ML20140G491
| ML20140G491 | |
| Person / Time | |
|---|---|
| Site: | South Texas  |
| Issue date: | 06/13/1997 |
| From: | Alexion T NRC (Affiliation Not Assigned) |
| To: | NRC (Affiliation Not Assigned) |
| References | |
| NUDOCS 9706160299 | |
| Download: ML20140G491 (84) | |
Text
{{#Wiki_filter:. _ . . . . _ . _ _ . _ . . _ . . _ _ _ _ - _ . _.. .. _ . _ _ _ _ . _..~ _..____.. .._.- - - J j . - . June 13, 1997 j i MEMORAMdVMT0: PD IV-1 File f 1
. FR0rt: Tom Alexion ORIG SIGNED BY: -
il Project Directorate IV-1 ', Division of Reactor Projects III/IV -
. Office of Nuclear Reactor Regulation !
4-i ]
SUBJECT:
LICENSEE'S AUDIT OF THE CARBOLINE COMPANY j I received the attached information on the licensee's audit of the ! Carboline Company from HQMB, who received it from the licensee. The purpose i j of this memo is to place this information ir, the public document room. I Docket Nos. 50-498 and 50-499
Attachment:
As stated 1 1 4 i DISTRIBUTION: Docket File PUBLIC (PDR) WBeckner TAlexion Document Name: STPAUDIT.C_AR OFC PD4,l [ b PD4-1 _ a i NAME _TAlexidhk WBechneY DATE s/_l'/97 / b}3/97 l COPY LYES /NO YES/NO j OFFKIAL RECORD COPY p\ 3
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10c.n3 NRC RE CENTER CO 97o6160299 970613 8 i PDR ADOCK 0500 t e i
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p h UNITED STATES g 2 j NUCLEAR RESULATORY COMMISSION WASHINGTON, D.C. 20645 4001
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June 13, 1997 MEM0P.AMDUM T0: - PD IV-1 File i FROM: \ Tom Alexion Project Directorate IV-1 Division of Reactor Projects III/IV Office of Nuclear Reactor Regulation
SUBJECT:
LICENSEE *S AUDIT OF THE CARBOLINE COMPANY I received the attached information on the licensee's audit of the Carboline Company from HQMB, who received it from the licensee. The purpose of this memo is to place this information in the public document room. Docket Nos. 50-498 and 50-499
Attachment:
As stated
The Light South Texas Project Electric Generating Station P.O. Bos 289 Wadsworth, Texas 77483 l Ilouston Lighting & Power March 6,1997 Ms. Marikay Speckert l Quality Assurance Manager Carboline Company - 350 Hanley Industrial Court St. Louis, MO 63144-1599
Subject:
Houston Lighting & Power Audit of the Carboline Company St. Louis, MO, Xenia and Alpha, OH - Audit No. 97-021 (VA)
Dear Ms. Speckert:
This is to confirm the arrangements made with you for Houston Lighting & Power (HL&P) to conduct an audit at your facilities in St. leuis, MO, Xenia, OH and Alpha, OH April 14-18,1997. The audit will be performed as a joint utility audit under the auspices of the Nuclear Procurement Issues Committee (NUPIC) Joint Audit Program. Attached for your information is the audit scope and a copy of the NUPIC Audit Program Description. Participating in the audit will be Mr. James E. Adkins, Audit Team Leader, Mr. Steve Lusk, Auditor, Tennessee Valley Authority, Mr. Johnnie Poston," Auditor, Florida Power Corporation, Mr. James Heil, Auditor, GPU Nuclear, and Mr. David L. Dujka, Technical Specialist, HL&P. Please plan on a brief entrance meeting at your St. Louis facility to begin at 8:30 a.m. on Monday, April 14,1997 to di'scuss audit details, objectives and schedule. An exit meeting will be conducted at the St. Louis, MO facility on Tuesday, April 15,1997. A brief entrance meeting will be conducted at the Xenia, OH facility at 8:30 a.m. on Wednesday , April 16,1997 with an exit meeting on Friday, April 18,1997. l You may reach Mr. Adkins at (512) 972-8516 should there be any questions concerning the audit. I Sincerely, H. G. Domschke Supervisor, Procurement Quality
, JEA/kmw Attachment ATTACHMENT Project Manger on Behalf of the Participants in the South Texas Project 9?C 21 val . doc i
1 l I i Hxstoa Lightirs & P:wer Comptry Mitch 6,1997 Seath haas Project Electric Generating Staties Page 2 l I c: L. E. Martin
' R. J. Rehkugler S. E. Thomas R. J. Tennant D. L. Dujka NUPIC Membership Audit File 97-021 (VA)
Vendor History File l l Mr. Steve Lusk Tennessee Valley Authority Quality Assurance Department 1101 Market Street (BR4J-C) Chattanooga,TN 37402
, 5 Mr. Johnnie Poston Florida Power Corporation Crystal River Energy Complex 15760 W. Power Line Street MAC SA2D Crystal River, FL 34428-6708 Mr. James Heil GPU Nuclear Nuclear Safety Assessment Department 1 Upper Pond Road Parsippany, NJ 07054 a
l I t I Project Manger en Behalf erthe Participants la the Seath Tesas Project 97021 val. doc
AUDIT SCOPE AUDIT NUMBER 97-021 (VA) 1 ORGANIZATION: Carboline Company l 350 Hanley Industrial Court 125 Fairgrounds Court Warehouse l St. Louis, MO 63144-1599 Xenia, OH 45385 Alpha, OH 45301 PURPOSE / SCOPE: To verify the adequacy and effective implementation of the Carboline Company's Quality Assurance Program as it relates to the manufacturing of nuclear grade coatings and thinners. AEPLICABLE DOCUMENTS: Carboline's Quality Assurance Manual, Revision 4, dated 01/30/97 REFERENCE DOCUMENTS: 10CFR21 - Reporting of Defects and Noncompliance 10CFR50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants ANSI N5.12- 1974, Protective Coatings (Paints) for the Nuclear Industry ANSI N101.2-1972, Protective Coatings (Paints) for Light Water Nuclear Reactor Containment Facilities ANSI N101.4-1972, Quality Assurance for Protective Coatings Applied to Nuclear Facilities CHECKLIST: The audit will be conducted using the Nuclear Procurement issues Committee (NUPIC) Checklist, Revision 7, dated April 30,1996 James E. Adkins bl5 '
/ 3/06/97 H. G. Domschk /06/97 Prepared By # Date Approved by Date I
i H. G. Domschk 6/97 L NUPIC Represen5tive (Alt) Date l b i. 97021YAI. doc w
I l The Light I South Texas Project Electric Generating Station P. O. Box 289 Wadsworth, Texa. 77483 flouston Lighting & Power March 6,1997 i TO: NUPIC Membership l
Subject:
Houston Lighting & Power Audit of the Carboline Company St Louis, MO, Xenia and Alpha, OH - Audit No. 97-021 (VA)
Dear Members:
HL&P is scheduled to lead the audit of the Carboline Company St. Louis, MO (corporate office), Xenia, OH (manufacturing facility) and Alpha, OH (warehouse facility). The audit,will be performell . under the auspices of the Nuclear Procurement Issues Committee (NUPIC) and will be supported by Tennessee Valley Authority (TVA), Florida Power Corporation (FPC) and GPU Nuclear (GPU). The tentative audh dates are April 14 through 1S,1997. Due to a refueling outage and circumstances beyond our control HL&P could not send out the notification within the (90) day requirement. Please submit any additional supplier history or technical requirements ofinterest on a PBSA Worksheet for potential use during the audit by April 4,1997. A preliminary PBSA Worksheet which'contains the same technical characteristics used during the last NUPlC audit is attached for your information and/or use. Please submit your response to the audit team leader by mail or fax to: Mr. James E. Adkins Houston Lighting & Power P. O. Box 289, Mail Code W1001 Wadsworth, TX 77483 FAX (512)972-8042 If you have any questions concerning this correspondence please contact Mr. James E. Adkins at (512) 972-8516. Sincerely,
/
/-
H. G. Domschke NUPIC Representative (Alt) k., JEA Attachment c: Vendor Audit File 97-021 (VA) . 97021VA. doc l l l
. _ . _ _ - _ _ _ _ _ _ ~ _ . _ _ _ . _ _ . _ . . _. _ __. __.
i t, ! Revision 11 Supplier: Carboline Comnany - Audit No: 97-021 (VA) Page: I of 6 i PBSA WORKSIIEET ( It!ms
Description:
Nuclear Grade Protective Ca.ein m for Met =IIIe and Concrete Substrates frypical) (Part #, Pmcess, Service) Level I Coating System Comprised of Carbo Zine 1ISG Primer. Carboline 890 Toncoat
- 1) Technical Characteristics (Essential 2) 3)
For Form, Fit or Function) Supplier's References, and/or Acceptance Criteria ~ Method of Results (Checidist items ofinterest Control Section) Material Formulation Design Reviewsfresting Design Basis Accident /LOCA 300
- F/48 PSIG 302
- F/11 days (ORNL) i Radiation Tolerance !
(CZ-11SG) IX10' rads (890) 1.01 X10' rads
-Decontamination Per test method and ORNL procedures (890) ;
Chemoical Resistance 5 day immersion s
# i Technical Specialist Date Audit Team Leader Date t
. _ - - ._ . - _ _ _ _ __ _____--_ - _ - _- _ - _ _ _ _ _ _ _ _ _ _ _ - _ - - - _ _ _ _ _ _ _ _ _ _ _ _ _ _l
Revision 11 Supplier: Orboline Company - Audit No: 21-021 (VA) Page: 2 of 6 PBSA WORKSIIEET Items
Description:
Nuclear Grade Protective Coatings for Metallic and Concrete Substrates (Typical) (Pc;rt #, Process, Scavice) Level I Coating System comprised of Carbo Zine 1ISG Primer. Carboline 890 Toncoat
- 1) Technical Characteristics (Essential 2) 3)
For Form, Fit or Function) Supplier's References and/or Acceptance Criteria Method of Results (Checklist items ofinterest Control Section) Tcber Abrasion 1000 cycles 100g weight CS-17 Wheel (890) Elcometer Adhesion Per Test Method Fire Evaluation Pertest Method (Flame Spread Less j than 25) s W Technical Specialist Date Audit Team Leader Date
Revision 1I Supplier: Carboline Comnany Audit No: 97-02 I (VA) Page: 3 of 6 PBSA WORKSIIEET ltzms
Description:
Nuclear Grade Protective C9=ti=en for Metallic and Concrete Substrates (Typical) (Pcrt #, Process, Service) Level I Contine System comprised of Carbo 71=c 11SG Primer. Carboline 890 Toncoat
- 1) Technical Characteristics (Essential 2) 3)
For Form, Fit or Function) Supplier's References and/or Acceptance Criteria Method of Results (Checklist items ofinterest ' Control Section) Material / Physical Properties or Appearance (1) FinenessofGrind ASTM D1210 (2) Iliding Thickness (3) Weight per gallon ASTM D1475-68, FfMS 141a method 4184.1 & 4183 (4) Brookfield Viscosity ASTM 141a method 4287 (5) Leneta SAG Test ASTM D3780-78 (6) Drawdon and Cure FTMS 141a method 4061.1 and ASTM D1640 (7) Gloss Determination ASTM D523 v' Technical Specialist Date Audit Team Leader Date
. ~ - - -- . . .. -
,A C' Revision iI Supplier: Carboline Comoany ~
Audit No: 97-02I (VA Page: 4 of 6 PBSA WORKSIIEET Items
Description:
Nuclear Grade Protective Contines for Metallic and Conctcle Substrates (Tynical) (Part #, Process, Service) Level I Coating System comprised of Carbo Zine 11SG Primer. Carboline 890 Tor,cc,st
- 1) Technical Characteristics (Essential 2) 3)
For Form, Fit or Function) Supplier's References , and/or Acceptance Criteria Method of Results (Checklist items orinteurst Control Section) Markings and Identification (1) Product Name L (2) Lot / Batch Number and/or Date , (3) Identification of applicable industry stds. (4) Storage Conditions 40 - 110 *F 0 - 100% Humidity - s f f . TechnicalSpecialist Date Audit Team Leader Date - l
F ikevision i1 _ Supplier: Carboline Company - Audit No: 97-021 (VA Page: 5 of _ 6 , PBSA WORKSHEET , Items
Description:
Carboline Thinners frypical) (Part #, Process, Service) Thinners # 2. 4.15. 21. 25. 26. and 33
- 1) Technical Characteristics (Essential 2) 3)
For Form, Fit or Function) Supplier's References and/or Acceptance Criteria Method of Results (Checklist items ofinterest Control Section) Materials / Physical Properties or Appearance (1) AppearanceTest ! (2) Weight Per Gallon l (3) Gas Chronograph I t I t j Technical Specialist Date Audit Team Leader Date o _ _m.._ _ . _ _ _ _ _ . _ _ _ _ _ . . _ _ _ _ _ _ _ - - _ _ _ _ _ _ . . . _ _ _ _ _ _ _ _
. . _ . . . _ . . _ ~ . - . . . _ _ . _ _ - . -. -. . . . . -.
~
Revision iI Supplier: Drboline Company Audit No: 97-021 (VA Page: 6 of 6 PBSA WORKSIIEET ltems
Description:
Carboline Thinners (Typical) (Part #, Process, Service) Thinners # 2. 4.15. 21. 25. 26. and 33
- 1) Technical Characteristics (Essential 2) 3)
For Form, Fit or Function) Supplier's References and/or Acceptance Criteria Method of Results (Checidist items ofinterest Control Sectica) Markings and Identification (1) Product Name (2) Lot / Batch Number and/or Date (3) Identification of applicable industry stds. (4) Shelf Life (5) Storage Conditions TechnicalSpecialist Date Audit Team Leader Date
l
' ' 1 The Light South Texas Project Electric Generating Station P.O. Son 289 Wadsworth. Texas 77483 Houston Lighting & Power May 13,1997 i
File No: Q38 i Ms. Marikay Speckert Corporate Quality Assurance Manager Carboline Company - 350 Hanley Industrial Court St. Louis, MO 63144-1599 l
Subject:
Houston Lighting & Power Audit of Carboline Company g St. Louis, MO, Xenia and Alpha, OH - Audit No. 97t21 (VA)
Dear Ms. Speckert:
I Attached is Houston Lighting & Power (HL&P) Procurement Quality Audit Report 97-021 (VA) for the audit conducted at your St. Louis, MO, Xenia, OH and Alpha, OH facilities on April 14 - 18,1997. HL&P was the lead utility and was assisted by Tennessee Valley Authority, Florida Power Corporation, and GPU Nuclear. The audit was performed under the auspices of the Nuclear Utilities Procurement Issues Committee (NUPIC). The attached report is for your information and use. It describes the audit results as discussed with Carboline personnel during the audit and the Post-Audit Conference. The results of this audit may be shared with other utilities. As a result of this audit, five (5) audit findings with respect to order entry, procurement, material control / handling, storage and shipping and document control / adequacy were identified. The deficiencies are documented on four (4) Vendor Deficiency l Reports (VDRs) which are attached to the report. Please provide your response to the VDRs by June 12,1997. Your response should include the date(s) that the corrective actions were or are to be completed. If the due date can not be met, provide a written request for an extension explaining the circumstances and the actions taken to.date. This request must be received prior to the due date and must include a date by which you expect to provide the response. If at the time of your response, required actions have been completed, documented evidence should be submitted to HL&P for verification of the stated action (s). I Project Manger on Behalf of the Participants in the South Teams Project 9702tVA2 doc
Houston L';1 ting & Power Company May 13,1997 South Texas Project Electric Generating Station Page 2 Your cooperation during the audit was greatly appreciated. If you have any questions concerning the audit, please contact Mr. James E Adkins at (512) 972-8516. Sincerely, R. J. Rchkugler Director, Quality JEA/kmw - Attachment c: L. E. Martin M. E. Smith e * ' S. E. Thomas N. O. Laughlin N5010 R. J. Tennant NUPIC Membership A. J. Granger Audit File 97-021 (VA) D. L. Dujka Vendor History File D. 1. Towler Mr. Steve Lusk Mr. James Heil Tennessee Valley Authority GPU Nuclear Quality Assurance Department Nuclear Safety Assessment Department
!!01 Market Street (BR43-C) 1 Upper Pond Road Chattanooga,TN 37402 Parsippany,NJ 07054 Mr. Johr.nie Poston
- Florida Power Corporation Crystal River Energy Complex 15760 W. Power Line Street MAC SA2D Crystal River, FL 34428-6708 Project alsnger on Behalf of the Participsnts in the South Texas Project 97021VA2. DOC
1 l l
- o HOUSTON LIGHTING & POWER j STP PROCUREMENT QUALITY )
AUDIT REPORT 97-021 (VA) l AlfDIT NiiMBER: 97-021 (VA) ! I AliDIT DATE: April 14 - 18,1997 ORGANIZATION / ACTIVITY:
)
Carboline Company I 350 Hanley Industrial Court 125 Fairgrounds Road 2162 Heller Drive I St. Louis, MO 63144-1599 Xenia.OH 45385 Alpha,OH 45301
\
' I PliRPOSE/ SCOPE: l To verify the adequacy and effective implementation of the Carboline Company's Quality Assurance j j Program as it relates to the manufacturing of nuclear grade coatings and thinners. ' e % SifMM ARY: l
~
The overallimplementation of the Quahty Assurance program is effective and provides adequate controls for processes associated with the manufacture of nuclear grade coatings and associated thinners. This determination was made based on the review ofimplementing procedures, review of j records for items previously shipped to the nuclear industry, personnel interviews, and observations of j various activities in the manufacturing facility. Implementing procedures and batch tickets are I
- available where the activities are taking place and provide adequate guidance for those activities. i i
There were five (5) deficiencies identified which do not detract from the overall effectiveness of the l Quality Program implementation and have no adverse impact on coatings /thmners previously supplied. l l DEFICIENCIES:
- 1. Carboline is not entering all of the customer purchase order requirements into the order entry l
computer system.
- 2. Calibration services were procured from a supplier that was not audited or on the Approved
- Suppliers List.
l
- 3. Purchase orders issued to calibration service suppliers do not contain appropriate quality and technical requirements.
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- 4. No objective evidence is available to substantiate that Carboline is maintaining the warehouse l temperature within the specified requirements.
- 5. Maintenance and distribution of the Quality Assurance Manual and Quality Procedures Manual is not controlled in accordance with prescribed requirements.
l l l k 4 nonvA2 Doc Page 1 of 2 l l I
i HOUSTON LIGHTING & POWER
- STP PROCUREMENT QUALITY AUDIT REPORT 97-021 (VA) l CONCERNS: l l
None RECONDIENDATIONS: None l AUDIT TE AM: J. E. Adkins - Audit Team Leader S. M. Lusk J. O. Poston J. P. Heil D. L. Dujka PERSONNEL CONTACTED: (1) = Pre-Audit Meeting (2) = During Audit , 5 -
= Post-Audit Meeting (3) bl. Speckert (1) (2) (3)
T. Calkins (1) (2) (3) K. Davis (3) W. S. Lewis (3) ! S. J. Harrison (3) ; P. Henderson . (2) P. Dodge (2) J. Ladage (2) K. Bauer (2) hi. A. Wamer (2) D. Feltman (2) D. Baldwin (2) , E. Powers (2) { S. Polley (2) ; H. Payton (2) G. Chambliss (2) h!. Livingston (2) h!. Graham (2) A. Hackett (2) H. Tyree (2) ATTACHMENTS: Audit Report 97-021 (VA) Details Vendor Deficiency Reports 97-003 through 97-006 ( J. E. Adkins h8 / 05/08/97 H. G. Domschke - A15/08/97 Audit Team feader Date tpervisory Concurrence ' Date nonvA2 coc Page 2 of 2
l r l l. I l ATTACHMENT 1 AUDIT REPORT 97-021 (VA) DETAILS l ORDER ENTRY ! Nuclear utility purchase orders are reviewed by Customer Services Department personnel and the l Corporate Quality Assurance Manager. This review ensures that the customer purchase order requirements are entered into the computer system. Upon completion of this review, the purchase 1 order is assigned an invoice number which is used for tracking activities associated with the applicable purchase order. After completion of the manufacturing activities, the warehouse inspector enters the invoice number into the computer to obtain a packing list and the applicable purchase order l requirements. Purchase order requirements which cannot or"will not be met are communicated back to the customer and resolved before work activities take place. However, in some of the cases reviewed, Carboline did not enter all requirements of the customer purchase order into the computer system.
- Based on the processes observed and documentation reviewed, the audit team determined this shortcoming had no impact on product quality.
