Regulatory Guide 7.10
| ML003739404 | |
| Person / Time | |
|---|---|
| Issue date: | 06/30/1986 |
| From: | Office of Nuclear Regulatory Research |
| To: | |
| References | |
| RG-7.10 Rev 1 | |
| Download: ML003739404 (25) | |
RevisionI
U.S. NUCLEAR REGULATORY COMMISSION June 1986
1REGULATORY GUIDE
OFFICE OF NUCLEAR REGULATORY RESEARCH
REGULATORY GUIDE 7.10
ESTABLISHING QUALITY ASSURANCE PROGRAMS FOR PACKAGING
USED IN THE TRANSPORT OF RADIOACTIVE MATERIAL
USNRC REGULATORY GUIDES The guides are issued In the following ten broad divisions:
Regulatory Guides are issued to describe and make available to the public methods acceptable to the NRC stalff Of impiementing Csecific parts of the Commsion-s regultions, to delineate tech. 1. Power Reactors 6. Products niquas used by the staff in evaluatIng specific problems or postu 2. Research and Test Reactors
7. Transportation
"lted accidents. or to provIde guidance to applicants. Regulatory Guides are .not substitutes for regulations, and compliance
3.
4.
Fuels and Materials Facilities Environmental and Siting
8. Occupational Health
9. Antitrust and Financial Review with 5. Materlais and Plant Protection 10. General them is not required. Methods and solutions different from those set
"ist In the guides will be acceptable If they provide a basis for the requIsite tdlngs to the Issuance or continuance of a permit or ose by the Commission. CpiePS of Issued guides may be purchased from the Govemrnment Prnting. Office at the current GPO price, Information on current his guide was issued after consideration of comments received from G prices may be obtained by contacting the Superintendent of the Public. Comments and suggestions for Improvements In these Documents, U.S. Government Printing Office, Post Office Box guides are encouraged at all times, and guides will be revised, as 370 8, Washington, DC 20013-7082. telephone (202)275.2060 or
(202)275-2171.
apProprlate, to accommodate comments and to reflect new Informa tion or experience.
Written comments may be submitted to the Rules and Procedures Issued guldes may also be purchased from the National Technical Branch, DRR, ADM, U.S. Nuclear Regulatory Commission. Information Service on a standing order basis. Details on this Washington, DC 20555. service may be obtained by writing NTIS, 5285 Port Royal Road, Springfield, VA 22161.
TABLE OF CONTENTS
Page
A. INTRODUCTION
............................................................. 7.10-1
B. DISCUSSION
................................................................. 7.10-1
C. REGULATORY POSITION
. ....................................................... 7.10-1
D. IMPLEMENTATION
............................................................ 7.10-2 ANNEX I - Quality Assurance Programs Applicable to Design, Fabrication, Assembly, and Testing of Packaging Used in Transport of Radioactive Material...................................7.10-3 ANNEX 2 - Quality Assurance Programs Applicable to Procurement, Use, Maintenance, and Repair of Packaging Used in Transport of Radioactive Material .................................. 7.10-13 ANNEX 3 - Quality Assurance Programs Applicable to Procurement, Use, Maintenance, and Repair of Packages Designed To Transport Radiographic Exposure Devices ......................... 7.10-19 APPENDIX A - A Graded Approach to Developing Quality Assurance Programs for Packaging of Radioactive M aterial ............................................................ 7.10-21 VALUE/IMPACT STATEMENT ....................................................... 7.10-23 iii
A. INTRODUCTION
packaging. Annex I provides guidance on the essential elements needed to develop, establish, and maintain a
- Paragraph 71.37(a) of 10 CFR Part 71, "Packaging' quality assurance program for the design, fabrication, and Transportation of Radioactive Material," requires assembly, and testing of packaging. Similar guidance for applicants for package design approval to identify the procurement, use, maintenance, and repair of all types NRC-approved quality assurance (QA) program to be ap of completed packaging is presented in Annex 2. In rec plied to the design, fabrication, assembly, testing, main ognition of the fact that the QA program derived from tenance, repair, modification, and use of the proposed Annex 2 would be unnecessarily complicated for users packaging. of packages designed to transport radiographic exposure devices, the staff developed simplified guidance specif Section71.101, "Quality Assurance Requirements," ically for this application. Annex 3 provides guidance requires that licensees have a quality assurance program on QA programs for procurement, use, maintenance, and that has been submitted to and approved by NRC as repair of packages designed to transport radiographic satisfying the provisions of Subpart H of Part 71. Sub exposure devices. In developing the guidance in Annex 3, part H requires, in part, that licensees' quality assurance the staff took into account the elements of a QA program programs satisfy each of the applicable criteria specified specifically required for radiography licensees by 10 CFR
in Section71.101 to an extent consistent with their Part 34, "Licenses for Radiography and Radiation Safety importance to safety. Requirements for Radiographic Operations."
This regulatory guide provides persons subject to the
C. REGULATORY POSITION
QA requirements of Part 71 with information on the essential elements needed to develop, establish, and The essential elements of a quality assurance pro maintain a quality assurance program acceptable to the grain acceptable to the NRC staff for complying with NRC staff for packages to transport radioactive mate the quality assurance requirements of Subpart H of rials. Terms used in this guide are consistent with terms I
10 CFR Part 71 are contained in Annex I of this guide used in 10 CFR Part 71 and ANSI/ASME NQA-l-1979, for activities related to design, fabrication, assembly, and
"Quality Assurance Requirements for Nuclear Power testing of packaging and in Annex 2 for activities re Plants."** lated to procurement, use, maintenance, and repair of completed packaging.
Any information collection activities mentioned in this regulatory guide are contained as requirements in 10 CFR
Annex 3 contains simplified guidance specifically Part 71, which provides the regulatory basis for this guide. applicable to users of radiographic exposure devices for The information collection requirements in 10CFR activities related to procurement, use, maintenance, and Part71 have been cleared under OMB Clearance No. repair of packages designed to transport such devices.
3150-0008.
The recommendations of this guide apply to the gen
B. DISCUSSION
eral QA criteria contained in Subpart H of 10 CFR
Part 71. Subpart G, "Operating Controls and Procedures"
The quality assurance program is intended to provide of 10 CFR Part 71 and NRC certificates of compliance control over all activities important to safety that are applicable to particular packages contain specific cri applicable to the design, fabrication, assembly, testing, teria and requirements that should be incorporated into maintenance, repair, modification, and use of packaging the QA program.
for transporting specified types of radioactive materials This control should be applied to the various activities Persons subject to Subpart H should submit their in a graded approach, ie., the QA effort expended on programs to and obtain approval from the NRC prior to an activity should be consistent with its importance to engaging in any activity important to safety. Those en safety. Appendix A, "A Graded Approach to Developing gaging in activities important to safety prior to ob Quality Assurance Programs for Packaging of Radioactive taining approval of the established QA program risk Material," to this guide describes a method for develop having to demonstrate that such activities were in com ing a QA program with a graded approach. pliance with QA requirements after their QA program has been approved.
