EPICOR, INCORPORATED CORPORATE QUALITY MANUAL

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0.0 INTRODUCTION Epicor has established, documented, and maintains a formal quality system including a quality manual to ensure that products conform to specified requirements. This document contains Epicor’s Quality Assurance Manual and associated quality assurance procedures and work instructions. Accordingly, this quality manual describes the policies and company-wide control system of Epicor, Incorporated’s (Epicor’s) quality management system. This quality management system is designed to insure that the customer’s Ion Exchange resin purchase specifications are satisfied. The Quality Assurance Procedures and Work Instructions of Epicor are proprietary. The Quality Management System excludes all references to Design Control, use of Customer Supplied Product and Servicing, since Epicor does not engage in these activities.

0.1 APPROVAL

This quality assurance manual has been approved in its entirety prior to issue by the executive management, signatures of which are listed below the quality policy. All subsequent revisions shall be approved by the same functions using their signatures. Epicor reserves the right to make improvements of the quality assurance procedures and work instructions without necessarily revising the quality assurance manual. This manual will receive a general review through the internal audit process, and will be revised as needed.

0.2 QUALITY MANUAL CONTROL AND REVISION The quality manual summary of revisions is shown in Section 0.3. The participation of all Epicor's employees in the development and approval of quality assurance procedures and work instructions is encouraged. Revisions to the Quality Management System are made in accordance with Section 6.3 of this Manual. The quality manual is available on Epicor's website: www.epicorinc.com.

EPICOR, INCORPORATED CORPORATE QUALITY MANUAL

http://www.epicorinc.com/

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0.3 Quality Manual Revision History Date Page Number Revision Approvals 8/02/99 All 0 11/04/99 1, 3, 4, 17, 33 1 12/30/99 3, 5, 6, 7, 8, 9, 10, 14, 36 2 1/02/03 1, 3, 4, 5, 8, 9, 10, 15, 16, 3 21, 26, 30, 35 6/05/03 4, 10, 11, 12-18, 24, 33, 34 4 1/15/09 Manual incorporated into 5

Software Program

5/18/09 Manual revised to comply 6 with ISO 9001: 2008. 01/01/19 Manual revised to comply 7 with ISO 9001: 2015.


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1.0 SCOPE It is the policy of Epicor, Incorporated (Epicor) to assure customer satisfaction by providing

the optimum product quality based on customer specifications and within the requested delivery schedule. Laboratory analyses are conducted and evaluated for the purpose of adhering to all regulatory and legal requirements and customer specifications. All records are properly filed and maintained. A safe working environment is maintained for all employees. The quality system is subject to periodic management review to ensure its effectiveness and continual improvement.


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2.0 NORMATIVE

There are no normative references associated with this Quality Manual.


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3.0 TERMS AND DEFINITIONS

ASL Approved Supplier's List Audit A survey of an entire facility. (N.B. “Audit”, as defined herein, is based on the requirements of NUPIC. The ISO definition of audit is stated under “Survey”). Approved The status given to an entity when it has been demonstrated to be capable of fulfilling requirements. Competence The ability to apply knowledge and skills to achieve intended results. Concession Permission to release a product to the customer that does not perform to specified requirements. Conformity The fulfillment of specified requirements. Context of the Organization The business environment at Epicor. A combination of internal and external factors and conditions that can have an effect on Epicor’s approach to its products and interested parties. Continual Improvement A recurring activity to enhance performance. At Epicor, this is primarily done through the Quality Assurance Group meetings and external audits and surveys. Corrective Action Plan A plan for correcting a process or part quality issue. Corrective and Preventive Action Report (CPAR) Form 14-1. Used to file reports of non-conformance.


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Critical Characteristic A distinguishing feature of a raw material or product which may impact on the safety related requirements of 10 CFR 50, Part 21.

Critical Supplier A supplier which provides goods or services which are essential to the quality of the product. Customer The recipient of a product provided by Epicor. Customer Satisfaction The customers’ perception of the degree to which the customer’s expectations have been fulfilled. Document Change Request Form 05-1. Used to request changes to forms, ASP’s, etc. Documented Information Information required to be controlled and maintained by Epicor and the medium on which it is contained. End user See Customer. Environment All of the conditions surrounding and affecting the manufacture and quality of a part or product. EP – Epicor Procedure Work instructions. Executive Management The President/Quality Assurance Director, Quality Assurance Coordinator, and members of the Quality Assurance Group (See also "Top Management'').


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Functional Verification Testing to ensure the part conforms to all customer and supplier engineering performance and material requirements. Improvement An activity to enhance performance. This may be a recurring or a singular activity. Inspection An activity such as measuring, examining, testing or gauging one or more properties of a product and comparing the results with specified requirements in order to establish whether conformity is achieved for each property. Management System A set of interacting groups at Epicor, Inc. to establish policies, objectives and the processes to achieve those objectives. Nonconformance Product or material which does not conform to Epicor and/or customer requirements or specifications. Non-conforming Material Report Form 13-1. Used to file reports of non-conformance. Objective Evidence Information which can be proved true based on facts obtained through observation, Organization A company, corporation, firm, enterprise or institution, or part thereof, whether incorporated or not, public or private, that has its own functions and administration. Performance A measurable result. Policy The intentions and direction of Epicor, Inc. as formally expressed by top management.


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measurement, test or other means. Procedure A specified way to perform an activity. A documented procedure usually contains: the purpose and scope of an activity; what shall be done by whom; when, where and how it shall be done; what materials, equipment and documents shall be used; and how it shall be controlled and recorded. Process A set of interrelated resources and activities which transform input into output. QAP Quality System Procedure. See Section 11.0 Quality The totality of properties of a product that bear on its ability to satisfy stated and implied needs. Quality Assurance Group A committee, headed by the President/Quality Assurance Director, composed of personnel assigned to the following functions: Administrative/Document Control, Quality Assurance Coordinator, Plant Manager, Production Manager, Laboratory Manager, Laboratory Technician, Technical Support, and such other personnel as assigned by the President/Quality Assurance Director. Quality Management System A management system (q.v.) with regard to quality. Quality Manual A document that describes the elements of the quality system used to assure that Epicor and customer requirements, needs and expectations are met. (Also known as the Quality System Plan). Quality Policy The overall intentions and direction of an organization with regard to quality, as formally expressed by top management.


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Quality Record A document which provides objective evidence of the extent of the fulfillment of the requirements for quality or the effectiveness of the operation of a quality system element. Quality System Plan See Quality Manual. Release Permission to proceed to the next stage of a process as indicated by various ASP’s and EP’s. At Epicor, the term is generally used to indicate placement in inventory or shipment to the customer. Repair The action taken on a nonconforming product so that it will fulfill the intended usage requirements although it may not conform to originally specified requirements. Requirement A need or expectation that may be explicitly stated, generally implied, or obligatory. Rework The action taken on nonconforming product so that it will fulfill the specified requirements. Risk The effect of uncertainty on an expected result. A risk may have positive or negative consequences. Risk Analysis The process of identifying the potential risks and opportunities available to Epicor under various scenarios and deciding how to deal with them. Root Cause Analysis A detailed method of problem solving used for identifying the root causes of faults or problems. A root cause is a specific underlying cause which management has control to fix and for which Effective recommendations for preventing recurrences can be generated.


