ML20199L112
| ML20199L112 | |
| Person / Time | |
|---|---|
| Site: | 07100102 |
| Issue date: | 11/25/1997 |
| From: | SOURCE PRODUCTION & EQUIPMENT CO., INC. |
| To: | |
| Shared Package | |
| ML20199L102 | List: |
| References | |
| 97-01, 97-1, NUDOCS 9712010298 | |
| Download: ML20199L112 (4) | |
Text
--
MATRtX OF ASSIGNMENTS AND CORRECTIVE ACTIONS - PHASE III Revision (2), November 25,1997 Corrective Action implementation Plan SPEC QA Procedure 97 01. Rev (0)
Phase III Corrective Act6oes to SPEC Audit Findings Ref.
Assige Date Date Rank and NRC inspection Observations.
To assigned complete 01C SPEC petxedure 7.23, para 7.1.2.3 requires drawing number and Audit P,
i1/21/97 11/24/97 revision forjigs vid ftxtur. t. 'the working copy of the calibration Report Weber log does not prmide this.
Finding Cause? The author of the list did not comply with the wTitten
- 1 procedure. The creation of the docmnent was not reviewed or approved as required by the Q A manual.
What will be done to prevent the condiflom fruen recurring?
All QA personnel will be retrained in procedure 7.23 and QA manual chapter 6.0.
02C SPEC procedure 7.23 para 7.1.2.4 is not complied with.
Audit P.
I1/21/97 11/24/97 Cause? The author of the list did not comply with the written Report Weber 4
procedure. The creation of the document was not reviewed or Finding approved as required by the QA manual.
- 2 What will be done to cornet the problem? Calibration records for All fixtures andJigs will be reviewed. Re-calibrations will be performed as needed.
What wiH be done to present the condition from recurrisg?
This item wil! be added to the next audit checklist.
03C QAM 12.0, :ontrol of measuring and test equipment, requires Audit P.
11/21/97 11/24/97 listing caliper serial number and cal date on forms QA 10.3 and Report Weber QA 10.4. Fonn 10.3 complies, form 10.4 does not have an area Finding to record this information.
- 4 Cause? The author of the fonn did not include the required prmision for recording caliper information.
What will be doew to prevent the condition from recurring?
QA penonnel will be retrained in QA program chapter 12.0 and QA nunual chapter 10.4.
04C A survey instmment calibration certificate is used to record the Audit P.
11/21/97 results of an instrument " check" performed before cach lot of DU Repon
- Weber, castings is inspected. The fonn should only be used for true Finding G.
calibrations.
- 5 Moran Cause? Conflicting QA documentation. QA procedux 7.49 confHets with QA manual 12.1.c.8 The inspector followed QA procedure 7.49.
What will be done to cornet the problem? A new form will be created for wrifying calibration of sarvey meters. QA personnel will be retrained. Package safety is not affected so remedial action is unnecessary.
What will be done to prevent the condition fresa recurring?
As part of the scheduled independent audit, we will resiew the overall QA program and implementing procedures.
h 02 C
PM Aasiynwans A Conrain AaxmMauis.Ptawlit B-2 Revwkm(21 Novende 21,1997 s Sil' ETINOSJM P!AntATRDCtll3 LTR.WPD i
m...
m.,
e.,._,.
.m,
.-,---,_..-.,,..._.-,,,.,__my y
w
, - ~..
_ ~ _ - - _.
- -.._ - ~. _ -. -
Corrective Actions to SPEC A dit Findings Ref.
Assigs D:le D;te Ra:k and NHC Inspection Obsert:tions.
To casigned cosaplete OSC in general, travelers do not list the resision letters or offer blanks Audit P.
I1/21/97 11/25/9/
i to fill in revision letters for referenced documents.
Report Weber Cause? Lack o(consideration of the " big picture" when creating Finding travelers. Insufficient management resiew, Absence of a link
- 6 between travelers and engineering drawings. Travelers created by QA instead of production or engincenng.
What will be done to correct the problem? Revise travelers to include a blank for a revision letter for each referenced drawing.
06C Survey neter calibration certificates are not approved by the QA Audit P.
I1/21/97 11/24/97 manager.
Report Weber Cause? N/A Finding Survey meter calibration certificates are not approved by the QA
- 11 I
manager.
Cause? N/A What will he done to prevent the condition from recurring?
Generate a separate meter calibration record for internal use.
Include the pertinent requirements of 10%, verification immediately prior to use, etc. See QAM 12.1 Section C. 8 and incorporate this into Procedure 7.49. Note: Procedure 6.10, Suivey Meter Calibration already requires 10% accuracy (not 20% as allowed by regulation). We may want to reconsider this for custoner meter calibrations. Compare Procedure 6.10 to the QAM 12 0 for inconsistencies and resolve.
07C SPEC C 1 drum fabrication / tracking and inspection log Audit P.
I1/21/97 11/25/97 Cause? The log that was used to record the inspection was Report Weber created by Jake Kennedy (Procedure 4.16). The Form QA 10.11 Finding (from the QAM) was not included in that prucedure. Individuals
- 12 were instncted to use the procedure for the manufacturing and the log for docu.nenting the inspection. Tommy Ruiz and Mike Friiell wm aware that Form QA 10.11 existed. Tommy did not question.ake's inspection instructions (to use the log in Proce. dure 4.16). Mike Frir. ell didn't relate the Form QA 10,11 to drum manufacturing since it doesn't state " Shipping Dnim" (or something similar). Mike Williams was unaware that the form existed. There were drums that were not inspected since they were not brought ta QA's attention for inspection (per Tommy). Note: One of the findings was that the log used in Procedure 4.16 does not have a fonn number. This may not be a finding since that log is part of the approved procedure and the procedure is an extension of the marmal. Another finding is that tiere are no drawings or inspection criteria referenced on the log.
