ML20216B407
| ML20216B407 | |
| Person / Time | |
|---|---|
| Site: | 07100102 |
| Issue date: | 08/28/1997 |
| From: | Dicharry R SOURCE PRODUCTION & EQUIPMENT CO., INC. |
| To: | Matula T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| CAL-97-7-06, CAL-97-7-6, NUDOCS 9709080036 | |
| Download: ML20216B407 (9) | |
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08/29/1997 17:50 5044677685 SPEC PAGE.01 a.a 7 / - O 10 2.
Oo v..
FACSIMILE TRANSMISSION Total Pages 9 August 28,1997 Mr. Tom Matula Mail Stop 06F18 I
Transportation, Safety & Inspection Branch Spent Fuel Project OfYice, NMSS U. S. Nuclear Regulatory Commission Wr.shington D.C. 20555 i
FAX No: 301-415-8555
Reference:
Confirmatory Action Letter No. 97-7-006, dated June 24,1997.
Detr Tom:
Attached please find the independent QA Audit Repon submitted by Mr. Cassius L. Tillman of Quality Management Support, Inc. The hard copy will be mailed on Tuesday, September 2,1997. Part B of the report identifies the root causes and includes recommendations for improvements. This will be used to supplement SPEC's audit report and the NRC's inspection report to develop the Phase III Corrective Action Plan.
Please note that the completion of the independent audit satisfies item 5 of NRC Corrective Action Letter No. 97 006. We have completed all cf the items in the CAL but we are not yet requesting for the NRC to close the CAL since we are still implementing Phase 11 corrective actions. The Phase III Plan will be submitted to the NRC by September 15,1997.
/'
Sin e
/
R.
. (Donny)Dicharry President -
1 Enclosed:
QA Audit Report dated August 25,1997, Quality Management Support, Inc.
7 fj 08-28-97.GC1 i
9709080036 970828
{DR ADOCK 07100102 PDR urca Production A Fnisinment en Ine
08 29/4997 17:50 5044677685 SPEC PAGE 02 Qllalliv System Review / Evaluation Resiew Dates: August 19 and 25.1997 Lead Auditor: Cassius L Tillman. IV, Qaality Management Support. Inc.
. Seuree Production and Equipment Company, In..
St. Rose Facility Part A A review of each correctise action to SPEC findings and NRC Inspection Observation was made, anociated new procedures. changed proecdures, training records, and other types of documentstien were reviewed. Cometive Action 15 A through 36 A were riniewed as follows:
15A Resiewed Procedure 1.1 and the Engineering change orders system 16A Reviewed revised shop order travelers for Aem lock Assembly Spec 150 Main Traveler both contained print ID and revision level from quality with a comparisor and documentation ofthe prmt used.
17A See 15 A 18A All non in-process travelers hr.ve been removed frem the shop floor. Ken Joslyn issues work orders for production, the Quality Depanment ensures latest editien ofsimp traveler issuance and pnnt control Work Orders releated to Production a:ter Quality Deparunent sign off.
19A See above, a variety ofre-issued trav:lers were reviewed. All had General Manager sign off as well as Quality Depanment sign off.
20A A review ofdocumentation on the shop floor contained no " Sketches". Sketches have been removed from operational existence.
Sketch Spec 150 S tube cut offdated 10495 stored in non-production file drawer are red lined ' /" through text marked obsolete.
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21A Retiewed revised form QA 7.8 fer shield 22A Reviewed training retraining record ofJuly 18,1997 and revised traveler 150008 23A Prelimhwy status has been made obsolete. All drawings require the sarne review and approval process for control, ChanBes are controlled through the use ofthe Engineering Change Request System, 1
24A Calipers revicued in use in production areas were found to have the appropriate current calibration sticker, i.e. s,n 0034930 Mitatoyo. Training records of 714 97 efQA personnel to Calibratiott and Control of Calipers reviewed 25A Resiewed revised Standard Operating Procedure 6.10. -Survey Meter Calibration".
26A Reviewed document control proced tre 1.10. " Engineering Doeument control" paragraph 7.4 dealing with red line changes to enginecting documents. Red Line ability has not been climinated from the system but cornrols are more dermitive.
27A Reviewed Ship Traveler 150008, " Casting Depleted 1'ranium Shield". Resision 2 July 18,1997. Reviewed file for Spee 150 Camera en 0496. Certificats of Compliance from Manufaauring Science Corporation 804 Kerr Hollow Road Oak Ridge, TN 37830 was readily available.
28A Drawing books located at three differe:n locations were reviewed against the most current revision of the Master list. The latest revisions were availsble.
29A Reviewed newly generated procedures for SPEC 150 procedart a 1.30. "Doeument Distribution", Revision O. 718-97.
30A Revised Training records:
The majority of personnel were trained on July 16,1997. A make up traimng session was provided for three people on July 24,1997. Traveler Training was provided on 7-17 97, 31A.
Reviewed new shop crder procedure =3/J5, "Shep Orders", Revision 0. 7 18-97.
Reviewed shop orders and shop order log, i APernh A d-.
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32A Reviewed documentation ofreitupection ofparts in questions.
33A Reviewed newl) generated fenn titled Inspection'Fabriestion Doeumentation Audit Checklist. Checklist will be utilized to verify completion of all required process steps, and impections and test requires QA Sign off 34A A nonconformance room. locked. ecmplete with file cabinets for records and storage for nonconforming material has been established. A review ofitems in noncenfonnance area was performed. All items had appropriate marking red tags and copies of pertinent Nonconformance Reports attached.
.M A Reviewed newly generated fenn and procedure QA 18.1 " Spot Audits" and records of those " Spot Audits" performed. Limited number to date due to the implementation time cycle.
