ML20149D666
| ML20149D666 | |
| Person / Time | |
|---|---|
| Site: | 07100102 |
| Issue date: | 07/14/1997 |
| From: | Frizell C, Moran G, Weber P SOURCE PRODUCTION & EQUIPMENT CO., INC. |
| To: | |
| Shared Package | |
| ML20149D663 | List: |
| References | |
| 97-01, 97-1, NUDOCS 9707170209 | |
| Download: ML20149D666 (15) | |
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No. 97-01 QA PROCEDURE i
TITLE PHASEI of CORRECTIVE ACTION IMPLEMENTATION PLAN for SPEC QA Program PREPARED BY: C. M. Frizell Approval
/kh76sIA 7//4/97
[l cte cher, General Manager i
kdObta... 'lm l=n x
Geo)ge d oran)VicQresident l
NErdlaad rkk7 Donny Dicharry,ylesident DR. Roy Parker, Consultant i
Rev. (0) 13 July,1997 rn.E H OR SEXT/PROCEDUR/COVPROCA.97 Source Production & Equipment Company,Inc.
SPEC 002 113 Teal Street, St. Rose, LA 70087 4
9707170209 970714' PDR ADOCK 07100102 C
QA Proc: dura No: 97-01, Revision (0)
July 13,1997 Phase I of Corrective Action hnplementation Plan SPEC QA Program No. 0102
1.0 PURPOSE
1.1 To assure that all QA fabrication related activities are performed in compliance with the QA Program prior to the resumption of limited fabrication and distribution activities.
2.0 SCOPE
2.1 This plan will encompass all fabrication related activities; which include personnel training, purchasing, fabrication instructions, drawings, document control, special processes, measuring and test equipment.
3.0 REFERENCES
3.1 SPEC Quality Assurance Program Revision 2.2 of 25 May,1991.
3.2 SPEC Quality Assurance Manual.
3.3 SPEC Internal Audit Report, Rev (2), July 12,1997.
34 NRC Inspection Exit Meeting Minutes, Junenuly,1997.
4.0 PROCEDURE
4.1 Implementation Team oversight of the Plan.
4.1.1 Establish an Implementation Plan Oversight Team (Team) consisting of the President, Team Leader, Vice President, General Manager, QA Manager, Production Manager, Engineering Manager, and Special Projects Manager.
4.1.2 Conduct Team daily meetings during Phase I with written agendas & minutes. The minutes will provide the QA record of the implementation of Phase 1. The purpose of the meetings is to provide direction and oversight of Phase I of the Plan.
4.2 Transfer all activities and functions that are not directly QA related to other departments.
4.3 Coordinate with Dr. Roy A. Parker, an independent regulatory complience consultant, to prepare for oversight of fabrication related QA activities during Phase 11. Oversight activities are to include the following:
4.3.1 Audit fabrication personnel first hand on a random basis, thereby assuring management and the NRC that the fabrication activities are being conducted in accordance with the QA Program.
4.3.2 Audit QA inspection personnel first hand on a random basis, thereby assuring management and the NRC that the inspection activities are being conducted in accordance with the QA Program.
4.3.3 Upon resumption of fabrication, review and approve all new package fabrication records for completeness as part of final inspection of the package before release for distribution.
4.3.4 Report directly to the President on random observations and overall status of the Plan semi-weekly.
4.3.5 Serve as member of Materials Review Board, which acts on the disposition of all Non-conforming Materials Reports and initiates Corrective Action Reports as needed.
4.3.6 Report weekly to NRC on status of the Pir.n, number of devices fabricated, and other relevant infornmtion i
requested by the NRC.
4.4 Implement Corrective Actions (see Attachment A).
4.5 Retraining of Personnel.
4.5.1 Develop a training schedule, syllabus, and written examinations for QA Program retraining to be provided to SPEC personnel in all chapters of the QA Program.
4.5.2 Conduct retraining, including administering of written open-book examinations. Evaluate and document training in accordance with QAM 2.1.
4.5.3 Conduct retraining and reexamination as required (failed exams). Only personnel who have passed the exam will be authorized to perform fabrication related QA activities.
4.6
. Limit rate of fabrication of new packages to maximum five (5) packages per week (1/6 full capacity).
4.7 Report completion of Phase I to NRC. Request authority to resume fabrication and distribution activities.
Pit %Ibl.(0) l QA ProceJwe No3h01,. Rev (0)
Page1of1 July 13,1997
SPEC Quality Assurance Program, NRC Certificate of Compliance No. 0102 CORRECTIVE ACTION IMPLEMENTATION PLAN Revision (0), July 14,1997 PURPOSE To provide a plan to implement QA System corrective actions to address fmdings from:
1.
. SPEC Internal Audit conducted July 7,1997.
2.
NRC Inspection on June 16-19,1997.
3.
NRC inspection on July 9-10,1997.
4.
Independent QA Program audit to be conducted in accordance with CAL No. 97-7-006.
5.
QA Program Root Cause Analysis to be conducted in accordance with Independent Audit (above).
SCOPE The Corrective Action (CA) Implementation Plan (Plan) will consist of three phases. The CA's that will be completed in each phase of the Plan have been selected to support the specific goal of the respective phase.
Phase 1.
The goal of Phase I is to assure that all QA fabrication related activities are performed in compliance with the QA Program prior to the resumption oflimited fabrication and distribution activities. The fabrication related activities include personnel training, purchasing, fabrication instructions, drawings, document control, special processes, measuring and test equipment control, calibration, inspection, identification of parts, and non-comforming material control.