Vendor Deficiency Report 97-003 was issued. o % DESIGN Nuclear coating systems are generally commercial products which have an established formulation and history of performance. After the decision is made to evaluate the product for nuclear application, the coating system is then subjected to Design Bases Accident (DBA)/ Loss of Coolant Accident
- (LOCA)/ Irradiation qualification testing. Once qualified, nuclear grade coating formulations are i essentially frozen and often receive a similar yet different part number / product designation to the
- equivalent commercial coating. The design / formulation process is controlled in accordance with l requirements established in the Quality Assurance Manual, Quality Procedures Manual and Work l Instruction Manual. Selection and review for suitability of materials was performed during the design /fonnulation development process. Activities associated with a design / formulation change (e.g.
a certain raw material may no longer be available) are processed to the same requirements and controls applicable to the original design / formulation process. Design / formulation changes are processed on a Nuclear QA Product Evaluation Record, and are evaluated for impact as to performance, interchangeability and qualification. Carboline does not dedicate commercial grade items to be used in a nuclear safety related coatings. Raw materials used in the manufacture of coatings are not individually dedicated. Every lot of raw material for nuclear products and every batch of nuclear grade coating receives verification testing for the attributes defined in the raw material and/or product specification. These tests ensure that the final product meets its formulation requirements and does not invalidate its qualification tests. The program ; for the control of design / formulation is adequate and is effectively implemented. SOFTWARE OUALITY ASSURANCE Not applicable. The only software used is a simple database which is used for wide accessibility to read formulas and batch tickets. L mnvu ooc Page 1 of 6
f ATTACHMENT 1 AUDIT REPORT 97-021 (VA) DETAILS l PROCURENIENT I Procurement documents, including changes for nuclear sa fety related services or materials, are l prepared and/or approved by Quality Assurance (QA) or Q tality Control (QC) and submitted to l purchasing for processing. These orders are issued to suppliers on the Carboline Approved Suppliers Lin (ASL) which are audited on a triennial basis. , Carboline performs receipt inspection and/or surveillance to assure compliance with the purchase order requi;ements. Services are accepted based on the review of specific documentation and acceptance of raw material is based on inspection and product testing. However, purchase orders for calibration services do not contain adequate quality and technical requirements and one instance was noted where the purchase order was issued to an unapproved supplier. This shortcoming did not have a hardware impact. Vendor Deficiency Report 97-004 was issued. M ATERI AL CONTROL /II ANDLING. STORAGE & SillPPING Carboline's program provides for identification, control and traceability of materials throughout the receipt, manufacturing, storage and shipping processes. Lot numbers for raw materials are identified on the material packaging and are also recorded on a batch ticket. Identification and traceability of materials is maintained during the manufacturing process by the batch number via the batch ticket which stays with the material during manufacturing operations. This methodology provides traceability to the final product and to the raw materials used. Packaging requirements consist of commercial packaging in metal containers, packaged in cardboard boxes, marked and shipped with material safety data sheets and product certifications. Measures for the control of material, handling, storage and shipping are adequate however, no objective evidence was available to substantiate that Carboline maintains the storage warehouse at a temperature range of 110 degrees F. Vendor Deficiency Report 97-005 was issued. FABRICATION / ASSEMBLY /SPECIAL PROCESSESfrESTS AND INSPECTIONS Manufacturing activities are controlled by the use of batch tickets which identify what raw or bulk materials are to be used, applicable procedures, tests and inspections to be performed and their acceptance criteria. The batch ticket is the primary record for identification of all processes related to a specific batch number ofcoating material or thinner and are step by step initialed and dated prior to the next identified work activity. Carboline does not perform any activities that are considered special processes. Carboline's manufacturing, testing and inspection activities are well controlled and effectively implemented. l 9700lVA2. doc Page 2 of 6
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l ATTACIDIENT 1 l AUDIT REPORT 97-021 (VA) DETAILS 1 CAtlilRATION The calibration program includes instruments utilized for inspection and production activities as well as standards used for in house calibrations / verifications. Calibration activities are controlled by approved procedures. The majority of calibration activities are performed by approved suppliers and are traceable to the National Institute of Standards and Technology (NIST). In house calibrations and/or verifications are performed by persormel that are knowledgeable.and qualified to perform calibration / verification activities. Standards used for calibration of Measuring and Test Equipment (M&TE) have sufficient range and accuracy for the M&TE being calibrated. Calibration records are maintained and provide information relative to the identification of the equipment, calibration
- procedure, person o no performed the calibration, results, due date, as found ..id as left data. It was ]
noted that a thermometer was procured from an unapproved supplier. This condition is documented in the procurement section of this report. Calibrations are performed in an environment which is controlled to the extent necessary for the M&TE. Controls are in place which provide for the identification and evaluation of M&TE found to be oukf tolerance. These controls include segregation and an evaluation to determine the impact on product quality. Calibration of M&TE is adequate and effectively implemented. DOCif M ENT CONTROL >ADEOITACY Document control measures are in place but were not adequately implemented. Documents reviewed contained appropriate quantitative and qualitative acceptance criteria. Documents are controlled, revised, reviewed for adequacy, approved for release by authorized personnel and distributed in accordance with approved procedures. However, controlled copies of the Quality Assurance Manual provided to the auditors were not current. It was also noted that the latest revision of the Quality Assurance Manual and Quality Procedures Manual was not available at the Xenia, Ohio plant as of 04/17/97. Revisions to both documents were effective on 04/10/97.
, Vendor Deficiency Report 97-006 was issued.
PROGR AM COMPLI ANCE The Carboline Quality Assurance System is described in the Quality Assurance Manual, Revision 5, dated 04/10/97 and is supplemented by implementing procedures and work instructions. The programmatic and procedural controls are adequate and well established. The Director of Total Quality (DTQ) reports to the Carboline President and has overall responsibility for the Quality System. The Corporate Quality Assurance Manager has the functional responsibility for implementing and maintaining the QA program. The Corporate QA Manager reports to the DTQ and is independent of production pressures. The plant QA Manager is responsible for plant Quality Control activities and reports to the Corporate QA Manager. , The status and effectiveness of the quality program are reviewed and assessed through annual management review meetings and intemal audits. l l P no ivA2 00c Page 3 of 6
, e ATTFID1ENT 1 AUDIT REPORT 97-021 (VA) DETAILS PROGR A>f CO31PLTANCE (Con't)
The Carboline quality program provides for nonconformances to be identified, tagged, segregated, dispositioned and appropriately closed. The program provides for nonconformances to be reviewed and dispositioned by the appropriate personnel. Justification for " repair" or "use-as-is" disposition is documented on the nonconformance documentation. Review of nonconformance documentation during the audit determined that the bases for the dispositions were adequate and that closures were performed in a timely manner. The latest revision to 10CFR Part 21,is posted in the corporate and manufacturing facilities. At the time of this audit, Carboline has not had any 10CFR Part 21 issues. Intemal audits are perfonned throughout the year on specific areas or elements of the QA program. Audits are performed in accordance with an annual intemal audit schedule by qualified personnel having no direct responsibility for the area audited. The results of the audit and objective evidence reviewed are documented and distributed to the appropriate management persognel. Deficiencies > .;' identified during intemal audits are documented and follow up action is taken, as required. External audits of safety related suppliers are performed on a triennial basis and are adequately implemented. Extemal audits of these suppliers are performed by qualified personnel and checklist are used to document the attributes verified. Deficiencies noted during external audits are documented and follow up action is taken, as required. Measures for corrective action are established and implemented through the use of audit findings, Corrective Action Request (CARS), Nonconforming Item Reports (NCIRs), Continuous Quality Improvement Requests (CQIRs) and Raw Material Discrepancy Reports (RMDRs). These me:,ures provide for the identification of the condition, cause, actions taken to prevent recurrence and follow up action, as applicable. Provisions are in place for ensuring that personnel performing activities affecting quality are
' appropriately trained and qualified. Records substantiating the training and qualifications of personnel are available and maintained.
Records reviewed were legible, identifiable, retrievable and did not show any signs of unacceptable alteration. Changes to records can only be made by the department respo.isible for the record. The program provides specific requirements which must be followed when n:aking changes. The quality program identifies the records to be maintained , their storage locations, retention times and the department responsible for their control. Records are stored and maintained in a manner that will prevent damage or loss and provid. -tection against environmental effects. With exception of the identified deficiencies, Carboline implements a quality program that adequately controls the activities associated with the manufacture ofnuclear grade coatings and thinners. I l s M02tVA2 doc Page 4 of 6
ATTACIDIENT 1 AUDIT REPORT 97-021 (VA) DETAILS I PREVIOUS AUDIT FINDINGS With the exception of Findings V-1326-01 a-A V-1326-03 item (3), corrective action for the audit fmdings identified in American Electric Power Audit V-1326 were satisfactorily implemented. The conditions noted are documented on Vendor Deficiency Reports 97-004 and 97-005. STATUS OF NRC INSPECTIONS NUREG-0040 was reviewed and included as part of this audit. No concems involving Carboline were identified for review. TECHNICAL SPECI Al.lST EVALUATION , Carboline has procedures to control and verify design of products, to ensure that the specified requirements are met and to maintain product uniformity and performance.
, > s Design team members are chosen from groups such as Operations, Research and Development l
(R&D), Sales, Marketing, and Purchasing. The R&D Department is responsible for developing the formula and providing technical information. Requirements for the product are defined and documented in product design criteria. Design changes require documented review and approval prior to issue to production. Design changes must go through the same process, to the extent necessary, as the original design.
^
Specifications exist for raw materials and finished goods detailing required inspection and testing. R&D determines requirements for incoming testing / inspection based on use, criticality and knowledge of the raw material and the supplier. Logs of raw material test results and verification documents are maintained at the Xenia, OH Plant. During manufacture, in-process Quality Control (QC) testing is carried out at specified points
' indicated on the batch ticket / formula. The batch ticket /fonnula identifies all required testing for
! release of material, including acceptable ranges for specified tests. All results must be within the specification limits before manufacture proceeds to the next stage. After completion each batch receives a final QC check in accordance with the specifications identified in the QC section of the batch ticket / formula. To assure that changes to nuclear "QA" formulas are properly evaluated and approved, Carboline L follows Work Instruction D 02 entitled " Nuclear Formula Control". Changes in QC test method, value or specification changes to QA formula that result in change of manufacturing process or ingredient composition or quantity, must be evaluated for significance by the Director of R&D and appropriate laboratory manager and so documented. Changes in QC method, value or l specification requires approval of R&D and the Corporate QA Manager. The QA Department l maintains historical records of formula changes and evaluation reports. ( ! nouvuooc Page 5 of 6
- . . . . _ . . - . . . _ - - _ . - ~ , . _ _ _ . - . . - . . . - . - - . - -.. . _ - . ~.
ATTACHMENT 1 AUDIT REPORT 97-021 (VA) DETAILS TECHNICAL SPECI ALIST EVALUATION Based on observations and the review of existing documentation, Carboline follows the requirements contained in their Quality Assurance Manual, work instructions and documented procedures. Batch tickets / formulas are adequately controlled and clearly contain design as well as inspection requirements. Carboline has the technical capability to produce a qu:.iity product meeting regulatory and nuclear industry requirements. p > , l l l l i l 1 l 1 i k. , . 4 4 no:ivAmoc Page 6 of 6 i rM T
VENDOR DEFICIENCY REPORT VDR NO. 97-003 Page 1 of 2
- 1. Vendor: Carboline Company Vendor
Contact:
Ms. Marikay Speckert/ Tom Calkins
- 2. Programmatic: X Hardware impacting: No Condition Report Required: No
- 3. Hold on Shipment /Stop Work invoked: No Hold on Shipment /Stop Work Released: N/A
! 4. Requirement (s):
- Carboline Work Instruction Manual A 01, Order Processing Revision 3, dated 09/15/95, requires the customer l
purchase order requirements to t's entered into the computer system.
- 5. Deficiency (s): e
- Contrary to the above requirement, Carboline is not entering all of the customer purchase order requirements into the computer system as evident from review of the packing list against the purchase order requirements from Florida Power & Light Purchase Order 00014819, Virginia Power Company Purchase Orders CNT 549702 and CNT 549501, Houston Lighting & Power Purchase Orders OS-0008183 and OS-0007891 and Tennessee Valley Authority Purchase Order P-97N4R205946001 thereby affecting requirements such as, handling, storage, shipping, identification, etc..
l l
- 6. Recommended Action (s):
Provide remedial actions to correct the identified deficiency. Evaluate the extent of the deficiency. Provide adequate corrective actions that preclude recurrence of the identified condition. 7, initiator:
,O/[ -
) Date: 8/I/89 l 8. Response Acceptable: Evaluated By:
l Date:
- 9. Verification Acceptable: Verified By:
Date:
~
i VENDOR DEFICIENCY REPORT VDR NO. 97 003 i i Page 2 of 2 1 i { i
- 10. ResponseNerification/ Closure Details / Remarks: 1 1
I l l l 4 1 1 1 l 1 l l
, V ,l l
4 1 I 1 1 s l l l i , 11. Closed By: Date: i l
l VENDOR DEFICIENCY REPORT VDR NO. 97404 Page 1 of 2
- 1. Vendor: Carboline Company Vendor
Contact:
Ms. Marikay Speckert/ Tom Calkins
- 2. Programmatic: X Hardware impacting: No Condition Report Required: No l 3. Hold on Shipment /Stop Work invoked: No Hold on Shipment /Stop Work Released: N/A l
l
- 4. Requirement (s):
! 1.~ Work Instruction Manual P 04, Procurement of Nuclear Safety Related Services Revision 0, dated 09/15/95, requires that purchase orders clearly describe service procured, including all pertinent technical and quality requirements (i.e., ANSI, ASTM, Part 21, etc.).
- 2. Work Instruction Manual P 06, Approval of Nuclear Safety Related Suppliers Revision 0, dated 09/15/(5, requires an audited and approved source prior to issuing the purchase order. e I
1
- 5. Deficiency (s):
- 1. Contrary to the above requirement, purchase orders for calibration services do not contain adequate technical and quality requirements. Examples reviewed include purchase orders M31676, M31677 and M28592.
NOTE: This condition is a recurrence of Finding V-1326-01 identified in American Electric Power Audit Number V-1326, performed 05/08-12/95.
- 2. Contrary to the above requirement, Carboline procured a thermometer (ID Number M-T-1 A) which is used as the working standard for temperature measuring activities from a supplier (H-B instrument Company Collegeville, PA) that has not been audited and does not appear on the Approved Suppliers List.
- 6. Recommended Action (s):
1 Provide remedial actions to correct the iderstified deficiencies. ' Evaluate the extent of the deficiencies. Perform investigative actions to determine the reason for recurrence of the deficiency identified in item 1. Provide adequate corrective actions that preclude recurrence of the identified conditions.
- 7. Initiator: [. Date: 8-I~ff l V ~
l
- 3. Response Acceptable
- Evaluated By:
Date: l l
l VENDOR DEFICIENCY REPORT VDR NO. 97-004 Page 2 of 2
- 9. Verification Acceptable: Verified By: .
Date:
- 10. ResponseNerification/ Closure Details / Remarks:
i l l l l l i i e V i I l l - l l l 1 l l I I I l 4
- 11. Closed By: _ Date:
l
VENDOR DEFICIENCY REPORT VDR NO. 97-005 Page 1 of 2
- 1. Vendor: Carboline Company Vendor
Contact:
Ms. Marikay Speckert/ Tom Calkins
- 2. Programmatic: X Hardware impacting: No Condition Report Required: No
- 3. Hold on Shipment /Stop Work invoked: No Hold on Shipment /Stop Work Released: N/A
- 4. Requirement (s):
Purchase orders from Florida Power & Light (00014819), and Virginia Power Company (CNT 549702 & CNT , 549501), specify that handling, storage, and shipping is to be in accordance with ANSI N45.2.2 Level B. l ANSI N45.2.21972, Section 6.1.2 (2) states that level B items shall be stored within a fire resistant, tear resistant, weathertight building or equivalent enclosure. Precautions shall be taken against vandalism. This area Qall be ' situated and constructed so that it will not be subject to flooding; the floor shall be paved or equal, and well drained. Items shall be placed on pallets or shoring to permit air circulation. The area shall be provided with uniform heating ; and temperature control or its equivalent to prevent condensation and corrosion. Minimum temperature shall be 40* l F and maximum temperature shall be 140* F or less if so stipulated by a manufacturer. , ! Carboline Company stipulates that storage of their products has to be maintained at 40' F - 110* F.
- 5. Deficiency (s):
1 Contrary to the above requirements, no objective evidence was available during the audit (e.g. temperature ) recorder) to substantiate that Carboline maintains their warehouse at the specified temperature range.
)
l NOTE: This deficiency is similar to item (3) of Finding V-1326-03 identified in American Electric Power Audit Number V-1326, performed 05/08-12/95.
- 6. Recommended Action (s):
Provide remedial actions to correct the identified deficiency. Provide investigative actions to determine the recurrence of the identified condition. Provide adequate corrective action to preclude recurrence of the identified deficiency.
/
- 7. Initiator:
7
- [ . h. ._, .
Date: ,O88
- 8. Response Acceptable: Evaluated By:
Date: I
. _ ~ _ ._ _ . . _ _ _.
! I VENDOR DEFICIENCY REPORT l. VDR NO. 97-005 Page 2 of 2 l l l
- 9. Verification Acceptable: Verified By:
Date:
- 10. ResponseNerification/ Closure Details / Remarks: 1 l \
i l 1 I I l 1 l 1 4 i i I 1 l I
' j I
I l i
- 11. Closed By: Date:
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VENDOR DEFICIENCY REPORT VDR NO. 97-006 Page 1 of 2
- 1. Vendor: Carboline Company Vendor
Contact:
Ms. Marikay Speckert
- 2. Programmatic: X Hardware impacting: No Cor.dition Report Required: No e
I
- 3. Hold on Shipment /Stop Work invoked: No Hold on Shipment /Stop Work Released: N/A i
- 4. Requirement (s):
Carboline OuMy Assurance Manual, Revision 5, dated 04/10/97 Section 4.5.2, Document Data Approval and Use, requires cc:raded manuals to be issued along with an acknowledgement form instructing the holder to update documentation and:retum obsolete documents to Corporate QA Department, to assure that obsolete documents are not used. e V l S. Deficiency (s): Contrary to the above requirement, six (6) of six (6) controlled Quality Assurance Manuals provided to the auditors for use during the audit were missing current revisions of documents, contained both the new and obsolete revisions of documents or individual pages of superseded documents. Controlled manuals reviewed included serial numbers , 000,049,055,060,069, and 076.7 Additionally, the latest revisions of the Quality Assurance Manual and Quality P rocedures Manual had not been l received for use at the Xenia, OH plant as of 04/17/97, although the effective date of the revision to these , documents was 04/10/97. It should be noted that the revision to these two documents were administrative in nature and had no impact on quality at the manufacturing plant.
- 6. Recommended Action (s):
Provide remedial actions to correct the identified deficiency. Evaluate the extent of the deficiency. Provide adequate corrective act. ions that precludo recurrence of the identified condition. t ./
- 7. Initiator: [. MI/ Date: i, y -
- 8. Response Acceptable: Evaluated By:
Date: l
- 9. Verification Acceptabio: Verified By:
Date:
. _ . . - . ~ . . . _ _ . .. . . _ _ . _ _ _ _ . . . . . _ _. _
VENDOR DEFICIENCY REPORT VDR NO. 97-006 l Page 2 of 2
- 10. ResponseNerification/ Closure Details / Remarks:
1 o % 1 l l i l 1 4 i l
- 11. Closed By: Date:
- . . - = . _ _ . . . ...-- .- .-. - .- . . - -. . .
4
. a l
TECHNICAL SPECIALIST OUALIFICATION SUNI3f ARY l FOR DAVID L. DUJKA l Mr. Dujka is a Consulting Engineer in the Chil/ Structural Dhision ofDesign Engineering for Houston Lighting and Power at the South Texas Project Nuclear Electric Generating Station. The fallowing is a summary of Mr. Dujka's education and work experience: Education: Bachelor of Science in Cisil Engineering,1976 Texas A & M University, College Station, Texas Exnerience: Mr. Dujka has been involved in the civil / structural design and constructio}
- of the South Texas Project Nuclear Electric Generating Station for the past 20 years. His responsibilities include maintaining civil / structural design basis through the review and disposition of design changes, non-conforming conditions, station problem reports, operation expericace repons and through the issuance of operability and reportability reviews.
He has performed cognizant engineer duties with respect to work package redew, design support during installation and work package as well as plant impact assessment closure. He has provided overall direction for the development of a protective coating enhanced program that meets the needs during the operatica phase of the project. The program utilizes a computer data base that allows maintenance to access coating requirements for commodities requiring coating work, whether new work or repair.
, Readily available products as well as the latest technology in coating systems have been evaluated and added to the coating program. Mr. Dujka has provided technical support to Quality Assurance in evaluating results of audits, problem investigations and effectiveness inspections. He has provided support to various audits conducted by the Nuclear Regulatory Commission.
