ML20126D480

Comments on Reg Guide 1.144:documentation Requirements within Part C,Section B,External Audits,Should Be Same

ML20126D480
Person / Time
Issue date:	02/09/1979
From:	Boulden H NRC OFFICE OF INSPECTOR & AUDITOR (OIA)
To:	Anderson W NRC OFFICE OF STANDARDS DEVELOPMENT
Shared Package
ML20126D461	List: ML20126D459 ML20126D480 ML20126D483
References
RTR-REGGD-01.144, RTR-REGGD-1.144, TASK-OS, TASK-RS-035-2, TASK-RS-35-2 NUDOCS 8005020135
Download: ML20126D480 (21)

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MEMORANDUM FOR: William F. Anderson, Chief Structures and Components Standards Branch Division of Engineering Standards Office of Standards Development FROM: Harold Boulden, Chief Safety and Enforcement Audits Branch l

. Office of Inspector and Auditor  !

SUBJECT:

REGULATORY GUI'DE 1.144, DRAFT FOR COMMENT, ATTACHED HERETO

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We suggest your consideration of the following comments of this branch on the subject draft:

Part C, Section b, External Audits, Subsection (2) (a) is not clear as to whether or not the audit required to be conducted must be documented and whether an evaluation must also be made and documented as is prescribed by Subsection (2) (b). It woulsLstem to us that the docu-mentation requirements for Subsections (2) (a) and (2) _(b)_s_hauld. be the same.

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Attachment:

As stated

Contact:

H. Boulden, OIA 49-27051 d

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s Summary of Public Comments and Resolutions on -

Regulatory Guide 1.144, " Auditing of Quality Assurance Programs for Nuclear Power Plants" (Rev. O, January 1979)

(SD Task RS 035-2)

Public comments on Regulatory Guide 1.144, " Auditing of Quality Assurance Programs for Nuclear Power Plants" (Rev. O, January 1979), were received from those listed below. A discussion of the comments follows:

W. E. Medinger, Synectics, Inc.

A. J. Pressesky, Department of Energy J. B. Silverwood, United Engineers and Constructors, Inc.

T. E. Short, Omaha Public Power District J. C. Bryan, Ceramic Cooling Tower Co.

J. B. Violette, Bechtel Power Corporation P. V. Baynard, Florida Power Corp.

W. P. Johnson, Yankee Atomic Energy Co.

R. E. Uhrig, Florida Power and Light Co.

V. S. Boyer, Philadelphia Electric Co.

T. J. Sullivan, Consumers Power Co. l t

W. J. Cahill, Jr., Consolidated Edison Co.

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J. Ling, American Society of Mechanical Engineers 1

J. E. Gilleland, Tennessee Valley Authority R. Wilson, Exxon Nuclear Co.

D. L. Martin, American Society for Quality Control P. A. Crane, Jr. , Pacific Gas and Electric Co.

S. B. Jacobs,. Stone and Webster Engineering Corp.

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L. G. Marquis, General Electric H. Boulden, NRC General

1. Many comments have been lumped together since they are essentially the same comment. For this reason some individual comments appear not to be addressed in the specific section, however their comments are totally covered by the lumped comments and resolutions. .

2. Many specific comments have the same answer but vary in the nature of the comment. For this reason they are addressed separately.

Specific

1. Mr. Medinger suggests that the portion of the discussion section concerning auditing a supplier by one activity on behalf of more than one purchaser be moved to the Regulatory Position section in order to provide more force and effect.

Resolution: The change proposed by Mr. Medinger has been incorporated into the proposed version of the guide.

2. Mr. Medinger notes that Regulatory Positions C.3.a.(2) and C.3.b.(2) use the optional verb "should" in lieu of the mandatory verb "shall" with regard to scheduling and conducting audits and that if this is intentional, then the requirements are innocuous.

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Resolution: Consistent with guidance provided in other Regulatory Guides, -

the optional verb "should" has been used throughout the guide. No changes to the guide have been proposed in response to this comment.

