ML19241A965
| ML19241A965 | |
| Person / Time | |
|---|---|
| Site: | 07100189 |
| Issue date: | 06/05/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Hathway C TODD SHIPYARDS |
| References | |
| NUDOCS 7907110476 | |
| Download: ML19241A965 (12) | |
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c UNITED STATES
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1 NUCLE AR REGULATORY COMMISSION
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y, W ASHINGTON. D C. 20L%
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y, c' 1373 F ET R: idio 71-01U Todj Rmearch & Technical Division AfD:
l!r, C. W. Ha t h.;ay P. O. Box 1600 u l ve s to n, D
/7553 C ntlt 2n:
T h i t, letter replacc: our letter of April 2/, 1979.
It refers to your application d i ts:d June 26, 1978 re<;u es t i n ! approval of your Ocality Assurance (QA) prcgran as
- eet i nc; t!.e Q A prog rar rec:ui re; ents of 10 CFR 571. 51.
o fJi tional inf or'uition ", requirtd to satisfy the re';uirement, of Appendix E to 10 LFR iarr
To assitt you in pre')a ci ng thi s inf en a tion, we have enclosed the accept ince cri teric t!.
- tafi usm > to evaluate a licensee's G ?ro'jren for transport ition packages for nor al/special fon radioacti ve ina te rial. Please revi;e ; Jur QA progr,.i descript.cn to sddress tne enclosed criteric and sub
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,evcn copies of the revised prom ^v within 30 days followirq receipt of this letter.
h ive any questions et jaroing this request, plense cont:ict Jack Spraul at 11 vou (10 l ) W2 7 711.
Sincerely, es 4 <q (s -ks.,.y s v r
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E e r;'harles E. "acDonald, Chief Transporta tion Branch Pivision of Fuel Cycle and I'a teri ai Sa fety, lJ'.SS
,nclosure:
mceptance Criteria
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10 CFR 71 - APPENDIX E
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ACCEPTANCE CRITERIA - TPANSPORIATION PACKAGES FOR NORYAL/SPECIAL FOR" RADICACTI"E "ATERIAL i
I.
Orc an i za t ion 1.
Provide a sta teTent that the responsibility fcr the QA program is 3
retained and exercised by tne applicant.
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2.
Identify and describe the CA/QC functions performed by the applicant's
[j QA organization or dele' gated to other organizations providing controls i
to assure appropriate elements of Appendix E will be implementtd.
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3.
Provide a current organizational chart that identifies the organizational l
elements which function under the control of the QA program.
f 4.
Identify and describe the responsibilities of each job function shown on the organization chart.
I S.
Describe the duties and cualifications of the individual who retains j
overall authority and resransibility for the QA prcgram.
3 6.
Provide a stattm a t that designated QA individuals have the responsibility a
j and authority, celineated in writing, to stcp unsatisfactory acrk ind control further processing, delivery, or installation of no'nconfccming 4
material.
4 II.
Quality Assurance Procram A
ij 1.
Provide a statement that mnagement (i.e., above or outside the QA
]
organization) regularly assesses tne scope, status, "plementation, 2
9 and effectiveness of the :A prm; ram to assure that the orocram is 4
adequa te and ccmiies witn 10 CFR Part 71, Appendix E c'riteria.
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2.
Previde a statrent that ;ravisions are established to control the J
dis tributico of the CA anuals and revisions thereto.
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Pro /ide a statement that provisions are established for c^rnunicating to all responsible organizations and individuals that qu-lity policies, QA manuals, and procedures are mandatory requirt tents which riust be imolemented and enforced.
4.
Identify the safety-related systens, structures and components controlled by tne CA progra-5.
Provide d statement that provisions are established for the resolution of disputes involving quality, arising fron 3 difference of opinion between QA/QC personnel and other departnent (engineering, p. ocurement, anufacturing, etc. ) personnel, 6.
Provide a statement that an indoctrination and training progran is established such that:
(1)
Personnel responsible for cerforming quality-related activities are instructed as to the purpose, scope, and implementation of the QA manuals, instructions, and arocedures.
