ML20148L327

IE Inspec Rept 99900338/78-01 on 780821-25 During Which 2 Items of Noncompliance Were Noted:Index for Records Had Not Been Established & Checklists Had Not Been Prepared for Internal Audit

ML20148L327
Person / Time
Issue date:	09/08/1978
From:	Foster W, Hunnicutt D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
Shared Package
ML20148L317	List: ML20148L311 ML20148L327
References
REF-QA-99900338 NUDOCS 7811200231
Download: ML20148L327 (10)

Text

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D-VENDOR INSPECTION REPORT U.S. NUCLEAR REGULATORY. COMMISSION

'0FFICE OF INSPCTION AND ENFORCEMENT REGION IV Report No. 99900338/78 Program No. 44075 Company: Siemens-Allis Incorporated Small Motors Division 14000 Dineen Drive Little Rock, Arkansas 72206 Inspection Conducted: August 21-25, 1978 Inspectors:

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Foster, Contractor Inspector, k$ 7./

pt W. E. / Date Vendor Inspection Branch

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Hunnicutt, Chief, Components WV/7Y

' Da'te Section II, Vendor Inspection Branch Suninary:

Inspection on August 21-25, 1978 (99900338/78-01).

Areas Inspected: Implementation of 10 CFR 50, Appendix B criteria, and applicable codes and standards, including quality assurance manual review; quality assurance program; and design control. The initial management meeting was also conducted. The inspection involved fifty-eight (58) inspector hours on site by two (2) NRC inspectors.

Results: In the four (4) areas inspected, no apparent deviations or unresolved items were identified in three (3); the following were identified in the remaining area.

Deviations: Quality Assurance Program - Practices were not consistent with 10 CFR 50, Appendix B (Enclosure, Items A. and B.).

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Siemens-Allis, Incorporated Small Motors Division Docket'No. 99900330/78-01 ,

NOTICE OF DEVIATION Based on the results of an NRC-inspection conducted 'n August 21-25, 1978, it appeared that certain of your activities were not conducted in-full accordance with NRC requirements as indicated below:

A. Criterion XVII of Appendix B to 10 CFR 50 states in part, " Con-sistent with applicable regulatory requirements, the applicant -

shall establish requirements concerning record retention, such as duration, location, and assigned responsibility."

Section LRN 10.01, dated February 11, 1977, of the Quality Assurance Manual for Nuclear Safety Related Equipment states in part, "An index is to be established prior to submittal of records, and is to indicate, as a minimum, record retention times, where records are to be stored, anJ location of records with the storage area."

Contrary to the above, an index had not been established for records pertaining to completed orders; e.g. order Nos. 8-5101-90300, 8-5103-90300, 8-5102-90300, and 8-5125-90306.

B. Criterion XVIII of Appendix B to 10 CFR 50 states in part, "The audits shall be performed in accordance with the written procedures or checklists . . . ."

Section LRN 8.01, dated February 11, 1977, of the Quality Assurance -

Manual for Nuclear. Safety Related Equipment states in part, " Check lists will be used for Internal . . . audits to determine extent of conformance. If a checklist is not available at the time an audit is assigned, it must be prepared by the auditor before the audit can be conducted."

Contrary to the above, checklists had not been prepared for the-internal audit conducted during the period of March 13-17, 1978.

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' DETAILS SECTION I' (Prepared by W. E. Foster) .

t A. Persons Contacted

• C. E. Barry, Manager - Manufacturing Operations 4 T.'Boyd, Manager -. Manufacturing Engineering W. Chesser, Auditor - Quality Assurance J. B. Crowd- , Controller J. Culpepper, Supervisor - Process Planning / Industrial Engineering B. Deaton, Engineer ' Quality Assurance

• R. G. DeVinney, Manager - Marketing R. E. Hunter, Supervisor - Personnel C. Jones, Stenographer R. Krebs, Supervisor - Tool Engineering B. G. Mefford, Planner - Process B. Moody, Supervisor - Final Assembly / Test / Packaging.

, *W. E. Onyett, Manager - Quality Assurance L. Parker, Supervisor - Connecting and Winding / Test R. Poellot, Jr. , Engineer - Electrical

• A. C. Varner, Manager - Product Engineering

• Attended Exit Meeting.

B. 0A. Manual Review

1. Objectives The objectives of this area of the inspection were to verify that:

a. The QA Manual contained a management policy statement end'orsing the QA Program and establishing the Manual as an authoritative document.

b. The QA Manual provided for identification and completion of.  ;

prerequisites such as skills, processes, controls, etc.,

necessary to attain. quality objectives,

c. The QA Manual provided for indoctrination'and training.

d. The QA Manual provided for review by management of other organizations for that portion of the QA Program for which '

they were responsible.

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e. The QA Manual identified management.and staff responible -

for planning and implementation of'the QA Program and QA Manual Control.

f. The QA Manual identified hardware and services subject to provisions of the QA Program and participating organizations.

g. The QA Manual addressed the eighteen (18) criteria of Appendix B to 10 CFR 50.

2. ' Methods of Accomplishment The preceding objectives were accomplished by:

Review of the Quality Assurance Manual for Nuclear Safety Related Equipment and the Small Motors Division Quality Assurance Manual to verify management endorsement of the QA Program; identification and completion of prerequisites necessary to attain quality objectives; indoctrination and training; personnel responsible for the QA Program; iden-tification of affected hardware and services; and recognition of Appendix B criteria.

! 3. Findings No' deviations or unresolved items were identified in this area of the inspection.

C. ' Organization

1. ' Objectives The objectives of this area of the inspection were to verify that:

a. Authority and duties of persons and organizations performing activities affecti_ng the safety-related functions had been clearly established and delineated in writing. These activ-ities include both the performing functions of attaining quality objectives and the quality-assurance functions.

b. Performers of the quality assurance functions had sufficient authority and freedom to:

(1) Identify quality problems, (2) Initiate, recomend or provide solutions, (3) Verify implementation of solutions.

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c. The -individual (s) responsible for assuring effective execution of.any portion of the quality assurance program had direct access to such levels of management necessary to perform this function.

2. Methods of Accomplishment The preceding objectives were accomplished by:

a. Review of Zurn Industries, Incorporated, Purchase: order No. CT-1005-004, dated August 31, 1977, and attendant documents to verify the requirement' for organization had been invoked.

b. Review of the Small Motors Division Quality Assurance Manual, Section 1.01, dated January 17, 1978; and various Position Descriptions of various dates to verify authority and duties of persons and organization performing safety-related functions had been clearly established and delineated in writing.

t c. Review of the Manufacturing Engineering Manual, dated January 22, 1976, to verify the-authority and duties of this organi%ation had been ' clearly established and delineated in w"iting,

d. Re/iew of the Quality Assurance Manual for Nuclear Safety Related Eo sment, Section LRN 9.01, dated August 1,1977, to verify 'rformers of the quality assurance functions had

,ufficit uthority and freedom to identify quality problems.

Fint.ings 3.

No deviations or unresolved items were identified in this area of the inspection.

D. Quality Assurance Program

1. Objectives The objectives of this area of the inspection were to verify that:

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e. The program had been documented by written policies, pro-cedures, or instructions, and performance was in accordance 1 j

with them.

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b. Identification of hardware covered by program, major or-ganizations participating in the program together with their designated functions had been established.

c. Controls had been established over activities affecting quality to an extent consistent with importance to safety.

d. The program provided for:

(1) Special controls, processes, test equipment, tools and skills to attain required quality and inspection and test, (2) Indoctrination and training of personnel performing activities affecting quality.

e. Management of other organizations participating in the quality assurance program regularly reviewed'the status and adequacy of that part of the quality assurance program they were executing.

i 2. Methods of Accomplishment The preceding objectives were accomplished by:

a. Review of Zurn Industries, Incorported, Purchase Order No. CT-1005-004, dated August 31, 1977, and attendant documents to verify the requirement for quality assurance program had been invoked.

b. Review of the Quality Assurance Manual for Nuclear Safety Related Equipment and the Small Motors Division Quality Assurance Manual to verify:

(1) The program had been documented, (2) Controls had been established, i (3) Provisions were evident for test equipment, tools and skills, and indoctrination and training, and

-(4) Affected hardware and responsible organizations, and their functions had been identified.

c. Review of the Manfacturing Engineering Manual, Sub- ,

i function 3.0, Element 3.4, dated November 17, 1975, to verify existence of the requirement to document instructions ,

and procedures.

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d. Review of_ Product Engineering Manual General Procedure No. 1.13, dated March 1977, to verify provisions existed for document and test control.

e. Review of selected instructions and observation of related activities.to verify performance was in accordance with the instructions.

3. Findings

a. ' Deviations (1) See Enclosure, Item A.  ;

(2) See Enclosure, Item B.

b. Unresolved Items None E. Design Control

' 1. Objectives The objectives of this area of the inspection were to verify that:

a. Measures had been established to assure applicable regulatory requirements and design basis had been correctly translated into specifications, drawings, procedures, and instructions.

b. Established measures included provisions for assuring that appropriate quality standards had been specified and made a portion of design documents and that deviations from such standards were controlled.

c. Measures had been established for the selection and review for suitability of application of materials, parts, equipment and processes that are essential to safety-related functions.

d. Measures had been established for identification and control of design interfaces and for coordination among participating design organizations, and provided for the establishment of procedures among participating design organizations for review, approval, release, distribution,

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e. Design. control measures provided' for: .

(1' ) Design reviews, alternate or simplified calculational methods. performed by individuals or groups other than those who orginated the design, (2) Alternatively, performance 'of a suitable testing program.

involving qualification testing of a prototype under.the most adverse design conditions,

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(3) Considerations for: ~ reactor physics, stres's, thermal, hydraulic, accident analyses, compatibility of materials, ,

accessibility for inservice. inspection, maintenance and repair, delineation of acceptance criteria for= inspections-and tests, and (4) Approval by the organizaticn. that originated the design, or a designated responsible organization in the advent of design changes, including field changes. 4

2. Methods of Accomplishment i ~

The preceding objectives were-accomplished by:

a. Review of Zurn Industries, Incorporated, Purchase Order No. CT-1005-004, dated August 31, 1977, and attendant documents to verify the requirement for design control had been invoked.

-b. Review of Section 3.01 of the Small Motors Division Quality <

Assurance Manual and Sections LRN 3.01, LRN 4.01, LRN 5.01, and LRN.9.01 of- the Quality Assurance Manual for Nuclear Safety Related Equipment to verify establishment of measures for translation of design requirements, and selection and review of materials,. parts, equipment and processes;.and <

included provisions for deviations, as well as, design reviews, testing, and changes.

c. Review of Product Engineering General Procedures 1.13 and 1.4 to verify establishment of measures for interface control, design reviews, testing, and changes.

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d .- Review of selected Notices and Minutes of Ussign Review Minutes, Design Review Action Reports, test data and drawings to verify implementation of established measures.

3. Findings No deviations or unresolved items were identified in this area of the inspection. F F. Exit Interview  ;

1. The inspectors met with management representatives denoted in - -s paragraph A. t.t the conclusion of the inspection on ' August 25, 1578.

2. The following sebjects were discussed:

a. Areas inspected.

b. Deviations identified.

c. Contractor respor.se to the report.

i The contractor was reqcested to structure'his response under headings of corrective action, preventive measures, and dates for each deviation.

3. Management representatives acknowledged the findings. ,

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DETAILS SECTION II-(Prepared by D. M. Hunnicutt)

Initial Management Meeting An Initial Manaaement Meeting (IMM w and imposed on safety vendors b of the putlic and to inform thvend ty to protect the health (Public Law 93-438).y the " Energy Reorganization Act of C. E. Barry These in attendance were: .

W. Chesser,, Auditor - Quality AssuranceManager -

J. B. Crowder, Contr B. Deaton, E R. DeVinney,ngineer ollerManager -Quality Assurance W. E. Onyett Manager Marketing A. C. Varner,, Manager - Product EngineerQuality Assuran 1.

Obiectives, t

The objectives of the IMM were to:

a.

Meet with the Vendor's mana channels for communications,gement personnel and establis b.

of Public Law 93-438, Acquaint them_of their resp

c. under Section 206 Learn how the Company operates and its practices control (QC), concerning qualitypolicies assurance and (QA) 1 d.

and quality Obtain information to the nuclear industry. related to the Compan '

2. y s contribution Method of Accomplishment 4.

The preceding objectives were e accomplish d b y:

b.

for the Vendor Inspection n cated the Program need (VIP) are conducted,En laining the inspection base and how th e inspections

c. '

Describing how inspection results are do cumented and

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4 how proprietary items are handled, including the vendor's opportunity to review the report for the '

purpose of identifying items considered to be pro-prietary,

d. Describing the vendor's responsibility 16 responding-to identified enforcement items relating to:

(1) Correction:of'the identified deviation,.

(2) Action to be implemented to prevent recurrence, (3) The date(s) when corrective action (s) for both (1) and (2) above will be implemented or' completed,

e. Explaining that all reports and communications are placed in the Pvblic Document Room (PDR),

f. Explaining the publication and function of the " White Book,"

g. Requesting the Cecpany's management to explain its policies and practices concerning QA and the Company's. organ- "

izational structure,

b. Requesting brief summarj of the Company's operations, its

- contribution to the nuclear industry and management's involvement to. assure adequste QA for nuclear products.

3. Findings Management explained their organizatico and summarized the Company's contribution to the nuclear industry. No unusual

, questions or discussions were presented.

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