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Category:CORRESPONDENCE-LETTERS
MONTHYEARML20236R7951998-07-14014 July 1998 Informs That on 980628,NRC Authorized AEA Technology/Qsa,Inc to Proceed W/Fabrication of Models OP-660 & OPL-660 Packages in Response to Questions ML20247H2371998-05-0606 May 1998 Discusses Re NRC CAL 97-7-006,dtd 970624 & CAL Suppl .Actions Which Have Been Taken or Will Be Taken to Correct Issues Identified & Initiatives Taken to Correct Safety & Quality Attitude at Facility,Acceptable ML20217Q6331998-04-0303 April 1998 Describes Basis for NRC to Authorize Licensee to Resume Full Production of NRC-certified Packagings,Per CAL 97-7-06 Issued on 970624 ML20216B2311998-03-10010 March 1998 Requests Clarification of Definition of Used Type B Package.Authorization to Proceed W/Refurbishment of Used Packages Requested If Clarification Not Readily Available from NRC ML20198F8281997-12-30030 December 1997 Ack Receipt of Informing NRC of Steps Taken to Correct Nonconformance Noted in Insp Rept 70-0102/97-211. Receipt of QA Plan, ,which Provided Plan for Implementing Revised QA Procedures,Ack ML20199L0981997-11-25025 November 1997 Forwards Update on Status of Licensee Corrective Action Plan,In Response to CAL 97-7-06.Revised Phase II & III Corrective Actions Plan Encl ML20212F9331997-10-27027 October 1997 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 ML20198J1121997-10-0101 October 1997 Ack Receipt of 970925 & s,Requesting Extension to Response to NRC Notice of Nonconformance from 970928-1028 ML20211G6221997-09-19019 September 1997 Forwards Rev 1,dtd 970919,to QA Procedure 97-01, Matrix of Assignments & Corrective Actions - Phase III for Corrective Action Implementation Plan ML20210S5271997-09-0202 September 1997 Forwards Independent QA Audit Rept Satisfying Item 5 of NRC CAL 97-7-06.Part B of Rept Identified Root Causes & Includes Recommendations for Improvements IR 07100120/19972111997-08-28028 August 1997 Forwards Insp Rept 71-0120/97-211 on 970616-19 & 970709-10 & Notice of Nonconformance ML20216B4071997-08-28028 August 1997 Forwards Independent QA Audit Rept Submitted by Cl Tillman of Quality Mgt Support,Inc.Part B of Rept Identifies Root Causes & Includes Recommendations for Improvements to Be Used to Develop Phase III Corrective Action Plan ML20217M2861997-08-20020 August 1997 Reiterates Purpose of Independent Audit of Spec'S QA Sys Being Conducted IAW Phase II of Corrective Action Plan,Rev 0 & Item 5 from Confirmation Action Ltr CAL-97-7-06 ML20217H9411997-08-0404 August 1997 Forwards Rev 1 to Matrix of Assignments & Corrective Actions - Phase II for Corrective Action Implementation Plan, IAW Discussion W/R Parker on 970801 ML20149H6821997-07-23023 July 1997 Informs of Authorization to Resume Limited Fabrication of New Type B Packaging at Rate Not to Exceed Five Packagings Per Week & Requests,In Writing,Date Independent Audit Is Completed & Results of Audit Re CAL 97-7-06 ML20149J2241997-07-21021 July 1997 Forwards Listed Addl Info Requested to Support Rept to Verify Completion of Phase I of Spec QA Procedure 97-01,Rev 1 ML20149J1881997-07-18018 July 1997 Provides Certification That Activities & Corrective Actions Specified in Spec Rev 1 to QA Procedure 97-01,have Been Completed W/Two Exceptions Listed,In Response to CAL-97-7-06,dtd 970624 ML20196H0931997-07-15015 July 1997 Describes Basis for NRC to Authorize Resumption of Fabrication of NRC-certified Packagings Per CAL 97-7-06 ML20149D6601997-07-14014 July 1997 Forwards Rev 0 to QA Program CA Implementation Plan, Re CAL 97-7-06,dtd 970624.Plan Specifies CAs in Response to Exit Meeting Observations Discussed After NRC Insp of Licensees QA Program,Nrc Coc 0102 on 970616-19.W/audit Rept ML20141C9861997-06-24024 June 1997 Confirmatory Action Ltr Re Insp on 970616-19.Listed Actions to Be Completed by Dates Specified ML20126K8251992-07-10010 July 1992 Final Response to FOIA Request for Source Production & Equipment Co Insp Rept.App a Document Already in PDR IA-92-316, Final Response to FOIA Request for Source Production & Equipment Co Insp Rept.App a Document Already in PDR1992-07-10010 July 1992 Final Response to FOIA Request for Source Production & Equipment Co Insp Rept.App a Document Already in PDR ML20126K8111992-06-23023 June 1992 FOIA Request for Insp Rept of Source Production & Equipment Co on 880524-26 ML20058E0441990-11-0101 November 1990 Responds to 900626 & 1018 Ltrs Describing Corrective Actions in Response to Items of Violation & Nonconformance Identified in NRC ML20206K2541988-11-16016 November 1988 Forwards Rev 2.1 to QA Plan for Reinstatement of QA Program Plan approval:0102.W/o Encl ML20195G7521988-11-16016 November 1988 Requests 3 Month Extension Until 890308 to Submit Info Requested in ,Per 881115 Meeting.Addl Time Required to Mfg Prototypes,Perform Type B Package Tests & Prepare Repts ML20151P3381988-08-0505 August 1988 Advises That QA Program Plan Must Be Resubmitted for Review & Approval,In Order to Reinstate QA Program Approval 0102. Implementing Procedures/Instructions Should Be Provided as Part of Submittal ML20154C8601986-02-26026 February 1986 Forwards QA Program Approval for Radioactive Matl Package: 0102,Rev 2.All Refs to App E in QA Program Description Should Be Changed to Subpart H ML20137S2891986-01-31031 January 1986 Advises That QA Program Approval for Radioactive Matl package:0102 Expires on 860331.Renewal Must Be Requested within 30 Days of Expiration.If Renewal Not Desired,Nrc Should Be So Notified 1998-07-14
[Table view] Category:OUTGOING CORRESPONDENCE
MONTHYEARML20236R7951998-07-14014 July 1998 Informs That on 980628,NRC Authorized AEA Technology/Qsa,Inc to Proceed W/Fabrication of Models OP-660 & OPL-660 Packages in Response to Questions ML20247H2371998-05-0606 May 1998 Discusses Re NRC CAL 97-7-006,dtd 970624 & CAL Suppl .Actions Which Have Been Taken or Will Be Taken to Correct Issues Identified & Initiatives Taken to Correct Safety & Quality Attitude at Facility,Acceptable ML20217Q6331998-04-0303 April 1998 Describes Basis for NRC to Authorize Licensee to Resume Full Production of NRC-certified Packagings,Per CAL 97-7-06 Issued on 970624 ML20198F8281997-12-30030 December 1997 Ack Receipt of Informing NRC of Steps Taken to Correct Nonconformance Noted in Insp Rept 70-0102/97-211. Receipt of QA Plan, ,which Provided Plan for Implementing Revised QA Procedures,Ack ML20212F9331997-10-27027 October 1997 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 ML20198J1121997-10-0101 October 1997 Ack Receipt of 970925 & s,Requesting Extension to Response to NRC Notice of Nonconformance from 970928-1028 IR 07100120/19972111997-08-28028 August 1997 Forwards Insp Rept 71-0120/97-211 on 970616-19 & 970709-10 & Notice of Nonconformance ML20149H6821997-07-23023 July 1997 Informs of Authorization to Resume Limited Fabrication of New Type B Packaging at Rate Not to Exceed Five Packagings Per Week & Requests,In Writing,Date Independent Audit Is Completed & Results of Audit Re CAL 97-7-06 ML20196H0931997-07-15015 July 1997 Describes Basis for NRC to Authorize Resumption of Fabrication of NRC-certified Packagings Per CAL 97-7-06 ML20141C9861997-06-24024 June 1997 Confirmatory Action Ltr Re Insp on 970616-19.Listed Actions to Be Completed by Dates Specified ML20126K8251992-07-10010 July 1992 Final Response to FOIA Request for Source Production & Equipment Co Insp Rept.App a Document Already in PDR IA-92-316, Final Response to FOIA Request for Source Production & Equipment Co Insp Rept.App a Document Already in PDR1992-07-10010 July 1992 Final Response to FOIA Request for Source Production & Equipment Co Insp Rept.App a Document Already in PDR ML20058E0441990-11-0101 November 1990 Responds to 900626 & 1018 Ltrs Describing Corrective Actions in Response to Items of Violation & Nonconformance Identified in NRC ML20151P3381988-08-0505 August 1988 Advises That QA Program Plan Must Be Resubmitted for Review & Approval,In Order to Reinstate QA Program Approval 0102. Implementing Procedures/Instructions Should Be Provided as Part of Submittal ML20154C8601986-02-26026 February 1986 Forwards QA Program Approval for Radioactive Matl Package: 0102,Rev 2.All Refs to App E in QA Program Description Should Be Changed to Subpart H ML20137S2891986-01-31031 January 1986 Advises That QA Program Approval for Radioactive Matl package:0102 Expires on 860331.Renewal Must Be Requested within 30 Days of Expiration.If Renewal Not Desired,Nrc Should Be So Notified 1998-07-14
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7/-0/a2-p 4 UNITED STATES
= E NUCLEAR REGULATORY COMMISSION
- 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."
, i)
QMS' Recommer'dation "A totai review and rewrite of the quality system documentation. . . ."
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R. D. Dichany 2 i
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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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