ML19318C584
| ML19318C584 | |
| Person / Time | |
|---|---|
| Site: | 07100005 |
| Issue date: | 06/12/1980 |
| From: | MQS INSPECTION, INC. (FORMERLY MAGNAFLUX CORP.) |
| To: | |
| Shared Package | |
| ML19318C582 | List: |
| References | |
| 16587, NUDOCS 8007020047 | |
| Download: ML19318C584 (11) | |
Text
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I.
ORGANIZATION.
Page I-2 II.
_ QUALITY ASSURANCE PROGRAM-Page 2-3
'III.
DESIGN CONTROL Page 3-4 IV.
PROCURE >ENT DOCUMENT CONTROL Page 4-V.
. INSTRUCTIONS, PROCEDURES AND DRAWINGS' Page 4-5 VI.
DOCUMENT CONTROL Page 5 VII.
CONTROL OF PURCHASED MATERIALS, PARTS AND COMPONENTS Page 5-6 VIII.
IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND Page 6 CO!PONENTS IX.
CONTROL OF SPECIAL PROCESSES Page 6
-X.
INSPECTION Page 6 XI.
. TEST CONTROL Page 7 XII.
CONTROL OF MEASURING AND TEST EQUIPMENT Page 7 XIII.
HANDLING, STORAGE AND SHIPPING Page 7-8 XIV.
INSPECTION, TEST AND OPERATING STATUS Page 8 XV.
NONCONFORMING MATERIAL, PARTS OR COMPONENTS Page 8 XVI.
CORRECTIVE ACTION Page 8 XVII..
QUALITY ASSURANCE RECORDS Page 9 XVIII.
AUDITS Page 9 i
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10 CFR 71 - APPENDIX E ACCEPTANCE CRITERIA - TPld!SPORTATION PACKAGES FOR NOR'!.AL/SPECIAL FOR'.! RADI0 ACTIVE MATERIAL ORGANIZATION MAGNAFLUX CORPORATION retains and exercises responsibility for the Quality Assurance Program.
The final program responsibility rests with the president of MAGNAFLUX CORPORATION and is implemented by the Quality Assurance manager.
The design, manufacture, inspection and storage phases for the Exposure Device, are conducted in an orderly fashion as shown on the Organication Chart of Figure 1.
Description of Responsibilities:
~1.
President: Overall mansgement of the company.
2.
Radiation Safety Officer:
Responsible Efor overall administration of the radiation safety program, supervise and. review any rsdiation inspections and storage of the depleted uranium shield castings, train personnel in radiation safety procedures, document control, and audit the radiation safety program.
.He is responsible for using, storing, shipping, inspection, testing and record keeping of radioisotope sources and devices as prescribed in our By Product Material License #12-00622-08.
3 Vice President of Quality Assurance and Research and Engineering:
Responsible for implementing, coordinating and revising the Quality Assurance Program, and also is Executive hhnager of Research and Engineering.
4.
-Vice President of Manufacturing:
'hnages the support departments of Production Control, Ihterial Control, Production, and Quality Control.
5.
Manager of Production Control:
Responsible for implementing equipment Production runs, issue drawings and direct purchase or stock requisitions.
6.-
?.hnager of !.hterial Control:
Responsible for Inventory and Purchasing departments. All purchases are from written documents which are kept as a permanent record.
7.
Inventory Control:
4 Responsible for all purchased and finished materials storage and records.
8.
Purchasing:
Responsible for purchasing all materials per written documents.
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~1U CFR'71 - App;ndix E
.Acc:ptanca Critsrie - Transportation Packagts For Normal /Special For : Radioactive Material-9.
Production, Superintendent:
Responsible for the operation of the welding, assembly, sheet metal and machine shop departments. He also decides en use of outside vendors if they are required.
L10.
Shop Foremen:
Responsible for review and assignment of all work to the shop workers.
11.
!!anager of Quality Control:
Responsible' for all inspection procedures, enforce strict adherance to the Standard Practice Instructions (Quality Control ihnual) and conduct periodic reviews.
12.
Manager of Engineering:
' Responsible for the operation of the Fcgineering departcent, review all Engineering projects, coordinate and enforce ecmpany drafting procedures.
13 Vice President of !!arketing:
-Responsible for all product and service sales.
14.
Director of Product ihnagement:
. Supervises and coordinates activities of all product managers.
15.
Product Manager:
Responsible for specific product forecasts, promotion, and sales. Coordinate product parameters, design phases, prototype evaluation, quality assurance specifications and instruction manual completeness.
Designated Quality Assurance individuals have the authority, delineated in writing, to take all necessary action (including stop work action) required to assure'that any deficiency in activities is corrected and re-audits are stipulated until the required corrections have been made operable.
