ML19324B681

Forwards Response to Request for Addl Info Re C-E QA Program & CESSAR-DC,Chapter 17,proposed Rev to CESSAR-DC & Rev 5 to CENPD-210, QA Program:Description of Nuclear Power Businesses QA Program.

ML19324B681
Person / Time
Site:	05000470
Issue date:	10/30/1989
From:	Scherer A ABB COMBUSTION ENGINEERING NUCLEAR FUEL (FORMERLY
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
Shared Package
ML19324B682	List: ML19324B681 ML19324B683
References
PROJECT-675A LD-89-117, NUDOCS 8911080004
Download: ML19324B681 (20)

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EMINEERIM October 30, 1989 LD-89-117

. Project No. 675 U. S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, D.C. ' 20555

Subject:

Response to NRC Request for Additional Information

Reference:

Letter, J. A. Zwolinski (NRC) to A. E. Scherer (C-E),

dated January 23, 1989

Dear Sirs:

.1 The Reference requested that Combustion Engineering provide additional information concerning C-E's Quality Assurance Program.

This program is referenced in Chapter 17 of the Combustion Engineering Standard Safety Analysis Report - Design Certification  ;

(CESSAR-DC). Enclosure I to this letter provides our responses.

Enclosure II provides the proposed revisions to CESSAR-DC,- '

Enclosure III provides the proposed revisions to our Quality Assurance Program description (CENPD-210, Revision 5), and Enclosure IV provides a marked-up copy of the report for your convenience. ,

Should you have any questions, please feel free to contact me or ,.

Mr. S. E. Ritterbusch of my staff at (203) 285-5206.

Very truly yours, COMBUSTION ENGINEERING, INC.

Director Nuclear Licensing g

AES:jeb , g

Enclosures:

As Stated I cc: F. Ross (DOE-Germantown)

R. Singh (NRC)

J. Spraul (NRC)

Power Systems 1000 Prospect Hill Road (203) 688-1911 Combustion Engineering, Inc. Post Office Box 500 Telex: 99297 mson Conndcut omowo 6911060004 691030 PDR A

ADOCK 0500047o PDC

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Page 1 of 17

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l RESPONSE TO NRC REQUEST FOR ADDITIONAL INFORMATION  ;

CONCERNING C-E'S QUALITY ASSURANCE PROGRAM AND CESSAR-DC, CHAPTER 17 t

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Enclosure I a,. Page 2 of 17 Ouestion 1:

The third paragraph of Section 11.2 addresses stop work authorization and apparently limits it to NQS personnel. The second paragraph of Section 111.10 allows _ inspections by personnel outside NQS. Clarify how stop ,

work for noncompliance to requirements is initiated when inspections are performed by personnel outside NQS. (184)

' Response 1:

Stop work orders may be originated at any organization level and unit within C-E's Nuclear Power Business Division as delegated by NQS.

Fection 11.2 has been revised to state this, i

Question 2:

Describe measures which assure that, at each NPS facility, designated QA individuals are involved in day-to-day activities important to safety )

(i.e., NQS routinely attends and participates in daily work schedule and 1 status meetings to assure they are kept abreast of day-to-day work assignments and that there is adequate QA coverage relative to procedural and inspection controls, acceptance criteria, and QA staffing and qualification of personnel to carry out QA assignments). (186)

Response 2:

The details of interactions between NQS personnel and other organizations is described in QA manuals and procedures for those organizations ,

(Section III.1 of CENPD-210, Revision 5). These manuals and procedures provide assurance that NQS personnel are able to accomplish their objectives and meet their responsibilities (Table III-1). Involvement of QA personnel in the specific activities listed in the questien is applicable to nuclear plant site construction activities. CESSAR-DC (Chapter 17) will be revised, therefore, to reference the site-specific Safety Analysis Report for a description of such activities.

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Enclosure I L

Page 3 of 17 0uestion 3:

The last paragraph of Section 111.1 addresses personnel qualifications.

Clarify whether C-E's Managers, Quality Assurance, at the time of assignment.to the position, are required to have at least 6 years

,. experience in the field of QA with at least 1 of these years within a QA organization. ANSI /ANS-3.1-1978 indicates that at least 1 but not more than 4 of the 6 years experience shall be fulfilled by related technical or academic training. Clarify whether C-E meets this portion of that

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standard. (102) ,

Response 3:

Combustion Engineering's QA Manager; are selected on an individual basis, considering QA-related experience, education, and management experience.

This selection process does not include fixed time limits for specific areas of experience in order to permit flexibility in the selection of the best qualified candidate.

