PY-CEI-NRR-2411, Informs That Firstenergy Nuclear Operating Co Has Developed Corporate QA Program Manual for Davis-Besse Nuclear Power Station & Perry Nuclear Power Plant,As Discussed on 990318 Between Util & Nrc.Revised USAR Pages,Encl
| ML20211F118 | |
| Person / Time | |
|---|---|
| Site: | Davis Besse, Perry  |
| Issue date: | 08/19/1999 |
| From: | Stetz J CENTERIOR ENERGY |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| RTR-NUREG-0800 PY-CEI-NRR-2411, NUDOCS 9908300244 | |
| Download: ML20211F118 (53) | |
Text
EE 76 South Main St.
Akron, Ohio 44308 c%fm P. Seatt 330-384-5878 Senior Vee President Fax: 330-384-5669 FirstEnergy Nuclear Servces August 19,1999 DBNPS Letter Serial 2603 Letter Number PY-CEl/NRR-2411L :
I United States Nuclear Regulatory Commission '
Document Control Desk i Washington, DC 20555-0001 l
l I
Davis-Besse Nuclear Power Station ;
Operating License No. NPF-3 ;
Docket No. 50-346 '
Perry Nuclear Power Plant Operating License No. NPF-58 Docket No. 50-440 l 1
Subject:
Request for Approval of Quality Assurance Program Changes for the i Davis-Besse Nuclear Power Station and the Perry Nuclear Power Plant Ladies and Gentlemen:
The FirstEnergy Nuclear Operating Company (FENOC) has developed a corporate Quality Assurance Program Manual (QAPM) for its two nuclear facilities, the Davis-Besse Nuclear i Power Station (DBNPS) and the Perry Nuclear Power Plant (PNPP). This approach was discussed between the Nuclear Regulatory Commission (NRC) staff and FENOC ),h representatives on March 18,1999.
3 The FENOC QAPM was developed utilizing the guidance of NUREG-0800," Standard Review Plan", Section 17.3, " Quality Assurance Program Description", the recently issued Nuclear Regulatory Commission Safety Evaluation Report for the Entergy Operations, Inc.
Quality Assurance Program Manual, and each facility's Quality Assurance Program as described in the facility's Updated Safety Analysis Report.
As part of the FENOC QAPM implementation process, reviews were performed that \
compared the positions contained in the FENOC QAPM to each facility's docketed Quality 0 Assurance Program. As a result of these reviews, several changes at each facility were 3 c'
determined to require prior review and approval by the NRC pursuant to 10 CFR 50.54(a).
^
99083O6245^990819 PDR ADOCK 05000346 P PDR
I l
August 19,1999 l DBNPS Letter Serial 2603 '
PY-CEl/NRR-2411L Page 2 of 2 The details and bases for the changes requiring review at the DBNPS and the PNPP are contained in Attachments 1 and 2, respectively. There are no commitments generated by this submittal for either the DBNPS or the PNPP (Attachments 3 and 4).
If you have questions or require additionalinformation, please contact either Mr. James L. Freels, Manager - Regulatory Affairs (DBNPS), at (419) 321-8466, or Mr. Henry L. Hegrat, Manager- Regulatory Affairs (PNPP), at (440) 280-5606.
Very truly yours,
/f f Attachments cc: NRC Project Manager, Davis-Besse Nuclear Power Station l
NRC Project Manager, Perry Nuclear Power Plant NRC Senior Resident inspector, Davis-Besse Nuclear Power Station l NRC Senior Resident inspector, Perry Nuclear Power Plant NRC Region 111 Utility Radiological Safety Board 1
Attachment i DBNPS Lctt:;r SerL l 2603 PY-CEl/NRR-2411L-
. Page 1 of 3 Summary of the Proposed Chanoes at 'the Davis-Besse Nuclear Power Station The formation of a common operating company, FirstEnergy Nuclear Operating Company (FENOC), responsible for operation of multiple sites, the Davis-Besse Nuclear Power Station (DBNPS) and the Perry Nuclear Power Plant (PNPP), makes it prudent to have a common and consistent set of quality assurance standards. The FENOC Quality Assurance Program Manual (QAPM), developed in conjunction with the PNPP, will serve as the goveming Quality Assurance Program for the nuclear facilities within the FENOC organization. The FENOC QAPM will allow efficiencies and flexibility in implementing the quality assurance requirements, but will maintain sufficient control of activities affecting
- quality through administrative and programmatic controls.
The FENOC QAPM has been developed utilizing the guidance of NUREG-0800, " Standard Review Plan", Section 17.3, Quality Assurance Program Description, and the recently issued Nuclear Regulatory Commission Safety Evaluation Report for the Entergy Operations, Inc.
Quality Assurance Program Manual, and each facility's Quality Assurance Program as described in the facility's Updated Safety Analysis Report The DBNPS Quality Assurance Program as described in the DBNPS USAR Section 17,2 is being replaced by the FENOC QAPM. Once implementation of the FENOC QAPM is complete, the DBNPS USAR Section 17.2 will refer to the FENOC QAPM as containing the Quality Assurance Program description for DBNPS. As a result of converting to the FENOC QAPM, three (3) of the proposed changes have been identified as requiring NRC review and approval pursuant to 10 CFR 50.54(a) prior to implementation of the changes. However, the effects of the changes are minimal, and the successful performance and management of the quality assurance functions contained in 10 CFR 50, Appendix B have been assured.
Details and Bases of the Proposed Chanaes The proposed changes replace three existing Regulatory Guide and Industry Standard / Code i
clarifications described in DBNPS USAR Table 17.2-1 with revised clarifications. A description and the basis of the replacement clarifications follow.
- 1. DBNPS USAR Table 17.2-1, item 5, Regulatory Guide 1.37 (3/73) and ANSI N45.2.1-1973 l The current DBNPS USAR Position " requires that personnel who perform inspection, examination or testing activities required by ANSI N45.2.1 be qualified in accordance with ANSI N45.2.6.- In lieu of this, personnel who perform cleanliness inspections shall be i
qualified in accordance with Regulatory Guide 1.8." The proposed clarification would allow l.' cleanliness inspection personnel to be qualified in accordance with either Regulatory i
Guide 1.8, Revision 1-1971 or ANSI N45.2.6. The new clarification expands the DBNPS i position to include the original ANSI Standard qualification recommendation. The reason for !
the change is to permit the flexibility to allow cleanliness inspection personnel to be qualified j
~
to either standard's recommendations. Use of either standard will provide them with the necessary knowledge base to perform adequate cleanliness inspections. Therefore, the DBNPS Position, as modified, will continue to satisfy the requirements of 10 CFR 50, Appendix B, Criterion ll, " Quality Assurance Program."
- 1. . . . .. . . . - .. . .. . . .. ..
p Attachment 1 DBNPS Litt;r Seri:12603 PY-CEl/NRR-2411L Page 2 of 0 l
- 2. DBNPS USAR Table 17.2-1, item 9, Regulatory Guide 1.58, Revision 1 (9/80) and ANSI N45.2.6-1978 The current DBNPS USAR Position states that the qualifications of personnel who verify conformance of work activities to quality requirements shall follow the guidance of Regulatory Guide 1.58. The position goes on to state that the qualifications of personnel involved in the day-to-day plant operation, maintenance, and other selected activities shall follow Regulatory Guide 1.8. The proposed change exempts personnel from the qualification requirements of Regulatory Guide 1.58 who do not meet the definition of personnel performing inspections, examinations, or tests to ensure conformance of work activities to quality requirements as defined in ANSI N45.2.6-1978. The change exempts:
- 1) document review personnel who do not perform inspection or interpretation functions, and
- 2) local leak rate test personnel who are certified by a different training program. The qualification requirements of ANSI N45.2.6 are not required for these individuais to perform their duties and responsibilities in the proper manner. This clarification is currently described in the PNPP USA.R Table 1.8-2. The PNPP position has been incorporated into the FENOC QAPM. Therefore, the DBNPS Position, as modified, will continue to satisfy the requirements of 10 CFR 50, Appendix B, Criterion 11, Quality Assurance Program", and Criterion XI, " Test Control."
- 3. DBNPS USAR Table 17.2-1, item 10, Regulatory Guide 1.64, Revision 2 (6/76) and ANSI N45.2.11-1974 The current DBNPS USAR Position describes the use of a supervisor to perform design i verification. The proposed change includes the use of personnel who contributed to a l design as group design verification participants, as long as they do not verify portions of the j design that they contributed or act as chairperson of the group design verification. The ;
intent of this is for efficient use of personnel, but not to the extent that the requirements of )
the Regulatory Guide are compromised. This clarification is currently described in the PNPP l USAR Table 1.8-2. The PNPP position has been incorporated into the FENOC QAPM. ;
Therefore, the DBNPS Position, as modified, will continue to satisfy the requirements of l 10 CFR 50, Appendix B, Criterion Ill, " Design Control." ;
Enclosure 1 (Attachment 1) contains marked-up USAR pages identifying the proposed changes described above. l Conclusion The proposed changes outlined above are considered to be reductions to the DBNPS Quality Assurance Program commitments. However, each of the proposed changes is acceptable because they do not diminish the effectiveness of implementing quality assurance program requirements and are consistent with the guidance of NUREG-0800,
" Standard Review Plan", Section 17.3, Quality Assurance Program Description. These proposed changes are adopted from the currently docketed PNPP Quality Assurance l
Program for use at the DBNPS. The PNPP descriptions have been incorporated into the FENOC QAPM.
1
Attachment 1 DBNPS Ltttir Serial 2603
- PY-CEl/NRR-2411L Page 3 of 3 The proposed changes continue to satisfy the requirements of 10 CFR 50, Appendix B in that
- 1) The proposed changes will not diminish or reduce the effectiveness of the quality assurance functions as currently described.
- 2) The changes continue to provide sufficient authority and organizational freedom of l the quality assurance functions to
- identify quality problems; initiate, recommend or l provide solutions; or verify implementation of solutions.
- 3) The changes will not diminish the quality assurance functions independence from cost and schedule when opposed to safety considerations.
- 4) The requirements, functions, and responsibilities of 10 CFR 50, Appendix B will l continue to be met following approval of the proposed changes.
