ASME Codes and Standards (2) ACI, AISC, ANSI, ASNT, ASTM, AWS, IEEE, ISO, NFPA and others by similar societies or organizations (e) design conditions such as pressure, temperature, flow, fluid chemistry, and voltage

Changes from approved design inputs, including the reason for the changes, shall be identified, approved, documented, and controlled.

"Changes to design inputs, final design, field changes, and temporary and permanent modifications to operating facilities shall be justified and subject to design control measures commensurate with those applied to the original design" ( 3, 600,a,1)

3 DESIGN PROCESS 300 DESIGN PROCESS

The responsible design organization shall prescribe and document the design activities on a timely basis and to the level of detail necessary to permit the design process to be carried out in a correct manner, and to permit verification that the design meets requirements.

(a) The responsible design organization shall pre-scribe and document the design activities to the level of detail necessary to permit the design process to be carried out in a correct manner, and to permit verification that the design meets requirements.

Design documents shall be adequate to support facility design, construction, and operation.

Design documents shall support facility design, construction, and operation. Appropriate quality standards shall be identified and documented, and their selection reviewed and approved.

Appropriate quality standards shall be identified and documented, and their selection reviewed and approved.

2) specify required inspections and tests and include or reference appropriate acceptance criteria; and" (Req. 1,300,c, 2)


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Changes from specified quality standards, including the reasons for the changes, shall be identified, approved, documented, and controlled.

Changes to design inputs, final design, field changes, and temporary and permanent modifications to operating facilities shall be justified and subject to design control measures commensurate with those applied to the original design ( Req. 3, 600,a,1)

Design methods, materials, parts, equipment, and processes that are essential to the function of the structure, system, or component shall be selected and reviewed for suitability of application.

(b) The design methods, materials, parts, equipment, and processes that are essential to the function of the items shall be selected and reviewed for suitability of application.

Applicable information derived from experience, as set forth in reports or other documentation, shall be made available to cognizant design personnel.

Applicable information derived from experience, as set forth in reports or other documentation, shall be made available to cognizant design personnel.

The final design (approved design output documents and approved changes thereto) shall:

(c) The final design shall

(a) be relatable to the design input by documentation in sufficient detail to permit design verification; and

(1) be relatable to the design input by documentation in sufficient detail to permit design verification.

(2) specify required inspections and tests and include or reference appropriate acceptance criteria.

(b) identify assemblies and/or components that are part of the item being designed.

(3) identify assemblies and/or components that are part of the item being designed.

When such an assembly or component part is a commercial grade item that, prior to its installation, is modified or selected by special inspection and/or testing to requirements that are more restrictive than the Supplier’s published product description, the component part shall be represented as different from the commercial grade item in a manner traceable to a documented definition of the difference.

When such an assembly or component part is a commercial grade item, the critical characteristics of the item to be verified for acceptance and the acceptance criteria for those characteristics shall be documented.

If a commercial grade item, prior to its installation, is modified or selected by special inspection and/or testing to requirements that are more restrictive than the Supplier’s published product description, the component part shall be represented as different from the commercial grade item in a manner traceable to a documented definition of the difference. (Req. 3,300,c,3,4)

Critical characteristics to be verified are those that provide reasonable assurance that the item will perform its intended function.

If a commercial grade item, prior to its installation, is modified or selected by special inspection and/or testing to requirements that are more restrictive than


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the Supplier ’s published product description, the component part shall be represented as different from the commercial grade item in a manner traceable to a documented definition of the difference.

3.1 Design Analyses 400 DESIGN ANALYSES Design analyses shall be performed in a planned, controlled, and documented manner.

"Design analyses shall be performed in a planned, controlled, and documented manner". (Part III, 3A-1, 400, 1st sent.)

Design analysis documents shall be legible and in a form suitable for reproduction, filing, and retrieval.

Activities affecting quality and services shall be prescribed by and performed in accordance with documented instructions, procedures, or drawings. (Req. 5, 100, 1) Quality assurance records shall furnish documentary evidence that items or activities meet specified quality requirements.(Req. 17,100,1)

They shall be sufficiently detailed as to purpose, method, assumptions, design input, references, and units such that a person technically qualified in the subject can review and understand the analyses and verify the adequacy of the results without recourse to the originator.

Design analyses shall be sufficiently detailed such that a person technically qualified in the subject can review and understand the analyses and verify the adequacy of the results without recourse to the originator.

Calculations shall be identifiable by subject (including structure, system, or component to which the calculation applies), originator, reviewer, and date; or by other data such that the calculations are retrievable.

Quality assurance records shall furnish documentary evidence that items or activities meet specified quality requirements. (Req.17,100,1) " Records shall be retrievable." (17,800,b) Calculations should be identifiable by subject (including structure, system, or component to which the calculation applies), originator, reviewer, and date; or by other data such that the calculations are retrievable. (Part III, 3A-1, 400, 3rd sent.)


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401 Use of Computer Programs

(a) Computer programs may be utilized for design analysis without individual verification of the program for each application provided:

To the extent required in paras. 401(a) and (b) of this Requirement, computer program acceptability shall be preverified or the results verified with the design analysis for each application.

Preverified computer programs shall be controlled in accordance with the requirements of this Standard.

Note: See (3,802 Software Configuration Management)

(1) the computer program has been verified to show that it produces correct solutions for the encoded mathematical model within defined limits for each parameter employed; and

(a) The computer program shall be verified to show that it produces correct solutions for the encoded mathematical model within defined limits for each parameter employed.

(2) the encoded mathematical model has been shown to produce a valid solution to the physical problem associated with the particular application.

(b) The encoded mathematical model shall be shown to produce a valid solution to the physical problem associated with the particular application.

Computer programs shall be controlled to assure that changes are documented and approved by authorized personnel.


Where changes to previously verified computer programs are made, verification shall be required for the change, including evaluation of the effects of these changes on (1) and (2) above.


402 Documentation of Design Analysis (b) Documentation of design analyses shall include (1) through (6) below:

Documentation of design analyses shall include the following:

(1) definition of the objective of the analyses; (a) the objective of the analyses (2) definition of design inputs and their sources;

( b) design inputs and their sources

(3) results of literature searches or other applicable background data;

(c) results of literature searches or other applicable background data

(4) identification of assumptions and (d) assumptions and indication of those assumptions


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indication of those that must be verified as the design proceeds;

that must be verified as the design proceeds

(5) identification of any computer calculation, including computer type, computer program (e.g., name), revision identification, inputs, outputs, evidence of or reference to computer program verification, and the bases (or reference thereto) supporting application of the computer program to the specific physical problem;

(e) identification of any computer calculation, including identification of the computer type, computer program name, and revision, inputs, outputs, evidence of or reference to computer program verification, and the bases (of reference thereto) supporting application of the computer program to the specific physical problem

(6) review and approval. ( f) review and approval

4 DESIGN VERIFICATION 500 DESIGN VERIFICATION Design control measures shall be applied to verify the adequacy of design, such as by one or more of the following: the performance of design reviews, the use of alternate calculations, or the performance of qualification tests.

Note: See individual paragraphs (3,500) below.

Verification of computer programs shall include appropriate testing.

Computer program testing shall be performed and shall be in accordance with Requirement 11. ( Req.3, 801.5)

The responsible design organization shall identify and document the particular design verification method(s) used.

(a) The responsible design organization shall identifyand document the particular design verification method(s) used.

The results of design verification shall be clearly documented with the identification of the verifier clearly indicated.

The results of design verification shall be documented with the identification of the verifier clearly indicated.

Design verification shall be performed by any competent individual(s) or group(s) other than those who performed the original design but who may be from the same organization.

Design verification shall be performed by any competent individual(s) or group(s) other than those who performed the original design but who may be from the same organization.

This verification may be performed by the originator ís supervisor, provided (1) the supervisor did not specify a singular design approach or rule out certain design considerations and did not establish the design inputs used in the design; or (2) the supervisor is the only individual in the organization competent to perform the verification.


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Cursory supervisory reviews do not satisfy the intent of this Standard.

This verification may be performed by the originator's supervisor, provided the supervisor did not specify a singular design approach or rule out certain design considerations and did not establish the design inputs used in the design or, provided the supervisor is the only individual in the organization competent to perform the verification.

(b) Design verification shall be performed prior to releasing the design for procurement, manufacture, construction, or use by another design organization, except where this timing cannot be met, such as when insufficient data exist.

The purpose of design verification is to provide a confirmatory check of design adequacy by a person(s) competent to have prepared the design being verified but sufficiently independent such that they are not verifying their own work. Accordingly, design verifiers may be a supervisor, a subordinate, or any other individual from inside or outside the organization provided they are competent, they are not verifying their own work, and they have access to the necessary design information. (Part III, 3A-1, 500, 1&2)

Cursory supervisory reviews do not satisfy the intent of this Part.

Verification shall be performed in a timely manner.

Note: See above

Design verification, for the level of design activity accomplished, shall be performed prior to release for procurement, manufacture, construction, or release to another organization for use in other design activities except in those cases where this timing cannot be met, such as when insufficient data exist.

In those cases, the unverified portion of the design shall be identified and controlled.

In those cases, the unverified portion of the design shall be identified and controlled.

In all cases the design verification shall be completed prior to relying upon the component, system, structure, or computer program to perform its function.

In all cases the design verification shall be completed prior to relying upon the component, system, structure, or computer program to perform its function.

(c) If the design is modified to resolve verification findings, the modified design shall be verified prior to release or use.

Note: See 3, 4.2.3, 6th sentence. (1994)

4.1 Extent of Design Verification (d) Extent of Design Verification.

The extent of the design verification required is a function of the importance to safety, the complexity of the design, the degree of

The extent of the design verification shall be a function of the importance to safety, the complexity of the design, the degree of standardization, the state


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standardization, the state of the art, and the similarity with previously proven designs.

of the art, and the similarity with previously proved designs.

Where the design has been subjected to a verification process in accordance with this Part, the verification process need not be duplicated for identical designs.

Where the design has been subjected to a verification process in accordance with this Part (Part I), the verification process need not be duplicated for identical designs.

However, the applicability of standardized or previously proven designs, with respect to meeting pertinent design inputs, shall be verified for each application.

However, the applicability of standardized or previously proven designs, with respect to meeting pertinent design inputs, shall be verified for each application.

Known problems affecting the standard or previously proven designs and their effects on other features shall be considered.

Known problems affecting the standard or previously proved designs and their effects on other features shall be considered.

The original design and associated verification measures shall be adequately documented and referenced in the files of subsequent application of the design.

The original design and associated verification documentation shall be referenced in records of subsequent application of the design.

Where changes to previously verified designs have been made, design verification shall be required for the changes, including evaluation of the effects of those changes on the overall design and on any design analyses upon which the design is based that are affected by the change to previously verified design.

(c) If the design is modified to resolve verification findings, the modified design shall be verified prior to release for use"( Req 3, 500c) and "(a) Changes to design inputs, final design, field changes, and temporary and permanent modifications to operating facilities shall be justified and subject to design control measures commensurate with those applied to the original design. (Req.3, 600a.)

4.2 Methods 501 Methods Acceptable verification methods include, but are not limited to, any one or a combination of the following: design reviews, alternate calculations, and qualification testing.

Acceptable verification methods include, but are not limited to, any one or a combination of the following: (a) design reviews (b) alternate calculations (c) qualification testing

4.2.1 Design Reviews. 501.1 Design Reviews Design reviews shall provide assurance that the final

design is correct and satisfactory by addressing, where applicable, paras. 501.1(a) through (g) of this Requirement.


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These are critical reviews to provide assurance that the final design is correct and satisfactory. Where applicable, (a) through (f) below shall be addressed.

(a) Were the design inputs correctly selected? (a) Were the design inputs correctly selected?

(b) Are assumptions necessary to perform the design activity adequately described and reasonable?

(b) Are assumptions necessary to perform the design activity adequately described and reasonable?

Where necessary, are the assumptions identified for subsequent reverifications when the detailed design activities are completed?

Where necessary, are the assumptions identified for subsequent re-verifications when the detailed design activities are completed?

(c) Was an appropriate design method used? (c) Were appropriate design methods and computer programs used?

(d) Were the design inputs correctly incorporated into the design?

(d) Were the design inputs correctly incorporated into the design?

(e) Is the design output reasonable compared to design inputs?

(e) Is the design output reasonable compared to design inputs?

(f) Are the necessary design input and verification requirements for interfacing organizations specified in the design documents or in supporting procedures or instructions?

(f) Are the necessary design inputs for interfacing organizations specified in the design documents or in supporting procedures or instructions?

(g) Have suitable materials, parts, processes, and inspection and testing criteria been specified?

4.2.2 Alternate Calculations 501.2 Alternate Calculations. These are calculations or analyses that are made with alternate methods to verify correctness of the original calculations or analyses.

Alternate calculations shall use alternate methods to verify correctness of the original calculations or analyses.


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The appropriateness of assumptions, input data used, and the computer program or other calculation method used shall also be reviewed.

The appropriateness of assumptions; input data used; and the computer program, its associated computer hardware and system software, or other calculation method used shall also be reviewed.

4.2.3 Qualification Tests 501.3 Qualification Tests Where design adequacy is to be verified by qualification tests, the tests shall be identified.

(a) Test requirements, and acceptance criteria shall be provided or approved by the responsible design organization. (Req.11,200,a)

The test configuration shall be clearly defined and documented.

(a) Test procedures shall include or reference the test configuration and test objectives. (Req. 11,300,a)

Testing shall demonstrate adequacy of performance under conditions that simulate the most adverse design conditions.

Testing shall demonstrate adequacy of performance under conditions that simulate the most adverse design conditions.

Operating modes and environmental conditions shall be considered in determining the most adverse conditions.

Operating modes and environmental conditions in which the item must perform satisfactorily shall be considered in determining the most adverse conditions.

(f) environmental conditions anticipated during storage, construction, operation, and accident conditions, such as pressure, temperature, humidity, corrosiveness, site elevation, wind direction, exposure to weather, flooding, nuclear radiation, electromagnetic radiation, and duration of exposure; qualification test requirements; shelf or service life limitations; (Part III, 3A-1, 200, f) and "(o) operational requirements under various conditions, such as startup, normal operation, shutdown, maintenance, abnormal or emergency operation, special or infrequent operation including installation of design changes, and the effect of system interaction;" (Part III, 3A-1, 200, o)

Where the test is intended to verify only specific design features, the other features of the design shall be verified by other means.

Where the test is intended to verify only specific design features, the other features of the design shall be verified by other means.

Test results shall be documented and evaluated by the responsible design

Test results shall be documented and evaluated by a responsible authority to assure that test requirements


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organization to assure that test requirements have been met.

have been satisfied. Test results for design qualification test and software design shall be evaluated by the responsible design organization. (Req.11, 500, 1& 2)

If qualification testing indicates that modifications to the item are necessary to obtain acceptable performance, the modification shall be documented and the item modified and retested or otherwise verified to assure satisfactory performance.

If qualification testing indicates that modifications to the item are necessary to obtain acceptable performance, the modification shall be documented and the item modified and retested or otherwise verified to assure satisfactory performance. (Part 111, 3A-1,500, 5th para.)

When tests are being performed on models or mockups, scaling laws shall be established and verified.

When tests are being performed on models or mockups, scaling laws shall be established and verified.

The results of model test work shall be subject to error analysis, where applicable, prior to use in final design work.

The results of model test work shall be subject to error analysis, where applicable, prior to use in the final design.

5 CHANGE CONTROL 600 CHANGE CONTROL

Changes to final designs, field changes, modifications to operating facilities, and nonconforming items dispositioned use-as-is or repair shall be justified and subject to design control measures commensurate with those applied to the original design.

(a) Changes to design inputs, final designs, field changes, and temporary and permanent modifications to operating facilities shall be justified and subject to design control measures commensurate with those applied to the original design.

"Nonconformances to design requirements dispositioned use-as-is or repair shall be subject to design control measures commensurate with those applied to the original design."(Req.15,440, 3)

These measures shall include assurance that the design analyses for the structure, system, or component are still valid.

These measures shall include evaluation of effects of those changes on the overall design and on any analysis upon which the design is based.

Changes shall be approved by the same affected groups or organizations which reviewed and approved the original design documents; except where an organization which originally was responsible for approving a particular design document is no longer responsible, then the Owner or his designee shall designate a new responsible organization which could be the Owner's engineering organization.

Changes shall be approved by the same affected groups or organizations which reviewed and approved the original design documents; except where an organization which originally was responsible for approving a particular design document is no longer responsible, then the Owner or his designee shall designate a new responsible organization which could be the Owner's engineering organization. (Part III, 3A-1, 600, 1)

Deletion to Appendix 3A-1 600 CHANGE CONTROL Changes should be approved by the same affected groups or organizations that reviewed and approved


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the original design documents, except when an organization that was originally responsible for approving a particular design document is no longer responsible. ; then the Owner or its designee should designate a new responsible organization that could be the Owner’s engineering organization.

The evaluation shall include facility configurations that occur during operation, maintenance, test, surveillance, and inspection activities.

Changes shall be approved by the same affected groups or organizations that reviewed and approved the original design documents. When the organization originally responsible for review and approval of the original design documents is no longer responsible, the owner or his designee shall have responsibility or designate a new responsible organization.

The designated organization shall have demonstrated competence in the specific design area of interest and have an adequate understanding of the requirements and intent of the original design.

The design organization approving the change shall have demonstrated competence in the specific design area of interest and have an adequate understanding of the requirements and intent of the original design.

When a design change is approved other than by revision to the affected design documents, measures shall be established to incorporate the change into these documents, where such incorporation is appropriate.

(b) When a design change is approved other than by revision to the affected design documents, measures shall be established to incorporate the change into these documents, where such incorporation is appropriate.

Where a significant design change is necessary because of an incorrect design, the design process and verification procedure shall be reviewed and modified as necessary.

(c) Where a significant design change is necessary because of an incorrect design, the design process and verification procedure shall be reviewed and modified as necessary.

601 Configuration Management of Operating Facilities

Procedures implementing configuration management requirements shall be established and documented at the earliest practical time prior to facility operation.

These procedures shall include the responsibilities and authority of the organizations whose functions affect the configuration of the facility including activities such as operations, design, maintenance, construction, licensing, and procurement.


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601.1 Configuration management requirements shall include measures to ensure changes that may affect the approved configuration are recognized and processed.

601.2 The configuration shall be established and approved at the earliest practical time prior to initial operation of the facility, and maintained for the life of the facility.

601.3 The configuration shall include, as applicable, characteristics derived from regulatory requirements and commitments, calculations and analyses, design inputs, installation and test requirements, supplier manuals and instructions, operating and maintenance requirements, and other applicable sources.

601.4 Interface controls shall include the integration of activities of organizations that can affect the approved configuration.

