EED Nuclear QA Auditor Training Handbook The Vital ...asq.org/audit/2017/10/auditing/eed-nuclear-qa-auditor...EED Nuclear QA Auditor Training Handbook Supplements (cont’d) •2017

EED Nuclear QA Auditor Training

Handbook

The Vital Qualification Tool

Karen M. Douglas

13 October 2017

Applications of Nuclear Quality Assurance

• Domestic Commercial Nuclear Power Operations - US NRC Regulated,

10CFR50

– 99 Operating Nuclear Reactors

– Spent Nuclear Fuel – 10CFR72 Storage, 10CFR71 Transport, Disposal,

10CFR72 Casks

– Service Providers (ISI, Welding, Fabrication, Testing, Maintenance,

Calibration) follow ASME Section III, V, IX, XI

• Defense Nuclear Applications – US DOE Regulated, 10CFR830

– Radioactive Waste Management

– Nuclear Facilities and Nuclear Research

• Suppliers of Systems, Structures, Components & Services for Nuclear Safety

Applications

• International Nuclear Applications – ASME NQA-1, IAEA-GS-R3

– 449 Operating Nuclear Reactors in 30 Countries

– 66 New Reactors under Construction (2015)

26th Annual ASQ Audit Division Conference: The Intercontinental Addison

2

Evaluation of Nuclear Quality Assurance compliance

• ASME NQA-1 Quality Assurance Requirements for Nuclear Facility

Applications

– Dominant Standard for Domestic and International Nuclear Industry

– 4 Parts, 18 Criteria (2008 Standard)

– Specific Auditing Techniques Applicable

– Standardized Nuclear QA Auditor Training & Qualification

• Nuclear QA Auditor Qualification and Maintenance of Proficiency

– Specific Training, Examination, Experience for Nuclear Applications

(Figures 4.7, 4.8, 4.9)

– Tools and Learning Methods Essential to Nuclear QA Auditor

Proficiency


3

ASME NQA-1 QA Requirements for Nuclear Facility Applications

2008 with 2009 Addenda 18 elements


4

ASQ EED Nuclear Quality Assurance Auditor Training Handbook

• ASQ EED Nuclear QA Auditor Training Handbook – History (Contents)

– 1986 Quality Systems Auditor Training Handbook, ASQC Education and

Training Committee of the Energy Division

• Practical Examples for Nuclear QA Auditing Applications

– 2 Blank and 14 Completed Forms

– 4 Diagrams

– 4 Completed Tables

• 4 Case Studies

– Illustrate typical Nuclear Audit Scenarios

– Feature conversations between Auditor and Auditee

– Case Study Solutions and Audit Deficiencies with Criteria included

– 1999 Revision incomplete

– 2016 EED Handbook Requested for Auditor Training in China; previously

IAEA expressed interest


5

EED Nuclear Quality Assurance Auditor Training Handbook

2018 Revision

• Retains Practical Approach used for 1986 Auditor

Handbook

• Revises and Supplements Standards, Figures, and

Examples

• Incorporates new Programs instituted since 1986

– Section 7.1 Commercial Grade Dedication and

Commercial Grade Dedication of Software

– Section 7.2 Suspect/Counterfeit Items

– Section 7.3 Software Verification and Validation

– Section 7.4 Control of Electronic Records


6

EED Nuclear QA Auditor Training Handbook Supplements

(cont’d)

• 2017 Case Study Supplements

– Case Study #5 External – Subcontractor Readiness

Audit

– Case Study #6 Source Verification for Commercial

Grade Item Dedication (Method 3)

– Case Study #7 Suspect/Counterfeit Items

– Case Study #8 Software Use in Nuclear Applications

– Case Study #9 Software Verification and Validation

– Case Study #10 Control of Electronic Records


7

EED Nuclear Quality Assurance Auditor Training Handbook

Sample Figures

• Figures 4.5, 4.6 Example of Audit Plan Form &

Completed Audit Plan

• Figures 4.7, 4.8, 4.9

– Example of ASME NQA-1 Lead Auditor Qualification Form

– Completed ASME NQA-1 Record of Lead Auditor Qualification

(1993 & 2014)