References
- 1. 10 CFR 50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants
- 2. 10 CFR 50.54, Conditions of License
- 3. Amendment to 10 CFR 50.54(a), Direct Final Rule [ Federal Register (Vol. 64, No. 35, Page 9035) February 23,1999] (Effective April 26,1999)
- 5. NUREG-0800, Standard Review Plan (Section 17.3, Quality Assurance Program Description), Revision 0, August 1990 i
- 6. Entergy Operations, Inc. (Entergy) Quality Assurance Program Manual, Revision 0 (As !
approved by the NRC, November 6,1998 (TAC No. M97893)]
l l
l
Attichment 1 Enclosura 1 DBNPS Letter Serial 2603 PY-CEl/NRR-2411L Page 1 of 9 Davis-Besse Nuclear Power Station Updated Safety Analysis Chanaes The following pages are the Davis-Besse Nuclear Power Station (DBNPS) Updated Safety Analysis Report (USAR) pages with the proposed Quality Assurance Program l changes described in Attachment 1 marked on them. Note, several pages have I changes associated with them other than those described in Attachment 1. These other I
changes are not shown since NRC approval of these changes is not required.
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Attachnent 1, Enclosure 1 CAJO/%
4 [GI4 V VFirstEnergy Nu~1 ear Operating Company DBNPS LsttIr Sirial 2603 Pv-cEliNan-2<11L QUALITY ASSURANCE PROGRAM MANUAL o review can be accomplished in several ways, including (but not ,iy limited to): o ed step-by-step use of the procedure s ccurs when the procedure has a step-by-s -offassocia ' it or detailed scrutiny of the procedure as part of a document ram, drill, simulator exercise, or other l
such activity. A re ' ' a procedure constitute edure review." In lieu of these 1ents, controls are in effect to ensure that pro reviewed for possible revision upon identification of new or revised source material pote '
affectina the intent ofprocedures.
G. Regulatory Guide 1.37 (Revision 0) [ March 1973], Guality Assurance Requirementrfor l Cleaning ofFluidSystems andAssociated Components of Water-CooledNuclear Power l Plants
- 1. FENOC commits to the regulatory position of this Guide with the following clarifications:
- a. For operations, Regulatory Guide 1.37 will be applied to activities comparable in nature and extent to construction activities. '
{
- b. Regulatory Position C.3 requires that the water quality for final flushes of fluid .
systems and associated components be at least equivalent to the quality required for !
normal operation. This requirement is not applied to dissolved oxygen or nitrogen nor does it infer that additives normally in the system water shall be added to the I
flush water.
- c. Regulatory Position C.4 requires that chemical components that could contribute to intergranular cracking or stress corrosion cracking should not be used with austenitic stainless steel and nickel-based alloys. It is FENOC's position that materials such as inks, temperature indicating crayons, labels, wrapping materials (other than polyethylene), water soluble materials, desiccants, lubricants, and NDE penetrant materials and couplants, which contact stainless steel or nickel-based alloy material surfaces contain no more than trace amounts oflead, zinc, copper, or lower melting alloys or compounds. Maximum allowable levels of water leachable chloride ions, total halogens and sulfur compounds shall be defined and imposed on the f aforementioned materials.
- 2. FENOC commits to the requirements of ANSI N45.2.1-1973 with the following clarifications:
- a. During maintenance and modification activities, FENOC shall control the opening of clean systems and shall conduct inspections to verify that affected system cleanliness levels shall not be adversely affected by the maintenance or modification activity.
When system cleanliness is affected, specific cleaning procedures which incorporate
)
l Table 1 l
INSuf &I Regulatory Commitments Revision 0 20
Att:chment 1, Enclosure 1 DBNPS Lettsr Seri:12603 4 NO CFirstEn:rgy Nuclear Operating Company PY-CEllNkR-2411L i Pa QUALITY ASSURANCEe5of 9 PROGRAM MAN f yswr d I coWiYhdt> h the applicable portions of this Standard shall be developed and implemented to maintain system cleanliness.
~ l b.
Section 2.4 requires that personnel who perform inspection, examination or testing activities required by this Standard be qualified in accordance with ANSI N45.2.6. In .
lieu of this, personnel who perform cleanliness inspections may alternatively be !
qualified in accordance with Regulatory Guide 1.8.
- 1. Regulatory Guide 1.38 (Revision 2) [May 1977], Quality Assurance Requirementsfor 1
l ackaging, Shipping, Receiving, Storage, and Handling ofItemsfor Water-Cooled N lear werPlants l 1. NOC commits to the regulatory position of this Guide for activities comp able in nature an extent to construction phase activities
- 2. FENO commits to the requirements of ANSI N45.2.2-1978 with th ollowini~
I l
clarificat ns:
I
- a. Section 7 establishes the requirements for the classifi on ofitems. The fourlevel classificati system shall be used. However, classific ions differing from those established 'ng Section 2.7 shall be considered ac ptable provided no degradation '
of the item is a ured; for example, electric moto designed for outside service may ,
be stored in a lev C area rather than a level B ea. !
- b. Sections 3 and 4 speci a fourlevel classi ation system for the packaging and shipping ofitems. In lie of these requir ents, commercial grade items shall be packaged and shipped in a ordance standard commercial practices.
! c. Section 5.2.1 requires prelimin isual inspection or examination for shipping damage to be performed prior t u oading. In lieu of this requirement, visual l inspection shall be performe urin nloading and unpacking.
l
- d. Section 5.5 provides for ' ework" and "u -as-is" dispositions for nonconforming items. As an attemati" , the " repair" dispoMtion (as defined by ANSI N45.2.10-1973) shall also be ed.
- e. Section 6.5 r res that items released from stora and placed in their final locations wi the power plant be inspected and for in accordance with the requireme of Section 6 of this Standard and other ap icable Standards. In lieu of this reg
- ement, FENOC shall, whenever feasible, store i ms 'vithin their appro ate storage area and move the equipment to the plan areas for staging only in su ient time to support its installation. Within the plant, the quipment shall be s ged at locations which provide equivalent environmental con 'ons under which it Table 1 Regulatory Commi ents Revision 0 21
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Attrchment 1 Enclosura 1 EAIOO
)[Cl4 %! VFirstEn:rgy Nucl:ar Operating Cornpany DBNPS Lett r Strial2603 PY-CElINRR-2411L Pa QUALITY ASSURANCleSof 9E PROGRAM MANUA K. Regulatory Guide 1.55 (Revision 0) [ June 1973], Concrete Placement in Category 1 Structures
- 1. FENOC commits to the regulatory position of this Guide for activities that areiomparable in nature and extent to construction phase activities'for the Perry Nuclear Pmver Plant.
L. Regulatory Guide 1,58 (Revision 1) [ September 1980], Qual!/lcation ofNuclear Power Plant inspection, Examination and Testing Personnel
- 1. FENOC commits to the regulatory position of this Guide with the following clarifications: 1
- a. The guidance of this Regulatory Guide shall be followed as it pertains to the I
qualification of personnel who verify conformance of work activities to quality requirements.
- b. Personnel will not be certified as stated in this Guide in the following areaTs f
- 1) Individuals that handle test results or perform document control activities.
- 2) Quality assurance and staffpersonnel responsible for the review of documents for clarity and completeness. t
- 3) Test personnel utilizing gas test methods for information or data collection I activities (this includes those personnel performing local leak rate testing (LLRT) as stated in 10CFR50 Appendix J).
- 4) Plant operation personnel concerned with day-to-day operation, maintenance, l
and certain technical services (the qualifications of these personnel shall conform to the requirements of Regulatory Guide 1.8).
k
- c. Personnel who perform nondestructive examination activities shall meet the qualification requirements of SNT-TC-1 A (1980) as described below.
- 2. FENOC commits to the requirements of ANSI N45.2.6-1978 as modified by the I commitments to Regulatory Guide 1.58.
- 3. FENOC commits to the requirements of SNT-TC-1 A (1980) with the following clarifications:
- a. For Davis-Besse:
1
- 1) The word "should"in the following paragraphs of SNT-TC-1 A (1980) shall be considered "shall": 4.3(1), 4.3(2), 4.3(3), 6.3, 7.1, 7.2, 8.1, 8.1. l(1), 8.1.l(2),
o-L 5m n Regulatory Commitn.mts Revision 0 24 I
1 Attichment 1, Encic;ura 1 FENO Crirsten:,gr nacionc opo,ncing compan, we'v~",",92:: =
Page 9 of 9 QUALITY ASSURANCE PROGRAM MANUALf
, IAl5tM f'2- cov7W 4(ED 8.1. l(3), 8.1. l(4), 8.1.2(1), 8.1.2(2), 8.1.3(1), 8.1.3(2), 8.1.4(1), 8.1.4(2),
8.1.4(3), 8.1.5, 8.3, 8.3.1(1), 8.3. l(2), 8.3.2(3), 8.3.4, 8.4.2, and 9.7.3.
~
- 2) Paragraph 8.4.4 recommends a composite grade of 80% and a grade of 70% for the general, specific, and practical or the basic method, and specific 1 examination. Davis-Besse commits to this recommendation.
- b. For Perry:
l h '
l 1) Personnel who perform nondestructive examination activities (including NDE gas leak testing) shall meet the qualification requirements of SNT-TC-1 A (1980) as modified by ASME Code Case 356.
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f M. Regulatory Guidc54 (Revision 2) [ June 1976], Guality Assurance Requirementsfor the Design ofNuclearPowerPlants
~
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- 1. FENOC commits to the regulatory position of this Guide with the following clarifications:
- a. Section C.2(1) addresses the use of a supervisor in design verification. If, in exceptional circumstances, the supervisor is the only technically qualified individual
[ available, the design verification or checking shall be conducted by the supervisor I with the following provisions:
- 1) The other requirements of Section C.2 of this Guide shall be met.
- 2) Thejustification shall be individually documented and appmved by the next level of supervision.
- 3) Quality assurance audits shall melude review of frequency and effectiveness of j the use of the immediate supervisor to assure that this provision is used only in exceptional circumstances.