36A Reviewed procedures for Engineering Change orders 3.0 QAM Section 3 Scope -
Prototype and production drawing will require the same nature and extent ofreview and approval.
Completion corrective eetions associated with Phase I have been verified. Evaluation of the efectiveness of these actions will require the passing oftime and utilization of the systent f.alLD No one smgle element of the quality sy stem. nor one single event h respomible for the lapses in the current quality system at SPE.C Our root cause analysis uncovered a number ofcontributing factors, which exclusively may has e minor efect on the quality system. L'ut collectively have had a major negative impact.
Five major root causes have been identified for improvement:
1)
Quality System Documentatien and Document Contro!
- )
Qualification and Training
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3)
Control and Calibration ofInspection. Measuring and Test Equipment 4)
Nenconformance Reporting 5)
Corrective Action Sptem.
l On-u*v hatem Duw..en*H =
' Doc =
re canerol The current quality sptem documentation is disjointed with little flow from the Quality Program Manual to Quality Assurance Manual to the bulk ofthe Quality System which is pre.sented in the Standard Operating Procedure Manual. In some cases there is no continuity between requirements of one manual and those ofanother. Multiple authors over time have been a contributing factor to diis problem In seanc arena, i.e. corrective action. the requirements of when to use and how 1o use have not been well defuwd.
Recommendation:
- A total review of and remite of tlw quality system documentation 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 Manual) to the most specific document (Work Instructions).
Reviewirewrite of area specifi portions of the manual and procedures should be done in concert with the personnel who penbrm this work. Their involvement in th: proccos will help with acceptance of and cumnhip of the quality system.
o un, an -a TEw.
The cunent system for derming and documenting qualification requirements and training needs is inadequate. Qualification requirements are not well defined. Required training for
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personnel has not been established. Training is not " Evergreen" you can't do it once and expect it to last forever, Recommendation:
Rewrite the appropriate Quality Manual Section to def'me:
Method of qualification ofpersonnel for each definedjob classification.
Training required:
Quality System Training Job Specifle Training Establish methods, i.e. checklist. to document training required and training completed.
Training attendance records need to be revised to include at a nunimum:
Detailed dese-iption of training provided Date oftraining Duration oftraining Name of person providing the training List ofattendees if training to "all Penonnel" is identified, the system has to have propu eheeks and balances to assure that all personnel reeeive the required training.
A training schedule needs to be established and published.
As needed training needs to be identified and provided.
Control==8 Callhrstion ofInanection. Measurine and Test Enninment The calibration system needs to be reviewed and revised to more thoroughly detail the requirements for calibration. decumentation and traceability back to NIST for standards uwd.
Reconunendation:
Equipment calibration records should be expanded to include an identification ofuhich standard was used in the calibration.
The procedure need to be n evieuwd revised for calibration ofstandard used.
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The procedure 7.22 for the calibration of calipera' micrometers be revicuid and revised to ensure ful! : ale calibration.
Purchasing documents ofinspection, measuring, and test equipment (including standards) sont out for calibration should include a paragraph nimilar to attadunent 1
- Nonconfor, Rg==.if i
l Nonconformances are currently being well documented at the time ofoccurrence. The systems weakness seems to be in the timely review and disposition of the nonconforming material. The system also lacks controls ta ensure evaluation ofrepetitive nonconformances.
Recommendations:
That the nonconformance requirements in the quality runnual be expanded to in:lude a requirement for timely review and disposition ofnonconforming material.
At a minimum. twice yearly reviews ofnonconfonnances be performed and documented by the Quality Atauager. Production Alanager, and the General 5 tanager to evaluate and idemify repetitive trends. The corrective action sptem should be utilized as the vehicle for documentation.
Proceduren should be reticued' revised to emure defined requirements can be met, i.e.
sign off by the President on all scrap dispositions.
Correcthe Action The corrective action system as currently defined and implemented is inadequate and prosides little value added. -
Recommendation:
Manual sc.:tien and appropnate procedures associated with Cotteetive Action Requests should be revised rnstitten and greatly strengthened, The requirements ofISO 9000 element 4.14," Corrective and Preventive Action" would provide a good basic guideline for this section.
Corrective Actien should be generated to address audit findinp.
g A
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' That the SPEC Failure Reporting program be tied to, become past cf the. Corrective Action System.
A method for the evaluation of the effectiveness of corrective action taken be established and utilized.
The corrective action reporting form be expanded to address action steps taken. Iterns which cause the generation of a cortsetiva action report usually do not haw a simple one line answer. Normally multiple action need to be taken and traced. Performance and completion is otten by differmt pecple with different close out dates.
The problems with SPEC Quality System are not limited to the five items listed above. The philosophy ofquality, including the discipline and condstency requind by a quality system.
needs to be reintroduced tircughout all areas of the facility including all penonnel involved.
On a positive note, during my two day visit to the SPEC facility, SPEC personnel's positive attitudes staod out.
Posithas The Shop Order / Traveler System (already in the works) with eheeks and balane to enmre only the latest revision of the i;orrect print is utilized.
All penonnel imerviewed daring my two day visit are interested and expressed a desire to do it the right best way.-
Management personnel expressed a desire to not only correct the problems but to have this -
experience be value added and the end results be a better quality system to work with and a bener final product.
The SPEC Equipment Fail Reponing System is very good. Formally connecting it to the Corrective Action would make it even better.
' The Spot Audit Process provides an effective means to involve alllevels of management and all d:panments in the QA system.
a
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m Implementation of rewstien update, stronger quality uptem throughout the facility,
~ Ensuring ownerdtip of the Quality Systun by a!! SPEC personnel.
Maintaining long term focus on and attention to the Quality S.sem.
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