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o
,c-NUCLEAR PROCUREMENT ISSUES COMMITTEE AUDIT CHECKLIST
SUMMARY
SHEET Revisen 7 Page 1 of 54 SUPPLIER INFORMATION AUDIT SCOPE SUPPLIER: Carbohne Company ANSI N45.2 ( ADDRESS: 350 Hanley industnal Court 125 Fairgrounds Court Warehouse Facrhty ANSI N45.2.2 ( CITY. STATE AND ZIP CODE: St. Louts. MO 63144-1599 Xenia. OH 45358 2162 Heller Dr.. Alpha. OH 45301 ANSI N45 2.6 ( lELEPHONE NO.: (314)644-1000 FAX NO. (314) 644-4617 ANSI N45 2.9 ( PRODUCTISERVICE: Nuclear Grade Coatings and Thrnners ANSI N45 2.11 ( I ANSI N45 2.12 ( CODE STAMP AND AUTHC IZATIONS: N/A ANSI N45 2.13 ( ANSI N45 2.23 ( SUPPLIER CONTACTS ANSI N101.4 (X) SENIOR COMPANY OFFICER: Sherwin Stemberg TITLE: Prescent PHONE: (314) 644-1000 X-2100 10CFR50 App. B (X) SENIOR QA OFFICER- Ms. MarAsy Speckert TITLE: Quality Assurance Manager PHONE: (314)644-1000 NUREG 0040 (N) PLANT QAIOC Mr. Tom Calkms TITLE: Plant QAIOC Manager PHONE: (937) 372-3511 SEEE 323 ( AUDIT INFORMATION IEEE 344 ( AUDIT 10 NO: 97-021 (VA) AUDIT DATES: Aprd 14 - 18.1997 ASME NCA 3800 ( SDI Number: 15743
- ASME NCA 4000 (
AUDIT TEAM INFORMATION ASME SECT XI ( AUDIT TEAM UTILITY NAME CHECKLIST SECTIONS AUDIT TELEPHONE NUMBER ANSl/ASME NQA-1 ( TEAM LEADER HLP Jsmes E. Adluns X-A through X-G (512) 972-8516 SNT-TC-1A ( TEAM MEMBER TVA Steve Lusk 11. lit. V (423) 751-8346 TEAM MEMBER FPC Johnne O. Poston 1. VI. Vll.10.A.5 (352) 563-4600 0THER: TEAM MEMBER GPU James Hed IV, Vllt. IX,10 D (.M1) 316-7094 ANSI N5.12 (X) TECHNICAL SPECIAUST HLP David L Du;ka Assrst w/II. lit.4.5. 7.3. 7.4. & T.5 (512)972-7096 ANSI N101.2 (X) (SPECIFY DISCIPLINE) Civil / Structural Design Audit Team Leade [ Date ( [ NUPIC Representat' Date P0
- D
M D NUPIC SUPPLIER Carboll w Company _ Revision 7 AUDIT CHECKLIST
SUMMARY
SHEET AUDIT NO: 97-021 (VA)_ Page 1 of _64_ Vendor QA Manual Ovanty Assurance Manual Revision 5 Date 04/10/97 AUDIT QA PROGRAM IMPLEMEN1 ATION SECTIO SECTION DESCRIPTION C E REFERENCE STATUS COMMENTS / FINDING H I ORDER ENTRY / # 4.3 U VDR 97-003 11 DESIGN # 44 S fil SOF TWARE QUALITY ASSURANCE # # N/A N/A NIA IV PROCUREMENT # # 4.6,4.10 U VDR 97-004 V MATERIALCONTROUHANDLING STORAGE AND # 4 8,4.12,4.15 U VDR 97-005 SHIPPING VI FABRICATION / ASSEMBLY /SPECIAL PROCESSES 4.9 S VII TEST / INSPECTION 4.10 S Vill CALIBRATION # 4.11 S IX DOCUMENT CONTROUADEQUACY # # 4.5 U VDR 97-006 X-A ORGANIZATION / PROGRAM / / 4.1, 4.2 S X-8 NONCONFORMING ITEMS /PART 21 / # 4.13 S X-C INTERNAL AUDIT # # 4.17 S X-D EXTERNAL AUDIT # # 46 S X-E CORRECTIVE ACTION / # 4.14 S X-F TRAINING / CERTIFICATION # # 4.18 S X-G RECORDS # # 4.16 S LIWlELE_ MENTATION MEY S- SATISFACTORY U - UNSATISFACTORY , N/A - NOT APPLICABLE C = Recommended Caf6 ration Suppier Checkhst E = Recommended Engineering Services Checkhst
.s t
NUPlc SUPPUER Cart,oline Company Revision 7 AUDtT CHECKUST
, AUDIT NO: ,,_9I-02M VA) _ Page 3 of ___54_
t SECTION I- ORDER ENTRY METHOD OF VERIFICATION ASSESSMENT /
SUMMARY
RESULTS 1.1 Record the p-M e./mstructens anofor dreHs used to venfy unplementation m this area (Document O.E. on Figure 10) 1.2 Venfy that Utahty Purchase Order (PO) technical and quahty requwements are Utahty Purchase Orders are receeved by the Customer Services Department U correctly interpreted and translated on suppher's control documents (i e., and are revewed by Customer Services personnel and the Corporate OA VDR travelers, shop work orders, work tracking document including item desenption Manager. These rey ews are documented on the Purchase Order Review 97-003 and part numbers). Checkhst. The initials of the Customer Services personnel and the (Document O E. on Figure 1) Corporate OA Manager indicates that the purchase order review is NOTE: Technical and quality requirements include such items as: test /insp., documentation. C of C packaging /shippmg, hold points, etc. The technscal and quality requirements identdied in the utihty P.O.s are Appendix B/ ANSI N45 2 Ref: (3/4) entered into a computer system. Each department is displayed on the CRT ASME Section iti computer screen and edher a "Y' or "NSs entered indicating that the P.O. NOA-1 Supplement AS-1 requwements are opphcable to each department as indcated on the CRT computer screen. The P.O requwements are Ested in the " NOTES" section Vendor Program Ref- QA Manual Section 4.3 of the screen. An invoice number is assigned when the customers P.O. information and reqvwements are entered into the computer system. After the product is manufactured at the Xenia, OH plant, the items are transported to the Alpha OH warehouse and p epared for shipment. The warehouse QA Inspector enters the invoece number into the computer and ' the informaten and P.O. requwements are printed onto the Pading List - Pck/ Pack. A review of six (6) P.O.s from FPL,VPC, HLP and TVA was performed to verdy that the customer requirements are being translated to the suppher documents. (See Continuation Page) 1.3 Assure that the utihty ims-J,ase order requwements which we not/cannot be Cartehne uses the Purchase Order Revew Checkhst as a guede for S met a o evaluated by the suppher, promptly communicated back to the utility reviewing P.O. requwements and detads. The utihty is advised of any and documented,if required by the utility PO and/or the suppher program. descrepancies or requirements that can not be performed. Verified by review i (Document 0.E. on Figure 1) of VPC P.O. CNT 549702, dated 04/01/97 requesteg an eleven (11) month ! shelf #e. Cart > ohne contacted VPC via telephone and famed a notdication This includes notdicaten to utihty of design deviations / design changes if that they could only provide en eight (8) month shelf.hfe. VPC reviewed and by PO. concurred with the devishon to the original P.O. requwement. This concur ence was famed from VPC to Carbonne. The eight (8) month shelf-Appendix 8/ ANSI N45.2 Ref: (3/4) hfe material was in stock and Carbohne did not plan to produce the eleven ASME Section ill (11) month sheff#e material in the near future.
; 4S-1, 7S-1 NOA-1 Vendor *h Ref; QA Manual Secten 4.3 This was me onWxampie met was medh avaaabte for mvlew during the audt Activites associated wth notification to the customer of requirements that can not or wdl not be met are adequate and effectivety implemented i
NUPIC SUPPLIER CarbolintCompany Revision 7 AUDIT CHECKLIST AUDIT NO: __ 97-02MA)_ Page l of _5_4 l CONTINUATION PAGE Checkhst item 1.2 (Conteued) In some cases revewed. Carbohne dd not identify the customer requiremerits in the computer system that is used by the warehouse to prmt out the packing bst. The fonowmg custoner P.O. requirements were not entered into the computer system for pnntog out on the apphcable packing hst: VPC - Carbohne QA Program,10CFR50 Appendix B.10CFR Part 21. ANSI N45.2. ANSI N45.2.2 Level B. Chionde and tracembe contarniriants. HLP - 10CFR Part 21.10CFR50. Appendix B. HLP Specircation 4C080AS1007 Revisen 7. and HLP Attachment A apphes. FPL- OA requirements to SQAD 1001/1007 Revision 8,10CFR50. Appendix B 10CFR Part 21. Specifcaten C-010.ChemicalManufactunng and ANSI N45 2.2 Levet B. TVA - 10CFR50. Appendix B.10CFR Part 21. Shelf-Life and Product ident(cation. Order entry activities are unsatisfactory and are documented on Vendor Derciency Report 97-003 L
s-NUPIC SUPPLIER CarbMine Company
~ ~ ' ' ~ ' ~ ~
Revision 7 AUDIT CHECKLIST AUDIT NO: JZ-0211V!L__ Page _i_ of _54 , SECTION I- ORDER ENTRY (FIGURE 1) UTILITY P.01 TECH /QA UTILITY ITEM DESCRIPTION TRANSLATED TO CUSTO?JIER REQUIREMENTS STILITY APPROVAt.OF REQUIREMENTS IMPOSED AND SUPPLIER DOCUMENTS TRANSLATED DOCUMENTATION IF
- 1.2 PART NUMBER
- 1.2 YESINO
- 1.2 REQUIRED YES/NO
- 1.3
- 1.2 F PL P.O. 00014819, dated Carbohne 890, parts A & B, Color Translated to the manufacturing No Not required 03/22/96 - OA Regoirements of Gray, color number 4790, PN plant and warehouse via SQAD 1001/1007 Revision 8, 9.0868-1 mformation entered into the 10CFR50, Apnendix B 10CFR Carbotine 890 parts A & B, Color computer system at St. Louis, Part 21 P.O. number on all White. S60t., PN 0200867-1 MO. This information can be documents Spec (cation C-OiD, Carbohne 890 Epony, Color printed out by the warehouse MSDS, Produd ident(cation, Yellow,6666, PN 0199949-1 personnel on the packing Inst Chemcal Manufacturing, Special Cert (cation, ANSIN45.2.2 Level B
VPC P.O. CNT 549702, dated Starglaze 2011S, PN 06508393 Same as above No Yes 04/01/97 - 10CFR50, Appendix B, 10CFR Part 21. Carboline QA Program. ANSI N45.2. ANSI N45 2.2 Level B. Nuclear a Cert (cation, MSDS. Shelf Life, Toxicity statement, VPC Specircation NAP 0079/Sup. 0073. Product ident(cation, Batch Number, Manufacture Date. Empiration Date VPC P.O. CNT 549501, dated Carboline 890 S800, White, PN Same as above No Not required 03/31/97 - 10CFR50, Appendix B, 06505380 10CFR Part 21. Carboline QA Program ANSI N45 2 ANSI N45 2.2 Level B. Nuclear Cert (cation MSDS,Toxiety statement, VPC SpecFestion NAP 0079/Sup 0073, Product ident(cation, Batch number, Manufacture Date, Expiration Date TVA P O. P-96N2R-180309 dated Carbotine Epoxy, Multi-Gard 954, Same as above Yes Not requred 06/11!96 -(Commercial Product) PN N656 TVA OA Program, Standard Cert (cation, MSDS. Shelf L'fe, Produd ident(cation
- Refers to appbcable questen.
NUPtC SUPPUER Carbollne Company
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Revision 7 AUDIT CHECKUST AUDIT NO: 97-02j_{ VAL _ Page 6 of _64_ SECTION I- ORDER ENTRY (FIGURE 1) UTILITY P.O rTECH/'2A UT!LITY ITEM DESCRIPTION i TRANSLATED TO CUSTOMER REQU!REMENTS UTILITY APPROVAL OF REQUIREMENTS IMPOSED AND SUPPLIER DOCUMENTS TRANSLATED DOCUMENTATION IF
- 1.2 PART NUMBER
- 1.2 YES/NO
- 1.2 REQUIRED YES/NO
- 1.3
- 1.2 TVA P.O. P-97N4R205946001 Epoxy Thinner, Carbohne a2 Translated to the manufactunng No Not required dated C#114/97 - 10CFR50, plant and warehouse via Appendix B,10CFR Part 21, informaton entered into the MSDS Shelf Ufe, Product computer system at St. Louis, Identrfcation, Nuclear MO. This information can be Certification printed out by the warehouse personnet on the packing list.
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HLP P.O. QS-0008183 dated Carbo Zine 11SG. Gray 0700. PN Same as above No Not Required 02/05/97- 10CFR50, Appendix B, 560-24369 10CFR Part 21,70% Shelf Ufo remaining. Product identification record, Certificaten, Matl identification with PN, Cate of Manufacture, HLP Attachment A, HLP PN. item number, P.O. Number and refennce Nuclear 9tade NLP P.O. QS-0007891 dated Starglaze 2011S. Parts A, B. & C, Same as above No Not Required 11/19/96 - 10CFR50. Appendix B, Gray. PN 560-24174 10CFR Part 21,70% Shelf Ufe remaining. Certicaten, Manufacture Date. MSDS, Productidentification HLP Spec (cation 4C080AS107 Revision 7
- Refers to apphcable questen.
p. i NUPIC SUPPLIER Cart cline _ Company AUDIT CHECKLIST ;
, AUDIT NO: JM2J (VA) _ Page 7 of _64_ i i
SECTION II - DESIGN i METHOD OF VERIFICATION ASSESSMEf4Tf
SUMMARY
- RESULTS "
2.1 Record the procedureshnstructions and/or drawngs used to venfy unpiementation m thrs area. (Document O E. on Figure 10) 2.2 venfy that measures to control the translation of design requirements mto Nuclear coatmg systems are generapy w...M products wtuch have en S design documents are ' .v,i. ciel . estabbshed formulaten and hrstory of vs." .. .w in the marketplace. Arter , it is decided to evaluate the product for nuclear apphcahon, the coetmg r a) VerWy inclusion of contractustly identified design bases (regulatory system is then subjected to DBA/LOCAlirradiaten quahfication testino. n;i.,cae, Code Requwements, codes, standards, EQ/ Seismic Report Numbers, Analyses, etc ), technical and quahty mq;_... as in Once quahhed, nuclear grade costings formulation are essentially frozen. j
;,f--- "i documents. Nuclear costegs often receive a simdar yet different part numtwr/produd '
designation to the equivalent commercial coatmos (e g. Carbo Zinc 11 SG is k b) Verify that design is support by e..e.,, . bst dets (i e., calculations, the nuclear coatog whde Carbo Zme 11 is the commercial cooling upon v..-.-.- test, etc ) which 11 SG was based). I NOTE: Evi' +e reviewed to be used in Sectens ill & VI- a) Reviewed formulas / batch tickets listed on Figure 2. Formules/ batch (Ors nent O E. on Figure 2) tickets include apphcable technical %uahty ae;- cas. Appendiz 8/ ANSI N45.2 Ref: (3/4) b) Carbchne's formulatens for nuclear coatmg products are essentially ASME Sedian ill frozen and the original designs have been evaluated by previous audits. NOA-1 Supplement 35-1 However, quehfication test reports mviewed during this audit incorporated Vendor Program Ret GA Manual Sedian 4 4 the requiremen's of ANSI N101.2, ANSI N5.12, and other applicable ASTM standards. Raw matenalspecifications are based upon opphcable ASTM j standards. >
?
Translation of design requwements into design documents is adequate and : effectrvely :.ei. 2,,1 ' 2.3 Venfy that measures are estabhshed and implemented for the selecten and The deosens concerning the selecten and revew of metenets for sudatphty S review for suitatWhty of apphcotton, or metenals, parts, equipment and of appbcation were made when these products were first formulated for , processes that are enential to the safety reisted furtction of the product. If the w.... 6 coating systems. These cont 6ngs had sheady begun to develop ; suppher's safety soisted components have parts classified as non-safety a history of performona. These costings were then quahfied for nuclear i reisted, the fosowing floms should be considered: use. Changes in formuishons now recerve a documented record of m a s of chaiges
- a. Is the process controlled? ,
* '*""I* * * * "C'"9
- b. Is a functional evaluation approach used?
specifications OC test methods are controlled by the QA Manuel(QAM), the i c; Has the evaluahon included analysis of failure modes to assure the Quality Procedures Manual (OPM), and Work Instruchons L 04, P 01, and R part's failure would not prevent the w.ve ai; from performing its 01. The process to evaluate changes in formulaten is controNed by the safety related function? QAM, OPM, and Work Instructen D 02. Both activities are performed by
- l R&D and are based upon applicable ASTM standards and Carbohne's own Appendix BIANSI N45.2 Ref:(3/4) OC test i ;,;m. t' ASME Secten ill NOA-10; .,... c; 3S-1 b & c) N/A - Suitabihty of materials for nuclear pode costings is based on Vendor Program Ref: QA Manual Section 4.4 original commercial coating formulahons, DBA/LOCA quehficaten testeg, and formulation changes,if any.
This attnbute is adequate and effectively implemented. [ i i f 5
O HUPIC SUPPLfER Carbollt,e Company ' Revision 7 AUDIT CHECKLIST
~ ~~~ ~ -
4 AUDIT NO: J7 02]ff!.1 Pagelof 54 SECTION I - DESIGN METHOD OF VERIFICATION ASSESSMENT /SUMMAb RESULTS I 24 Venfy that measures are estabhshed and unplemented for the identdication and Ihere are minimal interdisciphnary (mechanicairetectricaucivd) anterfaces control of design interfaces. S involved with coatings. There are interfaces involved betwi en Research & Appendit B/ ANSI N45.2 Ref: (3/4) Development, Manufactunng, etc. The rnessures estabhsted to address ASME Section ill thrs interface is described in OAM 4 4.3 and OPM 4 4.3. This generally NOA-1 Supplement 3S-1 manifests itself in the form of team meetings but it is also e<ident in Vendor Program Ret GA Manual Section 4 4 purchase order reviews. Nuclear QA Product Evaluation Records review, procedure reviews etc., where more than one organization coordinates document reviews. Measures for the control of design interfaces is adequate and effectively implemented. 25 Verify that measures are estabhshed and implernented for the verification of Design adequacy for nuclear grade protective coatings is venfied by desagrt S design adequacy, basis accident (DBA)/ loss of coolant accident (LOCA)& radiation a) Assure the verircation method is identified (design review, altemate calculations or test) and that the verrrcation is performed by indeviduals or Verircation/quahrcation testing for the formulas reviewed was performed by groups other than those who performed the origiral design. but who may Oak Ridge National Laboratory, or by CarbolirWs Testing Department and be from the same organization. was witnessed by the customer. b) When the verification method used is qualircation test, verify that a Reviewed Quahrestion Test Reports 02182, dated 10/27/83; 027438.1, prototype unit is tested under the most adverse design conditions. dated 1/3/91; 02411, dated 9/8/87; and 03110. dated 10/5/94. Quatrication (Document O E. on Figure 2) testmg was performed to venfy that nuclear grade protective coatings meet Appendix B/ ANSI N45.2 Ret (3/4) DBA/LOCA test requirements of ANSI N101.2 and/or ANSI N5.12. Testing ASME Sectiort til reviewed included radiation toterance, decontamination. Taber abrasion, NOA-1 Supplement 3S-1 E1cometer adhesion, Gardner impact, weathering, chemical exposure, and , flame spread. Vendor Program Ret GA Manual Section 4.4 Verification of design adequacy is effectively implemented l
O NUPic SUPPLIER Cartoline_C_ompany Revision 7 AUDIT CHECKUST
, AUDIT NO: 97-021,[ val __ Page . _ 9 . of 54 SECTION 11 - DESIGN METHOD OF VERIFICATION ASSESSMENT /
SUMMARY
RESULTSl 2.6 Venfy that measures are estabhshed and implemented to control desgn Work instructons Manual (WiM). Secten D 02, addresses the control of S changes including changes for spare / replacement parts. (Document O E. on changes to nuclear formulas. a) Fonnulation changes were venfed to be controlled equally with that of the a) Review revised design documents, ( e g., calculatons, drawings, stress onginal formula. u tt se o th a sn b) Formula changes are addressed by the Nuclear QA Product Evaluation Records (NOAPER) which identifies the product, formula, change number, b) Ensure that design changes have been adequately evaluated to assure desenpton of change, reason for change, and a determination of that the impact of the change is carefutty considered (i st., performance, significance or requirement for further evaluation ofimpact as to interchangeabihty and quahTeation). performance, interchangeabahty, and qualtfcation. c) Review design changes to verify that they were reviewed and approved by c) NOAPERs are initiated by personnel from the original organization and the same organization as originalty reviewed and approved, or by other then reviewed and approved by the Vce President of Technology. See knowledgeable, quahfied and designated organizaten. Figure 2 for otgective evidence reviewed (Document O E. of Figure 2) Control of design and design changes is adequate and effectively Appendix B/ ANSI N45.2 Ref- (3/4) ASME Section III NOA-1 Supplement 3S-1 Vendor Program Ref: QA Manual Section 4.4 23 For equipment quahfed by pnor testing, venfy that when matenal substitutons See Queston 2 6. NOAPERs involved formulaten changes such as raw S or modifications (including changes for spare parts) are made the following are material substitutions or rnodifcations. As indcated above, a determination considered; is made conceming the effect on quahrcation and an evaluation indicating a) Prior qualification tests are reviewed to determi6e the effect on the item whether new quahfcation testing is required. In a couple of cases for older quakfcaten. NQAPERs there is no justircaton as to why new quahreation testing is not required. Furthermore there is no documented indication of the cumulative b) Evaluations indcate whether or not new quahrestion tests are required. effect of changes on the need for requalifcation as required by WIM D 02. The NOAPER form was revised during the audit with a mernorandum c) Justifications for not having to perform new quehfication tests are informing personnel that this amended form (which is an attachment to the documented. (Document O E. on Figure 2) QPM)is now in force. It was evident in other documents and from Appendix B/ ANSI N45.2 Ref- (3/4) discussions wdh the research speciahst that the effect of changes on ASME Section lit performance /quahrcation was considered. Since the cumulative effect NOA-1 Supplement 3S-1 evaluation will be required for future NOAPERs, this should adequately Vendor Program Ref: QA Manual Section 4.4 consider previous changes at that time therefore, no deficiency or further action is required.