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- b. An individual who contributed to a given design may participate in a group verification of that design provided that the individual who contributed to the design does not (1) verify his contribution to the design, and (2) serve as chairman or leader of the group verification activity.
l
- 2. FENOC commits to the requirements of ANSI N45.2.11-1974 with the clarifications as noted above for the use of an immediate supervisor for design verification activities and conduct of group verification activines.
l TdWLT b
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Table 1 -
Regulatory Commitments Revision 0 25
p i 1 Attachment 2 DBNPS Lcttrr Seriil 2603 PY-CEl/NRR-2411L Page 1 of 8 Summarv of the Proposed Chances at the Perry Nuclear Power Plant The formation of a common operating company, FirstEnergy Nuclear Operating Company (FENOC), responsible for operation of multiple sites, the Perry Nuclear Power Plant (PNPP) and the Davis-Besse Nuclear Power Station (DBNPS), makes it prudent to have a common and consistent set of quality assurance standards. The FENOC Quality Assurance Program Manual (QAPM), developed in conjunction with the DBNPS, will serve as the goveming Quality Assurance Program for the nuclear facilities within the FENOC organization. The FENOC QAPM will allow efficiencies and flexibility in implementing the quality assurance requirements, but will maintain sufficient control of activities affecting quality through
! administrative and programmatic controls.
l The FENOC CAPM has been developed utilizing the guidance of NUREG-0800, " Standard l Review Plan", Section 17.3, Quality Assurance Program Description, and the recently l
Nuclear Regulatory Commission approved Entergy Operations, Inc. Quality Assurance Program Manual, and each facility's Quality Assurance Program as described in the facility's i Updated Safety Analysis Report l
l The PNPP Quality Assurance Program as described in the PNPP USAR Table 1.8-2 and
. Section 17.2 is being replaced by the FENOC QAPM. Once implementation of the FENOC QAPM is complete, the PNPP USAR Section 17.2 will refer to the FENOC QAPM as l
containing the Quality Assurance Program description for PNPP. As a result of converting to the FENOC QAPM, eleven (11) of the proposed changes have been identified as requiring NRC review pursuant to 10 CFR 50.54(a) prior to implementation of the changes.
- However, the effects of the changes are minimal, and the successful performance and i i management of the quality assurance functions contained in 10 CFR 50, Appendix B have i been assured. i 1
Details and Bases of the Proposed Chanaes l
l
- 1. PNPP USAR Table 1.8-2 The proposed changes to PNPP USAR Table 1.8-2 revise the degree of conformance associated with seven (7) regulatory guides. A description and the bases of the proposed revisions follow,
- a. PNPP USAR Table 1.8-2, Regulatory Guide 1.28 (Revision 2 - 2/79)
The current PNPP degree of conformance associated with Regulatory Guide 1.28 states that PNPP complies with this guide. This regulatory guide endorses the use of ANSI N45.2.
! Implementation of the FENOC QAPM will maintain conformance with this regulatory guide.
l However, the FENOC QAPM contains a clarifying statement which addresses instances where attemate quality assurance program requirements are imposed on suppliers of non-pressure boundary components.
Regulatory Guide 1.28, Position C.4 states that, in these instances, the requirements of
' ANSI N45.2 should be used. ASME Code Quality Assurance Programs are not described within this regulatory guide position. The proposed revision is acceptable because ASME Code Section ill Certificate holders are required to have a quality assurance program that is l
Att:chment 2 DBNPS Lctt:r S; rill 2603 PY-CEl/NRR-2411L Page 2 of 8 consistent with either 10 CFR 50, Appendix B or ANSI N45.2. Hence, suppliers possessing an ASME Code Section 111 Certificate have a quality assurance program that would be acceptable for furnishing non-code pressure boundary items that are classified as safety-related. Imposing the supplier's ASME Code Quality Assurance Program in these instances will provide quality assurance controls equivalent to ANSI N45.2. The commitment to meet the requirements of ANSI N45.2 - 1977 remains unchanged. Therefore, the PNPP degree of conformance, as modified, will continue to satisfy the requirements of 10 CFR 50, Appendix B, Criterion 11, " Quality Assurance Program."
- b. PNPP USAR Table 1.8-2, Regulatory Guide 1.37 (Revision 0 - 3/73)
The current PNPP degree of conformance associated with Regulatory Guide 1.37 states that for operations, Regulatory Guide 1.37 will be applied to activities comparable in nature and extent to construction phase activities. Implementation of the FENOC QAPM will maintain conformance with this regulatory guide. However, the FENOC QAPM contains clarifying statements in two areas - use of certain materials on stainless steel or nickel based alloy surfaces, and personnel qualifications for cleanliness inspections.
The first clarification applies to Position C.4 of the regulatory guide. Position C.4 states that chemical compounds that could contribute to intergranular stress corrosion cracking should not be used with austenitic stainless steel and nickel-base alloys. The proposed change adds an exception to allow the controlled use of cedain materials on stainless steel or nickel-base alloy surfaces provided they contain no more than trace amounts of chemical compounds that could contribute to intergranular stress corrosion cracking. The exception is directed to materials such as inks, temperature crayons, labels, wrapping material, non-destructive examination penetrant, couplants, desiccants, lubricants, and water-soluble materials.
Concentration limits for chemical compounds that could contribute to intergranular stress corrosion cracking will be defined and mairdained through the PNPP chemical control program and design control prograrn to ensure that only trace amounts will be allowed. The trace amounts of the defined materials will have a negligible affect on contributing to interganular stress corrosion cracking in austenitic stainless steel or nickel-base alloys.
While the proposed change is an exception to the Regulatory Guide Position, the controls applied to detrimental chemical compounds will meet the intent of the Regulatory Guide Position and, at the same time, support plant functions such as, testing, inspection, packaging, and identification of items. Therefore, the PNPP degree of conformance, as modified, will continue to satisfy the requirements of 10 CFR 50, Appendix B, Criteria 11,
" Quality Assurance Program."
The second clarification applies to ANSI N45.2.1, which the Regulatory Guide endorses.
Section 2.4, " Personnel Qualifications", of this standard requires personnel who perform inspections, examinations, or testing activities required by this standard be qualified in accordance with ANSI N45.2.6. The proposed change would allow personnel who perform cleanliness inspections to be qualified in accordance with ANSI N18.1 as an alternate to ANSI N45.2.6. Use of ANSI N18.1 provides an equivalent means to qualify personnel who perform inspections, tests, and examinations required by ANSI N45.2.1 while adding
L Attachment 2 DBNPS Lettsr SGriol 2603 PY-CEl/NRR-2411L Page 3 of 8 flexibility to manage personnel resources. Therefore, the PNPP degree of conformance, as modified, will continue to satisfy the requirements of 10 CFR 50, Appendix B, Criterion ll,
" Quality Assurance Program."
- c. PNPP USAR Table 1.8-2, Regulatory Guide 1.38 (Revision 2 - 5/77)
The current PNPP degree of conformance associated with Regulatory Guide 1.38 states, with four clarifications, that for operations, Regulatory Guide 1.38 will be applied to activities comparable in nature and extent to construction phase activities. This regulatory guide endorses the use of ANSI N45.2.2. Implementation of the FENOC QAPM will maintain conformance with this regulatory guide. However, the FENOC QAPM contains a clarifying statement which will permit storage of equipment under classifications other than those described in ANSI N45.2.2.
ANSI N45.2.2, Section 2.7, " Classification of items", categorizes items into four levels of protective measures to prevent their damage, deterioration, or contamination. The proposed change adds a clarification, which permits the use of item classification other than those specified in the standard. This will provide additionally flexibility to store items under equivalent classifications when it is impractical to use one of the four level classifications.
Item classification differing from those established in Section 2.7 will be considered acceptable if no degradation of the item is assured. As a result, an acceptable level of control will be provided to the storage of items as intended by Regulatory Guide 1.38.
Therefore, the PNPP degree of conformance, as modified, will continue to satisfy the requirements of 10 CFR 50, Appendix B, Criteria Xill, " Handling, Storage, and Shipping."
- d. PNPP USAR Table 1.8-2, Regulatory Guide 1.39 (Revision 2 - 9/77)
The current PNPP degree of conformance associated with Regulatory Guide 1.39 states that PNPP complies with this guide. This regulatory guide endorses the use of ANSI N45.2.3. Implementation of the FENOC QAPM will maintain conformance with this regulatory guide. However, the FENOC QAPM contains a clarifying statement which permits the use of housekeeping zone designations other than those described in ANSI N45.2.3.
ANSI N45.2.3, Section 2.1, " Planning", establishes plant cleanliness requirements for housekeeping activities for five zone designations. The proposed change adds a clarification which will permit the use of attemate, equivalent zone designations and housekeeping requirements where it is necessary to handle unique and practical situations which are not covered in the standard. It is expected that this change will result in improved, more effective housekeeping measures. The intent of Regulatory Guide 1.39 will be maintained. Therefore, the PNPP degree of conformance, as modified, will continue to satisfy the requirements of 10 CFR 50, Appendix B, Criteria ll, " Quality Assurance Program",
and Criteria XIll, " Handling, Storage, and Shipping."
- e. PNPP USAR Table W Regulatory Guide 1.54 (Revision 0 - 6/77)
The current PNPP degrw of conformance associated with Regulatory Guide 1.54 states that for operations, ANSI N101.4-1972 will be applied to activities comparable in nature and extent to construction phase activities. Implementation of the FENOC QAPM maintains the
l Attachment 2 DBNPS Lettir S: rill 2603 PY.CEl/NRR-2411L Page 4 of 8 i l
l
)
conformance with Regulatory Guide 1.54 and ANSI N101.4-1972. However, the FENOC i QAPM contains clarifying statements to certain for protective coatings requiremenia.
The proposed clarification delineates specific program requirements for protective coatings l which augment the full requirements of the regulatory guide and the ANSI standard. The clarification also provides criteria with respect to not providing protective coatings of surfaces within containment when it is impractical to apply such coatings. l Coating work at an operating nuclear power plant is an infrequently performed activity. It generally consists of repair and touchup following maintenance, or the initial coating of hangers, supports, and piping installed during plant modifications. The proposed clarification is desired to provide requirements for protective coatings suitable for an operating nuclear power plant. Imposition of the coatings requirements as specified in the proposed change will provide adequate controls for protective coatings as intended by the regulatory guide. Therefore, the PNPP degree of conformance, as modified, will continue to satisfy the requirements of 10 CFR 50, Appendix B, Criteria ll, " Quality Assurance Program."
- f. PNPP USAR Table 1.8-2, Regulatory Guide 1.94 (Revision 1 - 4/76)
The current PNPP degree of conformance associated with Regulatory Guide 1.94 states that for operations, Regulatory Guide 1.94 will be applied to activities comparable in nature and extent to construction phase activities. The regulatory guide endorses the use of ANSI N45.2.5. Implementation of the FENOC QAPM maintains the conformance with the regulatory guide. However, the FENOC QAPM contains a clarifying statement which applies to procedures for the installation, inspection, and testing of structural steel and structural concrete.
