ML19309G656
| ML19309G656 | |
| Person / Time | |
|---|---|
| Site: | 07100009 |
| Issue date: | 04/15/1980 |
| From: | Dietz G ISOMEDIX, INC. |
| To: | |
| Shared Package | |
| ML19309G650 | List: |
| References | |
| 15979, NUDOCS 8005070307 | |
| Download: ML19309G656 (15) | |
Text
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8005070 3o1 O
O c
isommoix QA PROGRAM FOR THE PRODUCTION CONTROL AND SilIPMENT OF 20-WC-5 CONTAINERS AND GAMMACELLS (This Program supersedes any previous QA Programs related to this subject)
APPROVED BY:
General Manager h
QA Man &ger
-M_
Presid(nt j
EFFECTIVE DATE:
April 15, 1980 DATES OF CHANGES:
ISOMEOlX INC.
I COAPORATE OFFICES
- 80 SOUTH JEFFERSON ROAD. WHIPPANY. NEW JERSEY 07961 + (201) 867-4700 1 r; fW 4 l
16 J ' -
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4 TABLE OF CONTENTS Page GENERAL 1
I.
Organization 1
II.
Quality Assurance Program 2
III.
Design Control 3
IV.
Procurement Document Control 4
V.
Instructions, Procedures, and Drawings 5
VI.
Document Control 5
VII.
Control of Purchased Materials, Parts and Components 5
VIII.
Identification and Control of Materials, Parts, and Components 7
IX.
Control of Special Processes 7
X.
Inspection 8
XI.
Test Control 8
XII.
Control of Measuring and Test Equipment 8
XIII.
Handling, Storage, and Shipping 9
XIV.
Inspection, Test and Operating Status 9
4 XV.
Nonconforming Material, Parts, or Components 10 XVI.
Corrective Action 10 l
i XVII.
Quality Assurance Records 10 XVIII.
Audits Al 1
-1 Figure 1 - Isomedix Organization 4
Figure 2 - Responsibility Matrix l
IsOMEDIX INC.
coneoa rr omcts. So SOUTH JEFFERSON ROAD, WHIPPANY, NEW JERSEY 07901 + 201) 887-4700
QA PROGRAM Page 1 GENERAL Title 10 CFR 71 requires that a QA Program applicable to the construction and shipment of packages related to the shipment of radioactive material be in effect by the using company.
This requirement applies to Isomedix in the f abrication of the 20-WC-5 wooden cask, related to the shipment of self-contained sources in Gammacells, and to the Gammacell bodies.
Specifically, Isomedix ships Gammacells containing less than 3,000 curies of cesium-137 (Type B material), utilizing the 20-WC cask.
Isomedix is licensed to conduct this activity under License No. 29-15364-01.
The 20-WC series cask carries IAEA Certification No. USA /5800/B, and Isomedix is a registered user of the cask.
Isomedix shall retain the responsibility for the following QA Program.
I.
Organization 1.
The responsibility for the QA Program is retained and exercised by Isomedix, Inc.
2.
QA functions performed shall include but not be limited to:
(1)
Periodic design reviews.
(2)
Review of procurement documents for 10 CFR 71 Appendix E control.
(3)
Review of design control procedures.
(4)
Review and concur with'inspec. tion plans, calibration and test procedures, drawings and specifications, and changes thereto.
(5)
Review of outside vendor f acilities to assure f abri-cation compliance with specifications.
(6)
Participate in the evaluation of suppliers ' capabilities to provide acceptable quality products / services.
( 7 ),
Periodically inspect materials, parts.and components to assure that their identification and control is adequate.
(8)- Perform inspections to verify conformance with quality-af fecting activities.
i i
(
QA Program Page 2 (9)
Periodically review test instrument calibrations to determine calibration is performed at specified intervals.
(10)
Maintain Quality Assurance reco'rds.
(11)
Maintain Audit records.
3.
The current organizational chart is as shown in Figure 1.
4.
A responsibility matrix is shown in Figure 2.
5.
The duties of the QA manager are to implement and pursue those specific activities outlined in Item 2 above, and to assure general compliance with applicable regulations.
His qualifications shall include:
(1)
Previous experience in QA related activities.
(2)
A working knowledge of applicable regulations.
(3)
A background technically sufficient to enable accomplishment of assigned tasks.
6.
The designated QA Manager shall have the responsibility and authority to stop unsatisf actory work and to control further processing, delivery or installation of non-conforming material.
II.