The inspection criteria is included in the procedure as well, so this may not be a true finding.
What will be done to correct the pniblem? Retrain fabrication and QA workers to comply with procedure 4.16 para 7.l.9.
Revise procedure 4.16 to delete para 9.1.
What will be done to prevent the condition from recurring?
Training in all aspects of QAP and QAM.
Anignments & Comdw Actwn Matrio lhe 111 Ek3 Rmswn (2k November 25.1997 S 4t EETtNGSJ M PLAntATRIXPID LTR.WPD
_ _ _ =
t Corrective Actions to SPEC Audit Findings Ref.
Assign Cate Cate Rank j
and NRC Inspection Obsenations.
To assigned complete i
08C SPEC C;l drawing 62190(2), door bracket drawing 322002(0),
Audit K
11/21/97 11/24/97 dameplate does not have QA classification in accordance with Report Carrin-QA manual 3.0 E.1.
Finding gton Causef Unknowit Likely an oversight.
- 17 What will be done to corrset the problemt in addition to the two drawings noted abme, all C 1 drawings wi.I be evaluated and assigned a QA Classification designation. Currently, none of the C 4 drawings have been QA classified (all are dated prior to 1/1/92).
C Design activity record form QA 3.3. Design activity records are Audit N/A N/A N/A not available for C l.
Report Causef N/A. Not a finding.
Finding What will be done to prevent the condition from recurring?
10C QA system root cause analple finding: The current quality Ind. Audit O.
11/04/97 system is disjointed with littic flow from the Quality Program Report Moran Manual to Quality. Assurance Manual to the bulk of the Quality Part B 1 System u hich is presented in the Standard Operating Procedure Manual.
In some cases there is no continuity between requirements of one manual and those of another. Multiple authors over tine ime been a contributing factor to this problem.
In some areas, i c. corrective action, the requirenents of wien to use and how to use have not been well defined.
What will be done to correct the problem?
Crente a plan to totally res icw and rewrite Si EC's Quality system with emphasis on: Defirudon of requirements Consistency of requirements, a methodology to connect the multi tiered quality system to proside a logical flow from least specific document (Quality System Manual) to the most specific document (Work Instructions).
IlC QA s3 seem root cause analpis finding: The current system for Ind. Audit G.
I1/04/97 defining and documenting qualification requirements and Report Moran training needs is inadequate. Qualification requirements are not Part B 2 well defined. Required training for personnel has not been established.
What will be lone to correct the problem?
The plan to rewTite tic QA program desenbed in item IOC of this matrix will include the establishment of methods to define the method of qualification of personnel for each defined job classification. Tle plan will include means to document training and training completed. The plan will ir.clude revision of the training attendance record form to include all necessary information as noted in the audit report. The plan will include checks and balances to ensure that training is given to everyone it is intended for. The plan will call for a training schedule, and will provide for the identification of as needed training.
e Ansigvuneens A Constive Acton htatm Phane !!!
IM Roision (2k Nmmber 25,1997 S AMEETINGS.!MPtAVAtATRIWl D LTR.WPD
4 Corrective Actions to $PEC Audit Findirss Ref.
Assige D:t2 C:te Rank and NRC Inspect 6en Observations.
To assigned complete 12C QA systems runt cause analpis finding: The calibration sptem Ind. Audit G.
11/04/97 needs to be resiewed and inised to more thoroughly detail the Report Moran requirements for cabbration, documentation, and traceability to Part B 3 NIST for standards used.
What will be done to correct the problem?
The plan to rewrite the QA progra n described in item IOC of this matrix will include revision of the calibration system to reference the standard used in calibration. The plan will require that microners and calipers be calibrated at ful; scale. The plan will require procurement documents for out of house olibrations to require NIST traceability etc as noted on attachment I of the independent audit report.
13C QA sptem twd cause annipis finding: Nonconformance Ind. Audit G.
11/04/97 reports are not rniewed and acted on in a timely manner. The Report Moran system alre 'Qs controls to ensure evaluation of repetitive Part B-4 nonconfonnances.
What will be done to carrect the problem?
Tie plan to rewrite tic QA program described in item IOC of this matrix will include provision for the timely review and disposition of nonconforming material and provision for a biannual review of nonconformances by the Quality Msnager, Production Manager, and the General Manager to evaluate and identify repetitive trends. The plan will include a resiew of the practicality of requirements such as sign off by the President on all scrap dispositions.
14C QA sptem root cause analple finding: The corrective action Ind. Audit G.
11/04/97 system as currently defined and implemented is inadequate and Report Moran presides little value added, Part B 5 What will be done to correct the problem?
Tie plan to rewTite tic QA program described in item 10C of this matrix will include a resiew and reutile of the corrective action system. The plan will include: A corrective action should be generated to address each audit finding. Incorporation of the SPEC equipment failure reporting system into the corrective action system. A method for the evaluation of the effectiveness of corrective action taken. Expansion of the corrective action reporting form to address action steps taken, possibly by more than one person.
- Ansignmma A Corredive Astum Mauis Fliane !!!
D-$
Rmse(n Novemtwr 23,1997 -