Audit Checklist - Final - - Acuity Quality...

NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST

Supplier Name: SupplierName Document No: 7Audit ID No: Audit ID No. Revision 18

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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:



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NUPIC Representative: Date:



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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.



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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.:

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1.3 Describe and verify that measures are established and implemented for control of items returned from the member for repair/rework.


ASME Section III

NQA-1 Supplement 15S-1


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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 1 – CONTRACT REVIEW

Appendix B/ANSI N45.2 Ref: (6/7) (17/18)

ASME Section III



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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



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SECTION 2 – DESIGN



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.



ASME Section III



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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?


ASME Section III



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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.


ASME Section III



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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.



ASME Section III



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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).





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ASME Section III



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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.



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SECTION 3 – COMMERCIAL GRADE DEDICATION



3.2 Verify and assess the supplier’s controls for the dedication of purchased Commercial Grade Items and services. As a minimum the process should include a documented technical evaluation performed by the responsible engineering organization that establishes requirements that will provide reasonable assurance the item/service will perform its intended safety function. The process should include the following:

(a) Documented controls, which define the dedication process.

(b) Determination of the safety function for the item/service intended end use by review of documents associated with the technical evaluation, such as:

Classification of the item

Item equivalency evaluations

Consideration of credible failure modes (See Note 1)

(c) Identification of critical characteristics for acceptance, required to support the safety function. (See Note 1)

(d) Selection of the method(s) of dedication for each identified critical characteristic:

Method 1: Inspection, and Test (Figure 3A)

Method 2: CGI Surveys (Figures 3A and 3B) (See Note 3)

Method 3: Source Verification (Figures 3A and 3B)

Method 4: Supplier/Performance history in conjunction with Methods 1, 2, or 3, above.

NOTE 1: For suppliers who are unable to determine the items/materials safety function or end use (i.e., material suppliers, QSC holders, etc.), characteristics of the material specification, which are applicable to the finished product (i.e., chemical, physical, hydro, etc.) must be verified.

NOTE 2: This question applies to CGI’s dedicated by the supplier for member procurement as basic components or for internal use in safety-related functions (e.g. software, consumables, fasteners, elastomers etc.). Special consideration should be given to items that are seismically/environmentally qualified (e.g., relays, switches, nonmetallic items, etc.).

NOTE 3: Verify that when accreditation such as NVLAP, A2LA, ACLASS, L-A-B, IAS, and PJLA are used as part of the basis for acceptance of domestic commercial calibration sub-supplier services in lieu of commercial grade surveys, the process for using these services via this accreditation is documented as a commercial grade dedication. (Accrediting bodies that have been determined to provide an acceptable alternative to the methods used to qualify commercial grade calibration service sub-suppliers are identified in the NRC APS Safety Evaluation Report and subsequent NRC letter correspondence.)

(Document O.E. on Figure 3A and/or 3B, as applicable)


ASME Section III



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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



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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.

NOTE: Supplier surveys should ensure that distributors of commercial grade items adequately control the identified critical



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characteristics, as applicable (may not control material).


ASME Section III



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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


**To be completed for Method 1 only.



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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


**To be completed for Methods 2 and 3 only.



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SECTION 4 - SOFTWARE



4.2 Verify documented measures (plans, policies, and procedures) are established and implemented to control the quality of software (including firmware).

a. Verify that a “plan” for software quality exists at the start of software lifecycle for developed software or upon entry into the purchaser’s organization for procured software.

“Plans” may be unique to each project, may exist as a generic document (procedure), or may be incorporated into the overall QA program.

“Plans” identify:

The software product

Responsible organizations, tasks, and responsibilities

Documentation requirements

Standards , conventions, techniques, methodologies applied to the development

Review requirements

Error reporting/corrective action methods

b. Verify that the software lifecycle activities are identified and independently reviewed, as appropriate to the nature and complexity of the software application.

The lifecycle activity model for developed software typically includes requirements phase, design phase, implementation phase, testing phase, installation and checkout phase, operations and maintenance phase, and retirement phase. The number of phases, and emphasis placed on each, is dependent on nature and complexity of the software. For purchased software, the software typically enters the purchaser’s organization at the beginning of the installation and checkout phase.