3. The following individuals had the same comment concerning Regulatory Position C.3.a.(2):

Mr. Pressesky, Mr. Crane, Mr. Violette, Mr. Johnson, Mr. Uhrig, Mr. Boyer, Mr. Sullivan, Mr. Cahill, Mrs. Ling, Mr. Marguis, Mr. Nelson, and Mr. Martin.

Each stated that the requirements for annual internal audits was excessive and either offered alternate methods or recommended deletion of the requirement. l Resolution: The requirement for annual audits contained in Draft 3, Revision 4 of proposed standard N45.2.12 dated February 22, 1974 was incorporated into both WASH 1283, Revision 1 " Guidance on Quality Assurance Requirements During Design and Procurement Phase of Nuclear Power Plants," dated May 24, 1974 and WASH 1309 " Guidance on Quality Assurance Requirements During the Construction Phase of Nuclear Power Plants," dated May 10, 1974. Licensees to date have committed to an annual internal audit and no exceptions to the annual internal I audit frequency have been requested in topical submittals. In addition, the alternate provisions proposed in comment letters on Regulatory Guide'1.144

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are either unenforceable or offer a 3 year frequency which we do not concur with.

As a result of these considerations no changes to the proposed guide are pro-posed as a result of these comments.

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4. The following individuals had the same comment concerning Regulatory Position C.3.b.(2). .

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4 Mr. Crane, Mr. Martin, Mr. Nelson, Mr. Gilleland, Mr. Cahill, Mr. Boyer, Mr. Johnson, Mr. Bryan, Mr. Short, Mr. Silverwood, Mr. Pressesky, and Mr. Medinger each stated that the requirements for the annual audit listed in C.3 b.(2)(a) was excessive. Several further commented that it was also illogical to have this requirement in view of the triennial audit option of C.3.b.(2)(b).

Resolution: Section C.3.b.(2)(a) has been deleted as a result of these comments.

5. The following individuals all had the same comment regarding Regulatory Position C.3.b.(1):

Mr. Bryan, Mr. Violette, Mr. Uhrig, Mr. Boyer, Mr. Sullivan, Mr. Martin, Mr. Crane.

They all stated that alternate methods of acceptance as listed in 1

ANSI /ASME N45.2.13 should be added to the " Acceptance by Receiving Inspection" l method listed in Regulatory Position C.3.b.(1).

i Resolution: Regulatory Position C.3.b(1) has been rewritten to specify exemptions to the audit requirements as contained in ANSI N45.2.13-1976 section 10.

6. Mr. Silverwood has the following comments:

a. Pre-Awe'd audits should be covered by an NRC position.

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b. CASE and ASME surveys should be addressed in the Regulatory Guide.

c. Paragraph C.3.b(2)(b) mentions ASME or NRC Audits. Both the ASME and NRC refer to " Audits" as " Surveys", especially when performed on a triennial basis.

d. Paragraph C.3.b.(2) uses "should" in several places rather than "shall." A review of the use of "should" versus "shall" should be conducted.

Resolution: (a) Pre-Award audits and evaluations are covered in ANSI /ASME N45.2.13 and endorsed by Regulatory Guide 1.123. Some modification to Regul:1 tory Position C.3.b.(2)(b) includes pre-award surveys and their applicability. This modification is as a result of comments submitted by Ms. Ling of ASME.

(b) ASME surveys are required for code covered activities only. Since the guide covers additional areas ASME surveys are not specifically addressed.

CASE has been determined by the NRC to be an acceptable survey system, however, it covers pre-award surveys and is more appropriately addressed in Regulatory Guide 1.123.

(c) The term " audit" is used in ASME/ ANSI N45.2.12-1978 and defined in ASME/

ANSI N45.2.10. The NRC has used only this term in audit process discussions.

(d) Since regulatory guides are not regulations the term "should" is appropriate for all stated NRC positions.

