ML19309H327
| ML19309H327 | |
| Person / Time | |
|---|---|
| Site: | 07100005 |
| Issue date: | 04/16/1980 |
| From: | MQS INSPECTION, INC. (FORMERLY MAGNAFLUX CORP.) |
| To: | |
| Shared Package | |
| ML19309H321 | List: |
| References | |
| NUDOCS 8005130052 | |
| Download: ML19309H327 (10) | |
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8005130 QN O
INDE1 O'
I.
ORGANIZATION Page 1-2 II.
QUALITY ASSURANCE PROGRAM Page 2-3 III.
DESIGN CONTROL Page 3 IV.
PROCUREMENT DOCUMENT CONTROL Page 3-4 V.
INSTRUCTIONS, PROCEDURES AND DRAWINGS Page 4 Page 4 VI.
DOCUMENT CONTROL VII.
CONTROL OF PURCHASED MATERIALS, PARTS AND COMPONENTS Page 4-5 VIII.
IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND Page 5 COMPONENTS
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IX.
CONTROL OF SPECIAL PROCESSES Page 6 X.
INSPECTION Page 6 XI.
TEST CONTROL Page 6 XII.
CONTROL OF MEASURING AND TEST EQUIPMENT Page 6-7 XIII.
HANDLING, STORAGE AND SHIPPING Page 7 XIV.
INSPECTION, TEST AND OPERATING STATUS Page 7 XV.
NONCONFORMING MATERIAL, PARTS OR COMPONENTS Page 7 XVI.
CORRECTIVE ACTION Page 7-S XVII.
QUALITY ASSURANCE RECORDS Page S XVIII.
AUDITS Page 8
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10 CFR 71 - APPENDIX E ACCEPTANCE CRITERIA - TRANSPORTATION PACKAGES FOR NORMAL /SPECIAL FORM RADIOACTIVE MATERIAL 1.
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 organization chart of Figure I.
Description of Responsibilities:
1.
President: Overall management of the company.
2.
Radiation Safety Officer:
Responsible for overall administration of the radiation safety program, supervise and review any radiation inspecticas 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 Ey Product Fbterial License #12-00622-08.
3.
Manager of Ouality Assurance: Responsible for implementing, coordinating and revising the Quality Assurance Program.
Is of vice president rank and also is Manager of Research and Engineering.
4.
Manager of Research and Engineering: Executive manager of all Engineering and Research departments.
5.
Manager of Fbnufacturing:
Pbnages the support departments of Production Control, Material Control, Production,.and Quality Control.
6.
Manager of Production Control: Responsible for implementing equipment Production runs, issue drawings and direct purchase or stock requisitions.
- 7.
Manager of Fbterial control: Responsible for Invent:ry and Purchasing departments.
All purchases are from written documents which are kept as a permanent record.
8.
Inventory Control: Responsible for all purchased and finished materials storage and records.
9.
Purchasing: Responsible for purchasing all materials per written documents.
10.
Production Superintendent:
Responsible for the operation of the welding, assembly, sheet metal and machine shop departments.
He also decides on
(,j) use of outside vendors if they are required.
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11.
Shop Foremen: Responsible for review and assignment of all work to the shop workers.
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12.
Manager of Quality Control:
Responsible for all inspection procedures, enforce strict adherance to the Standard Practice Instructions (Quality Control Manual) and conduct periodic reviews.
13.
Manager of Engineering: Responsible for the operation of the Engineering department, review all Engineering projects, coordinate and enforce company drafting procedures.
Designated Quality Assurance individuals have the authority, delineated in writing, to take all necessary action required to assure that any deficiency in Quality Assurance activities is corrected and re-audits are stipulated until the required corrections have been made operable.
_UALITY ASSURANCE PROGRAM Q
II.
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 org.'nization, to assure the program is adequately applied and complies with 10 CFR 71 Appendix E'crite,ria.
The Quality Assurance Manager is responsible for the issuance of and revisions to the Quality Assurance Manuals.