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Service The results generated by activities at the interface between Epicor and a customer. Epicor only provides services to assist customers with the use of Epicor’s products. Statistical Process Control The use of statistical techniques such as control charts to analyze a process or its output so as to take appropriate action, which achieves and maintains a state of statistical control and improve the capability of the process. Supplier Provider of materials, parts or services to an organization. Survey A systematic and independent process for obtaining objective evidence and evaluating it objectively to determine the extent to which the survey criteria are fulfilled. (N.B. This is the ISO definition of “audit”). A survey applies to the specified portion of an operation. Top Management Epicor's President/Quality Assurance Director and the members of the Quality Assurance Group. Validation Confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled. Verification Confirmation by examination and provision of objective evidence that the specified requirements have been met. Work Instruction Epicor Procedure - EP


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4.0 CONTEXT OF THE ORGANIZATION

4.1 This quality manual describes the policies and company-wide control system of Epicor, Incorporated (Epicor) quality management system. This quality management system ensures that the customer specification will be met. The Quality Assurance Procedures and Work Instructions of Epicor are proprietary.

4.2 It is the policy of Epicor to apply the Quality Assurance System to supplies, materials and

services procured by Epicor (inputs) as well as products produced by Epicor for use by Epicor’s customers (outputs). Suppliers, once approved, are placed on an Approved Suppliers List and are evaluated by historical performance. They may be removed from this list through failure to meet expectations. Critical suppliers are also evaluated by periodic surveys/audits. Epicor maintains contact with customers to determine potential needs (Customer Satisfaction Surveys). Relevant customer requirements are monitored at Quality Assurance Group meetings as appropriate.

4.3Epicor provides ion exchange resins in powder and bead forms primarily to the power generation industry. Epicor considers that three classes of relevant interested parties exist. These are suppliers, customers, and Epicor’s internal personnel.

4.4 Epicor has established a Quality Management System which is intended to maintain

and improve its Quality Assurance program.

Work instructions and flow charts exist for products as well as product specifications. Outputs are expected to meet all customer specifications. Top Management will identify and provide the resources required to implement and maintain this Quality Management System including, but not limited to, capital equipment, trained personnel, and raw material, and provide the means for continual improvement and customer satisfaction.

4.5 Interaction between Processes Epicor employs several processes to ensure compliance with the goals and objectives of the quality management system. These processes and their interaction are described as follows: .


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4.5.1 Executive Management Executive management is responsible for ensuring that all aspects of the quality management system are adhered to and implemented as required. These include interactions internally with all aspects of company operation, and externally with suppliers, customers, and various regulatory agencies. This responsibility is carried out via various documented activities required by the Quality Assurance Manual such as frequent Quality Assurance meetings and compliance with all aspects of the quality assurance manual, as demonstrated by annual internal audits of appropriate quality assurance procedures. Reference: Section 11.0 - QAP’s 11.1 and 11.2. 4.5.2 Administration The administrative area is responsible for maintaining and filing all appropriate documents normally associated with an administrative activity as well as filing and control of most quality assurance documents. The administrative area interfaces primarily with management. Compliance is reviewed annually via internal audits. Reference: Section 11.0 - QAP’s 11.5 and 11.16. 4.5.3 Quality Assurance Group The Quality Assurance Group conducts periodic internal audits and quality assurance meetings to measure the effectiveness of the Quality management system. These audits and meetings are documented, and cover all aspects of the quality management system on an annual basis. The Quality Assurance Group approves and audits or surveys external suppliers to ensure the quality of raw materials. The Quality Assurance Group interacts primarily with Executive Management, but monitors all aspects of the organization. Reference: Section 11.0 - QAP’s 11.2, 11.14, 11.17 and 11.20.


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4.5.4 Purchasing/Shipping Purchasing/Shipping is responsible for receiving and processing all external customer purchase orders, as well as placing purchase orders to various Epicor suppliers. Purchasing interacts with Executive Management, external customers, suppliers and production. All Purchasing/ Shipping activities are monitored by internal audits of the appropriate Quality Assurance Procedures. Reference: Section 11.0 - QAP’s 11.3, 11.6 and 11.15.

4.5.5 Production The production area is responsible for manufacturing products in compliance with internal and external specifications and requirements. The Production area interfaces with Purchasing/Shipping and the Laboratory. Compliance with the Quality Management System is documented via internal quality audits and laboratory analysis. Reference: Section 11.0 - QAP’s 11.8, 11.9 and 11.15. 4.5.6 Laboratory The laboratory is primarily responsible for ensuring that all raw materials and finished products meet the appropriate internal and external specifications. Additionally, the laboratory must maintain "good laboratory practice" to ensure the laboratory operates within acceptable standards. The laboratory personnel interface primarily with the Quality Assurance Group, production personnel, technical personnel internally, and with customers and suppliers externally. Compliance with the quality management system is documented via internal quality audits. Reference: Section 11.0 - QAP’s 11.10, 11.11, 11.12, 11.13 and 11.20. 4.5.7 Technical Support Function The Technical Support Function assists in ensuring customer satisfaction by customer contact via telephone or on site visits. The Technical Support Function interfaces with the laboratory and the quality assurance group internally, and with external customers and suppliers. Reference: Section 11.0 - QAP’s 11.3 and 11.20.


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4.5.8 Human Resources The Human Resources area is responsible for maintaining all records normally associated with human resources activities, including employee training records. Human Resources interacts primarily with executive management. Compliance is reviewed annually via appropriate internal audits. Reference: Section 11.0 - QAP 11.18. 4.5.9 Suppliers Epicor maintains a critical suppliers list. Suppliers on this list are audited or surveyed on site periodically, or requested to submit documentation of their qualification via Epicor Form 06-1. Additionally, Epicor reviews critical suppliers’ performance at least annually via an internal rating system. Suppliers’ on-site visits to Epicor are documented regarding the issues discussed. Suppliers interact with Executive Management, Quality Assurance, Laboratory, Purchasing/ Shipping and Production. 4.5.10 Customers Epicor's Quality Management System ensures that all customer requirements are met, such as product quality (specifications), delivery and access to all internal resources to ensure customer satisfaction. In addition to frequent contact with the Epicor staff, customers are requested to respond to an annual customer satisfaction survey. Customer correspondence is reviewed periodically by the Quality Assurance Group to identify areas for improvement. Customers interact primarily with Purchasing/Shipping and Technical Support.


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5.0 LEADERSHIP The executive management team shall ensure that the quality policy is documented, communicated, understood, implemented and maintained throughout all levels in the organization. The objective and goal of the quality policy is 100 percent customer satisfaction. Quality objectives have been established for each function within the organization. These objectives are consistent with the Quality Policy and are measurable by laboratory analysis, frequent customer contact, executive management involvement in Epicor's quality program and internal quality audits.