The standard referenced in this question applies to construction at nuclear plant sites. A statement will, therefore, be added to CESSAR-DC (Chapter 17) to indicate that personnel qualification in accordance with ANSI /ANS-3.1 will be addressed in the site-specific Safety Analysis Report.

Ouestion 4:

Provide a list of typical items that are within the scope of CENPD-210-A.

I Also, the third paragraph of Section 111.3.3 addresses the control of l computer codes used in design analyses. Clarify what controls are used l on computer codes (software, firmware) supplied to C-E customers. (2A1)

Response 4:

The list of safety-related items within the CESSAR-0C scope (and 1

I therefore within the scope of CENPD-210) is given in Chapter 3 of CESSAR-DC.

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Enclosure I H' Page 4 of 17 Computer code software and firmware are subject to the same quality assurance controls as any other safety-related item or service that C E supplies.Section III.3.3 has been revised to reflect this.

i Ouestion 5:

C-E's commitment to QA regulatory guides is addressed in Section 111.2.1 and Table III-3 of Rev. 5 of CENPD-210-A. The commitment only addresses Regulatory Guide 1.28, Revision 3. While Revision 3 addresses guidance that was'previously addressed in Regulatory Guides 1.28, 1.58, 1.64, 1.74, 1.88, 1.123, 1.144, and 1.146, it does not address the guidance in Regulatory Guides 1.26, 1.29, 1.30, 1.37, 1.38, 1.39, 1.94 and 1.116.

Provide C-E's commitment regarding these regulatory guides. Table III-3 in Revision 5 of CENPD-210 A provides alternatives to Revision 3 of Regulatory Guide 1.28 and to NQA-1 referenced therein. Either eliminate or provide justification for the alternatives since they appear to give ,

lower levels of' quality control than provided for by the guide and the standard. (2B3)

Resoonse 5:

Regulatory Guides other than 1.28 are considered as design basis input.

QA procedures address the requirement to consider regulatory guidance in establishing the design basis. Therefore, any Regulatory Guide addressed 7

in CESSAR-DC will be considered as design basis input and their use verified as part of design verification.

L The alternatives taken to Regulatory Guide 1.28, (as given in Table III-3, of CENPD-210, Revision 5) provide, in C-E's opinion, an teceptable 1evel of quality. The ahernatives are equivalent in nature to many l

l recent published interpretations to NQA-1. These interpretations and l

categories are:

l l- Cateaory Interoretations No.

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l Personnel Qualifications QA85-018 QA86-003 QA86-009 QA87-009 QA88-001 i

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Page 5 of 17 l

Cateoory Interoretations No..

Auditing. QA87-008 Records- QA85-007 QA85-017 QA86-017 QA87-005 QA88-003 ,

Question 6:

Identify procedures that reflect the QA program described in CENPD-210-A.

(2B4)

Response 6:

Quality assurance procedures are contained in several manuals. Those currently include:-

a) Quality Assurance Procedures Manual b) Quality Control Procedures c) Operating Procedures ..,

The name, number and/or content of these QA procedure manuals may change over time. However, any such change will not invalidate compliance with .

QA program requirements. A typical list of QA procedures is discussed in I

Section III.5 and Table III-4 of CENPD-210.

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Ouestion 7:

NRC's perceived need for an annual independent management assessment of the scope, status, adequacy, and compliance of the QA program with L Appendix B of 10 CFR 50, with corrective action identified and tracked, I is not met by normal industry management appraisals as addressed in l

Section 111.2.3. Clarify how C-E will perform such an assessment. (2C1) 1

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Response 7:

NPB's approech to management assessment is consistent with recent NQA-1

, published interpretations QA85-012 and QA86-002.

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0uestion 8:

Section 111.2.4 indicates that proficiency tests, and/or performance reviews, and/or on-the-job obiervation are'used to determine adequacy of personnel training and qualifications. Clarify that, whatever method is used, the results are documented. Also clarify that certificates of

. qualification clearly delineate (a) the specific functions personnel are qualified to perform and (b) the criteria used to qualify personnel in each functions. (20)

Response 8:

The last paragraph of CENPD-210, (Revision 5), Section 111.2.4 has been modified to provide the requested clarifications.

l. Question 9:

L Section III.3 refers to the responsibilities and actions of the Cognizant l- Organization (s) (CO). Clarify C-E's organization to the point of identifying what organizations may and what organizations may not be L

' designated as CO. Clarify whether C-E records indicate the C0 for each project / task / contract. (38)

Response 9:

l A Cognizant Organization (CO) is any group that performs design activities. Several of these groups exist in each of the NPB business units. The C0 used for a particular type of activity is based on the scope of responsibility / expertise in the group. The C0s and their responsibilities are documented internally.