Provisions are established to communicate to all responsible parties that the MAGNAFLUX quality policies mast be applied to all products manufactured by or for MAGNAFLUX CORPORATION.
The safety related components of the FM-IC-100 Exposure Device which are controlled by the Quality Assurance Program are:
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.
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 / Quality Control and other departments is the president of FRGNAFLUX 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 superviser. 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.
Quality reisted cctivitics are p rformed with specified equipmint und:r controlled conditions and pre-requisites which must be satisfied prior to inspection and test.
II.
DESIGN CONTROL MAGNAFLUX CORPORATION 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 rust first be reviewed by responsible Engineering personnel. All changes are recorded and kepton file for future retrieval, if required.
The initial design and suggested changes are reviewed tb assure:
1.
That design characteristics can be controlled, inspectc{ and tested.
2.
That all tests and areas to be tested are identified on the drawings.
The exposure device was first designed by Standard Engineering principals and calculations, reviewed with the Radiation Safety Officer, a prototype was 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 requ~rements, and formal approval T'sobtained from the commission before commercial use is allowed.
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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 Manager of Product Development for each phase of the product development cycle.
The procedures for design reviews are identified in the corporate policy.
IV.
PROCUREMENT 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, steci 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 MACNAFLUX CORPORATION.
MAGNAFLUX procurement documents contain material and component identi-fication, drawing numbers, and specifications. When applicable, regulatory requirements, codes and industrial standards, test and inspection requiremen_s and special process instructions, will be added.
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When applicable, procurement documents shall identify the documentation
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(drawings procedures, inspection procedures, etc.) to be submitted to the purchaser for approval and his record files.
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All changes to procurement documents are subject to the same review and approval as the original document and must be recorded for future retrieval s
if required.
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Materials and components purchased for the MX-IC-100 Expbsure. 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.
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V.
INSTRUCTIONS, PROCEDURES AND DRAWINGS All activities affecting quality are prescribed and accomplished in accordance with documented instructions, procedures, and drawings.
i Written procedures list the sequence of actions to be followed for the preparation, review, approval and control of instr 6ctions, procedures and drawings.
The Quality Control manager has reviewed and concurs with the inspection plans, tests, catibration, special process procedures and drawings. Major changes affecting quality or safety are first reviewed with the Quality Assurance manager and the Radiation Safety Officer.
VI.
DOCUMENT CONTROL
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The review, approval and issuance of documents and changes thereto, prior to release, are procedurally controlled to assure they are adequate and that the quality rdquirements are stated.
All changes to documents are reviewed and approved by the same organization 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 Material", 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.
VII.
CONTROL OF PURCHASED MATERIALS, 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 comparabic products or service, and if required, a survey of the supplier's facilities to determine his capability to supply a O-product which meets the design, manufacturing, and quality requirements.
The results of cupplier facility evaluntiens are documinted and ktpt on file.
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Surveillance of suppliers, if required, during fabrication, inspection, testing and shipment of materials, equipment and components is planned and performed 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 tl:ose components which do not meet the documented standards listed on the purchase document.
Receiving inspection of all supplier-furnished material, equipment, and services is performed to assure:
1.
That material, ceaponent or equipment is properly identified and corresponds with the identification on receiving documentation.
2.
Materials, components, equipment and acceptance records are inspected and judged acceptable in accordance with predetermined inspection instructions, prior to installation or tse.
3.
Inspection records of material and components are available prior to installation or use.
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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 CONTE,L OF MATERIALS, PARTS AND COMPONENTS MAGNAFLUX 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 t o preclude use of incorrect or 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 marking location, and method of identification do not affect the fit, function 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.
4 IX.
CONTROL OF SPECIAL PROCESSES MAGNAFLUX CORPORATION controls special processes, such as welding, and
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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 processes are established, filed and kept current.
X.
INSPECTION:
MAGNAFLUX CORPORATION has established an inspection program which verifies conformance of quality - affecting activities.
Results are documented in accordance with written and controlled procedures.
f The inspection personnel are independent from the individuals who have performed the activity being inspected, j
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.
