ML20211G627
| ML20211G627 | |
| Person / Time | |
|---|---|
| Site: | 07100102 |
| Issue date: | 09/19/1997 |
| From: | SOURCE PRODUCTION & EQUIPMENT CO., INC. |
| To: | |
| Shared Package | |
| ML20211G625 | List: |
| References | |
| 97-01-01, 97-1-1, NUDOCS 9710030125 | |
| Download: ML20211G627 (4) | |
Text
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MATRIX OF ASSIGNMENTS AND CORRECTIVE ACTIONS-PilASE Ill R:visloa (1), Sept:mber 19,1997 '
Corrective Action Implementation Plan SPEC QA Procedure 97-01, Rey (0)
Phase (11 Corrective Actions to SPEC Audit Findings Ref.
Assign Date Date Rank and NRC Inspection Observatior.1.
To assigned complete 01C SPEC procedure 7.23, para 7.l.2.3 requires drawing number Audit and revision forjigs and fixtures. The working copy of the Report calibration log does not provide this.
Finding Cause? The author of the list did not comply with the
- 1 written procedure. The creation of the document was not reviewed or approved as required by the QA manual.
What will be done to prevent the condition from 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 Cause? The author of the list did not comply with the Report written procedure. The creation of the document was not Finding reviewed or approved as required by the QA manual.
- 2 What will be done to correct the problem? Calibration records for All Extures and jigs will be reviewed. Re-calibrations will be perfonned as needed.
What will be done to prevent the condition from recurring? sThis item will be added to the next audit checklist.
03C QAM 12.0, control of measuring and test equipment, Audit requires listing caliper serial number and cal date on forms Report QA 103 ud QA 10.4. Form 10.3 complies, form 10.4 does Finding not have an area to record this information.
- 4 Cause? The author of the form did not include the required provision for recording caliper information.
What will be done to prevent the condition from recurring? QA personnel will be retrained in QA program chapter 12.0 and QA manual chapter 10.4.
04C A survey instrument calibration certificate is used to record Audit the results of an instrument " check" performed before each Report lot of DU castings is inspected. The form should only be Finding used for true calibrations.
- 5 Cause? Connicting QA documentation. QA procedure 7.49 conflicts with QA manual 12.1.c.8 The inspector followed QA procedure 7.49.
What will be done to correct the problem? A new form will be created for verifying calibration of survey meters.
QA personnel will be retrained. Package safety is not affected so remedial action is unnecessary.
What will be done to prevent the condition from recurring? As part of the scheduled independent audit, we will review the overall QA program and implementing procedures.
l 9710030125 970919 PDR ADOCK 07100102 C
PDR Assignmenu & Corrective Action Matriz Phase 111 Page 1 of 4 S Mf E ETINGSilM Pl.AN1MATRI X\\CA lll ( l )
Revision (1), september 17.1997
Ccrrective Actio1s to SPEC Audit Fir. dings Ref.
Astign DIte D:te R:nk tid NRC Inspection Observctiois.-
To cssigned complete 05Q in general, travelers do not list the revision letters or offer Audit blanks to fill in rnision letters for referenced documents.
Report Cause? f.:td of consideration of the " big picture" when Finding creating twelers.. Insufficient management review.
- 6 Absence of a link between travelers and engineering dragvings. Travelers created by QA instead of production or engmeeting.
What will be done to correct the problem? Revise travelers to include a blank for a revision letter for each referenced drawing.
06C Survey meter calibration certi0 cates are not approved by the Audit QA manager.
Report Cause? N/A Finding Survey meter calibration certincates are not approved by the
- 11 QA manager.
Cause? N/A What will be done to prevent the condition from recurring? G nerate 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, Surv,y Meter Calibration already requires 10% accuracy (not 20% as allowed by regulation). We may l.
want to reconsider this for customer meter calibrations.
l Compare Procedure 6.10 to the QAM 12.0 for inconsistencies and resolve.
07C SPEC C-1 drum fabrication / tracking and inspection log Audit Cause? The log that was used to record the inspection was Report created by Jake Kennedy (Procedure 4.16). The Forra QA Finding 10.I (from the QAM) was not included in that procedure.
- 12 Indi,'iduals 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 10.1i 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 d um manufacturing since it doesn't state " Shipping Drum" (or something similar). Mike Williams was unaware that the form existed.