Quality Assurance Program 1.
The President or his dcsignated representative shall periodically assess the scope, status implementation and effectiveness of the QA Program to assure its adequacy and compliance with 10 CFR 71, Appendix E.
2.
This OA Manual and subsequent revisions shall be limited in its distribution to the Corporate Office and the Ia'sippany Plant, unless otherwise authorized by the r
President.
3.
. Provisions are established to assure that applicable organizations and individuals are apprised that quality policies, QA manuals and procedures are mandatory require-ments which must be implemented and enforced.
4.
Safety-related elements controlled by the QA Program include:
(1)
Assurance that welds conform to specifications.
l QA PROGRAM Page 3 (2)
Assurance that external dose rates (where applicable) are within specified limits.
(3)
Assurance that the final product is adequately pack-aged for shipment.
5.
Disputes between QA and other department personnel shall be resolved by the President or his designated represen-tative.
6.
An indoctrination and training program is established such that:
(1)
Personnel responsible for perforning quality related activi. ties are instructed as to the purpose, scope and implementation of the QA manual,. instruction and procedures.
(2)
Personnel performing quality-affecting activities are qualified in the principles and techniques of the activities being performed.
(3)
The scope, objective and method of implementing the indoctrination and training program are documented.
(4)
Proficiency of personnel performing quality-affect-ing activities is maintained by periodic retraining.
7.
Where applicable, quality related activities are performed with specified equipment under suitable environmental conditions, and prerequisites have been satisfied prior to inspection and test.
III.
Design Control 1.
Measures are established to carry out, design activities in a planned, controlled and orderly manner.
2.
Measures are established to correctly translate applicable regulatory requirements and design bases into specifica-tions, drawings written procedures and instructions.
3.
Quality standards are specified in the design documents.
Deviations and changes are controlled.
4.
Designs are reviewed to assure that' design characteris-
- tics can be controlled, inspected and tested, and inspec-
' tion and test criteria are identified.
1
QA PROGRAM Page 4 5.
Selection and accomplishment of design verification of Ga.amacell characteristics are accomplished by design l
reviews.
(This paragraph is not applicable to the 20-WC specification container.)
6.
Individuals responsible for design verification are other than the original designer or his immediate supervisor.
7.
Design and specification changes are subject to the same design controls and approvals applicabl'a to the original design, except where those controls an6 approvals have become more stringent.
. 8.
Positions responsible for design reviews and verifica-tion activities and their authority and responsibility are identified and controlled by written procedures.
IV.
Procurement Document Control 1.
Procedures are established that clearly delineate the sequence of actions to be accomplished in the preparation, review, approval and control of procurement documents.
2.
Procurement documents identify the applicable 10 CFR 71, Appendix E, requirements which must be complied with and described in the QA Program.
3.
Procurement documents reference the design basis technical requirments, including applicable regulatory requirements, material and component identification requirements, draw-ings, specifications, codes and industrial standards, test and inspection requirements, and special process instruc-tions.
4.
Procurement documents identify the documen' ation to be t
prepared, maintained and submitted to the purchaser f or review and approval.
S.
Procurement documents identify those records to be re- ~
tained, controlled and maintained by the supplier, and those. to be delivered to the purchaser prior to use or installation of the hardware.
6.
Procurement documents contain the procuring agencies right of access to suppliers' facilities and records for source inspection and audit.
7.
Changes and revisions to procurement docpments are sub.
e ject to at least the same review and approval as the original doument.
O'
QA PROGRAM Page 5 V.
Instructions, Procedures, and Drawings 1.
Activities affecting quality are prescribed and accom-plished in accordance with documented instructions, procedures, or drawings.
2.
Provisions are established which clearly delineate the sequence of actions to be accomplished in the prepara-tion, review, approval, and control of instructions, procedures, and drawings.
3.
The QA organization reviews and concurs with inspection plans; test, calibration, and special process procedures; drawings and specifications; and changes thereto or acceptable alternatives are described.
VI.
Document Control 1.
The review, approval, and issue of documents and changes there to, prior to release, are procedurally controlled to assure they are adequate and the quality requirements are stated.
2.
Changes to documents are reviewed and approved by the same organizatione that performed the original review and approval or by orber qualified responsible organizations as delegated.
3.
Approved changes are included in ins tructions, procedures,
drawings, and other documents prior to implementation of the change.
4.
Documents are available at the location where the activity will be performed prior to commencing the work.
5.
