ML19241A952
| ML19241A952 | |
| Person / Time | |
|---|---|
| Site: | 07100264 |
| Issue date: | 06/05/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Santoro M AUTOMATION INDUSTRIES, INC. |
| References | |
| NUDOCS 7907110464 | |
| Download: ML19241A952 (12) | |
Text
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UNITED STATES
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NUCl E AR HEGULATORY COMMISSION weau nu c. u. c. :rm c.
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o AN 0 5 G79 FLTR:FHO 71-0201 ato:aticn Industries, Inc.
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Mr. Micnael P. Santoro P.O. Cox 215 Uncenixville, P.;
lECO Sentle :en; fnio refers to j ur applica tion datN & J2r 27, l973 re:]Uc.;tinj oppro'.al Of
. cur Qu.11i ty ns urance (f;A) pro 9 'm as, 2eting the (hi progr; i rer;uiri ocnts of lb CFR 971.51.
c.aitional inf o: a tion is re ;ui red to sati sfy the requirc.nents of Ap;'endi.x C t o l u CFR Pct et 71.
10 assist you in preparinj th i s i nf onna tion, ',;e have en-closed the acceptance cri dia the e taff uses to evaluate a licensee's QA 2ro !rc fc ' transportation packages for nonial/special fona radioactive
- aterial.
Plene rm/iu your OA prcyrs description to aadress the enclosed cn ter b and su n c
<un cooies of the reviscd pregrr witnin 30 days ollc... ira r:
rieu of this letter, qutions rejardinj this rcquest, please contact Jack Spraul t; you havn ani f %,l ) 9 'f l ~ / l ~ r 4.
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\\ 3a Sincerely, n.
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Charics L. FacDonald, Chief T ra ns po r'.a t i e n B ran c h Divisico of ruel Cycl:' and M 4 cr ia l Sa fe ty, :, CS
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10 CFR 71 - APPEND _I_X _E i
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ACCEPTANCE CRITLRIA - TRANSPORTATION DACKAGES I
I FOR NORMAL /SPECIAL F0PM RADIOACTIVE MATERIAL I
j I.
O rg(n_i za t i o n 1.
Previde a statemant that the responsibility for the QA program is retained and exercised by the applicant.
1 1
a 2.
Identify and describe the QA/QC functions performed by the applicant's QA organization or dele'gited to other crganizations providing controls 1
to assure appropriate ele ents of Appendix E will be implemented.
3.
Provide a current organizational chart that identifies the organizational elements which function under the control of the QA program.
4.
Identify and describe the responsibilities of each job function shovn 3
on the organization chart.
j 5.
Describe the duties and qualifications of the individual who retains 3
overall authority and responsibiiity for the QA prcgram.
a 0
6.
Provide a sta tement that designated QA individuals have the resconsibility j
and authority, delineated in writing, to stcp unsatisfactory.crk 2nd control furtner processing, delivery, or installation of nonconforming A
material.
h II.
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1.
Provide a statement that manage ent (i.e., above or outside the QA organiza tion) re7:13rly asseses the scope, status, uplementa tion, y
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and effectiveness of the CA program to assure that the progran is i
adequa te and complies.vith 10 CFR Part 71, Appendix E criteria.
3 2.
Provide a stateTent that provisions are establi_:md to control the
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dis tributicri of the CA anuals and revisions thereto.
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. 3.
Provide a statement that provisions are established for connunicating to all responsible organizations and individuals that quality policies, QA manuals, and procedures are mandatory requirements which must be implerented and enforced.
4.
Identify the safety-related systems, st actures and components controlled by the QA progran.
5.
Provide a statement that provisions are established for the resolution of disputes involving quality, arising from a difference of opinior, between QA/QC personnel and other department (engineering, procurement, manufac tu ring, etc., < >rsonnel,
6.
Provide a sta tement tnit an indoctrination and training progran is establishcd such that-(1)
Personnel responsible for performing quality-related activities are instructed as to the purpose, scope, and implementa tion of the CA manuals, instructions, and orocedures.
'2)
Personnel performing quality-affecting activities are trained and qualified in the principles and tecnniques of the activity being perforTed.
(3)
The scope, the objective, and the metnod of implementing the indoctrination and training progran are documented.
(4)
Proficiency of personnel performing quality-a f fecting activities is maintained by retraining, reexamining, and/or recertifying.
7.
Provide a statement tnat quality-related activities are p ffor ed with 3pecified equiprent under suitable environmental conditions, and prerequisites nave been satisfied prior to inspection and test.
III.
Design Control 1,
Provi fe a r tatement tna t neasures are es tablished to carry out design activities in a planned, controlled, and orderly ranner.
2.
Provide a state ent that measures are established to correctl/ transla te tne applicable regulatory requirements and design tases into specifica-t ia ns, d ra.vi m;s, n ri tten procedu res, and i ns truc t io ns.
3.
Provije a st3trent that quality standards are specified in the desicn docu "ents, a nd devia tions 3 nd sr.anges frcm thcse quality standards are controlled.
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F 4.
Provide a staterrnt that designs are reviewed to acsure th3t (1) 5 design characteristics can be controlled, inspected and tested and (2) inspection and test criteria are identified.
5.
Peavide a state ent that proper selection and accomplishment of design verification or checking process 9s sucn as by desian reviews,
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alternate calculations, or qualification testing are perfonaed.
When a test progran is used to verify the adequacy of a desigr, a
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qualification test of a prototype unit under design conditions g,
should be used.
Ej 6.
Provide a Statement that individuals or groups responsible for design 2
verification are other than the original designer and the designer's irredia te supervisor.
7, Provide a staterent that design and specifica tion changes are subject t0 the same design controls and approvals that were applicable to the original design unless the licensee designates another qualified responsible organiza tion.
3.
Provide a statement that the positions or groups #esponsible for design reviews and other design ;erification activities and their authority and responsibility are identified and controlled by written procedures.
i IV.
Procurement Docu ent Control i
E 1,
Provide a statement that procedures are established that clearly delineate the sequence of actions to be accomplished in the prepara-tion, review, approval, and control of procurement documents.
2.
Provide a stateTent th3t procurerent documents identify the applicable h
q 10 CFR ":ct 71, Appendix E requi ments whicn must be conplied with J
and oescribed in the supplier's r program.
3.
Provide a statement that procurement dccurents contain or ceference
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the design basis technical requirements including the aDplicable g
regulatory requirements, material ano conponent identifica tion requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and sDecial process instructions.
-F 4.
Provide a stat +: ent th3t procurement docu~ents identify the dncumen-
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tation (e.g., drawings, speci fica tions, procedures, inspection and ir f abrication plans, inscection and test record:, personnel and t
procedures cuali fica tions, and chonical and pnysical test results of naterial; to be prepared, mainta ined, and subnitted to the purchaser for revies and approval, 1
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Provide a statement that procurement documents identify those records to be retained, controlled, and maintained by the sepplier, and those delivered to the purchaser prior to use or installation of the hardware.
6.
Provide a statement that procurement documents contain the procuring agency's right of access to supplier's facilities and records for source inspection and audit.
7.
Provide a statement tha t changes and revisions to procurement documents are suoject to at least the same review and approval as the original document.
V.
Instructions, Procedures, and Drawings 1.
Provide a statement that activities affecting quality are prescribed and accomplished in accordance with documented instructions, procedures, or drawings.
2.
Provide a statement that 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.
Provide a s tatement tha t the QA organization reviews and concurs with inspection plans; test, calibration, anc' special process procedures; drawings and specifications; and changes thereto or acceptable alternatives are described.
VI.
Document Control 1.
Provide a statemeat that the review, approval, and issue of documents and changes thereto, prior to release, are procedurally controlled to assure they are adequate and the quality requirements are stated.
2.
Provide a statement that changes to documents are reviewed and approved by the same organizations that performed the original review and approval or by other cualified responsible organizations delegated by the applicant.
3.
Provide a statement that approved changes are included in instructions, procedures drawings, and other documents prior to implementation of the change.
