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NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
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 N45.2.13 IEEE 323 SNT-TC-1A
ANSI N45.2.2 ANSI N45.2.23 IEEE 344 CP-189
ANSI N45.2.6 ANSI N101.4 ASME NCA 3800 OTHER :
ANSI N45.2.9 10CFR50/Appendix B ASME NCA 4000
ANSI N45.2.11 ASME SECTION XI IEEE 383
ANSI N45.2.12 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:
EMAIL:
AUDIT INFORMATION
MEMBER AUDIT ID NO.: NUPIC AUDIT ID NO.: AUDIT DATES:
AUDIT TEAM INFORMATION
AUDIT TEAM NAME/NUPIC MEMBER
DESIGNATOR
PHONE EMAIL: CHECKLIST
SECTIONS
AUDITED
TEAM LEADER
TEAM MEMBER
TEAM MEMBER
TEAM MEMBER
TEAM MEMBER
TECHNICAL SPECIALIST
(SPECIFY DISCIPLINE)
Audit Team Leader: Date:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
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Audit ID No: Audit ID No. Revision 16
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NUPIC Representative: Date:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 3 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 21
12 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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 4 of 47
SECTION 1 – CONTRACT REVIEW
METHOD OF VERIFICATION
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).
(b) 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.
(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.:
RESULTS:
ASSESSMENT/SUMMARY:
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.:
RESULTS:
ASSESSMENT/SUMMARY:
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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
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SECTION 1 – CONTRACT REVIEW
Appendix B/ANSI N45.2 Ref: (6/7) (17/18)
ASME Section III
NQA-1 Supplement 17S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 6 of 47
SECTION 1 - CONTRACT REVIEW(FIGURE 1)
MEMBER P.O. / CONTRACT NO.
AND DATE
PART NUMBER AND ITEM/SERVICE DESCRIPTION
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
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
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SECTION 2 – DESIGN
METHOD OF VERIFICATION
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.
b) 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)
ASME Section III
NQA-1 Supplement 3S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
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 supplier’s safety related components have parts classified as non-safety related, the following items should be considered:
a) Is the process controlled?
b) Is a functional evaluation approach used?
c) 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)
ASME Section III
NQA-1 Supplement 3S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
METHOD OF VERIFICATION
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
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Audit ID No: Audit ID No. Revision 16
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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.:
RESULTS:
ASSESSMENT/SUMMARY:
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.:
RESULTS:
ASSESSMENT/SUMMARY:
METHOD OF VERIFICATION
2.6 Verify that measures are established and implemented to control design changes including changes for spare/replacement parts.
a) 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.
b) Ensure design control measures are equal to those of the original design.
c) 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
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
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Audit ID No: Audit ID No. Revision 16
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SECTION 2 – DESIGN
NQA-1 Supplement 3S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
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Audit ID No: Audit ID No. Revision 16
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SECTION 2 – DESIGN(FIGURE 2)
MEMBER/SUPPLIER DESIGN INPUT AND BASES
SUPPLIER DESIGN DOCUMENT
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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
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Audit ID No: Audit ID No. Revision 16
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SECTION 3 – COMMERCIAL GRADE DEDICATION
METHOD OF VERIFICATION
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 the following:
a) Documented controls, which define the dedication process.
b) 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 related function. These requirements shall
include: determination of safety function, identification of critical characteristics, and selection of verification methods.
c) 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)
d) Identification of critical characteristics for acceptance, required to support the safety function. (See Note 1)
e) 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)
ASME Section III
NQA-1 Supplement 7S-1
Vendor Quality Manual Ref.:
RESULTS:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
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Audit ID No: Audit ID No. Revision 16
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SECTION 3 – COMMERCIAL GRADE DEDICATION
ASSESSMENT/SUMMARY:
METHOD OF VERIFICATION
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
(b) 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
- That the plan provides for appropriate accept/reject controls
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.:
RESULTS:
ASSESSMENT/SUMMARY:
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
Figure 3B.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
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Audit ID No: Audit ID No. Revision 16
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SECTION 3 – COMMERCIAL GRADE DEDICATION
NOTE: Supplier surveys should ensure that distributors of commercial grade items adequately control the identified critical
characteristics, as applicable (may not control material).