The activities covered by the QA program may be divided into two major groups: those activities culmi Establishment of a QA program implies that all ac nating in completed packaging and those activities asso tivities important to safety applicable to the design, ciated with procurement and use of the completed fabrication, inspection, testing, purchase, use, mainte
- Lines indicate substantive changes from previous issue. nance, repair, and modification of packages are imple mented with written procedures approved by appropriate i*Copies may be obtained from the American Society of Mechan ical Engineers, United Engineering Center, 345 East 47th Street, levels of management and are contained in quality New York, NY 10017. assurance/quality control (QC) manuals.
7.10-1
D. IMPLEMENTATION
an acceptable alternative method for complying with speci fied portions of the Commission's regulations, the method This section provides information to applicants and described in the guide will be used (1) to evaluate sub licensees regarding the NRC staff's plan for using this mittals by applicants for establishing quality assurance regulatory guide. programs for packages that transport radioactive materials and (2) to assess licensees' performance with respect to Except in those cases in which an applicant proposes developing, establishing, and maintaining such QA programs.
7.10-2
ANNEX 1 Quality Assurance Programs Applicoble to Design, Fabrication, Assembly, and Testing of Packaging Used in Transport of Radioactive Material This annex provides guidance in formulating quality assurance (QA) programs applicable to design, fabrication, or corporate president or by a chief executive officer stating that it is company or corporate policy to perform assembly, and testing of packaging used in the transport work on items important to safety in accordance with of radioactive material. This guidance is presented in the the requirements of Subpart H as described in the QA
I same order as the criteria in Subpart H of 10 CFR Part 71.
program plan and implemented in QA manual
s. The policy I
statement should also identify those individuals delegated
1.1 Organization authority for (1)implementing and revising the provisions of the described QA program and (2) regularly assessing
1.1.1 Structure and Authority the scope, status, implementation, and effectiveness of the QA program.
The structure of the organization and the assignment of responsibility for each function should ensure that
1.2 Quality Assurance Program (I) specified quality requirements are achieved and main tained by those who have been assigned the responsibility Measures should be established for identifying (1) the for performing the work and (2) conformance to estab lished requirements is verified by individuals and groups components, structures, and systems to be covered by the QA program and (2) the approach used for verifying not directly responsible for performing the work. The that the applicable components, structures, and systems persons or organizations responsible for verifying quality should report through a management hierarchy so that meet design objectives. Although Part 71 allows for the development of a "graded" QA program, this does not required authority and organizational freedom, including sufficient independence from influences of cost and preclude the alternative of defining a program based on maximum controls if such a program is deemed neces schedule, are provided. Where more than one organiza sary to attain the confidence needed for meeting design tion is involved in the execution of activities important objectives Three major factors are necessary for an accept to safety, including maor contractors, the authority of able quality assurance program: appropriate docunentation, each organization should be clearly establishe
d. The QA
and quality control (QC) functions retained by the QA proficient personnel, and assurance that activities important to safety are performed under suitably controlled conditions.
organization or delegated to other organizations should be identified to ensure that all the appropriate elements
1.2.1 Documentation of Subpart H will be implemented.
The quality assurance program should ensure that activ A formal organization structure should be established, ities important to safety applicable to the design purchase, and organization charts identifying each organizational fabrication, and testing of packaging are described by element that functions under the QA program (e.g.,
engineering, procurement, inspection, testing, quality assur written procedures and instructions and will be in place prior to engaging in these activities.
ance) should be prepared. The interface relationships and QA responsibilities of each organizational element, includ ing those of principal contractors, should be identified To demonstrate that a documented QA program has to demonstrate assignment of responsibilities that meet been fully implemented by written procedures and is contained in QA/QC manuals, a master index of QA
Subpart H requirements. In addition, qualification require procedures related to all activities important to safety ments for principal QA and QC management positions and a matrix of those QA procedures that implement should be identified to demonstrate competence com each criterion of Subpart H should be established and mensurate with the responsibilities of these positions.
Measures should be established to ensure that designated maintained to reflect the current status of the QA
program. With respect to those anticipated activities QA individuals have the responsibility and authority to important to safety not yet initiated, the implementing stop unsatisfactory work and the processing, delivery, or procedures should be identified by title and procedure installation of nonconforming material; this authority number. A brief description of the content of the should be delineated in writing.
procedures with an estimated date *for completion should be included. Table I of this annex shows a
1.1.2 Top Management Endorsement of a Quality suitable format for listing procedures to demonstrate Assurance Program implementation of a documented QA program.
Top management needs to maintain a continuing in
1.2.2 Personnel volvement in QA matters if the QA program is going to*
be effective. To ensure the commitment of top manage The QA program should provide measures for ensuring ment, written policy should be established by a company (1)that personnel performing activities important to
7.10-3
I :
Table 1 FORMAT FOR LISTING OF IMPLEMENTING PROCEDURES*
10 CFR Part 71 I Implementing Document Title Subpart H Criteria Description Quality Assurance Manual (QAM), Organization Identifies organizations and their relation Quality Procedure (QP) I I
ships in performance of activities affecting quality.
QAM, QP 2 QA Program 2 Describes basic methods for establishing a I documented QA program that implements requirements of Subpart H to Part 71.
QAM, QP 3 Design Control 3 Describes design control measures established for structures, systems, and components.
QAM, QP 4 Procurement 4 Describes procedure for ensuring that appli Document cable regulatory requirements, design bases, Control and other requirements necessary to ensure adequate quality are suitably included or referenced in documents for procurement of material, equipment, and services.
C C C C * C C C C C * C C C * *
QAM, QP 18 Audits 18 Describes internal and external audit programs applicable to both in-house and major suppliers.
- The information requested for all 18 aiteda would be fisted; the table shows examples for Criteria 1, 2, 3, 4, and 18 only.
7.10-4
safety receive indoctrination and training commensurate are reviewed to emphasize critical parameters that can with the skill levels needed and (2)that qualified per be controlled by inspections or tests and to identify test sonnel within the organization be assigned to determine and inspection criteria and quality standards.
that functions delegated to principal contractors are properly accomplished. The required training should be Recognized engineering practices such as prescrib completed before the personnel engage in such activi ing drafting room standards; checking methods; review ties The program should identify the scope and objec and approval requirements; issuance and distribution tive of the training and the method for implementing it.
requirements, including revisions to them; maintaining The proficiency of the personnel should be maintained current "as-built" configurations; and storage and con by retraining, reexamining, and recertifying. Personnel trol of original and master copies should be established performing functions important to safety, e.g., inspect to control the preparation of drawings and specifications.
ing and testing, should be qualified based on their abilities gained through education, training, and expe
1.3.2 Controlof Design Input rience. Records of persons performing functions impor tant to safety should include the bases on which an Measures should be established to ensure that appro individual is qualified to perform a required function.
priate codes and standards are used in the design of the packaging. In the absence of such codes and standards For personnel performing special processes, e.g.,
for formulation of the design activities, alternative nondestructive examinations or welding, measures should approaches should be identified.
be established for obtaining proof of their certifica tion to perform the process, the period their certifi Measures should be established to ensure (1)that all cation remains in effect, and the conditions under which design parameters, e.g., criticality physics, cooling, and recertification would be required. Qualification and decontamination of an item, have been properly con certification of nondestructive testing personnel should sidered, reviewed, and approved by the responsible design be accomplished based on guidelines established by such organization and that the parameters are in accordance recognized authorities as the American Society for Non with the applicable performance codes, standards, and destructive Testing (ASNT), American Society of regulatory requirements and (2) that maintenance, repair, Mechanical Engineers (ASME), or American National inservice inspection, handling, storage, and cleaning Standards Institute (ANSI). requirements are specified in design documents.