601.5 Documentation shall identify the design bases and the approved configuration for the approved modes of operation.

601.6 Measures shall be established and implemented to ensure that proposed changes to the configuration are evaluated for their conformance to the design bases.

601.7 The implementation sequence for approved configuration changes shall be reviewed to determine that the configuration conforms to the design bases.

601.8 Approval by the design authority shall be required prior to implementation of a change to the design bases.

601.9 The configuration of the facility shall be documented in drawings, specifications, procedures, and other documents that reflect the operational status of the facility.


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The process used to control the current revision and issuance of these documents shall take into account the use of the document and the need for revision in support of operation.

6 INTERFACE CONTROL 700 INTERFACE CONTROL Design interfaces shall be identified and controlled and the design efforts shall be coordinated among the participating organizations.

Design information transmitted across interfaces shall identify the status of the design information or document provided and identify incomplete items which require further evaluation, review, or approval (REQ.3,700,1)

Interface controls shall include the assignment of responsibility and the establishment of procedures among participating design organizations for the review, approval, release, distribution, and revision of documents involving design interfaces.

Interface controls shall include assignment of responsibility and establishment of procedures among participating design organizations for review, approval, release, distribution, and revision of documents involving design interfaces.

"The documentation of the assignment of design responsibilities may be accomplished in procedures, internal or external correspondence, contracts or other suitable documents."(Part III, 3A-1, 700, 4)

Design information transmitted across interfaces shall be documented and controlled.

Design information transmitted across interfaces shall identify the status of the design information or document provided, and identify incomplete items that require further evaluation, review, or approval.

Transmittals shall identify the status of the design information or document provided and, where necessary, identify incomplete items which require further evaluation, review, or approval

"Design information transmitted across interfaces shall identify the status of the design information or document provided and identify incomplete items which require further evaluation, review, or approval" (3,700,1)

Where it is necessary to initially transmit design information orally or by other informal means, the transmittal shall be confirmed promptly by a controlled document.

Where it is necessary to initially transmit design information orally or by other informal means, the transmittal shall be confirmed promptly by a controlled document.

800 SOFTWARE DESIGN CONTROL The requirements of section 800 apply to computer

software design control and shall be used instead of section 200, Design Input; section 300, Design Process; section 500, Design Verification; and section 600, Change Control. Part II, Subpart 2.7, Quality Assurance Requirements for Computer Software for Nuclear Facility Applications, provides work practice requirements to implement the requirements of this paragraph.1


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1 Regulatory Guides 1.152, Criteria for Use of Computers in Safety Systems of Nuclear Power Plants, and 1.168, Verification, Validation, Reviews, and Audits for Digital Computer Software Used in Safety Systems of Nuclear Power Plants, provide guidance for nuclear power plant licensees and their suppliers on acceptable methods and techniques.

801 Software Design Process The software design process shall be documented,

approved by the responsible design organization, and controlled.

This process shall include the activities described in paras. 801.1 through 801.5 of this Requirement.

801.1 Identification of Software Design Requirements.

Software design requirements shall be identified and documented and their selection reviewed and approved.

The software requirements shall identify the operating system, function, interfaces, performance requirements, installation considerations, design inputs, and any design constraints of the computer program.

801.2 Software Design The software design shall be documented and shall

define the computational sequence necessary to meet the software requirements.

The documentation shall include, as applicable, numerical methods, mathematical models, physical models, control flow, control logic, data flow, process flow, data structures, process structures, and the applicable relationships between data structures and process structures.

This documentation may be combined with the documentation of the software design requirements, or the computer program listings resulting from implementation of the software design.

801.3 Implementation of the Software Design The software design shall be translated into computer

program(s) using the programming organization’s or design organization’s programming standards and


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conventions. Organization ís programming standards and conventions.

801.4 Software Design Verification Software design verification shall be performed by a

competent individual( s) or group(s) other than those who developed and documented the original design, but who may be from the same organization.

This verification may be performed by the originator’s supervisor, provided

(a) the supervisor did not specify a singular design approach or rule out certain design considerations and did not establish the design inputs used in the design, or

(b) the supervisor is the only individual in the organization competent to perform the verification.

Cursory supervisory reviews do not satisfy the intent of this Standard.

The results of verification shall be documented with the identification of the verifier indicated.

Software verification methods shall include any one or a combination of design reviews, alternate calculations, and tests performed during computer program development.

The extent of verification and the methods chosen are a function of the complexity of the software, the degree of standardization, the similarity with previously proved software, and the importance to safety.

801.5 Computer Program Testing. Computer program testing shall be performed and

shall be in accordance with Requirement 11.

802 Software Configuration Management Software configuration management includes, but is

not limited to configuration identification, change control, and status control.

Configuration items shall be maintained under configuration management until the software is retired.

802.1 Configuration Identification A software baseline shall be established at the

completion of each activity of the software design process.


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Approved changes created subsequent to a baseline shall be added to the baseline.

A baseline shall define the most recently approved software configuration.

A labeling system for configuration items shall be implemented that

(a) uniquely identifies each configuration item (b) identifies changes to configuration items by

revision

(c) provides the ability to uniquely identify each configuration of the revised software available for use

802.2 Configuration Change Control Changes to software shall be formally documented. The documentation shall include (a) a description of the change (b) the rationale for the change (c) the identification of affected software baselines The change shall be formally evaluated and approved

by the organization responsible for the original design, unless an alternate organization has been given the authority to approve the changes.

Only authorized changes shall be made to software baselines.

Appropriate verification activities shall be performed for the change.

The change shall be appropriately reflected in documentation, and traceability of the change to the software design requirement shall be maintained.

Appropriate acceptance testing shall be performed for the change.

802.3 Configuration Status Control The status of con-figuration items resulting from

software design shall be maintained current.

Configuration item changes shall be controlled until they are incorporated into the approved product baseline.

The controls shall include a process for maintaining the status of changes that are proposed and approved, but not implemented.

The controls shall also provide for notification of this information to affected organizations.


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7 DOCUMENTATION AND RECORDS 900 DOCUMENTATION AND RECORDS Design documentation and records, which provide evidence that the design and design verification processes were performed in accordance with the requirements of this Part (Part 1), shall be collected, stored, and maintained in accordance with documented procedures.

Activities affecting quality and services shall be prescribed by and performed in accordance with documented instructions, procedures, or drawings. (5,100, 1) Quality assurance records shall furnish documentary evidence that items or activities meet specified quality requirements. (17,100,1)

The documentation shall include not only final design documents, such as drawings and specifications, and revisions thereto but also documentation which identifies the important steps, including sources of design inputs that support the final design.

Design documentation and records shall include not only final design documents, such as drawings and specifications, and revisions to those documents, but also documentation that identifies the important steps in the design process, including sources of design inputs that support the final design.

BASIC REQUIREMENT 4 PROCUREMENT DOCUMENT

CONTROL

REQUIREMENT 4 PROCUREMENT DOCUMENT CONTROL

100 BASIC Applicable design bases and other requirements necessary to assure adequate quality shall be included or referenced in documents for procurement of items and services.

Applicable design bases and other requirements necessary to assure adequate quality shall be included or referenced in documents for procurement of items and services.

To the extent necessary, procurement documents shall require Suppliers to have a quality assurance program consistent with the applicable requirements of this Part (Part1).

To the extent necessary, procurement documents shall require Suppliers to have a quality assurance program consistent with the applicable requirements of this Standard.

SUPPLEMENT 4S-1 SUPPLEMENTARY REQUIREMENTS FOR PROCUREMENT DOCUMENT CONTROL

1 GENERAL

This Supplement provides amplified requirements for procurement document control.

It supplements the requirements of Basic Requirement 4 of this Part (Part1) and shall be


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used in conjunction with that Basic Requirement when and to the extent specified by the organization invoking this Part (Part1). 2 CONTENT OF THE PROCUREMENT DOCUMENTS

200 CONTENT OF THE PROCUREMENT DOCUMENTS

Procurement documents issued at all tiers of procurement shall include provisions for the following, as deemed necessary by the Purchaser.

Procurement documents issued at all tiers of procurement shall include provisions for the following, as deemed necessary by the Purchaser.

2.1 Scope of Work 201 Scope of Work A statement of the scope of the work to be performed by the Supplier shall be in the procurement documents.

Procurement documents shall include a statement of the scope of the work to be performed by the Supplier.

2.2 Technical Requirements 202 Technical Requirements Technical requirements shall be specified in the procurement documents.

Technical requirements shall be specified in the procurement documents.

Where necessary, these requirements shall be specified by reference to specific drawings, specifications, codes, standards, regulations, procedures, or instructions, including revisions thereto that describe the items or services to be furnished.

These requirements shall be speci-fied, as appropriate by reference to specific drawings, specifications, codes, standards, regulations, procedures, or instructions, including revisions thereto that describe the items or services to be furnished.

The procurement documents shall provide for identification of test, inspection, and acceptance requirements of the Purchaser for monitoring and evaluating the Supplier’s performance.

The procurement documents shall identify appropriate test, inspection, and acceptance criteria for determining acceptability of the item or service.

2.3 Quality Assurance Program Requirements

203 Quality Assurance Program Requirements

Procurement documents shall require that the Supplier have a documented quality assurance program that implements portions or all of the requirements of this Part (Part1).

Quality assurance program requirements shall be specified in the procurement documents.

The extent of the program required shall depend upon the type and use of the item or service being procured.

These requirements shall be consistent with importance and/ or complexity of the item or service being procured.

The procurement documents shall require the Supplier to incorporate appropriate quality assurance program requirements in subtier procurement documents.

The procurement documents shall require the Supplier to incorporate appropriate quality assurance program requirements in subtier procurement documents.


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2.4 Right of Access 204 Right of Access At each tier of a procurement, the procurement documents shall provide for access to the Supplier's plant facilities and records for inspection or audit by the Purchaser, his designated representative, and/or other parties authorized by the Purchaser.

The procurement documents shall provide for access to the Supplier‘s and subtier Supplier’s facilities and records for surveillance, inspection, or audit by the Purchaser, its designated representative, and others authorized by the Purchaser.

2.5 Documentation Requirements 205 Documentation Requirements The procurement documents at all tiers shall identify the documentation required to be submitted for information, review, or approval by the Purchaser.

The procurement documents shall identify the documentation required to be submitted for information, review, or approval by the Purchaser.

The time of submittal shall also be established.

The time of submittal shall also be established.

When the Purchaser requires the Supplier to maintain specific quality assurance records, the retention times and disposition requirements shall be prescribed.

When the Purchaser requires the Supplier to maintain specific records, the retention times and disposition requirements shall be prescribed.

2.6 Nonconformances 206 Nonconformances The procurement documents shall include Purchaser's requirements for reporting and approving disposition of nonconformances.

The procurement documents shall specify the Purchaser’s requirements for the Supplier’s reporting of nonconformances.

Note: (b) submittal of nonconformance notice to Purchaser by Supplier as directed by the Purchaser. (7,600b,1) and These submittals shall include Supplier-recommended disposition (e.g., use-as-is or repair) and technical justification. (7,600b,2)

2.7 Spare and Replacement Parts 207 Spare and Replacement Parts The procurement documents shall require the identification of appropriate spare and replacement parts or assemblies and the appropriate delineation of the technical and quality assurance related data required for ordering these parts or assemblies.

The procurement documents shall specify the Supplier’s requirements to identify spare and replacement parts or assemblies and the related data required for ordering these parts or assemblies.

3 PROCUREMENT DOCUMENT REVIEW

300 Procurement Document Review

A review of the procurement documents and changes thereto shall be made to assure that documents transmitted to the prospective Supplier(s) include appropriate provisions to assure that items or services will meet the specified requirements.

A review of the procurement documents, and changes thereto, shall be made and documented prior to award to assure that documents transmitted to prospective Supplier(s) include appropriate provisions to assure that items or services will meet the specified requirements.


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Reviews shall be performed and documented to provide objective evidence of satisfactory accomplishment of such review prior to contract award.

Note: Included in the above paragraph. (4, 300, 1)

Changes made as a result of the bid evaluations or precontract negotiations shall be incorporated into the procurement documents.

Technical or quality assurance program changes made as a result of bid evaluations or negotiations shall be incorporated into the procurement documents prior to their issuance to the Supplier.

The review of such changes and their effects shall be completed prior to contract award.

Note: Included in the above paragraph (4, 300, 2) and the following paragraph in Part III.

This review shall include the following considerations:

Prior to contract award, reviews of changes made resulting from bid evaluations or negotiations should include consideration of the following: (PIII,4A-1,200,2)

(a) appropriate requirements specified in Section 2 of this Supplement;

(a) applicable provisions described in Part I, Requirement 4, para. 200 (PIII,4A-1,200,2a)

(b) determination of any additional or modified design criteria,

(b) determination of any additional or modified design criteria (PIII,4A-1,200,2b)

(c) analysis of exceptions or changes requested or specified by the Supplier and determination of the effects such changes may have on the intent of the procurement documents or quality of the item or service to be furnished.

(c) analysis of exceptions or changes requested or as specified by the bidder and determination of the effects such changes may have on the intent of the procurement documents or quality of the item or service to be furnished. (PIII,4A-1,200,2c)

Reviews required by this Section shall be performed by personnel who have access to pertinent information and who have an adequate understanding of the requirements and intent of the procurement documents.

Procurement document review shall be performed by personnel who have access to pertinent information and who have an adequate understanding of the requirements and intent of the procurement documents.

4 PROCUREMENT DOCUMENT CHANGES

400 PROCUREMENT DOCUMENT CHANGES

Procurement document changes shall be subject to the same degree of control as utilized in the preparation of the original documents.

Procurement document changes affecting the technical or quality assurance program requirements shall be subject to the same degree of control as utilized in the preparation of the original documents.


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BASIC REQUIREMENT 5 INSTRUCTIONS, PROCEDURES, AND

DRAWINGS

REQUIREMENT 5 INSTRUCTIONS, PROCEDURES, AND

DRAWINGS

100 BASIC Activities affecting quality shall be prescribed by and performed in accordance with documented instructions, procedures, or drawings of a type appropriate to the circumstances.

Activities affecting quality and services shall be prescribed by and performed in accordance with documented instructions, procedures, or drawings that include or reference appropriate quantitative or qualitative acceptance criteria for determining that prescribed activities have been satisfactorily accomplished.

These documents shall include or reference appropriate quantitative or qualitative acceptance criteria for determining that prescribed activities have been satisfactorily accomplished.

The activity shall be described to a level of detail commensurate with the complexity of the activity and the need to assure consistent and acceptable results.

The need for, and level of detail in, written procedures or instructions shall be determined based upon complexity of the task, the significance of the item or activity, work environment, and worker proficiency and capability (education, training, experience).

BASIC REQUIREMENT 6 DOCUMENT CONTROL

REQUIREMENT 6 DOCUMENT CONTROL

100 BASIC The preparation, issue, and change of documents that specify quality requirements or prescribe activities affecting quality shall be controlled to assure that correct documents are being employed.

The preparation, issue, and change of documents that specify quality requirements or prescribe activities affecting quality such as instructions, procedures, and drawings shall be controlled to ensure that correct documents are being employed.

Such documents, including changes thereto, shall be reviewed for adequacy and approved for release by authorized personnel.

Such documents, including changes thereto, shall be reviewed for adequacy and approved for release by authorized personnel.

SUPPLEMENT 6S-1 Supplementary Requirements For Document Control


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1 GENERAL This Supplement provides amplified requirements for a document control system.


The documents which shall be controlled in accordance with this Supplement are only those documents which specify quality requirements or prescribe activities affecting quality such as instructions, procedures, and drawings.

The term document control used throughout this Supplement is defined as the act of assuring that documents are reviewed for adequacy, approved for release by authorized personnel, and distributed to and used at the location where the prescribed activity is performed.

2 DOCUMENT PREPARATION, REVIEW, APPROVAL, AND ISSUANCE

200 DOCUMENT CONTROL

The control system shall be documented and shall provide for (a) through (c) below:

The following controls shall be applied to documents and changes thereto:

(a) identification of documents to be controlled and their specified distribution;

(a) the identification of controlled documents

(b) the specified distribution of controlled documents for use at the appropriate location

(b) identification of assignment of responsibility for preparing, reviewing, approving, and issuing documents;

(c) the identification of individuals responsible for the preparation, review, approval, and distribution of con-trolled documents

(c) review of documents for adequacy, completeness, and correctness prior to approval and issuance.

( d) the review of controlled documents for complete-ness, and approval prior to distribution

(e) a method to ensure the correct documents are being used

3 DOCUMENT CHANGES 300 DOCUMENT CHANGES 3.1 Major Changes 301 Major Changes Changes to documents, other than those Changes to documents, other than those defined as


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defined as minor changes in para. 3.2 below, are considered as major changes and shall be reviewed and approved by the same organizations that performed the original review and approval unless other organizations are specifically designated.

minor changes, are considered major changes and shall be reviewed and approved by the same organizations that performed the original review and approval unless other organizations are specifically designated.

The reviewing organization shall have access to pertinent background data or information upon which to base their approval.

The reviewing organization shall have access to pertinent background data or information upon which to base their approval.

3.2 Minor Changes 302 Minor Changes Minor changes to documents, such as inconsequential editorial corrections, shall not require that the revised documents receive the same review and approval as the original documents.

Minor changes to documents, such as inconsequential editorial corrections, shall not require that the revised documents receive the same review and approval as the original documents.

To avoid a possible omission of a required review, the type of minor changes that do not require such a review and approval and the persons who can authorize such a decision shall be clearly delineated.

To avoid a possible omission of a required review, the type of minor changes that do not require such a review and approval and the persons who can authorize such a decision shall be clearly delineated.

BASIC REQUIREMENT 7 CONTROL OF PURCHASED ITEMS AND SERVICES

REQUIREMENT 7 CONTROL OF PURCHASED ITEMS AND

SERVICES

100 BASIC The procurement of items and services shall be controlled to assure conformance with specified requirements.

The procurement of items and services shall be controlled to ensure conformance with specified requirements.

Such control shall provide for the following as appropriate: source evaluation and selection, evaluation of objective evidence of quality furnished by the Supplier, source inspection, audit, and examination of items or services upon delivery or completion.

Such control shall provide for the following as appropriate: source evaluation and selection, evaluation of objective evidence of quality furnished by the Supplier, source inspection, audit, and examination of items or services upon delivery or completion.

SUPPLEMENT 7S SUPPLEMENTARY REQUIREMENTS FOR CONTROL OF PURCHASED ITEMS AND SERVICES

1 GENERAL

This Supplement provides amplified


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requirements for control of purchased items and services.

It supplements the requirements of Basic Requirement 7 of this Part (Part 1) and shall be used in conjunction with that Basic Requirement when and to the extent specified by the organization invoking this Part (Part 1).

This Supplement includes requirements for source selection, bid evaluation, Supplier performance evaluation, and verification of conformance.

