NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST

Transcription

1 Page: 1 of 47 SUMMARY SHEET SUPPLIER INFORMATION SUPPLIER: NUPIC SUPPLIER NO.: ADDRESS: CITY: STATE: ZIP CODE: TELEPHONE NO: FAX NO.: PRODUCT/SERVICE: ASME CODE STAMP, AUTHORIZATIONS, AND EXPIRATION DATES: AUDIT SCOPE ANSI N45.2 ANSI N IEEE 323 SNT-TC-1A ANSI N ANSI N IEEE 344 CP-189 ANSI N ANSI N101.4 ASME NCA 3800 OTHER : ANSI N CFR50/Appendix B ASME NCA 4000 ANSI N ASME SECTION XI IEEE 383 ANSI N ANSI/ASME NQA-1(Yr) Regulatory and Industry Issues Considered: Yes No SUPPLIER CONTACTS: COMPANY WEB ADDRESS: SENIOR COMPANY OFFICER: TITLE: PHONE: SENIOR QA OFFICER: TITLE: PHONE: AUDIT INFORMATION MEMBER AUDIT ID NO.: NUPIC AUDIT ID NO.: AUDIT DATES: AUDIT TEAM INFORMATION AUDIT TEAM TEAM LEADER TEAM MEMBER TEAM MEMBER TEAM MEMBER TEAM MEMBER TECHNICAL SPECIALIST (SPECIFY DISCIPLINE) NAME/NUPIC MEMBER DESIGNATOR PHONE CHECKLIST SECTIONS AUDITED Audit Team Leader: NUPIC Representative: Date: Date:

2 Page: 2 of 47 SUMMARY SHEET Supplier Quality Manual: Revision: Date: Audit Section Section Description E F Status Comments/Findings 1 Contract Review 2 Design 3 Commercial Grade Dedication 4 Software Quality Assurance 5 Procurement 6 Fabrication/Assembly Activities, Material Control and Handling, Storage and Shipping 7 Special Processes 8 Tests, Inspections, and Calibration 9 Document Control/Adequacy 10 Organization/Program 11 Nonconforming Items/Part Internal Audit 13 Corrective Action 14 Training/Certification 15 Field Services 16 Records KEY S SATISFACTORY U - UNSATISFACTORY N/A - NOT APPLICABLE E = Recommended for Engineering Services Suppliers F = Recommended for Field Services Suppliers Note: An audit section status identified as U only indicates that one or more attributes in this checklist section were found to be unacceptable and may not suggest that the entire section was found to be unsatisfactory.

3 Page: 3 of 47 SECTION 1 CONTRACT REVIEW 1.1 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation. 1.2 (a) Verify that Member Purchase Order (PO)/Contract technical and quality requirements are correctly translated on supplier s control documents (e.g., order review form, travelers, shop work orders, work tracking document including item description and part numbers). Verify that supplier exceptions are documented and communicated back to the member, and approved by the member. (Document O.E. on Figure 1) NOTE: (a) Technical and quality requirements include such items as: test/inspection, documentation, C of C, packaging/shipping, hold points, materials, etc. This includes notification to member of design deviations/design changes. Appendix B/ANSI N45.2 Ref: (3/4) NQA-1 Supplement 4S-1, 7S Describe and verify that measures are established and implemented for control of items returned from the member for repair/rework. Appendix B/ANSI N45.2 Ref: (15/16) NQA-1 Supplement 15S Verify that final record packages including Certificates of Compliance/Conformance meet contract/p.o. requirements. Verify the packages accurately describe the delivered products including the as built of the item or component, as applicable. NOTE: The final record packages should include material certification and test data for traceability and quality verification; reports of inspections, examinations, and test results for conformance verification; drawings, specifications, procedures, and instructions for use in control of configuration; and records of nonconformances and their resolution.

4 Page: 4 of 47 SECTION 1 CONTRACT REVIEW Appendix B/ANSI N45.2 Ref: (6/7) (17/18) NQA-1 Supplement 17S-1

5 Page: 5 of 47 MEMBER P.O. / CONTRACT NO. AND DATE SECTION 1 - CONTRACT REVIEW PART NUMBER AND ITEM/SERVICE DESCRIPTION (FIGURE 1) P.O. /CONTRACT REQUIREMENTS CORRECTLY TRANSLATED TO SUPPLIER DOCUMENTS (Yes/No) (LIST WORK ORDERS, TRAVELERS, DRAWINGS, ETC.) MEMBER APPROVAL OF EXCEPTIONS (Yes/No) *1.2 *1.2 *1.2 *1.2 * Refers to applicable question

6 Page: 6 of 47 SECTION 2 DESIGN 2.1 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation. 2.2 Verify that measures to control the translation of design requirements into design documents are implemented. (a) Verify inclusions of contractually identified design bases, and inputs, (regulatory requirements, Code Requirements, codes, standards, EQ/Seismic Report Numbers, Analyses, (etc.), technical and quality requirements in design/quality documents. Verify that the design is supported by engineering data (i.e., calculations, performance test, etc.), including verification that design inputs are satisfied. NOTE: Any software used shall be evaluated in Section 4. Any qualification/performance tests used shall be evaluated in Section 8. (Document O.E. on Figure 2) Appendix B/ANSI N45.2 Ref: (3/4) NQA-1 Supplement 3S Verify that measures are established and implemented for the selection and review for suitability of application of materials, parts, equipment and processes that are essential to the safety related function of the product. If the supplier s safety related components have parts classified as non-safety related, the following items should be considered: (a) (c) Is the process controlled? Is a functional evaluation approach used? Has the evaluation included analysis of failure modes to assure the part s failure would not prevent the component from performing its safety related function? Appendix B/ANSI N45.2 Ref: (3/4) NQA-1 Supplement 3S-1

