ML19282C801
| ML19282C801 | |
| Person / Time | |
|---|---|
| Site: | 07100088 |
| Issue date: | 04/11/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Mcclanahan H BABCOCK & WILCOX CO. |
| References | |
| NUDOCS 7905020407 | |
| Download: ML19282C801 (12) | |
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UNITED STATES 4g y-4 NUCLEAR REGULATORY COMMISSION ji1 j
WASHINGTON, D. C. 20555 8[
APR 111979
+....
FCTR:RH0 71-0088 Babcock & Wilcox Naval Nuclear Fuel Division ATTN: Mr. Henry H. McClanahan P. 0. Box 785 Lynchburg, VA 24505 Gentlemen:
This refers to your application dated June 26, 1978 requesting approval of your Quality Assurar.ce (QA) program as meeting the QA program requirements of 10 CFR 371.51.
Additional information is required to satisfy the requirements of Appendix E to 10 CFR Part 71.
To assist you in preparing this information, we have enclosed the acceptance criteria the staff uses to evaluate a licensee's QA program for transportation packages for normal form radicactive material.
Please revise your QA program description to address the enclosed criteria and submit seven copies of the revised program within 30 days following receipt of this letter.
If you he any questions regarding this request, please feel free to contact Mr. Jim Co..way at (301) 492-7741.
Sincerely, hCharles E. MacDonald, Chief J
Transportation Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Acceptance Criteria T
TMS DOCUMENT CONTAINffg 79 0502 o L/ o 7 W QUAUTY PAGES h
APR 111979 10 CFR 71 - APPENDIX E ACCEPTANCE CRITERIA - TRANSPORTATION PACKAGES FOR NORMAL FORM RADIOACTIVE MATERIAL I.
Orcaniza tion
[
1.
Provide a statement that the responsibility for the QA program is retained and exercised by the applicant.
2.
Identify and describe the QA/QC functions performed by the applicant's QA crganization or delegated to other organizations providing controls to assure appropriate elements of Appendix E will be implemented.
3.
Provide a current organizational chart that identifies the organizational elements which function under the control of the OA program.
4.
Identify and describe the responsibilities of each job function shcwn on the organization chart.
5.
Describe the duties and qualifications o. the individual who retains overall authority and respon.sibility for the QA program.
6.
Irovide a statement that designated QA individuals have the responsibilit:/
and authority, delineated in writing, to stop unsatisfactory work and control further processing, delivery, or installation of nonconforming ma terial.
II. Quality Assurance Procram 1.
Provide a statement that management (i.e., above cr outside the QA organization) regularly assesses the scope, status, implementation, and effectiveness of the QA program to assure that the program is adequate and complies with 10 CFR Part 71, Appendix E criteria.
2.
Provide a statement that provisions are established to control the distribution of the QA manuais and revisions thereto.
. 3.
Provide a statement that provisions are established for cctmunicating to all responsible organizations and individuals tnat quality policies, QA manuals, and procedurec are mandatory requirements which must be implemented and enforced.
4.
Identify the safety-related systems, structures and components controlled by the QA program.
5.
Provide a statement that provisions are establinned for the resolution 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 cnd 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.
(3) The scope, the objective, and the method of implementing the indoct ination and training program are documented.
(4) Proficiency of personnel performing quality-affecting activities is maintained by retraining, reexamining, and/or recerti fyilg.
7.
Provide a statement : hat quality-related activities are performed with specified equipment under suitable environmental conditions, and prerequisites have buen satisfied prior to inspection and test.
III. Desien 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 acplicable regulatory requirements and design bases into specifica-tions, drawings, written procedures, and instructions.
Provide a statement ' Mat quality standards are specified in the design documents, anc deviations and cnanges from these quality standarcs are -
controlled.
. 4.
Drovide 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 conditions should be used.
6.
Provide a statement that individuals or groups responsible for design verification are other than the original designer and the designer's immediate supervisor.
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 responsible 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 identified and controlled by written procedures.
IV. Procurement Document Control 1.
Provide a statement that proceduras 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 precurement 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 aoplicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
4.
Provide a statement that procurement documents identify the documen-tation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inscection and test records, personnel and procedures cualifications, and chemical and physical test results of material) to be prepared, maintained, and suonitted to the :urchaser for review and approval.
_4_
5.
Provide a statement that procurement 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 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 that changes and revisions to procurement documents are subject to at least the same review and approval as the original document.
V.