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No change to the proposed guide are proposed as a result of Mr. Silverwood's comments.

7. Mr. Violette and Mr. Boyer state the following:

Regulatory Position C.4.(a) is too restrictive in that it makes an audit mandatory when conditions in Section 3.5.3.3 through 3.5.3.6 exist and recommend that it be deleted.

l Mr. Violette further states that Regulatory Position C.4.(b) is too I restrictive in that it requires that specific attention be given to corrective measures taken on previous audits, and again recommends that the requirement be deleted.

Resolution: (a) Sections 3.5.3.3 through 3.5.3.5 are considered to have safety importance and therefore the NRC staff considers these recommendations should be requirements. Section 3.5.3.6 has been removed from this list as a result of Mr. Boyer's and Mr. Violette's comments.

(b) Corrective measures in response to an audit are essential. Regularly scheduled audits should cover this important part of the system. No changes to the proposed guide are proposed as a result of Mr. Violette's comments.

8. Ms. Baynard stated that clarification of the word " effectiveness" in paragraphs 4.3.2.3 and 4.4.4 of ANSI /ASME N45.2.12-1977 should be included in a regulatory position.

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to the vast areas this program covers and therefore qualitative criteria for each area would make the regulatory guide too cumbersome for effective use.

No changes to the proposed regulatory guide are prop; w a a result of Ms. Baynard's comments.

9. Mr. Johnson and Mr. Boyer offer the comment that Regulatory Position C.3 is confusing due to unclear reference to other regulatory guides.

Resolution: Regulatory Position C 3 has been rewritten to eliminate reference to other regulatory guides and state specifics.

10. Mr. Uhrig recommends that the second sentence of Regulatory Position C.3.b.(2) be rewritten and offers the following rewrite:

"The triennial period should begin with performance of an audit when sufficient work is in progress to demonstrate that the organization is implementing a Quality Assurance Program having the required scope for purchases placed during the triennial period."

Resolution: The above statement has been incorporated.

11. Mr. Boyer offers the following comments:

a. " Acceptance of Product" should not be addressed in a regulatory position since ANSI /ASME N45.2.12-1977 states "An audit should not l

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be confused with surveillance or inspection for the sole purpose of .

process control or product acceptance."

b. Regulatory Position C.3.b.(2) is unclear as to application prior to or after award of contract or both,

c. A clear definition of "other procurement actions" is necessary.

d. The meaning of the term " life of the activity" should be clarified.

e. Annual evaluations are covered by ANSI N45.2.13 and should-be more appropriately addressed by Regulatory Guide 1.123.

Resolution: (a) Regulatory Position C.3.b.(1) has been rewritten to provide specific exceptions to audit requirements rather than quote

" acceptance of products" from ANSI N45.2.13.

(b) Regulatory Position C.3.b.(2) covers both prior to and after award of the contract. Regulatory Position C.3.b.(2) has been modified to reflect this. l

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(c) "Other procurement actions" are defined as procurement actions other than listed in the revised C.3.b.(1) regulatory position. No change to the proposed guide is proposed as a result of this comment.

(d) " Life of the Activity" is not intended to cover individual procurement-orders, but rather covers a contract period. This term has been used in ASME/

ANSI N45.2.12-1978. In addition should a situation arise where a contract has i

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just been terminated and a new need exists, an audit of that supplier is not required as covered in the second paragraph of Position C.3.b.(2). " Life of the Activity" has been eliminated from this paragraph as a result of other changes, however, it is still used in paragraph C.3.a.(2).

(e) Since no limit is given for the ntaximum time between audits in ANSI /

ASME N45.2.12-1977, it is felt that annual evaluatior; are an acceptable method of extending the audit requirement to three years, and therefore the evaluations are justifiably addre n ed in this regulatory position.

l Changes to the prcposed regulatory guide have been made as indicated above.