II.
QUALITY ASSURANCE PROGRAM MAGNAFLUX CORPORATION management establishes and implements this Quality Assurance Program.
MAGNAFLUX shall conduct two audits per year, by personnel not directly related to the Quality Assurance organization, to assure the program is' adequately applied and complies with 10 CFR 71 Appendix E criteria.
The Quality Assurance Manager is responsible for the issuance of.and 1
- revisions to the Quality Assurance !Jhnuals.
Provisions are established to communicate to all responsible parties that the MAGNAFLUX Quality policies must be applied to all products nanufactured
-by or for MAGNAFLUX. CORPORATION per the Quality Assurance Manual and written procedures.
1 -
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10 CFR'71 - App:ndix E Ace 2ptanca Criteria - Transportation Packages For Normal /Special Form Radioactive ~ Material The following' safety rela' ted components of the MX-IC-100 Exposure Device, are shown'on a drawing approved by The Nuclear Regulatory Commission, and are controlled by the Quality Assurance Program:
A.
Adequate radiation shielding of the depleted uranium casting.
B.
Defect free welding of the primary shield casting housing.
C.
The lock must operate without failure.
D.
The assembled control cable connecting link must withstand 135 lb. pull test.
p E.
The assembled guide hose end connectors must withstand 150 lb. pull test.
The final authority to resolve any difference of opinion on matters of Quality Assurance /Qualit/ Control and other departments is the President of MAGNAFLUX CORPORATION.
Preliminary resolutions are handled by the Manager of Quality Assurance.
Personnel performing Quality Control functions as part of the Quality Assurance Program must be qualified by a three month training period under the guidance of an experienced qualified technician, inspector or supervisor. All tests conducted by the trainee will be ' retested by qualified personnel.
The trainee is instructed in the application of the Quality Assurance and Quality Control manuals, instructions or procedures delineated in the manuals and on specific product drawings. The proficiency of personnel is verified by the audits conducted during the year.
Audit variations are' cause for Quality Control personnel reviews and retraining.
The personnel performing " quality affecting" activities are instructed and guided by. their foreman in fulfilling manufacturing requirements per formal drawings'and procedures. The foreman is instructed by the Design Engineer on all critical operations.
Quality related activities are performed with specified equipment under controlled conditions and pre-requisites which must be satisfied prior to inspection and test.
III.
DESIGN CONTROL MAGNAFLUX CCRPORATION follows established procedures to carry out design activities.in.a planned, controlled and orderly manner. The applicable regulatory requirements are translated into drawings, specifications, written procedures and instructions by experienced Engineering personnel.
- Quality standards are specified on each drawing.
Changes must first be reviewed by-responsible Engineering personnel.
All changes are recorded and kept on file for future retrieval, if required.
The initial design and suggested changes are reviewed to assure:
l.'
That design characteristics can be. controlled, inspected and tv.
2.
That all. tests and~ areas to be tested are identified on the dra ingr.
10 CFR 71 - Appendix E Acceptance Criteria - Transportation Packages For.Norral/Special Form Radioactive "aterial The. exposure device was first designed by Standard Engineering principals and calculations, reviewed with the Radiation Safety Officer, a prototype was
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constructed, tests were conducted to verify the soundness of the design in compliance with 10 CFR 71.21 and specific tests that were required in 10 CFR 71 Appendix A & B-for eventual approval as a type "B" package.
Design verifications are reviewed with the radiation Safety Officer, models are made and tested for compliance with regulatory requirements, and formal approval obtained from the commission before commercial use is allowed.
All design and specification changes are subject to the same controls that applied to the original design.
All design phases must be approved by the Product Manager for each phase of the product development cycle.
The procedures for design reviews are identified in the corporate policy.
IV.
PROCURDENT DOCUMENT CONTROL MAGNAFLUX CORPORATION has procedures that clearly delineate the sequence of actions in preparation, review, approval and control of procurement documents.
The primary components of the exposure device, depleted uranium casting, steel metal, cabling and bulk guide hose do not require the supplier to submit or contain product description in his Quality Assurance program. All components are inspected and tested by MAGNAFLUX CORPORATION.
MAGNAFLUX procurement documents contain material and component identification, drawing numbers, and specifications. When applicable, regulatory requirements, codes and industrial standards, test and inspection requirements and special process instructions, will be added.
When applicable, procurement documents shall identify the documentation (drawingsj procedures, inspection procedures, etc. ) to be submitted to the purchaser for approval and his record files.
All changes to procurement documents are subject to the same review and approval as the original document and must be recorded for future retrieval, if required.
Materials and components purchased for the MX-IC-100 Exposure Device are of a non-critical nature which does not require the procurement document to contain rights of access to suppliers facilities and records for source inspection and audit.
V.
INSTRUCTIONS, PROCEDURES AND DPENINGS All activities affecting quality are prescribed and accomplished in accordance with documented instructions, procedures, and drawings.
'#ritten procedures list the sequence of t.ctions to be followed. for the preparation,. review, approval and control of instructions, procedures and drawings.
_4_
10 CFR 71 - Appendir E Acccptance Criteria - Transportation Packages For Normal /Special Form Radioactive Ihterial The Quality Control manager has reviewed and concurs with the inspection plans, tests, calibration, special process procedures and drawings. ??sjor changes affecting quality or safety are first reviewed with the Quality Assurance =anager and the Radiation Safety Officer.
VI.
DOCU).ENT CONTROL The review, approval and issuance of documents and changes thereto, prior to relcase, are procedurally controlled to assure they are adequate and that the quality requirements are stated.
All changes to documents are reviewed and approved by the same organication that performed the original review and approval.
All approved changes are included in instructions, procedure drawings and other documents prior to implementation of the change.
Documents for fabrication or inspection are available at the location where activity will be performed, prior to commencing the work.
A master list, known as the " Bill of flhterial", is established to identify the current instructions, procedures, specifications, drawings and procurement drawings. Current revisions are noted on the respective document affected and also recorded on a permanent record kept on file.
VIT CCNTROL OF FURCHASED I',ATERIALS, PARTS AND COMPONENTS Qualified personnel evaluate the supplier's capability to provide acceptable quality services and products.
The evaluation of supplier's is based on a review of previous performance, competitors who supply comparable products or service, and if required, a survey of the supplier's facilities to determine his capability to supply a product which meets the design, canufacturing, and quality requirements.
The results of supplier facility evaluations are documented and kept on file.
Surveillance of suppliers, if required, during fabrication, inspection, testing and shipment of caterials, equipment and components is planned and perforced in accordance with written procedures to assure conformance to the purchase order.
All suppliers furnish records to the purchaser that:
1.
Identifies the purchased material or equipment and any specific procurement requirements (codes, standards, etc. ) specified on the procurement document.
2.
Identify those components which do not meet ~the doducented standards listed en the purchase document.
Receiving inspection of all supplier-furnished. material,requipment, and services is performed to assure:
1.
That material, co=ponent or equipment is properly identified and corresponds with the identification on receiving documentation..
10 CFR 71 - Appendix E Acceptance Criteria - Transportation Packages For Normal /Special Form Radioactive ?/aterial 2.
Ihterials, components, equipment and acceptance records are inspected and judged acceptable in accordance with predetermined inspection instructions, prior to installation or use.
3 Inspection records of material and components are available prior to installation or use.
4.
That items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area, or releasing them for further work. ;
VIII.
IDENTIFICATION AND CONTROL OF ?/ATERIALS, PARTS AND COMPONENTS
?!AGNAFLUX CORPORATION has established procedures to identify and control materials, parts and components, including partially fabricated subassemblies.
The identification and control procedures assure that identification is maintained either on the item or on records traceable to the item to preclude use of incorrect er defective items.
Identification of parts, important to the function of safety-related components can be traced to the appropriate drawings, specifications, purchase orders, manufacturing and inspection documents, and deviation reports.
The msrking location, and method of identification do not affect the fit, functica or quality of the item being identified.
Correct identification of materials, parts and components is verified and documented prior to release for fabrication, assembly or installation.
CONTROL OF SPECIAL PROCESSES
?/AGNAFLUX CORPORATION controls special processes, such as welding, and nondestructive testing, by written procedures.
The procedures, equipment and personnel connected with special processes are qualified in accordance with applicable codes, standards and specifications.
Qualification records of procedures, equipment and personnel associated with special procesres are established, filed and kept current.
X.
INSPECTION:
?.'AGNAFLUX CCRFORATION has established an inspection program which verifies conformance of quality - affecting activities.
Results are documented in accordance with written and controlled procedures.
The inspection personnel are independent from the individuals who have performed the activity being inspected.
The inspectors are qualified in accordance with applicable codes, standards and company training programs; and their qualifications and certifications will be kept current.
All modifications, repairs and replacements are inspected in accordance with original design and inspection requirements or acceptable alternatives. -
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l 10 CFR 71 - Appendix E Acceptance Criteria - Transportation Fackages For liornal/Special Form Radioactive ?.:aterial Provisions are established, by specific notes on drawings, that identify l
mandatory inspection hold points for witness by an inspector.
XI.