4.
Provide a statement that documents are available at the location where the activity will be perforced prior to com mencing the work.
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Provide a statement that a master list, o equivalent, is established to identify the current revision.: umber of instructions, procedures, specifications, drawings, and procurement documents.
VII.
Control of Purchased Materials, Parti and Components 1,
Provide a statement that qualified persannel evaluate the supplier's capability to provide acceptable quality services and products.
2.
Provide a statement that the evaluation of suppliers is based on one or more of the following:
(1)
The supplier's capability to comply with the elements of Appencix E to 10 CFR Part 71 that are applicable to the type of material, equipment, or service being procured.
(2) A review of previous records and performance of suppliers who have provided similar articles of the type being orocured.
(3) A survey of the supplier's facilities and QA program to determine his capability to supply a product which meets the design, manufacturing, and quality requirements.
3.
Provide a statement that the results of supplier evaluations are documented and filed.
4 Provide a statement that surveillance, if required, of suppliers 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 orjer requireuents.
5.
Provide a s tatement that the supplier f t:rnishes the following records as a minimum to the purchaser:
(l' Docu entation that identifies the purchased material or equipment and the specific procurement requirements (e.g, codes, standards, and specifications) met by the itens.
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Documentation that identifies any procurenent requirements wnich have not been ret together with a description of those nonconformances dispositioned " accept as is" or " repair."
6.
prnvide a statement that recei ving inspection of the suppl er-furnished aterial, equip" ant, and services is performed to assure:
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(1) The material, component, or equipment is properly identified and corresponds with the identification on receiving documentation.
(2) Material, components, equipments, and acceptance records are inspected and judged acceptable in ac;ordance with predetermined inspection instructions, pr 10, to installation or use.
(3)
Inspection records or certificates of conformance attesting to the accep'ance of material and components are available prior to installation or use.
(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 work.
VIII.
Identification and Control of Materials, Parts, and Components 1.
Provide a st en !nt that procedures are established to identify and con *rol materials, parts, and components including partially fabricated subassemblies.
2.
Provide a statemc,t that the identification and control procedures assure that identification is maintained either on the item or on records tr ?ceable to the item to preclude use of incorrect or defective items.
3.
Provide a statement that 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.
Provide a statement that the location and the method of identification do not affect the fit, function, or quality of the item being identified.
5.
Provide a s ta tement tha t correct identifica tion of materials, parts, and components is verified and documented prior to release for f abrica tion, asse-bling and installa tion.
IX.
rontrol of Special Processes 1.
Provide a statement that special processes such as welding, heat treating, nondestructive testing, and cleaning are procedurally controlled.
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2.
Provide a statement that procedures, equipment, and personnel connected with special processes are qt.alified in accordance with applicable codes, standards, and specifications.
3.
Provide a statement that qualification records of procedures, equipment, and personnel associatea with special processes tre established, filed, and kept current.
X, inspection 1.
Provide a statement t1at an inspection program which ver ifies conformance of quality-affecting activities with requirements is established, documented, and accomplished in accordance with written and controlled procedures.
2.
Provide a statement that inspection personnel are independent from the individuals performing the activity being inspected.
3.
Provide a statement that inspectors are qualified in accordance with applicable codes, standards, and company training programs; and their qualifications and certifications are kept current.
4 Provide a statement that modifications, repairs, and replacements are inspected in accordance with the original design and inspection requirements or accepcable alternatives.
5.
Provide a statement that provisions are established that identify randatory inspection hold points for witness by Tn inspector.
XI.
Test Control 1.
Provide a state ent that 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.
Provide a statement that modifications, repairs, and replacements are tested i accordance w h the original design and testing reauirements or ecceptable alternatives.
3.
Provice a statement that test results are documented, evaluated, and
- heir acceptability determined by a qualified, responsible individual or grouo.
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Control of Measuring and Test Equioment 1,
Provide a statement that measuring and test instrut,.ents are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.
2.
Provide a statement that measuring and test equipment is identified and traceaole to the calibration test data.
3.