5.1 Leadership and commitment

5.1.1 Leadership and commitment for the quality management system Overall responsibility and authority for Quality Assurance functions are the purview of the President/Quality Assurance Director.

The responsibility and authority of all personnel who manage, perform, and verify work affecting quality are defined in Job Descriptions that are maintained in the Human Resources Office. An organizational chart representing lines of authority and responsibility is found on page ix of the Quality Manual.

5.1.2 Customer Focus Epicor's Quality Management System ensures that all customer requirements are met, such as product quality (specifications), delivery and access to all internal resources to ensure customer satisfaction. In addition to frequent contact with the Epicor staff, customers are requested to respond to a periodic customer satisfaction survey. All customer correspondence is reviewed periodically by the Quality Assurance Group to identify areas for improvement. Customers interact primarily with the President, the Traffic Department and with Technical Support.

5.2 Quality Policy It is the policy of Epicor to assure customer satisfaction by providing the optimum product quality within the requested delivery schedule. Laboratory analyses are conducted and evaluated for the purpose of adhering to all regulatory and legal requirements and customer specifications. All records are properly filed and maintained. A safe working


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environment is maintained for all employees. The quality system is subject to periodic management review to ensure its effectiveness and continual improvement.

5.3 Organizational Roles Epicor consultants are charged with reviewing modifications to the applicable statutes and regulations and notifying Epicor management of such. Epicor management is responsible for ensuring appropriate changes to procedures and/or documentation.


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6.0 PLANNING FOR THE QUALITY MANAGEMENT SYSTEM Epicor understands that its products are intended to be used in power plants in the areas of make-up demineralizers, deep-bed polishers and radwaste applications, and other areas, as appropriate.

6.1 Addressing Risks and Opportunities Epicor conducts risk analyses to identify potential risks and opportunities, and takes action on such matters as appropriate. Risk analyses are conducted as an agenda item, as needed, at Quality Assurance Group meetings and recorded in the minutes. Epicor’s Quality Control procedures and finished product controls are closely monitored to ensure consistent product quality and minimize the production of non-conforming materials. At Quality Assurance meetings, actual and potential non-conformance issues are discussed. Appropriate actions are taken in accordance with agreement by the Quality Assurance Group and the President/Quality Assurance Director. Epicor’s field consultants are charged with the responsibility for identifying new opportunities and any potential or pending modifications to customer requirements and reporting them to the President/Quality Assurance Director and to the Quality Assurance Group.

6.2 Quality Objectives

6.2.1 Corporate: 1. To provide optimum product quality to the customer. 2. To meet all requested delivery schedules and ensuring customer

satisfaction.

6.2.2 Top Management: 1. To coordinate activities of all functions in the company. 2. To provide all necessary capital equipment, personnel, and raw

materials. 3. To provide effective training for all personnel. 4. To provide a safe working environment for all personnel.


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5. To communicate to all employees the Corporate Quality Policy, and any changes thereto, through meetings, posting of notices, and/or training programs, as appropriate.

6.2.3 Administration:

1. To maintain appropriate records of all company activities.

6.2.4 Quality Assurance: 1. To monitor activities of all functions to ensure compliance with all policies,

procedures and instructions. 2. To collect and analyze data from all appropriate functions. 3. In order to ensure the achievement of its quality objectives, Epicor holds

frequent meetings of the Quality Assurance Group, led by the President/Quality Assurance Director.

6.2.5 Human Resources: 1. To maintain all appropriate employee records, including training records.

6.2.6 Purchasing/Shipping:

1. To arrange for the delivery of finished products to the customer. 2. To arrange for the delivery of raw materials to the company.

6.2.7 Production: 1. To manufacture all products in accordance with appropriate work instructions. 2. To maintain sufficient quantity of finished product and raw materials to meet

customer demand. 3. To properly operate and maintain all equipment in a safe manner.

6.2.8 Laboratory:

1. To assure all finished products meet Epicor and customer specifications. 2. To assure all raw materials meet Epicor specifications and are acceptable for

use in production.

6.2.9 Technical Support: 1. Provide technical expertise to both in-house and customers as required. 2. Assists in ensuring customers' satisfaction.


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6.3 Planning of changes Executive management shall review the quality system, including the Quality Policy periodically to ensure its-continuing effectiveness in satisfying the quality policy objectives and insure that the Quality System is continually improving. Records of this review shall be maintained. If any necessary change to the Quality Assurance System is identified, such change will be discussed at a Quality Assurance meeting and documented by a Document Change Request. The President/ Quality Assurance Director will be responsible for the allocation or reallocation of necessary resources, responsibilities, and authorities.


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7.0 SUPPORT

7.1 Resources 7.1.1 General The President/Quality Assurance Director, in conjunction with the Quality Assurance Group, shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. In the course of this determination, the following shall be considered:

The capabilities of, and constraints on, existing internal resources;

What needs to be obtained from external providers. 7.1.2 People

To ensure that Epicor can consistently meet customer and applicable statutory and regulatory requirements, Epicor shall provide the personnel necessary for the effective operation of the quality management system, including the processes needed. The President/Quality Assurance Director will ensure that Epicor’s field consultants and internal technical staff will monitor all applicable statutory and regulatory requirements and changes thereto. In addition, employees will be trained to meet these requirements as appropriate. 7.1.3 Infrastructure Epicor’s top management is responsible for providing and maintaining the infrastructure to consistently meet product specifications. 7.1.4 Environment for the operation of processes Epicor’s top management is responsible for providing and maintaining the environment to consistently meet product specifications. Epicor shall establish and maintain documented procedures for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the Quality System.


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Internal quality audits shall be carried out by personnel independent of those having direct responsibility for the activity being audited. The results shall be recorded and brought to the attention of the personnel who have direct responsibility for the area being audited and who will take timely corrective action to correct deficiencies found. Follow up activities shall verify and record the implementation and effectiveness of the corrective action taken. Executive management shall review the internal audits. 7.1.5 Monitoring and measuring resources

7.1.5.1 Epicor shall carry out all final inspection and testing in accordance with documented procedures to complete the evidence of conformance to the specified requirements. The inspection shall require that all receiving and in-process inspection and testing have been carried out and that their results meet specified requirements. Outside laboratories may be employed if required. No product shall be dispatched until all the activities specified in the documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized. 7.1.5.2 Epicor shall establish and maintain records which provide evidence that the product has been inspected and/or tested. These records shall clearly show whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria. Where the product fails to pass any inspection and/or test, the procedures for control of nonconforming product shall apply. Reference: Section 11.0 - QAP 11.13. 7.1.5.3 Records shall identify the inspection authority responsible for the release of product. Reference: Section 11.0 - QAP 11.16.


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7.1.5.4 Epicor has in place an effective monitoring and measuring system to monitor the effectiveness of the quality management system. The details of the monitoring and management systems are contained within the quality assurance procedures.

7.1.5.5 Records shall identify the inspection authority responsible for the release of product. Reference: Section 11.0 - QAP 11.16.

