ML20081H878
| ML20081H878 | |
| Person / Time | |
|---|---|
| Site: | Diablo Canyon  |
| Issue date: | 11/04/1983 |
| From: | Reynolds J CENTER FOR LAW IN THE PUBLIC INTEREST, JOINT INTERVENORS - DIABLO CANYON |
| To: | Gilinsky V, Palladino N, Roberts T NRC COMMISSION (OCM) |
| References | |
| ISSUANCES-OL, NUDOCS 8311080072 | |
| Download: ML20081H878 (42) | |
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CENTER FOR LAW
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00CHETED IN TH E P u s u c INTER Eg5MC LgGAL STAFF IOpst WEST Poco eOULEVARD ASHINGTON, D.C. CFFICE NANCY C. CRISM AN' C#,R LY LE W. HALL.JR. THIRD FLOOR -
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Susn eso JOEL R. REYNOLDS TELEPHONE: (PO2) 3 7t-019 9 M ARILYN O.TESAURO FREOR C O. WOOCHER NICHOLAS C. YOST ryg(( (( $(({i{iD #
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eAL BY FEDERAL EXPRESS Nunzio Palladino, Chairman Victor Gilinsky, Commissioner Thomas Roberts, Commissioner James Asselstine, Commissioner Frederick Bernthal, commissioner United States Nuclear Regulatory Commission ,
Washington, D.C. 20555 j Re: In the Matter of Pacific Gas and Electric Company (Diablo Canyon Nuclear Power Plant, Units 1 and 2), Nos. 50-2750L, 50-343OL Gentlemen:
Thir letter addresses two matters which relate to the subject of the Commission meeting scheduled for November 8, 1983. The first arises out of the disclosure yesterday, at the Disblo Canyon Nuclear Power Plant ("Diablo Canyon") design hearings in San Luis Obispo, California, of new information regarding programmatic deficiencies in Pacific Gas and Electric Company's ("PGandE") quality assurance program during the period after suspension of the license -- specifically, June 1982 through the present. We believe that such information is directly relevant to matters now before the Commission and, further, that it illustrates graphically why no licensing deci-sion should be made until completion of all safety hearings.
Second, this letter conveys to the Commission the recently stated intention of the Appeal Board not to consider 3311080072 831104 PDR ADOCK 05000275 G PDR BOARD OF TRUSTEES sAwEs = AoLEe p.utom s steer EuzAsEm as NOaowt2 Jvov certu=G eaE%r N. evsarO*ta str*Anv L woAtt
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U.S. Nuclear Regulatory Commission November 4, 1983 Page 2 the Joint Intervenors' stay application until after the Commission has acted. Accordingly, the Joint Intervenors hereby renew their request for Commission consideration of the stay application prior to, or concurrent with, the scheduled November 8, 1983 vote on reinstatement of the suspended license.
I. Project Assistance Corporation and EDS Nuclear, Inc.
Audits of PGandE's Post-1981 Quality Assurance Program During the Diablo Canyon design hearings held yesterday before the Appeal Board in San Luis OL._po, two recent audit reports were revealed which provide further evidence that PGandE's quality assurance program at Diablo Canyon remains seriously inadequate. The audit reports (copies attached hereto) were prepared in June 1982 by Project Assista' ice Corporation (" PAC") and EDS Nuclear, Inc. ("EDS"),
respectively, based on their independent reviews of PGandE's program as outlined in the PGandE Quality Assurance Manual.
Their findings, which are only excerpted briefly here, speak for themselves:
A. PAC Review -- Following a three and one-half week review of the PGandE Quality Assurance Manual and comparison to PGandE's quality assurance commitments, PAC summarized its findings as follows:
- 1. 46 instances were identified in which the Quality Assurance Manual failed to adequately address the require-ments of an ANSI Standard and/or Regulatory Guide to which PGandE is committed. In 36 of these instances, the requirements old not appear to have been addressed at all. In the remaining 10 instances, it appears there was an effort to address the requirement but it had been done in
U.S. Nuclear Regulatory Commission November 4, 1983 Page 3 such a manner that compliance with the requirement could not be assured.
- 2. 14 instances were identified in which responsibility for performance of a safety-related activity was inade-quately or inconsistently defined to the extent that compliance with a particular requirement could not be assured.
- 3. 6 instances were identified where the requirements set forth in the Quality Assurance Manual appear to directly violate or permit violation of an ANSI Standard requirement.
- 4. 5 instances were identified where the requirements of an ANSI Standard were adequately addressed in a Quality Assurance Procedure, but were not mentioned in the related Quality Assurance Policy section.
- 5. The finding reports identified problems in 12 instances which appeared to be one of a kind and did not fall into any of the above groupings.
Based on these findings, PAC concluded:
The nature and extent of the problems identified during this review of the PGandE Quality Assurance Manual, as detailed previously in this Summary Report and in Attachment IV and VI, leaves little doubt but that this Manual is deficient with respect to addressing the requirements to which PGandE has committed. A complete rewrite of the Manual to address these i detailed problems would appear to be I necessary. Though not the subject of this report, we are familiar with the review of l
U.S. Nuclear Regulatory Commission November 4, 1983 Page 4 the various implementing manuals, such as the Licensing Manual and the Nuclear Power Generation Manual, and understand it has produced similar results.
PAC Review, at 3-4 (emphasis added) .
The report goes on to explain that these deficiencies stem from two root problems that "must be resolved before PGandE can reasonably expect to have an effective, economical quality assurance program which will achieve its desired objectives." Id. at 5. Those are (1) the decentralized nature of the quality assurance program, and (2) the low level that the Quality Assurance Department occupies in the PGandE organization. Id. at 5-6. PAC concludes that "[t]o prevent the current situation of errors, omissions, and contradictions between the various manuals from repeating itself in the future," PGandE's quality assurance program must be restructured. Id.
B. EDS Nuclear, Inc. Review -- EDS reviewed the manuals of*the various relevant PGandE departments (e .g . ,
Quality Assurance and Engineering) and compiled a list of deficiencies in the areas of organization, program scope and l administration, nonconformance and corrective action, training, design control, procurement and materials control, and document control and records. Although the comments regarding the Quality Assurance Department are too lengthy to quote meaningfully here (see attached report) , EDS ' recommendations include:
(1) restructuring of the quality assurance department (p. 1);
(2) expanding the scope of the program to all activities affecting plant reliability and availability (p. 2);
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U.S. Nuclear Regulatory Commission November 4, 1983 Page 5 (3) establishing an effective corrective action program {p. 3); and (4) increasing the level of indoctrination and training to bring PGandE's program up to industry practice and regulatory requirements (p. 3) .
With respect to the Engineering Department, EDS summarized its general conclusions as follows:
there is a lack of defined responsibilities for personnel within the Engineering Department, interfaces and controls within the Engineering Department, and between Engineering and other PGandE departments are not well defined, the minimal role which quality assurance has been given in performance of activities such as procurement document review, and program / procedure development and review, the role of the Engineering Department during the operations phase and its interface with the various technical review committees is not adequately described, the lack of a comprehensive and well integrated corrective action program, a well defined system does not exist for assuring and verifying that all required documents are incorporated in the design program and that design changes, as necessary, are reflected in design documents, and with the exception of the piping design group and engineering quality control, department instructions for performing work activities are not current. (EDS Review, at 1.)
In addition, it made a number of critical findings specifically with regard to the reviewed areas mentioned above. Id. at 1-3.
U.S. Nuclear Regulatory Commission November 4, 1983 Page 6 i
C. Implications of PAC and EDS Reviews -- The findings in the attached reports confirm the questions already raised about the continuing inadequacy of PGandE's quality assurance program. It is very troubling to find that, over nine months after the initial design errors were discovered in i
September 1981, PGandE had still not taken the actions necessary to correct the fundamental problems outlined above.
Further, with the possible exception of a recent change in the line of reporting and the creation of a quality assurance study group, PGandE's witnesses admitted on cross-examination yesterday in San Luis Obispo that no significant changes had been made in the PGandE quality assurance program since the audit reports were issued.1/ Thus, the deficiencies -- all of which have apparently been neglected by the IDVP quality assurance review -- undoubtedly remain, as do any undetected
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errors in design resulting from them.2/
1/ Reopened Design Hearing Transcript, at D-1031.
2/ Also disclosed at yesterday's hearing is an April 4, 1983 audit report from PGandE's Engineering Quality Control i Department to the Vice President for Engineering. Based on a '
review of PGandE's Engineering Department procedure 5.1,
" Engineering Department Manual Control," the audit report concluded as follows:
Unfortunately, the audit also revealed that an excessive number of manuals had missing, misfiled, or out of date procedures. In fact, 48% of the 66 manuals inspected were found to be deficient in some way. This failure to keep our engineering manuals up to date appears to run uniformly across the i Engineering Department.
This finding suggests that, as recently as this year, PGandE's engineering personnel continued to demonstrate a lack of concern for procedures. As a minimum, one would expect that an adequate quality assurance program should be able to keep up to date all manuals of its procedures.
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U.S. Nuclear Regulatory Commission November 4, 1983 Page 7 1 The Joint Intervenors continue to be astonished that PGandE can, on the one hand, provide the assurances to the Commission that it has so freely offered during the past two years and, at the same time, be aware of information directly contrary to those assurances which it does not disclose to the NRC. Even more astonishing to the C :nt Intervenors is the fact that the Commission and its Staff seem unconcerned by such conduct.E/
Finally, the disclosure of these reviews through the hearing process illustrates its importance as the proper forum in which to gather the information on which a licensing decision is made. The Joint Intervenors continue to believe that Commission consideration of PGandE's request to reinstate the suspended Diablo Canyon license -- even for fuel loading --
is inappropriate until the Commission has on the record evidence sufficient to provide a basis for decision. The issues are too important and technically complex to base a decision on the assurances of the NRC Staff and Teledyne without providing the other parties to the proceeding a meaningful opportunity to test those assurances through the procedures firmly established by Congress in the Atomic Energy Act and the Administrative Procedure Act.
2/ The Commission should be aware that at yesterday's hearing, both PGandE and the NRC Staff initially sought to prevent the admission into evidence of the EDS and PAC audit reports. Reopened Design Faaring Transcript, at D-902.
Although PGandE's objection may not be surprising given the critical nature of the audit findings, the NRC Staff's attempt to prevent the Appeal Board from considering this clearly relevant evidence seems inconsistent with its proper role as the representative of the agency charged with protecting the health and safety of the public.
c U.S. Nuclear Regulatory Commission November 4, 1983 Page 8 II. Application For A S~ cay
, By express mail on October 31, 1983, the Joint Intervenors submitted to the Commission their Application For A Stay, filed nimultaneously with the Appeal Board. Since that time, the Appeal Board has informed us that it will not rule on the application until after the Commission has itself acted on PGandE's request for reinstatement of the suspended license.
That being the case, and because of the time necessary to seek emergency review in the United States Court of Appeals, the Joint Intervenors hereby reaffirm their prior request that the Commission consider and rule upon the Application For A Stay prior to, or concurrent with, the scheduled Commission vote on the license on November 8, 1983.
Very truly yours,
' s.
Je R. Rey ds l Counsel to the Joint Intervenors JRR:cc cc: Diablo Canyon Service List Hon. Morris Udall Hon. Leon Panetta Enclosures l
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-.m REVIEW OF THE d
PGandE QUALITY ASSURANCE MANUAL FOR NUCLEAR POWER PLANTS
SUMMARY
REPORT sa I. Introduction Project Assistance Corporation (i'AC) has counleted the Quality Assurance Manual evaluation portion of Ccutract No.- 31-07-82. This phase of'the contract was co=pleted in approximately three and ene-half weeks uith approx 1=ately seven =cn weeks of labor expended. During this phase of the work, PAC acccc:plished the following:
. identified the Quality Assurance progra= co==itennts for Diablo Canyon Power Plant,
. developed detailed evaluation checklists ' cased on these co==itments,
.. evaluated the PGaudE Quality Assurance Manual (pclicy and related procedures),
- . docu=ented the evaluation and identified proble= areas, and
- . provided reco= ended corrective action to resolve the problem areas.
II. Repcrt Details
,-. A. Attach =ent I contains che listing of' Quality !ssurance require =ents g eh PCandE has co f r M @ for 'che Diablo Canyon Power Plant b project. The listing identifies the industrisi (ANSI) sud ragulatory (Regulatory Guide) require =ents, revisicus, e.y erceptions , .v.d the doct=ent that detailed the cor=it=ent. Tiic list was generated by reviewdng the FSAR - Chapter 17, PGandE's res;:ense to NUREG t 37, -
Disble Canyon Power Plant Licensing Docu=ents (Technical Specifications and Operating License), Diablo Canyon Power Plant Safety Evaluation i Report - t.'hapter 16, discussions with PGandE Licensing Department personnel, and associated Licensing Depart =en?. correspondence.
The a.z:phasis has been placed on the Diablo Cea: yon Power Plant facility because of the status of the Humboldt Bay facility. Additional work would be necessary to finalize a listing cf ec==1t=ents for the Hu=boldt Bay facility.
B. Attach =ent II contains the checklists develcped to perforvi the Quality
- Assurance Manual evaluation. Evaluation checklists were developed I for the following "progra=atic" ANSI sts".d4 rds and their associated
( Regulatory Guides, as coc=itted [for Diablo Canyon Power ?lant:
Quality Assurance Program Requirements for Nuclear Pcwer g u
N45.2 Plants b N18.7 Quality Assurance Program Requirc=ents (Operations)
N45.2.9 Collection, storage, and =aintenance of Nuclear Power l
. Plant Quslity Assurance Record; Y
'_ N45.2.10= Quality Assurance Terms and Definitions m
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N45.2.11 Quality Assurance Requirements for the Design of Nuclear i y Power Plants N45.2.12 * ' Auditing of-Quality Assurance Programs for Nuclear Power
! Plants j N45.2.13 Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants
- The checklist for ANSI N45.2.10 consisted of comparing the definitions listed in the standard against those contained in the Quality Assurance Manual Glossary. -
Although PGandE has co=mitted to compliance with the entire ANSI N45.2 daughter series, it was not considered necessary to develop checklists for all the ramMning standards. Typically, these standards specify " process" t;ype requirements and are generally more appropriate for reviewing detailed implementing procedures.
Standards falling into this classification included:
N45.2.1 Quality Assurance Requirements for Cleaning of Fluid Syste=s and Associated co=ponents of Water Cooled
' Nuclear Power Plants l f, N45.2.2 . Quality Assurance Requir'ements for Packaging, Shipping, l Receiving, Storage, and Handling of Items for Water Cooled Nuclear Power Plants N45.2.3 Housekeeping Requirements for Water Cooled Nuclear Power
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j N45.2.4 Quality Assurance Requirements for Installation, Inspection, and Testing of Instrumentation and Electric Equipment N45.2.5 Quality Assurance Requirements for Installation, Inspection, and Testing of Structural Concrete and Structural Steel During the Construction Phase of Nuclear Power Plants N45.2.6 Qualification of Nuclear Power Plant Inspection, Examination, and Testing Personnel N45.2.8 Quality Assurance Requirements for Installation, Inspection and Testing of Mechanical Equipment and Systems N45.2.23 Qualification of Quality Assurance Program Audit Personnel l f;or Nuclear Power Plants N18.1 Personnel Selection and Training Detailed checklists can be developed later in the project to verify that depart =ent manuals and procedures address the requirements identified in these standards. 'O C. Attach =ent III contairs the co=pleted evaluation checklists. A checklist applicability = atrix, which precedes the completed checklists, h
identifies the checklists used to evaluate the various policy sections and associated procedures. The checklists were completed and are m U3
' organized in the attach =ent by QA Policy Section. Each checklist O
- was co=pleted independently by two reviewers and the results of the independent evaluations were compared to ensure an accurate interpretation
of the Quality Assurance Manual requirements and to identify problem areas.
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D. Attachnent IV contains 83 finding reports which document the specific *
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problem areas identified during the evaluation of the Quality Assurance Manual (policy and procedures). Findings against the Quality As'surance Mahual were assigned a classification code in accordance with project procedures as follows:
Class 1: A deficiency in the Quality Assurance Manual determined to be either a nonconformance (lA) or an open item (13).
Class 2: A potential problem or weakness in the Quality Assurance Manual.
The finding reports were processed to Quality Assurance Depart =ent personnel for review and co==ent. All findtg reports included in Attachment IV have been reviewed and concut.9 d with by Quality Assurance Department personnel.
Each individual finding report includes a reco=mendation for correcting that specifically identified proble=. Note, however, those recoc=endations were made independently of all other detailed findings and reco==endations. For identification of perceived generic problems evidenced by the finding reports plus rece==endations for co==on
corrective acticn, see the " Finding Report Trends" section of this
- report which follows.
E. Attachment V contains copies of the weekly status reports.
F. Attachment VI contains our finding report which lists those potential proble=s which were identified when the Quality Assurance Manual was reviewed against the NRC Standard Review Plans (NUREG 75/087, 17.1 and 17.2). ,It is expected that these items would also be identified as problem areas should the NRC perform an in-depth evaluation of the present Quality Assurance Manual utill:1ng the Standard Review Plans.
III. Finding Report Trends Following the review of the manual itself, the 83 resulting finding reports included in Attach =ent 17 were reviewed, analyzed, and grouped into logical generic categories. The results were as follows:
- 1. 46 instances were identified in which the Quality Assurance Manual failed to adequately address the requirements of an ANSI Standard and/or Regulatory Guide to which PGandE is cocsitted. In 36 of these instances, the requirements did not appear to have been ty addressed at all. In the remaining 10 instances, it appears there CT) 2b>
was an effort to address the require =ent, but ir. had been done in such a =anner that co=pliance with the requirement could not be _2 (n
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- 2. 14 instances were identified in which responsibility for performance ,
of a safety-related activity was inadequately or inconsistantly defined toi the extent that ce=pliance with a particular requirement could not be assured.
- 3. 6 instances were identified where the require =ents set forth in the Quality Assurance Manual appear to directly violate or per=it violation of an ANSI Standard require =ent.
- 4. 5 instances were identified where the require =ents of an ANSI
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Standard were adequately addressed in a Quality Assurance Procedure, but were not =entioned in the related Quality Assurance Policy section.
- 5. The finding reports identified proble=s in 12 instances which appeared to be one of a kind and did not fall into any of the above groupings.
Items 1, 3, and 4 above, in co=bination, strongly suggest that the current systa= used by the Quality Assurance Depart =ent to ide ntify and keep track of co==ittents =ade to the NRC is inadequate. It is re:o== ended that the Quality Assurance Depart =ent review thei,r current system and effect such f.
changes as are necessary to =ake it a positive =echanis= for identifying such co==itments at the time they are =ade, and for subsequently assuring they are adequately and accurately reflected in the Quality Assurance Manual.
Based on Ite= 2 above, it is reco== ended that consideration be given to including an activity = atrix as a part of each Quality Assurance Manual policy section. This = atrix would identify the various activities required to be perfor=ed for that section and the specific PGandE depart =ents responsible for i=ple=entation. Such a = atrix would readily resolve the responsibility proble=s identified during this review, and could also serve as an outline to identify the number and type of imple=entory procedures each department will require.
IV. Conclusion The nature and extent of the proble=s identified during this review of the PGandE Quality Assurance Manual, as detailed previously in this Su==ary Report and in Attach =ent IV and VI, leaves little doubt but that this Manual is deficient with respect to addressing the require =ents to which PGandE has co==1tted. A co=plete rewrite of the Manual to address these detailed proble=s would appear to be necessary. Though not the subject of this report, we are f amiliar with the review of the various 33 f
3 i=ple=enting =anuals, such as the Licensing Manual and the Nuclear Power Generation Manual, and understand it has produced si=11ar results. tn t>
c; PAC considers that an overview of this whole review effort leads to the on
- conclusion that there are two root proble=s which should be identified, highlighted, and discussed. Root proble=s which are interrelated and r - + , n e - - - - -n - -
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have contributed, if not directly lead to the current situation. It is our opinion these two problems must be resolved before PGandE can reasonably expect to have an effective, economical quality assurance
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program which will achieve its desired objectives.
First problem: Rather than the single, co=pany wide quality assurance program inferred by the corporate Quality' Assurance Manual, there are cultiple, al=ost wholly independent quality assurance programs in effect within various organizations throughout PGandE.
The corporate Quality Assurance Manual describes a single quality assurance program for PGandE which is lead, =anaged, and directed by the Quality Assurance Depart =ent. It further indicates that the Quality Assurance Department has delegated responsibility for perfor=ance of quality control functions described therein to independent quality control groups within the various organizational units performing activities affecting quality, such as Engineering or Planning and Research. And, finally, the Quality Assurance Manual requires those other organizations to each establish specific procedures and instructions for performance of the delegated quality control tasks and activities.
A most unusual arrangement, particularly in view of tee fact that the Quality Assurance Department doesn't retain the right of review and approval or concurrence with those other organization's quality control procedures and instructions By commenly accepted definitions of the terms, there is a fairly clear t
distinction between quality assurance and quality control. Thus, based on the corporate Quality Assurance Manual, it was anticipated the manuals of the other organizations would simply include procedures and instructions for perfor=ing what are generally acknowledged to be quality control functions, tasks, and activities. However, the review of those other =anuals revealed they go far beyond such limits; in most l
l instances, they describe co=plete, separate, and distinct cuality assurance l programs which are being imple=ented independent of each other and, to a very large extent, of the corporate quality assurance program.
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We consider that any rewrite of the corporate quality Assurance Manual which simply rectifies the detailed problems f.dentified with it individually during this review will be ineffective. To prevent the current situation of errors, oesissions, and contradictions between the various manuals from repeating itself in the future, it 1; our opinion the corporate quality assurance program =ust be restructured in a manner which will provide sc=e form of centralized control over the " quality control" functions, tasks, and activities of all i=ple=enting ~T) organizations. .
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-- 1 As a mini =um, such control could take the form of Quality Assurance .
Department review and approval or concurrence with the " quality control" procedures and instructions of,all other PGandE organizations. Op ti r-a l ly ,
the quality control groups of all the other organizations could be molded into the Quality Assurance Department.
But, whatever form such control takes, we consider it essential that one single organization, preferably the Quality Assurance Department,-be placed in a position of centralized control where they would at least have the capability of preventing recurrence of the existing situation - as the quality assurance program is currently structured, it would not appear that anyone could.
Second problem: The quality Assurance Department, and hence the Quality Assurance Manager, are at too lov of an organizational level to provice effective leadership, management, and control over the corporate quality assurance program.
In textbook theory, at least, the head of the quality assurance organization should report on that organizational level where his i==ediate superior has direct responsibility for and authority over all aspects of i=ple=entation of the quality assurance program. This is the reporting relationship strongly preferred by the NRC. Within the current organizational structure of PGandE, this would =ean that, in theory, the Quality Assurance Manager
should report directly to the Board of Directors.
Realistically, it would appear there are several viable options open to PGandE short of such a theoretical extre=e. To cite the most obvious option, it would appear to be both practical and desirable to have the Quality Assurance Manager report directly to the Senior Vice President, Facilities Development. This should provide sufficient stature and organizational independence for the Quality Assurance Manager to effectively lead, direct, and control the corporate quality assurance program since the Senior Vice President, Facilities Developcent does have direct responsibility and authority over all except three aspects of implementation of the corporate quality assurance program. These are: licensing, where the interface with l
I the NRC and final authority is the assistant General Counsel under the Senior Vice President and General Counsel; regular purchasing, where the final authority is the Materials Manager under the Senior Vice President, Operations; and uranium purchases where the final authority is the Vice President, Fuels Planning and Acquisition under the Executive Vice President. Considering the nature of these three, and the fact that the technical input to all three is provided by personnel from within the Senior Vice President, Facilities Development's organization, his lack of absolute control over these "'t?
aspects should not cause significant dif 'iculties. C')
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EDS/PGandE-82-086 0170-042-004 Pacific Gas and Electric Company 77 Beale Street San Francisco, California 94106 ATTENTION: -Mr. Frank Dodd
SUBJECT:
Project Summary Report Gentlemen: -
Attached is the Project Summary Report for the Pacific Gas and Electric Company Department Manual Review Project recently performed with the assistance of EDS Nuclear Inc.