(2)
Personnel performing quality-affecting activities are trained and qualified in the principles anc techniques of the activity beinj performed.
(3)
The scope, tre objective, and the nethod of implementing the indoctrination and training program are documented.
(4)
Proficiency of personnel performing quality-affecting activities is aintained by retraining, reexamining, and/or recertifying.
7.
Provide a statecent that quality-related activities are performed with spec i fied equi pmen t under sui tabl e environmental condi tions, and prer equisites nave been satisfled prior to inspec+ ion and test.
III.
Design t
' 01 1.
Provide a statement tnat measures are established to carry out design activities in a planned, controlled, and orderly manner.
2.
Provide a state ent that ~easures are established to correctly tra ns l a te tne applicable regu'3 ccy recuire ents and desian bases into specifica-t1cns, drawin7s,.sr tten oracedures, and instructiuns.
1 Provide a 3: ate ent that quality standards are recified in the cesign documents, and devia tions and cnan]es frOm these quality st3ndards are controlled.
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L 4.
Provide a statement that designs are reviewed to assure that (1) design characteristics can be controlled, inspected and tested and (2) inspection and test criteria are identified.
5.
Provide a state'"ent that proper selection and accomplishment of design verification or checking processes such as by design reviews, alterr. ate calculations, or qualification testing are performed.
When a test program is used to verify the adequacy of a design, :.
qualification test of a prototype unit under design conditions should be used.
6.
Pro /ide a s:atement that individuals or groups respons1 ole for design verificatior are other than the origina' designer and the desic,ner's immediate sapervisor.
7.
Provide a statement that design and specification changes are subject to the same design controls and approvals that were applicable to the original design unless the licensee designates another qualified responsib!e organization.
8.
Provide a statement that the positions or groups responsible for design reviews and other design verification activities and their authority and responsibility are identi fied and Controlled by written procedures.
IV.
Procurecen t Document Control 1,
Provide a statement that procedures are established that c'early delineate the sequence of actions to be accomplished in the prepara-tion, review, approval, and control of procurement documents.
2.
Provide a s ta tement that procurement documer*
fentify the applicable 10 CFR Part 71, Appendix E requirements which
..f be complied with and described in the smpplier's QA program.
3.
Provide a statement that procurement documents contain or reference the design basis technical requirements includiag the applicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
4.
Provide 3 s t3tement that procurement documents identify the documen-ta tion (e.g., drawings, specifica tions, procedures, inspection and f abrication plans, inspection and test records, personnel and procedares ;ualific ations, and chemical and physical test results of material) ta be prepared, aintained, and submitted to the purchaser for revien and approval.
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Provide a state".ent that procuremeat documents identify those records to be retained, controlled, and maintained by the supplier, and those delivered to the purchaser prior to use or installation of the h a r de.a r e.
6.
Provide a statement that procurement acuments contain the procuring agency's right of access to supplier' facilities and records for source inspection and audit.
7.
Provide a state ent that changes and rev..ons to procurement documents are subject to at least the same review 6..d approval as the original docuoent.
V.
Ins tructions, Procedures, and Dr awing 1.
Provide a statec ent that activities af fecting quality are prescribed and accomplished in accordance with documented instructions, procedures, or drawings.
2.
Provide a statement that provisions are established which cicarly delineate the sequence of actions to be accomplished in the prepara-tion, review, approval, and control of instructions, procedures, and drawings.
3.
Provide a staterer.t that the QA organization reviews and concurs with inspection plans; tes '., calibration, and special process procedures; drawings and specifications; and changes thereto or acceptable alternatives are described.
VI.
Docu'mnt Control 1.
Provide a statement that the review, approval, and issue of documents and changes thereto, prior to release, are procedurally controlled to assure they are adequa te and the quality requirements are stated.
2.
Provide a statement that changes ta documents are reviewed and approved by the same organizations that performed the original review and approval or by other qualified re ponsible 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 staten ent that documents are available at the location where the activity will be pcrforced prior to co encing the work g
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5.
Provide a statement t. hat a maste-list, or equivalent, is established to identiff the current revision number of instruc+ ions, procedures, specifications, drawings, and procurement documents.
1, VII.
C_o_ntrol of Purchased Ma teri al s, Parts and Componen_t_s 1
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1.
Provide a statement that qualified personnel evaluate the supplier's
-j ctpability to provide acceptable quality services and products.
2.
Provide a statement that the evaluation of suppliers is based on j
one or nore of tne following:
(1)
The supplier's c3pabilit, to comply with the elements of
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i Appendix E to 10 CFR Part 71 that are applicable to the type of material, equipment, or service being procureu.
8 (2) A review of previous resords and performance of suppliers j
who have provided similar articles of the type being crocured.
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(3) A sur"ey of the suppliar's facilities and CA program to p,
determine his capability is supply a product which meets the design, manufacturin, and quality requirements, 3.
Provide a statement that the results of supplier evaluations are e
documented nd filed.
4.
Provide a sta tement that sur illance, if required, c' suppliers during fabrication, inscection, testing, anu ohipmcnt af materials, equipment j
and components is planned and perforned in accordance with written f
procedures to assure conformance to the ourchase order requirements.
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5.
Provide a statement that the supp'.ier furnishes the following records as a minimum to the purchaser:
3 (l)
Dncu'rentation that identifies the purchased material or equipment ard the specific procurement requirements le.g., codes, standards, and specifications) met by the items.
y (2)
Documentation tnat identifies any procurement require ents G4 D}
nhich have not been met together with a description o-those nonconformances dispositioned " accept as is" or " repair."
6.
Wrovide a s ta tement tna t receiving inspection cf the supplier-fur 7ished "a teri a l, equi;1 ent, and services is perforred to assure:
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(1) The material, component, or equipment is properly identified and corresponds with the identification on receiving focumentation.
(2) Ma.arial, components, equipments, and acceptance records are inspected and judged acceptable in accordance with predetermined inspection instructions, prior to installation or use.
(3)
Inspection records or certificates of conformance attesting to the ecceptance 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 arer or releasing them for further work.
VIII.
Identification and Control of Materials, Parts, and Components 1.
Provic. a sta tement that procedures are established to identify and control materials, parts, and components including partially fabricated subassemblies.
- 2..
Provide a statement that the idencification and control procedures assure that identification is maintained either on the item or on records traceable to the item to preclude use of incorrect or defective items.
3.
Provide c 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 iten being identified.
5.
Frevide a sta tement tha t correct identifica tion of m6 terials, parts,
and components is verified and documented prior to release for f abrica tion, a ssembling and installation.
IX.
Control of Scec_ial Processes 1.
Provide a statement that special processes such as welding, heat treating, nondestructive testing, and cleaning are procedurally controlled.
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Provide a s ta temen t that procedures, equipment, and personnel connected with special processes are qualified in accordance aith applicable codes, standards, and specifications.
3.
Provide a statement that qualification records of procedures, equipment, and personnel associated with special processes are established, filed, and kept current.
X.
Inspection 1.
Provide a statement that an inspection program which verifies confonnance of quality-af fecting 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 perfarning the activity being inspected.
3.
Provide a statement that inspectors are qualified in ac ordance with applicable codes, standards, and compariy 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 acceptable alternatives.
5.
Provide a statement that provisions are established that identify nandatory inspection hold points for witness by an inspector.
XI.
Ig_st Control 1.
Provide a sta te"'ent that a test program to denonstrate that the item or component will perform satisfactorily in service is established, documented, and accorplished in accordance with written controlled procedures.
2.
Provide a statement that mocifications, repairs, and replacements are tested in accordance with the original design and testing requirements or acceptable alternatives.
3.
Prov ide a s ta tement t na t test resuits are documented,
- aluated, and tneir acceptability determined by a qualified, responsible inJ1 sidual er group.
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. XII.
Control of Measuring and Test Equipment 1,
Provide a statement that 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.
Provide a statemlnt that measuring and test equipment s identified and tr3Ceable to the calibration test data.
