ML19291A810
| ML19291A810 | |
| Person / Time | |
|---|---|
| Site: | 07100109 |
| Issue date: | 04/20/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Perhauch J UNION CARBIDE CORP. |
| References | |
| NUDOCS 7905241000 | |
| Download: ML19291A810 (12) | |
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'4 UNITED STATES r
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,, t NUCLEAR REGULATORY COMMISSION j.h/J ) h WASHINGTON, D. C. 20555
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ApR o n 370 FCTR: RHO 71-0109 Union Carbide Corporation Corporate Research Laboratory ATTri:
Mr. Joseph C. Perhauch P.O. Box 324 Tuxedo, fly 10987 Gentlemen:
This refers to your application dated June 29, 1973 requesting approval of your Quality Assurance (QA) program as meeting the QA program require-ments of 10 CFR 971.51.
Additional information is required to satisfy the requirerents of Appendix E to 10 CFR Part 71.
To assist you in preparing this infomation, we have enclosed the acceptance criteria the staff uses to evaluate a licensee's QA program for transportation packages for normal form radioactive material.
Please revise your quality assurance program to address the asterisked items of the enclosed criteria.
In addition, identify the location of the fluclear Safeguards Committee and clarify the meaning of the dotted lines in Figure 1.
In Figure 2, clarify the apparent discrepancy between the titles in the first three columns.
Please submit seven copies of the revised program within 30 days following receipt of this letter.
Althougn supporting drawings, such as those enclosed with your application, are required to implement your QA program, they should not be submitted as part of your QA program description.
If you have any questions regarding this request, please feel free to contact Mr. Jim Conway at (301) 492-7741.
Sincerely, h
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wh Ae Charles E. MacDonald, Chief Transportation Branch Division of Fuel Cycle and Material Safety, fiMSS
Enclosure:
Acceptance Criteria 19052 40 /CO O
i i
t l.0 CFR 71 - /dlflg(DIX E.
ACCEPTANCE CRITERIA FOR I;0RMAL FORM RADI0ACT-IRAt;S Organ iza t inn IVE MA TLRIAL I.
1 Pro v ide a retained and exercised bs ta tecent that the responsib 2
y the applicant.ility for the QA prog Ias-janization or delegated toify and describ QA ram is to assure appropria te functions performed b other Provide a elements 3
of Appendix E will be im lorganiz ele. ' ants which functioncurrent organizational ch con trols p emented.
M4.
control of the QAart that id under the Identify and describe th on the organization o
chart.e responsibilities program. rgan iza t iona l TS.
Desc Mbe the daties of each job function show overall authority and rand qualifica tions n
//-6.
Provide a s ta ten esponsibility for the QAof the individual who control further processiand authority, delinea ted program.
ns n
n s top unsa tisfactory work material.
uriting to ng, delivery,, or ins tall ility II.
Lfis urance_Prograg a tion of nonconforming {
Qualit and 1
Provide a
organiza tion) regularlys ta tement tha t management (
and effec tiveness i.e the QA program toassesses the scop., above or adeluate and complies of e, s tatus, outside the QA
.k2.
distrlhution ofs tatement tha t provis iwith 10 CFR
~
Provide a n
x E criteria.
s the QA manualsons are and revisions theretoestablished to control the
,.wa=
. 4' 3. Provide a statement that provisions are established for communicating to all responsible organizations and individuals that quality policies, QA manuals, and procedures are mandatory requi-rements which must be implemented and enforced.
4.
Identify the safety-related systems, structures and components controlled by the QA program.
pp 5.
Provide a statement that provisions are established for the resoiution of disputes involving quality, arising from a difference of opinion between QA/QC personnel and other department (engineering, procurement, manufacturing, etc.) personnel, 6.
Provide a statement that an indoctrination and training program is established such that:
(1) Personnel responsible for performing quality-related activities are instructed as to the purpose, scope, and implementation of the QA manuals, instructions, and procedures.
(2) Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being performed.
s (3) The scope, the objective, and the method of implementing the indoctrination and training program are documented.
(4) Proficiency of personnel performing quality-affecting activities is maintained by retraining, reexamining, and/or recerti fying.
7.
Provide a statement that 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.
Provide a statement that measures are established to carry out design activities in a planned, controlled, and orderly manner.
2.
Provide a statement that measures are established to correctly translate the applicable regulatory requirements and design bases into specifica-tions, drawings, written procedures, and instructions.
