ML20217N878
| ML20217N878 | |
| Person / Time | |
|---|---|
| Site: | 07109056, 07100102, 07109036, 07109263 |
| Issue date: | 04/28/1998 |
| From: | Matula T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Haughney C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| CAL-97-7-06, CAL-97-7-6, NUDOCS 9805050460 | |
| Download: ML20217N878 (22) | |
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.t WASHINGTON, D.C. wa8 *1 April 28, 1998 MEMORANDUM TO: Charles J. Haughney, Director Spent Fuel Project Office Office of Nuclear Material Safety and Safeguards l
FROM:
Thomas O. Matula
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l Safety inspection Engineer Transportation Storage and inspection Section i
Spent Fuel Project Office, NMSS
SUBJECT:
MEETING WITH SOURCE PRODUCTION AND EQUIPMENT COMPANY, INC., TO DISCUSS ITS QUALITY CULTURE I
A meeting was held between representatives of Source Production and Equipment Company, Inc. (SPEC), and the U.S. Nuclear Regulatory Commission (NRC) on April 23,1998. The purpose of the meeting was to discuss the actions taken by SPEC to correct and prevent a lack of quality culture and to discuss issues associated with the Confirmatory Action Letter (CAL)
No. 97-7-006 dated June 24,1997, and the CAL Update datad October 27,1997. CAL No. 97-7-006 and the CAL Update documented the actions that SPEC committed to take in l
response to safety concems identified during the NRC inspections performed on June 16-19, and July 9-10,1997. Attachment 1 is the meeting attendance list. Attachment 2 contains the i
slides presented by SPEC to the NRC. The meeting was noticed on April 3,1998.
After opening remarks by the NRC, SPEC's President stated that he is confident that SPEC has met all of the requirements specified by the CAL and CAL Update, introduced the members of his management staff present at the meeting, and turned the meeting over to the SPEC Vice President (VP). The VP stated that the focus of his presentation was to (1) review SPEC's response to issues raised in the CAL 97-7-006 and (2) discuss actions taken to change the -
quality culture at SPEC. The VP made the following points during his presentation:
i SPEC's organization has been changed to better meet the demands of changing the quality culture. The SPEC organization chart showed the Quality Assurance (QA) Manager, who started work at SPEC on April 1,1998, reporting to the General Manager. The General Manager reports to the VP, and the VP reports to the President. NRC made the observation that the organization chart did not show any lines of communication from the QA Manager to the President or VP. SPEC agreed that it would add dotted lines to its organization chart to reflect those lines of communication.
Regarding the CAL Action item 1, "... suspend fabrication...." the VP stated that SPEC
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stopped fabrication on June 20,1997. SPEC developed a three-phase corrective action plan which was completed on January 30,1997.
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i Regarding the CAL Action item 2, "... submit a test plan which... would verify the validity 1
of previbusly performed puncture tests," the VP stated that this action item was completed on June 24,1997.
I Regarding the CAL Action item 3, " Perform testing of the Model SPEC-150... " the VP stated that this action item was completed on June 26,1997, j
Regarding the CAL Action item 4, " Preserve all packaging... [and] submit test reports to the NRC...." the VP stated that this action item was completed. Following the tests, all items tested were placed in storage at SPEC and the test reports were submitted to NRC.
P Regarding the CAL Action item 5, "Obtain the services of an independent QA expert to audit the effectiveness of SPEC's QA program...." the VP stated that this action item was completed on September 2,1997. SPEC reviewed the deficiencies identified by the QA expert and performed a root cause analysis. SPEC stated that the root causes of the QA system failure were identified as (1) lack of Senior Management involvement in, and commitment to, SPEC's QA program and (2) lack of offective intemal audits that would Kjentify to SPEC's management shortcomings in the implementation of its QA program.
SPEC also stated that it plans to have a second audit perfornied by the same QA expert who performed the first audit by June 1999. This independent evaluation of SPEC's QA program will identify any shortcomings in its implementation that may have been overlooked.-
The VP. presented SPEC's philosophy toward quality culture and discussed each of the following Quality Operating Principles in detail: (1) Management must take the lead, (2) Focus on the customer, (3) Streamline processes, (4) Empower people, and (5) Measurement and data. The VP then presented the initiatives that SPEC has undertaken for each of these five Quality Operating Principles.
The President provided a list of lessons leamed that emphasized the importance of Senior Management commitment and involvement, and the need for an effective intemal audit system.
The QA Manager closed the presentation with information regarding her background, her initial impressions of SPEC, and her observations regarding the role of quality at SPEC.