Appendix B/ANSI N45.2 Ref: (10, 11/11, 12)
ASME Section III
NQA-1 Supplement 10S-1, 11S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
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Audit ID No: Audit ID No. Revision 16
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SECTION 3 – COMMERCIAL GRADE DEDICATION(FIGURE 3A)
COMMERCIAL GRADE ITEMS
ITEM DESCRIPTION P/N, S/N, MODEL NO., SOFTWARE NAME/ID
NO., ETC., AS APPLICABLE
CRITICAL CHARACTERISTICS AND METHOD OF
DEDICATION
**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, 4.5 3.2, 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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
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SECTION 3 – COMMERCIAL GRADE DEDICATION(FIGURE 3B SURVEYS/SOURCE VERIFICATION) **
CGI SUPPLIER NAME, LOCATION
AND DATE(S) PERFORMED
EVALUATION METHOD
(COMMERCIAL GRADE SURVEY OR
SOURCE VERIFICATION)
SCOPE OF SUPPLY AUDITORS CRITICAL CHARACTERISTICS
(CC) VERIFIED
DO CCs VERIFIED
BY THE
EVALUATION
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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
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SECTION 4 - SOFTWARE
METHOD OF VERIFICATION
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.
(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.:
RESULTS:
ASSESSMENT/SUMMARY:
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.:
RESULTS:
ASSESSMENT/SUMMARY:
METHOD OF VERIFICATION
4.4 Verify that measures are established and implemented to assure that the changes to software are formally documented, evaluated
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
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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)
ASME Section III
NQA-1-1994 Basic Requirement 3, Supplement 3S-1 and Subpart 2.7
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
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 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.
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.
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)
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.:
RESULTS:
ASSESSMENT/SUMMARY:
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.
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SECTION 4 - SOFTWARE
NOTE: Corrective actions should be forwarded to the users in a timely manner.
(Document O.E. on Figure 4)
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.:
RESULTS:
ASSESSMENT/SUMMARY:
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.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
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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.
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Audit ID No: Audit ID No. Revision 16
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SECTION 5 – PROCUREMENT
METHOD OF VERIFICATION
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) Statement of the scope of work.
b) Technical requirements by reference to specific drawings, codes, specifications.
c) Requirement for a documented quality assurance program, implemented, and meeting applicable code/regulatory
requirements.
d) Requirement for right of access to plant facilities and records for source inspection/audit.
e) Identification of document submittals for approval.
f) Identification of deliverable records.
g) Requirement for reporting and approving disposition of nonconformances.
h) Requirements for records availability, retention and disposition.
I) Requirements for extending applicable Technical and QA requirements to lower tier suppliers.
j) Applicability of 10CFR21.
NOTE: If the supplier utilizes accreditation in lieu of commercial grade surveys for domestic commercial calibration service sub-
suppliers, procurement documents should include:
k) Additional technical and administrative requirements, as necessary, to satisfy the supplier’s QA program and technical
requirements.
l) 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)
ASME Section III
NQA-1 Supplement 4S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
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 supplier’s program addresses audits of Appendix B sub-
suppliers, 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.
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SECTION 5 – PROCUREMENT
b) Verify that the scope of approval of the sub-supplier is commensurate with the requirements of the procurement
documents.
c) Verify that only approved suppliers are used.
d) 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 17025
2. 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)
ASME Section III
NQA-1 Supplement 7S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
METHOD OF VERIFICATION
5.4 (a) Verify that measures are established and implemented to ensure a comprehensive system of planned and periodic
external audits (including 3rd party audits).
(b) 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.
(c) 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. 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 3rd 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)
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SECTION 5 – PROCUREMENT
ASME Section III
NQA-1 Supplement 18S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
METHOD OF VERIFICATION
5.5 (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.
(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.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 23 of 47
SECTION 5 - PROCUREMENT
(FIGURE 5A)
ITEM DESCRIPTION NAME
(P/N, S/N, MODEL NO.,
SOFTWARE NAME)
SUPPLIER
AND
LOCATION
P.O. NUMBER
AND
DATE
METHOD AND DATE
OF SUPPLIER
EVALUATION
SCOPE OF SUPPLIER
APPROVAL
*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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 24 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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 25 of 47
SECTION 6 - FABRICATION/ASSEMBLY ACTIVITIESMATERIAL CONTROL, HANDLING, SHIPPING AND STORAGE
METHOD OF VERIFICATION
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) Identification of the work activities;
b) Identifies instructions, procedures and drawings to be used for each item/activity;
c) Identifies hold/witness points;
d) Identifies any environmental requirements;
e) Special handling/cleanliness requirements;
f) 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)
ASME Section III
NQA-1 Supplement 9S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
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.:
RESULTS:
ASSESSMENT/SUMMARY:
METHOD OF VERIFICATION
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 26 of 47
SECTION 6 - FABRICATION/ASSEMBLY ACTIVITIESMATERIAL 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) Items are adequately identified as to inspection/test status.