• Case Study #3 Nuclear Utility Construction (1986

Handbook with Worksheet identifying Deficiencies)

• Case Study #6 Commercial Grade Dedication (Nuclear

Application & Figures)


8

Audit Plans – Blank and Completed


AUDIT NOTIFICATION

AND

AUDIT PLAN

AUDIT NO.:

#####

NOTIFICATION OF AUDIT

DATE:

TO: LOCATION:

FROM: LOCATION:

DATE OF AUDIT: CC:

An audit has been scheduled to be performed as indicated below. If there is a problem concerning the plan, or a conflict with the

schedule, please contact the team leader. Any changes to the plan or date of audit must be confirmed in writing.

AUDIT TEAM LEADER / TELEPHONE NO.:

AUDIT TEAM:

TENTATIVE SCHEDULE:

PRE AUDIT:

POST AUDIT:

AUDIT PLAN

ORGANIZATION / ACTIVITY TO BE AUDITED:

PURPOSE / SCOPE:

PROGRAM REQUIREMENTS / APPLICABLE PROCEDURES:

Quality Program:

Departmental Procedures:

Project Procedures:

Other:

CHECKLIST REFERENCE:

PREVIOUS AUDIT:

Audit No: Date:

AUDIT TEAM LEADER SIGNATURE

Findings: Yes: [ ] No: [ ]

AUDIT NOTIFICATION

AND

AUDIT PLAN

AUDIT NO.:

2017- Nuc –PF8

NOTIFICATION OF AUDIT

DATE: June 6, 2017

TO: John Harmen, QA Manager, Pennsylvania Forge LOCATION: 5401 1st St. NW, Pittsburgh, PA

FROM: Josephine Kemp, QA Manager, Rodey Fabrication LOCATION: Charlotte, NC

DATE OF AUDIT: July 11-13, 2017 CC: Edith Talbot, Technical Manager

An audit has been scheduled to be performed as indicated below. If there is a problem concerning the plan, or a conflict

with the schedule, please contact the team leader. Any changes to the plan or date of audit must be confirmed in writing.

AUDIT TEAM LEADER / TELEPHONE NO.:

Carla Thomas/(807) 295- 6186

AUDIT TEAM:

Robert Wilmot

Peter Jenkins

Bernadette Diaz

TENTATIVE SCHEDULE: July 11 – 13, 2017

PRE AUDIT: Tuesday, July 11 9 :00 am

POST AUDIT: Thursday, July 13 3 :00 pm

AUDIT PLAN

ORGANIZATION / ACTIVITY TO BE AUDITED:

Pennsylvania Forge Supplier qualification/Machining and QC inspection of component for 10CFR72 Dry Cask Storage

of Nuclear Material

PURPOSE / SCOPE: Addition to Rodey Fabrication Qualified Supplier List/ASME NQA-1 2008 with 2009 Addenda

PROGRAM REQUIREMENTS / APPLICABLE PROCEDURES:

Quality Program: Pennsylvania Forge Quality Assurance Program, April 2016

Departmental Procedures: Pennsylvania Forge procedures controlling:

Training and Qualification, Receiving Inspection, Identification and Control of Items, Mechanical Inspection, Control of

Measuring and Test Equipment, Procurement, QA Records

Project Procedures: Rodey Manufacturing Control Drawing #2015- UCL33267, Rev. G; Rodey Material Specification

#CS-4J275, Rev. B, 2/15/14

Other:

CHECKLIST REFERENCE: N/A

PREVIOUS AUDIT: N/A

Audit No: Date:

AUDIT TEAM LEADER SIGNATURE

Carla Thomas

Findings: Yes: [ ] No: [ ]

9

Figure 4.7 ASME NQA-1 Lead Nuclear Auditor Certification

(blank)


Lead Auditor Qualification Record

Name: _____________

Sheet 1 of ___

Qualification Requirements Credits

Education - University / Degree / Date Maximum Credits - 4

Associate Degree (1 or 2 Credits)

Bachelor Degree (2 or 3 Credits)

Masters Degree (1 Credit)