ASME Section III

NQA-1-1994 Basic Requirements 3, 11 and 17, Supplement 3S-1, 11S-2, 17S-1 and Subpart 2.7


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4.3 Verify that measures are established and implemented to assure that software acceptance testing is planned and performed to demonstrate that software adequately and correctly performs all intended functions (i.e., specified software design requirements) and does not perform any unintended function.

Software validation, performed during the testing phase, ensures that the code satisfies the requirements by development and execution of test plans and test cases. To evaluate technical adequacy, test case results can be compared to alternative “Methods



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of Acceptance” such as:

hand calculations

other validated computer program

experiments/tests

standard problems with known solutions

confirmed published data and correlations

In addition, testing for installation and integration of software should be included in the life cycle installation and checkout phase.


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


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4.4 Verify that measures are established and implemented to assure that software configuration is maintained and the changes to software are formally documented.

A configuration baseline defines completion of each major phase of software development. Approved changes added to the baseline define the current approved software configuration. Configuration management includes documentation of the approved configuration, the status of proposed changes to the configuration and the status of approved changes to the configuration.

Verification ensures changes to software are reflected in traceable software documentation. Changes to software require formal documentation identifying:

description of the change

rationale for the change

identification of affected baselines (e.g. Requirements documentation, Design documentation)

a. Verify software is the documented current approved configuration and the status of proposed and approved changes is documented.

b. Verify evaluation (verification) and approval of software changes by the organization responsible for the original software development.

NOTE: Configuration management includes controls for backups, maintenance, disaster recovery, and virus protection..





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ASME Section III

NQA-1-1994 Basic Requirement 3, Supplement 3S-1 and Subpart 2.7


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4.5 Verify measures are established and implemented for the procurement of software as safety related or commercial grade (to be dedicated).

Procured software typically enters the purchaser’s organization at the start of the lifecycle installation and checkout phase. This phase includes software verification and validation activities which consist of testing for installation and integration and documentation of software approval for operational use. The purchaser’s software quality plan should address applicable lifecycle activities (i.e. installation and checkout, operations and maintenance, retirement), once the software has entered the purchaser’s organization.

a. Verify that Safety Related software procurement provides controls (i.e. acceptable supplier qualification, procurement practices and receipt inspection) to ensure that the software supplier is providing software that meets the technical and quality requirements specified in the purchase order. The purchaser’s audit of the software supplier should ensure that the software was developed and maintained in accordance with software quality assurance program requirements similar to those identified in this checklist section (4).

b. Verify commercial grade (commercial) software procurement provides Commercial Grade Item Dedication controls per Checklist Section 3. Dedication activities should establish configuration control and ensure, as a minimum, that application requirements are identified, test plans/test cases to validate software acceptability are performed and user documentation is generated (input/output specifications, system limitations, etc.).

NOTE: Verification of dedication activities for commercial grade software are performed in checklist 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


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4.6 Verify that problem reporting measures are established and implemented to assure that software errors and failures from both internal and external sources are identified, documented, evaluated, resolved, and assessed for impact on past and present



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applications.

a. Verify methods of notification consistent with those identified in the problem reporting system.

b. Verify problem classification with defined criteria based on impact of software output.

c. Verify problems and their significance promptly reported to affected organizations.



ASME Section III

NQA-1-1994 Basic Requirement 16 and Subpart 2.7


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4.7 Verify measures are established and implemented to assure that software is adequately packaged, marked, stored, and shipped.

a. Verify that when duplicate copies are generated, methods are in place to ensure exact duplication.


ASME Section III

NQA-1-1994 Basic Requirement 13 and Supplement 13S-1


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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




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SECTION 5 – PROCUREMENT



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 )


ASME Section III



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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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(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.


ASME Section III



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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)




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ASME Section III



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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.


IE Notice 86-21 including supplements



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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




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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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SECTION 6 - FABRICATION/ASSEMBLY ACTIVITIESMATERIAL CONTROL, HANDLING, SHIPPING AND STORAGE



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)


ASME Section III



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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.



ASME Section III

NQA-1 Basic Requirement 8


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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.



ASME Section III



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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?


NOTE: This item does not apply to software because shipping of software is addressed in Item 4.7.