b) The authority for application and removal of identification markings/status indicators is defined.
c) Storage areas and methods comply with specified requirements and access controls.
d) Item markings are clear and not detrimental. (for example: if die stamps are used, verify stamps are low stress)
e) Subdivided items have satisfactory transfer of markings to each item.
f) Shelf-life requirements are defined and implemented.
(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.:
RESULTS:
ASSESSMENT/SUMMARY:
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) Observe and assess actual techniques being used and their acceptability relative to contract/procedural requirements.
b) Will cleaning, preservation and packaging practices prevent damage/deterioration?
c) Are requirements for environment/preservation, handling and documentation, adequately met?
d) 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.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 27 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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 28 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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 29 of 47
SECTION 7 - SPECIAL PROCESSES
METHOD OF VERIFICATION
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) Qualified personnel
b) Qualified procedures
c) 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)
ASME Section III
NQA-1 Supplement 9S-1, 10S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 30 of 47
SECTION 7 - SPECIAL PROCESSES
(FIGURE 7A)
ITEM DESCRIPTION
(NAME, P/N, S/N,
MODEL NO.)
PROCESS PROCEDURE AND
REV./DATE
QUALIFICATION
PERSONNEL AND
LEVEL
PROCEDURE EQUIPMENT
*7.2 *7.2 *7.2 *7.2 *7.2 *7.2
*Refers to applicable question.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 31 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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 32 of 47
SECTION 8 – TESTS, INSPECTIONS, AND CALIBRATION
METHOD OF VERIFICATION
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) Test/Inspection to be performed.
b) Hold or witness points.
c) Specifications, work instructions, drawings, etc., including document revision.
d) Acceptance criteria contained in applicable design documents.
e) Appropriate Inspection equipment, tools, gages, and instrumentation (correct type, range and accuracy).
Characteristics to be inspected.
g) Test prerequisites identified and met.
h) Personnel.
I) Results are approved by responsible authority.
j) 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.:
RESULTS:
ASSESSMENT/SUMMARY:
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:
RESULTS:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 33 of 47
SECTION 8 – TESTS, INSPECTIONS, AND CALIBRATION
ASSESSMENT/SUMMARY:
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 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)
ASME Section III
NQA-1 Supplement 7S-1, 10S-1, 11S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
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.:
RESULTS:
ASSESSMENT/SUMMARY:
METHOD OF VERIFICATION
8.6 Verify that M&TE controls are established and implemented for the following:
(a) Labeling/identification of M&TE, including person who performed calibration
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 34 of 47
SECTION 8 – TESTS, INSPECTIONS, AND CALIBRATION
(b) Calibration of M&TE and standards at periodic (recall) intervals
(c) Adequacy of standards to assure accuracy, stability, range, and resolution required for their intended use
(d) Reference (primary) and working (secondary) standards used traceable to the National Institute of Standards and
Technology (NIST), other recognized standards, or natural law
(e) As Found/As Left information documented
(f) Calibration History - Dates calibrated, by whom/supplier, results, due date, primary standard, and P.O. No., if
applicable
(g) 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.
(h) Was the M&TE reviewed within current calibration?
(i) Is calibration performed in an environment that is controlled to the extent necessary to assure required accuracy?
(j) Observe and assess actual calibration activities and their acceptability relative to procedure requirements.
NOTE: 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)
ASME Section III
NQA-1 Supplement 12S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 35 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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 36 of 47
SECTION 9 – DOCUMENT CONTROL/ADEQUACY
METHOD OF VERIFICATION
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) Reviewed for adequacy;
b) Approved for release by authorized personnel;
c) Distributed to applicable workstation;
d) 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)
ASME Section III
NQA-1 Supplement 6S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 37 of 47
SECTION 10 – ORGANIZATION/PROGRAM
METHOD OF VERIFICATION
10.1 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the
revision/date used to verify implementation.