ANSI N45.2.5, Section 2.2,
- Procedures and Instructions", requires that installation, inspection, and test procedures for structural concrete and structural steel be maintained current with the latest information. The proposed change adds a clarification which states ;
the standard will be used as guidance in the development of procedures for structural !
concrete and structural steel installation, inspect;on, and testing. The clarification goes on to state that procedures will be reviewed and updated prior to commencing any structural !
concrete or structural steel activities rather than maintaining them on an ongoing basis. l Since these activities occur infrequently, it is impractical to maintain the procedures current throughout the operations phase. The procedures were initially developed to support construction. If and when these procedures are needed, they would be updated with the latest information as described in Section 2.2 prior to use. Administrative controls will be established to ensure this activity is performed. Therefore. the PNPP degree of conformance, as modified, will continue to satisfy the requirements of 10 CFR 50, Appendix B, Criteria V,
- Instructions, Procedures and Drawings."
- g. PNPP USAR Table 1.8-2, Regulatory Guide 1.123 (Revision 1 - 7/77)
The current PNPP degree of conformance associated with Regulatory Guide 1.123 states, with two clarifications, that PNPP complies with this regulatory guide. Implementation of the FENOC QAPM maintains conformance with the regulatory guide. However, the FENOC
Attachment 2 DBNPS L:tt:r S;riil 2603 PY-CEl/NRR-2411L Page 5 of 8 QAPM contains a clarifying statement which applies to specifying the method of acceptance of an item or service.
l Regulatory Guide 1.123, Position C.4, requires that procurement documents specify the !
method of acceptance of an item or service. It also requires this information be made available to receipt inspection personnel so they are aware of what methods of acceptance have been established. The proposed change states that the method of acceptance for items and services will not be detailed in procurement documents. The PNPP procurement process requires that the technical and quality requirements for items in the scope of the quality assurance program be identified in a comprehensive procurement requirements document called a Technical Evaluation for Parts Procurement / Inspection (TEPPI), or in a Special Receipt inspection Plan associated with a TEPPl. The TEPPI documents are an integral part of purchase orders. The TEPPI documents are used by receipt inspection personnel at the time the subject item is received. Use of the TEPPI documents as described provide an equivalent means to meet the intent of the regulatory guide, i.e., the method of acceptance is documented and is available to receipt inspectors. Therefore, the PNPP degree of conformance, as modified, will continue to satisfy the requirements of i 10 CFR 50, Appendix B, Criteria Vil, " Control of Purchased Material, Equipment, and Services."
- 2. PNPP USAR Section 17.2 A description and the basis of the proposed changes to PNPP USAR Section 17.2 follows.
- a. PNPP USAR Section 17.2.1.3.5, " Company Nuclear Review Board" USAR Section 17.2.1.3.5 lists the audits, which will be performed under the cognizance of i the Company Nuclear Review Board (CNRB). The activities audited and performance frequencies are specified. The proposed change deletes this level of detail from the PNPP Ouality Assurance Program. Instead, the requirements and performance frequencies for audits are addressed through commitment to Regulatory Guide 1.33 and ANS 3.2-1982.
A comprehensive system of planned and documented audits is being carried out to verify compliance with all aspects of the PNPP Quality Assurance Program. Audits are performed with a frequency commensurate with their safety significance and in such a manner as to assure that an audit of all functions important to safety is completed within a period of two years.
The audits of Technical Specifications / Operating License conditions, and training and qualification will continue to be performed annually. Audits of the Corrective Action Program will continue to be performed every six months. These are consistent with current practices and commitments.
l l However, under the proposed change, the audits of fire protection equipment and program implementation, and Radiological Environmental Monitoring Program (REMP) will not be specifically identified as requiring an annual frequency as is presently detailed in the USAR.
The relaxation in performance frequency brings fire protection and REMP audits in line with the ANS 3.2-1982 treatment for other audited areas important to safety. As with any activity, if performance declines, the audit frequency can be increased.
l L______ _ ___________ _
Att chment 2 DBNPS L;tter Seri:12603 PY-CEl/NRR-2411L Page 6 of 8 Although the level of detail regarding the CNRB will be reduced in the FENOC QAPM when compared to the current PNPP USAR, the requirements of 10 CFR 50, Appendix B, Criterion XVill, " Audits", will still be maintained.
- b. PNPP USAR Section 17.2.2.2," Requirements"(Quality Assurance Program)
USAR Section 17.2.2.2.b states that the Operational Quality Assurance (QA) Program requires QA Program controls for computer code programs which affect safety , elated items.
The proposed change deletes this level of detail from the PNPP Quality Assurance Program. Control of computer code programs is not mentioned in the PNPP degree of conformance to regulatory guides or endorsed standards.
The controls for computer codes and computer software used at PNPP are imposed through administrative procedures. These controls were developed from Software Quality Assurance (SQA) requirements used in the software development industry and from certain NRC NUREGs on the topic of software. Any changes to software administrative controls are subject to review under 10 CFR 50.59. Computer programs used in safety-related design analyses or operational activities have increased controls applied, and are also reviewed under 10 CFR 50.59. SQA requirements have close correlation to 10 CFR 50, Appendix B criteria.
Although the level of detail regarding the QA Program controls for computer programs will be reduced in the FENOC QAPM when compared to the current PNPP USAR, the requirements of 10 CFR 50, Appendix B, Criterion 11 " Quality Assurance Program", will still be maintained.
- c. PNPP USAR Section 17.2.2.3.2, " Manager, Quality Assurance Section (QAS)"
USAR Section 17.2.2.3.2 describes the responsibilities of the Manager, Quality Assurance ,
Section. The proposed change reduces the level of detail within the quality assurance program description in that the proposed description does not specifically state that the individual that has overall responsibility for the Quality Assurance Program is the final approval authority for any changes thereto.
i The FENOC QAPM states that the individual responsible for the Quality Assurance Program has overall authority and responsibility for establishing, controlling, and verifying the implementation and adequacy of the program. The FENOC QAPM also states that revisions of controlled documents are reviewed for adequacy and approved for release by the same organization that originally reviewed and approved the documents. Therefore, changes to the Quality Assurance Program are the responsibility of the Manager, Quality Assurance Section.
Although the current level of detail will be reduced, based upon the factors discussed above, the Quality Assurance Program continues to satisfy the requirements of 10 CFR 50, Appendix B, Criterion ll, " Quality Assurance Program."
i j
Attachment 2 DBNPS L;tt:r Serhl 2603 PY-CEl/NRR-2411L Page 7 of 8
~
- d. PNPP USAR Section 17.2.3.2," Requirements"(Design Control)
USAR Section 17.2.3.2.n describes the control measures for computer programs used in the design process. The proposed change deletes this level of detail from the PNPP Quality Assurance Program. Control of computer code programs is not mentioned in the PNPP degree of conformance to regulatory guides or endorsed standards.
The controls for computer codes used in design are imposed through administrative procedures. These controls include approval of the software programs prior to use. The software programs must be suitable for the applications, and be subject to verification / validation or testing. The Software Quality Assurance (SQA) requirements were developed from standards and guidelines used in the software development industry and from certain NRC NUREGs on the topic of software. Any changes to software administrative controls are subject to review under 10 CFR 50.59. Software programs used in safety-related de' sign analysis have increased controls applied, and are also reviewed under 10 CFR 50.59. SQA requirements have close correlation to 10 CFR 50, Appendix B criteria.
Although the level of detail regarding the QA Program controls for design-related computer programs will be reduced in the FENOC QAPM when compa ed to the current PNPP USAR, the requirements of 10 CFR 50, Appendix B, Criterion Ill, " Design Control", will still be maintained.
Enclosure 1 (Attachment 2) contains marked-up USAR pages identifying the proposed changes described above.
Conclusion The proposed changes outlined above are considered to be reductions to the PNPP Quality ;
Assurance Program commitments. However, each of the proposed changes is acceptable !
because they do not diminish the effectiveness of implementing quality assurance program i requirements and are consistent with the guidance of NUREG-0800,
- Standard Review ,
Plan", Section 17.3, Quality Assurance Program Description. l The proposed changes continue to satisfy the requirements of 10 CFR 50, Appendix B in that:
, \
- 1) The proposed changes will not diminish or reduce the effectiveness of the quality assurance functions as currently described.
- 2) The changes continue to provide sufficient authority and organizational freedom of the quality assurance functions to: identify quality problems; initiate, recommend or provide solutions; or verify implementation of solutions.
- 3) The changes will not diminish the quality assurance functions independence from cost and schedule when opposed to safety considerations.
- 4) The requirements, functions, and responsibilities of 10 CFR 50, Appendix B will continue to be met following approval of the proposed changes.
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Att:chment 2 DBNPS Litttr S: rill 2603 L- PY-CEl/NRR-2411L
- Page 8 of 8 References
- 1. 10CFR50 Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocesbing Plants
- 2. 10CFR50.54, Conditions of License
- 3. USNRC Standard Review Plan, Section 17.3, Quality Assurance Program Description (NUREG-0800, Revision 0 - August 1990)
- 4. PNPP USAR Section 1.8,"NRC Regulatory Guide Assessment"
- 5. PNPP USAR Section 13.0," Conduct of Operations"
- 6. PNPP USAR Section 17.2," Quality Assurance During the Operations Phase"
- 7. Entergy Operations, Inc. (Entergy) Quality Assurance Program Manual, Revision 0 [As approved by the NRC, November 6,1998 (TAC No. M97893)]
Att chment 2, Enclosura 1 DBNPS Letter Serial 2603 PY-CEl/NRR-2411L Page 1 of 29 Perry Nuclear Power Plant Updated Safety Analysis Chanaes The following pages are the Perry Nuclear Power Plant (PNPP) Updated Safety Analysis Report (USAR) pages with the proposed Quality Assurance Program changes described in Attachment 2 marked on them. Note, several pages have changes associated with them other than those described in Attachment 2. These other changes are not shown since NRC approval of these changes is not required.