Experience - See Resume Maximum Credits - 9

Technical (0 to 5 Credits) and

Nuclear Industry/ (0-1 Credit) or ISO 9000

Quality Assurance (0 to 3 Credits) or

Auditing (0 to 4 Credits)

Professional Accomplishment - Certificate / Date Maximum Credits - 2

Professional Engineer

Society

Rights of Management Maximum Credits - 2

Justification:

Evaluated By: Title: Date:

Credits Assigned By: Title: Date: Total Credits

Audit Communications Skill

Evaluated By: Title: Date:

Audit Training: See Training Records

Audit Participation: See Audit Participation

Examination

Written: (Grade)

Oral: (Evaluation)

Practical: (Evaluation)

Evaluator Title Date

Qualification Certified By: Title: Date:

10

Figure 4.8 ASME NQA-1 Lead Nuclear QA Auditor Recertification

2014


{Graphic}

11

Figure 4.9 ASME NQA-1 Lead Nuclear QA Auditor Recertification

1993


12

Case Study #3 Nuclear Construction Supplier Assessment

1986 Handbook


13

Case Study #6 – Commercial Grade Dedication

Source Verification (Method 3)


Case Study #6 (Commercial Grade Dedication)

Application

Source Verification for Commercial Grade Item Dedication (Method 3) - see Figure 7.2

Source Verification

Scope

Compliance to ASME NQA-1, Part II, Subpart 2.14 QA Requirements for Commercial Grade

Items and Services, 2009; 604 Method 3 Source Verification

Setting

The Audit begins in the Conference room of Hanover Forge. Following presentation of Hanover

Forge History, Manufacturing Capabilities, and Industries Served by QA Manager, the NuCargo

Auditor/Source Inspector, Hanover Engineer and QA Manager proceed to QC Department,

where Hanover Quality Engineer initiates the tour of Manufacturing. The QA Manager departs,

requesting that she is informed when NuCargo is concluding the Source Verification, and will

join them later the same afternoon.

Main Characters

James T. Randall – NuCargo Auditor/Source Inspector

Jeanette Finlay – Quality Assurance Manager, Hanover Forge

Mark Sanders – Quality Engineer assigned by Hanover Forge as a guide

“James, Hanover has a long history dating back to 1974 with customers in the Defense industry,

Automotive industry, farm equipment manufacturing, and Energy producers. Although this is

our first item produced for NuCargo, we anticipate additional orders from Nuclear Power Plants

in the future. Defense industries were our initial customer base and our QA Program has been

audited annually for compliance to Defense Standards. We expect you will be pleased with our

personnel qualification, measurement capabilities, and records retention.”

“Mark, NuCargo reviewed some of Hanover’s records including prior products to ensure

manufacturability as the component you are processing for NuCargo, the Nuclear Fuel Shipping

Cask Inner Shield Lid, is both expensive and requires compliance to rigorous Nuclear Safety

provisions specified in the Code of Federal Regulations. Please include the equipment used to

finish the Inner Shield Lid during Hanover Forge tour.”

“You just viewed the fabrication equipment used to finish the NuCargo Cask Lid, and these are

the Training Records for Jay Watson, indicating he was initially qualified to operate this

equipment in March 2011 and requalified to production using current Hanover procedure #HF-

M13 Rev B on 10/12/16.”

14

Completed Handbook Figures Demonstrate Application

• Section 7.1 Commercial Grade Dedication of

Items and Processes

– 4 Methods (Inspection and Test, Commercial Grade

Survey, Source Verification, and Supplier/Item

Performance record)

– Figure 7.1 Commercial Grade Item Technical Evaluation

– Figure 7.2 Source Verification for Commercial Grade

Item Dedication

– Figure 7.3 Acceptance of Commercial Grade Item


15

Section 7.1 Commercial Grade Dedication


Procurement Considerations

As CGD applies only to Safety Items, the SSC must reliably perform its intended safety function.