O ( NUPlc SUPPLIER Carbol ne_ Company Re,ts3cn 7 AUDIT CHECKLIST AUDIT NO: J7-021 (V,AL_ Page 10 of _ 5 _4 SECTION il - DESIGN METHOD OF VERIFICATION ASSESSMENT
ISUMMARY
RESULTS 28 Verify and assess the suppher's controts for dedication of Not apphcable - Raw matenats used in the manufacure of coatings are not N/A manufactured / purchased Commercial Grade items. As a minimum the individualty Jedcated. Due to the nature of protective coatnis being a process should include the fonowing: mixture of raw materials blended to produce a final produd, the final product Documented controts which define the dedication process- is accepted by a combination of raw matenal testmg and final product a) testeg. Neither raw material testing nor final product testing stands alone. b) Determination of the safety function for the items intended end use Every lot of raw material and every batch of fnal product receives by review of documents associated with the technical evaluation, venfcaten testeg for the attributes dermed in the product! raw material such as. specification. See Checklist Sections IV and Vit.
- Classification of the item
- Item equivalency evaluations
- Consideration of credible failure modes c) Identification of critical characteristics for acceptance, required to support the safety function.
d) Selection of the method (s) of dedication for each identifed critical
. characteristic-1, insp, and Test - to be assessed with section 7
- 2. CGI Surveys - to be assessed with sections 4 and 10
- 3. Source Venfication - to be assessed with sections 4 and 10
- 4. Suppher/ Performance history in coriunction with methods 1,2 or 3 above.
NOTE: For suppliers who are unable to determine the items / materials safety function or end use (i.e., material suppliers. OSC holders, etc..) characteristics of the material specification, which are applicable to the finished product (i.e.. chemscat, phys ~ cal, hydro, etc.) must be venfied NOTE: Sampling plans for acceptance of cornmercial grade items shaft be assessed under question 7.3. NOTE: This question applies to CGl's dedicated by the supplier for utihty procurement as basic components (this does not address items sold by suppliers as CGI which require utihty dedication). Appendix B/ ANSI N45.2 Ref- (3/4) ASME Section til NQA-1 Supplement 7S-1 Vendor Program Ref: Not Anoticable
O
, i O
NUPtC SUPPLIER Ca_rbeli_ne_ Company Revision 7 AUDIT CHECKLIST
, AUDIT NO: 97-021EA'_,,,_,, Page 11 of _,,J4_
SECTION 11. DESIGN (FIGURE 2) , DEStGN SUPPORT BY METHOD OF DEStGN DESIGN CHANGE DOCUMENT BASES ENG/ TEST DATA VERIFICATION CONTROL AND REV/DATE
- 2.2
- 2.2
- 2.2
- 2.5
- 2.5, 2.7 Formula / batch tachet: Carbo Zmc ANSI N101.2. ANSI N5.12, and Test Project 02182, dated Des gn basis accident (DBA)/lcss Nuclear OA Product Evaluation 11 SG Base, Green 0300, applicable ASTM crderia 10f27/83 for Houston Lighting & of coolant accident Record (NOAPER) #11, dated Method 9 Altemate 0, dated Power (LOCA)/wradiation testing per 4/28/94 5/25/95 ANSI N 101.2, ANSI N5.12, and NOAPER 810, dated 9/1/93 6 ASTM criteria NOAPER #9,9/1/93 i NOAPER #8,8/23/93 NOAPER 87,6/18/93 Formula / batch ticket Cartyne Same as above Test Propet 027438.1, dated same as above NOAPER #6, dated 6/14/94
- 890, Part A, Method N,r nate 1/9/91 for Houston Lighting & NOAPER #5, dated 6/17/93 N, dated 2/6/96 Power NOAPER 84, dated 6/17/93 ,
Formula / batch ticket Carboline Same as above Same as above Same as above Same as above 890, Part B, Method S, Alternate ' 1, dated 8/23/96 l l Raw Material Various ASTM standards Quality Control Tests 155A,100 Raw material testing None reviewed Spec 6 cations /ReceMng including 086 D1078, D56, D93 Final product testing ' Spec 6 cations: Tt1, D1133 dated 11/7/95 Raw Material Specifcations/ Receiving Various ASTM standards Quahty Control Tests 016. 017 Raw material testing None reviewed Specrfications: RS266, including D1475. D1639, D1544, 027 Final product testing dated 11/4/94 D1644 i Raw Material - Specercations/ReceMng Various ASTM standards Quality Control Tests 089,096, Raw material testing None reviewed Specifestions: H18, including D281, D153 D1218 103 Final product testing dated 6/27/95 ' Raw Material Spec 6 cations / Receiving Variou, ASTM standards Quality ControlTests 100,137 Raw material testing None reviewed Specercations: T144, ircluding 01544 D1364 D802, 143,155A Final product testing dated 11/7/95 056,D93 Federal Test Method Standard 141s 41t'3, and 141a - 4242
- Refers to apphcable question.
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- O NUPic SUPPUER CarbgleneDmpany Revision y AUDIT CHECKLIST f AUDIT NO: _9F021_{ VAL Page 13 of _64_ ;
i SECTION lit - SOFTWARE QUALITY ASSURANCE METHOD OF VERIFICATION ! ASSESSMENT
ISUMMARY
RESULTS ! 3.1 Record Procedures, instructens & Drawings used to verdy rnplernentaten an this area (Document O E. on Fogure 10) 32 Identify an-house developed software used m safety related appicatens (e g., Not Ai+;.c.ble. . The only software used es a sunple database which is used design, producten, cahbration, acceptance). Venfy documented measures are N/A
- for wide accessitHhty to read formulas and batch tickets. It is a PC based '
estabbshed and implemented to control-system whch replaced the mainframe system that has been used for years. a) systemate methodology used It is not u.ed to do design calculatens, product evaluaten, or acceptance. i b) inputs to be used se the basis for the software program c) C. bnt of the computer code , d) documented interim and Enat reviews of the software program prior to ' release e) software validation (i.e., the testing and evaluation of the completed software to ensure
- m. , ~ - .,. with software control .W.'....-.as)
- f) software veMication (i.e., the process of determining whether of not the 4 product of a gisen ,
i phase of the so8tware development cycle fulfills the requirements knposed ! by the previous
- phase) !
g) configurahon baselining of the tohwere code after review, valufstion, ' ven6cahon, ! approval and release for use h) changes or revisions to the software code are developed and subjected to l the same levels of controlas the originalcode j (Document O.E. on Figure 4) Appendiz 8/ ANSI N45.2 Ref: (3/4) - ASME Secten lit i NOA-1 Supplement 3S-1 i Vendor Program Ref- Not Anoticable l 1 3.3 Identdy software W.M as safety related from an audited vendor. Venfy Not apphcable. See Checkhst questen 3.2 N/A adequate controls are in place to ensu'e that the purchased software meets the ' technical and quality requirements. The supplier's audst of the software manufactunng program shall ensure testing, wenncation, and validation is sufficient for the software intended funcien. (Document O.E. on Figure 5) Appendht B! ANSI N45.2 Ref. (4/5,7/8) ASME Section lit ; NOA-1 Supplement 3S-1 (para. 3.1) & Supplement 7S-1 Vendor Program Ref: Not Anchcable ;
1 itOPIC SUPPLIER CarbqllM_Qompany Revision 7 AUDIT CHECKLtST AUDIT NO: 97 02_1(VA)_ Page 14 of 54 SECTION 111 - SOFTWARE QUALITY ASSURANCE METHOD OF VER!FICATION ASSESSMENT
ISUMMARY
RESULTS 34 For software procured as a w...ercial grade dem, assure that dedcatson N/A - See Checkhst Question 3.2 actruites such as verification and validat on are performed and documented to N/A ensure the software funchons as intended. (Document O E. on Figures 3 and 5) Appendix B/ ANSI N45 2 Ref. (4/5. 7/8) ASME Section til NOA-1 Supplement 35-1 (Para. 3.1) and Supplement 7s-1 Vendor Program Ret Not Anoticable 35 Venfy that we=Cuve action measures extst to document software problems N/A - See Checkhst Question 3 2 N/A from intemal and extemal sources. Appendix B/ ANSI N45.2 Ret (16/17) ASME Section til NQA-1 Basic Requirement 16 : Vendor Program Ret Not Anolicable 36 Venfy adequate measures are estabhshed and implemented to ensure that as h/A - See Checkhst Ouestson 3.2 N/A users (intomat and ortemef) that could potentiaHy be impacted are notified of the software problem and corrective actions and the impact of the deficiencies on that customer. Appendix B/ ANSI N45.2 Ret (15/16) ASME Section til NOA-1 Basic Requirement 15 Vendor Program Ret Not Aneticable __,_______m_ _ _ _ _ _ _ _ - - - - - - - - - - - - - - - - - - - - - - - - - - - ^ ^ - -' -' -
NUPlc SUPPLIER Carboll_ne Company Revision 7 AUDIT CHECKLIST a AUDIT NO: _97_-021(VAL , Page 15 of _54_ SECTION lit . SOFTWARE QUALITY ASSURANCE (FIGURE 4) SOFTWARE PROGRAM PROGRAM END USE (E.G. DESIGN, VERIFICATIONt (NAME. NO., REVfDATE) PROD, CAL. ACCEPTANCE) Mt1THODIPROCEDURE TO VAllDATION CONTROLISSUANCE OR CHANGES '
- 3.2
- 3.2
- 3.2
- 3.2 r
N/A - See Checklist Ovesten 3.2 i r [
- Refers to applicable question.
4 NUPlc SUPPLIER Carbo Ine Company Revision 7 AUDIT CHECKLIST
- --- - '~
AUDIT NO: 97-021(VA)_ Page _1S_ of _64_ SECTION IV- PROCUREMENT METHOD OF VERIFICATION ASSESSMENT /
SUMMARY
RESUt.TS 4.1 Record the procedures /mstructions and/or drawings used to venty ..v;... Entaten m thrs area (Document O E. on Figure 10) 4.2 Ven!y that measures are estabhshed and .v;wn nted to assure that Verrhed by revew of purchase orders for raw matenals, cahtrat:on and ' appbcable requerements are included in documents for procurement of items U euclear
- safety related" services identifed in Figure 5. Procurement VDR includeg spare and replacement parts and services. i documents are not consistent when prescribing requirements. 97-004 Verify that Vendor's ,.wi. .s... documents, including changes, include Purchase orders for cahbration services do not contain adequate provisions for the followmg. as appbcable: technical / quality requwements. Examples include POs M31676. M31677 a) Statement of the scope of work. M28592. This deficiency is documented on Vendor Deficency Report 97-004.
b) Technscal sw; ...a.as by reference to specific drawings, codes. specifications. NOTE: This conddion is a recurrence of Findeg V-1326-01 identified in s c) Requirement for a documented quality assurance program, implemented. Amencan Electric Power Aud4 Number V-1326, performed 05/06-12/95 and meetmg l apphcable codehogulatory requirements. d) Requirement for right of access to plant facilites and records for source l inspection / audit. e) Identification of document submittais for approva!. l f) Identificahon of deliverable records g) Requwement for reportmg and approveg disposition of nonconformances. h) Requirements for records availabihty, retention and disposition. . t i) Requirements for extending apphcable requirements to lower ter suppliers. j) ApphcatM1ity of 10CFR21. (Document 0.E. on Figure 5 and Figure 9.( as applicable)) Appendix B/ ANSI N45.2 Ref- (4/5) ASME Sechon Ill NOA-1 Supplement 4S-1 - Vendor Program Ref: QA Manual Secten 4 6 43 Venfy .v ,... .ea,.. of the system used to control and release prwsu nt I' Purchase Orders (POs) for Nuclear " Safety Related'sennces are prepared S documents, includmg changes. by Quahty Assurance or Qualdy Control and submdted to Purchasing. POs Appendix BIANSI N45.2 Ref: (6-7) for raw materials are prepared semi-automatically via computer based on matedet levels and projected production schedule. The POs for Nuclear ASME Secten 111 NOA-1 Supplement 4S-1
- Safety Related" materialis reviewed by OA then submdted to purchasing.
No P.O s for safety related material were avaMable for review. Vendor Program Ref: QA Manual Section 4.6 Raw material is specified in Materist Speedications prepared by R&D. Supplers of raw material are assessed by R&D for conformance to Material Specircations. , Activities associated with the control and release of procurement documents including changes,is adequate and effectively implemented
HUPlc SUPPUER Carbc line Company Revision 7 AUOtY CHECKLIST AUDIT NO: ___. 97-021 NAL_ Page 17 _ of 5 4__ SECTION N- PROCUREMENT METHOD OF VERIFICATION ASSESSMENT
ISUMMARY
RESULTS 4_4 Venfy that measures are estabhshed and amplemented for the evaluation. These activities are govemed by Quahty Procedure Manual 5.6 and Work U selection and assessment of supplers (including distributors and cahbration, instruction Manual P 04. P 05 and P 06. Supplers of Nucleat
- Safety VDP.
NDE. testing tabs, software supplers, heat treatment services supphers) Related" services are audded on trentual basis 97-004 cons ent with the importance, cumplexity and quakty of the product or surveillance. However, one instance was noted where a thermometer (10: a) Verify evaluations are performed 1) prior to award of contract. 2) at the M-T-1 A) was procured to act as the working standard for temperature specified frequency, and 3) ensure only approved suppiers are used measuring equipenent for in process and inspection activites. The suppher b) Verify that the scope of approvalof the sub-suppher is commensurate with has not been audeted and does not appear on the Approved Supplers List. the requirements of the procurement documents. The supplier is H-B instrument Company. P.O. Box 770. Collegeville. PA. This defciency is also documented on VDR 97-004. (Document O E. on Figure 5) Appendix B/ANSt N45 2 Ref. (7/6) b). Venfed by revew of the P.O.s identifed in Figure 5. that with the ASME Section exception identified above, the scope of approval for the sub-suppliers are NOA-1 Supple. nt 7S-1 consistent with the requirements of the procurement documents. Vendor Program Ref. QA Manual Section 4 6 4.5 Venfy that measures are estabhshed and implemented to assure that Quahty Control Test procedures have been developed and implemented to S purchased material, equipment and services conform to the procurement venfy physical and chemical charactenstics for raw material and final documents (i e., receipt inspection) (Document O E. on Figure 5) product acceptance testing. Receiving inspection is performed for each lot NOTE: Evaluate sampling plans at receipt in accordance with question 7.3. of raw material received. Results are documented and maintained in a log book The log book contains the inspector. lot, material, tests performed. ' Appendix B/ ANSI N45.2 Ref. (7/8) date tested, and results. ASME Section fil Activities associated with venfication that purchased material / services NOA-1 Supplement 7S-1 Vendor Program Ref: QA Manual Section 4.10 conform to the procurmrent document are adequate and ef'ectively implemented i 46 Venfy where Wance of matenal from an ASME certifcate holder or ASME Not appticable. Carbohne does not provide ASME matenats to the nuclear N/A material organization is based on certifcation from Subsuppliers including industry. materists supplied under provisions of NX2610 that the Supplier yahdates the certifcatson via surveillance, audit and/or independent tests. If validation of the certifcation is based on independent test, ensure the test encompasses characteristics of the material speorcation (i.e chemical, physical hydro, etc.) which are apphcable to the finished product. Appendix B/ ANSI N45.2 Ref- (7/8) IE Notia 86-21 including supplements ; NQA-1 Supplement 7S . Vendor Program Ref; N/A a
NUPic SUPPLIER Carix4tne_ Company Revision 7 AUDIT CHECKLIST AUDIT NO: _9Z-021_(VAL Page .18 of _54_ 6 SECTIONIV PROCUREMENT (FIGURE 5) ITEM METHOD & DATE SCOPE OF SUPPLIER & DESCRIPTION OF SUPPLIER ACCEPTANCE M&TE P.O. AND DATE LOCATION (P/N, S/N, MODEL SUPPLIER APPROVALS & DOCUMENT USED INSPECTOR NO. EVALUATION LIMITATIONS SOFTWARE NAME)
- 3.3, 3.4, 4.2, 4.4
- 3.3, 3.4, 4.2, 4.4
- 3.3, 3.4, 4.2, 4.4
- 3.3, 3.4, 4.4
- 3.3, 3.4, 4.4
- 3.3, 3.4,4.5 4.5 4.5 28899 UNITHERM Cahbration servces Survestlance QA observe Memo to file, N/A M. Speckert f 09/28/95 Fumace. 09/28/95 (surveit) allwork Observation To Wentzville. MO Caitraten 28882 Controts for Decontammation Audit 09/14/94 Decontammaton Testing Protect N/A M. LeBeck ;
09/25/95 E. .;.e..m..tal test IAW ANSI Testmg 03239 Abstract l (App B & Part 21) Pollution, Santa Fe, N5.12 & ASTM Report 10/27/95 NM DA256 Ref: Testeg Project 03239 28881 ISOMEDtX Inc., Radiaton Testog,2 Audd 02/22/96 Radiaton Testing Testmg Project N/A M. LeBeck 09/25/95 Whippany, NJ steel panels,2 03239 Abstract (App B & Part 21) concrete blocks, Report 10/27/95 Ref. Testing Project 03239 LAW ASTM D4082-89 wth exception 31676 Mettler-Toledo, Caltrate Balances Audd 03/23/94 Cahbrate Balances Caltraton Record N/A DLF 01/15/97 Hightstown, NJ M&TE Approval (App B & Part 21) 31677 Cannon S200KU. S600KU Audd 02/20/96 Vrscosty Standards Cahtwaton N/A T. Callkms 01/08tg7 Instrurnents.. State Vrscosity Standards certificate. College, PA 31476 UNITHERM Caltraten per Surveillance OA observe Caltraton N/A M. Speckert 09/26/96 Fumace, ASTM D3911 & 10/01/96 (serveil) all work certificate. Wentrvele. MO ANSI 1012 31335 Urwers4y of irradiation of Audit 02/23/95 Matenal trradiaton Test Protect 03280 N/A C. Braun 08/16/96 Massachusetts, concrete disks. Abstract Report (App B & Part 21) Lowell. MA concrete blocks, One,10/14/96, steet panels IAW DBA Testing for ASTM D4082-89 Callaway Nuclear Plant. Test Project 03321, Abstract Report One, 10/17/96, for ANO 28592 Preos60n Gage & Cahbraton, Audd 02/02/95 Cahbraton Cahbraton N/A T. Calkms 07/14/95 Tool, Deyton, OH applicators, meters, certircates gages i
- Refers to applicable question. i
HUPlc SUPPLIER Carb_othe_ Company Revision 7 AUDIT CHECKLIST 2 AUDIT NO: _ 97 021 IVA) Page 19 of _54__ SECTION IV- PROCUREMENT (FIGURE 5) ITEM METHOD & DATE SCOPE OF SUPPLIER & DESCRIPTION OF SUPPLIER ACCEPTANCE M&TE P.O. AND DATE LOCATION (P/N, S/N, MODEL SUPPLIER APPROVALS & DOCUMENT USED INSPECTOR NO. EVALUATION LIMITATIONS SOFTWARE NAME)
- 3.3, 3.4, 4.2, 4.4
- 3.3, 3.4, 4.2, 4.4
- 3.3, 3.4, 4.2, 4.4
- 3.3, 3.4, 4.4
- 3.3, 3.4, 4.4
- 3.3, 3.4, 4.5 4.5 4.5 M08377 Synthetic RH 98 (Lot FG720) R&D Evaluaten - RH98 OCT 000, Visual N/A" Specialties, 8.Wdhams 01/30/97 Materlat only 02/05i97 RCPT 9460 Middletown, NJ Speofcation M08677 C. L Z . .erman. Y6 (Lot FN1001) R&D Evaluaton - Y6 OCT 000. Visual N/A B. Wdhams 04/09/97 WestChester OH Materiat only 04/17/97 RCPT 9838 Specircaten M08299 Eastman C6.wi, T14 (Lot - BULK R&D Evaluation - Y6 OCT 016. OCT N/A H. Payton 01/10/97 Kingsport TN 01/13/97) Material 155A (Specirc Spearcation Gravity) OCT 130 (Hydranaf).