Enclosure 1 Page 7 of 17 Question 10:

It appears that design verification does not involve C-E's QA i organization. When QA performs surveillance and/or audits of design verification, clarify that design documents are reviewed to assure that L they are prepared, reviewed, and approved in accordance with company procedures and that they contain the necessary QA requirements, and the extent of documenting inspection and test results. (3E2)

Response 10:

When NQS personnel perform surveillance or audits, compliance with company procedures is monitored. Section 111.3.1 of CENPD-210, (Revision .

5) has been revised to clarify this.

Question 11:

The first two paragraphs of Section 111.3.1 refer to procedures for design control. The third paragraph states that these procedures are  ;

applied "as required by contract." Since most contracts do not require implementation of specific procedures, clarify or delete "as required by contract." (3F2)

Response 11:

The words "as required by contract" have been removed from Section 111.3.1 of CENPD-210 (Revision 5).

Question 12:

Describe C-E's organizational arrangement for design verification shcwing the independence of the verifiers from the designers. (3E4)

Fesponse 12:

Verifiers are selected by cognizant management in accordance with QA procedure requirements. There is no separate group of verifiers.

J y l Enclosure ! I Page 8 of 17 p Ouestion 13:  ;

The second paragraph in Section 111.3.7-2 allows the designers' i supervisor to verify a design under certain conditions. The "or" should H be changed to "and', and the following conditions should be included:

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a. The need is individually documented and approved in advance by i the supervisor's management. .:

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b. Audits by NQS cover frequency and effectiveness of use of supervisors as design verifiers to guard against abuse. (3E4) r Resuonse 13:

A NQA-1, 1986 Edition does not require the use of the word "and" ("or" is stated in'the standard). Also, the additional conditions (a) and (b) noted in the question are not required by NQA-1. C-E meets NQA-1 requirements for supervisor review. CENPD-210 (Revision 5) has been l revised to state that audits by NQS address the use of supervisors as design verifiers to guard against abuse. ,

Question 14:

Describe measures which assure that, when C-E has SAR responsibilities, i procedures require design documents to reflect the commitments of the r SAR, (3E4) l Resoonse 14:

Section 111.3.2 of CENPD-210 has been revised to clarify that procedures require Standard Safety Analysis Report information to be treated as design input.

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_ Question 15:

Describe measures which assure that, when design verification is done by design review or by alternate calculation, the responsibilities of the .

verifier (s), the areas and features to be verified, the pertinent l conditions to be verified, and the extent of documentation are  !

identified. (3E4)  !

Response'15:

Section 111.3.7 of C-E's Quality Assurance Program description (CENPD 210, Revision 5) is revised to reflect the above requirements.

P Ouestion 16:

Describe C-E's organizational arrangement for the review of procurement documents showing the incependence of the reviewer from the originator.

Clarify that the review verifies that quality requirements are correctly stated, inspectable, and controllable; there are adequate acceptance and  :

rejec. tion criteria; and procurement documents have been prepared, -

reviewed,'and approved in accordance with QA program requirements. (4A1)

Resoonse 16:

The cognizant group responsible for procurement of specific equipment reviews procurement documents and changes thereto. These revicws are ,

done by personnel who have adequate understanding of the procurement ,

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! requirements, who have access to pertinent information, and who are i trained in applicable QA procedures. Results of such reviews are-i documented and the review process is included in QA procedures. These procedures are in compliance with NQA-1 and meet the intent of the l Standard Review Plan. Therefore, no revisions to the Quality Assurance Program description are necessary.

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Clarify whether C-E's topical reports (like CENPD 210-A') are within the scope of the C E document contrcl program. (6A1)

Response 17:

Combustion Engineering topical reports are used to summarita and communicate methods, procedures, and/or results of design activities to organizations' external to Combustion Engineering. Numbering, distribution, and revisions to topical reports are controlled by administrative procedures which are consistent with Section 111.6 of CENPD-210. Topical reports that have been approved by the NRC are designated by the addition of "-A" to the report number and the letter of NRC approval is bound with the report.

Quality assurance procedures are applied, as appropriate, to the data, analyses, and design activities on which the topical report is based, as is the application of the information to specific design activities.