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Attrchment 2, Enclosura 1 p p NNPS Lettir Striil 2603 i UFirstEnergy Nuclear Operating Company n-cEiinnn-2411L Page 3 of 29 QUALITY ASSURANCE PROGRAM MANUAL
/
Regulatory Guide 1.8 (Revision 1) [ September 1975], Personne/ Selection and Training
- 1. FENOC commits to the regulatory position of this Guide with the following cla ~ ications:
(
- a. Regulatory Guide 1.8 states "The RPM should have a bachelor's de e or the e ivalent in a science or engineering subject including some fo al training in radia ' n protection and at least 5 years of professional experi ce in applied radiatio rotection." It is FENOC's position that equival as used in this Regulatory tide for the bachelor's degree means (a) f r years of post secondary schooling in sci ce or engineering, or(b) four ye of applied experience at a l nuclear facility in t area for which qualificatio s sought, or(c) four years of l operational or technica xperience or trainin n nuclear power, or (d) any combination of the above aling four ye . The years of experience used to meet the education requirements as lowed this exception shall not be used to also meet the experience requirements. -
- b. Other modifications to the re atory po ' ion of this Guide are as specified in the site's Technical Specifica ' ns and USARs.
- 2. FENOC commits to the r uirements of ANSI N18.1-1 as modified by the site's Technical Specificati s and USARs.
B. Regulatory Guide 1 (Revision 3-R) [ March 1976], Guality Group assi/lcation, andStandardsfo Yater , Steam , and Radioactive-Waste-Containing Co onents of Nuclear Powe 'lants
- 1. F ' OC commits to the regulatory position of this Guide as described in each p t's l SARs.
~ -
C. Regulatory Guide 1.28 (Revision 2) [ February 1979], Quality Assuranc.; Program Requirements (Design and Construction)
- 1. FENOC commits to the regulatory position of this Guide with the following clarification:
- a. A supplier's ASME Code Quality Assuranca Program may be extended to cover non-1 pressure boundary components which perform safety related functions provided that the Code Program is evaluated to determine that it contains the necessary requirements to ensure the quality of the non-pressure boundary components. This is i in lieu ofinvoking the requirements of ANSI N45.2 on the supplier.
- 2. FENOC commits to the requirements of ANSI N45.2-1977.
1NSERT 6I Table 1 Regulatory Commitments Revision 0 16
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At'.achment 2, Enclosure 1 g p DBNPS kttu S$ rid 2603 E1% VVFirstEnergyNuclearOperating Company G;E 2WL QUALITY ASSURANCE PROGRAM MANUAL follow-up review can be accomplished in several ways, including (bu ecessarily limited to): documented step-by-step use of the procedure as occurs when the pr v a step-by-step check-off associate it) or detailed scrutiny of the procedure as part o a tra' rogram, drill, simulator exercise, or other
~
such activity. A revision o cedure rocedure review. In lieu of these requireme ntrols are in effect to ensure that proce 'ewed for possi ision upon identification of new or revised source material potentia y ecting theintent ofprocedures.
G. Regulatory Guide 1.37 (Revision 0) [ March 1973], Quality Assurance Requirementsfor Cleaning ofFluid Systems andAssociated Components of Water-Cooled Nuclear Power Plants
- 1. FENOC commits to the regulatory position of this Guide with the following clarifications:
- a. For operations, Regulatory Guide 1.37 will be applied to activities comparable in nature and extent to construction sctivities.
\ b. Regulatory Position C.3 requires that the water quality for final flushes of fluid systems and associated components be at least equivalent to the quality required for normal operation. This requirement is not applied to dissolved oxygen or nitrogen nor does it infer that additives normally in the system water shall be added to the flush water.
- c. Regulatory Position C.4 requires that chemical components that could contribute to j intergranular cracking or stress corrosion cracking should not be used with austenitic l f stainless steel and nickel-based alloys. It is FENOC's position that materials such as ,
inks, temperature indicating crayons, labels, wrapping materials (other than polyethylene), water soluble materials, desiccants, lubricants, and NDE penetrant materials and couplants, which contact stainless steel or nickel-based alloy material f surfaces contain no more than trace amounts oflead, zinc, copper, or lower melting alloys or compounds. Maximum allowable levels of water leachable chloride ions,
, total halogens and sulfur compounds shall be defined and imposed on the aforementioned materials.
k 2. FENOC commits to the requirements of ANSI N45.2.1-1973 with the following I
clarifications:
- a. During maintenance and modification activities, FENOC shall control the opening of k d f
clean systems and shall conduct inspections to verify that affected system cleanliness levels shall not be adversely affected by the maintenance or modification activity. a l When system cleanliness is affected, specific cleaning procedures which incorporate W l t y $gf g{ Table l !
( Regulatory Commitments '
Revision 0 i 20 I
r i
Attachment 2. Enclosura 1 i DBNPS L&ttzr Strial 2003 ENO CFirstEnergy Nuclear Operating Company -2411L i
GE QUALITY ASSURANCE PROGRAM MANUAL i
TN%t342 CoMW uc'D the applicable portions of this Standard shall be developed and implemented to I maintain system cleanliness.
l b. Section 2.4 requires that personnel who perform inspection, examination br testing I
activities required by this Standard be qualifi6d in accordance with ANSI N45.2.6. In lieu of this, personnel who perform cleanliness inspections may alternatively be qualified in accordance with Regulatory Guide 1.8.
I' . Regulatory un etssTRevisio'iir2T[May 1977J, Guality Assurance Requirementsfor l ackaging, Shipping, Receiving, Storage, andHandling ofItemsfor Water-CooledN clear wer Plants
- 1. OC commits to the regulatory position of this Guide for activities com able in nature an xtent to construction phase activities
~
- 2. FENO ommits to the requirements of ANSI N45.2.2-1978 with th ollowing clarificati s:
- a. Section . establishes the requirements for the classifica ' n ofitems. The four level classificatio system shall be used. However, classific ions differing from those l established usi Section 2.7 shall be considered acc table provided no degradation ;
of the item is ass ed; for example, electric motors esigned for outside service may '
be stored in alevel area rather than a level B .
l
- b. Sections 3 and 4 speci fourlevel classifi tion system for the packaging and shipping ofitems. In lieu these require ents, commercial grade items shall be packaged and shipped in acc dance wi standard commercial practices.
- c. Section 5.2.1 requires prelimin Qual inspection or examination for shipping ,
i damage to be performed prior to 1 ding. In lieu of this requirement, visual inspection shall be performed 'ng u oading and unpacking.
- d. Section 5.5 provides for"r ork" and "use- -is" dispositions for nonconforming items. As an alternative e " repair"dispositi (as defined by ANSI N45.2.10-1973) shall also be us .
l e. Section 6.5 requir that items released from storage d placed in their final locations withi e power plant be inspected and care rin accordance with the l
requirements Section 6 of this Standard and other appli ble Standards. In lieu of this require ent, FENOC shall, whenever feasible, store ite within their appropri e storage area and move the equipment to the plant as for staging only in suffici t time to support its installation. Within the plant, the eq ' ment shall be stag at locations which provide equivalent environmental conditio under which it le 1
, Regulatory Commitm ts Revision 21
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Attachment 2, Enclosura 1 DBNPS Littir Striil 2603
) NO CFirstEnergy Nuclear Operating Company G;EV
-2411 L 9
QUALITY ASSURANCE PROGRAM MANUAL l
the applicable ponions of this Standard shall be develo mplemented to stem cleanliness.
- b. Section 2.4 require rso erform inspection, examination or testing activi ~ tred by this Standard be quali ne nee with ANSIN45.2.6. In neu of this, personnel who perform cleanliness inspections may > 1 be H. Regulatory Guide 1.38 (Revision 2) [May 1977], Quality Assurance Requirementsfor Packaging, Shipping, Receiving, Storage, and Handling ofItemsfor Water-CooledNuclear Power Plants ;
i
- 1. FENOC commits to the regulatory position of this Guide for activities comparable in nature f I k and extent to construction phase activities
~
- 2. FENOC commits to the requirements of ANSI N45.2.2-1978 with the following clarifications: f <
1 k a. Section 2.7 establishes the requirements for the classification ofitems. The four level I classification system shall be used. However, classifications differing from those {
! established using Section 2.7 shall be considered acceptable provided no degradation of the item is assured; for example, electric motors designed for outside service may be stored in a level C area rather than a level B area. ,
t
- b. Sections 3 and 4 specify a four level classification system for the packaging and
) shipping ofitems. In lieu of these requirements, commercial grade items shall be {
.f packaged and shipped in accordance with standard commercial practices. ;
i , ,
- c. Section 5.2.1 requires prehmmary visual inspection or exammation for shipping damage to be performed prior to unloading. In lieu of this requirement, visual inspection shall be performed during unloading and unpacking.
\
- d. Section 5.5 provides for " rework" and "use-as-is" dispositions for nonconforming items. As an altemative, the " repair" disposition (as defined by ANSI N45.2.10-1973) shall also be used.
I
- e. Section 6.5 requires that items released from storage and placed in their final locations within the power plant be inspected and cared for in accordance with the requirements of Section 6 of this Standard and other applicable Standards. In lieu of f
this requirement, FENOC shall, whenever feasible, store items within their appropriate storage area and move the equipment to the plant areas for staging only in sufficient time to support its installation. Within the plant, the equipment shall be j staged at locations which provide equivalent environmental conditions under which it Table I i i f g gf .O Regulatory Commitments Revision 0 I
21
Attichment 2, Enclosura 1 DBNPS Lett2r StriIl 2603 NO CFirstEnergy Nuclear Operating Company l GE NRR , 2411L l QUALITY ASSURANCE PROGRAM MANUAL 1N$tfi .:#3 ' Co#7<#d b is designed to operate. Materials placed in staging areas shall be stored in accordance with the applicable requirements of Paragraphs 6.1,6.3 and 6.4.2 of ANSI N45.2.2.
- f. Various Sections of ANSI N45.2.2 address the use of non-halegenated miterials when in contact with austenitic stainless steel'or nickel-based alloys. The exceptions applicable to Regulatory Guide 1.37 regarding this subject also apply to ANSI I l N45.2.2. /
- g. Section A.3.4.2 addresses inert gas blankets. .There may be cases involving large or -
complex shapes for which an inert or dry air purge flow is provided rather than static l
gas blankets in order to provide adequate protection due to difficulty of providing a leak-proof barrier. In these cases, a positive pressure purge flow may be used as an alternative to a leak-proof barrier.
I. gulatory unde 1.3 vinisioMr 1977 Wa -CooledNuclear Power Plants 1
- 1. FE C commits to the regulatory position of this Guide.
- 2. FENOC mmits to the requirements of ANSI N45.2.3-1973 with the following j clarification
- a. Section 2.1 ablishes requirements for five zone levels. Alte ive equivalent zone designations an requirements may be utilized to cover thos ituations not included in the subject Stan ds; for example, situations in whic oe covers and/or coveralls are require ut material accountability is .