01/13/97 M08378 McWhorter, RS266 (Lot R&D Evaluaten - RS266 OCT 016;OCT 017 N/A 8. Wdhams 01/30/97 Carpenterville, IL M08378) Matenal (Wgt/ Gal). OCT RCPT 9492 Specircation 027 (Gardner Color). 02/06/97 M08485 C. L Zrnmerman, H2O (Lot 03037) R&D Evaluaten - H2O OCT 089 (Wet N/A D.Gnau 03/01/97 West Chester, OH Material Seive) OCT 027 ' RCPT 9619 Speorcation (Gardner Color), 03/10/97 M08480 Aqualon, CM419 (Lot 4046) . R&D Evaluaten - CM419 N/A OCT 044 ( B. Wdhams 02/28/97 li .-..s W., DE Materlat Viscosity). 03/13/97 RCPT 9648 Specircation M08481 Shell Solvents, T18 (Bulk 03/03/97) RAD Evaluation - T18 OCT 155a,-3/13/97 N/A B. Wdhams 02/28/97 Houston, TX Materist , RCPT 9599 Specirication X3234 Ohc County Scale / Scale Inspecten / Aud411/14/95 Scale inspecten / Cahbraton N/A T. Calkans 12/12/"5 South, Cincinnati, Calibraten Cahbration certifcate OH
- Refers to applicable question.
" Although M&TE is used for some receiving inspecten testing, the M&TE rs not used for final product acceptance, which is based on additional testing.
y 1 R"I'" 7 AUDIT C KLIST
' d **P*"Y t t
, t i AUDIT NO: _97-021EAL Page A of _54_
- SECTION V . WATERIAL CONTROL AND f HANDLING. SHIPPING AND STORAGE . i Ik METHOD OF VERIFICATION ASSESSMENT 1
SUMMARY
RESULTS 5.1 Record the prococureshnstructens and/or drewmgs used to verdy . .v'.....aaten m this area. (Document O.E. on Figure 10) ii 5.2 Verdy that a - - x em estabhshed end .y .. ..;ed for the identdecaten and OA M==. section 4 s. and ouse.ty h=; Manvas, secten 4 a. control of items. Vertly the following u address the identihesten, control, and tracestety of matenals 1 J..." VDR a) Items are adequetely identified as -to . ,.a.m.st status. . receweg producten, warehousing, and shipping gy.ggg ,
^
b) The autherty for application and removal of identdicaten merkingststatus a) Fineshed products and row meterists were identdied; and every produd in , indicators is denned stock is contromed by the computer system. Any batches or Bots that are not 6 accepted cannot be allocated for use by the computer c) Storage areas and methods cornply with specslied ; s.-...,..ae and b) Quahty personnel are the only ones authonred to apply # remove status acess controls markers i k d) nem merkings am clear and not detrimental c) Warehouse is cemete controlled however, the temperature recorder, which tied previously been located in the wasehouse had been temoved i e) Subdivided items have satisfactory transfer of markings to each item. This was documented on Vendor Dencency Report 97-005 i d) leem merkings were cteer and on containers for both Anished products f) Shelf 40s requiremerAs are deRned and L.v ..~.J. and raw matenets. Finished product labets have product descnphon, code. batch number, manufactured date, shew Iife, and storage requirements. . (Document 0.E. on Figure 6) i Raw meterial contamers have raw molenet codes and tot numbers Appendtx BtANSI N45.2 Ref' (8.13/9.14) e) Each container of product batches is marked vnth the batch number ASME Section IN When a small amount of raw matenalis taken from the main container, the , y o g.9 e- ;33 9,133.g smaller contamer is likewise identdied with the raw rnstenal code and tot Vendor Priyam_Ref; QA Manual Sechon 4 8 numter. 3 f) Sheflife ;G. ... .as are defined on each final produd label s Adddionsey, the manufactunng date is on the label (as well as the botch ; number which inchcates the manufactunng date) from which the espiration *
, date can be detemuned. It was wenhed that the computer system j
automaticaWy puts a hold on products which have exceeded their empiration date. With the exception of item c. identdication and control of Iloms is adequate i and efgectively implemerded. a t s [ I i P
NUPIC SUPPLIER Revision y Cartst!n,_ Company AUDIT CHECKLIST AUDIT NO: JI-021Df%L Page. 21 of 54 SECTION V- MATER!AL CONTROL AND HANDLING, SHIPPING AND STORAGE METHOD OF VERIFICATION ASSESSMENT
ISUMMARY
RESULTS 53 Verdy that measures are estabbshed to assure the traceabihty of items (t e., OA Manual Section 4.8 and Quakty Procedures Manual Section 4 8 materials, parts, weld filler materlat, etc ) is maintained, as required throughout S addresses the traceab4 sty of matenals throughout processing in the plant. processing operatsns. Lot numbers for raw materiats are identifed on the material packaging. Raw (Document O.E. on Figure 6) materiallot numbers are also recorded on the batch tickets. Batch tickets contain the batch number for the finished product as does the mixing Appendix B/ ANSI N45 2 Ref. (8/9) container of the product. Therefore, batch numbers can be traced to the ASME Mn pl final produd tests and to the raw materials and lots used. Raw materials NOA-1 Basic Requirement 8 are identifed with the lot numbers which are traceable to OC receiving tests Vendor Program Ref. QA Manual Section 4 8 in bboratory logs. TraceabMy of materials throughout the manufacturing processes is adequate and effectrvely implemented. 54 venfy that measures are estabhshed and unplemented for the control of OA Manual Section 4.15 and Quakty Procedures Manuat Section 4.15 U shipping activities which include: packaging, marking, storing, status and addresses the handling, storage, sh pping and packaging of the product. shipment of items and -v,,was including spare and replacement parts. VDR The warehocse is located at 2162 Heller Drive Alpha, OH which is about five 97-005 (Document O.E. on Figure 6) miles from the manufactunng plant. The actualmethods used for these activities are acceptable. Packaging requirements are basically commercial a) Observe and assers actual techniques being used and their acceptabildy packaging in metal containers, packaged in cardboard boxes adequately relattve to contr4ocedural requirements. marked and shipped with Material Safety Data Sheets and artifications. b) Will cleaning, preservation and packaging practices prevent Some nuclear utili'y P.O s invoke ANSt N45.2.2 Level B for handling. I damage / deterioration? storage, packaging and shipping. No objective evidence was available during the audit (e g Temperature 8% corder) to substantiate that Carboline c) Are customer PO requiremerits for environmentaFpreservation and maintains the warehouse at a temperature range of 40-110 degrees F, This handkng adequate 8y met? deficiency is documented on Vendor Deficiency Report g7 005. Appendur BIANSI N45.2 Ref- (13,14/14,15) With the exception of the above deficiency, handling, storage, packaging ASME Seden ill and shipping is adeounte and effectivety implemented. NOA-1 Supplement 13S-1 Vendor Program Ref. QA Manual Section 4.15
S NUPic SUPPLIER Cart-#ne Company Revis%: ? AUDIT CHECKLIST AUDIT NO: JZ.021.[V.A]_ Page 22 of 54 SECTION V ~ ATATERIAL CONTROL ANO HANDLING, SHIPPING AND STORAGE (FIGURE 6)
~
ITEM DESCRIPTION METHOD OF (PAGE 8/P.O ETC) IDENTIFICATION & TRACEABILITY INSPECTION STATUS
*5.25.4 *5.25.35.4
- 5.2. 5.4 IN PROCESS MATERIALS PRODUCT Carbohne 8812, Part A. Batch 7D2216M Batch Ticket identi'ied produd, batch number, phss raw Produd in process materialidentification and tot twmber utthred RAW MATERIALS Product Code W35 Lot Number 12367 Raw Material Code Number and/or Lot Number identifed Accepted Product Code Y96 Lot Nurnber 61662 ori containers. -
Product Code T11 but accepted 04/11/97 *
= .
RAW MATERIALS IN STOCK
- Product Code W36 Lot Number 12367 .
Product Code Y96 Lot Number 6t662 . Produd Code CM561 Lot Number 9607H . Produd Code H84 Lot Number 0282044 * . Product Code Y6 Lot Number FN7001 - Product Code T11 but accepted 04/11/97 * . Produd Code T1B but accepted 04/11/97 * . FIN 1SHED PRODUCTS - Carbonne 890, Part B,010986. Batch 7C9818M Labels on containers include Carboline 890. Part B. 010986, Batch 7C9815M ltem desenption - Carbotme 890. Part B. 010986, Batch 7C9814M product code = Carbohne 890, Part A,010986. Batch 7A9730M batch number -
. Carbchne 890, Part A,010986. Batch 7C9832M manufactured date -
Carbohne 890, Part A. 010986. Batch 789767M shef life - Carbo Zme 11SG. 010231, Batch 7D9850M storage requirements - Zinc Filler for CZ11 SG 010229. Batch 780255Z
- Thinner 826. 010526. Batch 7C9837M
- Thinner #26,010526. Batch 789796M *
=
Thinner #33,010533. Batch 7C9825M * -
- Refers to apphcable question.
NUPlc SUPPLIER Carbotjne_ Company Revision 7 AUDIT CHECKLIST AUDIT NO: _97-{L21[ VAL Page 23 of 64 SECTION VI . FABRICATIONIASSEMBLYtSPECIAL PROCESSES METHOD OF VERIFICATION ASSESSMENT
ISUMMARY
RESULTS 6.1 Record the svwdures/mstructons and/or drawmgs used to verify amp!ementaten m this area. (Document O E. on Figure 10) 62 Venfy that measures are estabhshed and unplemented for the control of Witnessed the mixmg and blendog of Carbohne 890 Part A. PN 09862332A, S fatwicatentassemtdy edivities by record revew and observaten,if possible. Batch Numbef 7C9846M and the filhng process of Carbohne 890 Part A, PN These activites shouki be controlled by a shop work order / traveler type 986 S800. Batch Number 7D9873M of formulated raw materials into a document which includes the followeg (as apphcable): feished product. The processes witnessed were performed in accordance Identification of the work process; with the apphcable Work Instruction Manual, Promdures and Batch Ticket a) requirements and included the followmg: b) Ident(es instructions, procedures and drawings to be used for each item / activity; a) Batch Number 7C9846M-Mixing / Blending Operation, Batch Number c) Ident#es holdhvitness points; 7D9873M-Fimng Operations d) IdentWes any environmental requwements; b) Work Instructens Manual F 01 & F 02, for filling and 0 014 0 02, for e) Venficatice of use of corred parts or materials. Mixing / Blending (Document O E. u rigure 7) c) These Carboline products did not requwe any intermediate testing. Only final testing was required to accept and release the products for filleg. Appendix B/AN5i N45.2 Ref: (5/6,8/9) Testeg of Cartehne products was venfed in Secten Vit. ASME Section lit d) No Special envronmental requwements are necessary. NQA-1 Supplement SS-1 e) The Blendog Operator venfes each raw material or butk rnaterial that is Vendor Program Ref: OA Manual Secten 4 9 hsted on the Batch Ticket and ensures that the identifed raw or bulk materials batch / lot number on the Batch Ticket matches the batchtlot NOTE: Assessment of sonware controls relatmg to the manufacturing numbers identfed on the containers or storage tanks. processes are to be verred in Section lit. Acceptable traceability to be verired in Section V. These activities are well controlled and effect;vety implemented. [ 6.3 Venfy that specsat processes are accomphshed utitemg: Not opphcable. Carbohne does not perform special processes. N/A l a) QuatWed personnel , b) Oualified procedures c) Qualified equipment, as applicable (Document O E on Figure 7) NOTE: Personnel qualifications to be verired by auditor in Sect on X. Unique identification and acceptabihty of instruments to be checked under Secten Vill. Acceptable traceabihty to be verired in Section V. Appendix B/ ANSI N45 2 Ref; (9/10) ASME Section ist NOA-1 Supplement 9S-1 Vendor Program Ref. N/A
NUPIC SUPPLIER ' C_arbot'ne_ Company Revision 7 AUDIT CHECKLIST 4 AUDIT NO: _97 021 [V.A]._ Page 24 of _ 54 _ SECTION VI- FABRICATIONIASSEMBLY/SPECIAL PROCESSES (FIGURE 7) QUALtFICATION ITEM DESCRIPTION ACTIVITYIPROCESS AND (P/N, SIN, MODEL NO.) WORK DOCUMENT PROCEDURE & PERSONNEL PROCEDURE EQUIPMENT REVIDATE
- 6.2, 6.3
- 8.2, 6.3
- 6.2, 6.3
- 6.3
- 6.3
- 6.3 Cart > ohne 890, Part A, Batch Tschet 7C9646m Witnessed mixing /btendmg George Cnambhss Work Instruction Manual O Weigh Scales Neutral Base, PN of Carboline 890, Part A, Biending Operator 01,02,& 03 SN 002128 099G2332A Quahty Procedures Manual 4 8. Revision 1, dated SN 002139 05/01/95, Work Instruction SN 002143 Manual M 01, Revision 1 Toledo Scale SN 6118250-6TX dated 05/01/95 Carbohne 890, Part A, Batch Ticket 7D9873M Witnessed filhng of Marty Livingston Work Instruction Manual F Weigh Scale White S800, PN 986 S800 Carboline 890, Part A, MchaelGraham 01 and F 02 SN 060373 Work Instruction Manual F Utihty Fdlers 01, Revision S, dated 01130/97 and F 02, i
Revision 4, dated 09/06/96 I
- Refers to apphcable question.
HUPlc SUPPLIER Carbp!he_ Company Revision 7 AUDIT CHECKLIST AUDIT NO: 97-021. IVA) Page 25 of _54._ SECTION Vil-TESTS AND INSPECTIONS METHOD OF VERIFICATION ASSESSMENT /
SUMMARY
RESUt.TS 7.1 Record the procedures /mspecitons and/or drawmgs used to venfy implementation m thes area. (Document O E. on Figure 10) 7.2 Venfy that adequate measures are estabhshed and amplemented (Dy record Witnessed the feel testeg of Carbohne 890 Part A Batch Tecket 709873M, S review snd/or observation) for the inspection and testmg of rnaterials, PN 986 S800. The pre-prmted Batch Ticket included: components and parts. Verify these documents include: a) Each type of test to be performed is listed on the Batch Ticket for product venfication, a) Test / Inspection to be performed. b) No hold points are r-yi cd b) Hold or witness points,if applicable. c) Each test to be penormed has the required OCT Specrreation/ Procedure indicated. c) Specircations, work instructions, drawings, etc., includmg document d) The acceptance criteria br the required test limits are indicated on the revision. Batch Ticket. 4 AWm W1 e) Test equipment used is identifed in the applicable OCT Specifcation/ Procedure. e) Inspection equipment, tools, gages, and instrumentation. f)Inspectson requimments are fested on the Batch Teket. g) Test prerequisites are indicated in the OCT Specircation and on the f) Characteristics to be inspected. Batch Tcket. g) Test prerequisites identified and met. h) The Batch Operator and OC Inspector initials by the applicable area of responsibihties on the Batch Ticket. h) Personnel. t) The final inspection indcated on the Batch Tickets are initiated and dated by the appropriate OC Inspector performing the test. The Batch Tickets are
- 1) Results and approved by responsible authonty. reviewed by the QA/QC Manager.
j) Action taken relative to any deficiencies noted. N " *"' "9 * " " testing performed for Batch Ticket 7D9873M. (Document O E. on Figure 8) NOTE: Acceptance materlat traceability to be verited in Section V.
' " P "' '
- Impte n Unique identircation and acceptability of instruments to be verited under section Vtil. .
Appendix B/ ANSI N45.2 Ref (10,11/11,12) ASME Section Ill NOA-1 Supplement 10S-1,11S-1 Vendor Program Ref: QA Manual Section 4.10 7.3 Assess the adequacy and desenbe the supphers samphng plan (s) mcluding its Not Apphcable. N/A documenW bash Carboline does not use a sampling plan.100% testing is performed on raw NOTE: The basis for the plan's selection and application should consider tot materials and fmished products. traceabihty and homcgeneity, complexity of the item and adequacy of subtier suppliers controls. Appendix B/ ANSI N45.2 Ref: (10, 11) ASME Section lit NOA-1 Supplement 10S-1,11S-1 Vendor Program Ref. Not Anoticable
HUPic SUPPUER Carbo Ino_ Company psvistori y AUDIT CHECKLIST AUDIT NO: J7-021 (VA)_ Page 26 of _ 64_ SEf' TION VII. TESTS AND INSPECTIONS METHOD OF VERIF# CATION ASSE SSMENTISUMY.ARY RESul.1S 7.4 Venfy that the s .veg plan (s) are controned and acceptably unplemented Not Apphcable. See checklest item 7.3. N/A Appendim B/ ANSI N45.2 Ref. (10,11) ASMF Secten it! NO#-f Supplement 105-1,11S-1 Veno? Program Ref. Not Aooficable s 7.5 venfy that the *ests and inspections specded for the acceptance of w. .ercial Not Apphcable. Carbohne does not perform commercialgrade dedcatert N/A grade items adequately verify the identifed crdical charactenstics. NOTE: Ttds question applies to CGI e dedicated by the suppler for utstay pihm. ant as basic components. (Document O.E. on Figure 8). Appendix B/ ANSI N45.2 Ref; (1011111,12) ASME Section ill NOA-1 Supplement 10S-1 Vendor Program Ref; Not Aeolicable 7.6 If anspecten of processed stems es unpossible or disadvantageous, venfy that AM required testing per the OCTs are bsted on the apphcable Batch Tickets. S Inderect controts by monitoring processing methods, equipment and personnel The acceptance crderia is also listed and after completion of att testing. the is A results are recorded and initsled and dated by the OC Inspector and (Document O E. on Figure 8) revie'ved by the QA/QC Manager. Indtrect rnonitoririg processes are not
.g used.
Appendix B/ ANSI N45.2 Ref. (10/11) l ASME Secten til The inspection / testing process at Carbotine is adequate and effectively ! implemented. NOA-1 Supplement 10S-1 . Vendor Program Ref- QA Manual Section 4.10 7.7 For equ.pn,+nt containing femware venfy that testing deiiivnstrates the Not apphcable. Coating matenal supphed by Carbohne does not contain N/A capabildy of the computer program to produce repeatable, valid results for its firmware. intended functiori. Firmware example: programmable integrated chips. (Document O.E. on Figure 8) Appendix B/ ANSI N45.2 Ref. (11/12) ASMC Section Ill NOA-1 Supp'ement 11S-1 VendorProgramRef; N/A l [
NUPtC SUPPLIER Revision 7 Carbefine Company
- ~ ~ ~
AUDtT CHECKUST AUDIT NO: _9Z-021_(VA}_ Pagelof _S4_ SECTION Vil-TESTS AND INSPECTIONS (FIGURE 8) CONTROLLING INSPECTOR / INSPECTION! TESTANSPECTION REPORT TESTER TEST DOCUMENT M&TE USED ITEM DESCRIPTION TYPE CF TITLE / NUMBER & EQUtPMENT (P/N, S/N, ACTIVITY NUMBER /DATE NAME/ STAMP REVIDATE ID AND NO. DATE USED RESULTS NCR NO. ETC)
- 7.2. 7.5. 7.6,
- 7.2. 7.5, 7.6,
- 7.2,7.5. 7.6,
- 7.2, 7.5. 7.6,
- 7.2, 7.5. 7.6. 7.7
- 7.2. 7.5, 7.6. 7.7
- 7.2, 7.5, 7.6, 7.7
- 7.2, 7.5, 7.6,
- 7.2, 7.5, 7.6, 7.7 7.7 7.7 7.7 7.7 7.7 Carbohne 890 Brookfeks Batch Tecket H. Payton. OC OCT 844.06/17/96 Brookfeld vescosdy 04/17/97 S N/A Part A PN 986 ViscosiN Nurnber Inspector M-P-1 S800, and 890 7D9873M,
- Part B color 04/17/97
#6908. Batch Nurnber Weight per OCT 817,09/13/96 Mettler Scale C55016 04/17/96
*
- S N/A 7C9816M Gallon & Work Instruction Weight per Ganon Cup Manual E 14. Rev. ME-3 1,06/23/95 Fineness of OCT #1,04/11/95 Grind Gage M-A-165A 04/17/97 g . . S N/A Leneta Sag
- OCT #33. 06/17/96 Mettler Scale C55016 04/17/97
*
- S N/A Test
- Leneta Anti-Sag Mettler 060895-3 Drawdown & QCT #15. 06/17/96 10 Md Drawdown 04/17/97 S Cure Test *
- N/A Gage M-C-3
* *
- 8 Gloss OCT W22. 04/11/95 Mero-Gloss 60 04/17/97
* *
- S N/A Determination Cahbrate Prior to each use.
Thickness OCT #211 Coating Thickness 04/17/97
- S N/A required for *
- 06117/96 Gage M-K-2 hiding
- Refers to apphcable question.
_ _ _ . _ m . . . m m ._ ---- - - - -- - - - ~ " - " - NUPlc SUPPUER Carbolledgmpany Revistort 7 AUDIT CHECKUST
, AUDIT NO: 97-021DlAL_ Page 28 . of _54__
SECTION Vill- CAllBRATION METHOO OF VERIFICATION ASSESSMENT
ISUMMARY
RESULTS 8.1 Record the envvoGoreshnstructions and/or drawings used to wwJy 6,amentation m this area. (Document O E. on Figure 10) 82 Review the reference (pnmary) and working (secondary) standards used and Verifed by revew of the follownng ttems that standards used a 4 tracestHe to verify traceabitty to the Nationalinstitute of Standards and Technology (NIST), S NIST or other recognized standards: other recognized standards, or natural law.
, p (Document O E. on Figure 9) Coatmg on Steel,40 uM,80uM,140uM,205uM.