A master list is established to identify the current revision number of instructions, procedures, specifica-tions, drawings, and procurement documents.
VII.
Control of Purchased-Materials, Parts and Components 1.
Qualified personnel evaluate the supplier's capability to provide acceptable quality services and products.
2.
The evaluation of suppliers is based on one or more of the following:
e
QA PROGRAM Pag e 6
( 1)
The supplier's capability to comply with the elements of Appendix E to 10 CFR Part 71 that are applicable to the type of material, equip-ment, or service being procured.
(2)
A review of previous records and performance of suppliers who have provided similar articles of the type being procured.
(3)
A survey of the supplier's f acilities and QA Program to determine his capability to supply a product which meets the design, manuf acturing,
and quality requirements.
3.
The results of supplier evaluations are documented and filed.
4.
Surveillance, if required, of suppliers during fabrica-tion, inspection, testing, and shipment or materials, equipment and components is planned and performed in accordance with written procedures to assure conformance to the purchase order requirements.
5.
The supplier furnishes the following records as a minimum to the purchaser:
(1)
Documentation that identifies the purchased material or equipment anu the specific procurement require-ments (e.g., codes, standards, and specifications) met by the items.
(2)
Documentation that identifies any procurement re-quirements which have not been met together with a description of those nonconformances dispositioned
" accept as is" or " repair".
6.
Receiving inspection of the supplier-furnished material, equipment, and services is performed to assure:
(1)
The material, component, 7r equipment is properly identified and corresponds with the identification on receiving documentation.
( 2)
Material, components, equipmen't, and acceptance records are inspected and judged -acceptable in accordance with predetermined inspection -instruc-tions, prior to installation or use.
(3)
Inspection records or certificates of conformance attesting to the acceptance of materials and com-ponents are available prior to installation or use.
4
n QA PROGRAM Page 7 l
(4)
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 wor)-
VIII.
Identification and Control of Materials, Parts, and Components 1.
Procedures are established to identify and control mate-rials, parts, and components including partially fabricated subassemblies.
2.
The identification and control procedures assure daat identification is maintained either on the item or on records traceable to the item to preclude use of in-correct or defective items.
3.
Identification of materials and parts important to the function of safety-related systems and components can be traced to the appropriate documentation such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports.
4.
The location and the method of identification do not affect the fit, function, or quality of the item being identified.
5.
Correct identification of materials, parts, and components is verified and documented prior to release for f abrica-tion, assembling and installation.
IX.
Control of Special Processes 1.
Special processes such as welding, heat treating, non-destructive testing, and cleaning are procedurally con-trolled.
2.
Procedures, equipment, and personnel connected with special processes are qualified in accordance with applicable codes, standards, and specifications.
3.
Qualification records of procedures, equipment, and personnel associated with special processes are es tablished, filed, and kept current.
o Y
QA PROGRAM Page 8 X.
Inspection 1.
An inspection program which verifies conformance of quality-affecting activities with requirements is established, documented, and accomplished in accordance with written and controlled procedures.
2.
Inspection personnel are independent from the individuals performing the activity being inspected.
3.
Inspectors are qualified in accordance with applicable codes, standards, and. company training programs ; and their quclifications and certifications are kept current.
4.
Modifications, repairs, and replacements are inspected in accordance with the original design and inspection require-ments or acceptable alternatives.
5.
Provisions are established that identify mandatory inspec-tion hold points for witness by an inspector.
XI.
Test Control 1.
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.
2.
Modifications, repairs, and replacments are tested in accordance with the original design and testing require-ments or acceptable alternatives.
3.
Test results are documented, evaluated, and their acceptability determined by a qualified, responsible individual or group.
XII.
Control of Measuring and Test Equipment 1.
Measuring and test instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.
2.
Measuring and test equipment is identified and trace-able to the calibration test data.
15374 s
QA PROGRAM Page 9 3.
Measures are taken and documented to determine the validity of previous inspections performed when measuring and test equipment is found to be out of calibration.
4.
Reference and transfer standards are traceable to nationally recognized standards; or, where national standards do not exist, provisions are established to document the basis for calibration.
XIII.
Handling, Storage, and Shipping 1.
Special handling, preservation, storage, cleaning, packaging, and shipping requirements are established and accomplished by qualified individuals in accord-ance with predetermined work and inspection instruc-tions.
2.
All conditions (operations, tes ts, inspections, specifications, etc.) of the NRC package approval and the U. S. Department of Tr'ansportation shipping requirenmnts are satisfied prior to shipment.