Provisions should be established for resolving dis
1.3.3 Control of Design Verification putes involving quality that arise from a difference of opinion between QA/QC personnel and personnel from Methods to be used in verifying the adequacy of the other departments (e.g., engineering, procurement, manu design (e.g., qualification testing, design review, or facturing). alternative calculations, including use of computer pro grams) should be established. Individuals or groups re
1.2.3 Controlled Conditions sponsible for design verification should be other than the original designer. The designer's immediate supervi Measures should be established to ensure that ac sor may perform the verification provided (1) the super tivities important to safety are accomplished using ap visor is the only technically qualified individual, (2) the propriate production and test equipment, suitable envi need is documented and approved in advance by the ronmental conditions, applicable codes and standards, supervisor's management, and (3) the QA audits cover and proper work instructions. The assignment of respon the effectiveness of use of supervisors as design ver sibility for each task and method used to verify fiers to guard against abuse of this practice.
conformance to these quality requirements should be documented. During the sequence of design verification, changes to the final design may result; consequently, measures
1.3 Design Control should be established for ensuring that drawing and specification changes are reviewed and approved by the Good interrelationships among those responsible for same individuals or organizations that reviewed and ap preparing design disclosures, conducting independent proved the original documents. Changes in design that design analyses, coordinating interfaces, and maintain could result in conditions differing from those pre ing lines of communication are essential for adequate scribed on the certificate of compliance should be ap design control. To ensure an adequate commitment to proved by NRC prior to implementation.
control of design activities, three principal areas need to be considered: control of the design process, control of Design verification, if other than by qualification design input, and control of design verification.
testing of a prototype or lead production unit, should be satisfactorily completed prior to (1) release for
1.3.1 Control of Design Process procurement or fabrication and (2) release to other or ganizations for use in other design activities except Measures such as "classification of characteristics"
when this timing cannot be met. In these cases, design should be established to ensure that packaging designs verification may be deferred provided the justification
7.10-5
for this action is documented and the unverified portion 1.4.3 Review and Changes to ProcurementDocuments of the design output documents are appropriately identi fied and controlled. When a test program is used to ver ify the adequacy of a design, the prototype should be Measures should be established to ensure that review and approval of procurement documents are recorded subjected to the most adverse design conditions.
prior to release and that changes and revisions to pro curement documents are subject to at least the same re view and approval as the original documents.
1.4 Procurement Document Control
1.5 Instructions, Procedures, and Drawings
1.4.1 Preparation and Issuance of Procurement Documents 1.5.1 Quality Assurance ProgramProcedures Measures should be established to control the prepara tion, reviews, concurrences, and approvals of procure Measures should be established to ensure that:
ment documents. 1. Activities important to safety are prescribed and accomplished in accordance with documented instruc tions, procedures, or drawings.
1.4.2 Content of ProcurementDocuments
2. Methods for complying with each of the appli Measures should be established to ensure that pro curement documents include the following information cable 18 criteria of Subpart H of 10 CFR Part 71 are I
specified in instructions, procedures, and drawings.
as applicable:
3. Instructions, procedures, and drawings include quantitative (e.g., dimensions, tolerances, and operating
1. A statement of the scope of work to be per limits) and qualitative (e.g., workmanship samples)
formed by the prospective supplier.
acceptance criteria to verify that activities important to safety have been satisfactorily accomplished.
2. The design basis technical requirements (or references thereto), including the applicable regulatory requirements,
1.5.2 Quality AssuranceReview and Concurrence material and component identification requirements, draw ings, specifications, codes and standards, special process Measures should be established to ensure that the instructions, and test and inspection requirements.
QA organization reviews and concurs in inspection plans;
test, calibration, and special process procedures; and
3. Applicable Subpart H requirements that must be specifications and any changes thereto. Prior to fabri complied with and described in the supplier's QA pro cation of an item, manufacturing plans should be re gram. This QA program or portions thereof should be viewed to obtain concurrence by QA of scheduled reviewed and concurred in by qualified QA personnel witness and hold points during fabrication.
from the purchaser's organization prior to initiation of activities affected by the program. Also, where subtier
1.6 Document Control suppliers are involved, the QA provisions appropriate to those procurements should be specified. (The extent of
1.6.1 ControlledDocuments the supplier's or subtier supplier's QA program will depend on the particular item or service being procured.)
Each of the documents under the control of the QA
program should be maintained to reflect current status.
4. Permission to gain access to the supplier's or As a minimum, control should be exercised over the fol subtler supplier's plant facilities and records for in lowing items:
spection or audit purposes.
1. Design documents (e.g., drawings, specifications,
5. Identiication of the documentation (e.g., drawings, and computer codes),
specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure
2. Procurement documents, qualifications, results of chemical and physical tests on material) to be prepared, maintained, and submitted to
3. QA and QC manuals, purchaser for approval.
4. Operating, maintenance, and modification proce
6. Identification of those records to be retained, dures, controlled, and maintained by the supplier and of those records delivered to the purchaser prior to installation
5. Inspection and test procedures, of hardware.
6. Nonconformance reports,
7. Requirements for reporting and approving dis position of nonconformances. 7. Design change requests, and
7.10-6
8. Corrective action reports. 1. 7.4 SupplierPerformance Control
1.6.2 Control of Document Generationand Issuance Measures should be established for pre- and post award activities such as meetings and other communi Controls should be established to ensure that all docu cations to ensure that the supplier understands procure ments and changes thereto are adequately reviewed and ment requirements, including, if applicable, "hold"
approved prior to their issuance. Measures (e.g., the use points (Le., preestablished inspection points in the of a master document list) should be included to ensure manufacturing process that require inspection approval that current issues of applicable documents are available and release by the quality assurance organization prior at the location where the activity is being performed to to further processing) during manufacturing and testing preclude use of obsolete or superseded documents. All and prior to shipment.
packaging affected by design changes should be checked to verify that it is in accordance with the appropriate 1.7.5 Verification Activities revision. Those individuals or groups responsible for reviewing, approving, and issuing documents and revi The extent to which source surveillance during fab sions thereto should be identified. rication, inspection, testing, and shipment is performed to ensure conformance with the purchase order require
1.6.3 Control of Document Changes ments should be established. The measures should cover instructions specifying characteristics or processes to Measures should be established to ensure that changes be witnessed, inspected, or verified; the documentation to documents are reviewed and approved by the same required; and identification of those responsible for organization that performed the original review and implementing source surveillance. The extent to which approval and that the changes are in accordance with receipt inspection of supplier-furnished hardware is configuration control procedures. performed to ensure that items are properly identified and correspond with procurement documentation should
1.7 Control of Purchased Material, Equipment, aid Services be established. When acceptance of an item is con tingent on tests after installation in the package, the Measures should be established in the areas identified acceptance documentation should be mutually estab below to ensure that materials, equipment, and services lished with suppliers of the item prior to its use.
conform to procurement documents.