This report is based upon the individual findings submitted as part of the Department Manual Reviews. The report identifies generic issues or trends which were common to all manuals.
Recommended corrective actions are also included.
If you have any further questions, please contact me'or Mr.
T. F. Lydon.
Very truly yours,
,) V J M . lUW R. M. Polivka Project Manager RMP/FJS/wrl Attachment cc: Mr. W. Raymond - PGandE (w/ attach.)
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SUMMARY
REPORT ORGANIZATION A. It is strongly recommended that PGandE perform an evaluation ,
of its current org,anization with respect to quality assurance responsibilities and activities. We believe that the e' present reporting level of the Quality Assurance Department and the various departmental quality control groups reflects the limited role and responsibility which quality assurance has had within the PGandE corporate structure. In order for quality assurance to be fully integrated into the organization , responsibilities should be expanded to encompass more activities within areas such as procurement, program / procedure development, and design.
In accordance with Appendix B, 10 CFR 50, Criterion I, the quality organi,zation should have " sufficient authority and organizational freedom to identify quality problems, to initiate, recommend or provide solutions; and to verify ~
implementation of solutions". Within the current PGandE structure, the quality organization and the associated responsibilities are being implemented by the Corporate Quality Assurance Department and also by the various department quality control groups. This method of organization has limited PGandE's ability to totally comply with the intent of Criterion I.
One possible method for satisfying Criterion I is to change the present reporting level of the Quality Assurance Department within PGandE. -
Another method for strengthening the quality assurance role is to provide the Quality Assurance Department review and approval authority over a wider range of subjects.
This could include:
o Other Department QA/QC manuals, o All nonconformances and discrepancy reports, and o Procurement documents.
We believe that these changes should be evaluated further for possible impl emen ta t ion .
After this evaluation, there are two (2) possible "O alternatives which also should be studied. CC) 2>
o All department quality assurance / control personnel _3 to be included within the Quality Assurance a Depa r tmen t . C.)
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Project Summary Report Page Two ORGANIZATION (continued) o Department quality control personnel other than ,.
the Quality Assurance Department, be technically responsible to the respective department manager,
! and administratively responsible to the Manager, Quality Assurance.
Within the nuclear industry, there are examples of both structures working effectively and efficiently.
We believe that these proposed organizational modifications will inherently strengthen PGandE's ability to satisfy its commitment to quality assurance by integrating it into all project phases. It will also provide improved efficiency and assist in implementing functional programs such as auditing and procurement more ef f ectively. -
B. As described within the various manuals, procurement activities are the responsibility of numerous individuals and/or departments. We recommend that the procurement process be studied to identify inefficiencies and/or inadequate procurement control which may result from overlapping authorities and unclear interface responsibilities.
I PROGRAM SCOPE AND ADMINISTRATION A. It is recommended that a procedure review and rewrite task be conducted to accomplish the following:
l o To describe PGandE interdepartment interfaces.
This can best be accomplished by including procedure references of other departments within the text as well as including a " reference" section within each procedure. The development of flow charts for functional activities, such as procurement, will also assist in the development of clear, concise procedures, and i
[ o To provide consistency among " purpose", " scope",
and the actual text of the procedures.
l B. " Standard Practices" are referenced and used extensively within the organization to control safety related work, f
33, however, the requirements are not contained within controlled procedures. Potential solutions are to make s
" Standard Practices" controlled documents or to elevate ,i the control of safety related activities to OA controlled C) procedures. '3 w
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-Project Summary Report Page Three PROGRAM SCOPE AND ADMINISTRATION (continued)
C. The Quality Assurance Manual, department manuals, and implementing procedures all establish the scope and applicability of the. quality assurance program. Although ,.
the stated criteria comply with regulatory standards, it is clear that many quality control activities are not applied to "of f the shelf" or "non-saf ety related" equipment, materials, and/or components. This is most evident in a review of procurement activities. Con-sideration should be given to the application of quality assurance / control developed methods to all activities effecting plant reliability and availability.
NONCONFOPRANCE AND CORRECTIVE ACTION PROGRAM It is recommended that the following actions be taken in order to establish and implement a consistent and comprehensive _
noncont'ormance and corrective actica program within the
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organiza tion .
A. The number of forms being utilized by the various departments for the documenting of nonconformances, discrepancies and problems should be minimized. There are over ten (10) forms currently in use. The procedures for using the forms should be clarified so that it is clear under what circumstances each form is to be used.
B. Firm criteria should be established for the method of reporting nonconformances and/or discrepancies. The current program permits the use of lower level documents for reporting problems. Therefore, trends or major problems have the potential to go unnoticed or be disguised over an extended length of time.
C. The program should be expanded to encompass suppliers, contractors, and consultants, as well as the PGandE internal audit program.
TRAINING The indoctrination and training of personnel was f ound to be a general weakness throughout the various manuals and departments.
It is recommended that the existing program be modified as follows, in order to bring the program into conformance with 'TI industry practice and regulatory requirements. fhf s
A. Training programs should be initiated early in the employmen t period. We recommend that programs for CD continued updating of the training be firmly established. C1 LD A
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Z M :' O U a o ;> U Z Project Summary Report Page Four TRAINING (continued)
B. Department personnel, particularly should
- be trained in'a manner consistent with the responsibility / ,..
authority which has been delegated to the discipline i
engineers.
C. The qualifications and training programs for personnel performing audits should be modified to comply with the regulatory standards to which PGandE has committed.
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ENGINEERING DEPARTMENT MANUAL
SUMMARY
The Engineering Department Manual has been established in order to describe the design and engineering activities performed by the Engineering Department. In general, the department procedures comply with. requirements contained within the ,
PGandE Ouality Assurance Manual.
It is evident, however, that the following deficiencies exist with respect to the manual and procedures presently being utilized:
there is a lack of defined responsibilities for personnel within the Engineering Department, interfaces and controls within the Engineering Depa r tm en t , and between Engineering and other PGandE departments are not well defined, the minimal role which quality assurance has been given in performance of activities such as procurement document review, and program / procedure development and -
review, -
the role of the Engineering Department during the operations phase and its interface with the various technical review committee's is not adequately described, the lack of a comprehensive and well integrated corrective action program, a well defined system does not exist for assuring and verifying that all required documents are incorporated in the design program and that design changes, as necessary, are reflected in design documents, and with the exception of the piping design group and engineering quality control, department instructions for performing work activities are not current.