7 Page: 7 of 47 SECTION 2 DESIGN 2.4 Verify that measures are established and implemented for the identification and control of design interfaces. These measures shall include the establishment of procedures among participating design organizations (internal/external) for the review, approval, release, distribution, and revision of documents. Appendix B/ANSI N45.2 Ref: (3/4) NQA-1 Supplement 3S Verify that measures are established and implemented for the verification of design adequacy. (a) Assure the verification method is identified (design review, alternate calculations or test) and that the verification is performed by individuals or groups other than those who performed the original design, but who may be from the same organization. When the verification method used is qualification test, verify that a prototype unit is tested under the most adverse design conditions. (Document O.E. on Figure 2) Appendix B/ANSI N45.2 Ref: (3/4) NQA-1 Supplement 3S Verify that measures are established and implemented to control design changes including changes for spare/replacement parts. (a) (c) Review revised design documents, (e.g., calculations, drawings, stress reports), to verify that design changes are made by the same organization as originally reviewed and approved, or by other knowledgeable, qualified and designated organizations. Ensure design control measures are equal to those of the original design. Ensure that design changes have been adequately evaluated to assure that the impact of the change or cumulative effect of multiple changes are carefully considered (i.e. material substitutions, performance, interchangeability, EQ/seismic, test and equipment qualification). (Document O.E. on Figure 2) Appendix B/ANSI N45.2 Ref: (3/4)

8 Page: 8 of 47 SECTION 2 DESIGN NQA-1 Supplement 3S-1

9 Page: 9 of 47 MEMBER/SUPPLIER DESIGN INPUT AND BASES SUPPLIER DESIGN DOCUMENT SECTION 2 DESIGN (FIGURE 2) DESIGN INPUTS CORRECTLY INCORPORATED (Yes/No) METHOD OF DESIGN VERIFICATION DESIGN CHANGE CONTROL AND REV./DATE *2.2 *2.2 *2.2 *2.5 *2.6 *Refers to applicable question.

10 Page: 10 of 47 SECTION 3 COMMERCIAL GRADE DEDICATION 3.1 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation. 3.2 Verify and assess the supplier s controls for the dedication of purchased Commercial Grade Items and services. As a minimum the process should include a documented technical evaluation performed by the responsible engineering organization that establishes requirements that will provide reasonable assurance the item/service will perform its intended safety function. The process should include the following: (a) Documented controls, which define the dedication process. Determination of the safety function for the item/service intended end use by review of documents associated with the technical evaluation, such as: Classification of the item Item equivalency evaluations Consideration of credible failure modes (See Note 1) (c) Identification of critical characteristics for acceptance, required to support the safety function. (See Note 1) (d) Selection of the method(s) of dedication for each identified critical characteristic: Method 1: Inspection, and Test (Figure 3A) Method 2: CGI Surveys (Figures 3A and 3B) (See Note 3) Method 3: Source Verification (Figures 3A and 3B) Method 4: Supplier/Performance history in conjunction with Methods 1, 2, or 3, above. NOTE 1: For suppliers who are unable to determine the items/materials safety function or end use (i.e., material suppliers, QSC holders, etc.), characteristics of the material specification, which are applicable to the finished product (i.e., chemical, physical, hydro, etc.) must be verified. NOTE 2: This question applies to CGI s dedicated by the supplier for member procurement as basic components or for internal use in safety-related functions (e.g. software, consumables, fasteners, elastomers etc.). Special consideration should be given to items that are seismically/environmentally qualified (e.g., relays, switches, nonmetallic items, etc.). NOTE 3: Verify that when accreditation such as NVLAP, A2LA, ACLASS, L-A-B, IAS, and PJLA are used as part of the basis for acceptance of domestic commercial calibration sub-supplier services in lieu of commercial grade surveys, the process for using these services via this accreditation is documented as a commercial grade dedication. (Accrediting bodies that have been determined to provide an acceptable alternative to the methods used to qualify commercial grade calibration service sub-suppliers are identified in the NRC APS Safety Evaluation Report and subsequent NRC letter correspondence.) (Document O.E. on Figure 3A and/or 3B, as applicable) Appendix B/ANSI N45.2 Ref: (3/4) NQA-1 Supplement 7S-1

11 Page: 11 of 47 SECTION 3 COMMERCIAL GRADE DEDICATION 3.3 For Method 1 dedications, verify that the tests and inspections specified for the acceptance of commercial grade items: (a) Adequately verified the identified critical characteristics Incorporate and implement sampling plans which are controlled and their technical basis established and documented. Proper consideration should be given to: NOTE: Lot formation/degree of homogeneity/lot Traceability Sample selection Complexity of the item Adequacy of the sub-supplier controls Performance history of the sub-supplier Safety significance of the item Number of other critical characteristics being verified That the plan provides for appropriate accept/reject controls This item applies to critical characteristics identified in Item 3.2 that are dedicated by the supplier for member procurement as basic components. Adequacy of controls for commercial grade dedication is identified in Item 3.2. (Document O.E. on Figure 3A). Appendix B/ANSI N45.2 Ref: (10, 11/11, 12) NQA-1 Supplement 10S-1, 11S For Method 2 and Method 3 dedications, verify that the commercial grade survey and/or surveillance used for the acceptance of commercial grade items: (a) Adequately verify the identified critical characteristics Adequately document the procedure/instruction/program controls in place to control the identified critical characteristics (c) Are performed in accordance with a procedure describing the applicable commercial grade survey and/or surveillance process (d) Verify that the surveys were conducted by qualified personnel and are of sufficient depth and scope to ensure adequacy and effectiveness of the sub-suppliers program (e) Verify that checklists or procedures were used with objective evidence documented and that follow-up action is taken where needed. NOTE: Commercial grade surveys and surveillances reviewed to verify acceptability in this area need to be documented on Figure 3B. NOTE: Supplier surveys should ensure that distributors of commercial grade items adequately control the identified critical