J. Regulatory Guide 1.54 (Revision 0) une 1973], Gua
- Assurance Requirementsfor Protective Coatings Applied to Water-C edNuct Powerplants
- 1. FENOC commits to the regulatory posi ' of this Guide with the following clarifications:
- a. This Regulatory Guide an associated SI Standard implies that a significant amount of coating wo s required at the pl site. Although this is correct for construction sites, e coating work at an opera ' site generally consists of repair and touchup w following maintenance and rep activities or the initial coating of componen such as hangers, supports, and piping d facility modifications.
Theref e, in lieu of the full requirements of this Regula Guide and ANSI N .4, FENOC shall impose the following requirements:
- 1) The quality assurance requirements of Section 3 of ANSI 1.4 applicable to the coating manufacturer shall be imposed on the coating man ctv.rer through the procurement process. ;
Table
, Regulatory Commitments Revision 0 22
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Att chm 3nt 2. Enclosure i
' DBNPS L5ttir Strid 2603 FENO Crirseen.,or nacioac opor,eing como.nr :" ;2<"'
l QUALITY ASSURANCE PROGRAM MANUAL is designed to operate. Materials placed in staging areas shall be stored in accordance with the applicable requirements of Paragraphs 6.1,6.3 and 6.4.2 of ANSI N45.2.2.
- f. Various Sections of ANSI N45.2.2 address the use of non-halegenated materials when in contact with austenitic stainless steel or nickel-based alloys. The exceptions applicable to Regulatory Guide 1.37 regarding this subject also apply to ANSI N45.2.2.
- g. Section A.3.4.2 addresses inert gas blankets. There may be cases involving large or complex shapes for which an inert or dry air purge flow is provided rather than static gas blankets in order to provide adequate protection due to difficulty of providing a leak-proof barrier. In these cases, a positive pressure purge flow may be used as an attemative to a leak-proof barrier. -
'I. Regulatory Guide 1.39 (Revision 2) [ September 1977], Housekeeping Requirementsfor Water-CooledNuclear Power Plants
\
- 1. FENOC commits to the regulatory position of this Guide.
- 2. FENOC commits to the requirements of ANSI N45.2.3-1973 with the following k clarifications:
h
- a. Section 2.1 establishes requirements for five zone levels. Alternative equivalent zone designations and requirements may be utilized to cover those situations not included j in the subject Standards; for example, situations in which shoe covers and/or coveralls are required but material accountability is not. _
/
'f J. Regulatory Guide 1.54 (Revision 0) [ June 1973], Guality Assurance Requirementsfor IN567 h Protective Coatings Applied to Water-CooledNuclear Power Plants
\
- 1. FENOC commits to the regulatory position of this Guide with the following clarifications:
- a. This Regulatory Guide and its associated ANSI Standard implies that a significant amount of coating work is required at the plant site. Although this is correct for constmetion sites, the coating work at an operating site generally consists of repair and touchup work following maintenance and repair activities or the initial coating of components such as hangers, supports, and piping during facility modifications.
Therefore, in lieu of the full requirements of this Regulatory Guide and ANSI l
\ N101.4, FENOC shall impose the following requirements:
1
- 1) The quality assurance requirements of Section 3 of ANSI N101.4 applicable to i the coating manufacturer shall be imposed on the coating manufacturer through I the procurement process.
Table 1
- Regulatory Commitments f i k Revision 0 22 1 1
Attichment 2. Enclosura 1 1
& jap DBNPS Lett:r Strel 2603
) I4 %f %sFirstEnergy Nuclear Operating Company 2411L g;Ei1N ,
QUALITY ASSURANCE PROGRAM MANUAL f .TNSoLT 1T 1 copTiP W'D
)
- 2) Coating application procedures shall be developed based on the manufacturer's recommendations for application of the selected coating systems.
- 3) Coating applicators shall be qualified to demonstrate their ability to satisfactorily apply the coatings in accordance with the manufacturer's recommendations.
l
- 4) Quality control personnel shall perform inspections to verify conformance of k the coating application procedures. Section 6 of ANSI N101.4 shall be used as guidelines in the establishment of the inspection program.
- 5) Quality control personnel shall be qualified to the requirements of Regulatory Guide 1.58 (Revision 1).
- 6) Documentation demonstrating conformance to the above requiremen,t_s shall be maintained.
( b. The requirements of Position A of this Guide apply to surfaces within containment I with the following exceptions:
- 1) Surfaces to be insulated.
- 2) Surfaces contained within a cabinet or enclosure. !
- 3) Repair / touchup areas less than 30 square inches or surface areas such as: cut
{
ends; bolt heads, nuts and miscellaneous fasteners; and damage resulting from spot, tack or arc welding.
- 4) Small items such as small motors, handwheels, electrical cabinets, control panels, loud speakers, motor operators, etc. where special painting requirements would be impracticable.
- 5) Stainless steel or galvanized surfaces.
- 6) Banding used for insulated pipe.
l t
,f 2. FENOC commits to the requirements of ANSI N101.4-1972 for activities comparable in l nature and extent to constmetion phase activities as modified by the commitment to Regulatory Guide 1.54.
~ _
l Table 1 Regulatory Commitments Revision 0 23 l
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l P. Regulatory Guide 1.94 (Revision 1) [ April 1976), Quality Assurance Requirements forInstallation, Inspection and Testing ofStructuralSteelDuring the Constructi6n j Phase ofNuclear Powerplants
- 1. FENOC commits to the regulatory position of this Guide for activities comparable
\ in nature and extent to construction phase activities.
- 2. FENOC commits to the requirements of ANSI N45.2.5-1974 with the following clarification:
k a. Section 2.2 requires that installation, inspection, and test procedures be kept k current with the latest information. This Standard was written to address _
f requirements associated with construction phase activities. However, during l the operations phase, activities associated with installation, inspection, and l testing of structural concrete and stmetural steel are very minor in frequency I and extent. Consequently, procedures for these activities shall only be i f reviewed or updated prior to commencing the activity. Funhermore, f procedures for structural concrete and stmetural steel installation, inspection, !
and testing activities shall not necessarily comply with the full requirements / l 1
of this Standard. Instead, this Standard shall be used only as gpidance in the '
l development of these procedures, jg l Regulatory Guide 1.116 (Revi lon 0) [May 1977], Quality Assurance Requirements l r Installation, Inspection and Testing ofMechanical Equipment andSystems
- 1. F- C commits to the regulatory position of this Guide for ectivi ' comparable in natu nd extent to construction phase activities.
j 2. FENOC commi the requirements of ANSI N45.2 975 with the following clarifications:
l a. Sections 2.4 and 2.6 requ that cedures define system restoration requirements as needed to pr t contamination after cleanliness class is achieved in accordance co . ents to ANSI N45.2.1 and ANSI N45.2.3.
- b. Section 2 equires that evidence of compliance the manufacturer with pure e requirements, including quality assurance re 'rements, be available e site prior to applying the requirements of this Stand- In lieu of this requirement, FENOC may proceed with installation, inspection, d testing Table 1 Regulatory Commitments Revision 0 28
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Attachment 2. Enclosure 1 DBNPS Lstt;r SIrial 2603 FENOCrir. ten.,gynuci..co .c.n ting como.nr l
ge:~n2<"' 1 QUALITY ASSURANCE PROGRAM MANUAL l 1
activities of equipment lacking its quality documentation provided that s
.quipment has been identified and released in accordance with none orming m rials procedures. .-
- c. Section . I provides requirements for the cicaning, fius ' ig, and *- !
- conditioning 'nstalled systems. FENOC's position i Regulatory Guide !
! 1.37 and ANSI .2.1 also apply to this Section d take precedence over l the requirements of SI N45.2.8 when con . ' exist.
- d. Section 4.5.1.b: At Perry, pip were ed to maximum velocity using permanent plant equipment or h aser cleaning.
- e. Section 5 provides require ts for the operational, cold functional, and hot functional checking
- spection, and test on installed systems. These requirements are ap cable only for major mo i ations requiring prior NRC approval. In the cases, the requirements of Sectio of this Standard shall
~
be used as ance in determining the checking, inspec ' n, and testing l
require ts following such modifications. For modificatio not requiring l prior C approval or maintenance performed during the opera ~ nal phase, F OC shall perform checking, inspection, and/or post-modificatio r post-maintenance tests to verify that work has been satisfactorily accomplish ,
~ \
[R. Regulatory GDI.123 (Revision 1) [ July 1977], Guality Assurance Requirements for Control ofProcurement ofItems and Servicesfor Nuclear Power Plants l 1. FENOC commits to the regulatory position of this Guide with the following i I clarification: i
- a. Regulatory Position C.4 requires that the procurement documents specify the method of acceptance of an item or service. In lieu of this requirement, I procurement documents shall not detail the method of acceptance. However, this information shall be available to receipt inspection personnel,
- 2. FENOC commits to the requirements of ANSI N45.2.13-1076 with the following h clarifications: j
- a. Section 4 provides for the selection of procurement sources. For " commercial grade" items and for non-safety related items within the scope of the Quality I Assurance Program for which there are no quality assurance program or quality documentation requirements, the requirements of this Section need not be adhered to. However, the procurement documents shall specify requirements specific to the item being procured, sufficient to provide
) MSM N) Table 1 Regulatory Commitments l Revision 0
Att:chtm.nt 2. Enclosura 1 g p DBNPS Lcttir Szrial 2603
) C4 p%! %sFirstEnergy Nuclear Operating Company 2WL PYQN QUALITY ASSURANCE PROGRAM MANUAL
) wsoci #J cw n u cb adequate certification or other records to ensure that items and activities meet the specified requirements. [
- b. Section 8.2 provides requirements for the control of nonconformances.
Suppliers qualified by FENOC as design agen'ts in accordance with **
Regulatory Guides 1.64 and 1.123 may be permitted under specific contractual provisions to disposition nonconformances as "use-as-is" or
" repair" on behalf of FENOC. All nonconformances dispositioned "use-as-is" or " repair" by suppliers qualified by FENOC as design agents on behalf of FENOC are required to be submitted to FENOC for engineering approval at the time equipment is received on site. If FENOC determines that a disposition has been incorrectly made, a nonconformance report is generated on site to document the problem and effect resolution.