7.1.6 Organizational knowledge Epicor has determined the knowledge necessary for the operation of its processes and to achieve conformity of its products and services. Epicor increases its knowledge through internal staff and field consultants’ meetings with suppliers and customers, monitoring of industry publications, and attendance at conferences and seminars.

7.2 Competence Epicor has determined the necessary competence of persons doing work under its control that affects its quality performance. Top management will ensure that all employees have the necessary training to perform their tasks. Production Department management will monitor competency of Production personnel on a continuing basis. Performance evaluations are documented for each employee on Form 18-1 and maintained in the Human Resources Department. The President will monitor the competency of staff members and document such annually per memo. Reference: Section 11.0 - QAP 11.18.4.4. 7.3 Awareness All employees are trained annually in Epicor's Quality Assurance Program. Reference: Section 11.0 - QAP 11.18.4.4. 7.4 Communication The President/Quality Assurance Director will communicate any changes to the


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Quality Assurance Program or any changes to the Company operations to the affected employees and/or end users as appropriate. Such communication may be in the form of memos, letters, meetings and/or the posting of notices, as appropriate. Purchase orders are processed by the Administrative Staff and forwarded to the President for acceptance. If the purchase order cannot be complied with for any reason, the customer will be contacted by the Administrative Staff. Customer views are obtained through periodic surveys as described in Section 5.1.2. 7.5 Documented Information The maintenance of records is designed to comply with the Power Industry requirements.

7.5.1 General Documented information retention requirements will be determined by Epicor and such documents listed in the “Quality Control Matrix”. 7.5.2 Creating and Updating Documents which are created, or which require revision will be recorded on a “Document Change Request” and reviewed and approved by appropriate personnel. Such documents are reviewed by an annual internal audit to ensure their continued suitability. 7.5.3 Control of Documented Information A master list will be used to identify the current revision status of documents issued.

7.5.3.1 Management has access to all quality records. Other personnel may have access to quality records that are pertinent to their area or responsibility. 7.5.3.2 Disposition, storage location, retention times and indexing of documents are specified in the “Quality Records Control Matrix” (Form 16-1).


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All quality records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage and deterioration and to prevent loss. Retention and control are defined in the “Quality Records Control Matrix” (Form 16-1). Retention times are determined by contract, by regulations, and/or the requirements of applicable standards organizations. Documented information of external origin shall be evaluated and, if retained, maintained in the same manner as documents of internal origin. 7.5.3.3 Changes to documents are recorded on the “Document Change Request” and approved by a member of the Quality Assurance Group. The Quality Assurance Coordinator shall ensure that older versions are promptly removed and replaced with the latest versions. Obsolete documents may be retained for knowledge purposes in a special file to prevent unintended use. 7.5.3.4 Temporary handwritten instructions revisions to procedures may be made. Permanent revisions must be made within 30 days. Reference: Section 11.0 - QAP. 11.16.


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8.0 Operation

8.1 Operational planning and control

In Section 11.0 of this Quality Manual is a system of Quality Assurance Procedures (QAP’s) that ensure adequate control of processes. Strict quality control monitoring ensures conformance with end user specifications. Quality Control records are maintained as appropriate (see Section 7.5.3.2). 8.2 Requirements for products and services

8.2.1 Customer communication The President and Epicor’s Technical Consultants are responsible for handling communications with end users concerning products and/or services. 8.2.2 Determination of requirements related to products and services Epicor’s customers provide the specifications for the products. Orders are reviewed for acceptability by the President or designate. 8.2.3 Review of requirements related to products and services Prior to acceptance of a purchase order, the Administrative Staff shall consider customer requirements, whether or not explicitly stated, applicable contractor or statutory requirements, any deviations from previous orders, or any of the requirements which are unclear. If the purchase order shall be deemed unacceptable for any reason, the customer will be contacted by the President or designated representative.

8.2.4 Changes to requirements for products The QA Manager will have centralized control of the quality system. This function will control revisions and their distribution. Each department manager is responsible for ensuring that all appropriate employees have been made aware of the changes. All employees are responsible for implementing the procedures and to provide guidance for any changes required for continuous improvement.


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The QA Manager shall maintain a master index indicating number assignment, procedure titles and the latest revision level. The index will be filed in the designated files. (Refer to EP - 5000) The President and QA Manager shall have authority to review and approve procedures involving all departments. In the absence of the QA Manager, the Quality Assurance Group shall have authority to review and approve procedures involving all departments. Changes to the documents will be revised by the same functions listed above. These functions shall have access to pertinent background information upon which to base their review and approval. Revision history shall be maintained by the procedure approval box located on the front page of every procedure. It shall include the revision number and date and a brief description of the change. The initial release of a procedure shall be labeled "0". Subsequent revisions shall be sequentially numbered and dated. The QA Manager is responsible for maintaining the revision system. Changes to procedures may be requested by any Epicor employee by submitting a “Document Change Request” Form to the QA Manager. Temporary changes may be made on any procedures, records, etc. The department manager must initial and date the change. Permanent changes must be made within 30 days of the Temporary change. This is done by requesting a change on the “Document Change Request” form. After approval, new revisions shall be reviewed with the appropriate departments by the department manager. Epicor will ensure that documents remain legible and readily identifiable.

All revised documents will be attached to the Document Change Request and filed. Those retained for knowledge or legal preservation will be marked “obsolete” and kept in a separate file.


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8.3 Design and development of products and services Not applicable. Epicor does not engage in design or development activities. 8.4 Control of externally provided products and services

8.4.1 General Epicor establishes specifications for products whether for internal processing or those products purchased externally and supplied directly to end users. Incoming raw materials are evaluated by laboratory testing and/or visual examination. Where supplied products are not tested, Epicor receives a Certificate of Analysis from the manufacturer. Such suppliers are evaluated by on-site Quality Assurance surveys/audits or questionnaires which validate the Certificates of Analysis. Records are maintained in accordance with Epicor’s “Quality Control Matrix”. 8.4.2 Type and extent of control provision Epicor will determine the type and extent of controls of external products according to end user or statutory requirements and/or by evaluation of supplier history. 8.4.3 Information for external providers Epicor provides suppliers with product specifications and delivery requirements. Suppliers requiring on-site inspections are informed of such. Suppliers are informed on what activities will occur on the inspections.

8.5 Production and service provision

8.5.1 Control of production and service provision Epicor will ensure that either a Certificate of Analysis exists for each manufacturing lot or the material is tested by Epicor's QA Laboratory. Epicor will ensure that suppliers for whom it relies on “Certificates of Analysis” without further testing, have and use appropriate monitoring resources, and utilize qualified personnel through the on-site Quality Assurance surveys/audits or questionnaires inspections described above. 8.5.2 Identification and traceability Each manufacturing batch at Epicor is assigned a unique identification number. The Production Sheet shows the lot number and quantity of each supplied raw material. Records are maintained in the Production Office and duplicated in the Admin office.


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Files. 8.5.3 Property belonging to customers or external providers Not applicable. 8.5.4 Preservation Epicor will ensure that products are packaged properly and warehoused and shipped in such a manner as to maintain product requirements.