12 Page: 12 of 47 SECTION 3 COMMERCIAL GRADE DEDICATION characteristics, as applicable (may not control material). Appendix B/ANSI N45.2 Ref: (10, 11/11, 12) NQA-1 Supplement 10S-1, 11S-1

13 Page: 13 of 47 ITEM DESCRIPTION P/N, S/N, MODEL NO., SOFTWARE NAME/ID NO., ETC., AS APPLICABLE SECTION 3 COMMERCIAL GRADE DEDICATION CRITICAL CHARACTERISTICS AND METHOD OF DEDICATION (FIGURE 3A) COMMERCIAL GRADE ITEMS **INSPECTION/ TEST PROCEDURE REV./DATE **INSPECTOR/ TESTER NAME/ STAMP **ID NUMBER OF M&TE USED **RESULTS SAT. OR UNSAT. IF UNSAT., RECORD NCR NO. IF APPLICABLE *3.2, 3.3, 4.5 *3.2, 3.3, , 3.3, 4.5 *3.2, 3.3, 4.5 *3.2, 3.3, 4.5 *3.2, 3.3, 4.5 *Refers to applicable question. **To be completed for Method 1 only.

14 Page: 14 of 47 SECTION 3 COMMERCIAL GRADE DEDICATION (FIGURE 3B SURVEYS/SOURCE VERIFICATION) ** CGI SUPPLIER EVALUATION SCOPE OF SUPPLY AUDITORS CRITICAL DO CCs VERIFIED NAME, LOCATION METHOD CHARACTERISTICS BY THE AND DATE(S) (COMMERCIAL (CC) VERIFIED PERFORMED GRADE SURVEY OR EVALUATION SOURCE VERIFICATION) MATCH THOSE SPECIFIED (Yes/No) *3.4, 4.5 *3.4, 4.5 *3.4, 4.5 *3.4, 4.5 *3.4, 4.5 *3.4, 4.5 *Refers to applicable question. **To be completed for Methods 2 and 3 only.

15 Page: 15 of 47 SECTION 4 - SOFTWARE 4.1 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation. 4.2 (a) Verify documented measures are established and implemented to control software quality. Assure the measures include provisions for the acquisition, development, operation, maintenance, and retirement of software, as applicable. (c) Verify that measures are established and implemented to assure that the life cycle activities are adequately and effectively reviewed. A systematic life cycle includes activities such as requirements, design, acceptance testing, maintenance, configuration management and retirement. The life cycle activities should proceed in a traceable, planned, and orderly manner. The number of activities and relative emphasis placed on each activity will depend on the nature and complexity of the software. Assure that individuals other than those who designed the software review the design activities. These activities generate documentation that should be considered a quality assurance record. NOTE: This includes firmware. (Document O.E. on Figure 4) Appendix B/ANSI N45.2 Ref: (3/4) NQA Basic Requirements 3, 11 and 17, Supplement 3S-1, 11S-2, 17S-1 and Subpart Verify that measures are established and implemented to assure that acceptance testing for the software/firmware is performed to demonstrate that the software/firmware adequately and correctly performs its intended function (i.e., specified software design requirements). (Document O.E. on Figure 4) Appendix B/ANSI N45.2 Ref: (4/5, 7/8) NQA Basic Requirement 11, Supplement 11S-2 and Subpart Verify that measures are established and implemented to assure that the changes to software are formally documented, evaluated

16 Page: 16 of 47 SECTION 4 - SOFTWARE and approved by the organization responsible for the original software development. Verify the changes are controlled commensurate with those applied to the original software development. Assure the change is appropriately reflected in software documentation and configuration management is maintained. NOTE: Configuration management includes backups, maintenance, disaster recovery, and virus protection. (Document O.E. on Figure 4) Appendix B/ANSI N45.2 Ref: (3/4) NQA Basic Requirement 3, Supplement 3S-1 and Subpart Verify measures are established and implemented for the procurement of software either safety related or commercial grade. (a) When software is procured as safety related, verify adequate controls are in place (i.e. acceptable supplier qualification, procurement practices and receipt inspection) to ensure that the supplier is providing software that meets the specified technical and quality requirements. The purchaser s audit of the software supplier shall ensure that reviews and acceptance testing are controlled, documented, and adequate when considering the intended function of the software. For software procured as a commercial grade item, assure that dedication activities such as reviews and acceptance testing are performed and documented to ensure the software functions as intended. NOTE: Verification of controls shall be evaluated during procurement and test and inspections for safety related software. NOTE: Verification of dedication activities for commercial grade software shall be encompassed in Section 3. (Document O.E. on Figure 3, 5A and 5B as appropriate) Appendix B/ANSI N45.2 Ref: (3/4, 4/5, 7/8) NQA Basic Requirements 4, 7, 11, Supplements 4S-1, 7S-1, 11S-2 and Subpart Verify that measures are established and implemented to assure that the software errors and failures from both internal and external sources are identified, documented, resolved, evaluated, assessed for impact on past and present applications, and resolved. Verify this problem reporting system assures methods of notification are identified. Verify that problems and the significance of the problems on that customer are promptly reported to affected organizations, including users. NOTE: Corrective actions should be forwarded to the users in a timely manner.