- c. Section 10.2.d is interpreted as follows: The person attesting to a certificate-shall be an authorized and responsible employee of the supplier and shall be identified by the supplier.
g S. Regu tory Guide 1.144 (Revision 1) [ September 1980], Auditing of Quality Assura ProgramsforNuclearPowerPlants
- 1. FENO commits to the regulatory position of this Guide for activities at are comparab in nature and extent to construction phase activities.
- 2. FENOC comn ' s to the requirements of ANSI N45.2.12-1977 'ith the following clarification:
- a. Section 4.5.1 o is Standard discusses follow- and conective actions.
FENOC may utili the provisions of the co ctive action program outlined in Section A.6 instea of these requireme , as long as the appropriate time limits are applied to si 'ficant conditi adverse to quality. Also, no additional documentation ' necess- if needed corrective actions are taken and verified prior to audit te rt ' uance.
T. Regulatory Guide 1.146 (Revision 0 u st 1980], Gualification ofQuality Assurance Program Audit Person forNuc arPowerPlants
- 1. FENOC commits to the gulatory position o his Guide.
- 2. FENOC commits the requirements of ANSI N 2.23-1978.
Table 1 Regulatory Commitments Revision 0 30
Attachment 2, Enclosura 1 DBNPS Lattsr Ssrial2603 PY-CEl/NRR-2411L Page 20 of 29
, 17.2.1.3.5.2 Audits of unit activities shall be performed under the cognizance of the CNRB. %ese audits shall encompass:
- a. The conformance of unit operation to provisions contained yithin the Technical Specifications and applicable licer.se conditions at least once per 12 months; l b. The performance, training and qualifications of the entire unit 1
staff at least once per 12 months;
- c. The results of actions taken to correct deficiencies occurring in unit equipment, structures, systems, or method of operation that affect nuclear safety, at least once per 6 months; -
)
, d. The performance of activities required by the Operational Quality Assurance Program to meet the criteria of Appendix B, 10 CFR Part 50, at least once per 24 months;
)
- e. The fire protection programmatic controls including the inclementing procedures at least once per 24 months by qualified licensee QA personnel;
- f. "t fir; pret;;ti= Opi.- nt -M pr-:-gre M1-'mteti= st 1:::
l ^ ace per 12 rrth utili:in; cither . ;21ifi d ;ng;= t; licea;;;
I fi:: ; : tecti = ::;ir:::( ) : = =t:id; ind:padat fire 1 p.meetie..cene It.at. M.'e teide '-dependent fire p.eim, Lien
- 1 tat ;i.
- .li be utili;ed et le-et ...sy i.i. lad ywai,
- g. "c.; adici;;ial ; Ji;: -- t:1 ~::itain; p;e,..;. = 0 tr.e resulte
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- h. The Offsite Dose Calculation Manual and iniplementing procedures at least once per 24 months; 1
/
Revision 8 17.2-16c Oct. 1996
Attichment 2, Enclosura 1
)[%C Of
%f %rFirstEnergy Nuclear Operating Company DBNPS Lsttrr Strial 2603 PY-CEl/NRR-2411L Page 21 of 29 QUALITY ASSURANCE PROGRAM MANUAL l
'S; individual =pc=ib! fcr :natcri6, purch=ing, and ccatrac'a 1 rapcmib!
fcr =pp!!;: =!untic=, ccume m!&2tiene, pecm cM, sa~;rar, raaair
! cage, and ! rue cf m2!ed , p .t,2nd ccmpenents.
- d. The on-site and off-site safety review committees independently review activities to provide additional assurance that the units are operated and maintained in accordance with the Operating License and applicable regulations which address nuclear safety. !
3.
-t sponsibility V TNSOS A8 x x l
- a. ENOC has the responsibility for the scope and implementation of an effective uality as ce program. {
- b. FENO may delegate all or part of the activities of planning, establishin and impleme ing the quality assurance program to others, but retains the r ponsibility for the prograr ' effectiveness.
l
- c. The adequacy o the QAPM's implementation is continually ass sed by the individual (s) l responsible for qu ity assurance and the associated executive r overall plant nuclear l safety, and is reporte to the chief executive officer. !
- d. FENOC is responsible f ensuring that the applicable p rtion(s) of the quality assurance program is properly doc ted, approved, and imp! ented (peop]e are trained and resources are available) befo an activity within th scope of the QAPM is undertaken by FENOC or by others.
- c. Responsible individuals are to ens that pe onnel working under their management cognizance are provided the necess- rai ng and resources to accomplish their assigned tasks within the scope of the Q 'M.
- f. Procedures that implement the QAP are ap oved by the management responsible for the applicable quality function. ese proced s are to reflect the QAPM and work is to be accomplished in accordance 'ith them.
- 4. Authority
- a. When FENOC delegate esponsibility for planning, esta ishing, or implementing any part of the overall Q rogram, sufficient authority to acco plish the assigned responsibilities is d egated.
- b. The individual sponsible for quality assurance has the responsib 'ty and the authority to stop unsat' actory work (except reactor operation) and control f her processing, delivery,i lation, or use of non-conforming items or services:. Co and schedule conside sons will not override safety considerations.
3 Revision 0
Attichmznt 2. Enclosura 1 DBNPs Lsttsr Strict 2603 PY-CEl/NRR-2411L Page 22 of 29 r C^ puter pr0;r ured in the design pr0Cerr are appreved prior to - l
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_ use and cirurer chill 50 pr0Vid0d t0 2 cur 0 th:t th0 prograr. is -
appenpriara fnv the n.ve 4 -1 c application, it i ured ::::::tly, 1
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$(6 JMSM N k 17.2.3.3 Responsibilities and Authorities
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17.2.3.3.1 General Manager, PNPPD, and Director, PNED The General Manager, PNPPD and Director, PNED, are responsible for-recommending design changes and modifications and for assuring that design modifications to structures, systems or components are verified and approved by the responsible design organization prior to installation. The General Manager, PNPPD and Director, PNED, are also
') responsible, in conjunction with the responsible installation organizations, for assuring that approved modifications are properly installed.
Additionally, the Director, PNED, is responsible for:
a.
Determining whether design modifications will be prepared by PNED or by contract with an approved outside design organization, b.
Developing and implementing design control procedures for PNED.
- c. Coordinating design changes and modifications with the architect / engineer (AE), NSSS Supplier, or other outside organization, and the General Manager, PNPP.
,/
Revision 8 17.2-25 Oct. 1996 t
Attichment 2, Enclosure 1 DBNPS Lstt r Szrial2603
) NO CFirstEnergy Nuclear Operating Company PY-CEllNRR-2411L P
QUALITY ASSURANCEa e23of 29 PROGRAM MANU
- d. Cri!ci;in! &E= ==pt:b!: que!!!y : ::peciE:d, =d qu !!!y !: veriSed ;;ai=! k.;c cdent
~
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- 2. Design Control ~
- a. The design control program is established and implemented to assure that the activities 1
associated with the design of systems, components, structures, and equipment and modifications thereto, are executed in a planned, controlled, and orderly manner.
t
- b. The program includes provisions to control design inputs, processes, outputs, changes, i
interfaces, records, and organizational interfaces.
- c. Design inputs (e.g., performance, regulatory, quality, and quality verification requirements) are to be correctly translated into design outputs (e.g., specifications, drawings, procedures, and instructions). _
- d. The final design output is to relate to the design input in sufficient detail to permit verification.
- e. The design process is to ensure that items and activities are selected and independently verified consistent with their importance to safety to ensure they are suitable for their intended application.
- f. Changes to final designs (including field changes and modifications) and dispositions of non-conforming items to either use-as-is or repair are to be subjected to design control measures commensurate with those applied to the original design and approved by the organization that performed the original design or a qualified designee.
- g. Interface controls (intemal and extemal between participating design organizations and across technical disciplines) for the purpose of developing, reviewing, approving, releasing, distributing, and revising design inputs and outputs are defined in procedures.
- h. Design documentation and records, which provide evidence that the design and design verification process was performed in accordance with this program, shall be collected, stored, and maintained in accordance with documented procedures. This documentation includes final design documents, such as drawings and specifications, and revisions f
f thereto and documentation which identifies the important steps, including sources of design inputs that support the final design.
- i. Additional details concerning design control activities may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.g.,
Regulatory Guide 1.64).)SWT $Q Revision 0 t
Att:chment 2 Enclosura 1 DBNPS Lsttzt Szrial 2303 PY-CEl/NRR-2411L Page 24 of 29 m I Any corrective action which may be deemed necessary, as a result of these yearly assessments, shall be formally identified and tracked to resolution.
- .c -
l f . l .2.2.3.2 Manager, Quality Assurance s'ection (QAS) ** l l The Mana r, QAs, maintains overall responsibility for the con t and quality of operational QA program as described in this pter and l shall exercise 1 approval authority for any changes ior to implementation. The Manager, QAs, as the o cial given direct esponsibility for
- i verifying the effective impl tation of Perry Operational QA Program, shall establish and imp 1 t, ormally documented and procedurally controlled program to e te and report to the Vice President, NOclear - Perry on the dequa continued effectiveness of the overall Perry OQA Frep Reports of udits performed by PQPDD
'3 l
% or their agents, and qualit trend analysis will ovide the basis for this evaluation. corre ve action shall be inqpl d'by responsible management, as d appropriate, when analysis reveals verse quality l
. trends. These ac ons may involve specific actions to provi conqpliance wit the QA Program, and may include follow-up audits r {
revision t OQA Program. Implementation and close-out of corre ve f actions 11 be monitored by the Manager, QAs, to assure timely corr tion and compliance. r SEE IN SWit # M M *'!"2 -
- 17. z . z . s .b T' eterfa ==ral Manager of Each Or-4 ";is The Director / General Manager of each organization is responsible for implementing training and indoctrination programs for their respective organizations which meet the requirements in section 17.2.2.2., Item g.
17.2.2.4 12pleented Authorities Quality assurance programs and implementing procedures for suppliers or Revision 9 17.2-21 April, 1998
r Attachment 2, Enclosura 1 DBNPs Lettrr Ssrial 260:,
] NO CFirstEnergy Nuclear Operating Company PY-CElINRR-2411L Page 25 of 29 QUALITY ASSURANCE PROGRAM MANUAL
- b. The executive responsible for overall plant nuclear safety, operations support, and engineering at each site reports to the chief executive officer. This executive is l
responsible for establishing and maintaining policies, goals, and objectives of this QAPM at the respective site and overseeing activities of the off-site safety review conimittee. l l
- c. The individuals fulfilling the following management functions report to the executive identified in Paragraph 2.b above. These individuals may report through an additional layer of management but shall maintain sufficient authority and organizatior al freedom to implement the assigned responsibilities. These individuals may be responsible for a single unit / location or for multiple units / locations and may fulfill more than one function described below:
- 1. The individual responsible for quality assurance has overall authority and
/ responsibility for establishing, controlling, and verifying the implementation and
) adequacy of the quality assurance program as described in this QAPM. The
( individual responsible for quality assurance has the authority and responsibility to (u escalate matters directly to the chief executive officer when needed. v fml9Cx:7 e to A ~ - - -
- 2. The individual responsible for plant operations assures the safe, reliable, and efficient operation of the plant within the constraints of applicable regulatory requirements and the operating license.