Appenden B/ ANSI N45.2 Ref; (12/13) NBS Certificate - Standard Reference Material (SRM) 1363a, Non Magnetic ASME Sedion til Coating on Steel,250uM,400uM. 500uM,650uM NOA-1 Supplement 12S-1 Vendor Program Ref; QA Manual Section 411 Thermometer Cahbration Report - H-8 Instrument Company Thermometer, Partial immersion, S/N HB/B 17209. 02/24/95, Range: -20/+110* C Cannon Vrscosity Standard, S200 (KU). Lot 97101 Cannon Viscosity Standard, S600 (KU), Lot 97101 Traceability is adequate and effectively implemented 8.3 Assess spm '.s M&TE standards used as to their range and accuracy relatrve M&TE standards used by Carbohne (SRMs and thermometer) are certshed to items cahbrated S to tolerances of at least four times the nominal accuracy of the measuring NOTE: Cahbrahon standards should have a definitive accuracy range- and test equipment being calibrated. (e g. thickness, viscosity, and consstivity and stability for the instrument being cahbrated. The temperature measuring equipment). Other M&TE is calibrated via standard shall have a nominal accuracy of four times the nomenal calibration m s@ and conforrns W -t' -Mh the NOTE of this checklest item. accuracy of the measuring and test equipment being cahbrated. If not postele, documented and authorized basis of acceptance shall Maintenance of accuracy relative to the items being calibrated is adequate be prov6ded - and effectively implemented. (Document 0.E on Figure 9) Appendia BIANSI N45.2 Ref. (12/13) ASME Section ill NOA-1 Supplement 12S-1 Vendor Program Ref; QA Manual Section 4.11
a 4 I t i NUPlc SUPPLIER Carbol.ne_Comparty Revision 7 AUDIT CHECKLIST AUDtT NO: _SI-021(VA)._ Page 29 of_._5 _4 ! SECT 10N Vtit - cat IBRATION METHOD OF VERIFICATION ASSESSMENT /
SUMMARY
RESul.TS 84 Venfy memtenance of cahbrated equipment & records. Review the equipment Venfed by exammaten of cahbraten records for M&TE used for recemng S
& records for the fonoweg, as a minrnum. (Document O E. on Figure 9) inspection, in process measu ement and acceptance testmg. Verdied each a) Uniqua identifters (a g.,1 D.. S/N., name, manufacturer); item was identifed with unique identifier, status indscator (in talerance) I b) location /pm cohbration interval, procedure for cal braten or venfication, cahbration I history and as found/as left condden.
f.) Status indicator; t d) Cahbraten (recall) intervat, it should be noted that much of the primary calibration is performed by e) Calibraten procedure includeg revision service supphers although Carbohne performs periodic accuracy f) Calibration History - Dates cahbrated, by whom, results, due date, primary verrricatens. g) I" foul as-ien dMa/condaion. *'*a=a= implemented. o'c=*rataa =ad r*=ros i"*au= =ad aci~e'r NOTE: Utilize des from Sections IV, VI, Vll. Appendix B/ ANN 145.2 Ref. (12/13) I ASME Section : ' NOA-1 Supplement 12S-1 Vendor Program Ref: QA Manual Section 4.11 85 Venty that cahbraten is performed by quanted personnel Venfed by revew of tne trarning/gushficaten records for the mdeduals S wnt O E. on Figures 9 and 13) identifed m Fegure 13, that cahbrations and/or venfications are performed or verified by qualded personnet.
. - endin B/ ANSI N45.2 Ref; (12/13)
This attribute is adequate and effectively implemented. ASME Section til NOA-1 Supplement 12S-1 Vendor Program Ref- QA Manual Section 4.11 86 Verify that cahbraten is Mm..,4 in an environment that es controned to the in accordance with OPM 4.112G, cahbratens are camed out under the S extent necessary to assure required accuracy. same environmental conddions as normal equipment usage. This is , because many of the in process instruments are trounted or available on ! Appendix B/ ANSI N45 2 Ref; (12/13) ASME Secten lit the producten noor. Remaining instrumedWien used for m em . NOA-1 Supplement 12S-1 acceptance testing are maintained in the OC Lab. This space is in an Vet:br Program Ref; QA Manual Section 4.11 enclosed owim wes and mairdained as a staW emm I Environmental controls are adequate and effectivey implemented. I 83 Venfy that measures are estabhshed and .G.,nted to evaluate pnor use No examples were available however, QPM 4.112F requires that equipment S and control of M&TE found to be *out-of tolerance
- or *out of cahbration*, Verify found not cahbrated at specifed intervats or outside cahbrateon tolerances be that affected customers were notified, where appropriate. tagged *out of Service
- and physically removed where practical.
Appendix B/ ANSI N45.2 Ref. (12/13) AdddionaNy, the foHowing is gathered f,4 review and evaluation by QA Manager and appropriate groups: 1) amount of deviation from the ASME Sedian tti acceptable standard,2)last date when acceptable performer'ce could be NOA-1 Supplement 12S-1 Vendor Program Ref; QA Manual Section 4.11 established,3) products tested using instrument dunng thet period 4) . impact, if any, on product qualdy dunng this period. Steps are recommended and action points assigned for corrective action as necessary.
P NUPlc SUPPLIER Carbellne Company Revision y AUDIT CHECKLIST
. AUDIT NO: _97-021.(VA,' _ Page Jg_ of _S4_
SECTION Viff - CALIBRATION (FIGURE 9) PURCHASE ORDER NAMEAND CAL PROC AS-FOUND AS-LEFT STANDARDS NIST/lNDUSTRY NUMBER IF M&TE ID & REV. DATE CAL DATE DUE DATE CAllB. BY CALIBRATION USED (YES/NO) SUB-SUPPLIER
- 8.2, 8.3. 8.4
- 8.4
- 8.4
- 8.4
- 8.4. 8.5
- 8.4
- 8.2, 8.3. 8.4
- 8.2, 8.3, 8.4
- 8.2, 8.3, 8.4, 4.2 SRM 1362a NBS 06/05/88 06/05/58 N/A NBS / / NBS Master YES N/A Standards SRM 1363a NBS 05/01/84 05/01/84 N/A NDS / / NDS Master YES N/A Standards Shrn Xema 1 WI E 16. Rev 10/03/95 10/03/98 R Reals / / SRM 1362a YES N/A 1,09/13/96 Shrn Xenta 2 WI E 16. Rev 10/03/95 10/03/98 R. Reais / / SRM 1362a YES N/A 1,09/13/96 Shrn Xenia 5 WI E 16. Rev 10/03/95 10/03/98 R.Reats / / SRM 1362a YES N/A 1.09/131%
Sham Xema 10 WI E 16. Rev 10/03/95 10/03/98 R. Reals / / SRM 1362a YES N/A 1.09/13/96 Shrn Xema 20 WI E 16. Rev 10/03/95 10/03/98 R.Reats / / SRM 1362a YES N/A 1,09/13/96 Metal Plate WI E 16, Rev 10/03/95 10/03/98 R. Heats / / SRM 1362a YES N/A DAPRA 62036 1,09/13/96 Mettler-Toledo WI E 03. Rev 12/05/96 06/97 T. Hurst. / / 132. 09/30/96 YES 31676 Balance 1.05/01/95 Mettler-Toledo 822/255443-95 PE360 C550t6 Brookfield WI E 02. Rev 02/97 02/98 T.Camms / / S200 Lot YES N/A Visccmeter M- 1.09/13/96 95101 S600 p-1 Let 95101 Mettier-Toledo Wl E 03. Rev 12/05/96 06/97 T. Hurst. / / 310.07/24/96 YES 31676 Balance 1.05/01/95 Mettler-Toledo 822/255443-95 AG204 1114112732 Gas OCT 137 03114/97 04/97 T. Catkms / / Alcohot N/A N/A Chromatograp 0G/17/96 h Seres 550 M-AA-1 Mettler-Totedo WI E 03. Rev 12/05/96 06/97 T. Hurst. / / 132.09/30/96 YES 31676 Balance PB30 1.05/01/95 Mettler-Toledo 822/255443-95 737892 : Toledo Model Wl E 03. Rev 03/19/97 05/30/97 T. Hurst. / / 132.09/30/96 YES 31676 8525 6118950- 1,05/01/95 Mettler-Toledo 822/255443-95 6TX Weegh-Trona WI E 04. Rev 02/24/97 05/30/97 Ohc Countog / / 096-035.096- YES X3234 Scale 002128
- 0,10/05/93 Scale / South 054 inc.
- Used for gross checkmg only per QA/QC Maeegt r note c ated 02/29/97. Acceptance measurement try use of other M&TE.
HUPlc SUPPLIER Carboilne Company _ Revision 7 AUDIT CHECKLIST AUDIT NO: _97_-021 (VA)_ Page 31 of _54 _ SECTION Vill . CAllBRATION (FIGURE 9) PURCHASE ORDER NAME AND CAL PROC AS-FOUND AS-LEFT STANDARDS NISTflNDUSTRY NUMBER IF M&TEID &REV.DATE CAL DATE 'DUE DATE CALIB. BY CALIBRATION USED (YES/NO) SUB-SUPPLIER
- 8.2,8.3,8.4
- 8.4
- 8.4
- 8.4
- 8.4. 8.5
- 8.4
- 8.2. 8.3. 8.4
- 8.2. 8.3. 8.4
- 8.2,8.3. 8.4 4.2 Weigh-Tronix WI E 04. Rev 02/24/97 0$t30/97 Ohe Countog / / 096-035.096- YES X3234 Scale 002139 0,10/05/93 Scate/Soutti 052 Inc Weigh-Tronix Wl E 04. Rev 02/24/97 05/30/97 Ohe Countog / / 096-035.096- YES X3234 Scale 002143 0.10/05/93 Scate/ South 052 Inc Cannon Suppiers 01/14/97 04I30/98 Cannon / / Cannon Master YES 31677 Viscosity STD Procedures instrurnent S200 (KU) Lot 97101 Canrion Supphers 01/14/97 03/31/98 Cannon / / Car.non Master YES 31677 viscosity STD Procedures instrurnent S600 (KU) Lot 97101 Gnnd Gage M- WI E 16. Rev Annual Visual. Annual Visual: T. Camms / / Annual Visuat YES N/A A-t-65A 1.09/13/96 05/96 05/97 050195 J. Arnold. p p pGAT Master YES 28592 Suppliers 05/04/95 05/04/98 Precisen Gage set # 8173 Procedures & Toot 821/254921-95 Laneta Ants Suppler 06/08/95 06/08/98 J. Arnold. / / PG&T Master YES 28592 Sag Meter Procedures Precision Gage set # 8173 060895-3 & Tool 821/254921-95 10 Md Draw WI E 16. Rev Annual Visuat Annual Visual. T. Camms / / Annual Visual YES N/A Down Gage M- 1.09/13/96 05/96 05/97 C-3 050495-3 J. Arnold. PG&T Master YES 28592 05/04/95 05/04/98 Precision Gage set # 8173
& Tool 821/254921-95 Costeg WI E 16. Rev Annual Visuat. Annual Visual. T. Cakms / / Annual Visuat YES N/A Thickness 1.09/13/96 04/96 04/97 Gage Positector 6000 M-K-2 9665
.__ __ . _ . . . ._ . . . . . . _ _ _ . ._ . . _. . . .__ _ _ m NUPic SUPPLIER Cartoline Company -
Revision 7 AUDIT CHECKLIST
, AUDIT NO: _97.-021 (VA) .,,,,_ page J2_ of _,.54_
SECTION Vtit - CAllBRAT10N (FIGURE 9) l PURCHASE I ORDER NAME AND CAL PROC AS-FOUND AS-LEFT STANDARDS NIST/tNDUSTRY NUMBER IF M&TE ID & REV. DATE CAL DATE DUE DATE CAllB. BY CAllBRAT!ON USED (YES/NO) SUB- , SUPPLIER
- 8.2. 8.3, 8.4 8.4
- 8.4
- 8.4
- 8.4. 8.5
- 8.4
- 8.2. 8.3. 8.4
- 8.2. 8.3. 8.4
- 8.2. 8.3. 8.4 4.2 Staixlard W1 E 13. Rev 02/24/95 02/98 H-B 1ristrument / / S/N 878728 YES N/A Thermometer 3.09/13/96 Co Test 247503 '
M-T-1 A 17209 S/N 866301 Test 247503 Wegh-Tronts WI E 04. Rev 02/24!97 05/30/97 8 Copley. / / 096-035 &
- YES 24 Scale 0373. M- 0.10/05/93 Ohio Countmg 096-054 AAA-21 Scale / South '
inc Weght per WI E 14. Rev 08/96 08/97 T. Canuns / / M-T-1 A Yes Gaflon Cup N/A 1.06/23/95 t ME-3 i i I I L l
. . _ . _ _ ~ _ _. _.m_ . _ . ~ . _ . . ~ . -_ 4 m-> . - . . . . - - - . - - . - - _ . - - - , .. ..-_m. mm - .._ -..___.. - . .. ..
i I i NUPlc SUPPUER Revision 7 AUDIT CHECMusT Carborne Cm
- ~ - ~ ^
AUDIT NO: _97 021LVAL _ Page 33 of _s4_ ; l' ! SECTION IX - DOCUMENT CONTROUADEQUACY esETHOO OF VERIFICATION ASSESSMENT /
SUMMARY
RESUt.TS 9.1 Venfy that measures are estatWeshed and .w' .. ..:ed to control the essuance incrysdual documents (QA Manual. (OAM) Quahty Program P ocedures
- i of documents (i e.. procedures, instructions, drawings, work orders, etc.) U (OPM). Work Instructen (WI). & Quahty Control Test (OCT)) prepared by VDR includrng changes. These measures shot assure that documents are: ,
OA Manager. Revewed by apphcable corporate and producten faciety 97-006 t (Docunent O.E. on Figure 10) management as necessary. Approved by OA Manager. ! a) Reviewed for adequacy; Distributen authorized by OA Manager. Destrepution performed using l b) Approved for release by authorized personnel, transmetalletter requesteg return of obsolete documents. Fonow up is performed h actu'Amnt is M W h W m hg g [ c) Destrbuted to apphcable work station, and include definitive eks). Second fonow up cancels controNed status for apphcable manual i quantdativeAtualdative acceptance creeria as opphcable copy. Evidena to be obtained from Sectens I-Vlit & X shas be identdied wdhin thes Siu (6) of six (6) ControNed OA Manuals presented for suddor use were g ,- rmssing current revisions of documents, contained both old and new revisens of documents, or indnndual pages of superseded documents. This NOTE: Objective evidence is recorded by each suddor on Figure 10. The is an indication that obsolete documents were not retumed as required > responsible team member completes the assessment / summary for question 9.1 based on input from auddors and/or as documented on Controned document manual serial numbers included: 000. 049. 055. 060 ) 069, and 076. l Adddenally, the latest revision of the OA Manual and Quality Procedures Appenda B/ ANSI N45.2 Ref: (5. 64. T) Manual had not been received at the Xenia. OH piant as of 04/17/97. ASME Section att Revisions to both documents were effective on 04/1057 and had no impad NOA-1 S.,,,:...,4 65-1 on product quahty. f* Vendor Program Ref: QA Manual Section 4 5 The above deficiencies were documented on Vendor De8iciency Report 97 006.