3.
All necessary shipping papers will be prepared, as required.
4.
Departure, arrival tine and destination of a ' package will be established and monitored to a degree con-sistent with the safe transportation of the package.
XIV.
Inspection, Test and Operating Status 1.
Identification of the inspection, tes t, and operating status of packages and components is known by affected organizations.
2.
The application and removal of inspection and welding stamps and status indicators such as tags, markings,.
labels, and stamps are procedurally controlled.
3.
Bypassing of required inspections, tests, and other critical operations is procedurally, controlled.
4.
The status of nonconforming, inoperative or malfunction-ing packages or components is identified to prevent inadvertent use.
1537G
k QA PROGRAM Page 10 XV.
Nonconforming Material, Parts, or Components 1.
The identification, documentation, segregation, review disposition, and notification to affected organizations of nonconforming materials, parts, components, or ser-vices are procedurally controlled.
2.
Documentation identifies the nonconforming item; describes the nonconformance, the disposition of the nonconformance, and the inspection requirements; and includes signature approval of the disposition.
3.
Nonconforming items are segregated from acceptable items
.and identified as discrepant until properly dispositioned.
4.
Acceptability of rework or repair of materials, parts, components and systems is verified by reinspecting and retesting the item as originally inspected and tested or by a method which is at least equal to the original inspection and testing method.
XVI.
Corrective Action 1.
Evaluation of conditions adverse to quality (such as nonconformances, failures, malfunctions, deficiencies, deviations, and defective material and equipment) is conducted to determine the need for corrective action in accordance with established procedures.
2.
Corrective action is initiated following the determina-tion of a condition adverse to quality to preclude recurrence.
3.
Follow-up reviews are conducted to verify proper implementation of corrective actions and to close out the corrective action documentation.
XVII.
Qfality Assurance Records 1.
Sufficient records are maintained to provide documen,tary evidence of the quality and safety of items and the activities affecting quality and safety.
2.
QA records include operating logs; results of reviews, inspections, tests, audits, and material analyses; qualification of personnel, procedures, and equipment; l
and other documentation such as drawings, specifications, j
procurement documents, calibration procedures and re-ports; nonconformance reports; and corrective action reports.
QA PROGRAM Page 11 3.
Records are identifiable and retrievable.
4.
A lict of the required records and their storage locations will be maintained.
5.
Design related records (e.g., drawings, calculations,
etc.) are maintained for the life of the shipping package and all other records are maintained for a minimum of two years.
6.
Inspection and test records contain the following where applicable:
(1)
A description of the type of observation.
(2)
Evidence of completing and verifying a manuf acturing, inspection, or test operation.
(3)
The date and results of the inspection or test.
l (4)
Information related to conditions adverse to j
quality.
(5)
Inspector or data recorder identification.
(6)
Evidence as to the acceptability of the results.
t XVIII.
Audits i
1.
Audits are performed in accordance with preestablished written procedures or check lists and conducted by per-sonnel not having direct responsibilities in the areas being audited.
2.
Audit results are documented and then reviewed with management having responsibility in the area audited.
3.
Responsible management takes the necessary action to correct the deficiencies revealed by the audit.
4.
Deficient areas are reaudited on a timely basis to verify implementation of corrective actions which minimize recurrence of deficiencies.
5.
Audits of the QA program are per. formed at least annually based on safety significance of the activity being audited.
~
FIGURE 1 C
ISOMEDIX ORGANIZATION Isomed'ix,'Inc.
Rad ~iation President Safety Officer l
l l
General Manager, Parsippany QA Manager OA Operations Operations Purchasing Shipping Gammator Section l
ISOMEDIX INC.
CORMOMTE OFFCES
- 80 SOUTH JEFFERSON ROAD, WHIPPANY, NEW JER$EY 07901 e (201! 087 4700
FIGURE 2 RESPONSIBILITY MATRIX General QA QA FUNCTION President Manager Manager QA Program A,
C, D
C A, B Training C
A, D,
E Certification A
A
,=
Testing A
A, D,
E Document Change A
A A,
D, E
Shipping A, D, E A
Specifications A,
D, E
Audit A
A A,
D, E
A - Approve B - Accept C - Concur D - Initiate E - Perform e r:: 9 ?.*.
IBOMEDIX INC.
.Lv C0iPOAATE OfflCES = 80 SOUTH JEFFERSON ROAD, WHIPPANY. NEW JERSEY 0790I (201) 8874700