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12. Mr. Sullivan offers the following comments:

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a. The requirement to conduct an audit for increased scope of work changes which do not change the QA progran as required by Regulatory Position C.3.b.(2) is excessive.

b. The second paragraph of Regulatory Position C.3.b.(2) is excessive and misplaced in that it duplicates sections of ANSI N45.2.13-1976 and Regulatory Guide 1.123.

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c. Regulatory Position C.4.a reduces the flexibility of purchasers by requiring the following:

I (1) assessment (audit) of contractor's QA program prior to award of a contract or purchase order.

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(2) audits to determine adequate performance after award of a -

contract in the QA area.

(3) audits to verify implementation of corrective action.

d. The regulatory guide needs to address the problem of redundancy in I

audits and clarify this area.

Resolution: (a) When a subsequent contract or a contract modification signifi-cantly enlarges the scope of ,1vities by the same supplier, we consider it important that an audit be performed which encompasses the enlarged scope, com-pared to the scope previously audited.

(b) Audits are mentioned as one means of verification of activities by the purchaser and the last paragraph of 7.3.1 of ANSI /ASME N45.2.13 states that "when conformance to procurement requirements is verifed by audits, such audits shall be conducted in accordance with established methods." ANSI /ASME N45.2.12 and Regulatory Guide 1.144 provide guidance on such audit methods to be used for verification of purchaser activities. -

(c) We agree that Regulatory Position C.4.a. removes the flexibility as Mr. Sullivan suggests. This has been done because it is important to perform  !

the audits enumerated in Sections 3.5.3.3 through 3.5.3.5. Further Mr. Sullivan was apparently misled by the opening phrase "Section 3.5.3..." contained in Regulatory Position C.4.a. since:

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(1) Section 3.5.3.1, which recommends audits "when necessary to assess the capability of a contractor's quality assurance program prior to awarding a contract or purchase order," is not included in sub-paragraph C.4.a. To clarify this point the phrase "Section 3.5.3..."

has been deleted to remove the implication that section 3.5.3.1 is included.

(2) Section 3.5.3.2, which recommends audits after award of a contract "to determine that the organization is adequately performing the functions as defined in the quality assurance program description, codes, standards, and other contract documents," is not included in subparagraph C.4.a. To clarify this point the phrase "Section 3.5.3..." has been deleted to removed the implication that section 3.5.3. 2 is included.

(3) New regulatory position C.6 has been written to correct the error of section 3.5.3.6 of ASME/ASNI N45.2.12-1978 in using an audit "when necessary to verify implementation of required corrective action."

10 CFR 50, Appendix B, Criterion XVIII did not intead that audits be the sole means of verifying implementation of corrective action.

(d) Regulatory Guide 1.144 discussion section B last paragraph addresses the area of redundancy. (It is now regulatory position 5.)

Changes to the proposed regulatory guide are proposed as a result of Mr. Sullivan's comments as indicated above.

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13. Mr. Cahill offers the following comments: -

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a. Paragraph C.3 of the Regulatory Positions should be deleted for the following specific reasons:

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(1) Position 3.a.(1) is already addressed in Regulatory Guide 1.33.

(2) In Position 3.a.(2) some elements may not need to be audited if other methods of verification are used.

(3) Position C.3.b.(1) guidance is already contained in Regulatory Guide 1.123.

(4) Position C.3.b.(2) guidance is already contained in Regulatory Guide 1.123.

(5) The phrase " Life of the Activity" is too vague and would result in much interpretation.

(6) The term " assessment of supplier performance" is too vague.

Resolution: (1) Regulatory Position 3.a.(1) is a referral to Regulatory Guide 1.33.

(2) Means of verification other than audits are addressed under C.3.b.(1) and P

C.3.b.(2) for external audits. Internal audits are to be conducted annually with the scope as determined in modified position C.3.a.(2).

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(3) C.3.b.(1) has been modified to state specific areas of audit exemption rather than make a general referral to Regulatory Guide 1.123.