ASME Section III



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(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




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(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




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SECTION 7 - SPECIAL PROCESSES


7.1 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation

7.2 Verify that measures are established and implemented and that special processes (e.g., welding, heat treating, soldering, NDE, painting, etc.) are accomplished utilizing:

(a) 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)


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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




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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




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SECTION 8 – TESTS, INSPECTIONS, AND CALIBRATION


8.1 Within the assessment/summary section of each checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation

8.2 Verify that adequate measures are established and implemented for the inspection (receipt, in-process, and final) and testing of materials, components and parts. Verify these documents include, as applicable:

(a) 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).

(f) 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.



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NQA-1 Supplement 7S-1, 10S-1, 11S-1


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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.



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ASSESSMENT/SUMMARY:


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


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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.


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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



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(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.



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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




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SECTION 9 – DOCUMENT CONTROL/ADEQUACY


9.1 Within the assessment/summary section of this checklist question, record the procedures/instructions/drawings including the revision/date used to verify implementation.

9.2 Verify that measures are established and implemented to control the issuance of documents (i.e., procedures, instructions, drawings, work orders, etc.) including changes. These measures shall assure that documents are:

(a) 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.


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SECTION 10 – ORGANIZATION/PROGRAM



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)

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SECTION 11 – NONCONFORMING ITEMS/PART 21



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.


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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) A clear connection between the nonconformance process and the Part 21 procedure exists such that a mechanism exists to identify and elevate conditions requiring 10CFR21 evaluation.

(g) Closeout is adequate.

(Document NCR Numbers of items reviewed under the Assessment/Summary)

NOTE: If the supplier uses a Material Review Committee or similar organization, review a sample of the meeting minutes of this organization to verify follow through on any commitments from the meeting pertaining to significant conditions adverse to quality.


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NQA-1 Supplement 15S-1 (para. 4.1)




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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) Review a sample of 10CFR21 evaluations performed to verify procedure implementation for conditions determined to be

potentially reportable.

(Document NCR/CAR Numbers for evaluations reviewed in the Assessment/Summary)

(f) Identify any NRC inspections performed since the previous NUPIC audit identifying noncompliance to 10CFR21 requirements

(10CFR21.41).

Regulatory Reference: 10CFR21.3, 10CFR21.6, 10CFR21.21, 10CFR21.41



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Vendor Quality Manual/Procedure Ref.:

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SECTION 12 – INTERNAL AUDITS



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.



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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.


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NQA-1 Basic Requirement 18S-1


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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




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SECTION 13 – CORRECTIVE ACTION



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 and notification to appropriate levels of management 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) A clear connection between the corrective action process and the Part 21 procedure such that a mechanism exists to identify and elevate conditions requiring 10CFR21 evaluation;

(f) Follow-up actions for closeout to verify that the corrective action has taken place or are scheduled.

(Document CAR Numbers of items reviewed under the Assessment/Summary.)

NOTE: If the supplier uses a Corrective Action Review Board or similar organization, review a sample of the meeting minutes of this organization to verify follow through on any commitments from the meeting pertaining to significant conditions adverse to quality.


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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.


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SECTION 13 – CORRECTIVE ACTION


13.4 Verify the overall effectiveness of the corrective action process based upon the following:

(a) Evaluate the adequacy of actions taken to prevent recurrence for any significant conditions adverse to quality.

(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.


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SECTION 14 - TRAINING/CERTIFICATION



14.2 Verify that measures are established and implemented to ensure quality program indoctrination and training of personnel who perform activities affecting quality.


NOTE: Evidence to be obtained from Sections 2, 3, 5, 7, 8, and 12.


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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.


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)

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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




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SECTION 15 – FIELD SERVICES


15.1 (a) Describe the field services provided by the supplier and the quality program(s) under which the services are provided.

(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

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SECTION 16 – RECORDS



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.

(d) Verify records are retained and maintained per 10CFR21.51 for 10CFR52 licensed plants including:

Notifications sent to purchasers and affected licensees for a minimum of 5 years after the date of notification.

Record of purchases purchasers for 15 years after delivery of design which is the subject of the design certification rule or service associated with the design.

Records should include the following, as applicable:

Inspection and test records;

Audit reports;

Quality related procedures/instructions/drawings;

Qualifications and certifications;

Material Analysis records;

Certifications of Compliance/Conformance;

Laboratory/Engineering/Manufacturing Operating Logs;

Calibration Records;

Nonconformance Documents.


10 CFR 21.51

10 CFR 52

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