DEPARTMENT ORGANIZATION There are inefficiencics and/or lack of control which may result from the division of responsibilities between the Quality Assurance Department and Engineering Department. Two major examples of this are:
- 1) Quality Assurance and Engineering QC are performing internal PGandE auditing activities. This results in duplicate administrative efforts being accomplished for "I3 audit scheduling, corrective action programs, and hh training of personnel. _,
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- 2) Pre-award supplier quality assurance programs are received and approved by the Quality Assurance Department while post-award supplier procurement control is accomplished by Engineering Quality Control and the discipline engineers. QA therefore, is eliminated from the review cycle after contract award, and this may result in a lack of continuity for ,
controlling procu,r e, ment.
J-QA PROGRAM, PROCEDURES / INSTRUCTIONS The Engineering Procedures have the following weaknesses:
Within individual procedures, the " Purpose," and
" Scope" sections and the title are inconsistent and do not describe the actual scope of the procedure, There is a lack of clearly defined responsibilities and scope within the individuals procedures. This is a result of the use of terminology such as, "as appropriate," and "as specified", and The identification of interfaces be. tween Engineering and other departments is not well defined. This could be improved substantially by including a reference to other department procedures both within the text, and as part of.the " reference" section.
TRAINING Procedures delegate a great deal of responsibility to discipline engineers in areas such as design interface control, procurement, document review, and nonconformance resolution and disposition. It is not evident, however, that the training program adequately covers such topics.
DESIGN CONTROL The manual does not provide procedures to assure that all design documents are controlled and integrated into the design control program. Procedures and responsibilities for t controlling and incorporating field change documents, such as j Minor Variation Reports, and engineering programs (Systems Interaction Program) into the design process are not clearly established.
The role of the Engineering Department in implementing plant modifications during the operations phase, nor their interface with the various technical committees is not described within the pr ocedures.
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zH t U06 ba 05 PROCUREMENT AND MATERIALS CONTROL Engineering procedures permit the use of various documents for procurement of services, equipment and/or material. The criteria for utilizing each of the documents and the responsibilities for initiating, reviewing, and approving each is not well defined. .
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Responsibilities for procurement activities have been delegated to the various dicipline engineers. Since no central group exists for providing the interfaces, procedures / instructions should contain detailed requirements.
DOCUMENT CONTROL AND RECOFOS The scope of the manual with respect to the control of '
documents and records is not established. The existing procedures do not adequately describe the engineering interface with the Records Management System nor identify the various engineering documents and/or programs which have been utilized on the project. This would include, for example, the Systems Interaction Program, engineering ccmputer inf ormation, letters ~
of design delegation, field "as built" criteria, and special procedures / instructions.
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ITEM NUMBER X X X 1A-EDM-028 i
X X 1B-EDM-001 IB-EDM-004 X X X X IB-EDM-011
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1B-EDM-013 X X IB-EDM-016 X X X IB-EDM-017 X X IB-EDM-018 X X X 1B-EDM-019 IB-EDM-020 X X X 1B-EDM-021 X X --
1B-EDM-022 X X f IB-EDM-026 1
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X- X 2-EDM-002 2-EDM-006 X X X 2-EDM-008 X
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IDE IFICATION: MMU &bCUME cv No.)
Revi er: . Stock EDM, Section 10, Corrective Action, Rev. 3/15/82 EDM, Proc'edure 10.1, " Discrepancies" Date: 4/29/82
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Attachment:
PROBLEM STATEMENT:
The theirEngineering corrective action Department Manual (EDM) does not have a procedure adequately describing system.
Behind the " Corrective Action" tab of the.EDM is ,
Procedure 10.1, " Discrepancies." This procedure is really part of the Nonconformance Section of the EDM. This procedure does not describe how Engineering meets the e
requirements established in the Quality Assurance Manual for a corrective action system.
REFERENCE REGUuTORY REQUIREMENT: (Rev. No. or Date)
QA Manual, Policy Section XVI and Procedure 10.1 RESOLUIION/ COMMENT:
EDM, Procedure 10.1 should be included in Section 9 of the EDM, "Nonconfor=ances" Procedure (s) to establish the corrective action system should be written which includes responses to NCR's, open items, and Discrepancy Reports. This procedure should also disctss
) hov QA audit findings are closed out and Engineering Department responsibilities with regati to QA audits.
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' IDENTIFICATION: MA50AIN Db
.r.N ( v.bo.3 Reviewer:f*J. Stock EDM - 12.1 " Internal Audits" Date: 5-6-82
, EQC - Implementing Procedure 1.1
Attachment:
PROBLEM STATEMENT: --
Procedures for-lead auditor 12.1 qualification.
and 1.1 do not describe the certification and evaluation requirements necessary The requirements are not referenced or included in the ,
white book either and therefore are not in compliance with ANSI N45.2.23.
e s REFERENCE RECULATORY REQUIREMENT: (Rev. No. or Date)
Rag. Guide 1.146 Implements ANSI N45.2.23 " Qualification of Auditors" RESOLUTION / COMME.NT:
The recommended action is as follows: Expand Implementing Procedure 1.1 to cover the auditor qualification program and reference 1.1 in EDM 12.1.
I Also, establish the QA Department as having responsibility for developing and maintaing the qualification of auditors and the audit program for all departments. -
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IDENTI.FICATION: MANUAL & DOCUMENT (Rev. No.) Revievar:FJ. stock QAP 1.1 Training of Personnel Date: 5-5-82 EDM - 2.2 - Engineering Personnel Indoctrination and raining (7/78)
Attachment:
PROBLEM STATEMENT:
QAP 1.1 establishes guidelines for proficiency and skills training of department personnel.
Engineering Procedure 2.2 does not establish similar requirements within the Engineering
- Dapt. for development of training schedules, upgrade proficiency, scope of training, reviews, etc. '
s Review of individual department manuals (Mech., i.e., Civil) does not indicate any consistent approach to proficiency / skills training.