2 PROCUREMENT PLANNING

200 Procurement Planning (Part III,7A-1)

Procurement activities shall be planned and documented to assure a systematic approach to the procurement process.

Procurement activities should be planned and documented to assure a systematic approach to the procurement process. (…,200,1,1)

Procurement planning shall result in the documented identification of procurement methods and organizational responsibilities.

Procurement planning should result in the documented identification of procurement methods and organizational responsibilities. (…,200,1,2)

Planning shall determine the following: Planning should consider the following: (…,200,2) (a) what is to be accomplished; what is to be accomplished; (…,200,2) (b) who is to accomplish it; who is to accomplish it; (…,200,2) (c) how it is to be accomplished; how it is to be accomplished; (…,200,2) (d) when it is to be accomplished. when it is to be accomplished. (…,200,2) Planning shall be accomplished as early as practicable, and no later than at the start of those procurement activities which are required to be controlled, to assure interface compatibility and a uniform approach to the procurement process.

Planning should be accomplished as early as practicable, and no later than at the start of those procurement activities which are required to be controlled, to assure interface compatibility and a uniform approach to the procurement process. (…,200,3)

Planning shall result in the documented identification of methods to be used in procurement activities, sequence of actions and milestones indicating the completion of these activities, and the preparation of applicable procedures prior to the initiation of each individual activity listed below.

Planning should result in the document identification of methods to be used in procurement activities, sequence of actions and milestones indicating the completion of these activities, and the preparation of applicable procedures prior to the initiation of each individual activity below. (…200,3)

Planning shall provide for the integration of (a) through (i) below:

Planning would provide for the integration of (a) through (i) below: (200,3)

(a) procurement document preparation, (a) procurement document preparation, review, and


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review, and change control; change control; (b) selection of procurement sources; (b) selection of procurement sources; (c) bid evaluation and award; (c) bid evaluation and award; (d) Purchaser control of Supplier performance; (d) Purchaser control of supplier performance; (e) verification (surveillance, inspection, or audit) activities by Purchaser, including notification for hold and witness points;

(e) verification (surveillance, inspection, or audit) activities by Purchaser, including notification for hold and witness points;

(f) control of nonconformances; (f) control of nonconformances; (g) corrective action; (g) corrective action; (h) acceptance of item or service; (h) acceptance of item or service (i) quality assurance records. (i) quality assurance records. 3 SUPPLIER SELECTION 200 SUPPLIER EVALUATION AND

SELECTION

3.1 Source Evaluation and Selection The selection of Suppliers shall be based on evaluation of their capability to provide items or services in accordance with the requirements of the procurement documents prior to award of contract.

Prior to award of a contract, the Purchaser shall evaluate the Supplier’s capability to provide items or services in accordance with the requirements of the procurement documents.

Procurement source evaluation and selection measures shall be implemented by the Purchaser and shall provide for identification of the Purchaser's organizational responsibilities for determining Supplier capability.

Where the evaluation involves more than one organization of the Purchaser, it is desirable to develop interface descriptions and sufficient program procedures to control the evaluations and define responsibilities. (PIII,7A-1,300,1,2)

Measures for evaluation and selection of procurement sources, and the results therefrom, shall be documented and shall include one or more of (a) through (c) below:

Supplier evaluation and selection and the results therefrom shall be documented and shall include one or more of the following:

(a) evaluation of the Supplier's history of providing an identical or similar product which performs satisfactorily in actual use. The Supplier's history shall reflect current capability.

(a) Supplier’s history of providing an identical or similar product that performs satisfactorily in actual use. The Supplier’s history shall reflect current capability.

(b) Supplier's current quality records supported by documented qualitative and quantitative information which can be objectively evaluated;

(b) Supplier’s current quality records supported by documented qualitative and quantitative information that can be objectively evaluated.

(c) Supplier's technical and quality capability as determined by a direct evaluation of his

(c) Supplier’s technical and quality capability as determined by a direct evaluation of the facilities,


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facilities and personnel and the implementation of his quality assurance program.

personnel, and the implementation of the Supplier’s quality assurance program.

4 BID EVALUATION 300 BID EVALUATION Bid evaluation shall determine the extent of conformance to the procurement documents.

If bids are solicited, the bid evaluation shall include a determination of the Supplier’s capability to conform to the technical and quality assurance requirements.

This evaluation shall be performed by individuals or organizations designated to evaluate the following subjects, as applicable to the type of procurement:

(a) technical considerations (b) quality assurance requirements (c) Supplier's personnel

The bid evaluation should consider the following performance and schedule considerations that have the potential to affect the procurement quality: (a) Supplier’s personnel (PIII,7A-1,400)

(d) Supplier's production capability (b) Supplier’s production capability (PIII,7A-1,400)

(e) Supplier's past performance (c) Supplier’s past performance (PIII,7A-1,400) (f) alternates (d) Supplier’s alternates and exceptions (PIII,7A-

1,400) (g) exceptions. See (d) above. Prior to the award of the contract, the Purchaser shall resolve or obtain commitments to resolve unacceptable quality conditions resulting from the bid evaluation.

Prior to the award of the contract, the Purchaser shall resolve or obtain commitments to resolve unacceptable technical and quality assurance conditions resulting from the bid evaluation.

5 SUPPLIER PERFORMANCE EVALUATION

600 SUPPLIER PERFORMANCE EVALUATION (Part III,7A-1)

The Purchaser of items and services shall establish measures to interface with the Supplier and to verify Supplier's performance as deemed necessary by the Purchaser.

The Purchaser of items and services should establish measures to interface with the Supplier and to verify. Supplier’s performance as deemed necessary by the Purchaser. (PIII,7A-1,600,1)

The measures shall include (a) through (f) below:

The measures may include paras. 600(a) through (f) of this Appendix: (PIII,7A-1,600,2)

(a) establishing an understanding between Purchaser and Supplier of the provisions and specifications of the procurement documents;

(a) establishing an understanding between Purchaser and Supplier of the provisions and specifications of the procurement documents;

(b) requiring the Supplier to identify planning techniques and processes to be utilized in

(b) requiring the Supplier to identify planning techniques and processes to be utilized in fulfilling


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fulfilling procurement document requirements;

procurement document requirements;

(c) reviewing Supplier documents which are generated or processed during activities fulfilling procurement requirements;

(c) reviewing Supplier documents which are generated or processed during activities fulfilling procurement requirements;

(d) identifying and processing necessary change information;

(d) identifying and processing necessary change information;

(e) establishing method of document information exchange between Purchaser and Supplier;

(e) establishing method of document information exchange between Purchaser and Supplier;

(f) establishing the extent of source surveillance and inspection activities.

(f) establishing the extent of source surveillance and inspection activities.

These verification activities shall be conducted as early as practicable.

These verification activities should be conducted as early as practicable.

The Purchaser's verification activities, however, shall not relieve the Supplier of his responsibilities for verification of quality achievement.

The Purchaser’s verification activities, however, are not intended to relieve the Supplier of the responsibility of verification of quality achievement.

5.1 Extent of Activities 601 Extent of Activities (PIII, 7A-1) The extent of verification activities, including planning, shall be a function of the relative importance, complexity, and quantity of the item or services procured and the Supplier's quality performance.

The extent of verification activities, including planning, should be a function of the relative importance, complexity, and quantity of the item or services procured and the Supplier’s quality performance. (PIII,7A-1,601,1)

Verification activities shall be accomplished by qualified personnel assigned to check, inspect, audit, or witness the activities of Suppliers.

Verification activities should be accomplished by qualified personnel assigned to check, inspect, audit, or witness the activities of Suppliers. (PIII,7A-1,601,2) Note:These requirements were not dropped but are included in other Requirements as noted. The program shall provide for indoctrination, training, and qualification as necessary, of personnel performing or managing activities affecting quality to assure that suitable proficiency is achieved and maintained. (2, 100b, 1) Inspection for acceptance shall be performed by qualified persons other than those who performed or directly supervised the work being inspected. (10, 100, 4)


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5.2 Records Wording does not constitute a requirement 602 Records (PIII, 7A-1)

Activities performed to verify conformance to requirements of procurement documents shall be recorded.

Activities performed to verify conformance to requirements of procurement documents shall be recorded. (PIII,7A-1,602,1)

Source surveillances and inspections, audits, receiving inspections, nonconformances, dispositions, waivers, and corrective actions shall be documented.

Source surveillances and inspections, audits, receiving inspections, nonconformances, dispositions, waivers, and corrective actions should be documented. (PIII,7A-1,602,2)

The Purchaser shall assure that his documentation is evaluated to determine the Supplier's quality assurance program effectiveness.

The Purchaser should assure that Supplier documentation is evaluated to determine the Supplier’s quality assurance program effectiveness. (PIII,7A-1,602,3) Note: Documentation requirements are contained in other Requirements.

6 CONTROL OF SUPPLIER GENERATED DOCUMENTS

400 CONTROL OF SUPPLIER-GENERATED DOCUMENTS

Supplier generated documents shall be controlled, handled, and approved in accordance with established methods.

Controls shall be implemented to ensure that the submittal and evaluation of Supplier-generated documents and changes are accomplished in accordance with the procurement document requirements.

Means shall be implemented to assure that the submittal of these documents is accomplished in accordance with the procurement document requirements.

Note: Included in (Req 7,400,1)

These measures shall provide for the acquisition, processing, and recorded evaluation of technical, inspection, and test data against acceptance criteria.

These controls shall provide for the acquisition, processing, and recorded evaluation of the quality assurance, technical, inspection, and test documentation or data against acceptance criteria.

7 CONTROL OF CHANGES IN ITEMS OR SERVICES

The Purchaser and Supplier shall assure that measures to control changes in procurement documents are established, implemented, and documented and are in accordance with this Part (Part 1).

Procurement document changes affecting the technical or quality assurance program requirements shall be subject to the same degree of control as utilized in the preparation of the original documents. (Req 4, 400, 1)


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8 ACCEPTANCE OF ITEM OR SERVICE 500 ACCEPTANCE OF ITEM OR SERVICE 8.1 General 501 General Methods shall be established for the acceptance of an item or service being furnished by the Supplier.

Prior to offering the item or service for acceptance, the Supplier shall verify that the item or service being furnished complies with the procurement requirements.

Prior to offering the item or service for acceptance, the Supplier shall verify that the item or service being furnished complies with the procurement requirements.

The extent of the verification activities by the Purchaser shall be a function of the relative importance, complexity, and quantity of the item or services procured and the Supplier’s quality performance.

Where required by code, regulation, or contract requirement, documentary evidence that items conform to procurement documents shall be available at the nuclear facility site prior to installation or use.

Where required by code, regulation, or contract requirement, documentary evidence that items conform to procurement requirements shall be available at the nuclear facility site prior to installation or use.

8.2 Methods of Acceptance 502 Methods of Acceptance Purchaser methods used to accept an item or related service from a Supplier shall be supplier Certificate of Conformance, source verification, receiving inspection, or post-installation test at the nuclear facility site, or a combination thereof.

Purchaser methods used to accept an item or service from a Supplier shall be a Supplier Certificate of Conformance, source verification, receiving inspection, or post-installation test at the nuclear facility site, or a combination of these methods.

8.2.1 Certificate of Conformance 503 Certificate of Conformance When a Certificate of Conformance is used, the minimum criteria of (a) through (f) below shall be met.

When a Certificate of Conformance is used, the mini-mum criteria of paras. 503( a) through ( f) of this Requirement shall be met.

(a) The certificate shall identify the purchased material or equipment, such as by the purchase order number.

(a) The certificate shall identify the purchased material or equipment, such as by the purchase order number.

(b) The certificate shall identify the specific procurement requirements met by the purchased material or equipment, such as codes, standards, and other specifications.

(b) The certificate shall identify the specific procure-ment requirements met by the purchased material or equipment, such as codes, standards, and other specifications.


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This may be accomplished by including a list of the specific requirements or by providing, on-site, a copy of the purchase order and the procurement specifications or drawings, together with a suitable certificate.

This may be accomplished by including a list of the specific requirements or by providing, on-site, a copy of the purchase order and the procurement specifications or drawings, together with a suitable certificate.

The procurement requirements identified shall include any approved changes, waivers, or deviations applicable to the subject material or equipment.

The procurement requirements identified shall include any approved changes, waivers, or deviations applicable to the subject material or equipment.

(c) The certificate shall identify any procurement requirements that have not been met, together with an explanation and the means for resolving the nonconformances.

(c) The certificate shall identify any procurement requirements that have not been met, together with an explanation and the means for resolving the nonconformances.

(d) The certificate shall be signed or otherwise authenticated by a person who is responsible for this quality assurance function and whose function and position are described in the Purchaser's or Supplier's quality assurance program.

(d) The certificate shall be signed or otherwise authenticated by a person who is responsible for this quality assurance function and whose function and position are described in the Purchaser’s or Supplier’s quality assurance program.

(e) The certification system, including the procedures to be followed in filling out a certificate and the administrative procedures for review and approval of the certificates, shall be described in the Purchaser's or Supplier's quality assurance program.

(e) The certification system, including the procedures to be followed in filling out a certificate and the administrative procedures for review and approval of the certificates, shall be described in the Purchaser’s or Supplier’s quality assurance program.

(f) Means shall be provided to verify the validity of Supplier certificates and the effectiveness of the certification system, such as during the performance of audits of the Supplier or independent inspection or test of the items.

(f) Means shall be provided to verify the validity of Supplier certificates and the effectiveness of the certification system, such as during the performance of audits of the Supplier or independent inspection or test of the items.

Such verification shall be conducted by the Purchaser at intervals commensurate with the Supplier's past quality performance.

Such verification shall be conducted by the Purchaser at intervals commensurate with the Supplier’s past quality performance.

8.2.2 Source Verification 504 Source Verification When source verification is used, it shall be performed at intervals consistent with the importance and complexity of the item or service, and it shall be implemented to monitor, witness, or observe activities.

When source verification is used, it shall be performed at intervals consistent with the importance and complexity of the item or service, and shall include monitoring, witnessing, or observing selected activities.

Change to Appendix 7A-1 600 SUPPLIER PERFORMANCE EVALUATION 601 Extent of Activities The extent of verification activities, including


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planning, should be a function of the relative importance, complexity, and quantity of the item or services procured and the Supplier’s quality performance. Verification activities should be accomplished by qualified personnel assigned to check, inspect, audit, or witness the activities of Suppliers. 601 Extent of Activities The extent of verification activities, including planning, should be a function of the relative importance, complexity, and quantity of the item or services procured and the Supplier’s quality performance. Verification activities should be accomplished by qualified personnel assigned to check, inspect, audit, or witness the activities of Suppliers. 602 Records Activities performed to verify conformance to requirements of procurement documents shall be recorded. Source surveillances and inspections, audits, receiving inspections, nonconformances, dispositions, waivers, and corrective actions should be documented. The Purchaser should ensure that Supplier documentation is evaluated to determine the Supplier’s quality assurance program effectiveness.

Source verification shall be implemented in accordance with plans to perform inspections, examinations, or tests at predetermined points.

Source verification shall be implemented in accordance with plans to perform inspections, examinations, or tests at predetermined points.

Upon Purchaser acceptance of source verification, documented evidence of acceptance shall be furnished to the receiving destination of the item, to the Purchaser, and to the Supplier.

Upon Purchaser acceptance of source verification, documented evidence of acceptance shall be furnished to the receiving destination of the item, to the Purchaser, and to the Supplier.


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8.2.3 Receiving Inspection 505 Receiving Inspection When receiving inspection is used, purchased items shall be inspected as necessary to verify conformance to specified requirements, taking into account source verification and audit activities and the demonstrated quality performance of the Supplier.

When receiving inspection is used, purchased items shall be inspected as necessary to verify conformance to specified requirements, taking into account source verification and audit activities and the demonstrated quality performance of the Supplier.

Receiving inspection shall be performed in accordance with established procedures and inspection instructions, to verify by objective evidence such features as proper configuration; identification; dimensional, physical, and other characteristics; freedom from shipping damage; and cleanness.

Receiving inspection shall verify by objective evidence such features as:

(a) configuration (b) identification (c) dimensional, physical, and other characteristics (d) freedom from shipping damage ( e) cleanliness Receiving inspection shall be coordinated with review of Supplier documentation when procurement documents require such documentation to be furnished prior to receiving inspection.

Receiving inspection shall be coordinated with review of Supplier documentation when procurement documents require such documentation to be furnished prior to receiving inspection.

8.2.4 Post-Installation Testing 506 Post-installation Testing When post-installation testing is used, post-installation test requirements and acceptance documentation shall be mutually established by the Purchaser and Supplier.

When postinstallation testing is used, postinstallation test requirements and acceptance documentation shall be mutually established by the Purchaser and Supplier.

8.3 Acceptance of Services Only 507 Acceptance of Services Only In certain cases involving procurement of services only, such as third party inspection; engineering and consulting services; and installation, repair, overhaul, or maintenance work, the Purchaser shall accept the service by any or all of the following methods:

In cases involving procurement of services only, such as third-party inspection; engineering and consulting services; auditing; and installation, repair, overhaul, or maintenance work, the Purchaser shall accept the service by any or all of the following methods:

(a) technical verification of data produced; (a) technical verification of data produced


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(b) surveillance and/or audit of the activity; (b) surveillance and/ or audit of the activity

(a)review of objective evidence for conformance to the procurement document requirements such as certifications, stress reports, etc.

c) review of objective evidence for conformance to the procurement document requirements

9 CONTROL OF SUPPLIER NONCONFORMANCES

600 CONTROL OF SUPPLIER NONCONFORMANCES

The Purchaser and Supplier shall establish and document methods for disposition of items and services that do not meet procurement documentation requirements.

Methods for control and disposition of Supplier nonconformances for items and services that do not meet procurement document requirements shall include paras. 600(a) through (e) of this Requirement:

These methods shall contain provision for (a) through (e) below:

(a) evaluation of nonconforming items; (a) evaluation of nonconforming items. (b) submittal of nonconformance notice to Purchaser by Supplier as directed by the Purchaser.

(b) submittal of nonconformance notice to Purchaser by Supplier as directed by the Purchaser.

These submittals shall include Supplier-recommended disposition (e.g., use-as-is or repair) and technical justification.

These submittals shall include Supplier-recommended disposition ( e.g., use as-is or repair) and technical justification.

Nonconformances to the procurement requirements or Purchaser-approved documents, which consist of one or more of the following, shall be submitted to the Purchaser for approval of the recommended disposition:

Nonconformances to the procurement requirements or Purchaser-approved documents, which consist of one or more of the following, shall be submitted to the Purchaser for approval of the recommended disposition:

1) technical or material requirement is violated;

(1) technical or material requirement is violated

(2) requirement in Supplier documents, which has been approved by the Purchaser, is violated;

(2) requirement in Supplier documents, which has been approved by the Purchaser, is violated

(3) nonconformance cannot be corrected by continuation of the original manufacturing process or by rework;

(3) nonconformance cannot be corrected by continuation of the original manufacturing process or by rework

(4) the item does not conform to the original requirement even though the item can be restored to a condition such that the capability of the item to function is unimpaired;

(4) the item does not conform to the original requirement even though the item can be restored to a condition such that the capability of the item to function is unimpaired


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(c) Purchaser disposition of Supplier recommendation;

(c) Purchaser disposition of Supplier recommendation.