Application of the methods, procedures, and results described generically in a topical report to a particular task (e.g., a specific contract) is '

documented and controlled under QA procedures related to " design input" (Section 111.3.2 of CENPD-210). The cognizant engineer is responsible for assuring that appropriate design inputs are used in the design process. When ccmpliance with a topical report is a requirement for a specific task, the cognizant engineer is responsible to assure that the design inputs from that topical report (computer code version, for example) are consistent with the topical report and remain valid.

Question 18:

Describe C-E's organizational arrangement for the review of quality-affecting documents (other than design and procurement documents covered in items 12 and 16 above) showing the independence of the

Enclosure I 1 Page 11 of 17 1

reviewer from the originator. Clarify that the review verifies the  ;

i inclusion of appropriate QA requirements by an individual trained and 1 qualified in QA practices and concepts. (6A2) )

Response 18:

Consistent with NQA-1, documents that specify quality requirements or that describe activities affecting quality are reviewed for adequacy, completeness, and correctness prior to approval and issuance. The control of such documents is consistent with the importance of those documents to quality. For example, detailed QA procedures are strictly ,

controlled since these procedures directly affect the quality of design activities. The topical report describing the Quality Assurance Program is controlled by Nuclear Quality Systems group through the normal management process, and revisions are reported to NRC consistent with the requirements of 10 CFR 50.55 (f)(3). Reviews of quality-affecting documents are performed by individuals experienced in the topic being reviewed.

I 0uestion 19:

The last paragraph on page 21 refers to " periodic" audits of suppliers.

Clarify that, in accordance with Section C.3.2 of Regulatory Guide 1.28, suppliers are audited at least trisnnially. (786)

Response 19:

Consistent with NQA-1, supplier audits are conducted at a frequency commensurate with the status and importance of the activity. The audit schedule is reviewed periodically and revised as necessary to assure that coverage is maintained current. Regularly scheduled audits are supplemented by additional audits of specific subjects when necessary to provide adequate coverage. The issues considered when establishing audit frequencies are listed in Table 111-3. Although the triennial auditing

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Page 12 of 17  ?

interval of Regulatory Guide 1.28 is not imposed, the intent of  ;

Regulatory Guido 1.28 (Section C.3.2) is met through the application of NQA-1 guidance and the process described in section 111.7 and Table 111-3 f of CENPD 210.  ;

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. Describe organizational responsibilities for the control of purchased items and services including interfaces between design, procurement, and '

QA. (7A1)

Resoonse 20:

The organizational groups (design, procurement, and NQS) involved in -

purchase of items and service are identified in Revision 5 to CENPD-210, Section 111.4. ,

i Ouestion 21:

Section 111.11 states that, if necessary, testing is witnessed. Indicate who (by position title) decides the necessity of testing and the bases of the. decision. (llA1)  ;

Response 21: I The qualifier "if necessary" has been removed from Section 111.11 in Revision 5 to CENPD-210. ,

Ouestion 22:

Identify the organization (s) responsible for maintenance and control of measuring and test equipment. (12.3) l I

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' Response 22: l The cognizant organization in each NPB business unit controls measuring J and test equipment in accordance with documented and accepted procedures. i L

For example, one such organization is Engineering and Technology in the Nuclear Services unit.

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1he last sentence in'the first paragraph of Section 111.13 states: "When required, these (handling, storage, and shipping) activities are e accomplished by appropriately trained personnel." This appears to ,

. contradict the basic commitment in Section 111.2.4 that personnel. ,

performing Clarify. (activities affecting quality are appropriately trained.

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. Response 23:

The qualifiers "when required" and " appropriately" are removed from Section 111.13 in Revision 5 of CENPD-210.

Question 24:

Describe measures used to control altering the sequence of required operations important to safety. Clarify whether such actions are subject to the same controls as the original review and approval. (14.3)

Response 24:

Section 111.14 of CENPD-210 (Revision 5) is revised to provide the requested description and clarification.

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Question 25:

Identify the organization (s) responsible for documenting the status of  :

l' nonconforming items and identifying them to prevent inadvertent use. ,

(14.4)  !

Response 25: .

I The C0s within each NPB business unit, in addition to NQS, are responsible for identifying and dispositioning nonconforming items.

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Ouestion 26:

Clarify the role of NQS in nonconformance control. (15.2)

Response 26:

The role of NQS in control of nonconforming' items is described in Section III.15 (of CENPD-210, Revision 5) at the end of the second paragraph and in the last paragraph, e

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Ouestion 27:

The second paragraph of Section 111.15 indicates that procedures describe g

l the control of nonconforming items to prevent inadvertent use, and l Section III.7 addresses the shipment of items. Clarify that nonconformances are corrected or resolved prior to an item undergoing preoperational test. (15.3)

Response 27:

Nonconformances are resolved prior to shipment.Section III.15 of CENPD-210 is revised in Revision 5 to provide the requested clarification.