REFERENCE REGULATORY REQUIREMENT: (Rev. No. or Date)
RESOLUTION / COMMENT:
Procedure EDM 2.2 should be updated (presently revised on .7/78) to reflect QAP require::ients.
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. ".. Reviewar: F. Stock EQC Implementing Procedure 3.5 Date: 5-11-82
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Attachment:
PROBLEM STATEMENT:
Procedure makes reference to IFR (Item for Review) procedure as part of corrective-action program; however, no procedure is currently included in the EQC Manual or the Engineering ,
Dapartment Manual. .
A REFERENCE REGULATORY REQUIREMENT: (Rev. No. or Date) 10CFR50, Appendix B, Criterion II RESOLUTION /COMMEhT:
A procedure to establish requirements and criteria for use of IFR should be developed and distributed.
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V Oa 6 a i I IDENTIFICATION:, MANUAL & DOCUMENT (Rav. No.) Reviewer: F. Stock Engineering Department Procedure 1.1 - Organization Date: 5-11-82 -
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PROBLEM STATEMENT:
Responsibilities of vice president - Engineering and " Nuclear Project engineer" are not consistent with QA Manual and other references such as the NPG Manual. ,
Procedure 1.1, paragraph 3.2.2, indicates that vice president - Engineering may designate a s-single engineering department as responsible for coordination of engineering work for a given jcb. This conflicts with the QA Manual Policy Section I and NPC Manual since the manager-Nuclear Projects is assigned this responsiblity.
Tha "Nuc1 car Project engineer" referenced in EDM Procedures is not defined with respect to the Engineering and/or Nuclear Project interfaces. This position's responsibilities are
- not clearly defined.
REFERENCE REGULATORY REQUIRDfEh7- (Rev. No. or Date)
QA Manual Policy,Section I, Crganization RESOLUTION / COMMENT: 1
- 1. Procedure 1.1 should be revised to reflect current organization and role of Nuclear s Projects Department with respect to the Engineering Department.
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a 2. The responsibilities of the " Nuclear Project engineer" should be clearly defined.
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IDENTIFICATION: EEU & DOCUME. hev No ) O Reviewer: F. Stock Engineering Department Manual, Procedure 6.2 " SUPPLIER Date: 5/18/82 DOCLHENTS 7.ngineering Department Manual, Procedure 7.1 - Quality
{RequirementsforProcurement"
Attachment:
PROBLEM STATEMENT:
Procedures do not describe the method or system for identifying, controlling, and approval of supplier documents and procedures.
Items such as the following are not described:
. QA and/or QC role in approval of supplier documents
. Review criteria / checklists for Engineering /QC approval '
. Control for release to manufacture, fabricate (interfaces are necessary) .
. Msthod for verifying that all procedures / documents have ultimately been submitted prior to installation htEFERENCEREGULATORYREQUIREMENT: (Rev. No. or Date)
QA Manual Policy Section VII, " Control of Purchased items and Services" i
- RESOLlrrION/COMMEhT:
Revise applicable procedures to establish system for coritrolling the review and approval
'of docu=ents. .
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IDE! IFICATION: MA AL & CUMES ( ev. No. Reviewar: F. Stock EDM - Procedure 11.1 " Files and Records Date: 5/4/82 k,.EQCM '- Procedure 1.11 and 1.12 - Files and Records
Attachment:
PROBLEM STATEMENT: .
EDM Procedure 11.1 does not adequately address / define those engineering records which are part of the system. Since there is no QAM procedure covering records, this procedure basically stands on its own and'contains no references to ANSI N45.2.9 or other baseline documents. -
The info contained in EQCM 1.11 is only part of the overall system.
EDM 11.1 makes reference to a future RMS; this wists at present. This procedure is over
! 3 years old and should be revised.
REFERENCE REGULATORY REQUlREMENI: (Rev. No or Date) ,
l RESOLUTION / COMMENT: -
EDM Procedure 11.1 should be revised to reflect current records system and include a list of engineering documents to be included in the syste=. It should be interfaced with the f~ RMS. -
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EQCM 1.11 and '.12 could be combined into 1 procedure.
i The documents in 1.11 could be included in EDM 11.1.
The estimate for revising the above procedures is 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br />. .
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. IDENTIFICATION: MANUAL & DOCUMENT (Rev. No.) Reviewer: F. Stock EQC Manual Date: 5-3-82
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Attachment:
PROBLEM STATEMENT:
Tha administration and control of the Engineering Quality Control Manual is not consistent nor in compliance with the procedures in the EDM, specifically 5.1 and 5.2. '
Examples of this are: .
. Procedure revisions not identified on pages of EQC Manual ,
. Use of lines to denote change are not consistent with EDM
. Procedure for=ats are not consistent within EQC Manual and are not in compliance with EDM 5.2 REFERENCE REGULATORY REQUIREMENT: (Rev. No. or Date)
Engineering Department Manual Procedure 5.1 - Implementing Procedures .
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RESOLUTION / COMMENT:
.( procedures for uniformity and conformance with EDM.
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y M / d Oa 6 a 1 'a I ID,ENTIFICATION: MANUAL & DOCUMENT (Rev. No.) Reviewer: F. Stock i Engineering Manual, Procedure 12.1, " Internal Audits" Date: 5/3/82 EQC Manual, Procedure 1.4, " Auditing" PROBLEM STATEMENT:
The referenced procedures indicate that audits shall be performed in sufficient scope and dspth to cover the entire program every 2 years. -
L The frequency is not sufficient considering the scope of the enginee, ring program. If a ,
t continuous monitoring / surveillance program was instituted, it may-be satisfactory.
However, such a program is not discussed / referenced.
i REFERENCE REGULATORY REQUIREMENT: (Rev. No. or Date)
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RESOLUTION /COMMEl.'r:
- It is recocmended that a program.to cover the entire program every year be initiated, and that surveillance / monitoring also be accomplished by EQC. -
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Attachment:
PROBLEM STATEMENT:
Method for approval of procedures is inconsistent and not being complied with.