1.7.6 ControllingNonconformances
1.7.1 ProcurementDocument Planning Measures should be established to ensure the proper Procurement planning procedures should be established disposition of items or services that do not meet pro to describe each procurement step leading to contract curement requirements. These measures should include award of items and services. Responsible organizations evaluation of nonconforming items categorized by the for each procurement step should be identified. supplier, along with technical justification and recom mended disposition (e.g., use as is or repair).
1.7.2 Selection of ProcurementSources
1.7.7 Records Measures should be established for evaluating and select ing procurement sources, including the extent of QA and Measures should be established to ensure that the engineering involvement. Provisions that should be considered, supplier furnishes to the purchaser the following records if applicable, include (I)the supplier's capability to comply as a minimum:
with applicable criteria of Subpart H, (2) results of the survey of the supplier's facility and QA program, and (3) 1. Documentation that identifies material or equip review of the supplier's previous records and performance. ment and the specific procurement requirements (e.g.,
codes, standards, and specifications met by the items).
1.7.3 Bid Evahuationand Award
2. Documentation that identifies any procurement Measures should be established to ensure that designated requirements that have not been met along with a de individuals or organizations evaluate proposed suppliers scription of those nonconformances designated "use as based on the following criteria as applicable to the type is" or "repair."
of procurement: (1)technical considerations, (2) conform ance to QA requirements, (3) production capability, and 1.8 Identification and Control of Materials, Parts, and
(4) past performance. Prior to contract award, all unao Components ceptable conditions identified during the bid evaluation should be iesolved if possible. If any unacceptable con 1.8.1 Identificationand Control ditions cannot be resolved prior to contract award, a commitment from the supplier should be obtained indi Measures should be established to ensure that mate cating that resolution will be made at a mutually agree rials, parts, and components, including partially fabricated able date during the contract period. assemblies, are adequately identified to preclude the use
7.10.7
of incorrect or defective items. The measures should provide the means for physical identification (e.g., of radioactive material) received at the plant meet the requirements specified on the purchase order. Also pro stamping, tags, labels, or lot-follower cards) and trace ability to appropriate documentation (e.g., drawings, visions for the control of accepted items until they are specifications, placed in stock or released for use and provisions for or mill reports) throughout fabrication, installation, and use. Also, where replacement of limited the proper disposition of rejected items should be life items is specified, measures should be established to established.
preclude use of items whose shelf life or prescribed
1.10.2.2 In-Process. Measures should be established to operation time has expired.
ensure that process specifications and their supporting documentation provide for indirect control by monitor
1.8.2 ConditionalReleases ing processing methods, equipment, and personnel Measures should be established to facilitate con if direct inspection is impractical.
tinued processing when required inspections or tests have not been completed in order to maintain physical 1.10.2.3 Final. Measures should be established to identity and control over affected material ensure that final inspection provides for resolution of nonconformances identified in earlier inspections, that the inspected item is identifiable and traceable to spe
1.9 Control of Special Processes cific records and is adequately protected from physical Measures should be established to ensure that spe or environmental damage, and that supervisors review cial processes (e.g., welding, radiography, heat treat inspection records to verify that all inspection re ing) are controlled in accordance with the following quirements have been satisfied.
criteria:
1.10.3 Inspectors
1. Procedures, equipment, and personnel are qual ified in accordance with applicable codes, standards, Measures should be established to ensure that in spectors are qualified in accordance with applicable and specifications.
codes, standards, and company training programs; that
2. The operations are performed by qualified per such qualifications and certifications are kept current;
sonnel and accomplished in accordance with recorded and that inspection personnel are independent from indi viduals performing the activity being inspected.
evidence of verification.
3. Qualification records of procedures, equipment, 1.11 Test Control and personnel are established, filed, and kept current.
1.11.1 Requirements
1.10 Inspection Control Measures should be established to ensure that ap plicable test programs, including prototype qualifica
1.10.1 Inspection Planning tion tests, production tests, proof tests, and operational Measures should be established to ensure that in tests, are accomplished in accordance with written spection procedures, instructions, or checklists include procedures. Measures should be established to ensure identification of characteristics and activities to be that modifications, repairs, and replacements are tested inspected, acceptance and rejection criteria, identifi in accordance with the original design and testing cation of the individuals or groups responsible for per requirements.
forming the inspection operation, recording of objective evidence of inspection results, identification of hold 1.11.2 Procedures or witness points, approval of data by the supervisor to ensure that all inspection requirements have been satis Measures should be established for ensuring that fied, and the prerequisites to be satisfied prior to test prerequisites identified in the appropriate design inspection, including operator qualification and equip disclosures (e.g., instrument calibrations, monitoring ment calibration. Where sampling is used to verify ac to be performed, mandatory hold points, suitable envi ceptability of a group of items, the standard used as ronmental conditions to be maintained, condition of the test equipment, methods for physical identification of the basis for acceptance should be identified.
test specimen, methods for documenting or recording test data, and criteria for acceptance) are properly trans
1.10.2 Inspections lated into test procedures.
1.10.2.1 Receiving. Measures should be established to ensure that items important to safety (ie., those 1.11.3 Results features of a structure, component, or system under control of the QA program and necessary to ensure the Measures should be established to ensure that test results are documented and evaluated and that their ac integrity of the packaging or its capability to prevent or ceptability is determined by a qualified individual or mitigate the consequences that could result from release group.
7.10.8
1.12 Control of Measuring and Test Equipment Also, measures should be established for control ling the application and removal of status indicators
1.12.1 CalibrationControl (e.g., tags, markings, stamps) and for ensuring that the bypassing of a required inspection or test or any other Measures should be established for ensuring that required operation is procedurally controlled and under measurement and test equipment (e.g., gauges, fixtures, the cognizance of the quality assurance organization.
reference standards, and devices used to measure product characteristics) should be calibrated, adjusted, and 1.15 Control of Nonconforming Materials, Parts, or Com maintained at prescribed intervals or prior to use. The ponents measuring and test equipment should be labeled or tagged to indicate the planned date of its next calibra An acceptable program for controlling nonconforming tion, and the calibration records should be identified items should include the following principal elements:
and traceable. Measures should be established to ensure
(1) proper identification, (2) segregation of discrepant that in-house reference or transfer standards used in cali or nonconforming items, (3) disposition of the items of brating measuring and test equipment are traceable to nonconformance, and (4)evaluation of the items of nationally recognized standards. Calibrating standards nonconformance.
should have known valid relationships to nationally rec ognized standards. If no known recognized standard ex
1.15.1 Identification ists, the basis for calibration should be documented.
Measures should be established to identify noncon
1.12.2 Out-Of-CalibrationEquipment formances (e.g., Deviating Material Reports that identify detailed processing steps leading to item disposition, Measures should be taken to validate previous in inspection requirements, and corrective action) along spection and test results up to the time of previous with the individuals or groups responsible for approval calibration when test and measuring equipment is found of the disposition of nonconforming items.
to be out of calibration. If any measuring equipment is consistently out of calibration, it should be repaired
1.15.2 Segregation or replaced.
Measures should be established to ensure that non
1.13 Handling, Storage, and Shipping conforming items are quarantined or placed in controlled hold areas until proper disposition is completed.