3.
Provide o statement that measures are taken and documented to determine '.he validity of previous inspections performed when measuring ano test equipment is found to be out of calibration.
4.
Provide a sta tenent that refere.1ce and transfer standards are traceable to nationally reccgnized standards; ir, where national standards do no* exist, provisions are established to document the casis for calibration.
XIII.
Handling Storage, and Shipoing 1.
Provide a statement that special handling, preservation, storage, cle3ning, packaging, and shipping requirements are established and accomplished by qualified individuals in accordance with neecatencined work and incpection instructions.
2.
Provica a statement that all conditions (operations, tests, inspections, specifications, etc.) of the NRC package approval and the U.S.
Department of Transportation shipping requirements are satisfied prior to shipment.
3.
Provide a statement that all necessary shipping papers will be prepared, as required.
4.
Provide a statement that departure, arrival time and destination of a package will be established and monitored to a degree consistent with tre safe transportation of the package.
XIt.
.I n_s pec t i o n, Test and Operating Status 1
Provide a statement that identification of the insoection, test, and operating status of packages and components is known by af fected organizations.
2.
r'rovide a s ta tement tha t the application and removal of inspection and welding stamps and status 1olcators such as tags, markings, late i s, and sta Ts are procedurally controlled.
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3.
Provide a statement that bypa2 sing of required inspections, tests, and other critical operations is procedurally. controlled.
4.
Provide a statement that the status of nonconforming, inoperative, or malfunctioning packages or components is identified to prevent inadvertent use.
fl.
Donconfrraing Mate _ rial, Parts, or Components 1.
Provide a statement that the identification, documentation, segregation, review disposition, and notification to affected organizations of nonconforming na teria's, parts, components, or services are procedural'y controlled.
2.
Provide a statement that documentation identifies the nonconforming item; describes the r uaconfernance, the disposition of the nonconformance, and the inspection requirements; and includes signature approval of the disposition.
3.
Provide a statement that nonconforming items are segregated from acceptable items and identified as discrepant until properly dispositioned.
4 Provide a statement that 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 wnich is at least equal to the original inspection and testing method.
C.' I.
Corrective Action 1.
Drovide 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.
Pro vide a stater'r t tha t corrective action is initiated following the determination of a condition adverse to quality to preclude recurrence.
3.
Prov ide a sta teTent that follow-up reviews are conducted to verify acoper implementation of corrective actions 3nd to close out the corrective action documentation.
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palitt Assur1ncejecords 1.
Provide a state ent tnat sufficient records are maintained to provide Jcco'entarj evidence of tne quality and safety of itens and the activities hYi affectirg quality and safety.
2.
Provide a statemen'. that QA records include operating logs; results of reviews, inspections, tests, audits, and material analyses; qualification of personnel, p.'ocedures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration procedures and report s; nonconformance reports; and corrective action reports.
3 Provide a statement that records are icentifiable and retrievable.
4 Drovide a statement that a list of tne required records and their storage locations will be maintained.
5.
Provide a statement that design related records (e.g., drawings, calculations, etc.) are maintairad for the life of the shipping package and all other records are maintained for a minimum of two yea rs.
6.
Provide a statement that inspection and test records cont 3in the following where applicable:
(1) A description of the type of observation.
(2)
Evidence of completing and verifying a manufacturing, inspection, or test operation.
(3)
The date 3rd results of the irspection or test.
(4)
Infon ation related to conditions adverse to quality.
(5)
Inspector or data recorder identification.
(6)
Evidence as to the acceptability of the results.
XVIII.
Audits 1.
Provide a statement that audits are performed in accordance with preestablished written procedures or check lists and conducted by personnel not h3ving direct responsibilities in the areas being audited.
2.
Provide a statement that audit results are documented and then reviewed with ranagement having rosponsibility in the area audited.
3.
Prov ide a sta tement that responsible management takes the necessary action to correct t,ie deficiencies revealed by the audit.
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. 4.
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 perfcmed at least annually based on safety significance o' the activity being a ud i ted.
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