Provisions are established, by specific notes on drawings, that identify
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mandatory inspection hold points for witness by an inspector.
XI.
TEST CONTROL A test program to demonstrate that the item or component will perform satisfactorily in service is established, documented and accomplished in accordance with written controlled procedures.
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Modifications, repairs and replacements are. tested in accordance with the i
original design and testing requirements or acceptable alternatives.
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Test results are documented, evaluated and their acceptability determined by a qualified, responsible individual or group.
4 XII.'
' CONTROL OF MEASURING AND TEST EQUIPMENT Measuring and test instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability character-istics and other conditions affecting the measurement.
Test equipment (survey meters) is identified and traceable to the calibration test data.
All previous inspections must be repeate'd if it is determined that the test instrument was.out of calibration.
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Reference standards are traceable to nationally recognized standards or to documented previous tests traceable to recognized standards.
I.
HANDLING, STORACE AND SHIPPING Special handling, storage, packaging and shipping requirements are established and accomplished by qualified individuals in accordance with written work and inspection instructions.
All conditions (operations, tests and inspections) of the Nuclear kegulatory 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 operating status of packages and components is known by affected organizations.
The application and removal of inspection and welding stamps, and status indicators such as tags, markings and stamps are procedurally controlled.
Required inspections, tests and critical operations may not be bypassed.
O the t t et #e ce rermi 8. i= Per tive er 1r==ctie=1 8 P c* 8e er 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 organizations 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 items and identified
_ as discrepant until properly dispositioned.
Reworked or repaired materials, parts an'd components are reinspected and tested, the same as was originally performed.
XVI.
CORRECTIVE ACTION Evaluation of adverse quality (nonconformances, 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.
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Fallow up riview2 era csnducted to v;rify propar inplcmentation of corrective actions.
II.
QUALITY ASSURANCE RECORDS Sufficient records are maintained to provide documentary evidence of the quality and safety of items and activitics affecting quality and safety.
Quality Assurance records of operating logs, revicws, in spec t' ions, test, 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 locations 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.
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4.
Information related to conditions adverse to quality.
5.
Inspector identification by signature.
6.
Evidence as to acceptability of the results.
XVIII.
AUDITS Audits shall be performed in accordance with pre-established written procedures and conducted by personnel not having direct responsibilities in the areas being audited.
The audit results are documented and reviewed with management who then initiate corrective steps to prevent recurrance of the deficiencies revealed by the audit. The deficient areas are re-audited on a tieely basis to verify implementation of corrective measures.
Audits will be cor. ducted twice annually based on the safety significance of the activity being audited.
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ORGANIZATION CHART PRESIDE'iT i
l I
i VICE PRESIDENT AND RADIATION SAFETY OUALITY ASSURANCE VICE PRESIDENT AND X1ACER OF MANAGER OF MANUFACTURING OFFICER MANAGER RESEARCH AND ENGINEERING I
MANAGER OF MANAGER PRODUCTION CONTROL MATERIAL CONTROL PRODUCTION Mt. NAGER OF MANAGER OF SUPERINIENDENT QUALITY CONTROL ENGINEERING INSPECTOR 3 ENGINEERS INVENTORY PURCil A '"";
CONTROL WELDING ASSEMBLY SHEET METAL MACilINE DEPARTMENT DEPARTMENT DEPARTMENT SHOP DEPARTMENT NOTE: COMPILED FROM MAGNAFLUX OUALITY CONTROL MANUAL CHART #1 & #5 AND M.O.P. PART III, CIL\\RTS VI & VII AND SECTIONS 1 - PACE 46 - 1.
QUALITY ASSURANCE PROGRAM ORGANIZATION CHART FOR MAGNAFLUX CORPORATION AS IT RELATES TO MODEL NO. MX-IC-100 EXPOSURE DEVICE MANUFACTURED IN COMPLIANCE WITH 10 CFR PART 71, APPENDIX - E.
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U1 FIGURE 1 lck 4/17/80
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