8.5.5 Post-delivery activities Epicor’s Traffic Department follows up with the end users to ensure that the products have arrived in an acceptable manner. Epicor personnel, as appropriate, will respond to any end user requests or comments. 8.5.6 Control of changes Any unplanned changes can be approved by a member of the Quality Assurance Group. Such changes are documented on the appropriate process form. Should it be determined that such will be made permanent, such change will be approved and documented on a Document Change Request within thirty (30) days. Reference: Section 11.0 - QAP 11.5.6.6-8.

8.6 Release of products Products are tested at appropriate stages and records maintained in the Laboratory. Conforming products are not released until approved by the appropriate personnel. Non-conforming products are documented on the “Non-Conforming Materials Report”. Such products may be shipped to the end user with customer concession (Form 13-2), reworked or disposed. Such disposition shall be approved by the President/Quality Assurance Director and recorded on the “Non-Conforming Materials Report”. Reference: Section 11.0 - QAP 11.13.


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8.7 Control of non-conforming process outputs and products Epicor shall ensure that products that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.

8.7.1 Procedures

Non-conforming products are identified with an Epicor label stamped "Rejected", if appropriate. The non-conforming material is placed into the rejected materials area when possible. All safety related non-conformances whether supplier discrepancy, customer returns, or internal problems must be documented, evaluated and dispositioned through the “Non-

Conforming Materials Report”. (Form 13-1) or “Corrective and Preventive Action” Report” (Form 14-1) and may be followed up for clarification through an appropriate Quality Assurance Memo. Any Quality Assurance Group member may complete this form. The originator of the Non-Conforming Materials Report must enter it in the “C/PAR & NCM Report Log” and will assign a tracking number before forwarding the form. A Quality Assurance Group Member receives a copy of the “Non-Conforming

Materials Report” and files it appropriately. A member of the Quality Assurance Group will evaluate and make recommendations as to disposition. Final approval will be made by the President/Quality Assurance Director. Disposition can be complete, used as is with a customer concession “Request for Deviation or Waiver”, (Form 13-2), recycled, scrapped, or returned to the vendor. Nonconforming raw materials may be returned to the vendor, or used with customer concession. For nonconforming raw materials, a Suppliers “Corrective Action Request” (Form 13-3) may be completed by the Lab Manager or a member of the Quality Assurance Group as a record of the nonconformity and to notify the supplier. If a material is found to be nonconforming after delivery upon review by Epicor, or by contact from a customer, the Quality Assurance Group will decide the appropriate action.


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8.7.2 Disposition The President/Q.A. Director will make all decisions as to final disposition. Use as is: If necessary, as decided by the Quality Assurance Group, customer approval, with or without concession, is sought by completing the “Request for Deviation or Waiver” (Form 13-2). Recycle: Material or parts will be sent to the workstation with the shop order and a copy of the “Non-Conforming Materials Report”. . Scrap: Instructions required to scrap materials will be recorded on the “Non Conforming Material Report”.


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9.0 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General Epicor has determined that the following items need to be monitored: raw materials and finished products prior to shipment to the end user. Required testing for monitoring and measurement is prescribed in EP-210 and EP-220. Test methods are prescribed in EP-010 through EP-090. The laboratory will ensure that all tests are performed, that the products meet Epicor’s specifications, and that the results are documented to ensure traceability, and that they are maintained in the appropriate files. 9.1.2 Customer satisfaction Epicor maintains frequent contact with its end users to ensure customer satisfaction and also conducts periodic surveys to determine customer views and opinions of Epicor’s organization and products. Results of the surveys are documented and maintained. Epicor has a commitment to an expeditious response to customers’ issues and to the implementation of follow-up actions, if required. 9.1.3 Analysis and evaluation Laboratory analyses are evaluated to ensure product conformity. Laboratory data undergoes data analysis to identify any trends which may lead to eventual non-conformance. If any progression is identified which could potentially lead to non-conformance, Epicor will discuss the issue with the supplier and/or investigate the possibility of a change in the production process. The results of the evaluation and corrective actions are reviewed by Epicor Management at Quality Assurance Group meetings, which may provide improvements to the Quality Management System.


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9.2 Internal Audits

9.2.1 Epicor publishes, annually, an internal audit schedule which ensures that all Section 11.0 QAP’s are reviewed once a year. Auditors use a comprehensive checklist throughout the audit process to ensure audit quality. Results are reviewed by the President to ensure that all required actions are resolved expeditiously. Auditors are qualified through the method described in Section 11.17.

9.3 Management review Top management reviews the Quality Management System and any issues arising therefrom at all Quality Assurance Group meetings to ensure and maintain the quality of the system. The agenda of the meeting covers the relevant issues concerning the Quality Management System. Frequent Quality Assurance Group meetings ensure that necessary actions are taken to improve the Quality Management System and determine any resources required. All reviews and actions are documented in the Quality Assurance Meeting minutes.


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10.0 Improvement

10.1 General Epicor, as a result of the Quality Assurance Group and other meetings, will assess the opportunities for actions to improve the Quality Management System. Such improvements could include corrective actions for non-conforming material or preventive actions. 10.2 Non-conformity and corrective action When a non-conformity occurs, Epicor will identify the cause. If the matter is considered sufficiently serious by the Quality Assurance Group, a root cause analysis shall be conducted. If the cause is identified as external, the supplier will be contacted for a resolution. If the cause is determined to be internal, Epicor will take appropriate action as identified in Section 11.0 - QAP 11.13 and/or QAP 11.14. Any corrective action implemented will be followed up to completion and reviewed at Quality Assurance meetings to determine the effectiveness of the action. After an appropriate time with no recurrence, the matter will be considered closed.

10.3 Continual improvement Epicor shall continually improve the suitability, adequacy and effectiveness of the Quality Management System through reviews at Quality Assurance Group meetings.


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11.0 Quality System Procedures Procedures will be documented and will be consistent with Epicor's quality policy. Effective implementation of the quality system and documented procedures is supported, analyzed and monitored by top management. Epicor will implement actions needed to achieve planned results and continual improvement of these processes.

11.1 MANAGEMENT RESPONSIBILITY

11.1.1 Quality Policy (Refer to page vii of the Quality Manual) The executive management team shall ensure that the quality policy is documented, communicated, understood, implemented and maintained throughout all levels in the organization. The objective and goal of the quality policy is 100 percent customer satisfaction. 11.1.2 Quality Objectives (Refer to page viii of the Quality Manual) Quality objectives have been established for each function within the organization. These objectives are consistent with the Quality Policy and are measurable by laboratory analysis, frequent customer contact, executive management involvement in Epicor's quality program and internal quality audits. 11.1.3 Organization (See Organization Charts on pages ix & x for interrelationships)

11.1.3.1 Responsibility and Authority The responsibility and authority of personnel who manage, perform, and verify work affecting quality, are defined by job descriptions. 11.1.3.2 Resources Executive Management will identify and provide the resources required to implement and maintain this Quality System including capital equipment, trained personnel, and raw material, and provide the means for continual improvement and customer satisfaction.