17 Page: 17 of 47 SECTION 4 - SOFTWARE (Document O.E. on Figure 4) Appendix B/ANSI N45.2 Ref: (15/16) NQA Basic Requirement 16 and Subpart Verify measures are established and implemented to assure that software is adequately packaged, marked, stored, and shipped. NOTE: Verify when duplicate copies are generated, that methods are in place to ensure exact duplication. Appendix B/ANSI N45.2 Ref: (13, 14/14, 15) NQA Basic Requirement 13 and Supplement 13S-1

18 Page: 18 of 47 SECTION 4 - SOFTWARE (FIGURE 4) SOFTWARE PROGRAM (NAME, NO., REV./DATE) METHOD OF ACCEPTANCE TESTING AND DATE ERROR NOTICE/DATE AND STATUS (OPEN/CLOSED) *4.2, 4.4 *4.2, 4.3 *4.6 *Refers to applicable question.

19 Page: 19 of 47 SECTION 5 PROCUREMENT 5.1 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation. 5.2 Verify that measures are established and implemented for the control and release of procurement documents, including changes. Ensure the following requirements are included in procurement documents, and changes, for items and services, as applicable. (a) (c) (d) (e) (f) (g) (h) (i) (j) Statement of the scope of work. Technical requirements by reference to specific drawings, codes, specifications. Requirement for a documented quality assurance program, implemented, and meeting applicable code/regulatory requirements. Requirement for right of access to plant facilities and records for source inspection/audit. Identification of document submittals for approval. Identification of deliverable records. Requirement for reporting and approving disposition of nonconformances. Requirements for records availability, retention and disposition. Requirements for extending applicable Technical and QA requirements to lower tier suppliers. Applicability of 10CFR21. NOTE: If the supplier utilizes accreditation in lieu of commercial grade surveys for domestic commercial calibration service subsuppliers, procurement documents should include: (k) (l) Additional technical and administrative requirements, as necessary, to satisfy the supplier s QA program and technical requirements. Requirement for reporting as-found calibration data when calibrated items are found to be out-of-tolerance. (m) Requirement that calibration reports include identification of the laboratory equipment/standards used. (Document O.E. on Figure 5A ) Appendix B/ANSI N45.2 Ref: (4/5) NQA-1 Supplement 4S Verify that measures are established and implemented for the evaluation, selection and assessment of sub-suppliers (including distributors and calibration, NDE, testing labs, software suppliers, heat treatment services suppliers, etc) consistent with the importance, complexity and quality of the product or service. Verify the supplier s program addresses audits of Appendix B subsuppliers, surveys for commercial grade suppliers, if applicable, and the use of accreditation in lieu of commercial grade surveys for domestic commercial calibration sub-suppliers. (a) Verify evaluations are performed prior to award of contract, and at the specified frequency.

20 Page: 20 of 47 SECTION 5 PROCUREMENT (c) (d) Verify that the scope of approval of the sub-supplier is commensurate with the requirements of the procurement documents. Verify that only approved suppliers are used. Verify that if the supplier utilizes accreditation in lieu of commercial grade surveys for domestic commercial calibration service suppliers, the supplier s evaluation shall include the following: 1. Sub-supplier has accreditation to ANSI/ISO/IEC Accreditation is issued by NVLAP, A2LA, ACLASS, LAB, IAS, and PJLA or other accrediting body that has been determined by the NRC to be an acceptable alternative to the methods used to qualify commercial grade calibration service sub-suppliers. 3. Sub-Supplier is a commercial grade, domestic (US) calibration laboratory 4. The published scope of accreditation for the calibration laboratory covers the necessary measurement parameters, ranges, and uncertainties. (Document O.E. on Figure 5A) NOTE: Content of CGI surveys will be addressed in Section 3. Appendix B/ANSI N45.2 Ref: (7/8) NQA-1 Supplement 7S (a) Verify that measures are established and implemented to ensure a comprehensive system of planned and periodic external audits (including 3 rd party audits). (c) Verify that the audits were conducted by qualified personnel and are of sufficient depth and scope to ensure adequacy and effectiveness of the sub-suppliers program. Verify that checklists or procedures were used with objective evidence documented and that follow-up action is taken where needed. NOTE: When 3 rd party audits e.g., NIAC, Consultant performed, are used as a basis for supplier qualification the evaluation shall be documented and shall address: 1. Performance of the audit by qualified personnel. 2. Performance of the evaluation by qualified personnel to ensure the users program requirements are satisfied. 3. The Scope of the audit envelops the current scope of procurement. 4. The applicable regulatory and/or commercial program requirements are adequately addressed in the audit scope. 5. Sufficient objective evidence is available to support conclusions of the audit. NOTE: Use of 3 rd party audits should be addressed within the supplier s program/procedures. (Document O.E. on Figure 5B) Appendix B/ANSI N45.2 Ref: (18/19)

21 Page: 21 of 47 SECTION 5 PROCUREMENT NQA-1 Supplement 18S (a) Verify that where the supplier s acceptance of safety related material from a sub-supplier ASME Material Organization is based on certification (including materials supplied under provisions of NX2610), the supplier validates the certification via surveillance, audit and/or independent tests. If validation of the certification is based on independent test and end use is not known, ensure the test encompasses all characteristics of the material specification (i.e., chemical, physical, hydro, etc.). NOTE: Question 5.5 only addresses testing in lieu of auditing to validate ASME certification. Appendix B/ANSI N45.2 Ref: (7/8) IE Notice including supplements NQA-1 Supplement 7S-1

22 Page: 22 of 47 SECTION 5 - PROCUREMENT (FIGURE 5A) ITEM DESCRIPTION NAME (P/N, S/N, MODEL NO., SUPPLIER AND P.O. NUMBER AND METHOD AND DATE OF SUPPLIER SCOPE OF SUPPLIER APPROVAL SOFTWARE NAME) LOCATION DATE EVALUATION *4.5, 5.2, 5.3 *4.5, 5.2, 5.3 *4.5, 5.2, 5.3 *4.5, 5.3, 5.4 *4.5, 5.3, 5.4 *Refers to applicable question.