1.13.1 Preservation
1.15.3 Disposition Measures should be established to ensure that cleaning, handling, storage, and shipping are accomplished in Measures should be established to ensure that the accordance with design requirements to preclude damage or deterioration by environmental conditions such as acceptability of nonconforming items is verified by re inspecting or retesting the item against the original temperature and humidity. When necessary, provisions requirements after designated repair or rework. Final should be established for the use of special handling, disposition of nonconformances should be identified and lifting, or storage provisions (e.g., cranes, shock absorbers, documented.
or special markings) to adequately identify and preserve packaging components or assemblies.
1.15.4 Evaluation
1.13.2 Preparation,Release, and Delivery to Purchaser
"Nonconformance reports should be analyzed by QA
personnel to determine quality trends for appropriate Measures should be established to ensure that a management review and assessment.
final prerelease review has been completed. This pre release review should ensure that packaging is pre pared for delivery to the purchaser in accordance with
1.16 Corrective Action approved drawings, specifications, and government regu-.
lations; has passed all applicable inspections and tests; is
1.16.1 Reporting properly identified by physical markings or tags; and contains operating manuals, maintenance manuals, and Measures should be established to ensure that the generic procedures relating to its use.
causes of conditions detrimental to quality (e.g., those resulting from failures, malfunctions, deficiencies, devia
1.14 Inspection, Test, and Operating Status tions, and defective material and equipment) are promptly identified and reported to appropriate levels Measures should be established to ensure that the of management. Measures should be established for ob identification of the inspection, test, and operating taining corrective actions from suppliers and for ensur status of items is known by organizations responsible ing that followup is documented to verify that correc for assurance of quality. tive actions were implemented and effective.
7.10-9
L- -_____
1.16.2 Closeout 1.1 7.4 Receipt, Retrieva4 and Dispositionof Records Measures should be established to ensure that cor Measures should be established to provide a receipt rective actions designated by cognizant individuals have control system, including identification of individuals been implemented to preclude recurrence. Individuals or organizations responsible for closing out corrective in each organization responsible for receiving records and assessing the current status of records in their actions and documenting their resolution should be possession. Measures should be established to ensure identified. that records maintained in house or at other locations are identifiable and retrievable and are not disposed of
1.17 Quality Assurance Records until prescribed conditions are satisfied.
1.17.1 General 1.17.5 Storage, Preservation,and Safekeeping Quality assurance records should furnish documen Facilities used to store records should be constructed tary evidence of the activities affecting quality and to minimize the risk from damage or destruction by should provide sufficient information to permit identi severe natural conditions such as wind, flood, or fire;
fication of the record with the items or activities to temperature and humidity; and infestation of insects, which it applies. Quality assurance records should in rodents, or mold. kecords should be firmly attached in clude, as a minimum, design, procurement, manufacturing, binders or placed in folders or envelopes for storage in and installation records; supplier evaluations; noncon steel file cabinets. If dual facilities are used to ensure formance reports; results of inspections, tests, and the integrity of records, they should be sufficiently audits; failure analyses; as-built drawings and specifi remote from each other to preclude damage to both cations; qualification of personnel, procedures, and facilities from a single event such as a fire or flood.
equipment; calibration procedures; training and retrain ing records; and corrective action reports. Measures should be taken to preserve special records (e.g., radiographs and microfilm) from excessive light, electromagnetic fields, and temperature. Measures should Where applicable, inspection and test records should also be taken to preclude the entry of unauthorized contain (1) description of the observation, (2) evidence personnel into record storage areas. Measures should be of completion of the inspection or test operation, established for prompt replacement of a record that is
(3) results of inspections or tests with appropriate data, lost or damaged.
(4) conditions detrimental to quality, (5) names of inspectors, testers, or data recorders, and (6) evidence of
1.18 Audits acceptability.
1.18.1 Elements of Audit Program
1.17.2 GeneratingRecords A comprehensive audit program should include assur Measures should be established to ensure that docu ance of the authority and organizational independence ments designated as QA records are legible and completed of the auditors; commitment to adequate manpower, to reflect the work accomplished and are processed funding, and facilities to implement the audit; identifica quickly to avoid unnecessary delay when the record is tion of audit personnel and their qualifications; provi needed. sions for reasonable and timely access of audit personnel to facilities, documents, and personnel necessary for per
1.17.3 Indexing and Classificationof Records forming audits; use of checklists; methods for reporting audit findings to responsible management of both the Quality assurance records should be classified as audited and auditing organizations; provisions for ac either "lifetime" or "nonpermanent." cess by the audit team to levels of management that have responsibility and authority for corrective action;
Lifetime records include records pertaining to fab and methods for verification that effective corrective ac rication of the package and those of a particular item tion has been accomplished on a timely basis.
while it is installed in the packaging or stored for future use. These are the records that demonstrate the
1.18.2 Scheduling of Audits capability for safe operation; provide evidence of re pair, rework, replacement, or modification; aid in de Schedules for internal, external, and management termining the cause for an accident or malfunction of audits should be established. Measures should be estab an item; or provide a baseline for inservice inspection.
lished to ensure that key activities of the QA program (e.g., design, fabrication) are given priority consider Nonpermanent records are those that show evidence ation. For management audits, the schedules should that an activity has been performed but do not meet identify the level of management (usually from corporate criteria for lifetime records. Records pertaining to use of office or another division) designated to assess the a package must be retained for a period of 2 years after overall effectiveness of the implementation of the de the shipment. scribed in-house QA program. The activities important
7.10-10
to safety (e.g., procurement, training of personnel) to be
1.18.4 PreauditConference included in the audit program should be identified.
The nature and scope of the preaudit conference Internal audits of the applicable elements of the between management of the organizations being audited quality assurance program should be audited at least and the team conducting the audit should be specified annually or at least once within the life of the activ prior to an audit. The purpose of the conference should ity, whichever is shorter. be to confirm the audit scope and planned dates, meet counterparts, discuss the sequence and duration of the External audits of the elements of a major supplier's audit, set the time for the postaudit conference, estab or major contractor's quality assurance programs should lish channels of communication, and prepare an agreed be audited on a triennial basis. The 3-year period should to agenda for the audit.
begin with performance of an audit when sufficient work is in progress to demonstrate implementation of a
1.18.5 PostauditConference quality assurance program having the required scope for purchases placed during the 3-year period. Manage Measures should be established to conduct a postau ment audits should be conducted at least once every dit conference between the audit team and the manage
12 months. ment of the audited organization to present the results and clarify misunderstandings.
1.18.3 Team Selection
1.18.6 Reportingand Response Qualifications of auditing personnel, including the lead auditor, should be established, and the responsi Measures should be established identifying time bilities of the audit team members and the lead auditor constraints imposed for issuing audit reports and the with respect to evaluation and issuance of audit reports requested date for corrective-action response by the should be specified. It is the responsibility of the auditing audited organization. The response should clearly state organizations to establish qualifications for prospective the corrective action taken to prevent recurrence of audit personnel and the requirement for the use of nonconformances. In the event that corrective action technical specialists to accomplish auditing activities cannot be taken immediately, the response of the important to safety. audited organization should include scheduled dates for initiation and completion of the corrective action.
Sp -'c guidance for determining qualifications for indiviu.. auditors and lead auditors may be obtained
1.18.7 Followup Action by referring to Supplement 2S-3, "Supplementary Require ments for the Qualification of Quality Assurance Program The audit team leader should verify that the audited Audit Personnel," to ANSI/ASME NQA-I-1979.*
organization provides a timely response to the audit
- Copies may be obtained from the American report, that the response is adequate, and that the cor ical Engineers, United Engineering Center, 345 Society of Mechan East 47th Street, rective action has been accomplished within the pre NewYork, NY 10017.
scribed schedule.
7.10-11
ANNEX 2 Quality Assurance Programs Applicable to Procurement, Use, Maintenance, and Repair of Packaging Used in Transport of Radioactive
! Material Paragraphs 71.12(b), 71.14(b), 7 vide users with a general license and 1.16(c)(2) pro equipment and under suitable to deliver packaged environmental licensed material to a carrier for transport provided (2) designated QA and QC responsibilities for conditions, certain conditions are met. One of implementa these conditions is tion of activities important to safety are contained in that the user must provide for the QA/QC manuals, and (3) indoctrination and establishment and training execution of a quality assurance (QA) programs are established so that personnel performing program consistent with the provisions of Subpart H activities important to safety are trained of 10 CFR and qualified The user may delegate to other organizations Part 71. to perform these activities.
of establishing or executing the QA the work program or any part thereof but retains the responsibility 2.2.2 Applicability of Quality Assurance for its overall Program effectiveness. Therefore, the user must (1) determine that during design and fabrication Measures should be established to ensure that all quality assurance items provisions applicable to packaging covered by the QA program are compatible have been followed, with and
(2) describe to the NRC how this emphasize characteristics identified in the manufacturer's determination has been made, and (3) submit to the QA program. The rationale used to identify NRC for evaluation items and approval the established QA program classified as important to safety and subject applicable to to the procurement, use, maintenance, and user's QA program should be established.
repair of packaging.
This annex provides guidance on 2.3 Design Control the essential ele ments needed to develop, establish, and maintain a QA
program applicable to procurement, Design activities are not normally performed use, maintenance, by and repair of packages that must meet users of packaging; consequently, this the requirements criterion of of Subpart H of 10 CFR Part 71. Subpart H should not be applicable. However, it should be established that the design was accomplished under
2.1 Organization control of an NRC-approved QA program (see Sec tions 2.4.1 and 2.7 of this annex).
A formal organization structure should be estab lished and documented by organization 2.4 Procurement Document Control charts identify ing each organizational element that functions under the QA program. Measures should be established 2.4.1 PackagingProcurement to provide adequate control over activities important to inspecting, cleaning, purchasing preparing safety (e.g., Measures should be established to ensure that the packag pro ing for delivery). If, because of curement documentation (I)requires the manufacturers limited personnel, multiple functions, including QA, are of packaging to supply appropriate certifications verify performed by the same individuals, measures should ing that the designated (model and serial be established to en number)
sure that the designated individuals packaging was manufactured under the control when performing QA of an and QC functions have the responsibility NRC-approved QA program, (2)identifies the to stop unsatisfactory work, stop and authority type of delivery or installa verification activities required during use and maintenance, tion of nonconforming material, and and (3) designates other pertinent documentation have direct access to be to management levels that can ensure furnished with the packaging (e.g., certificate that QA proce of compli dures important to safety have ance, as-built drawings, photographs, sketches, been accomplished. use and maintenance manuals).
The duties and qualifications required individual who has overall authority for (1)the and responiubility 2.4.2 Replacement PartProcurement for the QA program and (2) the other principal personnel performing QA and QC functions should Measures should be established to require that pro be established and documented and should have curement of replacement parts important the written endorse to safety be ment of top management. reviewed by QA personnel to ensure that appropriate technical and QA requirements are included in purchase
2.2 Quality Assurance Program orders and that the purchase orders are placed with sup pliers previously qualified during fabrication of the
2.2.1 Scope of Qualty Assrunce Program packaging. If replacement parts are purchased from sup pliers not previously identified as qualified sources, Measures should be established to ensure that (1) activ the user must assure himself or herself that the re ities important to safety are performed placement parts meet requirements at least with specified as stringent as the original criteria.
7.10-13
2.5 Instructions, Procedures, and Drawings changes to documents are reviewed and approved by the same organization that performed the original review
2.-51 PreparationofPackagingfor Use and approval.
Procedures for meeting the requirements of of 10CFR Part71 for placing the packaging §in71.87 use
2.7 Control of Purchased Material, Equipment, and should be established and approved by appropriate levels Services of management. A listing of these procedures should be Measures such as source surveillance and audits of maintained to always reflect current status.
records should be taken as appropriate to ensure that the design and fabrication of packaging were performed
2.5.2 Repair, Rework, and Maintenance under the control of an NRC-approved QA program.
Measures should be established to ensure that plans for necessary repairs or rework of packaging are pre Measures should be established to ensure that pack scribed before the work begins. These plans should be aging when received at the destination designated by the user is accompanied by appropriate documentation as coordinated with quality assurance personnel to ensure identified in the purchase order. Such documents should that appropriate inspection and hold points are incor be referenced in the certificate of compliance, should porated into the plans to verify that effective repairs or rework have been satisfactorily performed. Also, mea relate to the use aid maintenance of the packaging, and sures should be established to ensure that plans for should identify necessary actions to be taken prior to maintenance are reviewed by quality assurance personnel delivery of the licensed material to a carrier for transport.
to verify that the plans emphasize those characteristics that are important to safety. 2.8 Identification and Control of Materials, Parts, and Components
2.5.3 Loading and Unloading Contents Measures should be established to ensure that mate Measures should be established to ensure that load rials, parts, and components used for repair or rework ing radioactive material into packaging and unloading for maintenance purposes are adequately identified to radioactive material from packages are controlled (e.g., preclude use of incorrect or defective items.
