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a) To date , no specific person or persons , by title or name , are restricted access. QAI #4, Rev. O , approved 11/10/81 gave the re iponsibility for controlling access to the QA furchase Order /CMTR f1;Js to the Quality Assurance Manager. QAI #4, Rev. 1, dated 2/1/82 delegated that to the Quality Assurance Documentation Supervisor. QAI #4, Rev. 2,-approved 5/11/82 continued to recognize that responsibility as belonging to the Document Control Supervisor. A later Zack memo, dated 5/14/82 reiterated that access control remains a responsibility of the Document Control Supervisor. | a) To date , no specific person or persons , by title or name , are restricted access. QAI #4, Rev. O , approved 11/10/81 gave the re iponsibility for controlling access to the QA furchase Order /CMTR f1;Js to the Quality Assurance Manager. QAI #4, Rev. 1, dated 2/1/82 delegated that to the Quality Assurance Documentation Supervisor. QAI #4, Rev. 2,-approved 5/11/82 continued to recognize that responsibility as belonging to the Document Control Supervisor. A later Zack memo, dated 5/14/82 reiterated that access control remains a responsibility of the Document Control Supervisor. | ||
! b) With regard to physically handling the documents there were several l | ! b) With regard to physically handling the documents there were several l | ||
I posted memos as well as the letter dated April 16, 1982. One posted memo was issued 11/11/81, the second posted memo was issued 5/14/82. | I posted memos as well as the {{letter dated|date=April 16, 1982|text=letter dated April 16, 1982}}. One posted memo was issued 11/11/81, the second posted memo was issued 5/14/82. | ||
These memos cor.cerned materials leaving the document control room, where they were reviewed and whether copies are to be made for I review outside the documentation control area. | These memos cor.cerned materials leaving the document control room, where they were reviewed and whether copies are to be made for I review outside the documentation control area. | ||
: 4. Con.lusions: | : 4. Con.lusions: | ||
The posted memos cover hcw the documento could and could not be used, inside or outside the document control area. QAI #4 and the letter dated April 16, 1982 assigned specific responsibility to individuals relative to access control. There was no formal lis), by title or names, of individuals or groups that had no need-to-know or were excluded from access to the document control area. The informal controls should be incorporated into the formal Zack procedures. | The posted memos cover hcw the documento could and could not be used, inside or outside the document control area. QAI #4 and the {{letter dated|date=April 16, 1982|text=letter dated April 16, 1982}} assigned specific responsibility to individuals relative to access control. There was no formal lis), by title or names, of individuals or groups that had no need-to-know or were excluded from access to the document control area. The informal controls should be incorporated into the formal Zack procedures. | ||
F) "A company wide training program on documentation and records will be developed and implemented." | F) "A company wide training program on documentation and records will be developed and implemented." | ||
: 1. Action taken as of 10/23/81: | : 1. Action taken as of 10/23/81: | ||
Latest revision as of 19:10, 24 September 2022
| ML20094H485 | |
| Person / Time | |
|---|---|
| Site: | Midland |
| Issue date: | 07/13/1982 |
| From: | CONSUMERS ENERGY CO. (FORMERLY CONSUMERS POWER CO.) |
| To: | |
| Shared Package | |
| ML20094H471 | List: |
| References | |
| FOIA-91-187 M01-602-2, M1-602-2, NUDOCS 9203100304 | |
| Download: ML20094H485 (19) | |
Text
_ _ - - _ _ . .
- , PROJECTS. E NGINE ERINo e= = = e '
Powu AUDIT REPORT = co~$7:ucuoa-ouAuty Assu:ANCE DEPARTWENT g
C0mptly cA n 1 CATE cr IssvAscE 7/13/82 FA:r _1_ cr _4_
DIstnInunos:
WRbird HPleonard DATaggart F01-602-2 JE0 runner BWMarguglio RAWells nI2 aos >
DECalkins DBMiller ALAB-2 18.4.7 JWCook JARutgers DATs or AUDIT:
LEDovis MSkates Hay 17 through 20, 1982 MADietrich gSmith o m AsIZATIon AUDITrD GSKeeley RWSoderholm The Zack Cor.pany-Chicago SIO.OFAL'TTEAMLEADER/ DATER / APPROYT3 BY/DAJE .
PLAY! 6 TROJE:"tr b /Ac/MW NV/M- I e p/gr/82 Midland Units 1 and 2 I. SCOPE AND OBJECTI'VE The objectises of the audit were:
- 1) Verify the consistency of quality records among HPQAD-Midland Site , Zack Company-Chicago, and various Zack Company Suppliers by direct examination and comparison.
- 2) Determine the status of the implementation by Zack Company of the CAR-014 corrective action commitments established in the Corrective Action Report transmitted to MPQAD via Zack letter 7220-M-151-C/B-522, dated 10/23/81.