23 Page: 23 of 47 SECTION 5 PROCUREMENT (FIGURE 5B AUDITS/SOURCE VERIFICATION) SUPPLIER NAME, LOCATION AND DATE(S) PERFORMED EVALUATION METHOD (APPENDIX B AUDIT, SOURCE ACTIVITY) SCOPE OF SUPPLY AUDITORS NUMBER OF DEFICIENCIES (OPEN/ CLOSED) CORRECTIVE ACTION VERIFICATION METHOD AND DATE *3.4, 5.4 *3.4, 5.4 *3.4, 5.4 *3.4, 5.4 *3.4, 5.4 *3.4, 5.4 *Refers to applicable question.

24 Page: 24 of 47 SECTION 6 - FABRICATION/ASSEMBLY ACTIVITIES MATERIAL CONTROL, HANDLING, SHIPPING AND STORAGE 6.1 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation. 6.2 Verify that measures are established and implemented for the control of fabrication/assembly activities. These activities should be controlled by a shop work order/traveler type document which includes the following (as applicable): (a) (c) (d) (e) (f) Identification of the work activities; Identifies instructions, procedures and drawings to be used for each item/activity; Identifies hold/witness points; Identifies any environmental requirements; Special handling/cleanliness requirements; Verification of use of correct parts or materials. NOTE: Assessment of software controls relating to the manufacturing processes is to be verified in Section 4. (Document O.E. on Figure 6A) Appendix B/ANSI N45.2 Ref: (5/6, 8/9) NQA-1 Supplement 9S Verify that measures are established to assure the traceability of items (i.e., materials, parts, weld filler material, etc.) is maintained, as required throughout processing operations. (Document O.E. on Figure 6B) Appendix B/ANSI N45.2 Ref: (8/9) NQA-1 Basic Requirement 8

25 Page: 25 of 47 SECTION 6 - FABRICATION/ASSEMBLY ACTIVITIES MATERIAL CONTROL, HANDLING, SHIPPING AND STORAGE 6.4 Verify that measures are established and implemented for the identification and control of items. Verify the following: (a) (c) (d) (e) (f) Items are adequately identified as to inspection/test status. The authority for application and removal of identification markings/status indicators is defined. Storage areas and methods comply with specified requirements and access controls. Item markings are clear and not detrimental. (for example: if die stamps are used, verify stamps are low stress) Subdivided items have satisfactory transfer of markings to each item. Shelf-life requirements are defined and implemented. (Document O.E. on Figure 6B) Appendix B/ANSI N45.2 Ref: (7/8) NQA-1 Supplement 7S Verify that measures are established and implemented for the control of shipping activities, which include packaging, marking, storing, status and shipment of items and components including spare and replacement parts. (a) (c) (d) Observe and assess actual techniques being used and their acceptability relative to contract/procedural requirements. Will cleaning, preservation and packaging practices prevent damage/deterioration? Are requirements for environment/preservation, handling and documentation, adequately met? Are foreign material controls adequate to preclude contaminants/foreign material in the product, packaging and shipping containers? (Document O.E. on Figure 6B) NOTE: This item does not apply to software because shipping of software is addressed in Item 4.7. Appendix B/ANSI N45.2 Ref: (13, 14/14, 15) NQA-1 Supplement 13S-1

26 Page: 26 of 47 SECTION 6 - FABRICATION/ASSEMBLY ACTIVITIES MATERIAL CONTROL, HANDLING, SHIPPING AND STORAGE (FIGURE 6A) ITEM DESCRIPTION (NAME, PART NO., P.O./CONTRACT NO., ETC.) WORK DOCUMENT WORK ACTIVITY WORK ACTIVITY PROCEDURE REV./DATE *6.2 *6.2 *6.2 *6.2 *Refers to applicable question.

27 Page: 27 of 47 SECTION 6 - FABRICATION/ASSEMBLY ACTIVITIES MATERIAL CONTROL, HANDLING, SHIPPING AND STORAGE (FIGURE 6B) ITEM DESCRIPTION (NAME, PART NO., P.O./CONTRACT NO., ETC.) METHOD OF IDENTIFICATION AND TRACEABILITY INSPECTION STATUS *6.4, 6.5 *6.3, 6.4, 6.5 *6.4, 6.5 *Refers to applicable question.

28 Page: 28 of 47 SECTION 7 - SPECIAL PROCESSES 7.1 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation 7.2 Verify that measures are established and implemented and that special processes (e.g., welding, heat treating, soldering, NDE, painting, etc.) are accomplished utilizing: (a) (c) Qualified personnel Qualified procedures Qualified equipment, as applicable NOTE: Unique identification and acceptability of instruments to be checked under Section 8. NOTE: PT, UT and RT may be automated processes, as opposed to being manually performed. (Document O.E. on Figures 7A, 7B) Appendix B/ANSI N45.2 Ref: (9/10, 10/11) NQA-1 Supplement 9S-1, 10S-1

29 Page: 29 of 47 SECTION 7 - SPECIAL PROCESSES (FIGURE 7A) ITEM DESCRIPTION (NAME, P/N, S/N, MODEL NO.) PROCESS PROCEDURE AND REV./DATE PERSONNEL AND LEVEL QUALIFICATION PROCEDURE EQUIPMENT *7.2 *7.2 *7.2 *7.2 *7.2 *7.2 *Refers to applicable question.