3.
Provide a statement that quality standards are specified in the design documents, and deviations and changes from these quality standards are controlled.
. %1.
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 statement that proper selection and accomplishment of design verification or checking processes such as by design reviews, alternate calculations, or qualification testing are performed.
When a test program is used to verify the adequacy of a design, a qualification test of a prototype unit under design condittons should be used.
46.
Provide a statement that individuals or groups responsible for design verification are other than the original designer and the designer's immediate supervisor.
47, 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 responsible organization.
%3.
Provide a statement that the positions or groups responsible for design reviews and other design verification activities and their authority and responsibility are identified and controlled by written procedures.
1 IV.
Procurement Document Control M.
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 statement that procurement documents identify the applicable 10 CFR Part 71, Appendix E requirements which must be complied with and described in the supplier's QA program-
- 3.
Provide a statement that procurement documents contain or reference the design basis technical requirements including the applicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
yd. Provide a statement that procurement documents identify the documen-tation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedures qualifications, and chemical and physical test results of material) to be prepared, maintained, and submitted to the purchaser for review and approval.
- $5.
Provide a si.at.
.nt ti.a t in ocur, at dicn uts iden ti fy t hose r ecords to be ret,iined, inntrolled, wi a intained by ' he supplier, and f i>ase delivered to the purchaser,,rior to use or installa tion of the hard;are.
g6.
Provide a statu ant thit procur, int doc" ents ccntain the procuring agency's right of accoss to supplier's facilities and records for source inspeClion and audit.
M7.
Pr ovide a statt+ ent tha t cFinges and revisicns to procurr: Tnt docu.ents are subject to at least the sa c.e re /;ew and vpr oval as d.e original duru ent.
V.
Ins truc t ions, Procedpres, and Prgin_gs_
l.
Provide a statremnt th3t activities ai fccting r;uality are prescrihcd and ao:caplis! ed in occordance ui th i _. noted instructic,n>, g ccc f urus, or drawingc.
d2.
Provide a sta te : ant that provisicos are establishod which clearly delineo te the sequence of actions to be accoaplishcd in t!.e prepara-
- t. ion, review, approval, and control of instructions, peccedures, and drawings.
3.
Provide a s ta te ment tha t t he d c: ;in f ation re'.>ie /s and concurs with
.aspection plans; test, calibraticn, i.nd special process procedures; drawings and spacifications; and chanjes thereto or acceptable alternatives are described.
VI.
Dacument Cnntrol 1.
Provide a statr, ^:nt that the revie',i, epproval, and issue of docu 2nts and changes thereto, prior to release, are procedurally controlled to assure they are adequato and the quality requircznts are stated.
2.
Provide a state.m :nt tha t i:h7nges to doc ants are revie ed and w ected by the sane organiza Lions that performed the original rcvic : and approval or by other qualified resransible organizations delujated by the applicant.
X3.
Provide a state:"ent thtt approved changs are included in instructions, procedures drawings, and other doc: :ents prior to implo utation of the change.
4.
Pr ovide a statcNnt that docrents are available at the location -here the activity will be parfor:ned prior to cc-ncing the '..ork.
. 365.
Provide a statement that a master list, or equivalent, is established to identify the current revision number of instructions, procedures, specifications, drawings, and procurement documents.
VII.
Control of Purchased Materials, Parts and Comconents 1.
Provide a statement that qualified personnel evaluate the supplier's capability to provide acceptable quality services and produ, cts.
9t2.
Provide a statement that the evaluation of suppliers is based on one or more of the follcwing:
(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, equipment, 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 facilities and QA program to determine his capability to supply a product which meets the design, manufacturing, and quality requirements.
3.
N ovide 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 snigment of materials, equipment and components is planned and performed in accordance with written procedures to assure conformance to the purchase order requirements.
S.
Provide a statement that the supplier furnishes the folicwing records as a minimum to the purchaser:
(1) Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, standards, and specifications) met by the items.
(2) Documentation that identifies any procurement requirements which have not been met together with a description of those nonconformances dispositioned " accept as is" or " repair "
6.
Provide a statement that receiving inspection of the supplier-furnished material, equipment, and services is performed to assure:
s (1) The material, ccmconent, or equipment is properly identified and corresponds with tne identification on receiving documentation.