Enclosure !

Page 15 of 17 Ouestion 28:-

The third paragraph of Section III.16 states: " Follow-up action is taken by NQS to verify corrective action." Clarify whether this includes documented concurrence by NQS as to the adequacy of the corrective action. (16.2)

Resoonse 28:

NQS concurrence with the corrective action is documented. The requested-clarification is provided in Revision 5 to Section III.16 of CENPD 210.

Question 29:

Section III.16 does not appear to address the timeliness of corrective action. Describe measures which ensure that corrective action is taken in a timely manner. (16.3)

Resoonse 29:

Section 111.16 is revised to indicate that QA procedures assure that corrective actions are implemented in a timely manner. -!

l Ouestion 30:

The.last sentence in the second paragraph of Section 111.17 states" .

" Quality records are maintained in accordance with contract requirements." Clarify whether the maintenance of quality records and C-E's facilities for record storage are also in accordance with Revision i 3 of Regulatory Guide 1.28. (17.4 and 17.5)

Response 30:

As described in III.17, the records program is planned for a standard or generic system, but it may be modified in accordance with specific l contracts. To avoid confusion on this point. the last sentence of the i

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' second paragraph-in-Section III.17 bas been deleted (Revision 6 of .

CENPD 210). The maintenance of quality records and their preservation j are in accordance with NQA-1 and the guidance of Regulatory Guide 1.28 (Revision 3), as' clarified in Table 111-3.

i Ouestion 31:

Clarify the role of NQS-in C-E's audit program. For example, clarify whether all C-E audits r.re the responsibility of NQS and whether all C-E .

audits are led by an NQS lead auditor. (18A1)

Response 31:

NQS. performs compliance audits. Section 111.18 of CENPD-210 (Revision 6) is revised to clarify NQS's role.

g Question 32:

1 Clarify whether C-E's audit go beyond " programmatic" assessments and into  !

assessing the technical acceptability of the work of the audited organization. If so, briefly describe how this is done. (18A3) ,

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L l Verification for technical adequacy (Section III 3.7 of CENPD-210) is accomplished by either design review, verification testing, or alternate analysis. The requirements for verification, including required independence and technical considerations are specified in quality f

assurance procedures. These procedures implement NQA-1 requirements.

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l Audits by NQS-(also conducted per NQA-1 and Regulatory Guide 1.28

guidance) provide the oversight to give reasonable assurance that the

' applicable quality assurance procedures are being met for verification activities. In this manner, NQS audits address technical acceptability of the work of the audited organization.

Question 33:

Describe measures which assure that audit data are analyzed by NQS and the results reported to management, (1881)

Response 33:-

, The analysis.and reporting of- audit data are covered by written QA procedures. Results of audits, including trend analysis, are reported to management in specific audit reports and in general monthly reports.

h Ouestion 34:

l: The last paragraph of Section 111.18 states: " Incomplete corrective l.

action responses are brought to the attention of management for  !

resolution and if necessary to the Vice President, Nuclear Quality (

l i Systems." In most case:, corrective action required from audit findings j are the responsibility'of line organizations (the NPS Business Units) l h rather than NQS. Clarify why procedures do not require that unacceptable l corrective actions are escalated to the appropriate line Vice President and if required, to the Executive Vice President rather than to the NQS l

Vice President. (1881)  ;

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l Incomplete corrective action responses are brought to the attention of l whichever level of management is required to achieve complete responses, i This includes the management of the specific business unit and, if I

necessary, to the NQS Vice President or the llPB President.

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Page 1 of 2 1.

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.g. PROPOSED REV!SIONS Tf/ THE COMBUSTION ENGINEERING STANDARD SArCTY ANALYSIS REPOR1 i

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Enclosure !!  !

CESSARtR h . " ' " ' '" i

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17.0 00hLITY ASSURANCE PROGRAM f The Combustion Engineering Q ity Assurance Program is described )

in topical report CENPD-23 Revision 5, " Quality Assurance l Program" dated Of  ;;__. The list of specific equipment  ;

covered by tnis iro. i.., gram is cor,tained in Table 3.2-1 cf CESSAR-DC.,

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f Ok The day-to-day irivolvement of QA personnel in plant site constructf or, j

n acthities enc'. th9 opalification of personnel in accordance with ANS!/ANS-3.2 is addressed in tbc site-specific Safety Analysis Report, f

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Amendment E l 17.0-1 December 30, 1988 1 l

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