30 Page: 30 of 47 SECTION 7 SPECIAL PROCESSES (FIGURE 7B WELDER/WELD OPERATOR) NAME/STAMP CERT. TYPE (PROCESS & POSITIONS) CODE QUALIFIED TO WELD PROCESS SPECIFICATION (WPS) AND REV./DATE MAINTENANCE OF QUALIFICATION *7.2 *7.2 *7.2 *7.2 *7.2 *Refers to applicable question.

31 Page: 31 of 47 SECTION 8 TESTS, INSPECTIONS, AND CALIBRATION 8.1 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation 8.2 Verify that adequate measures are established and implemented for the inspection (receipt, in-process, and final) and testing of materials, components and parts. Verify these documents include, as applicable: (a) (c) (d) (e) (f) (g) (h) (i) (j) Test/Inspection to be performed. Hold or witness points. Specifications, work instructions, drawings, etc., including document revision. Acceptance criteria contained in applicable design documents. Appropriate Inspection equipment, tools, gages, and instrumentation (correct type, range and accuracy). Characteristics to be inspected. Test prerequisites identified and met. Personnel. Results are approved by responsible authority. Action taken relative to any deficiencies noted. (Document O.E. on Figure 8) Appendix B/ANSI N45.2 Ref: (7/8, 10/11, 11/12) NQA-1 Supplement 7S-1, 10S-1, 11S Verify that measures are established and implemented to assure that purchased material, items, equipment, software, services (including engineering services, studies, and evaluations) conform to the procurement documents (i.e., receipt inspection, source inspection, in-process inspection, or testing). (a) Observe and assess actual inspection activities and their acceptability relative to procedure requirements. (Document O.E. on Figure 8) Appendix B/ANSI N45.2 Ref: (7/8) NQA-1 Supplement 7S-1 Vendor Program Ref:

32 Page: 32 of 47 SECTION 8 TESTS, INSPECTIONS, AND CALIBRATION 8.4 Assess and describe inspection/testing processes (such as those used during receipt/in-process/final inspection or testing) for identifying suspect (including counterfeit/fraudulent) material, items or components that may not be those ordered, with indications such as: Altered manufacturer s name, logo, serial number, manufacturing date Items differing in configuration, dimensions, fit, finish, color, or other attributes from that expected Markings on items or documentation are missing, unusual, altered, or inconsistent with that expected Markings or documentation from country other than that of the subsupplier Items, sold as new, exhibit evidence of prior use Performance inconsistent with specifications or certification or test data furnished Documentation that appear altered, incomplete, or lack expected traceability, UL or manufacturer s markings Appendix B/ANSI N45.2 Ref: (7/8, 10/11, 11/12) NQA-1 Supplement 7S-1, 10S-1, 11S Verify that sampling plan(s) other than those used for commercial grade dedication (such as those used during receipt/inprocess/final inspection) are controlled and acceptably implemented. Appendix B/ANSI N45.2 Ref: (10/11) NQA-1 Supplement 10S-1, 11S Verify that M&TE controls are established and implemented for the following: (a) Labeling/identification of M&TE, including person who performed calibration Calibration of M&TE and standards at periodic (recall) intervals

33 Page: 33 of 47 SECTION 8 TESTS, INSPECTIONS, AND CALIBRATION (c) (d) (e) (f) (g) (h) (i) (j) NOTE: Adequacy of standards to assure accuracy, stability, range, and resolution required for their intended use Reference (primary) and working (secondary) standards used traceable to the National Institute of Standards and Technology (NIST), other recognized standards, or natural law As Found/As Left information documented Calibration History - Dates calibrated, by whom/supplier, results, due date, primary standard, and P.O. No., if applicable Control of M&TE found to be out-of tolerance, out of calibration, and/or past due for calibration. Verify evaluation is performed for past use of affected M&TE. Verify that affected customers were notified, where appropriate. Was the M&TE reviewed within current calibration? Is calibration performed in an environment that is controlled to the extent necessary to assure required accuracy? Observe and assess actual calibration activities and their acceptability relative to procedure requirements. If required by P.O./Contract the standard shall have a nominal accuracy of four times the nominal accuracy of the measuring and test equipment being calibrated. If not possible, documented and authorized basis of acceptance shall be provided, if required by customer P.O./Contract, or referenced industry standard. NOTE: Utilize data from Sections 3 and 7. NOTE If sub-suppliers are used, pass on information to auditor responsible for procurement and external audits. (Document O.E. on Figure 8) Appendix B/ANSI N45.2 Ref: (12/13) NQA-1 Supplement 12S-1

34 Page: 34 of 47 SECTION 8 TESTS, INSPECTIONS, AND CALIBRATION (FIGURE 8) ITEM DESCRIPTION (NAME, P/N, S/N, ETC.) TEST/INSPECTION ACTIVITY TYPE AND DATE CONTROLLING TEST/INSPECTION DOCUMENT TITLE/NUMBER AND REV./DATE INSPECTOR/ TESTER NAME/STAMP ID NUMBER OF M&TE USED CALIBRATION CURRENT (Yes/No) RESULTS SAT. OR UNSAT. IF UNSAT., RECORD NCR NO. IF APPLICABLE *8.2 *8.2 *8.2 *8.2 *8.2, 8.4 *8.2, 8.4 *Refers to applicable question.