The audit secpe consisted of 114 Purchase Order (PO) record packages. The packages were selected from the 556 PO packages that had been reviewed and found, acceptable as of 5/14/82 by Zack-Chicago. Accepted PO's were chosen because they represented documents revalidated since the initiation of CAR-014, and because they were construed as providing a demonstration of the current effectiveness of the Zack document and records mar.agement program. PO's were purposely selected from Zack's Suppliers in the Chicago area to allow a comparison of MPOAD records with Zack-Chicago's records and the records of some of Zack's Suppliers. The PO's and Suppliers selected were as follows:
- 1) Delta Screw Compary - 7 PO's
- 2) Hobart North Welding Supply - 20 PO's
- 3) Weld Star Company - 14 PO's
': ) Jc:lyr. Manurecturing and Supply - 5 PO's
- 5) Brightly Galvanized Products , Inc. - 20 P0's
- 6) Ryerson Steel - 20 PO's
! 7) Miscellaneous - 28 PO's ,
i Copies of the MPQAD records were taken to Chicago and compared with the corresponding
- records on file in the Zack-Chicago Document Control Center. A comparison was made ,
to determine if the documentation was consistent within a particular package and between MPQAD and Zack-Chicago records. During this review Zack-Chicago contacted Suppliers chosen by MPOAD in the Chicago area and made arrangements for a review of ..
l' their material docum-ntation files. Three Suppliers were selected for comparison.
They were Weld Star Company, Ryerson Steel and Delta Screw Company, totaling 41 .
record packages.
l The scope of the CAR-014 review was to determir.e the status of the corrective action l commitments from the 10/23/81 report.
l 9203100304 910827 PDR FOIA ,
M
^/
ZACK91-187 PDR -/
' PT.oJEC T S. E NGINE E RING AND CoHSTRUOTION-
- ,, CC0!!!'83
. QA24-0 nr 2 y 4 II. IDENTIFICATION OF AUDITORS -s The audit war performed by the following personnel:
M Verderosa - Audit Team Leader (MPQAD)
G Parker - Acting Audit Team Leader (MPQAD)
III. PERSONS CONTACTED DURING THE AUDIT:
Audit Audit Name Organization Titl e Entrance Audit Exit C Zack DeZutel Zack President X X J DeZutel Zack Exec. Vice President X X D Calkins Zack Project Manager X X X D Malzahn 7.a ck Vice President X M Skates Zack Manager QA X X R Bastaga Zack Lead QA Engineer X X E Houk Weld Star Co. Manager Customer Sve. X J Berry Weld Star Co. QA Coordinator X J Latonia Delta Screw Co. Vice President X W Lawler Ryerson Steel Quality Assurance X K Sellars Ryerson Steel QA Manager X C Parker CPCo HVAC QAE Supervisor X X X M Verderosa CPCo Mech. QAE Supervisor X X X H McGrane Zack Document Control X l Supervisor I
IV. AUDIT
SUMMARY
- 1) Notification of the audit date, time and scope 1 provided verbally to Mr.
( D Calkins of Zack and is. R W Soderholm of Bect, by H P Leonard of HPQAD on 5/11/82.
(
l 2) The audit checklist was developed to compare record package information for any i discrepancies among the Zack-Chicago, MPQAD-HVAC QA and Zack Supplier material l d6c0m'ntation.
e The CAR-014 portion of the audit was developed from the 8 l commitments identified in the CAR Report.
l l 3) An audit entrance meeting wLs held on 5/17/82 with personpel in attendance as l noted in paragraph III. The scope , plan and tentative schedule were discussed.
Contacts for the various phases of the audit were identified. Zack was requested j to contact the representatives from Ryerson, Delta Screw and Weld Star companies l for the purpose of reviewing their records, i
- 4) Daily meetings were held with senior Zack Company personnel to keep them appraised b of the audit progress and potential findings.
- 5) The audit resulted in 3 findings which are attached to this report.
i
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_ _ m. . . . _ _ . _____. _ _ _ _ _ _ . ___ _ - . _ . . . . . __. -- . - . . _ _ - -
g* PROJECTS. ENGINEERING
- AND CoNsTEUCTioN a COMSU gm -
ouALITY AssumANct Of>ARTMENT 90wti J ~
< Company umt n M01-6024 e .o o ._
- 6) The following observations were made as a result of this audit: ..
i
- 1. The review of Zack records identified some documents where changes to documtnts appeared to have been made. While consistency between the MPQAD records and Zack records was verified in mil cases, Zack should consider requesting from the appropriate Supplier, a new copy of the noted documents.
Those documents are as follows:
a) C-4451 - Delta Screw , chemical analysis , %1, e out" utilized.
b) C-4349 - Hobart, blurred type for lot number X4817L309L. .
c) C-1385 - Brightly Galvanizing /US Steel Supply, hand written properties on verification for 4" by 4" by !" tubing.
d) C-949 - Central Steel and Wire, hand written values for each certification of heat - 85332.
No response to this observation is required.
- 2. A review of Ryerson Corporation files identified 3 out of 20 purchase orders for which Ryerson was unable to provide supporting documentation at the time of the audit. Those were C-1076, C-1272 and C-1768. Ryerson agreed to locate these documents and provide them to Zack. MPQAD will verify acceptability at that time (AI: S-1602, priority 8. DCUMOO). .
- 7) The audit exit meeting was held on 5/20/82, with those in attendance as noted in paragraph III. At that time, the 3 draft audit findings and- 2 observations were t
presented and discussed. The results of the CAR-014 review were also discussed.
(See attachment for details of CAR-014 review. )
- 8) Responses to the audit findings and observation are to be forwarded to MPQAD- '
I V. EVALUATION OF EPPECTIVENESS
- 1) This audit verifying consistency among the MPQAD-HVAC QA, Zack-Chicago' and Zack's Suppliers record packages , resulted in identifying 9 nonconforming documents.
The nature of the nonconformances allawed grouping them into 3. findings. 3 items l each finding. The 9 nonconforming documents were individual misses in each of l the 9 record packages. From- 114 packages , approximacely 500 to 600 documents were reviewed, usually for several characteristics on each document. The misses were not discrepancies relating to.the' data describing th'e material, but were the lack of QA or purchasing signatures. However, other documents in the associated package , had the necessary r eview and approval signatures indicating that the nonconformances may be classified as-signature oversights, rather than the absence of intended reviews. Although 6.he misses are legitimate nonconformances ,
the document and records control function appears to be providing documentation -
that the material provided by-the Supplier. meets the requirements of Technical Specification 7220-M-151A. .
I j
- 2) The following is a summary of the 8 commitments specified in the 10/26/81 report.
They are identified by the ap1ha characters A through H, consistent with the designators in the attachment to this audit report.
/
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I PKoJECTS ENGlhEERING
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AND CCH37AUCTeoN =
- C00$MM OVALITY AS$URANCE oEPAjlf MEh?
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. QA24,0 ca:rmutus sm; "" "' N01-602-2 -
m 1 er _it a ,
t Actions have been initiated for each of the commitment items.
A) Items A and B were not completed by the commitment date(s) established and-have not been completed to date.
I B) Item C was partially completed , but no satellite records center at Midland has been established.
C) Items D and E have been addressed through PQCP's, QAI's and Zack Company j.l memos. ;
j D) Items F, O and H have been completed. Item F however, was initiated several months late.
E) Partial resolution for items B, D and E in the form of Zack Company memos ,
PQCP's and QAI's has provided, adequate results in terms of an improved document and records management program. However, this method of records management should be amended to incorporate memos , letters and other
-informal forms of control into the formal Zack procedures.
Continued effpet will be required to complete the commitment actions established rela?.ive to CAR-014 At the time of this report, no new commitment dates have been established.
- 3) At the time of this audit , the Zack Document Control group and QA Engineering were going through training and indoctrination (many of the po?sonnel are new to Zack and document control as related to nuclear construction). It was recommended at the exit meeting that the training these people receive continuously emphasize :
the importance of quality records relative to the end objective, e.g., to '
provide sufficient assurance that the HVAC system will function correctly and safely during nuclear operations. ,
VI. LIST OF ATTACHMENTS
- 1) CAR-Olu , Review of Corrective Action Implementation
- 2) Audit Finding Reports H01-602-2-01 through H01-602-2-03 ' "
- 3) Audit Plan (file copy only)
- 4) Completed Checklists (file copy only) ,
- i 4
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i PRIORTTY? 0 TREND: N6 Sust to Muu_ su t a-ious C moJtets. tNo4NCE21NQ A,ND CoNST.tuCTioN =
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H01-602-2-01 l Zack Co. procedure - QA Instruction #4, Rev. O , " Control, Content u,u,. .astw, l
and mintenance of QA Purchase Order /CMTR Files" paragraph 6.3 1 73cp re.m ny . em e.gn states in part, "Following receipt of the listed documentation ' ass or inwr.t.
(CMTR/C of C) the Document Control Clerk shall attach original and 7/13/82 copies in numbered binder,a tus r.sessi l
umaami Contrary to the above , the following PO's lacked the identified WRBird DATaggart CMTR information: JEBrunner RAWells DECalkins ALAB-2 C-4044 - Qo-5,5C (certification) page 1 dated 9/16/80 JWCook
. t-580 - 500 #E6011 heat 102220 certifica tion LEN vis l C-801 - Reliable Galvanizing Certification - Invoice 31777 MADietrich OSKeeley Each of these documents was located in the HPQAD files. HPleonard BW&rguglio DBHiller '
JARutgers MSkates ESmith RWSoderholm newaaa unaurs aan,
( Obtain copy of the above documentation and include in the Zack files.
1 .
G6TIVs acT&ce cushIntJrt e A response to this item is requested by 8/6/82.
um or cas ows.sttens eaa use a casi ram mum ces cweesnti uti or c/s unetmrusi The Zack Company Nrk Skates-l IELTMoD of 713UI3T1DRi 1
1s &F SDJrtASM FLM N.))te ji &F 'Is4* EdT3 of REPWT TO SC:
u w , roe or urcer to me, a rse , m s or oc omcIn to vmm anwro l
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a ms , vm mos unari ara c=>cir rp neursiuarts , wavison s sicprm .
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i (' PROJECTS,(>4G4NEERINo AND con 5fnUCTioN + COntumtr5 .. ,,
/ um QA50 1 AU ) -
\ )l \ G E. 01.. ouauTY ASSUa&NCE o(P
. m emnm was as awau en nazir emnm m armacui lm m mi Zack Co. procedure PQCP-15 " Procurement for Items used in Fabrica- a M01-60?-P-0?
tipn and Installation of Zack Work" Rev. 1, paragraph 6.9 states ""'"*""' in part , "after the P.O. is prepared. . .the Purchasing Agent signs nnv - Ne [aek g, ,, the P.O...." Also , paragraph 6.11 states in part , "The QAM stamps 7fnfgp the PC. He signe and dates . . . " ,,,,, man, 18.4.7 Contrary to the above, the following PO's lacked the identified "*"S**' reviews / signatures: WRBird DATaggart JEBrunner RAWella C 4344 - Purchasing Agent signature DECalkins ALAB-2 C-1727 - Purchasing Agent signature JWCook C-1476 - QA review / signature LEDavic MADiet rich GSKeeley HPLeonard BWMarguglio DBM111er JARutp: s MSkates ESmith RWSoderholm ucumaun svnam scru, Appropriate individuals review PO's and confirm document acceptability (signature). l l . _mm. _ A response to this item is requested by 8/6/82. l un er ces cc mra, cao. as , a e/4. enom mano sea cenert, un or e/s emerrmaasi lhe Zac'k 'Corapany Mark Skates'
. mon or mmurmi l
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a rrr . ros or u m t a me a ns , n..e or oc cencus a vuca aimmi N/A a rss , wwo mos sacer . are camr.4 *s :ca.evisiaan, curunson s sicumu4oni A,aMLw2riat sdb. ML4 man,m un, z4ss2 n,-, i < e,,m y,y . A. m.: 9 ee--? v-s w r r----w--se--w-.a- e-mv -e P--eer----sT* w v 'r W w e e, =wr -trw-w*- vv--=t vwe*y,-w,yp m-y y w y.vvy7yw f - dv=~t4-gMy-gy- w m> w ,+ p-e w ++ sur e-= ww-+-g-u=-e t --t Fv " T *gr* t sw*--~,wg"- - "' g *P#w mW w 9 -*TgM se tr e-*
.- . . ~ . . - . . . . . . . .._ .- . - . - . . . . . . _ . . _ .. _ . . . . . .. . _... . .- . . . - . . . . ~. . _ __~ --.
PRIORITY: 9 THEND: Nb SUS? Di'U MOU al; d-tov 5 PfGJtcT&, ENGINEEK143 AN) CoNSTituCTloN
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Consumers .. . ? % QAso.1 AU ) - l N J I \ G b 01.. ovauty AssuuNes oceAarucNT as ts" cuic:me rosa as awus / as auto countica n sava ui ars am noi H01-60?-2-03 Zack Co procedure - QA Instruction #4, Rev. O , " Control, Content ruiput ammi , atfd Maintenance of QA Purchase Order /CMTR Files" paragraph 6 3 1 zack comnany - ch t eue
- states , in part , "following receipt / acquisition of the listed **n or
- 5 5"L a documentation (CMTR/C of C) the DC Clerk shall... deliver to QA 7/13/02 Engineer for review / approval. Following review / approval by QA amm 18.4.7 Engineer... attach original and copies in numbered binder." umssuttai WRBird DATaggart Contrary to the above , the following PO's contained unsigned CMTR's JEBrunner RAWells as noted: DECalkins ALAB-2 JWCook C-1515 - Heat 85313, 84898 - MPQAD copy only LEDavis C-1228 - Heat (various) chemical / physical test results - MADietrich MPQAD and Zack copy CSKeeley C-4327 - C of C E6011 3/32" - MPQAD and Zack copy HPLeonard BWMirguglio DBM111er JARutgers MSkates ESmith RWSoderholm amor.o mancin acm.,
QA review and approve as required. i l CaascTivs active cureiJTraJrt 4 A response ** *.his item is requested by 8/6/82. nar cr en constrani , an. ase sua cui rasos mann esa c' c omi l ~~ oars or c/a arriersvnessi + 1he Zack Com'pany ' Hark Skates
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b - ( ( , Attachmant #1 ,
' Audit M01-602-2 Page 1 of 11 s
CAR-014 REVIEW OF CORRECTIVE ACTION IMPLEMENTATION The CAR-014 reput't attached to Zack letter 7220-M-151-C/B-552, dated 10/23/81, identified 8 areas where corrective action was to be implemented to preclude the following discrepancies in Pldland Project Material Certification Record Packages:
- 1. Incomplete material test reports.
- 2. Incorrect material test reports.
3 Improperly modified test reports. 4 Possibility of individual (s) within The Zack Company improperly changing test reports. This audit report identifies those 8 areas , the completed activities- as of 10/23/82, what corrective action is planned and the status as of this audit. 4 A) "All existing procurement documentation will be revalidated for compliance to contract technical specifications and other design data."
- 1. Action taken as of 10/23/81:
"A documentation task force , consisting of 6 persons , has been assembled.
This group has just completed a review of all known or available purchase orders and documentation for the three projects. A-centralized filing-system has been established and detailed quality assurance instructions have been developed for records and receipt inspection."
- 2. Scheduled completion identified as of 10/23/81: .
"A follow-up program to obtain the missing certifications or corrected certifications from Suppliers , is scheduled for December 31, 1981."-
. ~~ ..a Status as of 5/20/82:
3 4 a) As a result of the initial r3 view, approxisat.ly packages were acceptable-in the conditior.-thuy we,30% re filedof inthe-record when e reviewed. Since-the' initiation of the figliow-up program, approximately 50% have been made acceptable._ Aac9t 125 have been-worked through ~the follow-upf program, but efforts pere not aussessful~ in obtaining the necassary signatures or back-up dLta.. Record packages in that condition have been identified to_ dechtel via SDDR's. . The 'SDDR . > usually describes the material inso1Ved, the information that is available, describes what was done and_what_was not obtained, then 1 requests'that Bechtel accept as'is. Eight percent (8%) of the-packages are sti11' working through the follow-up program and are waiting for information from the respective Supplier. Some of the m 6 . -w w.ph-re q+t'- * -- e a 4-*g p- , ______A.x - - - - " - - - - - - - - ' -
i f l Attachm3nt #1 Audit H01-602-2 Page 2 of 11 8% will fall into the category of not having enough information and not being able to obtain enough information, and will be processed via SDDR 's. A portion of the 8% is expected to be found acceptable and will be added to the list of acceptable material. As of May 17, 1982, 115 SDDR's identifying material for which insufficient infor-mation was available, sere forwarded to Bechtel. Resolution of those SDDR's is still pending, b) A centralized filing system and quality assurance instructions are l addressed in subsequent sections of this attachment. i
- 4.
Conclusion:
The documentation task force was formed and began the follow-up program activity. The scheduled completion date , December 31, 1981, was not met. Although the follow-up program has cleared 80% of the packages , 20% are still outstanding. The program will have to remain in effect until these 20% are resolved. No date has been established by_which the 207 will either be identified as unacceptable by Zack and Bechtel, or as finally acceptable through Supplier information or Bechtel Engineering acceptance. The revalidation of existing procurement documentation is on-going and has not been completed. B) "A document and records management program will be developed and implemented."
- 1. Action taken as of 10/23/81 - none.
- 2. Scheduled completion identified as of 10/23/81:
"A document and records management program will be completed and
- implemented by December 31. 1981."
l 3 Status as of 5/20/82: a) No formal document and records ranagement program was completed or implemented by December 31,198't. No formal d6cument'and records' "~~ management program had been completed as of 5/20/82. Dave Calkinr has stated that no forr.al program was developed due to a Zack Management decision to utilize. the available man' power to resolve material documentation problems versus setting up a formal program. (No formal documentation was issued regarding this decision. ) l However, Mr. Calkins considers that issuance- of Quality Assurance Instructions (QAI's), existing PQCP's and other related letters and l memos placed sufficient controls on document and records management effort. b) The following is a list of the documents referred to by Mr. Calkins: l 1. QAI#3,RecordsManagement[Rev. 1, dated 5/11/82.
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( " j ( Attachm2nt #1 Audit M01-602-2 l Page 3 of 11
- 2. QAI #4, Control, Content and Maintenance of Purchase Orders and CMTR Flies , Rev. O , dated 10/26/81, Rev. 1, dated 2/1/82, Rev. 2, dated 5/11/82.
3 QAI f 5, Quality Records Index , Rev. O , dated 5/11/82.
- 4. QAI #7, QA Records Storage, Rev. O, dated S/14/82.
- 5. PQCP-15, Procurement , Rev. 2, dated 5/18/81.
- 6. PQCP-1, Receiving Inspection , Rev. 2, dated 11/24 /81.
- 7. Zack letter to all cognizant personnel, from C L Eichstaedt, Jr.
dated 11/4/81, regarding purchase requisitions and purchase orders for nuclear projects and commercial operations. c) As a result of CAR-014, Document Control was placed under the responsibility of the QA Department. Since then and up until May - 1982, the QA Department, under the QA Hanager, was responsible for Document Control. At the beginning of May, 1982 the responsibility for the Document Control group was changed from Quality Assurance to Engineering. QAI's , PQCP's and possibly some other documentation will be reviewed for applicability to the Document Control center as a part of the Engineering orgenization. Zack is considering developing some document control instructions directing the functions of the Document Control under Engineering. QAI's and PQCP's will be revised to recognize Document Control as a quality records stoarge area meeting the requirements of ANSI and 10CFR50. Howeser, QA will not be the organization that manages Document Control. QA will continue to revieu purchase orders, material documentation and other quality documents prior _to storage. QA will also be responsible for verifying (auditing) that document control is being implemented in accordance with ANSI and 10CFR50.
- 4. Conclucicn: .--
l a) A document and records managesent program was not completed nor i implemented by December 31, 1981. b) As a result of a review of the documents listed above, it was I concluded that document and records management was sufficiently , under control with the QAI #4 document and letter, item number l B.3.b)6., PQCP-15.and PQCP-1. Although producing adequate results, this method i.e., company memos, should be amended. Memos, - letters and other forms of informal control should be incorporated into the formal Zack procedures. . l I l e v U &5 +' C
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f Attachment #1 Audit M01-602-2 Page 4 of 11 C) "A centralized documentation group and center will be established with specific guidelines."
- 1. Action taken as of 10/23/81:
"A centralized Document Control Center is in the process of being constructed and satellite centers will be established at each of the sites."
- 2. Scheduled completion identified as of 10/23/81:
"The centralized documentation group will be made up of the Zack Company personnel presently assigned to the documentation task group now in effect. The centralized document center should be completed by November 30, 1981."
3 Status as of 5/20/82: A centralized document ocntrol center was formed on or about the end of November 1981. A separate room was identified for the document control center and is located on the first floor near the main entrance. The task force group which had been formc1 to address CAR-014 became the Document Control group. The original Document Control group functioned until the end of April 1981.- At that time, it was disbanded and reorganized , about three days later , under new supervision. Within a week, four new l clerks were hired, training of the new personnel was begun, and the Document Control group was removed from the QA organization and placed in the Engineering organization. Consistent with the new organizational arrangement , the document control center is *being relocated to the l second floor. The new location is expectsd to provide more storage area , more space for clerical work and more workable access control. Relocation of records and documents is expected to start on or about 5/24/82. In addition Jentralized document control center at the Zack-Chicago fccility,a .a131ta center.was to be estab)tshed at.gach.qf the site,s.
- With regard .o the Midland Project, no satellite center related to the Zack-Chicago document control center has established. .
4
Conclusions:
a) A centralized document control center was established by 11/30/81. b) A centralized documentation group was organized, formed from the personnel assigned to the documentation task force. + c) No Zack satellite documentation center was formed at the Midland Site. t 4
- +
~
V ( ! l Attachmsnt #1 Audit H01-602-2 ! Page r of 11 -> l D) " Procurement procedures and receiving inspection procedures will be developed and/or revised to include required quality review functions."
- 1. Action taken as of 10/23/81:
"All_ purchase orders and mateaial certifications are now being reviewed by a newly established Quality Engineering Group at The Zack Company Chicago offices. "
- 2. Scheduled completion date set as of 10/23/81:
.\
"No further action required."
3 Status as of 5/20/82: a) Procurement procedures are established in PQCP-15 " Procurement" Rev. 2, dated 5/18/81. Additional procurement instructions are provided in a Zack Company letter to all Cognizant Personnel from - C L Eichstaedt, Jr., dated 11/4/82. b) Receiving inspection procedures are established in accordance with PQCP-1, " Receiving Inspection" Rev. 2, dated - 11/24 /81. Additienal direction relative to material documentation is also addressed in the Zack Company QAI #4, " Control, Content and Maintenance of QA Purchase Order / Certified- Material- Test neport files" Rev. O, dated 11/10/81.- t c) The procedures and instructions listed in D.3.L) and'b) describe the- _ [ QA Engineer interface between procurement, receipt inspection and L document control. The quality review function, relative to the actual review point by point of the information in CMTR's , Certificates l I of Conformance or Compliance ,-and other material- documentation ic not described in these procedures..
% .Cor ilusing: _ _ _ _ . ,, .
a) The existing PQCP-15 and revised PQCP-1, as well as QAI #4 and ' the , Zack memo to all cognizant personnel, describe th>J QA function with relation _ to document control, procurement and re6eipt inspection. Although producing adequate results, this method 1.e., company memos, should be amended. Memos, letters and other forms of informal control should be incorporated into the formal Zack procedures. A: description or checklist of items and information which the- QA Engineer is required to review should also' beLincluded. . b) The newly established = Quality Engineering Group referred to in D.11 . . above , is a group that was formed in June of- 1981 and was
- functioning by the report date,,10/23/81. -
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Attachment #1 Audit M01-602,2 Page 6 of 11 w E) " Unauthorized personnel will be limited from access to recorda."
- 1. Action taken as of 10/23/81:
"All document packages revalidated are in locked file."
- 2. Scheduled completion date set as of 10/23/81:
" Completion of the centralized document center discussed above will put all records under locs and key and will limit access to only authorized personnel. This will be implemented by December 1,1981. "
3 Status as of 5/20/82: a) To date , no specific person or persons , by title or name , are restricted access. QAI #4, Rev. O , approved 11/10/81 gave the re iponsibility for controlling access to the QA furchase Order /CMTR f1;Js to the Quality Assurance Manager. QAI #4, Rev. 1, dated 2/1/82 delegated that to the Quality Assurance Documentation Supervisor. QAI #4, Rev. 2,-approved 5/11/82 continued to recognize that responsibility as belonging to the Document Control Supervisor. A later Zack memo, dated 5/14/82 reiterated that access control remains a responsibility of the Document Control Supervisor. ! b) With regard to physically handling the documents there were several l I posted memos as well as the letter dated April 16, 1982. One posted memo was issued 11/11/81, the second posted memo was issued 5/14/82. These memos cor.cerned materials leaving the document control room, where they were reviewed and whether copies are to be made for I review outside the documentation control area.
- 4. Con.lusions:
The posted memos cover hcw the documento could and could not be used, inside or outside the document control area. QAI #4 and the letter dated April 16, 1982 assigned specific responsibility to individuals relative to access control. There was no formal lis), by title or names, of individuals or groups that had no need-to-know or were excluded from access to the document control area. The informal controls should be incorporated into the formal Zack procedures. F) "A company wide training program on documentation and records will be developed and implemented."
- 1. Action taken as of 10/23/81:
No action taken to date.
, - - _ w a--- 7
~
+
Attachment #11 Audit M01-602-2 i' Page 7 of 'l
- 2. Scheduled completion dates set as of 10/23/82: '
"A company tr:4ning program on documenAntion will be completed by '
February 15, Ms2 and training will follow within four (4).wecks. 3 Status as of 5/20/82:
- 4 a) The following training sessions were held:
- 1. Date: 8/31/82
Subject:
10CFP/ ANSI Attendees: K Schaefer , QA - Engineer; C Richards , QC Manager; G Kollaritsch. Drafter; - A Wanniger, Engineer; . J Q'Connell, QA Engineer; E Bodley , QA Engineer; J Engh, Production; S Drozez, Drafting; N Rosa, Production; B Prim, Production; T Boyle , Production; R Greune , Engineer; C Z DeZutel, President - Zack; J C DeZutel, Executive Vice President; D Malazahn, Corporate Secretarf.
- 2. Date: 9/3/82
Subject:
PQCP-15 Attendees: S Drozez , Drafting; D Prim . Production; R Hagen, Purchasing; G Kollaritsch, Drafting; E Bodley, QA Engineer; J Engh , Production; C Richards , QC Manager; N Rosa , Production; J Micha11k, QA Inspector; A Wanniger . - Engineer. 3 Date: 11/18/81
Subject:
QAI #4 and ANSI-45.2.9 Attendees: T Howard , Document Control Supervisor; S Mare 11o , -Document - i Control Clerk;
- 4. Date: 12/30/81
Subject:
PQCP-1, Rev. 2 Attendees:- C Richards , Inspector; J Michalik, Inspector; N Rosa, Plant Superintendent.
- 5. Date: 2/17/82
Subject:
QAI #4,- Zack QA Manual Attendees: R Perry , QA Engineer Documentation.
- 6. Date: 4/27/82
Subject:
Proper- Flow of Documentation - Attendees :
;D Allbritten, QAE; M Cione , Document Control Clerk; T Howard ,
Document Control Supervisor; C Grant, Document Contro'1' Clerk; '- A Wanniger, Plant Engineer. 7 Date: 4/28/82
Subject:
Corrections to Quality' Assurance Records and Documentation Attendees: B Prim, General Foreman; D Allbritten, _ QAE; C Richards , QC Inspector; T Howard , Document Control Supervisor; M Cione, Document Control Clerk; S Marello, Document Control Clerk; C Grant ,- Document Control Clerk.
- 8. Date: 4/29/82
Subject:
Zack Quality ! Assurance Stamp on QA-- Documents and Records . Attendees: -D~Allbritten, QAE; T Howard . Document . Control Supervisor; M Clone ,- Document Control Clerk; R Basiaga,-QAE; S Marello, Document Control Clerk; C Richards , QC Inspectc ; D Calkins , Project Manager , Midland; C Eichstaedt , VP Marketing; - D Malazahn , VP Operation.
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- 1 :
Attachmsnt #1 Audit H01-602-2 O Page 8 of 11 - 4 I 9. As a result of the training records review, it was noted by Mr.1Calkins that training records for training accomplished during August, September and October, 1981 were missing. The
- individual (H McGrant) who provided some training during late 1981'was available during this audit.
~ Mr. McGrane remembered the time , content and attendees of the training sessions and , was willing to attest that the training occurred. Mr. McGrane provided an affidavit dated May '18,1982 attesting that training for the following people was provided: D Hennigan, T Howard, S Marello , E Hillyer , L. Mondak, R Perryi The training covered
- ANSI 45.2.9 ASTM standard content and requirements for certain Zack customer and technica2' specifications and the requirements of QAI #4. This training was provided subsequent to these people being employed by The Zack Company.-
- 10) A reading lir* for S Marello, datec 2/25/82 was found. It
, provided documentation that S Phrello had read QAI #4 and ANSI Standards, b)-Aformaltrainingschedulewasdevelopedon4/2h/82andjapresently_ being implemented.
- 4.
Conclusions:
a) No formal training program was initiated by 2/15/82. A' formal-i; - training program was started 4/22/82. The training should be-l continued as "on-going." l b) Several training sessions were held-in September and November to . l discuss procurement , PQCP-15, 'and Document Control QAI #4. . These { sessions wcre attended by personnel-representing the Drafting; j- Department, Production, Purchasing, Quality Engineering, Document l Control and Projact Engineering. Although this -is not a " company wide" training program, it'does involve the key. personnel-cogni ant for "Q" work. - . - - - G) "The Zack Company' management will address Limproper actions taken by employee,s to date and establish a definitive company policy on any further. improprieties."
.i
- 1. Action taken as-of 10/23/81:
"Those person (s) involved in the modifications to material certifications -
have: been identiff ed and reprimanded by The Zack Company ownership. This reprimand . consisted of demotions in position and documented letters to the personnel files. An intensive.and individualized. training was then given with respect to the requirements and necessity for accurate , and: controlled documentation." - l . l
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Attachment #1 Audit M01-602-2 Page 9 of 11
- 2. Scheduled completion as of 10/23/81:
"No further actions."
3 Status as of 5/20/82: Responsible individuals have been identified. Three individuels were involved. G Parker verified by a review of thn personnel files on 5/17/82 that the written reprimands were on file. Derparate policy was established about that time by a Zack letter to all Company Employees dated 8/18/81, relative to the need to follow procedures. " Procedures" includes procedures controlling the handling of quality documents. This policy, although intended for Zack Midland Plant personnel, is used for the Zack-Chicago location also. With regard to the persons involved in the mater 4*' certification alteration, those individuals have been demoted, al+ <erified by G Parke" (letters to personnel file , dated 8/24/81 and 9/30/61). The company policy as stated in the 8/18/81 letter, was applied to two of the three persons. They have received their first warning. For the third person, there is no second chance. Letters on file represent severe verbal reprimands as well as intense and brief individualized instruction regarding procedure violations and documentation alterations. A review of the training records shows an on-going training program for two of the individuals, while the other , has been put in a position where the need to deal with Midland QA documents is not a part of that person's job description or function. 4 Conclusions : l a) Improper actions taken by Zack Company employees has been addressed by Zack Company management. l b) The Zack Company letter dated 8./18/81 establishes a company policy regarding following procedures. In this case , procedures are what 's ellowed or not allowed and how to properly accomplish changes to "Q" documents. This is addressed in a training session on 4/28/82. ' ~ Training took an inordinately long time to be accomplished. ' 1 H) " Additional Quality Assurance / Quality Control personnel will be added as required to support the program."