- t t
t P g A i i 6 r e
NUPtC SUPFLIER Carbolir e_Cempany AUOtT CHECKUST AUDIT NO: J7-02jpAL Page M of _L SECTION IX - PROCEDURE DATA SHEET (FIGURE 10) PROCEDURES / INSTR /DRWG/ TITLE REVIDATE CORRECT REVISION CHECKLIST SECTION (YES/NO) OUALITY ASSURANCE MANUAL REV 5,04/10/97 Y ALL OPM 4.1, MANAGEMENT RESPONSIO!LITY REV 7.04/10/97 Y 10 A 1,10 A.2,10.A.3 OPM 4.2, QUALITY SYSTEM REV 3. 01/30/97 Y ALL OPM 4 3, CONTRACT REVIEW REV 5,09/06/96 Y g OPM 4 4, DESIGN CONTROL REV 4,09/06/06 Y ll OPM 4.5. DOCUMENT / DATA CONTROL REV 4. 01/30/97 Y LX OPM 4 6. PURCHASING REV 6. 01/30/97 Y ly QPM 4.8, PRODUCT IDENTIFICATION AND TRACEABILITY REV 1. 05/01/95 Y v OPM 4 9, PROCESS CONTROL REV 2,01/30/97 Y yt OPM 4.10, INSPECTION AND TESTING REV 3,10/26/95 Y Vil OPM 4.11, INSPECTION, MEASURING AND TEST EQUIPMENT REV 10,09/13/96 Y y gt OPM 4.12, INSPECTION AND TEST STATUS REV 1. 05/01/95 Y y OPM 4.13, CONTROL OF NONCONFORMING PRODUCT REV 2,05/01/95 Y 10B.1,10 B2 OPM 4.14, CORRECTIVE ACTION REV 3,09/12/96 Y 10 E OPM 4.15. HANDLING, STORAGE, PACKAGtNG AND DELIVERY REV 3,03/15/96 Y y OPM 4.16, QUALITY RECORDS REV 7.09/13/96 Y 10 G.1,10.G.2,10.G.3 OPM 417, INTERNAL QUALITY AUDITS REV 3,01/30/97 Y 10.C OPM 4.18, TRAINING REV 105/01/95 Y 10 F.1,10 F.2
* = OOCUMENT NOT
' VERIFIED
y-NUPlc SUPPLIER Carbolice Company Revision 7 AUDIT CHECKLtST
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AUDIT NO: _97-021 (VA)_ Page JL of J_ SECTION IX . PROCEDURE DATA SHEET (FIGURE 10) PROCEDURES /lNSTR/DRWG/ TITLE REVIDAT E CORRECT REVISION CHECK 1IST SECTION (YESINO) WI A 01. ORDER PROCESSING REV 3. 09/15/95 Y I WI A 02. MANUAL CHANGE ISSUANCE REV 2. 07/01/94 Y lx WI A 03. QUALITY BULLETINS REV 2. 07/01/94 Y IX WI A 04. INTERNAL QUALITY AUDITS REV 2. 01/30/97 Y 10 C WI A 05. UPDATING OF MANUALS REV 1. 07/01/94 Y IX WI C 01. CORRECTIVE ACTit. N. NONCONFORMING ITEM REPORT REV 3. 09/15/95 Y 10.B.1.10.B.2 WI C 02. CORRECTIVE AC' >N PROBLEM REPORTS REV 8. 01/30/97 Y 10 E WI C 03 GLOBAL HOLD SYSTEM REV 0,10/05/93 Y 10 B.1.10.B.2 WI D 02. NUCLEAR FORMULA CON TROL REV 2. 01/30/97 Y 11 WI D 03. MSDS AND LABEL CONTROL REV 2. 07/10/95 Y V WI D 11. PRODUCT t.ITERATURE REV 1. 05/01/95 Y 10A 4 WI E 01. CAllBRATlON PROCEDURE: STORMER VISCOMETERS REV 1. 09/13/96 Y Vill WI E 02, CAUBRATION PROCEDURE: BROOKFIELD VISCOMEIERS REV 1. 09/13/96 Y Vill WI E 03. CAUBRATION PROCEDURE: ELECTRONIC BALANCES REV 1. 05/01/95 Y Vlil WI E 04. CALIBRATION PROCEDURE: PRODUCTION SCALES. REV 0,10/05/93 Y Vlil WI E 05. CALIBRATION PROCEDURE: STOPWATCHES & TIMING REV 0,10/05/93 Y Vill DEVICES WI E 06. CALIBRATION PROCEDURE: FLOWMETERS REVc E3 Y Vill WI E 07. CAUBRATION PROCEDURE: OMEGA TEMPERATURE REV 2. 05/01/95 Y Vill INDICATOR WI E 08. CAUBRATION PROCEDURE: FOXBORO TEMPERATURE CHART REV 1. 05/01/95 Y Vlit RECORDER
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_. _ _ _ _ . _ _ _ _ _ _ _ _ __. _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ . _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _______________._o
NUPlc SUPPLIER Carbot'ne Company Revision 7 AUDIT CHECKLIST
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AUDIT NO: 37 0.21 NA)_ Page 36 of _ 6 _4 SECTION IX - PROCEDURE DATA SHEET (FIGURE 10) PROCEDURES / INSTR /DRWGITITLE REVIDATE CORRECT REVISION CHECKLIST SECTION (YES/NO) WI E 09. CALIBRATION PP.OCEDURE: OMEGA TEMPERATURE LOGGER REV 1,05/01/95 Y Vill WI E 10. CALIBRATION PROCEDURE: PRESSURE GAUGE REV 0,10/05/93 Y Vlie WI E 12. CALIBRATlON PROCEDURE: F T-IR-SPECTROPHOMETER REV 1,11/29/95 Y Vill WI E 13, CALIBRATION PROCEDURE: THERMOMETERS REV 3,09/13/96 Y Vill ; WI E 14 CAllBRATION PROCEDURE: WEIGHT PER GALLON CUPS REV 1,06/23/95 Y Vil, Vill ! WI E 15 CAllBRATION PROCEOURE: REFRACTOMETERS REV 1,11/06/95 Y Vill WI E 16, COATING THICKNESS CALIBRATION STANDARDS: REV 1,09/13/96 Y Vllt VERIFICATION OF ACCURACY WI F 01, BATCH PREPARATION FOR FILLING REV 5,01/30/97 Y VI W1 F 02, BATCH FILLING REV 4,09/06/96 Y VI WI L 02, BATCH REJECT REPORTS REV 3,01/30/97 Y 10.B.I.10 B.2 WI L 03, OUALITY IMPROVEMENT REQUESTS REV 0,10/05/93 Y 10 B.1,10 B.2 WI L 04, INCOMING RAW MATERIALS TESTING REV 1,10/26/95 Y IV,10.8.1,10 8 2 WI L 05, IN-PROCESS TESTING REV 1,05/01/95 Y Vil WI L 06, FINAL OC T ESTING REV 3,09/06/96 Y Vil WI L 07. RETAIN SAMPLES REV 2,01/30/97 Y Vil WI M 01, ISSUE BATCH TICKET REV 1,05/01/95 Y II, VI WI M 02, LABEL PREPARA1 TON REV 2,01/30/97 Y V V1 W1 M 03, PROCESSING COMPLETED BATCH TICKETS 9EV 1,05/01/95 Y
- vt WI M 04, BATCH NUMBERING LOGIC REV 1,06/23/95 Y V
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/ NUPlc SUPPLIER Carboline Company Revision ? AUDIT CHECKLtST AUDIT NO: J7-0211 VAL _ Page 37 of 54 SECUON IX - PROCEDURE DATA SHEET (FIGURE 10) PROCEDURES / INSTR /DRWGITITLE REVIDATE CORRECT REVLSION CHECKLIST SECTION (YES/NO) WI N 01,10CFR21 REPORTING F EV 1. 01/30/97 Y 10B.3 Wl O O1. PREPARATION FOR BATCH PRODUCilON REV 1. 05/01/95 Y vg WI O 02. BATCH PRODUCTION REV 2.10/26/95 Y y WI O 03. SAMPLING FOR TESTING REV 1,05/01/95 Y yll WI P 01. MATERIAL SPECIFICATIONS REV 7. 01/30/97 Y 31, ty WI P 02. PURCHASE ORDERS REV 4. 09/13/96 Y sy WI P 03. SET UP & MONITORING OF SUBCONTRACTORS REV 1. 09/13/96 Y tv W1 P 04. PROCUREMENT OF NUCLEAR SAFETY RELATED* SERVICES REV 0,09/15/95 Y tv WI P 05, APPROVED SUPPUERS UST FOR CAllBRATION SERVICES AND REV 2,01/30/97 Y gy NUCLEAR VFETY RELATED* TESTING SERVICES WI P 06. APPROVAL OF NUCLEAR
- SAFETY RELATED* SUPPLIERS REV 0,09/15/95 Y ly WI R 01. RAW MATERIAL RECEIVING REV 3.10/14/96 Y ly, y WI R 02. RAW MATERIAL GATHERING REV 3. 05/01/95 Y y WI W 01, RECEIVING FROM PRODUCTION REV 1. 05/01/95 Y V WI W 02. RECEIVING RETURNED GOODS REV 0.10/05/93 Y 10A5 WI W 03. COMPILING ORDERS FOR DELIVERY REV 2. 03/15/96 Y V OCT 211. THICKNESS REQUIRED FOR HIDING (RED / GREY SPRAY 06/17/96 Y 11, vil METHOD)
OCT 191. THlXOTROPIC INDEX 06/17/96 Y 11
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NUPIC SUPPLIER - Revision 7 Carboggn Company AUDIT CHECKLIST ' ~ ~ ~ ~ ~ - AUDIT NO: _9132HVAL, Page 38 of _ 54_ SECTION I
X. PROCEDURE
DATA SHEET (FIGURE 10) FROCEDURES/ INSTR!DRWG/ TITLE REV/DATE CORRECT REVISION CHECKLIST SECTION (YES/NO) OCT 1, e INENESS OF GRIND 04/11/95 Y 33, Vig OCT 2. STORMER VISCOSIT Y 06/05/95 Y : OCT 5, POT LIFE 01/09/95 Y 3: OCT 6, SIPHON SPRAY APPLICATION 06/17/96 Y 13 OCT 15. DRAWDOWN AND CURE TEST 06/17/96 Y gg, Vil OCT 16, APPEARANCE OF CLEAR MATERIAL 06/17/96 Y 13, IV OCT 17. WEIGHT PER GALLON TEST 09/13/96 Y 18, IV, Vig OCT 22 CLOSS DETERMINATION 04/11/95 Y 33, Vig OCT 27, GARDNER COLOR 06/17/96 Y gg, gV OCT 33, SAG TEST 06/17/96 Y 11, VII OCT 44, BROOKF ELD VISCOSITY 06/17/96 Y st, IV, VII OCT 66, OPERATION OF pH METER 06/17/96 Y : OCT 76, ORY SIEVE ANALYSIS 06/17/96 Y 31 OCT 86. Oil ABSORPTION - SPATULA RUB 4UT METHOD 06/17/96 Y gg OCT 89, WET SIEVE ANALYSIS 06/11/96 Y gt, ty OCT 100, REFRACTIVE INDEX 06/17/96 Y :: OCT 103, OtSPERSION TEST FOR PgGMENTS 06/17/96 Y 3: OCT 130, MOISTURE DETERMINATION WITH HYDRANAL KARL-FISHER 04/29/94 Y (1, IV OCT 137, STANDARD SOLVENT ANALYSIS BY GAS CHROMATOGRAPHY 06/17/96 Y at, Vill OCT 143. VISUAL INSPECTION FOR RECEIPT OF MATERIAL 06/17/96 Y tl OCT 155A, SPECIFIC GRAVITY BY DENS:TY 06/17/96 Y gg, IV OCT 172 COMPLETE CLEAR SOLUT!ON DETERMINATION 06/17/96 Y 3: OCT 178, APPROVAL TO RECEIVE TAOS 06/17/96 Y si r OCT 180, ADDENDUM TO OCT #180-GEL TIME INORGANIC ZINC 06/17/96 Y 31 VEHICLE OCT 185, PENCtl HARDNESS 06/17/96 Y I:
* = DOCUMENT NOT VERIFIED
NUPIC SUPPLIER Car %IIntAompany Revision 7 AUDIT CHECKLIST AUDIT NO: 97-021[yAl Page. 3g of 1 SECTION X - PROGRAM COMPT. LANCE METHOO OF VERIFICATION ASSESSMENT
ISUMMARY
RESULTS 10 1 Record the p-Mureshnstructens and/or draunngs used to verity unplernentaten en ttus area (Document O E. on Figure 10) 10 A.1 Verdy that the indnndue aneaten v responsitHe for de"--.y the overan in addition to the OA Maual, Quahty Procedures Manuet 4.1 Management S effectiveness of the OA Program: Responsbehty Revesion 7. dated 04/10/97, defines the a a) is designated (i e., authordy, organizational structure indnnduatstorganizations responsitde for definang th overaR effect#veness of the QA Program. and responsibehty is documented); b) is independent of production pressures; a) The Dweetor, Total Qualty (DTO) reports to the e::esident of Carboline and has overa8 responsitnidy for the Ouahty System. The DTO has c) has dired access to appropriate ., _ ..; levels; designated the responsibildy for implementation of the Qualty System to the Corporate OA Manager. d) reports regularly on the effectiveness of the Program. 1 Appender BIANSI N45 2 Ref: (1-3) ASME Section IX c) Has direct scress to the appropriate level of management as depicted in NOA-1 W 1S-1 the organizational reporting structure and responsbihtes defined in the above docurnents, Vendor Program Ref: OA Manual Sechon 4.1 d) Regularfy reports on the effectiveness of the qualty program through internal audts and management review meetings as identdied in checklist items 10 A.3 and 10 C. The O/VOC Manager at Xenia. OH reports to the Corporate QA Manager and is responsible for implementation of the quality program at the manufacturing plant. 10 A.2 Assess whether personnel perfomung werdicaten actvetes have the authonty, in adddson to the OA Manua!, Qualty Procedures Manual 4.1 grants quatty S Independence and organizational freedom to: personnel the independence and organizatenal freedom to accomplish items a) through d). b) Initiate, recommend or provide solutions to problems
- This was verified by interview with quality personnel, review of intemal audt reports, audt findings Corrective Action Request Nonconfomung flom c) Verify knplementation of solutions; Reports, etc. Identified in Figures 11 and 12.
d) Control further processing of nonconformances until proper disposdion Authordy independence and organizational W of personnel has occurred performing verdication activities is adequate and effectively implemented Appendhe BIANSI N45.2 Ref: (1-3) ASME Secten all NOA-1 Supplement 1S-1 Vendor Program Ref: QA Manual Sedian 4.1
?
- _ _ . _ - - _ . . . _ . - - - - - . . - _ - _ _ . . . . - _ . . _ _ _ . _ _ . - - - - . . _ _ _ _ . _ . - . - _ _ - - _ . ---.._n.- .____ - __--___-..-_.____-._-?
NUPic SUPPLIER Capoline_Qompany Revision 7 AUDIT CHECKLIST ; AUDIT NO: _97;C21_[V A)_ Page 40 _ of 54 _ I SECTION X - PROGRAM COMPLIANCE METHOD OF VERIFICATION ASSESSMENT /
SUMMARY
RESULTS to A.3 Verefy that the supphers management regularty reviews, assesses and in additon to the OA Manual. Quality Procedures Manuat 4.1 tequwes an evaluates the apphcation, status and effectiveness of the Qualdy Assurance S annual revew of the Quahty System for sudabddy and effe ctiveness. Program consistent weh importance to safety, rehrbddy and performance for the tems and services to which it apples. Thrs requirement is accomplished through management review meetings which address dems relatmg to the ef'ectiveness and/or shortcomings in the Appendix B/ ANSI N45 2 Ref: (2/2) qualty program such as CARS. NCIRs. etc. Activdies needing attention are ASME Section lit assigned to specific individuats responsible for obtainmg the applicable NOA-1 Basic Req. 2 action. Vendor Program Ref: QA Manual Section 4.1 Venfied by review of the management revew meetings conducted on 02/19/96 and 01/24/9E This activity is adequate and effectively implemented. 10 A 4 Desenbe the rnethod that is used to control revisions to vendor Work Instruction Manual D 11. Product Lderature Revision 1,06105/01/95 Technical /Mairdenance Manuals. Service Advice Letters. Instruction Manua! govems the requirements and responsibildies for developr...,nt, revision and Updates and the method for transmitting those changes to their customers. distnbution of Product Data Sheets and Apphcation instructions. These documents are normally provided to the customer by the Marketing Department.
- 10. A.S Desenbe and venty the rneasures that are estabhshed and emplemented for control of items returned from utdity for repair / rework. Carbohne issues a Retum Goods Authortzation (RGA) form that edentifes S the items needing to be returned and the reason for the re:um. An RGA Appendix B/ ANSI N45.2 Ref: (15/16) letter is transmitted to the customer which includes a copy of the Finished ASME Section til Goods Retum Checkhst. Instructions are provided to the customer for '
NOA-1 Supplement 15S-1 completing the shaded areas of the checklist and retum to Carbohne with Vendor Program Ref: Werk Instructioa Manua! W 02 the packing hst. Items returned to Carboline are processed in accordance with Work Instruction Manual W 02. Receiving Retumed Goods Revision 0, dated 10/05/93. When retumed goods are received, a RGA or warehouse transfer is required to receive the retumed items. The items received win be checked against the bdl of lading and the RGA number. Items retumed win be inspected using the partially completed Finished Goods Return Checkhst. The retumed material is property stored and the location is recorded on the Finished Goods Checkhst. This information is entered into the Carbohne computer system using the proper codes. If necessary, due to physical conddion of the containers. hold codes will be assigned and win also be entered into the computer system. (See Continuation Pags)
. _ _ . _ _ _ _ _ _ _ . _ _ _ _ _m..
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i NUPic SUPPUER Revision 7 Cartoline company AUOtt CHECKLIST AUDIT NO: _97-021 (VA) _ Page 42 of _64_ - SECTION X - PROGRAM COMPLtANCE METHOD OF VERIFICATION ASSESSMENT
ISUMMARY
RESULTS 100.1 verdy that measures are estat*shed and ..6mented to. Measures are estabhshed and implernented through Quakti Procedures S , a) identify .e~w.,#..- ..yitems; Manual 413, Control of Nonconforrning Product, Work Instructen Manual C l 01, Nonconforming item Repost (NCIR), Work Instructen Manuel L 02, b) ensure that responsibildy and authordy for revew/disposibon is identifed: Batch Reject Reports, Work Instructon Manual L 03, Quah4 Improvement c) controls further processing, dehvery and installatert of items until Request. and Work Instruction Manual L 04, Testmg of incommg c an Matenal. disposition is Completed. These measures provide for : d) notfication to ubidy of.e. woe" ny conddens when required by utihty PO. a) The identlicaten of nonconforming conditions. (Document 0 E. on Figure 11) b) The responsibihty and authordy for revew and/or despostion. Appendix B/ ANSI N45.2 Ref: (15/16) c) Controlling further processing or dehvery unt3 disposition is completed. ASME Section lit NOA-1 Supplement 15S-1 d) Notlication to the customer,if apphcable. Vendor Program Ref: QA Manual Section 413 4 Nonconformances initiated by the corporate office are documented on art NCIR. The Xenia plant uses the Continuous Qualdy Improvement Request (COIR) to docurnent batch retecten reports and the Raw Material Discrepancy Report (RMDR) to document deficiences assor:iated with the receipt of raw material. The measures for control of nonconformances are adequate and effectively smplemented. ; 10B.2 venty that the ....w..L.-.y items are revewed and dispositioned such that: Review of the NCIRs, COIRs and RMDRs identifed en Figure 11 venhed that S , a) The disposition is identified and adequate, nonconformances are revewed and dispositioned such that items a) through I g) ,, ,ppi, cable are adequately addressed. b) Documented justification !s provided venfying the tcceptabihty of the
,e, .:.,a.ng items which are disposihoned repair or use-as-es- ,
Identification and arsposition of nonconformances is adequate and effectively implemented. ( c) The as-built records shall reflect the accepted deviaton. . I r d) Procedures or instructions for repair and rework are provided. e) Repaired and reworked items are re inspected. f) Close-out is adequate. (Document O E. on Figure 11) Appendix 8/ ANSI N45 2 Ref. (15/16) e ASME Section Itt ? NOA-1 Suppler 9ent 15S-1 (para 4.1) Vendor Program Ref. QA Manual Section 4.13 t t s b
NUPIC SUPPLIER Carboline _ Company Revlalon7 AUDIT CHECKLIST
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AUDIT NO: 97-02M/A1 _Page 43 of _ 64 _ SECTION X - PROGRAM COMPLIANCE METHOD OF VERIFICATION ASSESSMENT
ISUMMARY
RESULTS 1083 10CFR21 a) At the St. Louis, MO facddy 10CFR21 es posted in tre Corporate OA a) Are appropriate documents posted? Managers offee, and the Test Lab. At the Xenia. OH facddy in the OAIOC Managers effce, the production area and office area bulletin boards. b) is there a mechanism to determine if a Part 21 conddion exists? b) The below identified procedure provides instructicos for the any employee c) is there a mechanism to provide for notrncation to the NRC or affected to lentify and report any defects in materials that may be supplied to a utildies? nuclear facady. c) Work Instruction Manual N 01. Part 21 Reporting Revision 1. dated end Re nst on Manual N 01 Revision 1 01/30/97 contains the appropnate requirements for reporting to the NRC and the purchaser any defects or noncomphance's. t l 10 C Venfy that measures are estabhshed and implemented to ensure a Measures are estabhshed and emptemented through Qualdy Procedures S comprehensive system of planned and periodic intemal audits. Venfy that the Manual 4.17,Intemal Audds Revision 3, dated 01/30/97 and Work participants have no direct responsibilty in the areas aud:ted. Venfy that instruction Manuat A 04,intemal Quahty Audds Revision 2, dated 01/30/97 checklists and/or procedures were used with obgective evxlence documented, that sudd results were documented and those results reviewed by Audds of specific areas or elements are audited on a1 annual basis in ' management having responsibility in the area audited. Venfy follow-up action accordance with an annual audit schedule. Audits are performed by is taken where needed personnel having no direct responsibildy for the area sudded. ! (Document O.E. on Figure 12). Results of the sudd are documented and include the objective ew;dence reviewed during the audit. Appendir B/ ANSI N45.2 Ref: (18/19) AS E Audit reports are provided to management personnet responsible for the
, areas audited and follow-up of audds findings is perhrmed, when apphcable.
Vendor Program Ref; QA Manual Section 4.17 Reviewed the intemat audit schedules for 1996 and 1997. It should be noted that sudds for 1997 are presently in-process. Verified imp 8ementation of this attribute by review of the internal sudets identmed in Figure 12. Activities associated with intemal audds are adequate and effectivety implemented. , t i k {
NUPIC SUPPUER Carbo'ine Company Revision 7
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AUDIT CHECKl.lST AUDIT NO: 974211V,. Al_,, Page . 44 of_ 54 SECTION X . PROGRAM COMPUANCE METHOD OF VERIFICATION ASSESSMENT
ISUMMARY
RESULTS 10.0 Venty that me== are estatdished and .6..,nted to ensure a Audds are performed of cahbraten and Nuclear' Safety Related servces S comprehensive system of planned and penodic entemal sudds, surveys and suppliers. Work Instruction P 05 is maintained as the Approsed Supplers source venncations. Verdy that checkusts were used with objective evidence t.ist for the aforementioned services. Resudit is required at a three year documented and that follow up action is taken where needed See Figure 5 for interval as a minwnum. One suppher does not have a written OA program supphers I and Carbohne QA requires that work performed by this suppHer be observed When 3rd party audits are used as a basis for supplier quatr6 cation the (surveilled) on each occasion. The remainder of Carbonne supphers have been audded. evaluation shat be documented and shall address:
. Perbrmance of the sudd by quahned personnet. Evidence exarruned included Quality Survey Form for Testing or CahbraNn Services (checkhst)indcating attributes venned during the sudd.
. T..L .. .c. of the evaluation by quahfied personnel to ensure the users program ;;w..,.C are satisfed. Adverse conddions noted were documented as findings and corrective acten required. Follow-up included reaudd and/or documentation review
. The scope of the audit envelopes the current scope of procurement. pror to Ending close-out.
. The applicable regulatory and/or w. .,.a program requirements are Venned by review of the extemal audits identined in Figure 12.
adeg.ataly addressed in the sudd scope, Extemal audds are adequately implemented however, objective evidence
. SufEcient objedive evidence is available to support conclusions of the documented in audd packages could be more consistent between audits.
g The inclusion of more detail in the documentation of objective evidence would better facihtate evaluation of the suppher's program and Capabihty to NOTE- Examples of 3rd party sudds: NIAC, consutant performance. provide required services. (Document O.E. on Figure 12) Appendix B/ ANSI N45.2 Ref (18/19) ASME Section 111 NOA-1 Supplement 18S.1 Vendor Program Ref- QA Manual Section 4.6 O _ _ . _ _ _ _ _ _ _ _ _ _ _ . _ __.______________m. _ _ _ _ _ _ _ _ _ _ _ ______________i- ___ _ __ ._-
NUPIC SUPPLIER Carboline Company Revision 7 AUDIT CHECKLIST
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AUDIT NO: _9]RL(YAL_ Page 45 of _ 5 _4 SECTION XI- PROGRAM COMPLIANCE METHOD OF VERIFICATION ASSESSMENT 1
SUMMARY
RESULTS 10 E venty that rnessures are estabteshed and emplemented to assure that in addition to the OA Manual, rneasures are estabhshed and unplernented conddions adverse to qualdy are promptly identJed and corrected. These S through Quahty Procedures Manua! 414, Correctrve Acten Revision 3, measures shallinclude as a msnamum. (Document O E. on Figure 11) 09/12/96 a) Identifcation and description of the conddion adverse to qualdy; These eneasures ensure that items a) through d) as applicable, are b) Determination of the cause and actions taken to prevent recurrence for - sigmficant conddions adverse to quahty; Venfed by review of the Correctrve Acton Request identified in Figure 11. c) Review and approvalby responsible authority on the adequacy of the Activites associated with the resolution of conditions adverse to quahty are cor'edive aden; adequate and effectively implemented. d) Follow-up action for closcout to verify that the corrective action has t& ken place or is scheduled. Appendix 8/ ANSI N45.2 Ref: (16/17) ASME Sedion ill NOA-1 Basic Requirement 16 Vendor Program Ref: QA Manual Sec' ion 4.14 10 F.1 Venfy that measures are estabhshed and implemented for indudunaten and Measures are estabbshed and unplemented through Quahty Procedures S training of personnel who perform activitses affecting quahty. Manual 4.18. Training Revision 1, dated 05/01/95. NOTE: Evidence to be obtained from Sections 11 and IV through Vil. These measures ensure that personnel performing activities affecting quality Appendix B/ ANSI N45.2 Ref: (2/2) receive adequate indoctnnation and training for their assigned responsibehtes. ASME Section lit NOA-1 Supplement 2S-4 Venfed by review of the training and/or quahfcations for the individuals Vendor Program Ref: OA Manual Section 4.18 identifed in Figure 13. indoctrination and training is adequate and effectively implemented. 10 F.2 Venfy that inspection / test personnel, auditors, NDE. welding and similar Carbohne does not perform NDE. welding. ASME Code work or any S
- speciatists (i.e., ASME Code work design personnet to ASME/ ANSI N626.3) activities considered to be special processes.
are qualified and have certifcaticas, as apphcable, on file in accordance with industry and/or suppher program requirements. (Document O E. on Figures Carboline does not commit to any ANSI standards for quahfication and/or 33,94) certifcation of personnel. NOTE- Evidence to be obtained from section 11, IV, VI. Vit, VIII and X.