10.2 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 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)
ASME Section III
NQA-1 Supplement 1S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 38 of 47
SECTION 11 – NONCONFORMING ITEMS/PART 21
METHOD OF VERIFICATION
11.1 Within the assessment/summary section of this checklist question, record the procedures/instructions/drawings including the
revision/date used to verify implementation.
11.2 Verify that measures are established and implemented to:
a) identify nonconforming items;
b) ensure that responsibility and authority for review/disposition is identified;
c) controls further processing, delivery and installation of items until disposition is completed.
d) notification to member of nonconforming conditions when required by member P.O./Contract.
Appendix B/ANSI N45.2 Ref: (15/16)
ASME Section III
NQA-1 Supplement 15S-1
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
METHOD OF VERIFICATION
11.3 Verify that the nonconforming items are reviewed and dispositioned such that:
a) The disposition is identified.
b) Documented justification is provided verifying the acceptability of the nonconforming items which are dispositioned repair
or use-as-is.
c) Procedures or instructions for repair and rework are provided.
d) Repaired and reworked items are re-inspected.
e) Member approval of use-as-is and repair dispositions when required by purchase order.
f) 10CFR21 evaluation completed, if required.
g) 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.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 39 of 47
SECTION 11 – NONCONFORMING ITEMS/PART 21
METHOD OF VERIFICATION
11.4 10CFR21
(a) Verify appropriate documents are posted per 10CFR21.6(a) OR (b) :
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(b )
• Section 206 of the Energy Reorganization Act of 1974, and
• Notice describing regulations/procedures.
(b) 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) Verify that there is a clear connection between the nonconformance/corrective action processes and the Part 21 procedure such that a mechanism exists to identify and elevate issues requiring 10CFR21 evaluation.
(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.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 40 of 47
SECTION 12 – INTERNAL AUDITS
METHOD OF VERIFICATION
12.1 Within the assessment/summary section of this checklist question, record the procedures/instructions/drawings including the
revision/date used to verify implementation.
12.2 (a) Verify that measures are established and implemented to ensure a comprehensive system of planned and periodic
internal audits.
(b) Verify that the participants have no direct responsibility in the areas audited.
(c) 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.
(d) 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.:
RESULTS:
ASSESSMENT/SUMMARY:
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.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
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
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 42 of 47
SECTION 13 – CORRECTIVE ACTION
METHOD OF VERIFICATION
13.1 Within the assessment/summary section of this checklist question, record the procedures/instructions/drawings including the
revision/date used to verify implementation.
13.2 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) Identification and description of the condition adverse to quality;
b) Determination of the cause and actions taken to prevent recurrence for significant conditions adverse to quality;
c) Review and approval by responsible authority on the adequacy of the corrective action;
d) Review of corrective actions to determine if they were timely and effective;
e) 10CFR21 evaluation completed, if required;
f) Follow-up actions for closeout to verify that the corrective action has taken place or are scheduled.
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.:
RESULTS:
ASSESSMENT/SUMMARY:
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 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)
ASME Section III
NQA-1 Basic Requirement 16
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
METHOD OF VERIFICATION
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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 43 of 47
SECTION 13 – CORRECTIVE ACTION
b) 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)
ASME Section III
NQA-1 Basic Requirement 16
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 44 of 47
SECTION 14 - TRAINING/CERTIFICATION
METHOD OF VERIFICATION
14.1 Within the assessment/summary section of this checklist question, record the procedures/instructions/drawings including the
revision/date used to verify implementation.
14.2 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.:
RESULTS:
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.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
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.
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 46 of 47
SECTION 15 – FIELD SERVICES
METHOD OF VERIFICATION
15.1 a) Describe the field services provided by the supplier and the quality program(s) under which the services are provided.
b) 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
ASME Section III
NQA-1 Basic Requirement 2
Vendor Quality Manual Ref.:
RESULTS:
ASSESSMENT/SUMMARY:
NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
Supplier Name: SupplierName Document No: 7
Audit ID No: Audit ID No. Revision 16
Page: 47 of 47
SECTION 16 – RECORDS
METHOD OF VERIFICATION
16.1 Within the assessment/summary section of this checklist question, record the procedures/instructions/drawings including the
revision/date used to verify implementation.
16.2 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.
b) Verify that records are legible, identifiable, and retrievable.
c) 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.
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.:
RESULTS:
ASSESSMENT/SUMMARY: