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Supplier Name: Audit ID No: SupplierName Audit ID No. Document No: 7 Revision 16 1 Page:
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SUMMARY SHEET
SUPPLIER INFORMATION SUPPLIER: ADDRESS: CITY: TELEPHONE NO: PRODUCT/SERVICE: ASME CODE STAMP, AUTHORIZATIONS, AND EXPIRATION DATES: STATE: FAX NO.: ZIP CODE: NUPIC SUPPLIER NO.:
AUDIT SCOPE ANSI N45.2 ANSI N45.2.2 ANSI N45.2.6 ANSI N45.2.9 ANSI N45.2.11 ANSI N45.2.12 ANSI N45.2.13 ANSI N45.2.23 ANSI N101.4 10CFR50/Appendix B ASME SECTION XI ANSI/ASME NQA-1(Yr) ____ IEEE 323 IEEE 344 ASME NCA 3800 ASME NCA 4000 IEEE 383 Regulatory and Industry Issues Considered: COMPANY WEB ADDRESS: TITLE: TITLE: EMAIL: AUDIT INFORMATION MEMBER AUDIT ID NO.: AUDIT TEAM INFORMATION AUDIT TEAM NAME/NUPIC MEMBER DESIGNATOR PHONE EMAIL: CHECKLIST SECTIONS AUDITED Date: Date: NUPIC AUDIT ID NO.: AUDIT DATES: PHONE: PHONE: Yes No SNT-TC-1A CP-189 OTHER :
TEAM LEADER TEAM MEMBER TEAM MEMBER TEAM MEMBER TEAM MEMBER
TECHNICAL SPECIALIST
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Supplier Quality Manual: Audit Section 1 2 3 4 5 6 Design Commercial Grade Dedication Software Quality Assurance Procurement Fabrication/Assembly Activities, Material Control and Handling, Storage and Shipping Special Processes Tests, Inspections, and Calibration Document Control/Adequacy Organization/Program Nonconforming Items/Part 21 Internal Audit Corrective Action Training/Certification Field Services Records KEY S SATISFACTORY U - UNSATISFACTORY N/A - NOT APPLICABLE F = Recommended for Field Services Suppliers unacceptable Section Description Contract Review E F Status Revision: Date: Comments/Findings
7 8 9 10 11 12 13 14 15 16
Note: An audit section status identified as U only indicates that one or more attributes in this checklist section were found to be and may not suggest that the entire section was found to be unsatisfactory.
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(b)
NOTE:
(Document O.E. on Figure 1) (a) Technical and quality requirements include such items as: test/inspection, documentation, C of C, packaging/shipping, hold points, materials, etc. (b) This includes notification to member of design deviations/design changes. Appendix B/ANSI N45.2 Ref: (3/4) ASME Section III NQA-1 Supplement 4S-1, 7S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 1.3 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) ASME Section III NQA-1 Supplement 15S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 1.4 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.
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SECTION 2 DESIGN
METHOD OF VERIFICATION 2.1 2.2 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation. Verify that measures to control the translation of design requirements into design documents are implemented. a) b) 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. 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) ASME Section III NQA-1 Supplement 3S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 2.3 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 suppliers safety related components have parts classified as non-safety related, the following items should be considered: a) b) c) Is the process controlled? Is a functional evaluation approach used? Has the evaluation included analysis of failure modes to assure the parts failure would not prevent the component from performing its safety related function?
Appendix B/ANSI N45.2 Ref: (3/4) ASME Section III NQA-1 Supplement 3S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION
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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) ASME Section III NQA-1 Supplement 3S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 2.5 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.
b) 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) ASME Section III NQA-1 Supplement 3S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 2.6 Verify that measures are established and implemented to control design changes including changes for spare/replacement parts. a) b) 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) ASME Section III NQA-1 Supplement 3S-1
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SECTION 2 DESIGN
Vendor Quality Manual Ref.:
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SECTION 2 DESIGN
(FIGURE 2) MEMBER/SUPPLIER DESIGN INPUT AND BASES SUPPLIER DESIGN DOCUMENT DESIGN INPUTS CORRECTLY INCORPORATED (Yes/No) *2.2 *Refers to applicable question. *2.2 *2.2 *2.5 *2.6 METHOD OF DESIGN VERIFICATION DESIGN CHANGE CONTROL AND REV./DATE
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c)
Identification of critical characteristics for acceptance, required to support the safety function. (See Note 1) Selection of the method(s) of dedication for each identified critical characteristic: Method 1 Method 2 Method 3 Method 4 Inspection, and Test (Figure 3A) CGI Surveys (Figures 3A and 3B) (See Note 3) Source Verification (Figures 3A and 3B) 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 CGIs 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) ASME Section III NQA-1 Supplement 7S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 3.3 For Method 1 dedications, verify that the tests and inspections specified for the acceptance of commercial grade items:
(a)
(b)
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: 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
NOTE:
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) ASME Section III NQA-1 Supplement 10S-1, 11S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 3.4 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 (b) 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 3B. NOTE: Supplier surveys should ensure that distributors of commercial grade items adequately control the identified critical characteristics, as applicable (may not control material). Figure
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*3.4, 4.5
*3.4, 4.5
*3.4, 4.5
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SECTION 4 - SOFTWARE
METHOD OF VERIFICATION 4.1 4.2 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation. (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. (b.) 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. (c.) 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) ASME Section III NQA-1-1994 Basic Requirements 3, 11 and 17, Supplement 3S-1, 11S-2, 17S-1 and Subpart 2.7 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 4.3 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) ASME Section III NQA-1-1994 Basic Requirement 11, Supplement 11S-2 and Subpart 2.7 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 4.4 Verify that measures are established and implemented to assure that the changes to software are formally documented, evaluated and approved by the organization responsible for the original software development. Verify the changes are controlled commensurate with
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SECTION 4 - SOFTWARE
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) ASME Section III NQA-1-1994 Basic Requirement 3, Supplement 3S-1 and Subpart 2.7 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 4.5 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 purchasers 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.
b)
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. Verification of controls shall be evaluated during procurement and test and inspections for safety related software. Verification of dedication activities for commercial grade software shall be encompassed in Section 3.
NOTE: NOTE:
(Document O.E. on Figure 3, 5A and 5B as appropriate) Appendix B/ANSI N45.2 Ref: (3/4, 4/5, 7/8) ASME Section III NQA-1-1994 Basic Requirements 4, 7, 11, Supplements 4S-1, 7S-1, 11S-2 and Subpart 2.7 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 4.6 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.
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SECTION 4 - SOFTWARE
Appendix B/ANSI N45.2 Ref: (15/16) ASME Section III NQA-1-1994 Basic Requirement 16 and Subpart 2.7 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 4.7 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) ASME Section III NQA-1-1994 Basic Requirement 13 and Supplement 13S-1 Vendor Quality Manual Ref.:
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SECTION 4 - SOFTWARE
(FIGURE 4) SOFTWARE PROGRAM NO., REV./DATE) *4.2, 4.4 (NAME, METHOD OF ACCEPTANCE TESTING AND DATE *4.2, 4.3 ERROR NOTICE/DATE AND STATUS (OPEN/CLOSED) *4.6
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SECTION 5 PROCUREMENT
METHOD OF VERIFICATION 5.1 5.2 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation. 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) b) 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) m) Additional technical and administrative requirements, as necessary, to satisfy the suppliers QA program and technical requirements. Requirement for reporting as-found calibration data when calibrated items are found to be out-of-tolerance. 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) ASME Section III NQA-1 Supplement 4S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 5.3 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 suppliers 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) b) Verify evaluations are performed prior to award of contract, and at the specified frequency. Verify that the scope of approval of the sub-supplier is commensurate with the requirements of the procurement documents.
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SECTION 5 PROCUREMENT
c) d) 1. 2. 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 suppliers evaluation shall include the following: Sub-supplier has accreditation to ANSI/ISO/IEC 17025 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 subsuppliers. Sub-Supplier is a commercial grade, domestic (US) calibration laboratory 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) ASME Section III NQA-1 Supplement 7S-1 Vendor Quality Manual Ref.:
3.
4.
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METHOD OF VERIFICATION 5.4 Verify that measures are established and implemented to ensure a comprehensive system of planned and periodic external audits (including 3rd party audits). 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 3rd party audits e.g., NIAC, Consultant performed, are used as a basis for supplier qualification the evaluation shall be documented and shall address: 1. 2. 3. 4. 5. Performance of the audit by qualified personnel. Performance of the evaluation by qualified personnel to ensure the users program requirements are satisfied. The Scope of the audit envelops the current scope of procurement. The applicable regulatory and/or commercial program requirements are adequately addressed in the audit scope. Sufficient objective evidence is available to support conclusions of the audit.
NOTE: Use of 3rd party audits should be addressed within the suppliers program/procedures. (Document O.E. on Figure 5B) Appendix B/ANSI N45.2 Ref: (18/19) ASME Section III NQA-1 Supplement 18S-1
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SECTION 5 PROCUREMENT
Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 5.5 (a) Verify that where the suppliers 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. (b) 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(b) only addresses testing in lieu of auditing to validate ASME certification. Appendix B/ANSI N45.2 Ref: (7/8) IE Notice 86-21 including supplements NQA-1 Supplement 7S-1 Vendor Quality Manual Ref.:
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SECTION 5 - PROCUREMENT
(FIGURE 5A) ITEM DESCRIPTION NAME (P/N, S/N, MODEL NO., SOFTWARE NAME) *4.5, 5.2, 5.3 SUPPLIER AND LOCATION *4.5, 5.2, 5.3 P.O. NUMBER AND DATE *4.5, 5.2, 5.3 METHOD AND DATE OF SUPPLIER EVALUATION *4.5, 5.3, 5.4 SCOPE OF SUPPLIER APPROVAL *4.5, 5.3, 5.4
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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
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(Document O.E. on Figure 6A) Appendix B/ANSI N45.2 Ref: (5/6, 8/9) ASME Section III NQA-1 Supplement 9S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 6.3 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) ASME Section III NQA-1 Basic Requirement 8 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 6.4 Verify that measures are established and implemented for the identification and control of items. Verify the following:
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(Document O.E. on Figure 6B) Appendix B/ANSI N45.2 Ref: (7/8) ASME Section III NQA-1 Supplement 7S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 6.5 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) b) 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) ASME Section III NQA-1 Supplement 13S-1 Vendor Quality Manual Ref.:
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*6.2
*6.2
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(Document O.E. on Figures 7A, 7B) Appendix B/ANSI N45.2 Ref: (9/10, 10/11) ASME Section III NQA-1 Supplement 9S-1, 10S-1 Vendor Quality Manual Ref.:
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*7.2
*7.2
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*7.2
*7.2
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Characteristics to be inspected. g) h) I) j) 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) ASME Section III NQA-1 Supplement 7S-1, 10S-1, 11S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 8.3 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) ASME Section III NQA-1 Supplement 7S-1 Vendor Program Ref:
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METHOD OF VERIFICATION 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 manufacturers 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 manufacturers markings
Appendix B/ANSI N45.2 Ref: (7/8, 10/11, 11/12) ASME Section III NQA-1 Supplement 7S-1, 10S-1, 11S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 8.5 Verify that sampling plan(s) other than those used for commercial grade dedication (such as those used during receipt/in-process/final inspection) are controlled and acceptably implemented. Appendix B/ANSI N45.2 Ref: (10/11) ASME Section III NQA-1 Supplement 10S-1, 11S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 8.6 Verify that M&TE controls are established and implemented for the following: (a) (b) Labeling/identification of M&TE, including person who performed calibration Calibration of M&TE and standards at periodic (recall) intervals
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(d)
(g)
NOTE: NOTE
(Document O.E. on Figure 8) Appendix B/ANSI N45.2 Ref: (12/13) ASME Section III NQA-1 Supplement 12S-1 Vendor Quality Manual Ref.:
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RESULTS SAT. OR UNSAT. IF UNSAT., RECORD NCR NO. IF APPLICABLE *8.2, 8.4
*8.2
*8.2
*8.2
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Evidence obtained from Sections 1- 16 shall be evaluated when assessing this item. Appendix B/ANSI N45.2 Ref: (5, 6/6, 7) ASME Section III NQA-1 Supplement 6S-1 Vendor Quality Manual Ref.:
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SECTION 10 ORGANIZATION/PROGRAM
METHOD OF VERIFICATION 10.1 10.2 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; b) 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.; c) Verify that the suppliers management regularly reviews, assesses, and evaluates the status and effectiveness of the Quality Assurance Program.; Appendix B/ANSI N45.2 Ref: (1-3) ASME Section III NQA-1 Supplement 1S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 11.3 Verify that the nonconforming items are reviewed and dispositioned such that: a) b) 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. 10CFR21 evaluation completed, if required. Closeout is adequate.
(Document NCR Numbers of items reviewed under the Assessment/Summary) Appendix B/ANSI N45.2 Ref: (15/16) ASME Section III NQA-1 Supplement 15S-1 (para. 4.1) Vendor Quality Manual Ref.:
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(c)
(d)
(e)
(f)
Regulatory Reference: 10CFR21.3, 10CFR21.6, 10CFR21.21, 10CFR21.41 Vendor Quality Manual/Procedure Ref.:
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(a)
(b) (c) (d)
Verify that measures are established and implemented to ensure a comprehensive system of planned and periodic internal audits. 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) ASME Section III NQA-1 Supplement 18S-1 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 12.3 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) ASME Section III NQA-1 Basic Requirement 18S-1 Vendor Quality Manual Ref.:
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*12.2
*12.2
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NOTE: Document CAR Numbers of items reviewed under the Assessment/Summary. Appendix B/ANSI N45.2 Ref: (16/17) ASME Section III NQA-1 Basic Requirement 16 Vendor Quality Manual Ref.:
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METHOD OF VERIFICATION 13.3 Verify that deficiencies identified/reported by customers (e.g., receipt inspection rejections, site nonconformances, etc.) are adequately assessed and entered into either the suppliers 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) ASME Section III NQA-1 Basic Requirement 16 Vendor Quality Manual Ref.:
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ASSESSMENT/SUMMARY:
METHOD OF VERIFICATION 13.4 Verify the overall effectiveness of the corrective action process based upon the following: a) b) 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)
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ASSESSMENT/SUMMARY:
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SECTION 14 - TRAINING/CERTIFICATION
METHOD OF VERIFICATION 14.1 14.2 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) ASME Section III NQA-1 Supplement 2S-4 Vendor Quality Manual Ref.:
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ASSESSMENT/SUMMARY:
METHOD OF VERIFICATION 14.3 Verify that inspection/test personnel, auditors, calibration, repair personnel and similar specialists (i.e., ASME Code work design personnel to ASME Section III, 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) ASME Section III NQA-1 Supplement 2S-1, 2S-2, 2S-3 Vendor Quality Manual Ref.:
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ASSESSMENT/SUMMARY:
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SECTION 14 TRAINING/CERTIFICATION
(FIGURE 14 PERSONNEL INDOCTRINATION/TRAINING/QUALIFICATION) NAME, STAMP, AND JOB TITLE *14.2, 14.3 INDOCTRINATION AND TRAINING COMPLETED (Yes/No) *14.2 QUALIFICATION/CERTIFICATION TYPE AND LEVEL *14.3 CERT.
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b)
(Refer to the Audit Implementation Guideline for guidance in completing the assessment for this question) Appendix B/ANSI N45.2 Ref: 2/2 ASME Section III NQA-1 Basic Requirement 2 Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
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SECTION 16 RECORDS
METHOD OF VERIFICATION 16.1 16.2 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. 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 including customer purchase orders.
b) c)
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) ASME Section III NQA-1 Supplement 17S-1, 6S-1 Vendor Quality Manual Ref.:
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ASSESSMENT/SUMMARY: