ML20199L106

Rev 8,dtd 971010,to QA Procedure 97-01, Matrix of Assigments & Corrective Actions - Phase Ii,Corrective Action Implementation Plan

ML20199L106
Person / Time
Site:	07100102
Issue date:	10/17/1997
From:	Frizell M, Moran G, Weber P SOURCE PRODUCTION & EQUIPMENT CO., INC.
To:
Shared Package
ML20199L102	List: ML20199L098 ML20199L106 ML20199L112
References
97-01, 97-1, NUDOCS 9712010297
Download: ML20199L106 (14)

Text

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MATRIX OF ASSIGNMENTS AND CORRECTIVE ACTIONS - PIIASE 11 Revision (8), Oct:ber 10,1997 Corrective Action Ineptementation Plan SPEC QA Procedure 97 01, Rev (0).

Ph se 11 Correc:lve Actions to SPEC Aadit Findings Ref.

Assign Date Date Rank and NRC Inspection Obsenations.

To assigned complete 018 Limit rate of fabrication of new packages to maximum five (5)

Qa 97 01, Pete 07/14/97 07/30/97 packages per week 4.1.6 02B Appoint Dr. Parker to serve as member of Materials Review Board Qa 97-01, Donny 07/14/97 07/30/97 (MRB).

4.3.5 03B Conduct acckly Team meetings with written agendas & minutes.

Qa 97 01, Pete 07/14/97 10/09/97 4.1.2 04B Audit fabrication personncI first hand on a random basis.

Qa 97-01, Dr.

07/23/97 10/09/97 4.3.1 Parker 65B Audit QA Inspection personnel first hand on a random basis.

Qa 97-01, Dr.

07/23/97 10/0997 4.3.2 Parker 06B Report directly to the President on random observations and Qa 97-01, Dr.

07/23/97 10/09/97 overall status of the Plan semi wcck y.

4.3.4 Parker 078 Team spot audits.

l.P.

07/23/97 Ongoing Team 08B Report weekly to NRC on status of the Plan, number of devices Qa 97-01, Dr.

07/23/97 10/09/97 fabricated, and other relevant information requested by the NRC.

4.3.6 Parker 09B Review and approve all new package fabrication records for Qa 97-01, Dr.

07/23/97 10/09/97 completeness as part of final inspection.

4.3.3 Parker 10B SPEC procedure 7.23, para 7.1.2.3 requires drawing number and Audit 07/30/97 09/12/97 revision forjigs and fixtures. The working copy of the calibration Report tog (kies not provide this. The working copy of the calibration log Finding vi.as not developed in accordance with SPEC procedure 7.23

1. 1 What happened? The working copy of the calibration log was not developed in accordance with SPEC procedure 7.23 Cause? The author of the list did not comply with the written procedure. The creation of the document was not reviewed or approved as required by the QA manual.

What will be done to correct the problem? Procedure 7.23 Mike rev(1) will bc 'revisod'to'dclete pani 7.1.2.3.LThe list will be

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reviewed and approved by the Presidcuh 9712010297 971125 PDR ADOCK 07100102 C

pm Assignments & Corrective Action Matrix - Phase 11 Revision (8L October 10.1997 A-2 S?AtEETtNGSilstPLANAI ATRI EPil21.TR.WPD

Corrective Actions to SPEC Audit Findings Ref.

Ast!gn D;te D:te Ra:k and NRC Inspection Observations.

Ta assigned complete llB SPEC procedure 7.23 para 7.1.2.4 is not comdied with.

Audit 07/30/97 09/12/97 What happened? The prucalure requires that ue fixture, Jig, and Report ga'uge list contain inspection and/or calibration instructions, and Finding critical dimensions with tolerances. The list does not contain

1. 2 these. They are present in the foldct as a calibration / inspection report for fixtures, jigs, and gauges, but this report is not associated with the list. Also, the reports are not completely filled out.

Cause? The author of the list did not comply with the written procedure. The creation of the document was not resiewed or Mike approved as required by the QA manual.

What will be done to correct the problem? A foldct will be created for.cach fixture andl Jig. The folder will contain a calibration sheet for that particular fixtme orjig 1 A cah'bration sheet will be fdled out and dated at cach calibration and placed in the folder. Tim fixture, Jig, and ry.:ge lht will be kept in n' separate folder and will serve as the master list. Procedure 7.23 will be Mike revised to incorporate thesc changes.

What will be done to present the condition from recurring?

All QA 'personact will bc retrained in procedure 7.23f and QA manual chapter 6.0 12B QAM 12.0, control of measuring and test equipment, requires Audit 07/30/97 09/12/97 listing caliper serial number and cal date on forms QA 10.3 and Report QA 10.4. Fonn 10.3 complies, form 10.4 does not have an area to Finding record this information.

1. 4 What happened? The required information was not recorded.

Cause? The author of the fonn did not inclC the required provision for recording caliper infonnation.

What will be done to correct the prublem? QAM iill be revised Mike 12.0 to delete the last sentence.

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13B A survey instrument calibration cenificate is used to record the Audit 07/30/97 09/12/97 results of nn instrument " check" perfonned before cach lot of DU Report castings is inspected. The fonn should only be used for truc Finding calibrations.

1. 5 What happened? An actual calibration form uas used to record the icsults of a " check" calibration. This form is not readily distinguishable from a true calibration certificate. QA manual 12.1.c.8 requires the serial numbers of the items surveyed to bc l

recorded on a copy of the last calibration fonn. Instead, a new l

calibration fonn was used to verify calibration and to record the serial numbers.

Cause?sConflicting QA documentation. QA procedure 7.49 Mike umilicts with QA manual 12.1.c.8 The inspector followed QA prwedure 7.49.

What will be done to correct the pmblem? The two QA procedures.. wil!. be reviewed L and ' modified ' as ~ necess'aryl!o

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reconcile, 1

Assignments & Corrective Action Matris -l'hase 11 Revmon (H)Jktober 10, ten A-3 S:4tEETtNOS1MPLAVAIATRI A J'll2LTR.wrD r

Corrective Actions to SPEC A:dit Findi gs Ref.

Assign D:te D:te Rank and NRC I:spection Observations.

To assigned complete 14B In general, travelers do not list the resision letters or offer blanks Audit 07/30/97 09/12/97 to till in revision letters for referenced documents.

Report What happened? The trawlers were created without provision to Finding record associated drawing resision letters. _Whereas this does not

1. 6 violate the QA manual, it makes it dimcult to audit the documentation used to fabricate a particular package.

Cause? Lack of consideration of the " big picture" w hen creating travelers. Insumcient management review, Absence of a link between trawlers and eng,ineering drawings. Travelers created by QA instead of production or engineering.

What wlil bc Jane to prevent the condition from recurring?

Pete/

Assisn the cmation of travelers to Engineering.M Asdit trayek,rs Ken Medically; j

Assignments & Corrective Action Matrix - Phase Il Revision (8), Oetober 10,1997 A-4 SSIEETINOSilMPtANalATRI XPllib.. IL

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l Corrective Action. to SPEC Audit Findi:gs Ref.

Assign D:te D:te Rank and NRC I:spection Chervations.

Ta assigned complete 15B The supplier evaluation records were not on file for all suppliers Audit 07/30/97 10/09/97 of C 1,2 T and SPEC 150 componcats.

Report What happened? QAM 4.0 Section D7 was not complied with.

Finding The QA Manager (Mike Frizell) n aware of the require icnt.

1. 9 Mike Frizell made a vendor list and felt like we could evaluate vendor's perfor: nance based on accept / reject re'es. (In fact, some verdars lunt been deleicd from the Accepted Vendor's List due to diis method of eval.iation). Mike had it:tentions of sending Form 4.3 to the "new vendois" that remained on the list primarily the i

3 SPEC-150 comporent suppliers (if documentation of the supplier evaluation did not aheady exist). This was not considered a high priority item by Mike Frizell.

Paul Guess (put:hasing). Mike Williams (QA) and Tour ny Ruiz r

(QA) were unaware that the scument existed.

Tommy commented that he was trained as a "part inspector" i.nd less focused on the details of the sections of the QAM that did not pertain to inspection instructions.

Cause? Not considered high enough priority in comparison with Mike other outstanding Q A tasks.

What will be done to correct the problem? Revicw'the vendor files, determine what sendors have rn been evaluated and perfonn the evaluation in accordance with QAM 4.0 Section D,7 Mike What will he donc to prevent reoccurrence?

I) LTrain or (re-train) all QA pctsoimcl in all aspects of thi QAP Petc

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and QAM.

2) Evaluate the " complexity and critical nature" (described in QAM 4.0,

. Section D.7) of each *nrt of the Type B packages Mike based on safety concerns (i.e. sourte lock verns source tag screw).

3) Determine the level of the "cyaluation't required based on safety concerns. (For example, depleted Uranium suppliers would require a closer evaluation than the vendor that suppFcs quick Mike /

disconnects for safety plugs).

Pete

4) Consider modifying QAM 4.0 to n: quire the evaluation tn'a'pply only to thoac vendors thal.rupply Q-A and Q-B. items, not Mike necessarily all sunnliers.

5) Plan an extensive evaluation of depicted Uranium shield Mike supplicts (possibly a visitE This is based on conunents by Tom Matula).

6) 6 nwnth re-evaluation of sendors and component lists to ensure Mike that cach vendor of a Type B package component has tcen evahiated us applicable.1 Put on QA maintenance cale.ndar.

7) Establish a requirement and method that pittents a Q-A or Q-B vendor' to be used before the evaluation is completed.

Assignments & Corrective Action Matrix - Phase 11 Revism (8). October 10.19'n A-5 snittTixosmirim3 ATai XTII2LTR.WPD

Correctivt httons t's SPEC Audit Findi:gs Ref.

Assign D:te Date.

Raik and NCC!roinctiro Observaticas.

To assigned complete 16B.

SPEC C 1 t.rn fabrication / tracking and inspection log Audit 07/30/97 09/12/97 Form does,not have a form number, Report af Several completed drums were not inspected.

Finding b.

No dr: wings are referenced.

1. 12 c.

Not recorded on form 10.11

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No qualifications for Tim Perrin.

What happened? Violation of QAM 10.0; Form QA 10.11 was not used to record the inspection of 2T and C 1 drums.

Cause? The log that was used to record the inspection was created by Jake Kennedy (Procedure 4.16). The Form QA 10.11 (from the QAM) was not included in that procedure. Individuals were instructed to use the procedure for the manufacturing and the log for documenting the inspection. Tommy Ruiz and Mike Frizell were aware that Form QA 10.11 existed. Tommy did not question Jake's inspection instructions (to use the log in Procedure 4.16).

Mike Frizell didn't relate the Form QA 10.11 to drum manufacturing since it doesn't state " Shipping Drum" (or something similar). Mike Williams was unaware that the form existat. Tiere were drums that were not inspected since they were not brought to QA's attention for inspection (per Tommy).

Note: One of tie findings was that the log used in Procedure 4.16 does not have a form number. This may not be a finding since that log is part of the approved procedure and the procedure is an extension of the manual. Another finding is that there are no drawings or inspection criteria referenced on the log. The inspection criteria is inchided in the procedure as well, so this may Mike not be a true finding.

What will be done to correct the problem? Revise QA manual 4.0 to nxpure' distribution of drawings 'to fabrication workers with shop orders, and the distribuuon of drawings to vendors with purchase orders. ~ Cmate a' shop oider form and probedure.

Qualify Tim Perrin per pmcedure 4.16; l'

Assignments & Corrective Action Matrix - Phase II Revision (8), October 10,1997-A-6 S SIEETINGS'ulPLAYMATRI i

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4 Cartwctisc Actions to SPEC Audit Findings

Ref, Assign Date D t2 -

Rank and NIC I:spection Observations.

Te assigned complet; 178 '

SPEC C-1 housing plates receiving records, Purchase order i12K Audit 07/30/97 09!)2/97 -

No,irupcetion records for 20 cx Top door, Sides / Bottom, Front Report door, inner pancis and Back Panels.

Finding What happened? Violation of QAM 7.0, Form QA 7.2.- Tlx A13 malcrial wu not documented as being received or inspected after receipt.

Note:'nus may not be a finding. %c retention of Form 7.2 is only two years. The material was purchased around 10/14/91.

Cause? Uncertain. Either the receiving inspection was not performed or the inspection report was misplaced. (There are plates in stock that appear to have been inspected since tley are Mike marked green).

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What will be done to correct the problem? Tius C 1 plates in stocif(thaf aFpainted green)'but do noi have' documentation

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avstlableiwill be se%M to' current drawings and inspectwa documerdation'will be generated before use of any'of theinatorial; Mike What will be done to prevent the condition from recurring?

'l)ERitrain.i LReceivinglinspecti6ns will bETperforlised in accordance withQAM 7,0!etc.

NotenThe ' plat'es~areLcurrently not'in~a controlled attahThis observation is' addressed in a' separate audit reportl

2) ProceduseYl.14:and ;QAM:7.0 have conAleting forins1for Itaceevisig inspection Repostsi These documents will be reviewed and reconciled.

18 8 SPEC C 1 component procurcinent Audit 07/30/97 10/09/97 What happened? %cre was a Violation of QAM 4.0 Section D.3.

Report The approvai drawing shows the part (C-1 outlet boss) to be %" in Finding length (drawing dated 10/20/89). When the part was ordered a

1. 14 copy of the approved drawing was marked showing e length of

.380" + 005".

Tis marked up drawing was identined as,

" Production Drawing Only. Not a QA Document" and the drawing muuber was scratched out. That unapproved and marked up drawicg was the one attached to the purchase order and packing slip. It was observed that the mating part (the outlet nippic for the C-1) has a thread length of.385" +.015". indicating that the.380" length boss is the correct length. In addition, some of the 200 series C-l's bosses were measured and confimied to be approximately 3/8" The approved drawing shows the length dimension at %" +.000.

.125" Although the part is at the low cnd of the tolerance, it remains in tolerance w hen the part is.380"

+,005" as ordered from the marked up drawing.

Cause? The drawing did not go through an ECR and resision process prior to ordering the component.

What will be done to correct the problem?

Pete 4'

1) Tac" drawing willio* throughLthe' ECRiprocess before re; ordering the component.

Mike 2)' Any remaining' components in-house will bs re inspected and documented using the revised (and approved) drawing.

3) Revise procedurcT3.01,to reqsire purchase orders fos SPEC designed l parts j to4 include Ta n copy 1 of ! theT ctirrentJ approved engineering drawing /

What will be done to prevent the condition from recurring?

See item 23B of this document.

Assignments A Corrective Action Matrix-Phase !!

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Correctisc Actions to SPEC Audit Findiras Ref.

Assign D;te D*te -

Raik and NIC Inspection Obsenttions. -

To assigned complete 198 -

SPEC C-1 U tubes, Show inspecting 34 U-tubes, no material or Audit 07/30/97 09/12/97 fabrication, inspections.-

Report What happened? Violation of QAM 4.0. Form QA 4.1.

No Finding procurement information was available.

1. 16 Note:

This may not be a finding. Retention of Form 4.1 is three years. Tb? Inspection reports on the u tubes were all in 1992.

Cause? Uncertain. Either the purchasing documentation (P.O.)

was not generated or it was misplaced after completion.

What will be done to prevent the condition from recurring?

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Retrain Purchasing ~and QA deptatments on'QA Manual chapter Mike 4.0/ Establish a noording method that ties purchasing information of' materials (rod. ' plate,' bar,.etc.) to the Recching inspection Report when SPEC is the supplier. : (For' example: We purchase titanhan tube to mais > tubes. Then' we ' cut the' material and make the s-tubesinen we inspect the a-tubes but there is no P.O. #,~

Packing Slip; etc; since that type ofinfonnatio:i is not applicable.

Theadbee; the pachasing information of the raw material that was used in not is~not able to be retraced. [7/16 resiew QAP for Q-B itemsh This might not be a finding,1 20B SPEC C-1 drawing 62190(2), door bracket drawing 322002(0),

Audit N/A N/A N/A N/A naneplate does not have QA classification in accordance with QA Report manual 3.0 E.1.

Finding What happened? Violation of QAM 3.0, Section E.1. The QA

1. 17 classification was not added to the drawings. The door bracket drawing was revised on 7/15/92. The nameplate drawing was created on 1/27/97. The QAM 3.0 Section E.1 requires that,"All drawings initiated or revised after 1/1/92 will include classification on the drawing" Cause? Unknown Likely an ov:rsight.

What will be done to prevent the condillon from recurring?

See item 28B of this' document; 21B Design activity record form QA 3.3, Design activity records are Audit 07/30/97 09/12/97 not available for C l.

Report What happened? QAM 3.0 re(trires the use of Form QA 3.3, Finding Design Activity Record for package designs to scrify conformance

1. 18 to 10 CFR Part 71. There are no Design Acthity Records avadable for the C-1. However, this is not a true finding since the C 1 was designed before the requirement was established.

Cause? N/A. Not a finding.

What will be done to prevent the condition from recur ing?

Pete r

Th' 'QA ' manager will beitrained in'QA Manual chapter 3l0, e

l Assigmnents & Corrective Action Matrix Phase 11 Revidori(R), October 10,1997 A-8 SMETNGS%1PLAntADU MPl:2LTR.WPD l

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Carnetive Actions tz SPEC Audit Findi:gs

Ref, Assig2 -

Date Date RaIk and NRC I:spection Obsenttions.

To tssigned complete 22B Tungsten ciectrodes and Titanium filler rod and Argon, receiving Audit 07/30/97 10/01/97 inspection reports and purchase order form QA 4.1 Report What happened? There was a violation of QAM 7.0, Form QA Finding 7.2., SPEC Receiving Inspection Peport.

1. 19 Cause? QA inspectors were instructed by the presious QA manager (Jake Kennedy) to file the document after the receiving inspection was performed and not to pass the document to him for tic QA Manager's review. Although this was contrary to presious instructions (by Jim Moore), the inspectors conducted the I

inspection as instructed by Jake. Additionally, QAM 7.0.iulol clsat that the QA Manager must sign the Receiving Inspection 4

Report. Section C.1 only states, "The receiving inspection shall give ca.cTul consideration to..

and comolcte documentation."

Also, Section C.ll states that the reports "shall be filed and maintained by the QA manager", not actually signed, Also, l

Procedure 7.36, Section 7.2.24 states that tLe QA Manager shall sign the report after reviewing. Note: The inspection form in the procedure is identified as SPEC Form 1.12 A (w hich is identical to Mike Form QA 7.2)

What nill be done to correct the problem? The'QA manager will reticw aind sign 'past receiving inspection reports, Mike What will be done to prevent the condition from recurring?

Mike n

1) Re-train QA stafTin QA Manual 7,0.'

2) All documentation will be resiewed by the QA manager r;nd Mike signed off before filing.

3). Procedure.7.36' and tic QAM' 7.0 will be~ reviewed for inconsistencies and revised appropriately, 23B SPEC 150 DU shield, drawing 15B008 rev 2, drawing 150008 rey Audit 07/30/97 10/09/97 2, traveler 15008 rev 1, ICL-149 in process survey inspection.

Report receiving inspection reports.

Finding What happened? There are two drawings, proprietary and non-

1. 20a proprietary for certain items that require a drawing for a package application. The non-proprietary drawing is denoted by the letter a

B in the drawing number. A revision was made to the non-proprietary & awing that did not alTect the proprietary drawing so no ECE was originated.

Cause? Originals of non-proprietary drawing for package l

applications are filed in a difTerent location than proprietary drawings.

Joc/Pete What will he done to present the condition from recurring?

File"non-proprietary' drawings adjacent to proprietary drawings.

Mandate,when resisions are made to one drawing ~ the ottwr drawing must be revised simultaneously.

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Assignments & Corrective Action Matrix - Phase Il j

Revision Ot), October to,1997 A-9 SatEETINGS%1Pt.AVAIATRI

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Corrective Actions in SPEC Audit Fin'&gs -

Ref, Assign Cate Date Raik and NRC Inspection Olnervations.

To assigned '

(omplete 24B.

SPEC-150 lock cap assembly, drawing 150916, traveler 150910, Audit 07/30/97 09/!2/97 receiving ipspection reports.

Report

-What happened? During the development of the SPEC 150 a Finding substantial number ~ of drawings were produced.. Prior to

1. 26a application approval development drawings were signed for apprmtd without completing the ECE (QA from 5.1). When the application was approved ECE (QA from 5.1) was completed for tie drawings. Tic drawing approval signature line on the form is one line away from the change authorization signature line. It appears some forms were signed on the wrong line or the whole for:n was accidentally skipped.

Cause? Oversight Mike What will be done to correct the problem? Procedural' problem 10 be corrected.

Mike What will be done to prevent the condition from recurring?

7tevise tiic FCE (QA form 5.1)'id eliminate the'apprmil' signature lineMThe ECE should be done before'a'revisior lainadiand iipproval granted to malic the change (change authorizabon).iThe drawing is approved by signirq the' drawing not tlw ECE, 25B SPEC C-!

NRC 07/30/97 10/09/97 What happened?

07/10/97 The outlet nipple boss is listed as 1/2" on the certificate of

1. 2 compliance.

I.~ic part actually is 0.380".

The part is within the minus 1/8" tolerance, but the patt was ordered using a drawing that did not specify 1/2". SPEC should check with Ross Chapel to determine if a drawing resi: ion is required.

Cause? SPEC maintains drawings for Application and drawings Joc/Pete foi fabrication. The two sets of dra, sings are not linked.

What mill be done to correct the problem? A linkiwillLbs established between the two sets of drawings.~- The drawings will bc reviewed and synchronized l Mr. Ross Chapel of NRC will be Joc/Pete contacted to discuss furt'twf remediai action, What will be done to prevent the condition from recurring?

Typc1B"Applicatioridrawinjis7will(bellinked to fabrication drawings.2 A procedure for application drawings will be created.

Engineering land QA will be trained.

- Assignments & Corrective Action Matrix - Phase II

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Corrective Actions to SPEC Audit Firdirgs Ref.

Assign D:te Date Ra-k and NIC Inspection Observations.

To-assigned complete 26B Calibration:

NRC 07/30/97 10/02/97 What happened?

07/10/97 ~

The caliper tracking list is not up to date.

1. 3 There is no procedure to remove calipers from nse.

One caliper had an " acceptable" tag after it was taken out of senice.

There was a consistent error in one caliper by 0.006".

Class I calipers wer: calibrated improperly.-

One caliper was out of calibration by 0.005"?

Here is no apparent safety significaixe to the calibration problems except perhaps for the effect on jigs and fixtures. (We need to evaluate tie safety significance of the calibration errors on jigs and fixtures).

Dere is no procedure to calibrate the calibration standard (Block).

Pctc/

Cause? Improper understanding and use of the calibration Mike procedure.

What will he done to cormt tbc problem? WE need 16 evaluate the safety significance of the calibration errors' on jigs and fixtures.

Petc These is no procedure y Cahbrale the calibration standard (Block)l What will be done to prtvent the condition from recurring?

Periojict auditsNillLasside[coniplianceiwith?theTcaliber.iG procedure, 27B Welding traveler Process:

NRC 07/30/97 10/09/97 What happened?

07/10/97 The process is burdensome.

1. 4 Some records have open blanks.(We should re cyahiate the process)

Cause? The travelers were not drafted by the department fabricating parts in accordance with them. This resulted in a lack ofownership.

Pete What w'll be done to present the condition from recurring?

D.rafWglof2 travelers iwilli bel.: assigned [tos thel Production

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departsnent; 28B QA Classification System:

NRC 07/30/97 09/12/97 A graded approach is needed.

07/10/97 Responsc: Spec has a graded classificati6n systim~ procedure'as

1. 5 Mike

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part of QA manual 3.0, Design Control.1The classification system

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will be reviewed and supplemented to' clearly; define the grading systeht.

n Assignments & Corrective Action Matrix Itase Il Revision (R), October 10,1997 A-11 SS!EETINOS1MPIMMATRI XTH2LTR.WPD

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Cornetive Act' ens G SPEC Audit Flings Ref.

Assign Dtc D;te Rank and NZC Inspection Observations.

Te assigned complete 29B =

Non Conforming Material Control:

NRC 07/30/97 08/20/97 What happened?

07/10/97 Non conforming material is not controlled.

1. 6 Some parts are not red tagged or not segregated.

Control areas should be locked.

Some non-conforming material is mingled with confonning material.

NCR Documentation is not current.

The non-conforming material tracking report is not able to detennine closc out status (no cpen/close dates on the report).

Many NCR's should be updated or completed.

There are multiple copics of the same Non-Confonning material report at various stages of completion.

A procedure is nceded to control non conforming material.

Add **open and closed" columns NCR tracking report, Add date and time.

Report forms need to be controlled. Making copies can cause problems Canne? These are symptoms of the systemic problem with SPEC's QA system and the concsponding lack of ownership of the NCR Mike system What will be skmc to correct the problem? NCR' documentation will be completedinki Aled2Open and closcout dates will be'added Mike lo the NCR status report.

What will be done to prevent the condition frvm recurring?

Thliis'an area where the"indepeixlent audi@ill bd focuied to herform a root cause analysis; 30B Audits:

NRC 07/30/97 09/12/97 What happened?

07/10/97 There is currently no audit schduled for 1997.

1. 8 The last internal audit was in 1993.

MSC has not been audited An audit should be perfonned for vendors of all Q-A items.

Cause? Lack of upper management support for the QA program.

What will be done to correct the prohlan? Aiiindependent George indit is Eheduledf A mot cause analysis isicheduled See item 15R -

310.

Qualification of personnel -

NRC 07/30/97 10/02/97 What happened? The inspector found no records to indicate that 06/19/97 Mr. Bob Lawrason was certified to perform survey meter

1. 2 calibrations. - Also, his training file was practically empty.

Cause? QA manual section 2.1 is not explicit in the control and administration of employee training. Procedure 2.1 overlaps and cotuhets with QA nuumal section 2.1. Administration and records of training have been informal.

What will he skme to prewnt the condition from recurring? A Pete iraining' coordinator wil! be appoln'tedJ Dutics' to' include the inalatenance of a training matrif scheduliniof training, land periodic review of training records for cach employee.

Assigmnents & Correctisc Acion Matrix l'hase II Resis'wm (Rh(ktober 10,1997 A-12

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4 Correse Acelens le $MC Avd(t F6mdensa Ref.

Ame8 n D:te D:te R:ak and N;C trapection Obsersations.

To casigned complete 32B SPEC lSO prototype inspected to unapproved drawings. Lack of NRC 07/30/97 10/09/97 QA procedures for prototype.

06/19/97 What happened? De pre production SFEC.150 prototypes used

1. 3 for testing were not built to a complete package of approved drawings. preliminary drawings were used for many parts. Thenc drawings were later approved. but in many cases there were no formal change control documents associated with tlic conversion from preliminary to prWuction drawing status.

Cause? The situation was caused by an attitude that pre.

production prototype units need not be docarnented to tie same level of detall as production units.

What will he done to corrut slee problem?T The QA manager hiike will review the preliminary drawings used to fabricate the early proselypos and creole a report doommenting any difloronoes froen the espdvalent approved drawings.

What will he done to prevent the condition from recurring?;

Ken /

De job desciptions for purchasing agerdl machinist,~and QA hiike inapostor are being rwined to include statements not to purchase, fabricate, or inspect to unapproved drawings, 4

33b QA signoffs, missing sipatures. hinterials Recciting Reports not NRC 07/30/97 10/02/97 signed off or signed by same individual.

06/19/97 What happened? The irupccior found missing final signatures on 45 QA (kctments. Tic final signatures indicate the QA manager has reviewed the documents for completeness. The inspector also found cases where the same individual signed as inspector and reviewcr.

Camer? There was not a good hand-off during recent changes in QA managers. During the current QA manager's administration, QA inspectors got out of the habit of bringing dxuments to the QA manager to sign, and the QA manager did not scck out (lic documents to sign.

hiike What will be done_ r9 correct the pniblem? The' Quality Assurance manager will review all receiving inspection reports, trawler pacLapos for SPEC 150 and SPEC 2.T. and all other QA documents requiring his review and signature deced January,1994 to present and sign with current date for review of form.

l Assignments & Corrective Action hiatris. phase 11 Revision (R), October 10.1997-A 13 sauxmasntrimtAW EPit2LTR.WrD

,..._,um._.,

7 Correctlie Actions b $PEC Audit Findings Ref.

Ansign Date Cate Rank and N C Inspecties Ohners athms.

Ta neelgaed

'cosaplete 34H No gparent prouces wies *y *prelimicr)" status is remos ed from NRC 07/30/97 09/12/97 drawings 7:

06/19/97 What happened? An inspector found versions of SPEC drawings

1. 6 nmAed "preliminar)" and versions of the sarue drawings with the preliminary maAing remcved. There appeared to be no process l

used to remove this marking. Procedure 1.10, Drawing Control l

allows tie une of preliminary drawings, which by definition are not approvcd The proccdure states that preliminary drawings will not be used for fabrication or QA. The preliminary drawings in this case wcre used for both of these purposes.

Cause? See item 3 of this report.

What will he done to correct the problem? No remedial action is required.

What will be done to prevent the condition from arcurring?

Pete All chanses in Crowing configuration 'will be controlled by this syseeni A change review board will snonitor all.chanses to drawings and cosnponent confisuration.

I Neviewed Hy:

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Date: //797

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MikrFriMA Manager

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Date: /O /7 7

Reviewed Hy:

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Pete Weber, General Manager mpb 0 P Irw n -

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Reviewed Hy:

George Moran, Vibe President

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Approved Hy:

Date:

R. D. (Donny) Dicidrry, President t

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. Assigrunents & Conective Action Matnx. Phase 11

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l Revision (R), October 10,1997 A-14 S %fEETINGSh!PLAVAIATR1 l

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