- 1. Action taken as of 10/23/81:
"The Quality Assurance and Control- organizations have been expanded by fourteen (14 ) people since June ,1981 and at least .two (2) more quality engineering positions at the Clinton Site are contemplated.
- 2. Scheduled completion as of 10/23/81i "No further action. "
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Attachm:nt #1 Audit M01-602 2 C Page 10 of 11 Status as of 5/20/82: 4 3 The following is a chart of the original (June 1, 1981) status, growth, attrition and present status of the QA, QC and Document Control groups: Level Level Personnel fe.sonnel Level Oroup June 1, Oct. 23. Reductions Additions 5/20/82 1981 1981 8 QAE O 5 4 2 3 QCI 1 2 1" 0 1 DOC. n yd y g e 5 e CONT. < b QAM 1 1 l 3 ) a) Three of four have made lateral .or upward moves within Zack. Two of the three are still associated with the Midland Project. The third is available for temporary assignments. The fourth individual has been terminated due to lack of work at LaSalle County Power Station, b) QAM was promoted to Project Manager , Midland Project. c) Left the company, d) Three (3) persons are permanent Zack personnel; 4 persons are temporary c'ontract personnel. '- -' e) One (1) is a temporary contract person, the others are permanent Zack personnel. , Relative to the Docu ent Control group, the temporary contract personnel were released when most of the task effort was completed. Several permanent Zack personnel were then hired to continue the remaining task-force effort and maintain the Document Control. The entire Document Control staff including the Supervisor , were released on April 30, 1982. On May 5,1982 a new Supervisor repor;cd for work. . on May 17, 4 new-Document Control Clerks reported for work.
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7
We Attachmont #1 Audit M01-602-2 U Page 11 of 11 4
Conclusions:
a) Although there has been turnover and reduction of staff from a peak level of 15 people, there has been a large improvement in QA and Document Control manpower since June 1,1981. The Document Control group has shown the largest fluctuations due to the reduced efforts necessary to support material documentation task force and terminations of the Document Control Supervisor and group. The impact of this condition has yet to be assessed. b) QA personnel are added as required to support the program. I l ., 1 T- + - w M = e
P HI') HIT Y : Y TtmNu: No dus: utunvu ru_: c- o c 3 ' 4- I NECTS, ENolNEEnlNG AND CoNST7:UCTioN - Consumtf5 .. QUAuTV AstU^"ANCE DETAfiTWENT
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.s ;s cwortton maus as smoon / as maso crmtrica vm ssrpacssa ars a not PQCP-7, Rev. 5, paragraph 6.2.4 states "When a procedure er procedure M01-601-2 09 reyision is approved, it is incorporated into the appropriate " / 8"' ' ** '
" Master Manual" and the "Nster Manual Index. " Zack Co./ Midland 1 &2 an or usaxt S/14/82 Contrary to this , WPS-7, 'Rev. 8 and PQCP-17, Rev. 1 were not incor- , , ,,
porated in the " Master Manual" or the " Master Manual Index." The 18,4.7 previous revisions of both procedures are still in use. simamm RCAsh NOTE: During the audit Zack Co. stated that the procedure revisions WRBird DATaggart in question had not been received from BPCo Subcontracts. Upon JEBrunner RAWells further investigation, it was discovered that WPS-7, Rev. 8 was DECalkins ALAB-2 transmitted to Zack Co. on 3/3/82 (#26949) and PQCP-17, Rev. I was JWCook transmitted on 5/20/81 (#22047). BPCo Subcontracts has receipt LEDavis acknowledgement copies of both transmittals on file signed by The MADietrich BJCole Zack Co. (see attached). CSKeeley KFHayes HPkonard ESmith BWMarguglio RWSoderholn RBMcCarley TKSubraman.. DBM111er JARutgers MSkates wm nasctm aerzoni
- 1) Update " Master Manual" and " Master Manual Index" with the current revisions of WPS-7 and PQCP-17. Remove the superseded copies fron use.
- 2) Train cognizant personnel in the requirements'of PQCP-7 and provide documentation of l this training to MPQAD.
came.w *erzca cu c>un i A response to this finding is requested on or before 6/3/82. mft 0F C/A Coef37:QR 30, azar rQR C/As FDaos sulLDu C/A CosM:TtSNrs
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uTsare/4 - - - i The Zack Company M Skates emco or marcanos l
- 1) Zack Co. corrected the " Master Manual Indes" to show the current revision of WPS-7 and PQCP-17. Copies of the Index were received by MPQAD on 7/13/82 (M151-C/B-628),
- 2) Superseded copies of these procedures were removed from use (as attested by RJBasiaga ,
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