- 3. The individual responsible for plant modification provides direction, control, and overall supervision of the implementation ofplant modifications and assigned maintenance.
- 4. The individual responsible for training provides direction, control, and overall supervision of all training of personnel required by regulations.
- 5. The individual responsible for records management provides direction, control, and overall supervision of the records management program and associated activities.
- 6. The individual responsible for document control provides direction, control, and I overall supervision of the document control program and associated activities.
- 7. The individual responsible for the corrective action program provides direction, l
control, and overall supervision of the corrective action program and associated ' activities.
- 8. The individual responsible for engineering is responsible for the development and maintenance of engineering programs, policies, and procedures and for providing engineering services.
{ 2 Revision 0
Attichment 2, Enclosura 1 DBNPS Letter Stri112603 IgENQ {%vFirstEnergy
%v Nuelcar Operating Company 2411L YjEilN pg
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QUALITY ASSURANCE PROGRAM MANUAL
~ _
- c. Revisions of controlled documents are reviewed for adequacy and approved for release by the same organizatiou that originally reviewed and approved the documents or by a !
designated organization that is qualified and knowledgeable. I zysaxn i 1 08 '.
- d. Controlled documents are available to and used by the pers5h pafunning tne activity,
- e. The distribution of new and revised controlled documents is in accordance with procedures. Superseded documents are controlled to prevent inadvertent use.
I
- f. Additional details concerning document control may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.g., Regulatory Guide 1.33).
- 15. Records
- a. A program is established and implemented to ensure that sufficient records ofitims and activities (e.g., design, engineering, procurement, manufacturing, construction, inspection and test, installation, preoperation, startup, operations, maintenance, modification, deconunissioning, and audits) are generated and maintained to reflect completed work.
- b. The program provides provisions for the administration, receipt, storage, preservation, safekeeping, retrieval, and disposition of records.
- c. Additional details concerning record requirements may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.g., l Regulatory Guide 1.88).
C. ASSESSMENT I
- 1. Methodology
- a. Personnel responsible for canying out audits are maintained cognizant of day-to-day activities by the ongoing involvement in the quality assurance program requirements so that they can act in a management advisory function.
- b. Organizations performing audits are to be technically and performance oriented commensurate with the activity being reviewed.
- c. Personnel performing audits have no direct responsibilities in the area they are assessing.
- d. Audits are accomplished using procedures, or other appropriate means that are of a detail commensurate with the activity's complexity and imponance to safety.
l 14 Revision 0
I l l Attichment 2, Enclosura 1 DBNPS lsttIt Suill 2603 PY-CEl/NRR-2411L l Page 27 of 29 l Program is mandatory for all CEI organizations and for all contractors or vendors providing items or services covered under the scope of this document. i Section17.2istheprimarycorporatedocumentdescribingthe.Nhclear Quality Assurance Program for Perry. Each of the eighteen criteria of 10 CFR 50 Appendix B, and the responsibilities for the corresponding activities are addressed in detail in the eighteen sections which comprise the document. The requirements of this program shall be implemented in accordance with detailed procedure manuals and instructions. All procedures and instructions shall be approved and established;-vith training accomplished, prior to the start of the activity being controlled. Issuance, distribution and revision shall be controlled to preclude the use of obsolete documents. 17.2.2.2 . Requirements The Operational OA Program requires j
- a. !
Identification of structures, systems and ccmponents to which the Operational Quality Assurance Program is applicable (see Sectio .
- b. Of. P :g :: ::::::1 for :::puter ::d: pregr- r ;hich ffeet r'fety : lated it:;;. Th::: coat ele . .11 oyyl, iv Jo 1vy..us,-
arcaer, ure, r !rt:n;;;;, and ;edificatieu .I mo-yoi . sudo Pr^gr--- Th::: ::n:::1 : hall include auificim..i .. . . io
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SEE M S*I # ll . 1 1 l Revision 3 17.2-18 March, 1991
AttachmInt 2, Enclosure 1 l DBNPS Lettu Striti 2603 FirstEnergy Nuclear Operating Company PY-CEl!NRR-2411L l P e 28 cf 29 l QUALITY ASSURANC PROGRAM MANUAL l a or,en,,;n,a ona e' ;,,,4 ,h o, a,n n, or,,n,okt, n,,21;, e,,, % 7 ,..m .a g,
. . ~ . .
- 2. Design Control 'I
- a. The design control program is established and implemented to assure that the activities i l
l associated with the design of systems, components, structures, and equipment and modifications thereto, are executed in a planned, controlled, and orderly manner.
- b. The program includes provisions to control design inputs, processes, outputs, changes, interfaces, records, and organizational interfaces.
- c. Design inputs (e.g., performance, regulatory, quality, and quality verification requirements) are to be correctly translated into design outputs (e.g., specifications, drawings, procedures, and instructions). _
- d. The fhal design output is to relate to the design input in sufficient detail to permit veriUcation.
l
- e. The design process is to ensure that items and activities are selected and independently verified consistent with their importance to safety to ensure they are suitable for their ,
intended application.
- f. Changes to final designs (including field changes and modifications) and dispositions of non-conforming items to either use-as-is or repair are to be subjected to design control l
measures commensurate with those applied to the original design and approved by the organization that performed the original design or a qualified designee.
- g. Interface controls (internal and external between participating design organizations and l across technical disciplines) for the pmpose of developing, reviewing, approving,
! releasing, distributing, and revising design inputs and outputs are defined in procedures. i f h. Design documentation and records, which provide evidence that the design and design verification process was performed in accordance with this program, shall be collected, stored, and maintained in accordance with documented procedures. This documentation , includes final design documents, such as drawings and specifications, and revisions l thereto and documentation which identifies the important steps, including sources of design inputs that support the final design.
- i. Additional details concerning design control activities may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.g.,
Regulatory Guide 1.64).
/ ~3NS # I
- ll 6
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EE i 4 s,- OO Attachment 2, Enclosure 1 DBNPS Latt r S:rizi 2603 V VFirstEn:rgy Nuclear Operating C:mpany PY-CEllNRR-2411L QUALITY ASSURANdMbGRAM MANUAL 3. Design Verification . SysM d a cwr.vuO \ f a. A program is established and implemented to verify the acceptability of design activities and documents for the design ofitems. The selection and incorporation ofdesign inputs l and design processes, outputs, and changes are verified. . .
}
- b. Verification methods include, but are not limited to, design reviews, alternative f calculations, and qualification testing. The extent of this verification will be a function of the importance to safety of the item, the complexity of the design, the degree of standardization, the state of the art, and the similarity with previously proven designs.
Standardized or previously proven designs will be reviewed for applicability prior to use.
- c. When a test program is used to verify the acceptability of a specific design feature, the test program is to demonstrate acceptable performance under conditions that simulate the most adverse design conditions that are expected to be encountered. _
j d. Independent design verification is to be completed before design outputs are used by other organizations for design work and before they are used to support other activities such as procurement, manufacture, or construction. When this timing cannot be achieved, the unverified portion of the design is to be identified and controlled. In all cases, the design verification is to be completed before relying on the item to perform its function.
- e. Indisiduals or groups responsible for design reviews or other verification activities shall be identified in procedures and their authority and responsibility shall be defined and controlled. Design verification shall be performed by any competent individuals or groups other than those who performed the c,riginal design but who may be from the same organization. The designer's immediate supervisor may perform the design
/ verification provided: the supervisor is the only technically qualified individual capable f of performing the verification, the need is individually documented and approved in advance by the supervisor's management, and the frequency and effectiveness of the supervisors use as a design verifier are independently verified to guard against abuse.
- f. Design verification procedures are to be established and implemented to ensure that an appropriate verification method is used, the appropriate design parameters to be verified are chosen, the acceptance criteria are identified, the verification is satisfactorily accomplished, and the results are properly recorded.
- g. Additional details concerning design verification activities may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.g., Regulatory Guide 1.64).
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Attschment 3 DBNPS Letter Serial 2603 PY-CEl/NRR-2411L Page 1 of 1 I I COMMITMENT LIST , THE FOLLOWING LIST IDENTIFIES THOSE ACTIONS COMMITTED TO BY THE { DAVIS-BESSE NUCLEAR POWER STATION (DBNPS) IN THIS DOCUMENT. ANY OTHER ACTIONS DISCUSSED IN THE SUBMITTAL REPRESENT INTENDED OR PLANNED ACTIONS BY THE DBNPS. THEY ARE DESCRIBED ONLY AS INFORMATION AND ARE NOT REGULATORY COMMITMENTS. PLEASE NOTIFY THE MANAGER - REGULATORY AFFAIRS (419-321-8466) AT DBNPS OF ANY QUESTIONS REGARDING THIS DOCUMENT OR ANY ASSOCIATED REGULATORY C'OMMITMENTS. COMMITMENTS DUE DATE None N/A 1 l I I i
Attachment 4 DBNPS Letter Serial 2603 PY-CEl/NRR-2411L Page 1 of 1 COMMITMENT LIST 1 THE FOLLOWING LIST IDENTIFIES THOSE ACTIONS COMMITTED TO BY THE PERRY NUCLEAR POWER PLANT (PNPP) IN THIS DOCUMENT. ANY OTHER ACTIONS DISCUSSED IN THE SUBMITTAL REPRESENT INTENDED OR PLANNED l ACTIONS BY THE PNPP. THEY ARE DESCRIBED ONLY AS INFORMATION AND I ARE NOT REGULATORY COMMITMENTS. PLEASE NOTIFY THE MANAGER - REGULATORY AFFAIRS (440-280-5606) AT PNPP OF ANY QUESTIONS REGARDING THIS DOCUMENT OR ANY ASSOCIATED REGULATORY COMMITMENTS. j COMMITMENTS DUE DATE None N/A 1 l l j l l l}}