During the meeting, and during the question and answer period following the presentation, the NRC staff commented on various issues raised by SPEC. The NRC staff asked many questions regarding SPEC's quality culture to determine the level of SPEC's understanding of what it must do to correct the quality culture and continue to improve it. The staff stated that, 4
while SPEC's response to the CAL and its presentation regarding the change in quality culture appears to be acceptable, the actual effectiveness of its QA program in meeting the regulatory requirements will be determined by future performance.
Dockets: 71-0102,-9036,-9056,-9263 Attachments:
- 1. Attendance List
- 2. Presentation Slides
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j U.S. Nuclear Regulatory Commission j
Meeting With Source Production and Equipment Company, Inc.
April 23,1998 Meeting Attendees Source Production and Equipment Company, Inc.
K. Carrington, Govemment Affairs Specialist R. Dicharry, President G. Moran, Vice President K. Richardt, Quality Assurance Manager U.S. Nuclear Regulatory Commission 1
NMSS/SFPO C. Haughney NMSS/SFPO/PCS R. Chappell D. Huang N. Osgood D. Tiktinsky L. Yang NMSS/SFPOTTSIS P.Eng T. Matula NRR/DRCH/HHFB D. Desaulniers NMSS/IMNS/IMAB M. Burgess L Camper ENCLOSURE 1
- s Distnbution: w/ attachments.
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- PUBLIC NMSS r/f
'TSIS route JLieberman,~ OE WReamer, OGC GJackson,0CC Haughney
~ELeeds FSturz SBaggett BSpitzberg, RIV NRC Attendees
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Presentation to USNRC
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Room 10-B-11 Rockville, MD April 23,1998 9:30 AM In response to closure of CAL 97-7-006 l
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Source Production and Equipment Co. ( SPEC )
113 Teal St.
St. Rose, LA 70087
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e U.S. Nuclear Regulatory Commission
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j Meeting With Source Production & Equipment Company,Inc.
J April 23,1998
Purpose:
To discuss the actions taken to correct and prevent a lack of quality culture and discuss issues associated with Confirmatory Action Letter 97-7-006.
1.
Opening remarks T. Matula 2.
Introductory comments R. Dicharry 3.
Review of actions taken by SPEC to conect issues G. Moran identified During NRCinspections By SPEC's quality assurance consultant In Confirmatory Action Letter 97-7-006 4.
Root cause analysis process and results G. Moran 5.
Immediate corrective actions taken by SPEC and G. Moran effectiveness 6.
Long term corrective actions to assure future compliance G. Moran Management involvement Quality culture -
Lessons leamed 7.
Comments and observations by the SPEC QA Manager K. Richardt
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8.
Discussion and questions R. Dicharry 9.
Closing remarks C. Haughney
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SPEC Source Production and Equipment Co. (SPEC )
Purpose ofMeeting with USNRC e Review SPEC's response to issues raised in Confirmatory Action Letter 97-7-006 e Discussions ofactions taken to change the Quality Culture atSPEC SPEC Presentston to US NRC 4/2340 1
Source Production &
Equipment Co. (SPEC) e R. D. "Donny"Dicharry PraMent e GeorgeMoran VicePresMent e KelleyRichardt QAManager e Kenny Carrington RegufatoryAgalesManager SPEC Presentamon to US KRC 4/2348 2
4/24/98 1
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SPEC SPEC's Organization
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SPEC Presentagon to US NRC 4/2348 3
Closure of Confirmatory
-Action Letter 97-7-006 Source Production & Equipment Co.
e Where we were e Where we'regoing n Where we are SPEC Presentegon to US HRC 4/2348 4
4/24/98 2
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SPED e
CAL 97-7-006 Dated June 24,1997 e Actions to be saken by SPEC
+1) Suspend fabricetion
+2) Submit %st plan
+3) Test packages
+4) Save specimens & components
+5) Conduct an independent audit
+6) Notify NRC when actions are completed SPEC Presernston to US NRC 4/23/96 6
Summary of Actions Taken e 1)Suspendfabrication
+to be addressed separately e 2) Submit testplan
)
+done 6/24/97; accepted; closed e 3) Testpackages
+done 6/26/97; accepted; closed SPEC Presentaton to US NRC 4/23/94 s
4/24/98 3
SPEC Summary of Actions Taken -
cont'd e 4) Save specimens & components
+done; accepted; closed e 5) Conduct an independent audit
+done 9/2/97; accepted; closed e 6) Notify NRC when actions are completed
+done 2/2/98; question on item 1 SPEC Fr.eentaton b US NRC MMe 7
Summary of Actions Taken -
cont'd e 1)Suspendfabrication
+ Fabrication halted by SPEC 6/20/97
+NRC inspection, and Intemal & Independent Audit resulted in 84 Corrective Actions
+CA's segmented into 3 action phases
+ Phase 1 completed and accepted by NRC 7/23/97
- NRC authorized SPEC to resume fabrication to no more than 5 per week sPac pr.o.nmuon = us wRe une e
1 4/24/98 4
SPEC Summary of Actions Taken -
cont'd e 1) Suspendfabrication - cont'd
+ Phase 2 completed October 10,1997, response by NRC 10/27/97 4 review & revise QA program and implementing procedures
+ Phase 3 completed January 30,1998 4 Revised procedures accepted by NRC 4/3/98 4 Clarification of suspended activities 4 Address "... general lack of quality culture at SPEC."