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11.1.3.3 Management Representative The Quality Assurance Manager of Epicor is appointed as the management representative having the authority and responsibility for ensuring that the quality system is established, implemented, and maintained in accordance with the requirements of the Quality Management System as identified in the “Corporate Quality Manual”. The Quality Assurance Manager will report the performance review of the quality system to Epicor's management.

11.1.3.4 Internal Communication Executive Management ensures that appropriate communication processes are established within the organization regarding the effectiveness of the Quality Management System. Quality Management System deviations are addressed immediately upon identification, resolved and documented. Such activities are discussed at frequent Quality Assurance Group meetings. In addition, the quality objectives are posted and reviewed at least annually with all employees.

11.1.4 Management Review Executive management shall review the quality system, including the Quality Policy, to ensure its continuing effectiveness by meeting the quality policy objectives and insuring the Quality System is continually improving. Records of this review shall be maintained.

Reference: QAP 4.1 -- Management Responsibility


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11.2 QUALITY SYSTEM

11.2.1 General Epicor shall establish, document, and maintain a formal quality system including a quality manual to ensure that products conform to specified requirements. Revisions to the quality manual will be issued, described and approved as shown on page 2. The Quality Management System excludes all references to design control, use of customer supplied product and servicing, since Epicor does not engage in these activities.

11.2.1.1 Interaction between Processes Epicor employs several processes to ensure compliance with the goals and objectives of the quality management system. These processes and their interaction are described as follows.

11.2.1.1.1 Executive Management Executive management is responsible for ensuring that all aspects of the quality management system are adhered to and implemented as required. These include interactions internally with all aspects of company operation, and externally with suppliers, customers, and various regulatory agencies. This responsibility is carried out via various documented activities required by the Quality Assurance Manual such as: frequent Quality Assurance meetings, compliance with all aspects of the Quality Assurance Manual as demonstrated by annual internal audits of all quality assurance procedures. Reference: QAP's 4.1, 4.2 11.2.1.1.2 Administration The administrative area is responsible for maintaining and filing all appropriate documents normally associated with an administrative activity, as well as filing and control of most quality assurance documents. The administrative area interfaces primarily with management. Compliance is reviewed annually via internal audits. Reference: QAP's 4.5, 4.16


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11.2.1.1.3 Quality Assurance The Quality Assurance Group conducts periodic internal audits and quality assurance meetings to measure the effectiveness of the Quality Management System. These audits and meetings are documented, and cover all aspects of the quality management system, on an annual basis. The Quality Assurance Group approves and audits or surveys external suppliers to ensure the quality of raw materials. The Quality Assurance Group interacts primarily with Executive Management, but monitors all aspects of the organization. Reference: QAP's 4.2,4.14,4.17,4.20 11.2.1.1.4 Purchasing/Shipping Purchasing/Shipping is responsible for receiving and processing all external customer purchase orders, as well as placing purchase orders to various Epicor suppliers. Purchasing interacts with Executive Management, external customers and suppliers and production. All Purchasing/Shipping activities are monitored by internal audits of the appropriate Quality Assurance Procedures. Reference: QAP's 4.3, 4.6, 4.15 11.2.1.1.5 Production The production area is responsible for manufacturing products in compliance with internal and external specifications and requirements. The production area interfaces with Purchasing/Shipping and the Laboratory. Compliance with the Quality Management System is documented via internal quality audits and laboratory analysis. Ref: QAP 4.8, 4.9, 4.15 11.2.1.1.6 Laboratory The laboratory is primarily responsible for ensuring that all raw materials and finished products meet the appropriate internal and external specifications. In addition, the laboratory must maintain "good laboratory practices" to ensure that the laboratory operates within acceptable standards. The laboratory


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personnel interface primarily with the Quality Assurance Group and production personnel and technical personnel internally, and with customers and suppliers externally. Compliance with the Quality Management System is documented via internal quality audits. Reference: QAP's 4.10, 4.11, 4.12, 4.13, 4.20

11.2.1.1.7 Technical Support Function The Technical Support Function assists in ensuring customer satisfaction by customer contact via telephone or on site visits. The Technical Support Function interfaces with the laboratory and the Quality Assurance Group internally, and with external customers and suppliers. Reference: QAP's 4.3, 4.20 11.2.1.1.8 Human Resources The Human Resources area is responsible for maintaining all records normally associated with human resources activities, including employee training records. Human Resources interacts primarily with executive management. Compliance is reviewed annually via appropriate internal audits. Reference: QAP 4.18 11.2.1.1.9 Suppliers Epicor maintains a critical suppliers list. Suppliers on this list are periodically audited or surveyed on site, or requested to submit documentation of their qualification via Epicor Form 06-1. In addition, Epicor reviews critical suppliers' performance at least annually via an internal rating system. Suppliers on site visits to Epicor are documented regarding the issues discussed. Suppliers interact with Executive Management, Quality Assurance, Laboratory, Purchasing/ Shipping and Production. 11.2.1.1.10 Customers Epicor's Quality Management System ensures that all customer requirements are met, such as product quality (specifications}, delivery and access to all internal resources to ensure customer satisfaction. In addition to frequent contact with the Epicor staff, a random sampling of customers is requested to respond to an annual customer satisfaction survey. Customer correspondence is reviewed


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periodically by the Quality Assurance Group to identify areas for improvement. Customers interact primarily with Purchasing/Shipping and Technical Support.

11.2.2 Quality System Procedures Procedures will be documented per Epicor's quality policy. Effective implementation of the quality system and documented procedures is supported, analyzed and monitored by management. 11.2.3 Quality Management System Planning Epicor will implement actions needed to achieve planned results and continual improvement of these processes. Epicor will document how requirements for quality will be met through the Quality Manual, and Work Instructions (EP's). The Quality Plan will address the Quality system projects or certifications, objectives and goals of the quality policy, additional training needs, the audit plan and schedule, and give consideration to the following activities:

The preparation of quality plans; Identification and acquisition of any controls, processes, equipment (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality; Ensuring the compatibility of the production process, inspection and test procedures and the applicable documentation; The updating, as necessary, of quality control, inspection and testing techniques including the acquisition of new instruments, as required; The identification of any measurement requirement that exceeds the capability of existing equipment, in sufficient time for the needed capability to be developed and acquired;


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The identification of suitable verification at appropriate stages in the realization of the production process; The identification and preparation of quality records; and The continual improvement of the Quality System.

Executive Management ensures that the Quality Management System is carried out to

meet the requirements of this document, as well as company quality objectives, via

ongoing involvement in the daily company activities, frequent supplier and customer

contact, and periodic, documented, Quality Assurance Meetings.

Reference: QAP 11.2 -- Quality Systems and Planning


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11.3 Contract Review

11.3.1 General The contract review system of Epicor shall establish and maintain documented procedures for contract review and for the coordination of these activities. 11.3.2 Review Before acceptance of a request for quote, order or contract, Epicor will review the contract to ensure that:

The requirements are adequately defined and documented; Verbal order requirements are documented and agreed to by all parties before their acceptance; Any requirements differing from the quote or accepted order are resolved and documented; and Epicor has the capability to meet the contractual requirements.