(d) verification of the implementation of the disposition;

(d) verification of the implementation of the disposition.

(e) maintenance of records of Supplier-submitted nonconformances.

(e) maintenance of records of Supplier-submitted nonconformances.

10 COMMERCIAL GRADE ITEMS 700 COMMERCIAL GRADE ITEMS AND SERVICES1

701 General Where the design utilizes commercial grade items, the following requirements as an acceptable alternate to other requirements of this Supplement, except as noted in (b) below and the requirements of Supplement 4S-l.

When commercial grade items or services are utilized, the dedicating entity can utilize the requirements of this section for procurement and acceptance of items or services as an acceptable alternative to sections 200 through 600 of this Requirement, except that Supplier evaluation and selection, where determined necessary by the Purchaser, shall be in accordance with section 200 of this Requirement. The applicable requirements of this Standard shall apply to dedication activities for acceptance. When section 700 of this Requirement is applied to nuclear power plants licensed pursuant to 10 CFR Part 50 or 10 CFR Part 52 and their suppliers, Part II, Subpart 2.14, Quality Assurance Requirements for Commercial Grade Items and Services, provides requirements for dedication activities for acceptance that are required by 10 CFR Part 21.

(a) The commercial grade item is identified in an approved design output document.

1 TheU.S. Nuclear Regulatory Commission issued Generic Letter 89-02 and Generic Letter 91-05 to licenses of nuclear power plants pursuant to 10 CFR Part 50, Appendix B. These generic letters conditionally endorse the guidelines contained in EPRI, NP-5652, Guidelines for the Commercial Grade Items in Safety-Related Applications (NCIG-07). These documents subsequently contributed to the development of the 10 CFR Part 21 related commercial grade item definitions. These sources were utilized in the development of the criteria in section 700 of Requirement 7. 10 CFR Part 21, Reporting of Defects and Noncompliance, is applicable to facilities per 10 CFR Parts 30, 40, 50, 60, 61, 70, and 72, unless specifically provided otherwise in the regulations. 10


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CFR Part 21, Definitions, §21.3, are pursuant to all identified 10 CFR Parts, unless a specific 10 CFR Part is identified in the definition. 10 CFR Part 21, Definitions, §21.3 contains two definitions related to commercial grade items. One definition relates to nuclear power plants licensed pursuant to 10 CFR 50 and the second relates to other facilities, per the applicable 10 CFR Parts. Additionally, other definitions in 10 CFR Part 21 have criteria that are only applicable to licensed nuclear power plants pursuant to 10 CFR Part 50. Section 700 of Requirement 7, Commercial Grade Items and Services, contains criteria applicable to 10 CFR Part 50 for nuclear power plants but provides sufficient quality criteria for the facilities identified in Part 1, Introduction, section 200, Applicability. Facilities other than 10 CFR 50 nuclear power plants utilizing this section may establish other commercial grade criteria for the applicable 10 CFR Part facility, per the definitions contained in 10 CFR Part 21 and other applicable regulations.

702 Utilization (a) The utilization of commercial grade items or

services shall include the following: (1) technical evaluation to determine that the item or service performs a safety function (2) confirmation that the item or service meets the commercial grade definition criteria (3) identification of the critical characteristics, including acceptance criteria (4) selection, performance, and documentation of the dedication method(s) for determining compliance with acceptance criteria (b) When one or more critical characteristics for acceptance cannot be verified by the dedication methods, the requirements of this section shall not be utilized to procure and accept the commercial grade item or service.

703 Critical Characteristics

Critical characteristic selection for acceptance shall address the following: (a) identifiable and measurable attributes or variables appropriate for the safety function (b) criteria related to the location of the item in the facility or criteria addressing the most severe location of the item in the facility, unless controls are in place to prevent usage in undesignated locations


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704 Dedication (a) The dedicating entity shall provide reasonable

assurance that the commercial grade item or service meets the acceptance criteria for the identified critical characteristics by inspections, tests, or analyses performed after delivery, supplemented as necessary by one or more of the following: (1) commercial grade survey of the Supplier (2) source verification of the item or service (3) acceptable Supplier/ item performance record (b) Prior to acceptance of the commercial grade item or service, the dedicating entity shall determine the following, as applicable: (1) damage was not sustained during shipment (2) the item or service has satisfied the specified acceptance criteria for the identified critical character-istics (3) specified documentation was received and is acceptable

704.1 Commercial Grade Survey (a) A commercial grade survey is performed in

accordance with a checklist or plan at the Supplier’s facility and includes or addresses the following: (1) identification of the item(s), or product line, or service included within the scope of the survey (2) identification of the critical characteristics to be controlled by the Supplier (3) verification of the Supplier ’s processes and quality program controls are effectively implemented for control of the critical characteristics (4) identification of the survey methods or verification activities performed with results obtained (5) documentation of the adequacy of the Supplier’s processes and controls

(b) A commercial grade survey shall not be employed as a supplemental basis for accepting commercial grade items or services from Suppliers with undocumented quality programs or with programs that do not effectively implement the Supplier’s own specified processes and controls. After a Supplier’s


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processes and controls have been determined to be adequate, the dedicating entity shall invoke or reference the verified processes and controls as a part of the purchase order or control requirements for the commercial grade item or service and require the Supplier to provide a Certificate of Conformance attesting to the implementation of the identified processes and controls.

(c) The dedicating entity shall establish the survey frequency for reconfirming the previous survey information for application to additional purchases.

704.2 Source Verification Source verification is only applicable to the actual

item( s) or service( s) that are verified at the Supplier’s facility or other applicable location.

Source verification shall be performed in accordance with para. 504 of this Requirement, including a checklist or plan with the documented evidence of the source verification furnished to the dedicating entity and shall include or address the following:

(a) identification of the item( s) or service( s) included within the scope of the source verification (b) identification of the critical characteristics, including acceptance criteria, to be controlled by the Supplier (c) verification of the Supplier’s processes and con-trols are effectively implemented for the identified critical characteristics (d) identification of the activities witnessed during the source verification and the results obtained (e) documentation of the adequacy of the Supplier’s processes and controls

704.3 Acceptable Supplier/ Item Services Performance Records

(a) An acceptable Supplier/ item/ service performance record shall include the following: (1) identification of the supplier/ item/ service being evaluated


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(2) identification of previously established critical characteristics specific to the Supplier/ item/ service (3) identification of industry data examined to evaluate the Supplier/ item/ service (4) identification of basis for determining that industry data substantiates acceptability of the Supplier/ item/ service (5) documentation of the adequacy and acceptance of the Supplier/ item/ service performance record

(b) An acceptable Supplier/ item/ service performance record shall not be employed unless (1) the established historical record is based on industry- wide performance data that is directly applicable to the critical characteristics and the intended facility application, i.e., a single source of information is not adequate to demonstrate satisfactory performance (2) the manufacturer/Supplier’s measures for the control of applicable design, process, and material change have been accepted by the dedicating entity

(c) Continued application of an acceptable Supplier/ item/ service performance record shall include a documented periodic update and review to assure the Supplier/ item/ service maintains an acceptable performance record.

705 Supplier Deficiency Correction Deficiencies identified in the Supplier’s processes and

controls identified in the dedication process shall be corrected by the Supplier and verified by the dedicating entity, if the specified dedication process is to be used to verify an identified critical characteristic.

An alternate commercial grade item may be applied, provided the cognizant design organization provides verification that the alternate commercial grade item will perform the intended function and will meet design requirements applicable to both the replaced item and its application.


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(b) Source evaluation and selection, where determined necessary by the Purchaser based on complexity and importance to safety, shall be in accordance with para. 3.1 of this Supplement.

(c) Commercial grade items shall be identified in the purchase order by the manufacturer's published product description (for example, catalog number).

(d) After receipt of a commercial grade item, the Purchaser shall determine that:

(1) damage was not sustained during shipment;

(2) the item has satisfied the specified acceptance criteria; and

(3) inspection and/or testing is accomplished, as required by the Purchaser, to assure conformance with the manufacturer’s published requirements;

(4) documentation, as applicable to the item, was received and is acceptable.

800 RECORDS Records shall be established and maintained to

indicate the performance of the following functions: (a) supplier evaluation and selection (b) acceptance of items or services (c) supplier nonconformances to procurement document requirements, including their evaluation and disposition (d) utilization and acceptance of commercial grade items


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BASIC REQUIREMENT 8 IDENTIFICATION AND CONTROL OF

ITEMS

REQUIREMENT 8 Identification and Control of Items

100 BASIC Controls shall be established to assure that only correct and accepted items are used or installed.

Controls shall be established to assure that only correct and accepted items are used or installed.

Identification shall be maintained on the items or in documents traceable to the items, or in a manner which assures that identification is established and maintained.

Identification shall be maintained on the items or in documents traceable to the items, or in a maner which assures that identification is established and maintained.

SUPPLEMENT 8S-1 SUPPLEMENTARY REQUIREMENTS FOR IDENTIFICATION AND CONTROL OF ITEMS

1 GENERAL This Supplement provides amplified requirements for identification and control of items.

It supplements the requirements of Basic Requirement 8 of this Part (Part 1) and shall be used in conjunction with that Basic Requirement when and to the extent specified by the organization invoking this Part (Part l).

2 IDENTIFICATION METHODS 200 IDENTIFICATION METHODS 2.1 Item Identification 201 Item Identification Items of production (batch, lot, component, part) shall be identified from the initial receipt and fabrication of the items up to and including installation and use.

Items of production (batch, lot, component, part) shall be identified from the initial receipt and fabrication of items up to and including installation and use.

This identification shall relate an item to an applicable design or other pertinent specifying document.

This identification shall relate an item to an applicable design or other pertinent specifying document.

2.2 Physical Identification 202 Physical Identification Physical identification shall be used to the maximum extent possible.

Physical identification shall be used to the maximum extent possible.

Where physical identification on the item is either impractical or insufficient, physical

Where physical identification on the item is either impractical or insufficient, physical separation,


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separation, procedural control, or other appropriate means shall be employed.

procedural control, or other appropriate means shall be employed.

2.3 Markings Identification markings, when used, shall be applied using materials and methods which provide a clear and legible identification and do not detrimentally affect the function or service life of the item.

Identification markings shall be applied using materials and methods that provide a clear and legible identification and do not degrade the function or service life of the item.

Markings shall be transferred to each part of an identified item when subdivided and shall not be obliterated or hidden by surface treatment or coatings unless other means of identification are substituted.

Markings shall be transferred to each part of an identified item when subdivided and shall not be obliterated or hidden by surface treatment or coating unless other means of identification are substituted.

3 SPECIFIC REQUIREMENTS 300 SPECIFIC REQUIREMENTS 3.1 Identification and Traceability of Items 301 Identification and Traceability of Items When specified by codes, standards, or specifications that include specific identification or traceability requirements (such as identification or traceability of the item to applicable specification and grade of material; heat, batch, lot, part, or serial number; or specified inspection, test, or other records), the program shall be designed to provide such identification and traceability control.

When codes, standards, or specifications include specific identification or traceability requirements (such as identification or traceability of the item to applicable specification and grade of material; heat, batch, lot, part, or serial number; or specified inspection, test, or other records), the program shall provide such identification and traceability control.

3.2 Limited Life Items 302 Limited Life Items Where specified, items having limited calendar or operating life or cycles shall be identified and controlled to preclude use of items whose shelf life or operating life has expired.

Items having limited calendar or operating life or cycles shall be identified and controlled to preclude use of items whose shelf life or operating life has expired.

3.3 Maintaining Identification of Stored Items

303 Maintaining Identification of Stored Items

Provisions shall be made for the control of item identification consistent with the planned duration and conditions of storage, such as:

Provisions shall be made for the control of item identification consistent with the planned duration and conditions of storage, such as

(a) provisions for maintenance or replacement of markings and identification records due to damage during handling or aging;

(a) provisions for maintenance or replacement of markings and identification records due to damage during handling or aging


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(b) protection of identifications on items subject to excessive deterioration due to environmental exposure;

(b) protection of identifications on items subject to excessive deterioration due to environmental exposure

(c) provisions for updating existing plant records.

(c) provisions for updating existing plant records

BASIC REQUIREMENT 9 CONTROL OF PROCESSES

REQUIREMENT 9 CONTROL OF SPECIAL

PROCESSES

100 BASIC Processes affecting quality of items or services shall be controlled.

Special processes that control or verify quality, such as those used in welding, heat treating, and nondestructive examination, shall be performed by qualified personnel using qualified procedures in accordance with specified requirements.

Special processes that control or verify quality, such as those used in welding, heat treating, and nondestructive examination, shall be performed by qualified personnel using qualified procedures in accordance with specified requirements.

SUPPLEMENT 9S-1 SUPPLEMENTARY REQUIREMENTS FOR CONTROL OF PROCESSES

1 GENERAL

This Supplement provides amplified requirements for control of processes.

It supplements the requirements of Basic Requirement 9 of this Part (Part 1) and shall be used in conjunction with that Basic Requirement when and to the extent specified by the organization invoking this Part (Part 1)

2 PROCESS CONTROL 200 PROCESS CONTROL Processes shall be controlled by instructions, procedures, drawings, checklists, travelers, or other appropriate means.

These means shall assure that process parameters are controlled and that specified environmental conditions are maintained.

Conditions necessary for accomplishment of the process shall be included. (9,201,3) These conditions shall include proper equipment, controlled parameters of the process, specified environment, and calibration requirements. (Req 9, 201, 4)


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3 SPECIAL PROCESSES 201 Special Processes Each special process shall be performed in accordance with appropriate instructions which include or reference procedure, personnel, and equipment qualification requirements.

Special processes shall be controlled by instructions, procedures, drawings, checklists, travelers, or other appropriate means.

Special process instructions shall include or reference procedure, personnel, and equipment qualification requirements.

Conditions necessary for accomplishment of the process shall be included.

These conditions shall include proper equipment, controlled parameters of the process, specified environment, and calibration requirements.

202 Acceptance Criteria

The requirements of applicable codes and standards, including acceptance criteria for the process, shall be specified or referenced in procedures or instructions.

203 Special Requirements For special processes not covered by existing codes

and standards or where quality requirements specified exceed those of existing codes or standards, the necessary requirements for qualifications of personnel, procedures, or equipment shall be specified or referenced in procedures or instructions.

3.1 Responsibility 300 RESPONSIBILITY It is the responsibility of the organization performing the special process to adhere to the approved procedures and processes.

It is the responsibility of the organization performing the special process to adhere to the approved procedures and processes.

3.1.1 Qualification of personnel, procedures, and equipment shall comply with specified requirements.

3.1.2 Conditions necessary for accomplishment of the process shall be included in procedures or instructions.


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These conditions shall include proper equipment, controlled parameters of the process, and calibration requirements.

3.2 Acceptance Criteria

The requirements of applicable codes and standards, including acceptance criteria for the process, shall be specified or referenced in the procedures or instructions.

3.3 Records 400 RECORDS Records shall be maintained as appropriate for the currently qualified personnel, processes, and equipment of each special process

Records shall be maintained as appropriate for the currently qualified personnel, processes, and equipment of each special process.

3.4 Special Requirements

For special processes not covered by existing codes and standards or where quality requirements specified for an item exceed those of existing codes or standards, the necessary requirements for qualifications of personnel, procedures, or equipment shall be specified or referenced in the procedures or instructions.

For special processes not covered by existing codes and standards or where quality requirements specified exceed those of existing codes or standards, the necessary requirements for qualifications of personnel procedures, or equipment shall he specified or referenced in procedures or instructions (Req.9, 203, 1)

BASIC REQUIREMENT 10 INSPECTION REQUIREMENT 10 INSPECTION

100 BASIC Inspections required to verify conformance of an item or activity to specified requirements shall be planned and executed.

Inspections required to verify conformance of an item or activity to specified requirements or continued acceptability of items in service shall be planned and executed.

Characteristics to be inspected and inspection methods to be employed shall be specified.

Characteristics subject to inspection and inspection methods shall be specified.

Inspection results shall be documented. Inspection results shall be documented. Inspection for acceptance shall be performed by persons other than those who performed or directly supervised the work being inspected.

Inspection for acceptance shall be performed by qualified persons other than those who performed or directly supervised the work being inspected.


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SUPPLEMENT 1OS-1 SUPPLEMENTARY REQUIREMENTS FOR INSPECTION

1 GENERAL This Supplement provides amplified requirements for inspection of items and activities.


2 INSPECTION REQUIREMENTS 200 INSPECTION REQUIREMENTS Inspection requirements and acceptance criteria shall include specified requirements contained in the applicable design documents or other pertinent technical documents approved by the responsible design organization.

Inspection requirements and acceptance criteria shall include specified requirements contained in the applicable design documents or other pertinent technical documents approved by the responsible design organization.

Inspection activities shall be documented and controlled by instructions, procedures, drawings, checklists, travelers, or other appropriate means.

3 PERSONNEL 3.1 Reporting Independence Inspection personnel shall not report directly to the immediate supervisors who are responsible for performing the work being inspected.

3.2 Qualification Each person who verifies conformance of work activities for purposes of acceptance shall be qualified to perform the assigned inspection task.

Inspections by persons during on-the-job training for qualification shall be performed under the direct observation and supervision of a qualified person and verification of conformance shall be by the qualified person until certification is achieved.


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4 INSPECTION HOLD POINTS 300 INSPECTION HOLD POINTS If mandatory inspection hold points are required beyond which work shall not proceed without the specific consent of the designated representative, the specific hold points shall be indicated in appropriate documents.

If mandatory inspection hold points are required beyond which work shall not proceed without the specific consent of the designated representative, the specific hold points shall be indicated in appropriate documents.

Consent to waive specified hold points shall be recorded prior to continuation of work beyond the designated hold point.

Consent to waive specified hold points shall be recorded prior to continuation of work beyond the designated hold point.

5 INSPECTION PLANNING 400 INSPECTION PLANNING 5.1 Planning 401 Planning Planning for inspection activities shall be accomplished and documented.

The documentation shall identify characteristics, methods, and acceptance criteria, and shall provide for recording objective evidence of inspection results.

Characteristics to be inspected, methods of inspection, and acceptance criteria shall be identified during the inspection planning process.

5.2 Sampling 402 Sampling Where a sample is used to verify acceptability of a group of items, the sampling procedure shall be based on recognized standard practices.

Sampling procedures, when used, shall be based upon standard statistical methods with engineering approval.