Also, surveys for contamination and radiation; measurements where replacement of limited-life items is specified, of pressure, temperature, and coolant radioactivity; ade measures should be established to preclude use of items quate venting of the package; preparation for immersion; whose shelf life or operation times have expired.
rigging and hoisting the package; and proper level of
2.9 Control of Special Processes antifreeze).
2.5.4 Transportof Package Special processes such as welding or nondestructive testing are not normally performed by the users of Measures should be established to ensure that pack packaging. However, if packaging requires major repairs ages are in good condition, adequately secured within or necessitating use of special processes, e.g., welding or on the transport vehicle, properly sealed, marked per heat treating, measures should be established to ensure DOT regulations, and identified by model and license that the special processes are controlled in accordance with the following criteria:
registration numbers.
1. Procedures, equipment, and personnel are qual
2.6 Document Control ified in accordance with applicable codes, standards, and specifications.
Each of the documents under the control of the QA
program should be identified. As a minimum, control should be exercised over the following documents: 2. The operations are performed by qualified per sonnel and accomplished in accordance with written pro cess sheets with recorded evidence of verification.
2. Operating Procedures, 3. Qualification records of procedures, equipment,
3. Maintenance Procedures, and personnel are established, filed, and kept current.
4. Inspection and Test Procedures,
5. Loading and Unloading Procedures,
2.10 Inspection Control
6. Packaging for Transport Procedures,
7. Repair Procedures, and
2.10.1 Receipt Inspection
8. Procurement Documentation.
Measures should be established to ensure that the Visual inspections should be performed upon receipt of most recent revision to an instruction, procedure, spec packaging to ensure compliance with procurement docu ments. The criteria for acceptance of each of these inspec ification, or drawing is available to those persons re sponsible for using these documents and to ensure that tions and the action to be taken if noncompliance is en countered should be established. These visual inspections
7.10-14
should include inspection of surface conditions; weld and structural integrity; the condition of flange faces or sealing 3. Component performance for the following:
areas, gaskets, seals, gauges, rupture disks, valves, and'
pressure relief devices; the condition of tiedown members a. Valves, (if applicable); labeling and marking; and leaktightness b. Gaskets, and c. Fluid transport devices, of the packaging.
4. Shielding integrity, and
2.10.2 Maintenance Measures should be established for an inspection 5. Thermal integrity.
program to ensure adequate maintenance of packaging.
The program should identify the items to be maintained, 2.11.2 Maintenance Tests criteria for acceptability or replacement, and the frequen Maintenance test programs should be established to cies of inspection assigned to each item.
ensure that packages remain usable and free of excessive radiation and contamination.
2.10.3 Final Inspection Checklists should be established to ensure that inspec The test program should include measures to ensure that tions are performed to verify that the following items test results are documented, evaluated, and determined by qualified responsible individuals to be acceptable.
have been complied with:
2.12 Control of Measuring and Test Equipment
1. Packages are properly assembled.
2. Moderators and 2.12.1 CalibrationControl neutron absorbers are present, if applicable. Measures should be established for ensuring that mea
3. Valves through which primary coolant flows are surement and test equipment (e.g., gauges, fixtures, refer ence standards, and devices used to measure product protected against tampering.
characteristics) should be calibrated, adjusted, and main tained at prescribed intervals or prior to us
e. The meas
4. Valves are set to specifications.
uring and test equipment should be labeled or tagged to indicate the planned date of its next calibration, and
5. All shipping papers are properly completed.
the calibration records should be identified and traceable.
6. Packages are conspicuously and durably marked Measures should be established to ensure that in-house reference or transfer standards used in calibrating measur as required by DOT regulations. ing and test equipment are traceable to nationally
7. Measures are established to ensure that an indi recognized standards. Calibrating standards should have known valid relationships to nationally recognized vidual designated by the user of packages signs the shipping tags or indicators prior to authorization standards. If no known recognized standard exists, the basis for calibration should be documented.
for shipping.
For all the inspections identified above, the in 2.12.2 Out-Of-CalibrationEquipment spection personnel should be independent from the indi vidual performing the activity being inspected. Measures should be taken to validate previous inspec tion and test results up to the time of previous calibration when test and measuring equipment is found to be out
2.11 Test Control of calibration. If any measuring equipment is consistently out of calibration, it should be repaired or replaced.
2.11.1 Use of Packages Measures should be established, as appropriate, to ensure that acceptance tests are conducted prior to de 2.13 Handling, Storage, and Shipping livering packages for transport to a carrier. The basis for acceptance criteria (e.g., certificate of compliance, main 2.13.1 Handlingand Storage tenance and operational manuals furnished by the pack aging manufacturers) should be identified. The following Measures should be established to ensure that:
items should be included in typical tests:
1. Special handling and lifting equipment to move packaging from one station to another is used.
1. Structural integrity,
2. Leaktightness (on containment vessel as well as 2. Special handling or storage provisions for packaging auxiliary equipment and shield tanks), (e.g., shock absorbers, tags, or markings to adequately protect and identify critical components) are used.
7.10-15
3. Proper environmental conditions to preserve packag
2.15.3 Disposition ing are maintained.
4. All conditions identified in a certificate of com Measures should be established to ensure that the acceptability of nonconforming items is verified by re pliance when unloading packaging are adhered to.
inspecting or retesting the item against the original requirements after designated repair or rewor
k. Final
2.13.2 Preparationfor Release and Shipment disposition of nonconformances should be identified and documented.
Measures should be established to ensure that:
1. Cavities within gas-cooled package containments have 2.15.4 Evaluation been adequately dried and cavities within liquid-cooled packages have been drained to allow adequate void space. Nonconformance reports should be analyzed by QA
personnel to determine quality trends for appropriate management review and assessment.
2. All conditions, including specified operations, in spections, and tests, have been completed prior to
2.16 Corrective Action delivery to a carrier.
3. All NRC and DOT requirements have been satis 2.16.1 Reportink fied prior to delivery to a carrier.
Measures should be established to ensure that the causes of conditions detrimental to quality (e.g., those
4. All necessary shipping papers have been pre resulting from failures, malfunctions, deficiencies, devia pared as required. .
tions, and defective material and equipment) are promptly
2.14 Inspection, Test, and Operating Status identified and reported to appropriate levels of manage ment for activities important to safety concerning use, maintenance, and repair of packages. Measures should be Measures should be established to ensure that the status of inspections, tests, and operating conditions, established for obtaining corrective actions from suppliers including maintenance, is known by organizations respon and for ensuring that followup is documented to verify that corrective actions were implemented and effective.
sible for assurance of quality.
2.16.2 Closeout Measures should be established to indicate by use of tags, markings, stamps, etc., that individual items of the packaging procedurally controlled by the QA program Measures should be established to ensure that corrective have not inadvertently bypassed required inspections and actions designated by cognizant individuals have been implemented to preclude recurrence. Individuals or orga tests. nizations responsible for closing out corrective actions and documenting their resolution should be identified.