Performance in this safety application is essential, therefore, procurement requires that Critical

Characteristics for Acceptance (CCFA) must be verified. This CCFA Verification may employ

these methods:

• Inspection and Test

• Commercial Grade Survey

• Source Verification, and

• Supplier/Item Performance record

The selection of dedication method(s) is based on the type of critical characteristics to be

verified for acceptance (derived from item form, fit, and function in actual service conditions),

available supplier information, quality history, and degree of standardization. Commercial

Grade Item acceptance criteria for the verification method selected should be consistent with the

plant-specific application and most severe conditions.

1) Inspection and Testing require supplier data regarding material pedigree (e.g.,

drawings/specifications, material composition and processing history). Supplier

acceptance method and selection of a sampling plan requires adequate review and

justification.

2) Commercial grade Surveys may be performed to ensure supplier processes and controls

are adequate for item production/service performance. Survey frequency should be

selected to ensure uniformity of controls for additional item/services. A supplier

Certificate of Conformance may be submitted verifying programs and processes

utilized during CGI production remained the same as evaluated during survey and adhere

to provisions of the procurement contract. Documentation/certification is acceptable only

from a sub-tier supplier that has been surveyed or audited by the dedicating entity and

when the basis for acceptability and validity of the supplier’s documentation has been

established and documented, as sub-tier suppliers may not be familiar with the part’s

design or intended function in the component. Surveys may not qualify items procured

from distributors where handling includes warehousing or repackaging of items.

3) During Source Verification, sampling plans selected for items must ensure homogeneity

and lot traceability is maintained. Services may be verified during performance or at

conclusion of service performance with identification of manufacturing or test phase

Figure 7.2 and Case Study #6). Additional supplier documentation and records examined

may include design, procurement, calibration and material processes and controls.

Objective evidence of information examined during the dedication process and activities

observed must be retained including verification method for CCFA and hold points

stipulated for witness of in-process measurements (Figure 7.2).

4) Supplier/Item Performance Record may supplement the previous 3 acceptance

methods but does not suffice for CGD approval of suppliers. Performance records

16

Figure 7.1 CGD Technical Evaluation (select Critical Characteristics)

ASME NQA-1 Requirements: #3 Design Control, #7 Control of Purchased Items and Services, #11 Test Control,

#12 Control of Measuring and Test Equipment


Figure 7.1 Commercial Grade Item Dedication - Technical Evaluation

Section A) Item Description

FuelPac International – UNF 385 Spent Nuclear Fuel Cask #67-1014

• Storage Overpack – Concrete Lid

• Inventory Control #FP-276

Section B) End-Use/Parent/Host Equipment Information

1. Safety Related Yes X No

2. Passive X Active

3. Basic Safety Function

a. Structural Integrity- Maintain Confinement (Retain Spent Nuclear Fuel within Cask),

Ensure Retrievability

b. Radiation Shielding – Radiation Protection to the Public and On-site Worker i/a/w

10CFR72.104, 10CFR72.106, 10CFR20

Section C) Eligibility for Dedication

1. Commodity or Standard Item Yes No X

2. Codes Applicable – Plain Concrete/American Concrete Institute Code #349-85; ASME Code

1995 Edition with Addenda through 1997

Section D) Failure Modes and Effects Analysis

1. Credible Failure Modes:

a. Thermal – Burial in soil with blockage of air inlets and without potential for cooling

b. Immersed in Flame – Modeled by ANSYS Computer Code; Risk accepted by NUREG

2943

2. Basis for Selection: 6/1/2000 NRC Safety Analysis Report, Section 9.1 Accident Analysis

Section E) Critical Characteristics

1. Dimensions: D- _85’ 11.125”____ Thickness- 8.624”______

2. Concrete Testing – ASTM C39 Test Specimens

a. Compressive Strength – ASTM C1107: Pass

b. Volume Change – ASTM C1107: Pass

Review and Approval

Prepared by: James Hoffman Date: 7/12/15

Reviewed by: Robert Barkley Date: 7/14/15

17

Figure 7.2 CGD Source Verification (Method 3)


Figure 7.2 Source Verification of Supplier for Dedication of Commercial Grade Item

Date: 12/21/16

Component: NuFab International – Shielded Shipping Cask for Irradiated PWR Fuel Assemblies

Transportation Cask Inner Steel Lid/Inventory Control #NuFab-27

Type 304 Stainless Steel product for further processing

Safety Application: Spent Nuclear Fuel Storage - Structural Integrity; Containment Boundary