6 IN-PROCESS INSPECTION 500 IN-PROCESS INSPECTION 6.1 Inspection

Inspection of items in-process or under construction shall be performed for work activities where necessary to verify quality.

Inspection of items under construction or otherwise in process shall be performed as necessary to verify quality.

If inspection of processed items is impossible or disadvantageous, indirect control by monitoring of processing methods, equipment, and personnel shall be provided.

If inspection of processed items is impossible or disadvantageous, indirect control by monitoring of processing methods, equipment, and personnel shall be provided.

Process monitoring shall be performed by qualified personnel or qualified automated means.

Both inspection and process monitoring shall be provided when control is inadequate without both.

Both inspection and process monitoring shall be provided when control is inadequate without both.


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6.2 Combined Inspection and Monitoring 6.2.1 A combination of inspection and process monitoring methods, when used, shall be performed in a systematic manner to assure that the specified requirements for control of the process and quality of the item are being achieved throughout the duration of the process.

When inspection and process monitoring are used, they should be performed in a systematic manner to assure that the specified requirements for control of the process and quality of the item are being achieved throughout the duration of the process. (PIII,10A-1,200,1)

6.2.2 Controls, where required, shall be established and documented for the coordination and sequencing of these activities at established inspection points during successive stages of the conducted process or construction.

Controls, where required, should be established and documented for the control and sequencing of these activities at established inspection points during successive stages of the conducted process or construction. (PIII, 10A-1, 2)

7 FINAL INSPECTIONS 600 FINAL INSPECTIONS 7.1 Resolution of Nonconformances 601 Resolution of Nonconformances Final inspections shall include a records review of the results and resolution of nonconformances identified by prior inspections.

Final inspections shall include a records review of the results and resolution of nonconformances identified by prior inspections.

The final inspection shall be planned to arrive at a conclusion regarding conformance of the item to specified requirements.

7.2 Inspection Requirements 602 Inspection Requirements Completed items shall be inspected for completeness, markings, calibration, adjustments, protection from damage, or other characteristics as required to verify the quality and conformances of the item to specified requirements.

Completed items shall be inspected for completeness, markings, calibration, adjustments, protection from damage, or other characteristics as required to verify the quality and conformance of the item to specified requirements.

Quality records shall be examined for adequacy and completeness if not previously so examined.

7.3 Acceptance

The acceptance of the item shall be documented and approved by authorized personnel.


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7.4 Modifications, Repairs, or Replacements

603 Modifications, Repairs, or Replacements

Modifications, repairs, or replacements of items performed subsequent to final inspection shall require reinspection or retest, as appropriate, to verify acceptability.

Any modifications, repairs, or replacements of items performed subsequent to final inspection shall require reinspection or retest, as appropriate, to verify accept-ability.

604 Acceptance

The acceptance of the item shall be approved by authorized personnel.

8 INSERVICE INSPECTION 700 INSPECTIONS DURING OPERATIONS 8.1 Planning and Performance

Periodic inspections (e.g., in-service inspections) or surveillances of structures, systems, or components shall be planned and executed to assure the continued performance of their required functions.

Required inservice inspection or surveillance of structures, systems, or components shall be planned and executed by or for the organization responsible for operation.

Required in-service inspection or surveillance of structures, systems or components should be planned and executed by or for the organization responsible for the operation. (PIII,10A-1,300,1)

8.2 Methods Changes to Appendix 10A-1 300 IN-SERVICE INSPECTION Required in-service inspection or surveillance of structures, systems, or components should be planned and executed by or for the organization responsible for the operation.

Inspection methods shall be established and executed to verify that the characteristics of an item continue to remain within specified limits.

Inspection methods should be established and executed to verify that the characteristics of an item continue to remain within specified limits. (PIII, 10A-1,300,2)

Inspection methods shall include evaluations of performance capability of essential emergency and safety systems and equipment, verification of calibration and integrity of instruments and instrument systems, and verification of maintenance, as appropriate.

Inspection methods should include evaluations of performance capability of essential emergency and safety systems and equipment, verification of calibration and integrity of instruments and instrument systems, and verification of maintenance, as appropriate. (PIII, 10A-1,300,2)


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9 RECORDS 800 RECORDS Records shall, as a minimum, identify (a) through below:

Appropriate records shall be established, maintained, and, as a minimum, identify the following:

Changes to Appendix 10A-1 400 RECORDS Inspections, process monitoring, and in- service inspections should be documented, and the results and acceptability should be determined by authorized personnel.

(a) item inspected (a) item inspected (b) date of inspection (b) date of inspection (c) inspector (c) inspector (d) type of observation (d) type of observation (e) results or acceptability (e) results or acceptability

(f) reference to information on action taken in connection with nonconformances

f) reference to information on action taken in connection with nonconformances

BASIC REQUIREMENT 11 TEST CONTROL

REQUIREMENT 11 TEST CONTROL

BASIC REQUIREMENT 100 BASIC Tests required to verify conformance of an item or computer program to specified requirements and to demonstrate satisfactory performance for service shall be planned and executed.

Tests required to collect data such as for siting or design input, to verify conformance of an item or computer program to specified requirements, or to demonstrate satisfactory performance for service shall be planned and executed.

Characteristics to be tested and test methods to be employed shall be specified.

Characteristics to be tested and test methods to be employed shall be specified.

Test results shall be documented and their conformance with acceptance criteria shall be evaluated.

Test results shall be documented and their conformance with test requirements and acceptance criteria shall be evaluated

Tests required to collect data, such as for siting or design input, shall be planned, executed, documented, and evaluated.

SUPPLEMENT 11S-1 SUPPLEMENTARY REQUIREMENTS FOR TEST CONTROL

1 GENERAL This Supplement provides amplified requirements for test control.


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2 TEST REQUIREMENTS 200 TEST REQUIREMENTS Test requirements and acceptance criteria shall be provided or approved by the organization responsible for the design of the item to be tested unless otherwise designated.

(a) Test requirements and acceptance criteria shall be provided or approved by the responsible design organization.

Required tests, including, as appropriate, prototype qualification tests, production tests, proof tests prior to installation, construction tests, pre-operational tests, and operational tests shall be controlled.

Required tests, including, as appropriate, prototype qualification tests, production tests, proof tests prior to installation, construction tests, preoperational tests, operational tests, and computer program tests such as software design verification, factory acceptance tests, site acceptance tests, and in-use tests shall be controlled.

Required tests shall be controlled under appropriate environmental conditions using the tools and equipment necessary to conduct the test in a manner to fulfill test requirements and acceptance criteria.

The tests performed shall obtain the necessary data with sufficient accuracy for evaluation and acceptance.

Test requirements and acceptance criteria shall be based upon specified requirements contained in applicable design or other pertinent technical documents.

(b) Test requirements and acceptance criteria shall be based upon specified requirements contained in applicable design documents, or other pertinent technical documents that provide approved requirements.

( c) If temporary changes to the approved configuration of a facility are required for testing purposes, approval by the design authority is required prior to performing the test.

3 TEST PROCEDURES 300 TEST PROCEDURES (OTHER THAN FOR COMPUTER PROGRAMS)

Tests procedures shall include or reference test objectives and provisions for assuring that prerequisites for the given test have been met, that adequate instrumentation is available and used, that necessary monitoring is performed,

(a) Test procedures shall include or reference the test configuration and test objectives.


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and that suitable environmental conditions are maintained. Test procedures shall also include provisions for

assuring that prerequisites and suitable environmental conditions are met, adequate instrumentation is available and used, appropriate tests and equipment are used, and necessary monitoring is performed.

Prerequisites shall include the following, as applicable: calibrated instrumentation, appropriate equipment, trained personnel, condition of test equipment and the item to be tested, suitable environmental conditions, and provisions for data acquisition.

Prerequisites shall include the following, as applicable: (1) calibrated instrumentation (2) appropriate equipment (3) trained personnel (4) condition of test equipment and the item to be tested (5) suitable environmental conditions (6) provisions for data acquisition

In lieu of specially prepared written test procedures, appropriate sections of related documents, such as ASTM methods, Supplier manuals, equipment maintenance instructions, or approved drawings or travelers with acceptance criteria, can be used.

(b) As an alternative to para. 300(a) of this Requirement, appropriate sections of related documents, such as ASTM methods, Supplier manuals, equipment maintenance instructions, or approved drawings or travelers with acceptance criteria, may be used. Such documents shall include or be supplemented with appropriate criteria from para. 300(a) to assure adequate procedures for the test.

Such documents shall include adequate instructions to assure the required quality of work.

400 COMPUTER PROGRAM TEST PROCEDURES

The requirements of section 400 of Requirement 11 apply, instead of section 300, Test Procedures, to testing of computer programs, and as appropriate, the computer hardware and operating system.

(a) Computer program test procedures shall provide for demonstrating the adherence of the computer program to documented requirements.

Note: This area corresponds to Supplement 11S-2, 2.1, Verification Testing, for NQA-1-94)

For those computer programs used in design activities, computer program test procedures shall provide for assuring that the computer program produces correct results.



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For those computer programs used for operational control, computer program test procedures shall provide for demonstrating required performance over the range of operation of the controlled function or process.

The procedures shall also provide for evaluating technical adequacy through comparison of test results from alternative methods such as hand calculations, calculations using comparable proven programs, or empirical data and information from technical literature.


(b) In-use test procedures shall be developed and documented to permit confirmation of acceptable performance of the computer program in the operating system.

Note: This area corresponds to Supplement 11S-2, 2.2, In-Use Tests, for NQA-1-94)

In-use test procedures shall be performed after the computer program is installed on a different computer, or when there are significant changes in the operating sys-tem.


Periodic in- use manual or automatic self- check in-use tests shall be prescribed and performed for those computer programs in which computer program errors, data errors, computer hardware failures, or instrument drift can affect required performance.


4 TEST RESULTS 500 TEST RESULTS Test results shall be documented and evaluated by a responsible authority to assure that test requirements have been satisfied.

Test results shall be documented and evaluated by a responsible authority to ensure that test requirements have been satisfied. Test results for design qualification tests and software design verification shall be evaluated by the responsible design organization.

5 TEST RECORDS 600 TEST RECORDS Test records shall, as a minimum, identify (a) through (g) below:

Test records shall be established and maintained to indicate the ability of the item or computer program to satisfactorily perform its intended function or to meet its documented requirements.


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Test records vary depending on the test type, purpose,

and application, but shall contain the following information, as a minimum, for the specified application identified in paras. 601 and 602.

"Test records very depending on the test type, purpose, application. The nuclear industry has found it desirable to consider at least the following records as applicable." (PIII,11A-1,300)

601 Test Records

(a) item tested (a) item tested

"(a) item tested (PIII,11A-1,301a)

(b) date of test (b) date of test

(b) date of test (PIII,11A-1,301b)

(c) tester or data recorder (c) tester or data recorder

(c) tester or data recorder (PIII,11A-1,301c)

(d) type of observation (d) type of observation

(d) type of observation (PIII,11A-1,301d)

(e) results and acceptability (e) results and acceptability

(e) results and acceptability (PIII,11A-1,301e)

(f) action taken in connection with any deviations noted

(f) action taken in connection with any deviations

(f) action taken in connection with any deviations (PIII,11A-1,301f)

(g) person evaluating test results (g) person evaluating test results (g) person evaluating test results ." (PIII,11A-1,301g)

602 Computer Program Test Records (a) Verification Test Records (1) computer program tested (2) computer hardware tested (3) test equipment and calibrations, where applicable (4) date of test (5) tester or data recorder (6) simulation models used, where applicable (7) test problems (8) results and applicability (9) action taken in connection with any deviations

noted

(10) person evaluating test results (b) In-Use Test Records (1) computer program tested (2) computer hardware tested (3) test equipment and calibrations, where applicable (4) date of test (5) tester or data recorder (6) acceptability


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Deletions to Appendix 11A-1 300 TEST RECORDS Test records vary depending on the test type, purpose, and application. The nuclear industry has found it desirable to consider at least the following records as applicable. 301 Noncomputer Test Records ( a) item tested ( b) date of test ( c) tester or data recorder ( d) type of observation ( e) results and acceptability ( f) action taken in connection with any deviations ( g) person evaluating test results 302 Computer Program Test Records ( a) Verification Test Records ( 1) computer program tested ( 2) computer hardware tested ( 3) test equipment and calibrations, where applicable ( 4) date of test ( 5) tester or data recorder ( 6) simulation models used, where applicable ( 7) test problems ( 8) results and acceptability ( 9) action taken in connection with any deviations noted ( 10) person evaluating test results ( b) In- Use Test Records ( 1) computer program tested ( 2) computer hardware tested ( 3) test equipment and calibrations, where applicable ( 4) date of test ( 5) tester or data recorder ( 6) acceptability


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SUPPLEMENT 11S--2 SUPPLEMENTARY REQUIREMENTS FOR COMPUTER PROGRAM TESTING

1 GENERAL This Supplement provides amplified requirements for testing of computer programs and associated computer systems.


"The requirements of Section 400 or Requirement 11 apply, instead of 300, Test Procedures, to testing of computer programs, and as appropriate, the computer hardware and operating system". (Req.11, 400,1)

2 TEST REQUIREMENTS

Test requirements and acceptance criteria shall be provided or approved by the organization responsible for the design of the item to be tested unless otherwise designated.

"Test requirements, and acceptance criteria shall be provided or approved by the responsible design organization." (Req.11, 200, a,1)

Required tests including (as appropriate) verification tests, hardware integration tests, and in-use tests shall be controlled.

"Required tests, including, as appropriate, prototype qualification tests, production tests, proof tests prior to installation, construction tests, pre-operational tests, operational tests, and computer program tests such as software design verification, factory acceptance tests, site acceptance tests, and in use tests shall be controlled." (Req.11,200,a,2)

Test requirements and acceptance criteria shall be based upon applicable design or other pertinent technical documents.

"Test requirements and acceptance criteria shall be based upon specified requirements contained in applicable design documents, or other pertinent technical documents that provide approved requirements." (Req.11, 200b)

2.1 Verification Tests Verification tests shall demonstrate the capability of the computer program to produce valid results for test problems encompassing the range of permitted usage defined by the program documentation.

"Computer program test procedures shall provide for demonstrating the adherence of the computer program to documented requirements." (Req.11,400a,1) (PII, 2.7, 300, 400 – particularly para. 304 and 400a) – 304 Testing Phase During this phase the design as implemented in code shall be exercised by executing the test cases. Failure to successfully execute the test cases shall be reviewed to determine


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if modifications of the requirements, the design, the implementation, or the test plans and test cases are required. Testing phase activities shall consist of the validation of the code to assure adherence to the requirements, and to assure that the software produces correct results for the test cases. To evaluate technical adequacy, the software test case results can be compared to results from alternative methods, such as: (a) analysis without computer assistance; (b) other validated computer program; (c) experiments and tests; (d) standard problems with known solutions; or (e) confirmed published data and correlations. See Part I Supplement 11 Test Control. Some factors to be considered in establishing computer program test procedures may include: (d) criteria for establishing test cases, (h) acceptance criteria. (PIII, 11A-1, 200d, h)

Acceptable test problem solutions are as follows:

304 Testing Phase During this phase the design as implemented in code shall be exercised by executing the test cases. Failure to successfully execute the test cases shall be reviewed to determine if modifications of the requirements, the design, the implementation, or the test plans and test cases are required. Testing phase activities shall consist of the validation of the code to assure adherence to the requirements, and to assure that the software produces correct results for the test cases. To evaluate technical adequacy, the software test case results can be compared to results from alternative methods, such as: (PII, 2.7, 304),, Some factors to be considered in establishing computer program test procedures may include: (PIII, 11A-1, 200)

(a) hand calculations; …the software test case results can be compared to results from alternative methods, such as: (a) analysis without computer assistance; (PII, 2.7, 304, 304a)


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(b) calculations using comparable proven programs; or

…the software test case results can be compared to results from alternative methods, such as: (b) other validated computer program; (PII, 2.7, 304b)

(c) empirical data and information from technical literature.

…the software test case results can be compared to results from alternative methods, such as: (c) experiments and tests; or (e) confirmed published data and correlations. (PII, 2.7, 304c,e)

For programs used for operational control, testing shall demonstrate required performance over the range of operation of the controlled function or process.

"For those computer programs used for operational control, computer program test procedures shall provide for demonstrating required performance over the range of operation of the controlled function or process. "( Req.11, 400a, 3)

Depending on the complexity of the computer program being tested, testing may range from a single test of the completed computer program to a series of tests performed at various stages of computer program development to verify correct translation between stages and proper working of individual modules, followed by an overall computer program test.

"Software verification methods shall include any one or a combination of design reviews, alternate calculations, and tests performed during computer program development The extent of the verification and the methods chosen are a function of: (a) the complexity of the software. (b) the degree of standardization. (c) the similarity with previously proven software, and (d) The importance to safety." (Req.3, 8013&4) also (c ) identification of stages at which testing is required. (PIII, 11A-1, 200c)

Regardless of the number of stages of testing performed, verification testing shall be sufficient to establish that test requirements are satisfied and that the computer program produces a valid result for its intended function.

"Computer program test procedures shall provide for demonstrating the adherence of the computer program to documented requirements." (Req.11, 400a, 1) "(c ) identification of stages at which testing is required." (PIII, 11A-1, 200c) also see PII, 2.7, 300, 400

2.2 In-Use Tests Test problems shall be developed and documented to permit confirmation of acceptable performance of the computer program in the operating system.

"In use test procedures shall be developed and documented to permit confirmation of acceptable performance of the computer program in the operating system." (Req.11, 400b, 1)


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Test problems shall be run whenever the computer program is installed on a different computer, or when significant hardware or operating system configuration changes are made.

"In-use test procedures shall be performed after the computer program is installed on a different computer, or when there are significant changes in the operating system." (Req.11, 400b, 2)

Periodic in-use manual or automatic self-check routines shall be prescribed and performed for those applications where computer failures or drift can affect required performance.

"Periodic in-use manual or automatic self-check in-use tests shall be prescribed and performed for those computer programs where computer program errors, data errors, computer hardware failures or instrument drift can affect required performance." (Req.11, 400b, 3)

3 TEST PROCEDURES 200 COMPUTER PROGRAM TEST PROCEDURES

200 COMPUTER PROGRAM TEST PROCEDURES (PIII, 11A-1, 200)

Test procedures or plans shall specify the following, as applicable:

"Some factors to be considered in establishing computer program test procedures may include (a) through (I) below:" (PIII, 11A-1, 200)

(a) required tests and test sequence "(a) required tests and test sequence (PIII, 11A-1, 200a)

(b) required ranges of input parameters (b) required ranges of input parameters (PIII, 11A-1, 200b)

(c) identification of the stages at which testing is required

(c) identification of the stages at which testing is required (PIII, 11A-1, 200c)

(d) criteria for establishing test cases (d) criteria for establishing test cases (PIII, 11A-1, 200d)

(e) requirements for testing logic branches (e) requirements for testing logic branches (PIII, 11A-1, 200e)

(f) requirements for hardware integration (f) requirements for hardware integration (PIII, 11A-1, 200f)

(g) anticipated output values (g) anticipated output values (PIII, 11A-1, 200g) (h) acceptance criteria (h) acceptance criteria (PIII, 11A-1, 200h) (i) reports, records, standard formatting, and conventions.

(i) reports, records, standard formatting, and conventions." (PIII, 11A-1, 200i)

4 TEST RESULTS Test results shall be documented. "Test results shall be documented and evaluated by

a responsible authority to assure that test requirements have been satisfied." (Req.11, 500, 1)

Verification test results shall be evaluated by a responsible authority to assure that test requirements have been satisfied.

"Test results for design qualification tests and software design verification shall be evaluated by the responsible design organization."(Req.11,500,2)


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5 TEST RECORDS

302Computer Program Test Records (PIII, 11A-1, 302)

(a) Verification test records shall identify (1) through (10) below.

"(a) Verification Test Records (PIII, 11A-1, 302a)

(1) computer program tested (1) computer program tested (PIII, 11A-1, 302a1) (2) computer hardware used (2) computer hardware tested (PIII, 11A-1, 302a2) (3) test equipment and calibrations, where applicable

(3) test equipment and calibrations, where applicable (PIII, 11A-1, 302a3)

(4) date of test (4) date of test (PIII, 11A-1, 302a4) (5) tester or data recorder (5) tester or data recorder (PIII, 11A-1, 302a5) (6) simulation models used, where applicable (6) simulation models used, where applicable (PIII,

11A-1, 302a6) (7) test problems (7) test problems (PIII, 11A-1, 302a7) (8) results and acceptability (8) results and acceptability (PIII, 11A-1, 302a8) (9) action taken in connection with any deviations noted

(9) action taken in connection with any deviations noted (PIII, 11A-1, 302a9)

(10) person evaluating test results. (10) person evaluating test results. (PIII, 11A-1, 302a10)

(b) in-use test results shall identify (1) through (6) below:

(b) In-Use Test Records (PIII, 11A-1, 302b)

(1) computer program tested (1) computer program tested (PIII, 11A-1, 302b1) (2) computer hardware used (2) computer hardware tested (PIII, 11A-1, 302b2) (3) test equipment and calibrations, where applicable

(3) test equipment and calibrations, where applicable (PIII, 11A-1, 302b3)

(4) date of test (4) date of test (PIII, 11A-1, 302b4) (5) tester or data recorder (5) tester or data recorder (PIII, 11A-1, 302b5) (6) acceptability. (6) acceptability." (PIII, 11A-1, 302b6)

BASIC REQUIREMENT 12 CONTROL

OF MEASURING AND TEST EQUIPMENT

REQUIREMENT 12 CONTROL OF MEASURING AND TEST EQUIPMENT

100 BASIC Tools, gages, instruments, and other measuring and test equipment used for activities affecting quality shall be controlled and at specified periods calibrated and adjusted to maintain accuracy within necessary limits.

Tools, gages, instruments, and other measuring and test equipment used for activities affecting quality shall be controlled, calibrated at specific periods, adjusted, and maintained to required accuracy limits.

Note: Comma added after "controlled." Error in published text.


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SUPPLEMENT 12S-1 SUPPLEMENTARY REQUIREMENTS FOR CONTROL OF MEASURING AND TEST EQUIPMENT

1 GENERAL

This Supplement provides amplified requirements for control of measuring and test equipment.


2 SELECTION 200 SELECTION Selection of measuring and test equipment shall be controlled to assure that such items are of proper type, range, accuracy, and tolerance to accomplish the function of determining conformance to specified requirements.

Selection of measuring and test equipment shall be based on the type, range, accuracy, and tolerance needed to accomplish the required measurements for determining conformance to specified requirements.

3 CALIBRATION AND CONTROL 300 CALIBRATION AND CONTROL 3.1 Calibration 301 Calibration Measuring and test equipment shall be calibrated, adjusted, and maintained at prescribed intervals or, prior to use, against certified equipment having known valid relationships to nationally recognized standards.

Measuring and test equipment shall be calibrated, at prescribed times or intervals and whenever the accuracy of the measuring and test equipment is suspect.

Calibration shall be against and traceable to certified equipment or reference standards having known valid relationships to nationally recognized standards, or to international standards known to be equivalent to and verified against corresponding nationally recognized standards.

If no nationally recognized standards exist, the bases for calibration shall be documented.

Where no such standards exist, the basis for calibration shall be defined.


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302 Reference Standards

Reference standards shall have a minimum accuracy four times greater than that of the measuring and test equipment being calibrated to ensure that the reference standards contribute no more than one- fourth of the allowable calibration tolerance. Where this 4: 1 ratio cannot be maintained, the basis for selection of the standard in question shall be technically justified.

3.2 Control 303 Control Calibration procedures shall identify or reference

required accuracy and shall define methods and frequency of checking accuracy.

The method and interval of calibration for each item shall be defined, based on the type of equipment stability characteristics, required accuracy, intended use, and other conditions affecting measurement control.

The calibration method and interval of calibration shall be based on the type of equipment, stability characteristics, required accuracy, intended use, and other conditions affecting performance.

When measuring and test equipment is found to be out of calibration, an evaluation shall be made and documented of the validity of previous inspection or test results and of the acceptability of items previously inspected or tested.

Out-of-calibration devices shall be tagged or segregated and not used until they have been recalibrated.

Measuring and test equipment, which is overdue for calibration or found to be out- of- calibration, shall be tagged and/ or segregated, or removed from service, and not used until it has been recalibrated.

If any measuring or test equipment is consistently found to be out of calibration, it shall be repaired or replaced.

Measuring or test equipment consistently found to be out-of-calibration shall be repaired or replaced.

A calibration shall be performed when the accuracy of the equipment is suspect.

303.1 Application Measuring and test equipment shall be traceable to its

application and use.


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303.2 Corrective Action When measuring and test equipment is lost, damaged,

or found to be out- of- calibration, the validity of previous measurement, inspection, or test results, and the acceptability of items previously inspected or tested shall be evaluated. This evaluation shall be from at least the last acceptable calibration of the M& TE. The evaluation and resulting actions shall be commensurate with the significance of the condition.

303.3 Handling and Storage Measuring and test equipment shall be properly

handled and stored to maintain accuracy.

Note: See 4 in 1994 edition.

303.4 Environmental Controls Measuring and test equipment shall be used and

calibrated in environments that are controlled to the extent necessary to ensure that the required accuracy and precision are maintained.

303.5 Precalibration Checks Measuring and test equipment and reference

standards submitted for calibration shall be checked and the results recorded before any required adjustments or repairs are made.

303.6 Status Indication Measuring and test equipment shall be suitably

marked, tagged, labeled, or otherwise identified to indicate calibration status and establish traceability to calibration records.

Note: See 5 in 1994 edition.

3.3 Commercial Devices 304 Commercial Devices Calibration and control measures may not be required for rulers, tape measures, levels, and other such devices, if normal commercial equipment provides adequate accuracy.

Calibration and control measures are not required for commercial equipment such as rulers, tape measures, levels, etc., if such equipment provides the required accuracy.


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4 HANDLING AND STORAGE

Measuring and test equipment shall be properly handled and stored to maintain accuracy.

5 RECORDS 400 RECORDS 401 General Records shall be maintained and equipment shall be suitably marked to indicate calibration status.

Records shall be established and maintained to indicate calibration status and the capability of measuring and test equipment to satisfactorily perform its intended function.

402 Reports and Certificates

Calibration reports and certificates reporting the results of calibrations shall include the information and data necessary for interpretation of the calibration results and verification of conformance to applicable requirements.

BASIC REQUIREMENT 13 HANDLING, STORAGE, AND SHIPPING

REQUIREMENT 13 HANDLING, STORAGE, AND SHIPPING

100 BASIC Handling, storage, cleaning, packaging, shipping, and preservation of items shall be controlled to prevent damage or loss and to minimize deterioration.

Handling, storage, cleaning, packaging, shipping, and preservation of items shall be controlled to prevent damage or loss and to minimize deterioration.

These activities shall be conducted in accordance with established work and inspection instructions, drawings, specifications, shipment instructions, or other pertinent documents or procedures specified for use in conducting the activity.

SUPPLEMENT 13S-1 SUPPLEMENTARY REQUIREMENTS FOR HANDLING, STORAGE, AND SHIPPING

1 GENERAL This Supplement provides amplified requirements for handling, storage, and shipping.


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2 INSTRUCTION Handling, storage, and shipping of items shall be conducted in accordance with established work and inspection instructions, drawings, specifications, shipment instructions, or other pertinent documents or procedures specified for use in conducting the activity.

3 REQUIREMENTS 200 SPECIAL REQUIREMENTS 3.1 General When required for particular items, special equipment (such as containers, shock absorbers, and accelerometers) and special protective environments (such as inert gas atmosphere, specific moisture content levels, and temperature levels) shall be specified, provided, and their existence verified.

When required, special equipment (such as containers, shock absorbers, and accelerometers) and special protective environments (such as inert gas atmosphere, specific moisture content levels, and temperature levels) shall be specified and provided and their existence verified.

3.2 Procedures 300 PROCEDURES When required for critical, sensitive, perishable, or high-value articles, specific procedures for handling, storage, packaging, shipping, and preservation shall be used.

When required for critical, sensitive, perishable, or high-value items, specific procedures for handling, storage, packaging, shipping, and preservation shall be used.

3.3 Tools and Equipment 400 TOOLS AND EQUIPMENT Special handling tools and equipment shall be utilized and controlled as necessary to ensure safe and adequate handling.

Special handling tools and equipment shall be utilized and controlled where necessary to ensure safe and adequate handling.

Special handling tools and equipment shall be inspected and tested in accordance with procedures and at specified time intervals to verify that the tools and equipment are adequately maintained.

Special handling tools and equipment shall be inspected and tested in accordance with procedures at specified time intervals or prior to use.

3.4 Operators 500 OPERATORS Operators of special handling and lifting equipment shall be experienced or trained in use of the equipment.

Operators of special handling and lifting equipment shall be experienced or trained in the use of the equipment.


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4 MARKING 600 MARKING OR LABELING Instructions for marking and labeling for packaging, shipment, handling, and storage of items shall be established as necessary to adequately identify, maintain, and preserve the item, including indication of the presence of special environments or the need for special controls.

Marking or labeling shall be utilized as necessary to adequately maintain and preserve the item, including indication of the presence of special environments or the need for special controls.

BASIC REQUIREMENT 14 INSPECTION, TEST, AND OPERATING

STATUS

REQUIREMENT 1 4 INSPECTION, TEST, AND

OPERATING STATUS

100 BASIC The status of inspection and test activities shall be identified either on the items or in documents traceable to the items where it is necessary to assure that required inspections and tests are performed and to assure that items which have not passed the required inspections and tests are not inadvertently installed, used, or operated.

The status of inspection and test activities shall be identified either on the items or in documents traceable to the items where it is necessary to ensure that required inspections and tests are performed and to ensure that items which have not passed the required inspections and tests are not inadvertently installed, used, or operated.

Status shall be maintained through indicators, such as physical location and tags, markings, shop travelers, stamps, inspection records, or other suitable means.

Status shall be maintained through indicators, such as physical location and tags, markings, shop travelers, stamps, inspection records, or other suitable means.

The authority for application and removal of tags, markings, labels, and stamps shall be specified.

The authority for application and removal of tags, markings, labels, and stamps shall be specified.

Status indicators shall also provide for indicating the operating status of systems and components of the nuclear facility, such as by tagging valves and switches, to prevent inadvertent operation.

Status indicators shall also provide for indicating the operating status of systems and components of the nuclear facility, such as by tagging valves and switches, to prevent inadvertent operation.


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BASIC REQUIREMENT 15 CONTROL

OF NONCONFORMING ITEMS REQUIREMENT 15

CONTROL OF NONCONFORMING ITEMS

100 BASIC Items that do not conform to specified requirements shall be controlled to prevent inadvertent installation or use.

Items that do not conform to specified requirements shall be controlled to prevent inadvertent installation or use.

Controls shall provide for identification, documentation, evaluation, segregation when practical, and disposition of nonconforming items, and for notification to affected organizations.

Controls shall provide for identification, documentation, evaluation, segregation when practical, and disposition of nonconforming items, and for notification to affected organizations.

SUPPLEMENT 15S-1 SUPPLEMENTARY REQUIREMENTS FOR THE CONTROL OF NONCONFORMING ITEMS

1 GENERAL

This Supplement provides amplified requirements for the control of nonconforming items.


2 IDENTIFICATION 200 IDENTIFICATION (a) Identification of nonconforming items shall be by marking, tagging, or other methods which shall not adversely affect the end use of the item.

Nonconforming items shall be identified by legible marking, tagging, or other methods not detrimental to the item, on either the item, the container, or the package containing the item.

The identification shall be legible and easily recognizable.

(b) If identification of each nonconforming item is not practical, the container, package, or segregated storage area, as appropriate, shall be identified.

3 SEGREGATION 300 SEGREGATION (a) Nonconforming items shall be segregated, when practical, by placing them in a clearly

(a) Nonconforming items shall be segregated, when practical, by placing them in a clearly identified and


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identified and designated hold area until properly dispositioned.

designated hold area until properly dispositioned.

(b) When segregation is impractical or impossible due to physical conditions such as size, weight, or access limitations, other precautions shall be employed to preclude inadvertent use of a nonconforming item.

(b) When segregation is impractical or impossible due to physical conditions such as size, weight, or access limitations, other precautions shall be employed to preclude inadvertent use of a nonconforming item.

4 DISPOSITION 400 DISPOSITION 4.1 Control 401 Control Nonconforming characteristics shall be reviewed and recommended dispositions of nonconforming items shall be proposed and approved in accordance with documented procedures.

Nonconforming items shall be evaluated and recommended dispositions shall be proposed.

Further processing, delivery, installation, or use of a nonconforming item shall be controlled pending an evaluation and an approved disposition by authorized personnel

Further processing, delivery, installation, or use of a nonconforming item shall be controlled pending the evaluation and an approved disposition by authorized personnel.

4.2 Responsibility and Authority 402 Responsibility and Authority The responsibility and authority for the evaluation and disposition of nonconforming items shall be defined.

The responsibility and authority for the evaluation and disposition of nonconforming items shall be defined.

Responsibility for the control of further processing, delivery, installation, or use of nonconforming items shall be designated in writing.

4.3 Personnel 403 Personnel Personnel performing evaluations to determine a disposition shall have demonstrated competence in the specific area they are evaluating, have an adequate understanding of the requirements, and have access to pertinent background information.

Personnel performing evaluations to determine a disposition shall have (a) demonstrated competence in the specific area they are evaluating (b) an adequate understanding of the requirements (c) access to pertinent background information

4.4 Disposition 404 Disposition The disposition, such as use-as-is, reject, repair, or rework, of nonconforming items shall be identified and documented.

A disposition, such as use- as- is, reject, repair, or rework of nonconforming items shall be made and documented.


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Technical justification for the acceptability of a nonconforming item, dispositioned repair, or use-as-is shall be documented.

Technical justification for the acceptability of a nonconforming item dispositioned repair or use- as- is shall be documented.

Nonconformances to design requirements dispositioned use-as-is or repair shall be subject to design control measures commensurate with those applied to the original design.

Nonconformances to design requirements dispositioned use-as-is or repair shall be subject to design control measures commensurate with those applied to the original design.

The as-built records, if such records are required, shall reflect the accepted deviation.

Required as- built records shall reflect the use- as- is or repair condition.

4.5 Repaired or Reworked Items 405 Reexamination

Reworked items shall be reexamined in accordance with applicable procedures and with the original acceptance criteria.

Repaired or reworked items shall be reexamined in accordance with applicable procedures and with the original acceptance criteria unless the nonconforming item disposition has established alternate acceptance criteria.

Repaired items shall be reexamined in accordance with applicable procedures and with the original acceptance criteria unless the disposition has established alternate acceptance criteria.

BASIC REQUIREMENT 16 CORRECTIVE ACTION

REQUIREMENT 16 CORRECTIVE ACTION

100 BASIC Conditions adverse to quality shall be identified promptly and corrected as soon as practical.

Conditions adverse to quality shall be identified promptly and corrected as soon as practicable.

In the case of a significant condition adverse to quality, the cause of the condition shall be determined and corrective action taken to preclude recurrence.

In the case of a significant condition adverse to quality, the cause of the condition shall be determined and corrective action taken to preclude recurrence.

The identification, cause, and corrective action for significant conditions adverse to quality shall be documented and reported to appropriate levels of management;

The identification, cause, and corrective action for significant conditions adverse to quality shall be documented and reported to appropriate levels of management.

follow-up action shall be taken to verify implementation of this corrective action.

Completion of corrective actions shall be verified.


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BASIC REQUIREMENT 17 QUALITY ASSURANCE RECORDS

REQUIREMENT 17 QUALITY ASSURANCE RECORDS

100 BASIC 100 BASIC The control of quality assurance records shall be

established consistently with the schedule for accomplishing work activities.

Records that furnish documentary evidence of quality shall be specified, prepared, and maintained.

Quality assurance records shall furnish documentary evidence that items or activities meet specified quality requirements.

This Appendix provides nonmandatory guidance on records, as specified in Part I,Requirement 17 that are generated and maintained in anelectronic format. Organizations that generate and maintain quality assurance records in an electronic format should develop controls and associated procedures that address the unique capabilities and requirements of this technology. Electronic record controls should address how electronic records are identified, generated, authenticated, stored and maintained, per the required retention schedule. (PIII,17A-2,100, 2005 Addenda)

Records shall be legible, identifiable, and retrievable.

Quality assurance records shall be identified, generated, authenticated, and maintained, and their final disposition specified.

Records shall be protected against damage, deterioration, or loss.

Requirements and responsibilities for record transmittal, distribution, retention, maintenance, and disposition shall be established and documented.

Record control requirements and responsibilities for these activities shall be documented.

SUPPLEMENT 17S-1 Supplementary Requirements for Quality Assurance Records

1 GENERAL

This Supplement provides amplified requirements for quality assurance records.


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The requirements of this Supplement apply to quality assurance records which have been completed.

The term records, used throughout this Supplement, is to be interpreted as Quality Assurance Records.

2 RECORDS ADMINISTRATION

2.1 Records System

A records system(s) shall be established by the organization responsible at the earliest practicable time consistent with the schedule for accomplishing work activities and in compliance with the general requirements of this Supplement.

The records system(s) shall be defined, implemented, and enforced in accordance with written procedures, instructions, or other documentation.

2.2 Generation of Records 200 GENERATION OF RECORDS

The applicable design specifications, procurement documents, test procedures, operational procedures, or other documents shall specify the records to be generated, supplied, or maintained by or for the Owner.

Documents that are designated to become records shall be legible, accurate, and completed appropriate to the work accomplished.

(a) Records shall be legible.

(b) Records shall be traceable to associated items and activities and accurately reflect the work accomplished or information required.


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(c) Records to be generated, supplied, or maintained shall be specified in applicable documents, such as design specifications, procurement documents, test procedures, and operational procedures.

2.3 Record Validation 300 AUTHENTICATION OF RECORDS Documents shall be considered valid records only if stamped, initialed, or signed and dated by authorized personnel or otherwise authenticated.

(a) Documents shall be considered valid records only if stamped, initialed, or signed and dated by authorized personnel or otherwise authenticated.

Corrections to documents shall be reviewed and approved by the responsible individual from the originating or authorized organization.

This authentication may take the form of a statement by the responsible individual or organization.

“Statements of authenticity, handwritten signatures, electronic signatures, or any other means which ensures traceability a specific individual or organization of authentication and associated date are acceptable methods of authentication.” (PIII,17A-1,103,1)

Handwritten signatures are not required if the document is clearly identified as a statement by the reporting individual or organization.

“If initials or codes are used for identification, then a system should be established to ensure traceability to the authenticating individual or organization”. (PIII,17A-1,103,2)

These records may be originals or reproduced copies.

“The records system should provide methods for authenticating copies of original records when the original record is contaminated or lost and a copy of the original is available.” (PIII,17A-1,103,3)

(b) Electronic documents shall be authenticated with comparable information as in para. 300(a), as appropriate:

(1) with identification on the media; or (2) with authentication information contained within

or linked to the document itself.

300 Authentication of Records

Provisions for the authentication of electronic records should provide for the use of automated systems for the identification and signature recognition of the personnel performing the record authentication. An electronic signature is a computer data compilation of any symbol or series


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of symbols executed, adopted, or authorized by an individual to represent the individual’s handwritten signature. If electronic codes or user account information (e.g. username and password) is used for identification, controls should be established to assure traceability to the authenticating individual or organization. Consideration should be given to periodically requiring the establishment of new user passwords. Methods for authenticating electronic records should be reliable and generally equivalent to paper records and handwritten signatures executed on paper. Electronic signatures that are not based on biometrics should employ at least two distinct verification components such as user identification and password. Electronic signatures based upon biometrics should be controlled to assure that they cannot be used by anyone other than the legitimate owners. The integrity of the records in the new system or media should be verified. It is recommended that a not easily alterable format be used to assure that the content, context and structure are maintained consistent with the original record copy. If use of a not easily alterable format is not practical, controls should exist to provide an equivalent level of control. When a record is converted to electronic media the authentication of that record does not need to be re-performed. (PIII,17A-2,200, 2005 Addenda)

2.4 Index The records shall be indexed. “The designee shall be responsible for organizing

and implementing a system of receipt control of records for permanent and temporary storage.” (17, 500, 4) and “Records shall be retrievable.” (17, 800b)


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The indexing system(s) shall include, as a minimum, record retention times and the location of the record within the record system.

“Record retention periods shall be documented” (17, 700a) “Records shall be retrievable.” (17, 800b) “Indexing can take many forms, including directories or listings. Indices should identify summary information for the records, such as the associated item or activity, title or description, originating individual or organization. Retention period (lifetime or nonpermanent), location, and the media used for retention. For nonpermanent records, the period of retention should be defined.” (PIII,17A-1,105) 400 Indexing Electronic records should be indexed to provide for the timely retrieval of the record. Organizations should develop and document external and/or internal indexing methods for the index system(s). External indexing includes the labeling of records stored on external off-line media. External labeling should be developed and attached to the media used. For example, magnetic tapes should include the recording density, number of tracks, block size, types of internal labels, and if the tape is part of a multi-reel set. Internal indexing of electronic records should enable the user to identify and access a specific record by using a table of contents, directory, key word or other index strategy. In some cases the index may be automatically created by the system, while in other cases the originator may generate it. Where the originator creates the index, provisions should be established to assure that all indices are identified using a common naming convention. (PIII,17A-1,400, 2005 Addenda)


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2.5 Distribution The records shall be distributed, handled, and controlled in accordance with written procedures.

2.6 Identification Records and/or indexing system(s) shall provide sufficient information to permit identification between the record and the item(s) or activity(ies) to which it applies.

2.7 Classification 400 CLASSIFICATION Records shall be classified as Lifetime or Nonpermanent by the Owner, or his agent when authorized, in accordance with the criteria given in paras. 2.7.1 and 2.7.2 below.

Records shall be classified as lifetime or nonpermanent and maintained by the Owner, or authorized agent, in accordance with the criteria given in paras. 401 and 402 of this Requirement and consistent with applicable regulatory requirements.

2.7.1 Lifetime Records. 401 Lifetime Records Lifetime records are those that meet one or more of the following criteria:

401.1 Lifetime records are those that meet one or more of the following criteria:

(a) those which would be of significant value in demonstrating capability for safe operation;

(a) those which would be of significant value in demonstrating capability for safe operation

(b) those which would be of significant value in maintaining, reworking, repairing, replacing, or modifying an item;

(b) those which would be of significant value in maintaining, reworking, repairing, replacing, or modifying an item

(c) those which would be of significant value in determining the cause of an accident or malfunction of an item;

(c) those which would be of significant value in determining the cause of an accident or malfunction of an item

(d) those which provide required baseline data for in-service inspections.

(d) those which provide required baseline data for in-service inspections

Lifetime records are required to be maintained by or for the plant owner for the life of the particular item while it is installed in the plant or stored for future use.

401.2 Lifetime records are required to be maintained by or for the Owner for the life of the particular item while it is installed in the plant or stored for future use.

2.7.2 Nonpermanent Records. 402 Nonpermanent Records Nonpermanent records are those required to show evidence that an activity was performed in accordance with the applicable requirements but need not be retained for the life of the item because they do not meet the criteria for lifetime records.

Nonpermanent records are those required to show evidence that an activity was performed in accordance with the applicable requirements but need not be retained for the life of the item because they do not meet the criteria for lifetime records.


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Nonpermanent records shall be maintained for the identified retention period.

2.8 Retention of Records 500 RECEIPT CONTROL OF RECORDS Records shall be retained in accordance with the above classifications.

Each organization responsible for the receipt of records shall designate a person or organization responsible for receiving the records.

The retention period for nonpermanent records shall be established in writing.

The designee shall be responsible for organizing and implementing receipt controls for permanent and temporary storage. Receipt controls shall provide a method for identifying the records received, receipt and inspection of incoming records, and submittal of records to storage.

2.9 Corrected Information in Records

Records may be corrected in accordance with procedures which provide for appropriate review or approval by the originating organization.

The correction shall include the date and the identification of the person authorized to issue such correction.

“Records may be corrected in accordance with procedures which provide for appropriate review or approval by the originating organization. Good practice for such corrections should include the date and identification of the person authorized to issue such corrections.” (PIII,17-A,106)

3 RECEIPT 3.1 Responsibility

The individual or organization responsible for receiving records shall provide protection from damage or loss during the time that the records are in their possession.

3.2 Receipt Control

Each organization responsible for the receipt of records shall designate a person or organization responsible for receiving the records.

The designee shall be responsible for organizing and implementing a system of


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receipt control of records for permanent and temporary storage. As a minimum, a receipt control system shall include the following:

“The receipt control system is established to ensure that records are protected from loss or damage.” (PIII,17A-1,107,1)

(a) a method for designating the required records;

“A method of verifying that the records are those designated.” (PIII,17-A,108d)

(b) a method for identifying records received; “Such systems provide a method for identifying records received, and the location of records during the receiving process.” (PIII,17A-1,107,2)

(c) procedures for receipt and inspection of incoming records;

“Normally, procedures are established for the receipt and inspection of incoming records and for transmitting records to a permanent storage facility in a timely manner.” (PIII,17A-1,107,3)

(d) a method for submittal of completed records to the storage facility without unnecessary delay.

Note: Included in the above paragraph. (PIII,17A-1,107,3)

3.3 Status Each receipt control system shall be structured to permit a current and accurate assessment of the status of records during the receiving process.

“Such systems provide a method for identifying records received, and the location of records during the receiving process.” (PIII,17A-1,107,2) and The designee shall be responsible for organizing and implementing a system of receipt control of records for permanent and temporary storage.(Req.17,500,4)

4 STORAGE, PRESERVATION, AND SAFEKEEPING

4.1 Storage 600 STORAGE The records shall be stored in predetermined location(s) that meet the requirements of applicable standards, codes, and regulatory agencies.

“Records should be stored in predetermined location(s) that meet the requirements of applicable standards, codes, and regulatory agencies.” (PIII,17A-1,108,1)

Prior to storage of records, a written storage procedure shall be prepared and responsibility assigned for enforcing the requirements of that procedure.

“A written storage procedure should be prepared and responsibility assigned for the implementing procedure.” (PIII,17A-1,108,2)

This procedure shall include, as a minimum, (a) through (g) below:

“Storage procedures are suggested which include the following:” (PIII,17A-1,108,3)

(a) a description of the storage facility; “(a) a description of the storage facility;” (PIII,17A-1,108,3)

(b) the filing system to be used; “(b) the filing system to be used; “ (PIII,17A-1,108,3)


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(c) a method for verifying that the records received are in agreement with the transmittal document and that the records are legible;

“(c) a method for verifying that the records received are in agreement with the transmittal document and that the records are legible;” (PIII,17A-1,108,3)

(d) a method of verifying that the records are those designated (see para. 3.2 above);

“(d) a method of verifying that the records are those designated;” (PIII,17A-1,108,3)

(e) the rules governing access to and control of the files;

“(e) the rules governing access to and control of the files;” (PIII,17A-1,108,3)

(f) a method for maintaining control of and accountability for records removed from the storage facility;

“(f) a method for maintaining control of and accountability for records removed from the storage facility;” (PIII,17A-1,108,3)

(g) a method for filing supplemental information (see para. 2.9 above) and disposing of superseded records.

“(g) a method for filing supplemental information and disposing of superseded records.” (PIII,17A-1,108,3)

500 Storage Storage of electronic records requires both media and compatible processing systems. The media containing the electronic records and the compatible processing systems access, should translate the records into an appropriate retrievable, legible format. A typical processing system may consist of a computer and an application program. The types of media utilized for electronic record storage should be identified in the records management program. The selection of the storage media should consider the shelf life of the media and the manufacturer’s recommended qualified life. The degradation of electronic media starts immediately after manufacture. Electronic records should be migrated onto new media before the manufacturer’s recommended useful life is exceeded. Two sets of electronic records should be maintained to assure timely recovery in the event they are damaged or lost. These sets may be established in processing systems


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installed on separate servers, stand-alone computer platforms, or in a removable media format (e.g. Optical Disk, floppy disk). The level of user access and the security of the compatible processing systems may also impact the required controls for the storage of electronic records. Controls for remote access, local access and secure processing systems should be established to prevent the alteration, damage or loss of electronic records. Remote access systems are systems that store records on a network server, which are accessible to multiple users through a network or Internet hub. Local access systems are systems that store records on a local area network server that is accessible only to local users. Secure processing systems are stand-alone processing systems that are not accessible through a local area network or Internet hub. Storage procedures for remote and local access systems should include security measures such as user passwords, network firewalls, file encryption, and virus protection. Appropriate environmental controls should be established for each type of electronic media to prevent damage to electronic media from environmental conditions such as light, heat, humidity or electro-magnetic fields. Recommendations from the media manufacturer should be considered in establishing environmental controls. Storage procedures should consider the control of the record media, and only release copies of the electronic records to requestors. All electronic processing systems should also have power isolation devices to minimize the risk of


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damage from voltages surges, spikes and other power line disturbances. If temporary storage for electronic records is used, two sets of in-process records should be maintained since the electronic media may be exposed to computer viruses and inadvertent alteration. (PIII,17A-2,500, 2005 Addenda),

4.2 Preservation Records shall be stored in a manner approved by the organization or organizations responsible for storage.

In order to preclude deterioration of the records, the requirements of (a) through (c) below shall apply.

(a) Provisions shall be made in the storage arrangement to prevent damage from moisture, temperature, and pressure.

(b) Records shall be firmly attached in binders or placed in folders or envelopes for storage in steel file cabinets or on shelving in containers.

“To help ensure the preservation and safekeeping of records, the following should be considered: (a) placement of records in binders, folders, or envelopes for storage in steel file cabinets or on shelving;” (PIII,17A-1,109)

(c) Provisions shall be made for special processed records (such as radiographs, photographs, negatives, microform, and magnetic media) to prevent damage from excessive light, stacking, electromagnetic fields, temperature, and humidity.

4.3 Safekeeping Measures shall be established to preclude the entry of unauthorized personnel into the storage area.

"(a) Records shall be protected from damage or loss." (17,800a) “To help ensure the preservation and safekeeping of records, the following should be considered: (a) placement of records in binders, folders, or envelopes for storage in steel file cabinets or on shelving;” (PIII,17A-1,109)

These measures shall guard against larceny and vandalism.

Measures shall be taken to provide for replacement, restoration, or substitution of lost or damaged records.


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4.4 Storage Facilities Records shall be stored in facilities constructed and maintained in a manner which minimizes the risk of damage or destruction from the following:

(a) Records shall be stored at a predetermined location(s) in facilities, containers, or a combination thereof, constructed and maintained in a manner that minimizes the risk of loss, damage, or destruction from

(a) natural disasters such as winds, floods, or fires;

(1) natural disasters such as winds, floods, or fires

(b) environmental conditions such as high and low temperatures and humidity;

(2) environmental conditions such as high and low temperatures and humidity

(c) infestation of insects, mold, or rodents. (3) infestation of insects, mold, or rodents

(4) dust or airborne particles (b) Activities deterimental to the records shall be

prohibited in the storage area. (c) Access to the processing, storage, and retrieval of records shall be limited to authorized personnel. (d) Provisions shall be made to prevent damage from harmful conditions (such as excessive light, stacking, electromagnetic fields, temperature, and humidity), as applicable to the specific media utilized for record storage.

602 Facility Types There are two equally satisfactory methods of

providing storage, single or dual.

602.1 Single storage consists of a storage facility, vault, room, or container(s) with a minimum two-hour fire rating. The design and construction of a single storage facility, vault room, or container shall be reviewed for adequacy by a person competent in fire protection or contain a certification or rating from an accredited organization.

602.2 Dual facilities, containers, or a combination

thereof shall be at locations sufficiently remote from each other to eliminate the chance exposure to a simultaneous hazard. Facilities used for dual storage are not required to satisfy the requirements of para. 602.1, but shall meet the requirements of para. 601.


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There are two satisfactory methods of providing storage facilities, single or dual.

603 Temporary Storage

When temporary storage of records (such as for processing, review, or use) is required, the storage facility or container shall provide a one-hour fire rating, unless dual storage requirements of para. 602.2 are met.

4.4.1 Single Storage Facility.

Design and construction of a single record storage facility shall meet the criteria of (a) through (i) below:

"Current industry practices identify the use of two methods of providing storage facilities, single or dual. (a) Single Facilities and Containers. NFPA-232-19911 provides a set of methods which may be used for the storage of records in vaults, file rooms, or records protection containers. Where file rooms are used, the following exceptions to NFPA-232-1991 should apply: (1) Work not directly associated with records storage or retrieval functions should be prohibited. (1) Forced air circulation system may be used provided it is dampered in accordance with the room rating." (Part III 17A-1,110,a) Note: There are currently more recent additions of NFPA-232 that are being considered by the committee."

(a) reinforced concrete, concrete block, masonry, or equal construction;

See discussion, above.

(b) floor and roof with drainage control; See discussion, above. If a floor drain is provided, a check valve (or equal) shall be included;


(c) doors, structure and frames, and hardware shall be designed to comply with the requirements of a minimum 2 hr fire rating;


(d) sealant applied over walls as a moisture or condensation barrier;


(e) surface sealant on floor providing a hard wear surface to minimize concrete dusting;


(f) foundation sealant and provisions for drainage;



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(g) forced air circulation with filter system; See discussion, above. (h) fire protection system; See discussion, above. (i) only those penetrations used exclusively for fire protection, communication, lighting, or temperature/humidity control are allowed; all such penetrations shall be sealed or dampered to comply with the minimum 2 hr fire protection rating.


The construction details shall be reviewed for adequacy of protection of contents by a person who is competent in the technical field of fire protection and fire extinguishing.


If the storage facility is located within a building or structure, the environment and construction of that building can provide a portion or all of these criteria.


4.4.2 Alternate Single Storage Facility. The following are acceptable alternatives to the criteria of para. 4.4.1 above for a single storage facility:


(a) 2 hr fire rated vault meeting NFPA 232-1986 or NFPA 232AM-1986 or both;1


(b) 2 hr fire rated Class B file containers meeting the requirements of NFPA 232-1986 or NFPA 232AM-1986 or both;1 or


(c) 2 hr fire rated file room meeting the requirements of NFPA 232-1986 or NFPA 232AM-1986 or both1 with the following additional provisions:


(1) early warning fire detection and automatic fire suppression capability with electronic supervision at a constantly attended central station;


(2) records storage in fully enclosed metal cabinets;


(3) adequate access and aisle ways; See discussion, above. (4) prohibition in the room of work not directly associated with record storage or retrieval;


(5) prohibition in the room of smoking, eating, or drinking;



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(6) 2 hr fire rated dampers or doors in all boundary penetrations.


4.4.3 Temporary Storage.

When temporary storage of records (such as for processing, review, or use) is required by an organization's procedures, the records shall be stored in a 1 hr fire rated container.

"The designee shall be responsible for organizing and implementing a system of receipt control of records for permanent and temporary storage." (17,500,4) “111 Temporary Storage. When temporary storage of records is necessary, such as for processing, review, or use, procedures should provide appropriate guidance on storage methods and duration.” (PIII,17A-1,111).

The procedures shall specify the maximum allowable time limit for temporary storage.

Note: Included in the above paragraph. (PIII,17A-1,111)

The container shall bear a UL label (or equivalent) certifying 1 hr fire protection or be certified by a person competent in the technical field of fire protection.

4.4.4 Dual Storage Facilities.

If dual storage facilities for each record are provided, the storage facilities shall be at locations sufficiently remote from each other to eliminate the chance of exposure to a simultaneous hazard.

“Dual Facilities. If storage at dual facilities for records is provided, the storage facilities should be sufficiently remote from each other to minimize the risk of exposure to a simultaneous hazard.” (PIII,17A-1,110b)

Each storage facility is not required to satisfy the requirements of para. 4.4.1, para. 4.4.2 or para. 4.4.3 above, but shall meet the other requirements of this Part (Part I).

Note: This section is not a requirement but presents storage facility options.

5 RETRIEVAL

Storage systems shall provide for retrieval of information in accordance with planned retrieval times based upon the record type.