4 Meeting set for 4/23/98 to review actions and assess the attitudinal nature of SPEC's quality culture SPEC Presenaton 2 US NRC MW 3
Quality e Whatis it?
e How is it measured?
e How doyou know whenyou have it?
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e It is not a destination but aJourney toward improvement l
eItis thefoundation ofour business SPEC ProesnwJn 2 US NRC M348 10 1
4/24/98 5
f SPEC I
. Definitions of Quality e Customer-based
+ ' Quality is fitness for use' a. swen
+ ' Total Quality is performance leadership in meeting customer requirements by doing the right things right the first time.' woens ouw n
+ ' Quality is meeting customer expectations. The Quality improvement Process is a set cf principles, policies, support structures, and practces designed to continually improve the efficiency and effectiveness of our way of life.' Arar sesc emeenisson to us NRC dr&M 11 Definitions of Quality-cont'd e Manufacturing-based
+ Quality (means) conformance to requirements."
PNrp a. coey
+ Quality is the degree to which a specific product conforms to a design or specification."
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- Pec emeenennen to us NRc 4/2M6 12 4/24/98 6
SPEC Definitions of Quality-cont'd e Product-based 1
+ Differences in quality amount to differences in the quality of some desired attribute or ingredient."
Lamence Abbott
+ " Quality refers to the arnount of the unpriced attribute contained in each unit of the pnced attribute."
Kath a. Lemer SPEC Presentoson to u8 NRc
- 4/23/H 13 Definitions of Quality-cont'd e Value-based
+ Quality is the degree of excellencs at an acceptable price and the control of variability at an accepted cost."
i Mo6ert A arch i
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+ Quality means best for certain custorner conditions.
These conditions are (a) the actual use and (b) the selling price of the product."
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i SPEC Presentaton to US NRc 4/23/98 14 4/24/98 7
SPEC Definitions of Quality-cont'd e Old Quality Culture atSPEC
+ Responsibility of QA
+ Required by NRC
+Added cost e New Quality Culture atSPEC
+The way we do business to achieve our mission
+The number one business strategy priority
+A joumey that will continue for many years
+Added value SPEC Presentaton to US NRC 4/22/90 16 Definitions of Quality-cont'd SPEC's Mission SPECis itspeople, united to be apremier, financially secure organization, recognized as a world-class manufacturer and supplier ofgamma radiography equipment SPEC Presentaton to US NRC 4rJ3/tt 10 e
4/24/98 8
SPEC Definitions of Quality-cont'd e How willwe achieve our mission ?
+ se an outstanding empiorer with anpior.e pmticipation in ine e. cision making process
+ Be the industry leader by excellmg in product design, quality, and vaiue; and in customer satisfaction, marketing, market responsiveness, and innovation.
+ Conduct ourselves with unfailing commitment te the highest ethical and professionalstandards.
+ Work with govemment and other stakeh.nders to improve safety in the radiography industry.
+ Produce safe products and conduct operations that ensure the p v.cuor of the public and the environment.
While achieving this mission, SPEC will investigate and capitalize on other business opportunities. SPEC will grow.
spec emenomon m us NRC 4r396 17 Quality Culture Quality is...
Quality is not...