There were drums that were not inspected since they were not brought to 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 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 Ot there 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 problem? [ Retrain fabrication and QA workers to comply with procedure 4.16 para 7.1.9. Revise procedure 4.16 to delete para 9.1.
What will be done to prevent the condition from recurring? Trainiag in all aspects of QAP and QAM.
Assignmems & Corrective Action Matrix. Phase 111 Pagt 2 or4
$41EETINGSilMP1EMATRIX\\CAni(1)
Revision (1), September 17,1997
Cerrective Actio1 sis SPEC Ardit Flidligs Ref.
Assign D:te D:te Rank cId NRC 1:spectin Obserntions.
To ts ;igned comphte 08C SPEC C-1 drawing 62190(2), door bracket drawing Audit 322002(0), nameplate does not have QA classification in Report accordance with QA manual 3.0 E.1.
Finding Cause? Unknown. Likely an oversight.
- 17 What wPI be done to correct the problem? In addition to the two drawings noted above, all C-1 drawings will be evaluated and assigned a QA Classification designation.
Currently, none of the C-1 drawings have been QA classified (all are dated prior to 1/1/92).
09C.
Design activity record form QA 33, Design activity records Audit are not available for C l.
Repor Cause? N/A. Not a finding.
Finding What will be done to prevent the condition from
- 18 recurring?
accordance w[ith SPEC's QA manual. Future design activity will be recorded in 10C QA system root cause analysis finding: The current quality Ind.
system is disjointed with little flow from the Quality Program Audit hianual to Quality Assurance hianual to the bulk of the Report Quality System which is presented in the Standard Operating Part B-1 Procedure hianual. In some cases there is no continuity between requirements of one manual and those of another.
hiultiple authors over time have been a contributing factor to this problem. In some areas, i.e. corrective action, the requirements of when to use and how to use have not been well defined.
What will be done to correct the problem?
Create a plan to totally review and rewrite SPEC's Quality system with emphasis on: Definition of requirements, Consistency of requirements, a methodology to connect the multi-tiered quality system to provide a logical flow from least specific document (Quality System hiannal) to the most specific document (Work Instructions).
1IC QA system root cause analysis finding: The current system Ind.
for defining and documenting qualification requirements and Audit training needs is inadequate. Qualification requirements are Report not well defined. Required training for personnel has not Part B-2 been established.
What will be done to correct the problem?
The plan to rewrite the QA program described in item 10C of this matrix will include the establishment of methods to define the method of qualification of personnel for each definedjob classification. The plan willinclude means to document training and training completed. The plan will include 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.
Assignments & Corrective Action Matrix. Phase 111 Page 3 of 4 S AM EETINGSilMPLANiMATRIX\\C Alli (1 )
Revision (I), September 17,1997 i
i
Correcthe Actiois to SPEC Audit Fixdings Ref.
Assign Date D:te Rink tid NRC lispectioi Observatiors.
To assigned complete 12Q QA system root cause analysis finding: The calibration Ind.
syst9m needs to be reviewed and revised to more thoroughly Audit detall the requirements for calibration, documentation, and Report traceability to NIST for standards used.
Part B-3 What will be done to correct the problem?
The plan to rewrite the QA program described in item 10C of this matrix will include revision of the calibration system to reference the standard used in calibration. The plan will require that micrometers and calipers be calibrated at full scale. The plan will require procurement documents for out-of house calibrations to require NIST traceability etc as noted on attachment I of the independent audit report.
13C QA system root cause analysis finding: Nonconformance ind.
reports are not reviewed and acted on in a timely manner.
Audit The system also lacks controls to ensure evaluation of Report repetitive nonconformances.-
Part B-4 What will be done to correct the problem?
The plan to rewrite the QA program described in item 10C of this matrix will include provision for the timely review and disposition ofnonconforming material and provision for
.i biannual review of nonconformances by the Quality Manager, Production Manager, and the General Manager to evaluate and identify repetitive trends. The plan will lL include a review of the practicality of requir 'ments such as sign off by the President on all scrap dispositions.
14C QA system root cause analysis finding: The corrective
- Ind, action system as currently defmed and implemented is Audit inadequate and provides little value added.
Report What will be done to correct the problem?
Part B-5 The plan te rewrite the QA program described in item IOC of this matrix will include a review and rewrite of the i
corrective action system. 'Ite 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.
Assignments & Conective Action Matrix - Phase ill Page 4 or4
$ 41L ETINGSil M PLA KM AT RI XiCA l tl.( l )
Revision (1), September 17,1997
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