Provide a statement that measures are taken and documented to determine the validity of previous inspections performed when Teasuring and test aquipment is found to be out of calibration.
4.
Provide a statement that refereace and transfer standards are traceable to nationally recognizcc standards; or, where national standards do not exist, orovisions established to document m
the basis for calibration.
XIII.
Handlinn, Storace, and Shippinc 1.
Provide a statement that special handling, preservation, storage, cleaning, packaging, und snipping requiremerts are established and accomolished by qualified individuals in accordance with predetermined work and inspection instructions.
2.
Pr ovide a statement that all conditions (n;erations, tests, inspections, specifications etc.) of the NRC package approval and the U.S.
Department of Transportation shipping r ^' 'e ents are satisfied prior to shipment.
3.
Provide a state ent that all nemessary s:
' papers will be prepared, as required 4.
Provide a statement that departure, arr ; val time and destination of a package wil'l be established and monitored to a degree consistent i th the safe transportation of the package.
w XIV.
Inspection, Test and Operating Status 1.
Provide a statement that identification of the inspection, test, and ocerating status of packages and comDonents is known by affected organizations.
2.
Provide a stateTent tnat the application and removal of inspection and welding stamps and status indicators such as tags, markings, labels, and st3 cs are procedurally controlled.
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Provide a statemnnt that bypassing of required inspections, tests, and other critical operations is procedurally. controlled.
4.
Provide a statement that the status of nonconforning, inoperative, or malfunctioning packages or components is identified t
~ event inadvertent use.
XV.
Nonconforming Material, Parts, or Components 1,
Provide a statement that the identification, documentation, segregation, review disposition, and notification to affected crganizations of ncnconfor-ing materials, parts, components, or services are procedurally controlled.
2.
Provide a statement that documentation identifies the nonconforming item; describes the nonconformance, the disposition of the nonconformance, and the inspection requirements; and includes signature approval of the dispos' tion.
3.
Provide a statement that nonconformira items are segregated from acceptable items and identified as discrepant until properly dispositioned.
4.
Prc /ide a statement that acceptability of rework cr repair of materials, parts, components and syst?m.s 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.
Provide a statement that 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.
Provide a statement that corrective action is initiated following the determination of a condition adverse to quality to precl Jde recurrence.
3.
Provide a statement that follow-up reviews are conducted to verify procer inpleTentation of corrective actions and to close out the corrective action documentation.
A'i ! I Quality Assur3nce Records 1.
Provide a statement tnat sufficient records are Taintained to provide cocucentary ev icence of tne quality and safety of items and the activities e;<:>
,c coo affecting quality and safety.
2.
Provide a statement that QA records include operating logs; resuits o# reviews, inspections, tests, audits, and material analyses; qualification of personnel, procedures, and equipment; and other docunentation such as drawings, specifications, procurement documents, calibration procedures and reports; nonconformance reports; and corrective action reports.
3.
Provide a statement that records are identifiable and retrievable.
4.
Provide a statement that a list of the required records and their storage locations will be maintained.
5.
Provide a statuaent that 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.
Provide a statement that inspection and test records contain the foll JWin9 Where applicable:
(1) A description of the type of observation.
(2)
Evidence of completing and verifying a manufacturing, inspection, or test oper' tion.
(3) The date and results of the inspection 0; test.
(4)
Information related to conditions adverse to quality.
(5)
Inspecto, or da ta recorder identification.
(6)
Evidence as to the acceptability of the results.
XVIII.
Audits 1.
Provide a statement that audits are performed in accordance witn preestablished written procedures or check lists and conducted by personnel not having direct responsibilities in the areas being audited.
2.
Provide a statement that audit resu!ts are documented and then reviewed with management havir g responsibility in the area audited.
3.
Provide a statement that responsible management takes the necessary action to Correct the deficiencies revealed by tne audit.
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Provide a statement that deficient areas are reaudited on a timely basis to verify implementation of corrective actions which minimize recurrence of deficiencies.
5.
Provide a statement that audits of the QA program are performed at least annually based on safety significance of the activity being audited.
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