35 Page: 35 of 47 SECTION 9 DOCUMENT CONTROL/ADEQUACY 9.1 Within the assessment/summary section of this checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation. 9.2 Verify that measures are established and implemented to control the issuance of documents (i.e., procedures, instructions, drawings, work orders, etc.) including changes. These measures shall assure that documents are: (a) (c) (d) Reviewed for adequacy; Approved for release by authorized personnel; Distributed to applicable workstation; Adequately controlled if maintained electronically. Evidence obtained from Sections 1-16 shall be evaluated when assessing this item. Appendix B/ANSI N45.2 Ref: (5, 6/6, 7) NQA-1 Supplement 6S-1

36 Page: 36 of 47 SECTION 10 ORGANIZATION/PROGRAM 10.1 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation (a) Verify that an individual/organization is responsible for defining the overall effectiveness of the QA Program; (c) Assess whether personnel performing verification activities have the authority, independence and organizational freedom to identify quality problems; recommend solutions; and control further processing of nonconformances until proper disposition has occurred.; Verify that the supplier s management regularly reviews, assesses, and evaluates the status and effectiveness of the Quality Assurance Program. Appendix B/ANSI N45.2 Ref: (1-3) NQA-1 Supplement 1S-1

37 Page: 37 of 47 SECTION 11 NONCONFORMING ITEMS/PART Within the assessment/summary section of this checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation Verify that measures are established and implemented to: (a) (c) (d) identify nonconforming items; ensure that responsibility and authority for review/disposition is identified; controls further processing, delivery and installation of items until disposition is completed. notification to member of nonconforming conditions when required by member P.O./Contract. Appendix B/ANSI N45.2 Ref: (15/16) NQA-1 Supplement 15S Verify that the nonconforming items are reviewed and dispositioned such that: (a) (c) (d) (e) (f) (g) The disposition is identified. Documented justification is provided verifying the acceptability of the nonconforming items which are dispositioned repair or use-as-is. Procedures or instructions for repair and rework are provided. Repaired and reworked items are re-inspected. Member approval of use-as-is and repair dispositions when required by purchase order. A clear connection between the nonconformance process and the Part 21 procedure exists such that a mechanism exists to identify and elevate conditions requiring 10CFR21 evaluation. Closeout is adequate. (Document NCR Numbers of items reviewed under the Assessment/Summary) NOTE: If the supplier uses a Material Review Committee or similar organization, review a sample of the meeting minutes of this organization to verify follow through on any commitments from the meeting pertaining to significant conditions adverse to quality. Appendix B/ANSI N45.2 Ref: (15/16) NQA-1 Supplement 15S-1 (para. 4.1)

38 Page: 38 of 47 SECTION 11 NONCONFORMING ITEMS/PART CFR21 (a) Verify appropriate documents are posted per 10CFR21.6(a) OR : 10CFR21.6(a) 10CFR21 regulations, and Section 206 of the Energy Reorganization Act of 1974, and Procedures adopted pursuant to the 10CFR21 regulations. 10CFR21.6 Section 206 of the Energy Reorganization Act of 1974, and Notice describing regulations/procedures. Verify procedures provide criteria (10CFR21.21(a)) for evaluation/determination, within 60 days of discovery of the deviation, if a defect or failure to comply exists under 10CFR21.3; or an Interim Report submitted within 60 days of discovery of the deviation. (c) Verify procedures establish notification timeframes consistent with 10CFR21.21(a), b) and (d): Purchaser/affected licensee within 5 working days of the determination of inability to perform the evaluation? Director or responsible officer within 5 working days after evaluation completion? Initial NRC notification by facsimile or telephone within 2 days of informing the responsible officer of a defect or failure to comply? Written NRC notification within 30 days of informing the responsible officer of a defect or failure to comply? (d) Verify 10CFR21 notifications issued since the previous NUPIC audit include (10CFR21.21(d)): Name/address of individual providing the report, Identification of facility/activity/basic component failing to comply or containing a defect, Identification of constructor/supplier, Nature of defect/failure to comply and safety hazard, Date information was obtained, Number and location of components in use/supplied/being supplied, Corrective actions, responsible entity, and time to complete, Advice related to the defect/failure to comply. (e) Review a sample of 10CFR21 evaluations performed to verify procedure implementation for conditions determined to be potentially reportable. (Document NCR/CAR Numbers for evaluations reviewed in the Assessment/Summary) (f) Identify any NRC inspections performed since the previous NUPIC audit identifying noncompliance to 10CFR21 requirements (10CFR21.41). Regulatory Reference: 10CFR21.3, 10CFR21.6, 10CFR21.21, 10CFR21.41 Vendor Quality Manual/Procedure Ref.:

39 Page: 39 of 47 SECTION 11 NONCONFORMING ITEMS/PART 21

40 Page: 40 of 47 SECTION 12 INTERNAL AUDITS 12.1 Within the assessment/summary section of this checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation (a) Verify that measures are established and implemented to ensure a comprehensive system of planned and periodic internal audits. (c) (d) Verify that the participants have no direct responsibility in the areas audited. Verify that checklists and/or procedures were used with objective evidence documented, that audit results were documented and those results reviewed by management having responsibility in the area audited. Verify follow-up action is taken where needed. (Document O.E. on Figure 12) Appendix B/ANSI N45.2 Ref: (18/19) NQA-1 Supplement 18S Verify the overall effectiveness of the internal audit process by review of previous internal audits and comparing the results/issues identified in these audits with the results of this NUPIC audit. Appendix B/ANSI N45.2 Ref: (18/19) NQA-1 Basic Requirement 18S-1

41 Page: 41 of 47 SECTION 12 INTERNAL AUDITS (Figure 12) AUDIT SCOPE AND DATE AUDITOR(S) NUMBER OF DEFICIENCIES & STATUS (OPEN/CLOSED) CORRECTIVE ACTION VERIFICATION METHOD *12.2 *12.2 *12.2 *12.2 *Refers to applicable question.