11.3.3 Amendments to Contract Contract amendments are reviewed, approved and documented. Upon acceptance, all affected functions are advised. 11.3.4 Customer Satisfaction Epicor measures customer satisfaction via weekly customer contact by telephone. Epicor also contacts end users periodically. All contacts are documented. Customer and end user contacts are reviewed periodically by the Quality Assurance Group to identify areas for improvement. 11.3.5 Records Records for contract reviews are maintained.


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Reference: OAP 11.3 -- Contract Review

11.4 [Reserved]


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11.5 Document and Data Control

11.5.1 General Epicor shall establish and maintain documented procedures to control documents and data that relate to internal documents as well as documents of external origin such as standards and customer specifications. 11.5.2 Document and Data Approval and Issue Documents and data shall be reviewed and approved for adequacy by authorized personnel prior to issue.

A master list (Quality Control Matrix) will be used to identify the current revision status of documents issued. Appropriate documents shall be available at locations where operations essential to the effective functioning of the Quality System are performed. Obsolete documents are promptly removed from all points of issue but may be retained for knowledge purposes in a special file to prevent unintended use. Temporary handwritten revisions to procedures may be made. Permanent revisions must be made within thirty (30) days. 11.5.3 Document and Data Changes Revisions to the Quality Management System cannot be implemented without the written approval of the President/Quality Assurance Director or a member of the Quality Assurance Group. Reference: QAP 4.5 -- Document and Data Control


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11.6 Purchasing

11.6.1 General

Epicor shall establish and maintain documented procedures to ensure that products and services obtained from outside suppliers conform to specified requirements.

11.6.2 Evaluation of Suppliers All existing suppliers are approved and listed on the Approved Supplier List. New suppliers are selected based on their ability to meet requirements including the Quality System and Quality Assurance requirements. All suppliers shall be controlled, depending on the type of product and the impact on the quality of the final product. The control may consist of questionnaires, actual audits or surveys, supplier performance, and/or quality records. 11.6.3 Purchasing Data Purchasing documents shall contain data clearly describing the products ordered, including where applicable: Precise identification of product type, class or grade; Specifications, drawings, process requirements, or other relevant technical data, including approval, qualification of product, process, personnel, etc.; and Identification of the quality system standard to be applied. Purchasing documents are reviewed and approved prior to release. 11.6.4 Verification of Purchased Product Epicor reserves the right to verify purchased product at the supplier’s facility when specified in the purchasing document. Where specified contractually, the customer may


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verify conformance to requirements at the supplier's facility and/or at Epicor's facility.

Customer verification shall not absolve Epicor of the responsibility to provide acceptable product nor shall it preclude rejection by the customer. Reference: QAP 4.6 - Purchasing


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11.7 [Reserved]


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11.8 Product Identification & Traceability

11.8.1 General Epicor shall establish and maintain documented procedures for identifying the product by suitable means from receipt, during all stages of production through delivery, where appropriate. Where and to the extent that traceability is a specified requirement, the raw material supplier shall establish and maintain documented procedures for unique identification of individual product or batches, which will be recorded. Reference: QAP 4.8 -- Product Identification and Traceability


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11.9 Process Control

11.9.1 General Epicor's Executive Management consistently provides and maintains the infrastructure required to achieve its quality objectives. Such infrastructure includes buildings, utilities, process equipment, and support services as required. Epicor shall identify and plan the production processes which directly affect quality and shall ensure that these processes are carried out under controlled conditions. Controlled conditions shall include the following: Documented work instructions (EP's); Use of suitable equipment and a suitable working environment. All existing equipment and the working environment are approved by executive management; Compliance with reference standards, codes and quality plans; Monitoring and control of process parameters and product characteristics; Approval of processes and equipment as appropriate; Criteria for workmanship, which will be stipulated in the clearest possible manner; and Suitable maintenance of equipment to ensure continuing process capability. Epicor does not have special processes. Records shall be maintained for qualified processes, equipment and personnel, as appropriate.

Reference: QAP 4.9 -- Process Control


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11.10 Inspection & Testing

1.10.1 General Epicor shall establish and maintain documented procedures for inspection and testing activities in order to verify that the specified requirements for product are met. The required inspection and testing, and the records to be established shall be detailed in the documented procedures. 11.10.2 Receiving Inspection and Testing Epicor shall ensure that the incoming raw material is not used or processed until it has been inspected or otherwise verified as conforming to specified requirements. Verification shall be in accordance with documented procedures.

In determining the amount and nature of receiving inspection, consideration shall be given to the amount of control exercised at the sub-contractor's premises and the recorded evidence of conformance provided. Raw material is not released to production prior to verification. 11.10.3 In-Process Inspection and Testing Epicor shall inspect and test in-process as required by documented procedures. Material will not be moved to the next operation until all inspections are carried out in conformance with specified requirements. 11.10.4 Final Inspection and Testing Epicor shall carry out all final inspection and testing in accordance with documented procedures to complete the evidence of conformance to the specified requirements. The inspection shall require that all receiving and in-process inspection and testing have been carried out and that their results meet specified requirements. Outside laboratories may be employed if required. No product shall be dispatched until all the activities specified in the documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized.


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11.10.5 Inspection and Test Records Epicor shall establish and maintain records, which provide evidence that the product has been inspected and/or tested. These records shall clearly show whether the product has passed or failed the inspections and/or tests in accordance with defined acceptance criteria. Where the product fails to pass any inspection and/or test, the procedures for control of nonconforming product shall apply (see Section 11.13). Records shall identify the inspection authority responsible for the release of product (see Section 11.16). 11.10.6 Monitoring and Measuring of Processes Epicor has in place an effective monitoring and measuring system to monitor the effectiveness of the quality management system. The details of the monitoring and management systems are contained within the quality assurance procedures. Reference: QAP 4.10 -- Inspection and Testing


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11.11 Control of Inspection, Measuring & Test Equipment

11.11.1 General Epicor shall establish and maintain documented procedures to control, calibrate and maintain inspection, measuring and test equipment (including test software) used by Epicor to demonstrate the conformance of product to the specified requirements. Inspection, measuring and test equipment shall be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability. Where test software or comparative references such as test hardware are used as suitable forms of inspection, they shall be checked to prove that they are capable of verifying the acceptability of product, prior to release for use during production, installation, or servicing, and shall be rechecked at prescribed intervals. Epicor shall establish the extent and frequency of such checks and shall maintain records as evidence of control (see Section 11.16). Where the availability of technical data pertaining to the measurement equipment is a specified requirement, such data shall be made available, when required by the customer or customer's representative, for verification that the measuring equipment is functionally adequate. 11.11.2 Control Procedure Epicor shall:

11.11.2.1 Determine the measurements to be made and the accuracy required, and select the appropriate inspection, measuring and test equipment that is capable of the necessary accuracy and precision. 11.11.2.2 Identify all inspection, measuring and test equipment that can affect product quality, and calibrate and adjust equipment at prescribed intervals, or prior to use, against certified equipment having a known valid relationship to internationally or nationally recognized standards. Where no such standards exist, the basis used for calibration shall be documented. 11.11.2.3 Define the process employed for the calibration of inspection, measuring and test equipment, including details of equipment type, unique


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identification, and location, frequency of checks, check method, acceptance criteria and the action to be taken when results are unsatisfactory. 11.11.2.4 Identify inspection, measuring and test equipment with a suitable indicator or approved identification record to show the calibration status. 11.11.2.5 Maintain calibration records for inspection, measuring and test equipment (see Section 11.16). 11.11.2.6 Assess and document the validity of previous inspection and test results when inspection, measuring and test equipment is found to be out of calibration. 11.11.2.7 Ensure that the environmental conditions are suitable for the calibration, inspections, measurements and tests being carried out. 11.11.2.8 Ensure that the handling, preservation and storage of inspection, measuring and test equipment is such that the accuracy and fitness for use are maintained. 11.11.2.9 Safeguard inspection, measuring and test facilities, including both test hardware and test software, from adjustment which would invalidate the calibration setting. Reference: QAP 4.11 - Control of Inspection, Measuring and Test Equipment


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11.12 Inspection & Test Status

11.12.1 General The inspection and test status of product shall be identified by suitable means, which indicate the conformance or nonconformance of product with regard to inspection and tests performed. The identification of inspection and test status shall be maintained, as defined in the documented procedures, throughout production to ensure that only product that has passed the required inspections and tests [or released under an authorized concession (see Section 4.13.2)] is dispatched. Reference: QAP 4.12 - Inspection and Test Status


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11.13 Control of Nonconforming Product

11.13.1 General Epicor shall establish and maintain documented procedures to ensure that product that does not conform to specified requirements is kept from unintended use or installation. This control shall provide for identification, documentation, evaluation, segregation (when practical), disposition of nonconforming product, and notification of the functions concerned. 11.13.2 Review and Disposition of Nonconforming Product The responsibility for review and authority for the disposition of nonconforming product shall be defined. Nonconforming product shall be reviewed in accordance with documented procedures. It may be:

Reworked to meet the specified requirements; Accepted with or without repair by concession; Regraded for alternative applications; Reworked into a new product; or Rejected or scrapped.

Where required by the contract, the proposed use or repair of a product which does not conform to specified requirements shall be reported for concession to the customer or customer's representative. The description of the nonconformity that has been accepted, and of repairs, shall be recorded to denote the actual condition (see Section 11.14). Repaired and/or reworked product shall be re-inspected in accordance with the quality plan and/or documented procedures. Reference: QAP 4.13 - Nonconforming Material Control


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11.14 Corrective and Preventive Action

11.14.1 General Epicor shall establish and maintain documented procedures for implementing corrective and preventive action.

Documented procedures will be changed and recorded based on corrective or preventive action. 11.14.2 Corrective Action Corrective action procedures shall include:

Effective handling of customer complaints;

Addressing of supplier non-conformances, as needed;

Reviewing of internal non-conformances in preventive actions;

Determination of the cause(s), corrective actions to alleviate the problem, and verification that the corrective action was effective.

11.14.3 Preventive Action Preventive action procedures shall include:

Reports and analyses are used to determine significant problems that need preventive actions. The reports may come from customer complaints, internal non-conformances, supplier non-conformances, internal audits, and quality system reviews. Determination of the cause(s), application of root cause analysis (if determined to be necessary by the QA Group), preventive action(s) to control problem(s), verification that preventive action(s) were effective. Information on actions taken is submitted for management review. Frequent customer contact.

Reference: QAP 11.14 - Corrective and Preventive Action


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11.15 Handling, Storage, Packaging, Preservation & Delivery

11.15.1 General Epicor shall establish and maintain documented procedures for handling, storage, packaging, preservation, and delivery of product. 11.15.2 Handling Epicor shall provide methods of handling products that prevent damage or deterioration. 11.15.3 Storage Epicor shall use designated storage areas or stock rooms to prevent damage or deterioration of product, pending use or delivery. Appropriate methods for authorizing receipt to and dispatch from such areas shall be stipulated. Stock shall be assessed periodically to determine the condition of the product. 11.15.4 Packaging Epicor shall control packing, packaging, and marking processes, including material used, to the extent necessary to ensure conformance to specified requirements. 11.15.5 Preservation Epicor shall apply appropriate methods for preservation and segregation of product when under Epicor's control. 11.15.6 Delivery Epicor shall arrange for the protection of the quality of product after inspection and test. This protection shall be extended to include delivery to destination. Reference: QAP 4.15 - Handling, Storage, Packaging, Packaging, and Delivery


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11.16 Control of Quality Records

11.16.1 General

Epicor shall establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance, retention, and disposition of quality records.

Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation for the quality system including records from suppliers.

Records shall be readily retrievable and placed in an environment suitable for preventing damage or loss. Where agreed, contractual records shall be made available for evaluation by the customer. Reference: QAP 4.16 - Quality Record Control


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11.17 Internal Quality Audits

11.17.1 General Epicor shall establish and maintain documented procedures for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the Quality System. Internal quality audits shall be carried out by personnel independent of those having direct responsibility for the activity being audited. The results shall be recorded and brought to the attention of the personnel who have direct responsibility for the area being audited and who will take timely corrective action to correct deficiencies found. Follow up activities shall verify and record the implementation and effectiveness of the corrective action taken. Executive management shall review the internal audits. Reference QAP 4.17 - Internal Quality Audits


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11.18 Training

11.18.1 General Epicor shall establish and maintain documented procedures for identifying training needs and providing for the training of all personnel performing activities affecting quality. Executive management ensures a competent work force by establishing job descriptions for the various activities performed by personnel affecting product quality. Training is provided for new employees or for existing employees, as required, to upgrade their skills. Education, previous experience and skills are considered in evaluating the need for training. Training regarding quality objectives is provided to all employees at least annually. All new employees receive safety training. Competency of such training is judged by the employees’ manager or by written examinations. Records of training and other skills are maintained in employee files located in the Human Resources Office. Reference: QAP 4.18 - Training


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11.19 [Reserved]


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11.20 Statistical Techniques 11.20.1 Identification of Need Epicor shall identify the need for statistical techniques required for establishing, controlling, and verifying process capability and product characteristics.

11.20.2 Procedures Epicor determines, collects and analyzes appropriate data to ensure the suitability and effectiveness of the quality management system and identify areas where continual improvement of the system can be implemented. This shall include data generated from monitoring and measuring and from other relevant sources such as customer satisfaction reports and supplier performance. Data analysis shall include product conformance to all related requirements, customer satisfaction, review of process and product trends, including opportunities for preventive action and correction of same if required. Supplier performance will be reviewed at least annually. Reference: QAP 4.20 - Statistical Techniques


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