ML20148S385
| ML20148S385 | |
| Person / Time | |
|---|---|
| Issue date: | 07/21/1978 |
| From: | Barnes I, Verrios P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20148S181 | List: |
| References | |
| REF-QA-99900086 NUDOCS 7812010326 | |
| Download: ML20148S385 (17) | |
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O VENDOR INSPECTION REPORT U.S. fluCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION IV Report No. 99900086/78-01 Program No. 44060 Company: Hopkinsons Limited Britannia Works Post Office Box B27 Huddersfield, ENGLAND HD2 2UR Inspection Conducted: June 19-22, 1978 Inspecto, :
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I. Barnes, Contractor Inspector, Vendor f/8l78 Da te /
Inspection Branch 4
- h? su+ & d?~ Tkyf7R (l P. I. Verrios, Contractor Inspector, Vendor <0 ate /
/yv Inspection Branch d
Approved by:
/l mucu f D. M. Hunnicutt, Chief, ComponentsSection II, 7/8/I8 Date' vendor Inspection Branch 1
Summary l
l Inspection on June 19-22, 1978 (99900086/78-01) l l
Areas Inspected: Implementation of 10 CFR 50, Appendix B, criteria and applicable codes and standards, including initial managenent meeting; control of welding and postweld heat treatment; material identification l and control; internal audits; vendor audits; equipment calibra tion and l nonconformances and corrective action. The inspection involved sixty-four '
(64) inspector-hours on site by two (2) NRC inspectors. s Results: In the seven (7) areas inspected, no apparent deviations or unresolved items were identified in two (2) areas; the followin9 were identified in the remainin9 areas:
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Deviations: Control of Welding and Postweld Heat Treatment - Allowed preheat temperature and lack of definition of torch type in hardfacing welding procedure specification not consistent with the requirements of Criterion IX of 10 CFR 50, Appendix B, and the ASME Code, Sections III and IX (Enclosure, Item A); performance of heat treatment af ter hard-facing not consistent with the requirements of Criterion V of 10 CFR 50, Appendix B, and Quality Control Procedure No. N9-3, Revision 2 (Enclosure, Item B); procedure test location requirements for weld metal impact specimens applicable to procedure qualifications not in conformance with the requirements of Criterion IX of 10 CFR 50, Appendix B, and the ASME Code,Section III (Enclosure, Item C); calibration procedure requirements for furnace instrumentation not consistent with Criterion XII of 10 CFR 50, Appendix B, and the ASME Code,Section III (Enclosure, Item D); performance of furnace calibration not consistent with the requirements of Criterion IX of 10 CFR 50, Appendix B, and Quality Control Procedure No. N9-2, Revision 8 (Enclosure, Item E).
Internal Audits - Frequency of internal audits not consistei.m with Criterion XVIII of 10 CFR 50, Appendix B, and Section 13.0 of the QA Manual (Enclosure, Item F). ,
Vendor Audits - Review and approval of lower tier supplier's QA program inconsistent with Criterion VII of 10 CFR 50, Appendix B, and Customer 5pecification No. 8791 (Enclosure, Item G); utilization of unapproved source for welding materials not consistent with Criterion VII of 10 CFR 50, Appendix B, and Section 3.0 of the QA Manual (Enclosure, Item H).
Equipment Calibration - Contrary to Criterion XII of 10 CFR 50, Appendix B, and Section 8.0 of the QA Manual, a master used for calibration of surface plates had not been calibrated (Enclosure, Item I).
Nonconformances and Corrective Action - Incomplete provisions for com-pliance with Criterion XVI of 10 CFR 50, Appendix B, and NCA-4134.16 of the ASME Code,Section III (Enclosure, Item J).
Unresolved Items Internal Audits - Use of subjective working in QA Manual not consistent with Criterion XVIII of 10 CFR 50, Appendix B (DetailsSection II, paragraph B.3.b.).
Equipment Calibration - Definition of scope in QA Manual relative to equipment
.in calibration program unclear with respect to requirements of Criterion XII .
r aof -10 CFR 50, Appendix .B,' and NCA'-4134.12 of the ASME Code,Section III (DetailsSection II, paragraph D.3.b.).
i;onconformances and Corrective Action - Failure of QA Manual to address segregation of nonconforming materials detected during manufacturing not consistent with Criterion XV of 10 CFR 50, Appendix B, and NCA-4134.15 of the ASME Code,Section III (DetailsSection II, paragraph E.3.b.). -
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'DETAli.S SECTION'1
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' (Prepared by I. Barnes) l .- .
Persons Contacted -
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- W. R. ' Pickering, Managing Director
- R. Watson, Engineering Dire.ctor
- R. Cresswell, Manufacturing Director
- R. Atkins, Works Manager
- R. Barrow, QA Manager
- P. E. Holt, Chief Metallurgist
- D. Weston, Assistant Commercial Director
- E. Wainwright, Commercial Manager
- K. Pycrof t, Foundries Manager
- L. Panagacopoulos, Project Engineer
- P. M. Etches, Special Projects
- S. Brooke, Project Engineer 2 ***P. A. Lang, Sales Executive .
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- D. Perkin, Export Manager
- J. Barraclough, QA Engineer
- J. P. France, Chief Designer
- J. K. Clayton, Design Engineer
- D. Fryer, QA Engineer P. Heaton, Instrument Technician C. Boothroyd, Machine Shop Welding Foreman
- Attended Initial Management Meeting and Exit Meeting.
- Attended Initial Management Meeting.
l *** Attended Exit Meeting.
B. Initial Management Meeting !
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An Initial Management Meeting (IMM) was conducted to acquaint l the Vendor's management with the Nuclear Regulatory Commission (NRC) responsibility to protect the health and safety of the public, and inform them of certain responsibilities imposed on vendors by the " Energy Reorganization Act of 1974" (Public Law 93-438),
also to inform management as to the scope of this inspection.
. 1. Objectives r ~ The: objectivesi of; this meeting were to accomplish the following:
- a. To meet the responsible officer.
- b. To establish channels of communications.
- c. To learn company management's policies and practices concerning quality assurance (QA).
, d. To learn how the company operates,'and its contribution l to the nuclear industry. ,
- e. To explain the legal obligations imposed on the responsible officers by Section 206 of Public Law 93-438.
- f. To explain the NRC direct inspection program.
9 To obtain an orientation tour of the facility.
- 2. Method of Accomplishment ;
The preceding objectives were accomplished by: !
- a. Introduction of all personnel in attendance.
- b. Explanation by a representative of the company of the following:
(1 ) The company's policies and practices concerning quality assurance.
(2) The background information concerning the company, its present organization, its progress to date, its future plans, and its contribution to the nuclear indus try.
(3) The identification of the personnel to be contacted on a day-by-day basis, and personnel to respond to enforcement items.
- c. The NRC reoresentative explained the following in detail:
(1) Background information which identified the need for an effective direct inspection program.
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.(2 ) Legal Entry provided by Public law 93-438.
., . .i: i t- (a) Responsibilities of the company's responsible
-o officer (s) to report "significant defects" '
31.n . imposed by Section 206 for U.S. suppliers and :
. solicitation of their cooperation in this area.
(b) tiRC's authority to perform " reasonable" inspec-tions of facilities, hardware and records to ensure compliance.
(3) Program's short range goals are as follows:
(a) To ascertain whether the vendor's QA program ensures compliance with the Code, and also ensures the successful achievement of the prescribed product quality.
(b) Provides for early detection, and positive correc-tion, of identified problem areas or product defects.
1 (c) Enable vendors to control all nuclear projects '
generically with a single QA program.
(d) To promote consistencies in findings and in I handling of enforcement matters. .
l (4) How we inspect:
(a) Ascertain whether the company's "commi tments" l concerning product quality as established by contractual documents, the code design speci-fications, the QA Manual, the detailed written procedures, instructions, drawings and speci-fications have been correctly implemented.
(b) Determine whether the drtailed implementing documents ensures com' iance with code require-ments and the successtal achievement of the products specified quality.
(c) Enforcerent Items are limited to " deviations from commitments," which promotes consistency in findings, and consistency in the manner in which enforcement items are handled.
- 5. How the results of our inspections are documented:
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ts(a) The company's responsibility to respond to '
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enforcement items identified in the summary of the report.
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(b) The response is to specifically address the corrective action to be initiated concerning the specific deviation, evaluation as to the cause of the deviation and what action is proposed to prevent recurrence, and the date the corrective actions will be completed.
(c) How proprietary items are handled.
(d) The Public Document Room (PDR).
(e) The White Book.
(6) The program's long range goals:
(a) To reduce redundant audits by licensee customers.
(b) Endorse the ASME inspection system.
Revise Criterion VII of Appendix B to 10 CFR 50 (c) to permit the licensee to accept the ASME Nuclear Certificate of Authorization and the flRC approved topical reports in lieu of conducting periodic assessments of the QA programs.
(7) The plan to accomplish the lot.g range goals:
(a) Implementation of a two (2) year pilot program to observe and audit the functions of the ASME system to determine its compatbility with flRC policies and practices.
(b) To provide confidence in the ASME system to a level where we can accept its findings as our own.
- 3. Pesults te Management acknowledged the above presentation as being understood by them.
C. Control of Welding and Postweld Heat Treatment
- 1. 01ectives The: objectives. of cthis area of the inspection were to verify that welding :and postweld heat treatment were controlled in accordance with NRC and ASME Code requirements.
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- 2. Method of Accomplishment 1
The preceding objectives were accomplished by: )
- a. Review of QA Manual, Section 6.0, Manual Issue C, " Welding Quality Assurance."
- b. Review of QA Manual, Section 9.0, Manual Issue C, " Heat T reatment. "
- c. Observation of welding material storage area and review of welding materials approval and release system.
- d. Review of temperature control and electrode segregation in !
electrode ovens.
- e. Review of welding procedure specifications and supporting procedure qualification records applicable to hardfacing and shielded metal arc welding of nuclear valves.
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- f. Review of certification data for welding materials currently approved for ASME use.
- g. Examination of manufacturing r. :ords relative to welding !
operations perforaed on valves manufactured to the !
requirements of Custoner Specification 8791.
- h. Review of welder qualifications for personnel identified as performing repair welding and build-up operations.
- i. Review of system used for maintenance of welder qualifi-cations.
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- j. Review of calibration system for welding equipment.
- k. Observation of production heat treat furnaces and verification of calibration status of temperature measurement ins trumen ta tion.
- 1. Examination of controls used to assure adequacy of metal temperature and metal temperature uni formity. ,
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m . L. ' Review of threec(3) postweld heat treatment charts for nuclear . components and. applicable Certificates of Heat Treatmen t.
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. .n. . Review of. current re' visions of procedures, QCP. N6-1, 7
1 . 9-1, N9-2, and N9-3.
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- 3. Findings
- a. Deviations from Commitment (1) See Enclosure, Item A. ,
(2) See Enclosure, Item B.
(3) See Enclosure, Item C. ;
t (4) See Enclosure, Item D. !
(5) See Enclosure, Item E.
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- b. Unresolved Items !
Hone. 1 D. Material Identification and Control .
- 1. Objectives The objectives of this area of the inspection were to veri fy that material identification and control during manufacturing was in accordance with the applicable regulatory and code require-ments.
- 2. Method of Accomplishment i The preceding objectives were accomplished by: i
- a. Review of QA Manual, Section 3.0, Manual Issue C, " Procure-ment Control."
- b. Review of QA Manual, Section 4.0, Manual Issue C, " Process Control."
- c. Review of QA Manual, Section 5.0, Manual Issue C, " Steel Pressure Containing Castings For nuclear Application."
- d. Verification of identity on two (2) valve bodies, 14 .n -four (4) discs,: sixteen (16) studs, and one (1)-bonnet. 1
- e. Comparison of. identity against material records,
- f. :Verificationeof Hopkinson approval of referenced materials
. e. .. and examination 1 of applicable Certified Materials Test
- -Reports ~with respect to procurement requirements.
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- 3. Findings Within this area of the inspection, no deviations from commit -
ments or unresolved items were identified.
E. Exi t Meeting 1
A post inspection exit meeting was held on June 22, 1978, with the 1 management representatives denoted in paragraph A. above. The I inspectors summarized the scope and findings of the inspection.
Management acknowledged their understanding of the reported 1 findings.
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'O 4 DETAILS SECTION II (Prepared by P. I. Verrios)
A. Persons Contacted -
R. Watson, Engineering Director R. Barrow, Quality Assurance Manager P. Holt, Chief Metallurgist G. Lockwood, Calibration Foreman D. Taylor, Section Leader S. Brooke, Project Engineer J. France, Chief Designer B. Internal Audits
- 1. Objectives The purpose of this inspection was
- verify that: -
- a. Procedures or policy documents clearly identify organiza-tions responsible for audits and define their responsibi-lities and authorities,
- b. Measures have been established to assure that auditors are independent of any direct responsibility for per-formance of activities which they are auditing and that persons having direct responsibility for performance of the activities being audited are not involved in the selection of the audit team.
- c. All auditing personnel including technical specialists are required to receive appropriate training or orientation to develop their competence for pei uranng required audits,
- d. Guidelines and requirements are established for audit scheduling and that they take into consideration the status and importance of the activities to be audited.
- e. Sufficient instructions or guidance are available to the auditors.in .the. form of checklists or procedures to
~i . perform the':. audits: effectively and in accordance with '-
the audit plan.
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- f. Deficiencies identified by the audits are closed out by appropriate corrective action and timely follow-up including reaudit of deficient areas.
- g. Audit records are collected, stored and maintained in ~
i accordance with applicable code and contract require-ments.
- 2. Method of Accomplishment The preceding objectives were accomplished by:
- a. Review of the QA fianual, Section 13.0, Manual Issue C, Revision 8.
- b. Review of QCP 13-1, Revision 4, dated December 5,1975. .
- c. Review of the following internal audits:
(1) Procurement Control. .
(2) Process Control.
(3) Welding Quality Assurance.
(4) Heat Treatment.
(5) Documen tation.
(6) Nonconformities and Corrective Action.
- d. Interviews with cognizant personnel.
- 3. Inspection Findiqqs.
- a. Deviations from Commitments See Enclosure, Item F.
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- b. Unresolved Item Criterion XVIII of Appendix B to 10 CFR 50 states in part, A comprehensive system of planned and periodic audits shall be carried out to verify compliance with atl' aspects of' the quality assurance program and to determine the effectiveness of the program . . . ."
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Article NCA-4134.18 in Section III of the ASME Code states in part, "A comprehensive system of planned and '
periodic audits shall be carried out . ...
Section 13.0 of the QA Manual contains subjective wording. Hopkinson's management agreed to review Section l 13.0 of the QA Manual and make required clarifications. ;
C. Vendor Audits i
- 1. Objectives l
The purpose of this inspection sas to verify that: '
- a. Written procedures for this activity are available and in use.
- b. Evaluations were performed prior to award of contracts and at specified frequency. ,
- c. Sufficient instructions or guidance is available to the auditors in the form of checklists or procedures to perform the audits effectively and in accordance with the audit plan. ,
- 2. Method of Accomplishment The preceding objectives were accomplished by:
- a. Review of the QA Manual, Section 3.0, Manual Issue C, l Revision 8.
- b. Review of QCP N3-1, Revision 4, dated May 9,1978.
- c. Review of QCP N3-2, Revision 5, dated May 9,1978.
- d. Review of the Approved Vendor List.
- e. Interviews with cognizant personnel.
- f. Review of Customer Specification 8791-G-QA1.
- 3. Inspection Findings
~~ :3 Deviations from Commitments (1) See Enclosure, Item G.
-(2) See Enclosure, Item H.
- b. Unresolved Items flone. '
i D. _ Equipment Calibration ;
- 1. Objecti ve f The purpose of this inspection was to verify that:
- a. A system has been established and is maintained to I assure that tools, gages, instruments, and other measuring I devices used in activities affecting quality are properly controlled, calibrated and adjusted at specified periods to maintain accuracy within specified limits.
- b. Calibration records are kept for each instrument and that these records include the following information:
(1) Purchase date and calibration history. ;
(2) Accuracy required and calibration results.
(3) Location for use.
(4) Present calibration interval and date due. l (5) All maintenance and repair details. l l
(6) Person or agency performing all calibration. l (7) Serial number or identification of each standard used to perform the calibration.
(8) fiumber or name of the calibration procedure.
(9) Environmental conditions used during calibration.
(10) Equipment recall schedules.
- 2. Method of Accomplishment
. . The preceding objectives were accomplished by:
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- a. Review of the QA Manual, Section 8, Manual Issue C, !
Revision 8. I l
- b. Review of QCP N8-1, Revision 4, dated April 12, 1978.
- c. Review of QCP N4-1, Revision 4, dated December 1,1975.
- d. Verification of calibration status of randomly selected _
instruments, examples: 0.D. micrometers, surface plates, dial calipers, I.D. micrometers, and dial indicators.
- e. Interviews with cognizant personnel.
- 3. Inspection Findings
- a. Deviations from Commitments See Enclosure, Item I.
- b. Unresolved Item Criterion XII of Appendix 8 to 10 CFR 50 states,
" Measures shall be established to assure that tools, '
gages, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at !
specified periods to maintain accuracy within necessary l limits." !
Article NCA-4134.12 in Section III of the ASME Code .
states in part, " . . . (c) When discrepancies in measuring or testing are found at calibration; the l Certificate Holder shall determine what corrective action i i s requi red . . . . " '
Section 8, paragraph 8.3.9, of Hopkinsons Quality Assurance i Manual is not clear as to the method by which compliance l to the Code will be achieved. Hopkinsons management agreed to review the manual and make required clarifications relative to what type of measuring or testing equipment i will be controlled in order to satisfy the require-ments.
E. Nonconformances and Corrective Action
- 1. Objectives The purpose of this inspection was to verify that: J
- a. A system has been established for identifying and reporting nonconformances and that this system is consistent with the QA program as described in QAM, Section .
- b. The system for nonconformance identification contains -
as a minimum, the following elements:
(1) Identification of item.
(2) Description of nonconformance.
(3) Segregation of the item, as appropriate.
(4) Signature of the reporting party.
- c. The assigned responsibilities are carried out by the designated persons.
- d. The system for identifying and reportiag nonconformances, and for evaluating and enacting corrective action is '
timely and effective.
- e. Corrective action follow-up was ef fectively performed.
- f. Corrective procedures on generic type items and changes thereto are developed, reviewed, and approved by personnel assigned to that responsibility by management.
- 2. MetFod of Accomplishment The preceding objectives were accomplished by:
- a. Review of the QA Manual, Section 12.0, Manual Issue C, Revision 6.
- b. Review of QCP N2-2, Revision 5, dated April 4,1978.
- c. Observations of the manufacturing areas, storage areas for finished and unfinished products, and scrap material areas.
d .- Interviews with cognizant personnel. >
- 3. Inspection Findings
'a . Deviations from Commitments See Enclosure, Item J.
- b. Unresolved Items Criterion XV of Appendix B to 10 CFR 50 states in part,
. . . These measures shall include, as appropriate.
procedures for identification, documentation, segregation Article fica-4134.15 in Section III of the ASME Code states in part, ". . . These measures shall include procedures for identifications, documentation, segrega-ti on . . . . "
Section 12.0 of Hopkinsons Quality Assurance Manual does not address segregation of nonconforming materials detected during manufacturing.
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