Safety Specification: NRC CoC #9235 Rev. 11 Package ID USA/9235/B(U)F-96

_____________________________________________________________________________________

Supplier Identification: Hanover Forge, 1406 Longview Road, Pittsburgh, PA

Critical Characteristics for Acceptance:

Dimensions:

1. Diameter (86.700’ +/_ 0.500 “ required/ 85’ 11.125 “ actual)

2. Thickness (9.000” +/- 0.125” required/ 8.946”actual)

Fabrication Process: Form and Finish (grind, polish to #7 finish, buff) Disc from NuFab Stock provided

to final specification per Procedure #HF-M13 Rev B 10/14/12 as specified on NuFab Drawing #9235-

423G Rev C 3/17/09

Raw Material: Type 304SS

Operator JNW Procedure #HF-M13 Rev B Training Records of Operator: Recertified 10/12/16

Calibration:

Records Critical Characteristics Attributes Inspection: 12/4/16 Calibration of Instruments used for

Mechanical Inspection

Sub-Tier Suppliers for CGI: Viking Instruments – Qualified for instrument calibration by NuFab

Corporate QA 11/7/16

Qualification Method: NuFab Corporate QA Assessment of Viking Instruments (ASME NQA-1 2008

with 2009 Addenda)

NuFab Source Inspector James T. Randall________ Date ____2/23/17____

18

Figure 7.3 CGID Acceptance (Critical Characteristics credited for Nuclear Safety)


Figure 7.3 Commercial Grade Item Acceptance Record

Date Received: 11/6/2016

Commercial Grade Item: FuelPac 125 Ton TranSNF Transfer Cask (for use in FuelPac

360 Cask System)

Safety Application: The function of the transfer cask is to provide radiation and structural

protection of the Spent Nuclear Fuel during loading, unloading, and transfer operations.

(The TranSNF transfer cask is used for various plant operations, such as, normal onsite

transport of spent nuclear fuel. In the event of a postulated accident, the transfer cask

must not suffer permanent deformation to the extent that the ready retrievability or

confinement integrity of the Spent Nuclear Fuel is compromised. Structural characteristics

as specified in 10 CFR 72.24).

Supplier: Atlas Fabrication Corporation Date Qualified: 2/17/16

Specification Stress Limits per ASME Code, Section III, Subsection NF, Class 3; TranSNF

transfer cask is a carbon steel, lead, steel layered cylinder (steel structural material, SA-516

Grade 70) which possesses sufficient fracture toughness to preclude brittle fracture.

Critical Characteristics for Acceptance: Fracture Toughness to ensure intact following

drop accident

Acceptance Method: Charpy V-Notch Test at minimum Service Temperature

Critical

Characteristic

Test

Method

Specification Acceptance Criteria Accept

Y/N

Fracture

Toughness for

Side-Drop Test

Charpy

V-Notch

Testing

at 0 F

ASME Code,

Section III,

Subsection NF,

Articles

NF-2300 and

NF-2430

TranSNF: Horizontal

(side) drop; meet level

D TranSNF

stress limits for NF

Class 3 components:

Shell - 3.4.9.1 away

from the impacted

zone; show lids stay

in-place.

Transfer Lid-

3.4.4.3.3.3

Show primary and

secondary impact

Slapdown - 3.4.9.2

decelerations are

within design basis.

(This case is only

applicable to

TranSNF)

Y

19

EED Nuclear QA Auditor Training Handbook

Path Forward

• Review and Update Codes and Standards

• Validate and Supplement Figures

• EED Nuclear Committee Review for Consistency and Style

• Editing and EED Council Review

• ASQ Audit Division Review

• Quality Press Publication 2018 (English)

• Translation for Emerging Markets (e.g., China, Korea,

MEA, UAE, India)


20

EED Nuclear Committee


Questions?

21

Documents

EED Nuclear QA Auditor Training Handbook The Vital ...asq.org/audit/2017/10/auditing/eed-nuclear-qa-auditor...EED Nuclear QA Auditor Training Handbook Supplements (cont’d) •2017