(4) Position C.3.b.(2) states specific maximum intervals for the conduct of audits. Regulatory Guide 1.123 does not address these specifics.

(5) The phrase " Life of the Activity" means the length of a contract period.

The term has been used throughout the ANSI N45.2 series and has been used by the NRC staff to avoid initiation by the NRC of new and possibly confusing terminology.

(6) The term " assessment of supplier performance" is not found in Regulatory Position C.3.b.(2) or in ANSI /ASME N45.2.12-1977. It was contained in an earlier draft of the regulatory guide dated May 3,1978. Changes to the proposed regulatory guide have been made as noted in (3) above as a result of Mr. Cahill's comments.

14. Ms. Ling offers the following comments:

a. Reword Section C.3.a.(2) as follows:

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Delete the phrase applicable elements ". . . should be audited at least annually . . ." and substitute, ". . . should be evaluated annually and audited at least on a triennial basis, or at least once within the life of the activity, whichever is shorter."

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Add the following sentence after that given above: "The first of the triennial audits should be conducted within the first year when sufficient work is in progress to determine whether the organization is complying with the established quality assurance program."

b. Reword Section C.3.b.(2)(b) second sentence:

Reword as follows: "The first of the triennial audits should be conducted when sufficient work is in progress to determine whether the organization is complying with required quality assurance provisions. "

. . . If, at the time of the pre-award survey, the I supplier is already implementing the same quality assurance program for other customers which he proposes to use on the auditing party's l

contract, then the pre-award survey may serve as the first triennial l

audit. When such pre-award surveys are employed as the first. '

I triennial audits, those surveys should have the same audit elements l l

and criteria as used on other triennial audits."

Resolution: (a) See resolution to comment #3 concerning scheduling of audits.

I (b) Rewording of Section C.3.b.(2)(b) second sentence has already been accomplished by previous comments from Mr. Ulrich. The additional wording l suggested by Ms. Ling has been incorporated into the proposed guide.

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Changes to the proposed guide have been made in accordance with (b) above as a result of Ms. Ling's comments.

15. Mr. Gilleland offers the commen', that Regulatory Position C.3.b is too restrictive in that it does not take into account recent audits of suppliers by other purchasers or by CASE, ASME, and the NRC.

Resolution: The last paragraph of Section 8 Discussion clearly states that one purchaser may perform an audit on behalf of several purchasers to reduce the number of external audits. This paragraph has been made Regulatory Position 5.

No changes are proposed as a result of Mr. Gilleland's comments.

16. Mr. Wilson offers the following comment:

The NRC is not taking several other references such as ANSI N45.2.12, NQA-1, and ANSI N45.2 into account when specific audit frequencies are laid down. He feels that suppliers and purchasers can meet the requirements of the 18th criterion of Appendix B 10 CFR 50 through setting their own audit frequencies.

He would base these on status, importance and the number of external audits conducted. He offers further recommendations for conducting supplemental audits.

Resolution: See resolution to comment #3 concerning scheduling of audits.

Mr. Wilson's comments on conducting supplemental audits are good but are already covered by Regulatory Position C.4.

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No changes to the proposed regulatory guide are proposed as a result of' .

Mr. Wilson's comments.

17. Mr. Martin offers the following comments: i l

a. Regulatory Position C.3.a(2) does not recognize methods other than audits for assuring an effective quality assurance program and offers alternate methods of surveillance and reviews,

b. Regulatory Position C.4 on supplementing regularly scheduled audits should include alternatives to other audits, such as source  ;

verification activities.

1 Resolution: (a) See resolution to comment #3 concerning scheduling of audits.

(b) The audits listed in Sections 3.5.3.3 through 3.5.3.5 have significant safety value and therefore should be requirements. Because of the safety aspect of these audits alternate approaches have not been addressed. Exceptions to these requirements submitted by licensees or applicants will be evaluated on a case-by-case basis. Section 3.5.3.6 has been removed from this list and Regulatory Position C.6 written to clarify that audits are not the only method of verifying implementation of corrective action.

i No changes to the proposed regulatory guide are proposed as a result of Mr. Martin's comments.