(2) Material, conconents, equipments, and acceptance recnrds 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 acceptance of material and ccmponents 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 Conconents 1.
Provide a statement that procedures are established to identify and control materials, parts, and components including partially fabricated subassemblies.
2.
Provide a statement that the identification and control procedures 3 sure 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 a statement that identification of materials and parts important to the function of safety-related systems and components can be traced to the approoriate documentation such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports.
Si4 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 gg. Provide a statement that correct identification of materials, parts, and components is verified and documented prior to release for fabrication, assembling and installation.
IX.
Control of Special Processes 1.
Provide a statement that special processes such as welding, heat treating, nondestructive testing, and cleaning are procedurally controlled.
7_
2.
Provide a statement that procedures, equipment, and perscnnel connected with special processes are qualified in accordance with applicable codes, standards, and specifications.
.yf3. Provide a statement that qualification records of procedures, equipment, and personnel associated with special processes are established, filed, and kept current.
X.
Inscection 1.
Provide a statement that an inscection program which verifies 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.
Yt3.
Provide a statement that inscectors are qualified in accordance with applicable codes, standards, and ccmaany training programs; and their qualifications and certifications are kept current.
344 Provide a statement that modifications, repairs, and replacements are inspected in accordance with the original design and inspection A quirements or acceptable alternatives.
5.
Provide a statement that provisions are established that identify mandatory inspection hold points for witaess by an inspector.
XI.
Test Control 1.
Provide a statement that a test program to demonstrate that the item or component will perform satisfactorily in service is established, documented, and accomplished in acco dance with written controlled procedures.
$d2.
Provide a statement that mcdifications, repairs, and replacements are tested in accordance with the original design and testing requirements or acceptable alternatives.
3.
Provide a statement that test results are documented, evaluated, and their acceptability determined by a qualified, responsible individual or group.
. XII. Control of Measuring and Test Jcuitment 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.
462. Provide a statement that ceasuring and test equipment is identified and traceable to the calibration test data.
3t3. Provide a statement that 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.
944. Provide a statement that 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 Shioping 1.
Provide a statement that special handling, preservation, storage, cleaning, packaging, and shipping requirements are established T"d accomolished by qualified individuals in accordance with predetermined work and inspection instructions.
2.
Provide a statement that all conditions (operations, t< sts, 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 destinatio^ of a package will be establishea and nonitored to a degree consisrent with the safe transportation of the package.
XIV.
Insoection, Test and Operating Status 1.
Provide a statement that identification of the inspection, test, and operating status of packages and components is known by affected organizations.
2.
Provide a statement that the application and removal of inspection ar.d welding stamps and status indicators such as tags, markings, labels, and stamps are procedurally controlled.
3.
Provide a statement that bypassing 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.
XV.
Nonconforming Material, Parts, or Comconents 1.
Provide a statement that the identification, documentation, segregation, review disposition, and notification to affected organizations of nonconforming materials, parts, components, or services are procedurally controlled.
jf72 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 disposition.
3.
Provide a statement that nonconforming items are segregated from acceptable items and identified as discrepant until properly d is posi tioned.
4
.{rovide 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 a:1d 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 preclude recurrence.
3.
Provide a statement that follow-up reviews are conducted to verify proper inplementation of corrective actions and to close out the corrective action documentation.
XVII.
Quality issurance Records 1.
Provide a statement that sufficient records are maintained to provide documentary evidence of the quality and safety of items and the activities
. affecting quality and safety.
2.
Provide a statement that QA records include ocerating logs; results of reviews, inspections, tests, audits, and material analyses; qualification of personnel, procedures, and equipment; and other documentation 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.
345. Provide a statement 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.
94,6.
Provide a statement tnat inspection and test records contain the following where applicable:
(1) A description of the type of observation.
(2)
Evidence of completing and verifying a manufacturing, k
inspection, or test operation.
(3)
The date and results of the inspection or test.
(4)
Information related to conditions adverse to quality.
(S)
Inspector or data recorder identification.
(6)
Evidence as to the acceptability of the results.
XVIII. Audi ts 1.
Provide a statement that audits are performed in accordance with 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 results are documented and then reviewed with management having responsibility in the area audited.
3.
Provide a statement that responsiole management takes the necessary action to correct the deficiencies revealed by the audit.
6.
s 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 progran are performed at least annually based on safety significance of the activity being audited.
- kt