+ demonstrating executive seeigning responelt4ty for leadership and commitment quality toothers
+ listening to customers to assuming you knowyour determine their requirements customer's requirements
+ dohg the right things right the doingit overto make it right firstim
+ identifying cost of quality and overiooking the hidden costs of focusing on prevention poorquality
+ contmuous process improvement one-time fix
+ taking ownership at alllevels of seeigning responeitely for the organization quality to one department
+ conformance to requirements spec Presenwoon a us NRC 4/ 2 00 to 4/24/98 9
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i Quality Operating Principles e Managementmust take thelead e Focus on the customer e Streamlineprocesses e Empowerpeople e Measurement anddata SPEC Preseniston m US NRC 4/23/96 10 j
Role of Management e Establishes the desired culture e Champions the effort
+ Set vision, direction and lead by example e Establish the businessfocus and direction l
+ Lead individuals
+ Lead teams
+ Lead change
+ Manage performance SPEC Proesntshon W US NRC 4/2 Wet 20 4/24/98 10
SPEC Customer Satisfaction eThefocus ofeverything we do
+ Customers are both intemal and extemal
+ Understand customer expectations
+ Develop partnerships with customers
+ Focus intemal activities to maximize customer value
+ Deliver products and services that meets or exceeds customer expectations
+ Continually assess customer satisfaction l
SPEC PreseMseon to US MC 4/23/98 21 Process Improvement e The means by which we continuously increase value to our customers
+Every activity is part of a process
+ Fully understand and continuously evaluate all processes
+Use the tools of quality to improve processes
+ Drive waste out of processes
+ Provide resources at the time they are needed SPEC ProceNeton to US MC 4/23/98 22 4/24/98 11
SPEC People e Participation and working together is and will be the basisfor oursuccess
+ Create an open and trusting environment, treating all people with respectand dignity
+ Set and communicate expectations
+ Engage the talent, energy and ideas of everyone
+ Accept Individual leadership and accountability
+ Provide training and coaching
+ Assure a safe work environment
+ Recognize and reward desired behaviors and results SPEC Presentegen to US MC 4/2340 23 Measurement and Data t
e The basisfor analysis, decisions, continuous improvement andinnovation
+ Focus on the customer
+ Assure compliance with requirements
+ Have the people who do the work do the measuring
+ Measure forimprovement
+ Measure individual and team processes and results
+ Benchmark againstthe best
+ Encourage sharing of data and information SPEC Presentseen to US MC 4/2348 24 4/24/98 12
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SPEC Quality Behaviors e These are the desired behaviors required at alllevels of the organization to create a " Quality First" culture. These
. need to be modeledflist at the top and then down throughout the organization.
+ Promote the QualityVision i
+ Live the Quality Elements
+ Effectively Allocate Resources and Remove Obstacles
+ Nurture People, Build Trust and Teamwork
+ Stay the Course
+ Leam and Coach Continuously arEc P,.eenmon a us Nac
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n Closure of Confirmatory Action Letter 97-7-006 Issue How to demonstrate that the attitudinalnature ofthe quality culture atSPEChas changed sufficiently to remove the restriction onfabrication ofType Bpackages SPEC Presenesson to US NRC 4/23/98 28 4/24/98 13
SPEC Where we are e Customer Focus
+ established dealer network
+ customer newsletter
+ web site
+ supplier alliances SPEC Presentehon to US NRC 4/2&98 27 Where we are - cont'd e ProcessImprovements
+in use with cross functional teams
- wipe tests
-+EFR shipping and receiving
-+other areas targeted
+ managers have been trained in process
+ revised suggestion program SPEC Presentaton to US NRC 4/23/98 26 4/24/98 14
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S'PEC Mere We are - cont'd ePeople
+ revised benefits package
+new evaluation system
+QA training by Sr. Mgmt.
+stop work authority
+ human factors production line changes
+ workers review and revise detailed work instructions SPEC Preseneston b US NRC 4/23/90 29 Mere We are - cont'd e Data & hieasurement
+ Spot audit
+EFR data base
> customer complaint process
+ scheduled and unscheduled audits
+ independent third party audit by June iS99 SPl!C Presenesson tr, US W,
4/2W98 30
-4/24/58 15
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Mere We are - cont'd e FullCommitment ofManagement to Quality
+new quality system ( ISO 9000 format )
+new organization and personnel
+ quality system covers all activities
+ formal assessment of company culture
+ opportunity to assess commitment first i
hand SPEC P vesnesson to US NRC 4/2 Wee 31 Lessons Learned e Cannot delegate responsibiltiyfor Quality e Sr. Manageme:st has to be committed and visible e Quality will not be effective without afully committed, well-trained workforce e Need an etTective internal audit system e Lack ofqualityisyely expensive; Bottom Line - do it right or don 't do it at all!
l SPEC P64eenesten to US NRC 4/2MBS 32 4/24/98 16
e SPED Action Requested Close CAL 97-7-006andauthorize SPECto resumefabrication of TypeBpackages without restrictions m CP n.,usNne ww n
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SPEC Premonesson to US NRC 4/WD5 34 4/24/98 17
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