ML20212F933

Ack Receipt of 970902 & 19 Ltrs Re Audit of QA Program & Corrective Action Implementation Matrix.Revised Implementing Procedures for Licensee QA Program Must Be Fully Implemented Before Resumption of Full Fabrication Can Be Authorized

ML20212F933
Person / Time
Site:	07100102
Issue date:	10/27/1997
From:	Haughney C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Dicharry R SOURCE PRODUCTION & EQUIPMENT CO., INC.
References
CAL-97-7-06, CAL-97-7-6, NUDOCS 9711050172
Download: ML20212F933 (4)

Text

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1. f WASHINGTON. D.C. 3000H001 1  % # October 27, 1997 Mr. R. D. Dichany, President Source Production and Equipment Company, Inc.

113 Teal Street St. Rose, Louisiana 70087-9691

SUBJECT:

CONFIRMATORY ACTION LETTER NO. 97-7-006 UPDATE .

REFERENCES:

1. U.S. Nuclear Regulatory Commton's Confirmatory Action Letter No.

97-7-006 dated June 24,1997.

2. Source Production and Equipment Company, Inc., letter dated September 2,1997, to Mr. Thomas Matula, regarding the indeper. dent audit of SPEC's quality assurance program.

3. Source Production and Equipment Company, Inc., letter dated September 19,1997, to Mr. Thomas Matula, regarding SPEC's Phase ill Corrective Action Implementation Plan Matrix.

Dear Mr. Dicharry:

We acknowledge receipt of your two letters dated September 2 and September 19,1997 (Reference Nos. 2 and 3, respectively). Your September 2,1997, letter provides trye audit report from the independent quality assurance (QA) expert, Quality Management Support, Inc.

(QMS), regarding the effectiveness of the Source Production and Equipment Company, Inc, i (SPEC), QA program in complying with the requirements of 10 CFR Part 71. This action addresses item No. 5 of the NRC's Confirmatory Action Letter No. 97-7-006, dated Jur'e 24, 1997 (Reference No.1). Your September 19,1997, letter provides the SPEC Phase lli Corrective Action Implementation Plan Matrix (Corrective Action Plan), Revision No.1, including your proposed corrective actions to resolve the findings of the QM6 audit of the SPEC QA program. ,

Part B of the QMS audit report identifies five major root causes r%ponsible for "the lapses in the current quality system at SPEC." A synopsis of the root causes and recommendations presented in the OMS audit report follows.

1. Quality Svstem Documentation and Document Cordrol. QMS states that "[t}he current fj quality system documentation is disjointed with little flow from the Quality Program Manual to Quality Assuranca Manuel to the bulk of the Quality System which is presented in the Standard Operating Procedures Manual. In some cases there is no I[

continuity between requirements of one manual and those of another."

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QMS' Recommer'dation "A totai review and rewrite of the quality system documentation. . . ."

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- 2. Qualification and Trainino. QMS states that "[t]he current system for defining and -

documenting qualification requirements and training needs is inadequate. [Porsonne')

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[q)ualification requirements are not well defined.- Required training for personnel has not been established."

GMS' Recommenda0on "Rewnte the appropriate Quality Manual Section to define

, method of qualification of personnel for each defined job classification. . . ."

3. Control and Calibration of Insoection. Measurina. and Test Eauioment. QMS states that

"[t]he calibration system needs to be rev6ewed and revised to more thoroug'nly detail the

• requirements for calibration, documentation and traceability back to NIST (National Institute of Science and Technology) for the standards used."

QMS' Rtcommendation: " Equipment calibration records should be expanded to include an identification of which standard was used in the calibration, The procedure needs to be reviewed and revised to include the calibration traceability of standard used."

4. Nonconformance Reportina. QMS states that "[t]he system's weakness seems to be in

- the timely review and disposition of the nonconforming material. The system also lacks controls to ensure evaluation of repetitive nonconformances."

QMS' Recommendation: "[t] hat tha nonconformance requirements in the quality manual be expanded to include a requirement for timely review and disposition of nonconforming material. . . . Procedures should be reviewed / revised to ensure defined requirements can be met. . . ."

5. Corrective Action. QMS states that "[t]he corrective action system as currently defined and implemented is inadequate and provides little _value added."

QMS' Recommendation: " Manual section and appropriate procedures associated with Corrective Action Requests should be revised /rewntion and greatly strengthened."

QMS c!so stated that "[t]he problems with the SPEC Quality System are not limited to the five items listed above. The philosophy of quality, including the discipline and consistency required by a quality system, needs to be reintroduced throughout all areas of the facility including all personnelinvolved."

QMS' findings indicate that the current SPEC QA program is not effective in complying with the requirements of 10 CFR Part 71 and that a total review and rewrite of the QA program implementing procedures is required. Furthermore, item No.10C of the Corrective Action Plan, which addresses what SPEC will do to correct Root Cause No.1 above, states that SPEC will

"[c)reate a plan to totally review and rewrite SPEC's Quality System." Item Nos.11C through 14C of the Corrective Action Plan, which address what SPEC will do to correct Root Caute Nos. 2 through 5 above, each state that SPEC will ". . rewrite the QA program described in item 100."

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l R. D. Dicharry 3 NRC staff has determined that the root causes identified by QMS in its audit of SPEC's QA program, the recommendations proposed by QMS to resolve the issues, and the corrective

. actions planned by SPEC indicato that the procedures that implement the SPEC QA program must be reviewed and revised in their entirety. Please be advised that the revised implementing procedures for the SPEC QA program must be fully implemented before resumption of full fabrication can be authorized. Please provide your plan to NRC by December 1,1997, for full implementation of your revised QA program.

Sincerely, I

Charles J. Hau ney, Director Spent Fuel Project Office t Office of Nuclear Material Safety and Safeguards Docket No.: 71-0102

R. D. Dicharry 3

- NRC staff has determined that the root causes identified by QMS in its audit of SPEC's QA program, the recommendations proposed by QMS to resolve the issues, and the corrective actions planned by SPEC indicate that the procedures that implement the SPEC QA program must be reviewed and revised in their entirety. Please be advised that the revised implementing -

procedures for the SPEC QA program must be fully implemented before resumption of full t fabrication can be authorized. Please provide your plan to NRC by December 1,1997, for full implementation of your revised QA program.

Sincerely, Original /s/ by:

Charles J. Haughney, Director Spent Fuel Project Office Office of Nuclear Material Ssfety and Safeguards Docket No.: 71-0102 t

Distribution:

"NRC E l SFPO r/f -XPUBUC L NMSS r/f '

TSIS route JLieberman, OE WReamer OGC GJackson, OC CHaughney ELeeds FSturz RChappell .

DTiktinsky SBaggett BSpitzberg, RIV -

O 1 OFC *SFPO C *SFPO C *SFPO C /V)fFPO ' C +

, NAME - TMatula/ tom GBennington PEng h Haughney~

DATE 10 /22 /97 10/23 /97 10/22 /97 10(JI)/97 C = COVER ~ E = COVER & ENCLOSURE N = NO COPY G:\ SPEC.LTR '

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