"(b) Records shall be retrievable." (17,800,b) “A key function of a records system is to ensure that records are retrievable through their life cycle. Therefore, the records system should provide for retrievability within a period of time commensurate with the importance and impact of the information contained in the record.” (PIII,17A,112,1&2)


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A list shall be maintained designating those personnel who shall have access to the files.

"(a) Records shall be protected from damage or loss." (17,800a) “These measures include access lists, …” (PIII,17A-1,109d,2)

Records maintained by a Supplier at his facility or other location shall be accessible to the Purchaser or his designated alternate, e.g., the Owner.

"The procurement documents shall provide for access to the Supplier’s and sub-tier Supplier’s facilities and records for surveillance, inspection or audit by the Purchaser, its designated representative, and others authorized by the Purchaser.(Req.4,204,1) “Records maintained at a Supplier’s facility or other location should be accessible to the Purchaser or a designated alternate.” (PIII,17A-1,112,3)

600 Disposal Electronic records designated for disposal should be erased or overwritten since use of the delete key may not actually delete the record but only make it irretrievable for one using the standard access methods. Physical destruction of the storage media or device may be used as an acceptable alternative. Storage media previously used for electronic records containing sensitive or proprietary information should not be reused. (PIII,17A-2, 600, 2005 Addenda)

6 DISPOSITION 700 RETENTION 700 Maintenance of Records Lifetime electronic records should be reviewed periodically for legibility. This review should also confirm the accessibility and retrievability of the record, thus providing assurance that compatible software and hardware systems are available. Media intended for storage of electronic records should be tested prior to use to assure that it is free of errors, defects and corruption. (PIII,17A-2, 700, 2005 Addenda))

(a) Record retention periods shall be documented.

(b) Records shall be maintained for their retention periods.


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The Supplier's nonpermanent records shall not be disposed of until the applicable conditions listed in (a) through (e) below are satisfied:

"When the Purchaser requires the Supplier to maintain specific records, the retention times and disposition requirements shall be prescribed." (4,205,3)

(a) items are released for shipment, a Code Data Report is signed, or a Code Symbol Stamp is affixed;

b) regulatory requirements are satisfied; (c) operational status permits; (d) warranty consideration is satisfied; (e) Purchaser's requirements are satisfied. 800 MAINTENANCE RECORDS (a) Records shall be protected from damage or loss. (b) Record controls shall provide for retrievability

within planned retrieval times based upon the record type or content.

(c) The methods for record changes shall be documented.

(d) Provisions shall be established to ensure that no

unacceptable degradation of the electronic record media occurs during the established retention period.

(e) Provisions shall be made to ensure that the records remain retrievable after hardware, software, or technology changes.

(f) Provisions shall be established to ensure the following when records are duplicated or transferred to the same media or to a different media for the purposes of maintenance or storage:

(1) duplication or transfer is appropriately authorized

(2) record content, legibility, and retrievability are maintained


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CHANGES TO NONMANDATORY APPENDIX 17A-1

NONMANDATORY APPENDIX 17A- 1 Guidance on Quality Assurance Records 100 GENERAL This Appendix provides nonmandatory guidance on records as specified in Requirement 17 of Part I.

101 Records System

Records systems should be established and documented prior to implementation of work activities.

102 101 Generation of Records

The applicable design specifications, procurement documents, test procedures, operational procedures, or other documents should specify the records to be generated, supplied, or maintained. Documents that are designated to become records should be legible, accurate, and completed appropriate to the work accomplished so that they can be read and understood and be traceable to the associated items or activities.

103 102 Authentication of Records Statements of authenticity, handwritten signatures, electronic signatures, or any other means that ensures traceability to a specific individual or organization of authentication and associated date are acceptable methods of authentication. If initials or codes are used for identification, then a system should be established to ensure traceability to the authenticating individual or organization. The records system should provide methods for authenticating copies of original records when the


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original record is contaminated or lost and a copy of the original record is available.

104 103 Records Stored on Magnetic or Optical Media Provisions should be made for the capability to retrieve information stored on magnetic or optical media. Compatible processing systems should be available, or information should be transferred to other readable media.

105 104 Indexing Indexing can take many forms, including directories or listings. Indices should identify summary information for the records, such as the associated item or activity, title or description, originating individual or organization, retention period ( lifetime or nonpermanent), location, and the media used for retention. For nonpermanent records, the period of retention should be defined.

106 105 Corrected Information in Records Records may be corrected in accordance with procedures that provide for appropriate review or approval by the originating organization. When records are corrected, it is a gGood practice for that such corrections should include the date and identification of the person authorized to issue such corrections.

107 Receipt The receipt control system is established to ensure that records are protected from loss or damage. Such systems provide a method for identifying records received, and the location of records during the receiving process. Normally, procedures are established for the receipt and inspection of incoming records and for transmitting records to a permanent storage facility in a timely manner.


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108 106 Storage

The records should be stored in predetermined location( s) that meet the requirements of applicable standards, codes, and regulatory agencies. A written storage procedure should be prepared and responsibility assigned for the implementing procedure. Storage procedures are suggested that include the following: ( a) a description of the storage facility ( b) the filing system to be used ( c) a method for verifying that the records received are in agreement with the transmittal document and that the records are legible ( d) a method of verifying that the records are those designated ( e) the rules governing access to and control of the files ( f) a method for maintaining control of and accountability for records removed from the storage facility ( g) a method for filing supplemental information and disposing of superseded records.

109 107 Preservation and Safekeeping To help ensure the preservation and safekeeping of records, the following should be considered: (a) placement of records in binders, folders, or envelopes for storage in steel file cabinets or on shelving. (b) prevention of damage from environmental conditions. (c) manufacturer’s recommendations on storage. (d) measures to preclude the entry of unauthorized personnel into the records system or storage area for protection from larceny or vandalism. These measures may include access lists, locked entry, and attendant security, or a combination of these measures. (e) measures for replacement restoration, or


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substitution of lost or damaged records. (f) inspections of records to detect deterioration.

110 108 Facilities and Containers Current industry practices identify the use of two methods of providing storage facilities, single or dual. (a) Single Facilities and Containers. NFPA- 232¹- 1991 provides a set of methods that may be used for the storage of records in vaults, file rooms, or records protection containers. Where file rooms are used, the following an exceptions to NFPA- 232- 1991 should be appliedy: ( 1) Work not directly associated with records storage or retrieval functions should be prohibited. ( 2) F to permit forced air circulation system may to be used, provided it is dampered in accordance with the room rating. ( b) Dual Facilities. If storage at dual facilities for records is provided, the locations of the facilities should be sufficiently remote from each other to minimize the risk of exposure to a simultaneous hazard. the establishment of sufficiently remote storage facilities depends on the type of hazard, such as earthquakes, fires, tornadoes, etc., and the probability for occurrence of these hazards.

111 Temporary Storage When temporary storage of records is necessary, such as for processing, review, or use, procedures should provide appropriate guidance on storage methods and duration.

112 109 Retrieval A key function of a records system is to ensure that records are retrievable through their life cycle. Therefore, the records system should provide for retrievability within a period of time commensurate


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with the importance and impact of the information contained in the record. Records maintained at a Supplier’s facility or other location should be accessible to the Purchaser or a designated alternate.

113 110 Records Transfer to Owner or Purchaser Records accumulated at various locations, prior to transfer, should be made accessible to the Owner or Purchaser directly or through the procuring organization. For records transferred to the Owner or Purchaser, it is recommended that the Owner or Purchaser inventory the submittals, and acknowledge receipt. Prior to transfer of the Supplier’s records, the Supplier should consider the following: ( a) ASME Boiler and Pressure Vessel Code requirements are met ( b) regulatory requirements are satisfied ( c) operational requirements are satisfied ( d) warranty consideration is satisfied ( e) Purchaser’s requirements are satisfied

BASIC REQUIREMENT 18 AUDITS REQUIREMENT 18 AUDITS

100 BASIC Planned and scheduled audits shall be performed to verify compliance with all aspects of the quality assurance program and to determine its effectiveness.

Audits shall be performed to verify compliance to quality assurance program requirements, to verify that performance criteria are met, and to determine the effectiveness of the program.

These audits shall be performed in accordance with written procedures or checklists by personnel who do not have direct responsibility for performing the activities being audited.

These audits shall be performed in accordance with written procedures or checklists by personnel who do not have direct responsibility for performing the activities being audited.

Audit results shall be documented and reported to and reviewed by responsible management.

Audit results shall be docu-mented and reported to and reviewed by responsible management.

Follow-up action shall be taken where indicated.

Follow- up action shall be taken where indicated.


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SUPPLEMENT 18S-1 SUPPLEMENTARY REQUIREMENTS FOR AUDITS

1 GENERAL This Supplement provides amplified requirements for quality assurance audits.

It supplements the audit requirements of Basic Requirement 18 of this Part (Part I) and shall be used in conjunction with that Basic Requirement when and to the extent specified by the organization invoking this Part (Part I).

2 SCHEDULING 200 SCHEDULING Internal or external quality assurance audits, or both, shall be scheduled in a manner to provide coverage and coordination with ongoing quality assurance program activities.

Audits shall be scheduled in a manner to provide coverage and coordination with ongoing activities, based on the status and importance of the activity.

Audits shall be scheduled at a frequency commensurate with the status and importance of the activity.

The audit schedule shall be reviewed periodically and revised as necessary to assure that coverage is maintained current.

Regularly scheduled audits shall be supplemented by additional audits of specific subjects when necessary to provide adequate coverage.

Scheduled audits shall be supplemented by additional audits of specific subjects when necessary to provide adequate coverage.

3 PREPARATION 300 PREPARATION 3.1 Audit Plan 301 Audit Plan The auditing organization shall develop and document an audit plan for each audit.

The auditing organization shall develop an audit plan for each audit.

This plan shall identify the audit scope, requirements, audit personnel, activities to be audited, organizations to be notified, applicable documents, schedule, and written procedures or checklists.

This plan shall identify the audit scope, requirements, audit personnel, activities to be audited, organizations to be notified, applicable documents, schedule, and written procedures or checklists.

3.2 Personnel 302 Personnel The auditing organization shall select and assign auditors who are independent of any direct responsibility for performance of the activities which they will audit.


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In the case of internal audits, personnel having direct responsibility for performing the activities being audited shall not be involved in the selection of the audit team.

Audit personnel shall have sufficient authority and organizational freedom to make the audit process meaningful and effective.

Audit personnel shall have sufficient authority and organizational freedom to make the audit process meaningful and effective.

3.3 Selection of Audit Team 303 Selection of Audit Team An audit team shall be identified prior to the beginning of each audit.

An audit team shall be identified prior to the beginning of each audit.

This team shall contain one or more auditors and shall have an individual appointed to lead the team who organizes and directs the audit, coordinates the preparation and issuance of the audit report, and evaluates responses.

This team shall contain one or more Auditors, one being designated Lead Auditor who organizes and directs the audit. The audit team shall have experience or training commensurate with the scope, complexity, or special nature of the activities to be audited.

The audit team leader shall ensure that the audit team is prepared prior to initiation of the audit.

"Prior to commencing the audit, the Lead Auditor should confirm that the assigned audit personnel collectively have experience or training commensurate with scope, complexity, or special nature of the activity being audited. To ensure that the audit team is prepared prior to initiation of audit, pertinent information, including policies, procedures, standards, instructions, codes, regulatory requirements, and prior audit reports, should be made available for review by the Auditors. (Part III, 18A-1, 302, 1 & 2)

Changes to Appendix 18A-1 302 Team Familiarization Prior to commencing the audit, the Lead Auditor should confirm that the assigned audit personnel collectively have experience or training commensurate with scope, complexity, or special nature of the activities being audited. To ensure that the audit team is prepared. prior to initiation of audit, Pertinent information......

4 PERFORMANCE 400 PERFORMANCE Audits shall be performed in accordance with written procedures or checklists.

Auditing shall begin as early in the life of the activity as practical and shall be continued at

"Auditing should begin as early in the life of the activity as practical and should be continued at


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intervals consistent with the schedule for accomplishing the activity.

intervals consistent with the schedule for accomplishing the activity." (Part III, 18A-1, 203, 1) 203 Frequency of Audits Auditing should begin as early in the life of the activity as practical and should be continued at intervals consistent with the schedule for accomplishing the activity. Frequency of regularly scheduled internal and external audits should be commensurate with the status and importance of the associated activities and based upon annual evaluations of all applicable and active elements of the quality assurance program. Audits These evaluations whether conducted separately or via audits should include an evaluation assessment of the effectiveness of the applicable and active elements of the program adequacy and effective implementation of the quality assurance program based upon review of such information as the following: (a) previous audit results and corrective actions their dispositions; (b) internal and supplier documents and records, such as nonconformance reports, corrective action reports, and their dispositions; (c) independent information, e.g., from external sources such as generic experience of the nuclear industry, ASME, peer organizations, regulating bodies, etc.; (d) supplier histories for similar products or services; and (e) changes in responsibilities, resources, or management. 203.1 Regularly Scheduled Internal Audits Internal audits of organizations and facility activities, conducted prior to placing the facility in operation, should be performed in such a manner as to assure that an audit of all applicable quality assurance program elements is completed for each functional area1, e.g., Operations, Maintenance,


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Engineering, Radwaste, at least once each year or at least once during the life of the activity, whichever is shorter. Internal audits of activities, conducted after placing the facility in operation, should be performed in such a manner as to assure that an audit of all applicable quality assurance program elements is completed for each functional area1 within a period of two years. Internal audit frequencies of well established activities, conducted after placing the facility in operation, may be extended one year at a time beyond the above two year interval based on the results of an annual evaluation of the applicable functional area and objective evidence that the functional area activities are being satisfactorily accomplished. The evaluation should include a detailed performance analysis of the functional area based upon applicable internal and external source data and due consideration of the impact of any functional area changes in responsibility, resources or management. However, the internal audit frequency interval should not exceed a maximum of four years. If an adverse trend is identified in the applicable functional area, the extension of the internal audit frequency interval should be rescinded and an audit scheduled as soon as practicable. 203.2 Regularly Scheduled External Audits External audits, e.g., supplier audits, should be performed on a triennial basis and supplemented by annual evaluations of the supplier’s performance. A continuous or ongoing evaluation of the supplier’s performance may be conducted in lieu of the annual evaluations provided that the results are reviewed in order to determine if corrective action is required. If more than one purchaser utilizes a supplier, the purchaser may arrange for an audit of the supplier on behalf of itself and the other purchasers to reduce the number of external supplier audits. The scope of the audit should address the needs of all purchasers and the report should be distributed to


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purchasers for whom the audit was conducted. Each purchaser relying on the results of such an audit remains individually responsible for the adequacy of the audit and for its use by their organization. 204 Supplemental Audits Regularly scheduled audits should be supplemented by additional audits for any of the conditions noted below: (a) to determine the capability of a supplier’s quality assurance program prior to awarding a contract or purchase order; (b) when, after award of a contract, sufficient time has elapsed for implementing the supplier’s quality assurance program and it is appropriate to determine that the organization is adequately performing the functions defined in the quality assurance program description, codes, standards, and other contract documents; (c) when significant changes are made in functional areas of the quality assurance program, such as: reorganizations, process or process control changes, mission or work scope changes or procedure revisions; (d) when it is suspected that the quality of a product is in jeopardy due to deficiencies in the quality assurance program; (e) when directed by management to verify the effectiveness of the quality assurance program; and (f) when it is necessary to verify effectiveness of required corrective action. (d) when it is suspected that the quality of a product is in jeopardy due to deficiencies in the quality assurance program; (e) when directed by management to verify the effectiveness of the quality assurance program; and (f) when it is necessary to verify effectiveness of required corrective action.


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205 Audit Equivalents Audit equivalent activities such as independent assessments and technical surveillances may be used to satisfy part or all of an audit requirement provided that (1) they each meet the requirements for a quality assurance audit as defined in this standard, and (2) they are reviewed and approved for such use by the organization responsible for quality assurance audits prior to their performance. 206 Audit Schedule Compliance A grace period of 90 days may be applied to the scheduled audit intervals but the periodicity of these audits should be based on the original schedule. Upon completion of a regularly scheduled audit, supplemental audit, or sanctioned audit equivalent activity that satisfies the audit requirement for all applicable quality assurance program elements, the time period for the next required audit may be reset. Quality assurance audit frequency extensions and grace periods should not be applied to other periodic assessments, evaluations or audits governed by regulations or by facility-specific technical specifications, unless approved by the appropriate authority. 1 “functional area” denotes plant activities such as Engineering, Construction, Procurement, Operations, Maintenance, Radiological Protection, Chemistry, Security, etc. (Part III, 18A-1, 203, 2005 Addenda)

Elements that have been selected for audit shall be evaluated against specified requirements.

Elements selected for audit shall be evaluated against specified requirements.

Objective evidence shall be examined to the depth necessary to determine if these elements are being implemented effectively.

Objective evidence shall be examined to the depth necessary to determine if these elements are being implemented effectively.

Audit results shall be documented by auditing personnel and shall be reviewed by management having responsibility for the area audited.


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Conditions requiring prompt corrective action shall be reported immediately to management of the audited organization.

Conditions requiring prompt corrective action shall be reported immediately to management of the audited organization.

5 REPORTING 500 REPORTING The audit report shall be signed by the audit team leader and issued, and it shall include the following information, as appropriate:

The audit report shall be signed or otherwise endorsed by the Lead Auditor and issued to the audited organization.

The contents of the report shall (a) description of the audit scope; (a) describe the audit scope (b) identification of the auditors; (b) identify Auditors and persons contacted (c) identification of persons contacted during audit activities;

(d) summary of audit results, including a statement on the effectiveness of the quality assurance program elements which were audited;

(c) summarize audit results, including a statement on the effectiveness of the elements audited

(e) description of each reported adverse audit finding in sufficient detail to enable corrective action to be taken by the audited organization.

(d) describe each reported adverse audit finding

6 RESPONSE 600 RESPONSE Management of the audited organization or activity shall investigate adverse audit findings, schedule corrective action, including measures to prevent recurrence, and notify the appropriate organization in writing of action taken or planned.

Management of the audited organization or activity shall investigate adverse audit findings, schedule corrective action, including measures to prevent recurrence of significant conditions adverse to quality, and notify the appropriate organization in writing of action taken or planned.

The adequacy of audit responses shall be evaluated by or for the auditing organization.

Audit responses shall be evaluated by or for the auditing organization.

7 FOLLOWUP ACTION 700 FOLLOW-UP ACTION Follow-up action shall be taken to verify that corrective action is accomplished as scheduled.

Follow-up action shall be taken to verify that corrective action is accomplished as scheduled.

8 RECORDS 800 RECORDS Audit records shall include audit plans, audit reports, written replies, and the record of completion of corrective action.

Audit records shall include audit plans, audit reports, written replies, and the record of completion of corrective action.