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18. Mr. Jacobs offers the following comments: .

a. Regulatory Position C.3.b.(2)(b) should have "such information as" inserted before "(1) review."

b. Proposal of a new regulatory position on pre- and post-audit conferences as approved by the NRC for Stone and Websters Quality I

Assurance Program as follows:

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" Pre- and post audit conferences may be fulfilled by a variety of communications such as telephone conversation."

Resolution: (a) Regulatory Position C.3.b.(2)(b) is intended to mean the same thing as Mr. Jacobs proposes and therefore inclusion of "such information as" is redundant.

(b) The statement " pre- and post-audit conferences may be fulfilled by a variety of communications such as telephone conversation." is not acceptable to the NRC staff. Post-audit conferences should be conducted as a group meeting to iron out any misunderstandings that arise from the audit. No changes to the proposed guide are proposed as a result of Mr. Jacobs' comments.

19. Mr. Marquis offers the following comments:

a. Move the last paragraph of Section B of the regulatory guide to Section C as a Regulatory Position. In addition he states that it should be modified as follows:

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4 "5. Where more than one purchaser buys from a single supplier, and it is deemed advantageous to the purchasers and suppliers to perform a single audit of the supplier on behalf of the pur-chasers, such an audit is acceptable to the NRC staff in meeting the requirements of this Regulatory Guide provided all other requirements of the Regulatory Guide are met."

b. Overriding the ASME code exclusion listed in ANSI /ASME N45.2.12-1977 J

may cause confusion among purchasers. Detailed analysis shows that i the NRC is rejecting the ASME audit program.

c. The second paragraph of Regulatory Position C.3.b.(2)(b) has been misinterpreted by some persons as being applicable to Sections C.3.b.(1) and C.3.b.(2)(2) and should be clarified. l

d. Regulatory Position C.3.a.(2) should be revised to allow annual evaluations to determine the need for an , audit,

e. The purchaser may not have all previous audits available to him so it is recommended that "if available" be added to item (4) of the second paragraph of Section C.3.b.(2)(b).

f. Making the "should" of paragraph 4.3.2.7 of ANSI /ASME N45.2.12-1977 a "shall" is unnecessary in view of making the "should" of paragraph 3.5.3.6 a "shall."

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Resolution: (a) The last Paragraph of Section B has been made new Regulatory .

Position C.5. Wording changes have been made.

(b) Since the NRC has made the " override" statement for all ANSI N45.2 standards in our endorsement, it is not anticipated that_there will be any confusion in this instance.

(c) The second paragraph of Regulatory Position C.3.b.(2)(b) is intended to be used in conjunction with the first paragraph concerning triennial audits.

(d) See resolution to comment #3 concerning scheduling of audits.

(e) The introductory words to this paragraph state "where applicable...." It is recognized that auditors cannot audit that which they do not have.

(f) Section 3.5.3.6 of ANSI /A5ME N45.2.12-1977 has been removed from the list of safety importance. Regulatory Position C.6 has been added to reflect the fact that 10 CFR 50 Appendix B allows methods other than audits to verify implementation of corrective action. Section 4.3.2.7 is a requirement to look at corrective action taken when conducting a regularly scheduled audit.

The only change made to the proposed guide in response to Mr. Marquis' comments are to move the last paragraph of Section B to Section C as a regulatory position.

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20. Mr. Boulden makes the following comment: .

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The documentation requirements of Regulatory Position C.3.b.(2)(a) and '

l C.3.b.(2)(b) should be the same. I I

Resolution: The NRC staff agrees with Mr. Boulden, however Section C.3.b.(2)(b) has been eliminated as a result of other comments.  !

l No changes to the proposed guide are proposed as a result of Mr. Boulden's comments.

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