42 Page: 42 of 47 SECTION 13 CORRECTIVE ACTION 13.1 Within the assessment/summary section of this checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation Verify that measures are established and implemented to assure that conditions adverse to quality are promptly identified and corrected. These measures shall include as a minimum: (a) (c) (d) (e) (f) Identification and description of the condition adverse to quality; Determination of the cause and actions taken to prevent recurrence and notification to appropriate levels of management for significant conditions adverse to quality; Review and approval by responsible authority on the adequacy of the corrective action; Review of corrective actions to determine if they were timely and effective; A clear connection between the corrective action process and the Part 21 procedure such that a mechanism exists to identify and elevate conditions requiring 10CFR21 evaluation; Follow-up actions for closeout to verify that the corrective action has taken place or are scheduled. (Document CAR Numbers of items reviewed under the Assessment/Summary.) NOTE: If the supplier uses a Corrective Action Review Board or similar organization, review a sample of the meeting minutes of this organization to verify follow through on any commitments from the meeting pertaining to significant conditions adverse to quality. Appendix B/ANSI N45.2 Ref: (16/17) NQA-1 Basic Requirement Verify that deficiencies identified/reported by customers (e.g., receipt inspection rejections, site nonconformances, etc.) are adequately assessed and entered into either the supplier s nonconformance or corrective action program. NOTE: Document NCR and/or CAR numbers of items reviewed under the Assessment/Summary. Appendix B/ANSI N45.2 Ref: (16/17) NQA-1 Basic Requirement 16

43 Page: 43 of 47 SECTION 13 CORRECTIVE ACTION 13.4 Verify the overall effectiveness of the corrective action process based upon the following: (a) Evaluate the adequacy of actions taken to prevent recurrence for any significant conditions adverse to quality. Review the adequacy of corrective actions taken as a result of the issues identified during the last NUPIC audit (if applicable) to determine if there are any repeat issues. Appendix B/ANSI N45.2 Ref: (16/17) NQA-1 Basic Requirement 16

44 Page: 44 of 47 SECTION 14 - TRAINING/CERTIFICATION 14.1 Within the assessment/summary section of this checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation Verify that measures are established and implemented to ensure quality program indoctrination and training of personnel who perform activities affecting quality. (Document O.E. on Figure 14) NOTE: Evidence to be obtained from Sections 2, 3, 5, 7, 8, and 12. Appendix B/ANSI N45.2 Ref: (2/2) NQA-1 Supplement 2S Verify that inspection/test personnel, auditors, calibration, repair personnel and similar specialists (i.e., ASME Code work design personnel to, Appendix XXIII) are qualified and have certifications, as applicable, on file in accordance with industry and/or supplier program requirements. (Document O.E. on Figure 14) NOTE: Evidence to be obtained from Section 2, 3, 5, 7, 8, and 12. Appendix B/ANSI N45.2 Ref: (2, 9, 10, 11, 18/2, 10, 11, 12, 19) NQA-1 Supplement 2S-1, 2S-2, 2S-3

45 Page: 45 of 47 SECTION 14 TRAINING/CERTIFICATION (FIGURE 14 PERSONNEL INDOCTRINATION/TRAINING/QUALIFICATION) NAME, STAMP, AND JOB TITLE INDOCTRINATION AND TRAINING COMPLETED (Yes/No) QUALIFICATION/CERTIFICATION CERT. TYPE AND LEVEL *14.2, 14.3 *14.2 *14.3 *Refers to applicable question.

46 Page: 46 of 47 SECTION 15 FIELD SERVICES 15.1 (a) Describe the field services provided by the supplier and the quality program(s) under which the services are provided. Verify the controls for these services have been evaluated in the appropriate sections of the checklist. (Refer to the Audit Implementation Guideline for guidance in completing the assessment for this question) Appendix B/ANSI N45.2 Ref: 2/2 NQA-1 Basic Requirement 2

47 Page: 47 of 47 SECTION 16 RECORDS 16.1 Within the assessment/summary section of this checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation (a) Verify that adequate measures are established and implemented to assure that all QA records not transferred to the member are maintained in facilities that provide storage, retention requirements and protection against environmental effects, damage and loss. (c) Verify that records are legible, identifiable, and retrievable. Verify records retained and maintained per 10CFR21.51 including Evaluation of deviations and failures to comply retained a minimum of 5 years after the date of the evaluation. Notifications sent to purchasers and affected licensees for a minimum of 5 years after the date of the notification. Record of purchases of basic components are retained for 10 years after the delivery of the basic component or service associated with a basic component. (d) Verify records are retained and maintained per 10CFR21.51 for 10CFR52 licensed plants including: Notifications sent to purchasers and affected licensees for a minimum of 5 years after the date of notification. Record of purchases purchasers for 15 years after delivery of design which is the subject of the design certification rule or service associated with the design. Records should include the following, as applicable: Inspection and test records; Audit reports; Quality related procedures/instructions/drawings; Qualifications and certifications; Material Analysis records; Certifications of Compliance/Conformance; Laboratory/Engineering/Manufacturing Operating Logs; Calibration Records; Nonconformance Documents. Appendix B/ANSI N45.2 Ref: (17/18) 10 CFR CFR 52 NQA-1 Supplement 17S-1, 6S-1