Instructions, Procedures, and Drawinas 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 accomplisned in the prepara-tion, review, approval, and control of instructions, procedures, and drawings.
3.
Provide a statement that the QA organization reviews and concurs with inspection plans; test, calibration, and special process precedures; drawings and specifications; and changes thereto or acceptable alternatives are described.
VI.
Document Control 1.
Provide a statament 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 qualified responsible organizations delegated by the applicant.
3.
Provide a statement that apcraved changes are included in instructions, procedures drawings, anc ather documents prior to implementaticn of the change.
4 Provide a statement that documents are available at the location wnere the activity will be performed prior co commencing the work.
. 5.
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 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 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 supoly 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 order requirements.
5.
Provide a statement that the supplier furnishes the following 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 recuirements 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 suoplier-furnished material, equipment, and services is performed to assure:
. (1) The material, component, or equicment is properly identified and corresponds with the identification on receiving documentation.
(2) Material, 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 acceptance 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 stcrage area or releasing them for further work.
VIII.
Identification and Control of Materials. Parts, and Comconents 1.
Provide a statement that procedures are established to identify and controi materials, parts, and components including partially fabricated subassemblies.
2.
Provide a statement that the identification 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 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 lccation and the method of identification do not affect the fit, function, or quality of the item being identified.
5.
Provide a statement that correct identir' cation of materials, parts, and components is verified and documented prior to release for fabrication, assembling and installation.
IX. Control of Scecial Processes 1.
Provide a statement tnat scecial processes such as welding, heat treating, ncndestructive testing, anc cleaning are procedurally controlled.
. 2.
Provide a statement that procedures, equipment, and personnel connected with special processes are qualified in accordance with applicable codes, standards, and ?ecifications.
3.
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 inspection 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. hat 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 qualificatio.ns and certifications are kept current.
J.
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 mandatory inspection hold points for witness by an inspector.
XI.
Test Control 1.
Provide a statement that a test program to cemonstrate that the item or comconent will perform satisfactorily in service is established, documented, and acc0mplished in accordance wi-h written controlled procedures.
2.
Provide a statement that modifications, 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 cualified, resconsible individual or group.
. XII. Control of Measurine and Test Ecuiement 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 statement that measuring and test equipment is identified and traceable to the calibration test data.
3.
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.
4.
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. Handlino, Storace, and Shiccina 1.
Provide a statement that special handling, preservation, storage, cleaning, packaging, and shipping recuirements are established and acccmolished by qualified individuals in accordance with predetermined work and inspection instructions.
2.
Provide 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 statamenc that all 'necessary shipping papers will be prepared, as required.
J.
Provide a statement that departure, arrival time and destination of a package will be established and monitored to a degree consistent with the safe transportation of the package.
XIV. Inscection, Test and Oceratino Status 1.
Provide a statement that identificaticn of the inscection, test, and operating status of packages and components is known by affected organications.
2.
Provide a statement that the acclication and removal of inspecticn and weiding stamos and status indicators such as tags, markings, lacels, and stamos are procedurally controlled.
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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. Nonconformina Material, Parts, or Comoonents 1
Provide a stttement that the identification, documentation, segregation, review disposition, and notification to affected organizations of nonconforming materials, parts, components, or services are procedurally controlled.
2.
Provide a statement that documentation identifies the nonconforming item; describes the nonconfermance, 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 dis posi tioned.
4.
Provide a statement that acceptability of rework or repair of materials, parts, components and systems is vcrified 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 concucted to determine the need for corrective action in accordance with estaclisned procedures.
2.
Provide a statement that corrective action is initiated following the determination of a ccndition adverse to quality to preclude recurrence.
3.
Provide a statement _ that follow-up reviews are conducted to verify proper implementation of corrective actions anc to close out the corrective action cocumentation.
XVI!. Cuality Assurance Pecords 1.
provice a statement that sufficient records are maintained to crovice documentary evicence of the quality and safety of itens and the activities
. affecting quality and safety.
2.
Provide a statement that QA records include acerating logs; results of reviews, inspections, tests, audits, and material analyses; qualificatton 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.
5.
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 yea rs.
6.
Provide a statement that inspection and test records contain the follcwing 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 and results of the inspection or test.
(4) Information 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 auc1ts are parformed 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 statament that audit results are cocumented and then reviewed with management having responsibility in the area audited.
3.
Provide a statement that resoonsible management takes the necessary action to correct the deficiencies revealed by the aucit.
c 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 performed at least annually based on safety significance of the activity being audited.