Phase II.
The goal of Phase 11 is to cssure that all QA activities are performed in compliance with the QA Program prior to the resumption of full fabrication rate and prior to the resumption of new package design, prototype and testing activities. Phase 11 will include the completion of all corrective actions related to the findings and observations from the NRC inspection and SPEC's Internal Audit with the exception of actions related to the longer range systemic issues to be addressed in Phase III. The Plan will be reviewed and revised as needed upon receipt of the NRC Inspection Report.
Phase 111.
The goal of Phase III is to assure that the QA System is highly effective and is commensurate with a premiere world-class manufacturing company. The process will include an independent, expert analysis of the QA System, including root cause analysis of system weaknesses. The Plan will be reviewed and revised as needed upon receipt of the Independent Audit and Rpoot Cause Analysis reports. The corrective actions will focus on systemic improvements to establish a total quality culture at SPEC. The audit process will be revised as needed to assure that senior management remains fully appraised of the status of the QA System and that the achievements of this Corrective Action Plan are maintained permanently.
Corvective Action impkmentation Plan SPEC Quality Assuranw Program Reviskm (0), July 14.1997 Page i NRC Certificate of Compliancc No. 0102
i iIMPLEMENTATION PLAN
- Phtse !,
The activities in Phase I are specified in SPEC QA procedure No. 97-01, Rev (0), titled " Phase I af Corrective
. Action implementation Plan." The Plan includes the following Phase 1 features:
1.-
Implementation Team oversight of the Plan.-
Establish an Imp' r..tation Plan Oversight Team (Team) consisting of the President, Team Leader, Viw President, General Manager, QA Manager, Production Manager, Engineering Manager, and Special Projects Manager.
Conduct Team daily meetings during Phase I (and weekly meetings during Phase II) with a.
written agendas'& minutes The minutes will provide the QA record of the implementation of Phase L The purpose of the meetings is to provide direction and oversight of Phase I of the Plan.
2.
- Transfer all non-QA related activities out of QA Dept.
4 3..
~ Employ an independent consultant to provide Phase II oversight of fabrication related QA activities.
Contract with Dr. Roy A. Parker to:
- i. Audit t brication personnel and fabrication related activities first hand on a random basis, thereby assuring management and the NRC that the fabrication activities are being conducted in accorhnee with the QA Program.
f ii. Audit QA inspection personnel and activities first hand on a random basis, thereby assuring management and the NRC that the inspection activities are being conducted in accordance with the QA Program.
iii. Upon resumption of fabrication, review all new package fabrication recoros and sign off on the package before release for distribution.
iv. Report directly to the President on random observations and overall status of the Plan semi-weekly.
k
- v. Become member of Materials Review Board, which acts on the disposition of all Non-conforming Materials Reports and initiates Corrective Action Reports as needed.
vi. Report weekly to NRC on status of the Plan, number of devices fabricated, and other relevant material. Unless directed otherwise by the NRC, initiate bi-weekly telephone conversations with the NRC to supplement written reports.
I
'4.
Implement Phase I. (QA Procedure No. 97-01). All Phase I CA's are redlined in the audit reports.
5.
Retraining of Personnel.
Develop a training schedule, syllabus, and written examinations for QA Program training to be provided to SPEC personnel.
Conduct training, including administering of written open-book examinations. Evaluate and a
document results. Place documentation in appropriate personnel files.
Conduct retraining and reexamination as required (failed exams). Only personnel who have
_ passed the exam will be authorized to perform fabrication related QA activities.
[6.
Resume limited fabrication (maximum 5 packages per week) upon NRC authorization.
Corrective Action Implementation Plan SPEC Quality Assurance Program Revision (0), July 14.1997 Page 2 NRC Certificate of Compliance No. 0102
i i
Phase II 1.
Implement Phase 11 CA's from SPEC's Internal Audit and findings from both portions of the NRC inspection.
2.
Make Otganizational changes.
_ Hire new QA Manager to provide more effective direction and control.
3.
Review of-NRC Inspection report l
Review report when received,' develop additional CA's if necessary, and implement as
=
appropriate, with Dr. Parker to verify implementation.
Reeducate personnel regarding the changes in 2 and herein.
4.
Expert Audit and Root Cause Analysis (RCA) 4
~
Contact has been made with several QA experts. The leading candidate has QA audit and Root Cause Analysis experience, including in the nuclear power and nuclear waste areas. As of this date audit availability is not set although an audit before the end of July is expected.
The NRC will be supplied with credentials of candidate prior to July 21,1997 and prior to selection.
.- Review prior audit results with QA expert (from internal audit and NRC inspection).
. Develop audit plan, conduct audit and RCA, obtain written report, and analyze.
Revise CA Implementation Plan based on independent audit and RCA.
Analyze RCA and develop action items to address recommendations and implement as appropriate.
5.
Resume full production upon NRC authorization. Conclude the contract with Dr. Parker.
I j-Phase 111 1.
Implement Phase 111 CA's from SPEC's Intemal Audit and findings from both portions of the NRC inspection.
2.
Develop actions and implement plans to:
Foster on-going quality cultural change.
Expand PI teams to address on-going QA improvements.
. Refine the on-going audit process, blenarne: IMP-PLAN (0) 1 4
l I
Corrective Action Impleraentation Plan
- SPEC Quality Assurance Program
- Revision (0), July 14,1997 Page 3 NRC Certificate orCompliance No. 0102 -
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