TEST CONTROL A test pregram to demonstrate that the item or ecmponent will perform satisfactorily in service is established, documented and acecmplished in accordance with written controlled procedures.
Ibdifications, repairs and replacements are tested in accordsnee with the original design and testing requirements or acceptable alternatives.
Test results are documented, evaluated and their acceptability determined by a qualified, responsible individual or group.
Physical test records for each exposure device are kept on file for the shield casting and housing weld inspections. The records are related to the parts by permanent serial numbers.
Accessory parts such as guide hoses, control cables, and safety plugs are dye colored for positive identification that acceptance tests have been performed.-
A final check list document is signed and dated for each unit, to verify that the shipping inspector did observe the previous test dye marks or completed test records for each shipped part.
These records are kept on file for the life of the exposure device.
Chemical tests are not required for the exposure device.
XII.
CONTROL OF ?2ASURING AND TEST EQUIP?.'ENT L:easuring and te.,t instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics and other conditiens affecting the measurement.
Test equipment (survey meters) is identified and traceable to the calibration test data.
All previous inspections must be repeated if it is determined that the test instrument 7;as out of calibration.
Reference standards are traceable to naticnally recogniced standards or to documented previous tests traceable to r.cogniced standards.
XIII.
HANDLING, STORAGE AND SHIPPING Special handling, storage, packaging and shipping requirements are established and accomplished by qualified individuals in accordance with written
- ork and inspection instructions. __
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.10 CFR 71-- Appendix E Acesptanco Criterin - Transportation Packages 1
' For Normal /Special Form Radioactive l'aterial J
3
. All conditions (operations, tests and inspections) of the Nuclear Regulatory Commission package approval and the United States Department of Transportation shipping requirements are satisfied prior to shipment.
All necessary shipping papers will be prepared as required.
Departure, arrival time and destination of.a package is monitored to a degree. consistent with the safe transportation of the package.
XIV.
INSPECTION, TEST AND OPERATING STATUS Identification of the inspection, test and cperating status of packages and components is known by affected organications.
The application and removal of inspection e.nd welding stamps, and status indicators such as tags, markings and stamps are procedurally controlled.
Required inspections, tests and critical operations may not be bypassed.
The ~ status of nonconforming, inoperative or malfunctioning packages or components is identified by tag or mark, to prevent inadvertent use.
XV.
NONCONFORMING MATERIAL, PARTS OR COMPONENTS Identification, documentation, segregation, review disposition, and notification to affected departments or organications of nonconforming materials, parts, components, or services are procedurally controlled.
~
Nonconforming items are identified by documentation which describes reason for nonconformance, disposition of the nonconformance, and includes signature approval of the disposition.
Nonconforming items are segregated from acceptable itens and identified as discrepant until properly dispositioned.
Reworked.or repaired materials, parts and components are reinspected and tested, the same as was originally performed.
XVI.
CORRECTIVE ACTION Evaluation of adverse quality (nonconformance, failures, malfunctions, etc.) is~ conducted to determine the need for corrective action.
Corrective action is then initiated by revisions to drawings or written inspection procedures.
Follow up reviews are conducted to verify proper implementation of corrective actions.
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- 10 CFR 71 Appendix E Acesptance Criteria - Transportation Packages For llormal/Special Form Radioactive Pateriil
? XVII.
QUALITY ASSURA!!CE RECORDS Sufficient' records are maintained to provide documentary evidence of the quality-and safety of. items and activities affecting quality and safety.
I Quality Assurance records of. operating logs, reviews, inspections, tests, audits, and follow-up reports, qualification of personnel, procedures, equipment,.
drawings, specifications,. procurement documents, calibration reports, nonconformance and corrective action reports are kept in identifiable and retrievable condition.
A list of the required records-and their storage loca tions will be maintained by.the Radiation Safety Officer.
Drawings, revisions and calculations are kept for the life of the shipping package and all other records are maintained for a minimum of two years.
Inspection and test records contain:
1.
The document numbers of the test instructions to be used for the test.
2.
Evidence of completing and verifying a manufacturing, inspection, or test operation.
3 The date and results of the inspection or test.
4.
Information related to conditions adverse to quality.
5.
Inspector identification by signature.
.6.
' Evidence as'to acceptability of the results.
XVIII.
AUDITS I
Audits shall be performed in accordance with pre-established written procedures and conducted by persennel not having direct responsibilities in i
the areas being-audited.
The audit results are documented and reviewed with management uho then i
I
. initiate. corrective steps to prevent recurrance of the' deficiencies revealed by the audit. The deficient areas are re-audited on a timely. basis ~to verify implementation of corrective measures.
1 Audits will be conducted twice annually based on the safety significance L of ~ the activity being audited.
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