Procedure 5.2 states that the Chiefs or Project Engineer are responsible for approving implementing procedrues. , P-1 in'dicates that the Chief M and NE or his delegate is e responsible for approval of the Piping Group - procedure. Review of the Piping Group ,
procedures show approval by the following individuals: Piping Design Coordinator, Lead Pipe Stress Engineer, Support-load Data Supervisor, Pipe Support Review Supervisor, and Supervising Engineer. ,
Although letters of delegation may exist in these cases, it does not show evidence of a controlled system. (distribution list, review and updating, acknowledgement of receipt, etc.) +
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' IDENTIFICATION:
MANpAL M DOCUME!qj O l 7 Reviewar- F. Stock T.nginaaring Dzpartment Manual, Procedure(FO. /.1, .) o.h ,,QA Require-
' uni:s 'for Procurement" Date: 5/17/82 -
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Attachment:
PROBLEM STATEMENT:
The division of responsibilities for review / approval of supplier QA programs and the conduct of plant surveys and inspections is inefficient since it requires complex coordination of the interfaces between the departments in order to perform effectively.
In addition, satisfying the requirements for training and qualification of personnel from both groups, under two different program's,:is also inefficient.
REFERENCE REGULATORY REQUIREMENT: (Rev. No. or Date)
RISOLUTION/CO E NT: . . .
Plant surveys / audits, which are normally program reviews, should be conducted by the QA department, since Engineering will not be f amiliar with the QA program aspects of the supplier.
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IDkNTIFICATION: !d &bCUMEh ev No ) Re e r:
F. Stock Engineering Manual - Section 3 " Design" Section 5 " Procedures" Date: 5/19/82 Attach =ent:
PROBLEM STATEMENT:
There is evidence of documents / procedures being issued by Engineering which effect design control activities, but have not been issued in a controlled manner. These documents /
proce,dures have not been referenced or included within the scope of the Engineering ,
Manual or other applicable manuals. ,
d Examples are as follows:
- 1) Procedure for Final As-Built Approval of Pipe Supports was issued uncontrolled and unapproved on 5/12/81 - requirements contained within the procedure were not included in applicable Engineering or General Construction procedures.
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- 2) System Interaction Program contains requirements which affect the design control , ,
pro' gram - new document such as the Action Request Transmittal (ART) has been introduced but no reference to the Program is included in Engineering Manual. i REFERENCE REGULATORY REQUIRE 2ENT: (Rev. No. or Date)
QA Manual Section III, " Design Control" : . '
QA Manual Section VI, " Document Control" .
RESOLUTION /CCMMEhT:
Engineering documents / programs which aff ect quality-related activities must be controlled since they are included within the scope of the PGandE Quality Assurance Program, i
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. ' s EDM - Section 3 - Design Date: 5-11-82 hr
Attachment:
PROBLEM STATEMENT:
Na interfaces and/or responsibilities of the Engineering Computer Applications Department are referenced within the Engineering Department Manual. ,
QA Manual,Section I, references the Engineering Computer Applications Dept [ Engineering &
D pt. role. However, the interface between the departments is not defined. Also, it is not stated that EQC has any control or audit responsibility over sof tware development and
- implementation.
REFERENCE REGULATORY REQUIREMENT: (Rev. No. or Date)
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RESOLITIION/ COMMENT: -
Since Engineering Computer Applications perfor=s quality and/or safety related activitiss,
, a QA Program should be established to encompass their scope of activities. This should be included / referenced in the Engineering Department Manual.
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, Reviewer: F. Stock EDM Procedure 4.5 - Contracts for Engineering Services Date: 5-10-82 k)
Attachment:
PROBLEM STATEMENT:
This procedure does not include requirements to assure that adequate control is established over engineering service contracts with respect to quality assurance / control. .
This procedure (1) does not include EQC or QA Dept in the evaluation process, (2) does not specify who deter =ines if QA is required (paragraph 4.21), and (3) states that "No QA requirements need be placed on the contractor if PGandE takes responsibility for design and procurement QA."
l These are examples of the minimal role EQC and/or QA play in the procurement of services process.
REFERENCE REGULATORY REQUIREMENT: (Rev. No. 'or Date)
Appendix B, Criterion VII Control of Purchased Material, Equipment, and Services 0
e RESOLIEION/ COMMENT:
i QA and EQC should be responsible for the evaluation of contractor engineering services, review of procurement for QA requirements.
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'rocedures should be revised to reflect this role.
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{ImplementingProcedure3.2,EMM's
Attachment:
PROBLEM STATEMEhT:
These procedures do not establish guidelines for when a procurement specification must be written, which specifications EQC reviews, or what in the procurement process is not done by specificaticns.
- Procedure 4.2 discusses t'he use of 'EM$1's for nuclear safety related ourchases when no '
specification is written. It is not clear when a specification is used and who has the authority to procure items in this manner. If a specification is not used, the methods and documents to be utilized should be discussed.
EMM Cuidelines, Procedure 3.2, indicates that "no" quality requirements be imposed on
" fire protection system" and " control room pressurization system '- this does not appear to be in compliance with technical requirements.
REFERENCE RECULATORY REQUIREMEhT: (Rev. No. or Date) f Appendix B, Criterion IV,' Procureme'nt ' Document Control
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RESOLLTION/CO.'^1EhT:
, Procedures should be rewritten to establish criteria for issuance of procurement is specifications and also identify documents to be utilized when this does not occur.
Guidelines for Quality Assurance requirements imposed in procure =ent documents must be established and delineated within the organization.
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IE'E! IFICATION: MA!dAL k DbCUMENh (hv.Sc.h U Raviewer[J. Stock
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'ED . nual - General Com:nent Date: 5-6-82 i
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PROBLEM STATEMENT: -
The NPC Manual specifies requirements for Diablo Problems (DP's) and Plant Design Co=ments (PDC's). .
The Engineering Design Manual does not establish or recognize the existence of these design control documents.
REFERENCE REGULATORY REQUIREMENT: (Rev. No. or Date)
NPG Manual Procedures D-444, III. B, D-444, IV. A 10CFR50, Appendix B QA Manual Policy V, lastructions Procedures and Drawings RESOLUTION / COMMENT:
l Engineering procedures sh'ould be established to define responsibilities for engineering interf aces with NPG and General Construction, PDC's and DP's. .
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