' Venfed by review of training and/or quatifcations records tnat the individuals identifed in Figure 13 were appropriately quahred for the ar*'.L .,ach Appendix B/ ANSI N45.2 Ref. (2,9,10,11,18/2,10,11,12,19) they perform.
A1 upp nt 2S-1,2S-2. 25-3 Training and/or quahfcaten of personnel b adequate and #ed% Vendor Program Ref: QA Manual Section 4.18 implemented.
L HUPIC SUPPUER Cartmline._Cornpany Revision 7 AUDIT CHECKLIST AUDIT NO: 97-021[yAL Page 46 of __S4_ SECTION X. PROGRAM COMPLIANCE METHOD OF VERIFICATION ASSESSMEN T
ISUMMARY
RESUI.TS 10 G.1 Venfy that Woate measures are estabbshed and emplemented to assure that Measures are established and rnplemented through Ouahty Procedures S records not transferred to the utshty are maintained in facilities that provide Manual 4.16. Quahty Records Revision 7, dated 09/t 3/96. stor nte nts a against environmental effects. ther locaten, and the department responsbie for th@ir control. a) Inspection and test records; b) Audit reports; addressed by this procedure. c) Ouahty related procedures /instructas/drawirigs; Records are maintained and stored in a manner that provides protection agaanst the environmental effects, damage or loss. d) Quahfications and cestifications; 1 Maintenance of records is adequate and effectively implemented. f) Certifications of Compliance /Conformance; g) Laboratory / Engineering / Manufacturing Operatog Legt; h) Calibration Records; l} Ner~m." .. ~. Documents. Appendix B/ ANSI N45.2 Ref (17118) t ASME Secton til NOA-1 Supplement 17S-1 Vendor Program Ref: QA Manual Section 4.16 m_ _..m _ . _ _ _ _ _ . . . _ _m._ _.. ___. _ _ . __ . - . _ _ _ _ _ . _ _ _ _ . _ _ _ . _ _ _ _ _ _ _ _ . _ _ . _ _ _ _ _ . . _ _ _ _ _ . _ _ _ ._______m _ ____ __
NUPtc SUPPLIER Carboilne_ Company Revision 7 AUDIT CHECKUST 4 AUDIT NO: JZ-02.1.jVAL Page 47 __ of 64 SECTION X - PROGRAM COMPLIANCE METHOD OF VERIFICATION ASSESSMENT /
SUMMARY
RESULTS 10 G 2 Venty that rus are legible, ident;fiable, and retrevante. Records reve.ved were legible, edentifiable, and readdy rettevable. S For minor changes, venfy that those which do not require the same revew and Corrections can only be enade by the responsible department by hning approvat and the persons who can authorire such a decisson are clearty through the incorrect data, initiahng and dating, as long as the original data is clear. defineated. Appendix 8/ ANSI N45.2 Ref; (17/18) No unauthorized alterations y changes were noted with the records revewed dunng the audit. ASME Secten ill NOA-1 Supplement 17S-1,6S-1 This attnbute is adequate and ef'ectnrely implemented Vendor Program Ref; OA Manual Section 4.16 _ to G.3 Venfy that vendor record packages are consistent with contract /P O. Purchase order record packages reviewed and edentifed below were S requirements and adequately document the *as-budt* of the item or component. consistent with the requirements of the purchase order Appropriate records Venty the packages accurately desenbe the delivered products. ident#ed in the NOTE of this checkhst item as applicable, to the product NOTE: These records should include materiat certifcation and test data for traceability and quahty verification; reports of inspectens, FPL P.O. 00014B19. VPC P.O. CNT 549702, VPC P.O. CNT 549501, HLP examinatens, and test results for conformance verifcation; drawings. P.O. QS-8183, Ht,P P.O. QS-7891. TVA P.O. P96NZR.18C309. specificatens, procedures, and instructions for use in contror of . configuration; and records of nonconformances and their resolution. This attribute is adequate and effectively implemented. Appendix B/ ANSI N45.2 Ref; (17/18) ASME Secten til Vendor Program Ref; QA Manual Section 4M6 10 G 4 Venfy that measures are estabhshed and implemented to assure Certifcates of Generally, product quality assurance certitcation may be signed by the S Compliance /Conformance are onty issued by authorized supplier personnel. Corporate OA Manager or by designated plant and/or QA/OC personnel. Appendix BIANSI N45 2 Ref; (6/7)(7/8) Venred by review of product certificatens included in the purchase order NOA-1 Supplemer t 17S-1 packages identifed in checklist item 10.G.3. r ASME Section ill Vendor Program Ref; QA Manuat Section 4.16
NUPIC SUPPLIER Carboling Compagy
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Revision 7 AUDIT CHECKLIST
, AUDIT NO: J 7J 21EAL Page 48 of _64_
i SECTION X . PROGRAM COMPLlANCE (FIGURE 11 NCR/ CAR) NCR/ CAR DATE R E- FOR US i-AS4S OR CLOSURE ITEM ID/DESCRfPTION NO. INITIATED DtSCREPANT DISPOSITION INSPECTION / REPAIR-CUSTOMER DATE CONDITION VERIFICATION NO1!FIED7
- 10.8.10.E
- 10.B. *10.9 &
- 10.B.10.E
- 10.B,10.E
- 10.B.2,10 E *10.8
- 10.8.10.E 10.E 10.E Customer Complamts on CAR 93- 10/01/93 Mistmts Pendmg - Item is bemg N/A N/A N/A Mistmts 002 mondored to determme cause, status report required monthly.
CZ 11 HS plus others CAR 96- 06/21/96 Contamination? Pendmg scheduled for N/A N/A N/A 034 Junk / Trash 06/01/97 Baumaste 300M CAR 95 11/15/96 Contamination improve f>!!ering process Monitored for 6 N/A 02/29/96 030 months, no recurrence CZ 11 HS CAR 94- 08/01/94 Unmatched colors Revised Work Instruction Monitored from N/A 01/1795 027 09/94 through i 12/01/95, results satisfactory ; SHG 891, Batch 781809M COIR 1307 02/18/97 PDNP used in error to Rework .use for other yes N/A 02/25/97 tml than 891/892 SHG 891, Batch 7A1728M CQtR 1306 02/05/97 Incortect paste used Rework - use as 890/705 yes N/A 02/13/97 891 Part B, Batch 6L9703M COtR 1293 12/06/96 i Product Code H84 not Add H84 and rework as Yes N/A 12/11/96 added to batch new batch Raw Mat 1 Code RS272 RMDR 168 12/06/96 Contaminated Retum to Vendor N/A N/A 12/06/96 Product GZ571T-75 Raw Mat 1 Code T101. VM+P RMDR 158 05/20/96 Failed Hydrometer Test Return to Vendor N/A N/A 05/24/96 Napthe Raw Mati Code W63. HITOX RMDR 161 08/12/96 Oil absorber.cw 26 Accept-as-is N/A N/A 08/19/96 Spec. requires W-40 t
- Refers to app 8 cable question. i
NUPIC SUPPLIER Carbol ne Company Revision T AUDIT CHECKLIST
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4 AUDIT NO: _97-021 [VA]_ Page 49 _ ol_64,,,,, i SECTION X . PROGRAM COMPLIANCE (FIGURE 11 NCR/ CAR) NCR/ CAR DATE RE- FOR USE-AS-4S OR CLOSURE ITEM ID/ DESCRIPTION NO. INtTIATED DISCREPANT DISPOSITION INSPECTION / REPAIR CUSTOMER DATE CONDITION VERIFICATION NOTIFIED 7
- 10.B.10.E
- 10.8, *10.8&
- 10.8.10.E
- 10.8.10.E
- 10.B 2,10.E
- 10.8 10.E 10.E
- 10.8.10.E ,
Carbo Zme 11 Base, Batch COlR 1334 04/11/9i Batch contains On hold pending N/A N/A N/A 7D9851N particles dispositen 890 Part A. Batch 6K9642M CQlR 1284 10'28/96 Color too dark and too On hold pending N/A N/A N/A , red dispositen ' Carbo 56 MultWard 954 HB NCIR 97- 01/22/97 Product Data Sheets Revise procedure. N/A N/A N/A f 001 being distnbuted prior pendmg estmated t to approval completon 04/15/97 , Color Formula, Batch NCIR % 09/11/96 Cnent Server Instalt separate routine Follow-up N/A 01/17/97 6E4857L 006 calcutshng formula for on server machine verification to pounds instead of ensure gallons Corrective action was effective i Carbomastic 801, color S800, NCIR 96- 07/29f96 Chent Server adding Clerical error, discussed Monitored for 3 N/A 01/21/97 ! Batch 6P0396M 007 %nce the amount of with operator to elmnate months, no , raw material RS191 duphcate entry recurrence ; I Carbothane 134 HS NCIR 96 02/01/96 Chent Server reported Rewrite calculation Verfed program N/A 02/02/96 i 004 ,formuta as sohds by program to calculate by formulas were volume instead of volume recalculated ' d sohds by weight r I r Therm 450 NCIR 96- 01/29f96 WIP batch over Rewnte computer Monitored for 3 N/A 05/15/96 003 allocated. Glitchin program months venhed computer program no recurrence i t t
- Refers to appEcable question. t
_ __ _ __ . _ _ . _ _ _ _ _ _ _ _ _ _ _ _ . _ . _ _ _ _ _ _ _ . _ _ _ _ _ _ . . _ _ _ _ _ _ . _ _ _ . _ _ _ _ _ _ _ _ = . _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
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I P NUPIC SUPPLIER Cart ollne Comparg pg,% y AUDIT CHECMLIST AUDIT NO: __tT_-0_211 val Page 50 e L 54_ SECTION X - PROGRAM COMPLIANCE (FIGURE 12 AUDITSISOURCE VERIFICATION / SURVEYS) . SUPPUER ITEMS CONSIDERED NUMBER OF NAME/ PERFORMANCE INTERNAtj AND SUPPLIER AUDITING DEFICIENCIES CORRECTIVE ACTION , REPORTID DATE SCOPE EXTERNAtJ(I PROCESSES ORGANtZATION (OPENICLOSED) VERIFICATION METHOD & ' s lE) EVALUATED TEAM MEMBERS DATE (SPECIFY) { t
- 10.C.10.D
- 10.C.10.D
- 10.C.10.D
- 10.C.10.0
- 10.C.10.0
- 10.C.10.D
- 10.C.10.0
- 10.C.10.0 i Cart > ohne 03/96 QA Manual Sec. 420 1 Statrstecal Techniques J. Peeter 1-Open N/A CIA pending Cart >oline 03/96 QA Manuat Sec. 4.14 i Corrective & J. Peeter 3-Closed Follow-up 04/26/96 I
, Preventive Acton '
Documentation review 07/19#96 and 08/15/96 I Cart >oline 05/96 OA Manual Sec. 4.4 1 Design Control J. Burst 1-Open NIA CIA perwhng . 1-Closed Documentation review I
, M Cart >oline 0?/96 OA Manual Sec. 4.3 I Centract Review T. McManus None N/A Cart > ohne 05/56 QA Manual Sec. 4.11 1 Control of Messunng J.Ladage 3 Closed Documentation Review
& Test Equipment 07/06/96 and 08/01/96 l 5-Open Follow-up aud4 of open l' findings scheduled for 04/97 Cart >oline 06/96 OA Manual Sectens 1 Management Revew, A. Montgomery 3 Closed Documentation Review i Xenia Plant 4.1,4.8.4.9.4.10.4.11 Product identercation 09/13/96 -
4.15,4.17 and 420 and Traceabihty. 09/17/96 { Process Control. 09I30/96 ! Inspection and Test l Records. Control Procedures, Storage, Intemal Audds and Statistical Tectwques ! Cart >oline 09/16 QA Manual Sec. 4.6 i Purchasing J. Pitstick None N/A Xenia Plant i Cart > ohne 11/16 QA Manual Sec. 4.10 I Inspection and Terting J.Kyne None N/A Xenia Plant Cart > ohne 11/56 OA Manuel Sec. 4.11 1 Inspection Measuring J.Kyne None N/A Xenia Plant & Test Equipment Cart >oline 03/9'? OA Manual Sec. 4.12 I Inspection and Test ' C. Holton None N/A + Xenia Plant Status ! i
- Refers to appleable quesion.
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NUPIC SUPPLIER Cartmline Corppany Revision 7 AUDIT CHECKLIST AUDIT NO: JIJ21 {YAL Page 51 of _._64_ SECTION X - PROGRAM COMPLIANCE (FIGURE 12 AUDITS / SOURCE VERIFICATION / SURVEYS) SUPPLIER ITEMS NUMBER OF t NAME/ PERFORMANCE INTERNAU CONSIDERED AND AUDITING DEFICIENCIES CORRECTIVE ACTION REPORT ID DATE SCOPE EXTERNAIJ(I SUPPLIER ORGANIZATION (OPENICLOSEDI VERIFICATION METHOD & s IE) PROCESSES TEAM MEMBERS DATE EVALUATED (SPECIFY)
- 10.C.10.D
- 10.C.10.D
- 10.C 10.D
- 10.C.10.D
- 10.C.10.D
- 10.C.10.D
- 10.C,10.D
- 10.C.10.D ISOMEDIX, 02/22/96 Testeg Servces E Testeg Servces M. Speckert None N/A inc.
Cannon 02/20/96 Calibraten Ods E Cahbraton Ods M Speckert 2-Closed Documentation Review Instruments 04/12/96 12/11/96 Precision 02/23/96 Cahbration of Pressure E Calibration Services D. Sangster None N/A Calibraton Gages Labs. UNITHERM 09/28/95 Calibration of LOCA E Cahbraten Services M. Speckert None N/A - Fumace Assemth Corp. Controts for 09/14/94 Safety Re:ated E Decontamination M Speckert None N/A Environment Decontameristion Services at Po!!ution Testeg (CEP), Inc. Mettier- 03/23/94 Calibration of Batances E Cahbration Services M. Speckert None N/A Toledo University of 02/23/95 trradiation of Paint Test E Irradiation Services M. Speckert None N/A MA Coupons Precision 02/20/95 Calibration of Laneta E Cahbration Services M. Speckert None N/A Gage & Tool Bars. Film Applicators and Grind Gages Ohio 11114/95 Calibration of Scales E Calibration Services T. Calkins 1-Closed Resudit of Traceability on Counting 11/16/95 Scale / South, Inc.
- Refers to applicat4e cuestion.
l NUPlc SUPPLIER Carbollne_C_ompany Revision 7 AUDIT CHECKLl3T
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i AUDIT NO: _97-021(V/A) ,,,_ Page $2 of _54__ SECTION X - PROGRAM COMPLIANCE + (FIGURE 13 AUDIT /tNSPECTIONINDE PERSONNEL) QUALIFICATION / CERTIFICATION NAME/ STAMP CERT TYPE AND LEVEL EYE EXAM PATES
- 10.F.2. 3.5
- 10.F.2. 8.5
- 10.F.2 M. Speckett Auditor (Corporate QA Manager) Not Requned J. Burst Audtor Not Required J. Peeler Auddor Not Required T. McManus Auddor Not Required J.Ladage Auddor Not Required D.Fe!tman Caleraten Not Required T. Mulder Caleraten Not Required S. Byron Caleraten Not Required B. Reats Caleration Not Required A. Montgomery Auditor (Lake Charles. LA OA/OC Manager) Not Required T. Cakins Auddor, Cahbraten (Xenia. OH OA/OC Manager) Not Required J.Kyne Auddor, Xenia Not Required C. Holton Auddor Xenia Not Required J. Pdstick Auddor. Xenia Not Required G. Chambliss Blendag Operator Xenia Not Required H. Payton OC Inspector. Xenia OtD01/91 D. Gnau OC Inspector, Xenia 01/29/96
- 8. Wilhams OC Inspector, Xenia 01/29/96 D. Chambhss OC Inspector, Xenia 02.92/78 P. Dodge Shipping Supervisor Xenia Not Required D. Brannan OA Inspector, Alpha Warehouse / shipping Not Required NOTE: Eye examinations for OC inspection personne! are ;
landed to a one time test la color bhndness.
- Rerers to applicable question.
t a
NUP1C SUPPLIER Cart oline Company
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Revision 7 AUDIT CHECKLIST AUDIT NO: J7_-02JJVA)_ Page 53 of _64_ SECTION X - PROGRAM COMPLIANCE ' (FIGURE 14 WELDER / WELD OPERATOR) NAME/ STAMP CERT TYPE (PROCESS &
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CODE QUALIFIED TO WPS PROCEDURES AND MAINTENANCE OF
- 10.F.2 POSITIONS)
- 10.F.2 REVIDATE QUALIFICATION
- 10.F.2
- 10.F.2
- 10.F.2 Not apphcable to Carene. No weldeg activities are performed in the manufacture of costegs I
I L i i
- Refers to applicable question.
j HousTord LsGHiseG & PowEH Col.4 Pare ! f'JALITY ASSUR AfJCE DEPARTMEt3T p j 5
- UDIT PERSONNEL QUALIFICATIOf3 \
RECORD OF QUALIFICATION NAME DATE Lead Auditor James E. Adkins 09/11/92 l OUALIFICATIDtd
]
I OUALIFICATION CREDIT REQUIREMENTS CREDITS l 1.A. EDUCATION - University / Degree /Date- -4 CREDITS MAX. '
- 1. Ur.derrad.;; . Len!
- 2. Graduate tswel 0
- 1. B. EXPERIENCE - Company / dates 9 CR EDITS MAX.
Technicat 80 5 Crcdial and 11 Years at Bailey conerols raucscar Induirry (0,1 Credit), or 14 Years Nuclear Qualiry Auuranu~ (0,2. 3 Crcdiul, or 13 Years Quality Assurance Auditing io,3. 4 Crediul 2 1/2 Years Auditing 9 1.C. PROFESSIONAL ACCOMPLISHMENT- Certificate /Date 2 CREDITS MAX.
- 1. P.E. .
- 2. Society , 0 1.D. M AN AG E M E NT . Justification / Evaluator /Da t e 2 CREDITS tiAX.
E
- Di":
Based on previous performance and training Evaluated by: B. J. Tedder . 2 TOTAL CREDITS jj Ji AUDIT COMMUNICATION SKILLS i Evaluated by:(Name & Titic] B. J. Tedder. Supervisor. Procurement QA 09/11/92. D8'? Ill - AUDIT TR AINING COURSES 2 Performance Based Auditing 04/11/90 D8 Auditor: training at Illinois Power 1984 IV AUDIT PARTICIPATION Location Audit Date _ Dresser-Rand,' Wellsville, NY - Audit # 92-031 (VA) 08/31/92 {3 STPEGS Corrective Action Program Audit # 91-19 (CA) 12/02/91 3 Nova Machine Products - Audit # 91-016 (VA) 03/13/91 [ Control Components Inc. - Audit # 91-003 (VA) 02/04/91 Valtek, Inc. 5. Audit # 90-135 (VA) 12/17/90 V EXAMINATION Written Passed 95.6 % 06/18/92 Daie VI AUDIT OUALIFICATION CERTIFIED BY Date cereiried (Signature & Tesfel . la t! \ P . A Vll ANNUAL EVALUATION J V gb. g (Signature and Daic) '
,gt* j l
OO robetesta3s ,,n
. n-Houston Lighting & Power Company OFFICE MEMORANDUM r, J. E. Adkins Training File November 18,1996 rr,=
YM H. G. Domschke l sa/ar Lead Auditor Annual Assessment ' In accordance with OPQP02-ZA-0004, Revision 0, J. E. Adkins has mamtained proficiency in the audit process (see list below), implementation of quality program procedures, procedure reviews and quality verification activities. Audit No. Comoanv Date 96-003 (VA) Astro Nuclear / Dynamics 02/13/96 96-012 (VA) John Fluke 01/16/96 96-019 (VA) Tektronix, Inc. 02/28/96 . 96-020 (VA) ACCUTECH 04/29/96 96-042 (VA) Durametallic 09/10/96 96-049 (VA) Valtek, Inc. I1/04/96 96-054 (VA) Allied Systems 07/23/96 l 96-063 (VA) Protection Technologies 08/08/96 96-067 (VA) Simco Electronics 09/30/96 . 96-075 (VA) Team, Inc. 10/10/96 ! Based on assessment of his continued satisfactory performance his Lead Auditor Certification is extended until November 18,1997. HGD/kmw - c: J. E. Adkins ' l 1 I i a 4 4 \ l}}