2.15 Control of Nonconforming Materials, Parts, or Components 2.17 Quality Assurance Records The following guidance for controlling nonconform ing items for completed packaging, replacement parts, or 2.17.1 General components should include the following principal ele The QA records that are to be retained for the ments: (I) proper identification, (2) segregation of dis lifetime of packaging should include appropriate design crepant or nonconforming items, (3) disposition of the and production-related records that are generated through items of nonconformance, and (4) evaluation of the items out manufacturing and furnished with packaging; records of nonconformance. demonstrating evidence of operational capability; records verifying repair, rework, and replacement; and audit
2.15.1 Identifiration plans, audit reports, corrective actions, and records that are used as a baseline for maintenance. Records showing Measures should be established to identify noncon formances (e.g., Deviating Material Reports that identify evidence of delivery of packages to a carrier and proof that all NRC and DOT requirements have been satisfied detailed processing steps leading to item disposition, should also be retained with their retention times inspection requirements, and corrective action) and the identified.
individuals or groups responsible for approval of the disposition of nonconforming items.
2.17.2 GeneratingRecords
2.15.2 Segregation Measures should be established to ensure that docu ments designated as QA records are legible and completed Measures should be established to ensure that non conforming items are quarantined or placed in controlled to reflect the work accomplished and are processed quickly to avoid unnecessary delay when the record is hold areas until proper disposition is completed.
needed.
7.10-16
2.1 7.3 Receipt, Retrieval and Disposition of Records established for prompt replacement of a record that is lost or damaged.
Measures should be established to provide a receipt control system, including identification of the individ 2.18 Audits uals in each organization responsible for receiving records and assessing the current status of records in their Measures should be established to ensure that audits possession. Measures should be established to ensure that are performed in accordance with preestablished written records maintained in house or at other locations are procedures or checklists and are conducted by qualified identifiable and retrievable and are not disposed of until personnel not having direct responsibility in the areas prescribed conditions are satisfied. being audited.
A listing of the activities important to safety to be
2.17.4 Storage, Preservation,and Safekeeping audited and the frequency at which each activity is to be audited should be established and maintained to reflect Facilities used to store records should be constructed current status. The frequency of audits should be based to minimize the risk from damage or destruction by on the importance of the activity to safety; however, severe natural conditions such as wind, flood, or fire; each activity should be audited at least once each year.
temperature and humidity; and infestation of insects, rodents, or mold. Records should be firmly attached in Measures should be established to ensure that audits binders or placed in folders or envelopes for storage in are made of the manufacturers of packaging to determine steel file cabinets. If dual facilities are used to ensure the extent of compliance with the purchase order and the integrity of records, they should be sufficiently to verify that the work is being controlled by a QA
remote from each other to preclude damage to both program approved by NRC.
facilities from a single event such as a fire or flood.
Measures should be taken to preserve special records Individuals or groups having responsibility and author (e.g., radiographs and microfilm) from excessive light, ity for ensuring that corrective actions resulting from electromagnetic fields, and temperature. Measures should findings during audits are accomplished on a timely basis also be taken to preclude the entry of unauthorized should be identified. Deficient areas should be reaudited on personnel into record storage areas. Measures should be a timely basis to verify implementation of corrective action.
7.10-17
ANNEX 3 Quality Assurance Programs Applicable to Procurement, Use, Maintenance, and Repair of Packages Designed to Transport Radiographic Exposure Devices
3.1 Organization of packages to supply appropriate certifications verifying Organization charts identifying each organizational that the designated (model and serial number)
package ment (e.g., purchasing, engineering, quality ele was manufactured under the control assurance) of an NRC-approved functioning under the QA program, including QA program, (2)identifies types of inspections principal and tests contractors, should be established. Because required during use and maintenance, and limited staff (3) designates may be devoted to QA/QC activities, certain other pertinent documentation to be furnished with the individuals may be performing multiple duties. If this package (e.g., certificate of compliance, is the case, as-built draw measures should be established to ensure ings, use and maintenance manuals, and that designated all other docu individuals performing QA/QC functions ments referred to in the certificate have written of compliance).
delegated authority to stop unsatisfactory work, unsatis factory processing, or the installation of 3.3.2 Replacement PartsProcurement(If Applicable)
nonconforming material and that they have direct access to management levels that can ensure the accomplishment Measures should be established to require of activities that pur important to safety. chase orders for spare or replacement parts be reviewed by QA personnel to ensure that appropriate technical Duties and qualifications should be identified and QA requirements are included in the purchase for the positions with responsibility for (1) establishment orders and that the orders are placed of the with suppliers QA program, (2) overall execution of the previously qualified during fabrication of the package. If QA program, and (3) assessing the scope, status, and replacement parts are purchased effectiveness of from suppliers not the QA program. (Typically this responsibility previously identified as qualified sources, is vested the user must in the Radiation Safety Officer.) The duties ensure that the replacement parts meet and qualifica requirements at tions of other key personnel performing least as stringent as the original criteria.
QA/QC func tions should also be identified.
3.4 Instructions, Procedures, and Drawings
3.2 Quality Assurance Program Measures should be established to ensure that load Measures should be established to ensure ing radioactive material into or unloading that items radioactive designated to be controlled by the QA program material from a package is controlled are com to protect the patible with and emphasize the characteristics public health and safety and the environment.
that are identified in the manufacturer's QA program.
33 Document Control Measures should be established to ensure that items important to safety requiring periodic replacement Controls should be established to ensure because that all of limited operating or shelf life are identified. documents and changes thereto are adequately reviewed and approved prior to their issuance. Measures should be Measures should be established to provide included to ensure that current issues for indoctri of applicable nation and training to ensure that personnel documents are available at the location where the activ engaged in use, maintenance, and repair activities important ity is being performed to preclude use of obsolete or to safety are knowledgeable before they engage in superseded documents. All packages affected such activities. by design or manufacturing changes should be checked to verify Measures should be established to ensure that that they are in accordance with the appropriate procedures revision.
implementing QA/QC activities important to safety are contained in QA/QC manuals. A matrix of instructions and procedures should be provided that Documents under the control of the cross-references QA program each applicable QA program requirement should include at least the following:
of Subpart RL
Identify each procedure or instruction by number and title and provide a brief description of the 1. QA and QC Manuals, content.
3.3 Procurement Document Control 2. Operating Procedures,
3.3.1 Package Procurement 3. Maintenance Procedures, Measures should be established to ensure 4. Inspection and Test Procedures, that pro curement documentation (1) requires the manufacturers
5. Loading and Unloading Procedures,
7.10-19
6. Packaging for Transport Procedures, and
3.8 Quality Assurance Records
7. Repair Procedures.
A list of records to be controlled under the QA program and identification of retention times for each record
3.6 Handling, Storage, and Shipping should be established. These records should include, as a minimum, procurement documentation; inspection, test,
3.6.1 Handling and Storage and audit results; nonconformance and corrective reports;
personnel training and certification; evidence of opera Measures should be established to ensure that procedures tional capability; and verification of repair, replacement, provide for any special handling required of the package and maintenance.
while in storage or when moving from one station to another. Particular attention should be given to precau Measures should be established to store records, pro tions required for ensuring radiation safety of the package.
vide for their safekeeping, and prevent their deterioration.
3.6.2 Preparationfor Shipment 3.9 Audit Measures such as use of checklists should be estab lished to ensure that all conditions have been met, in Elements of the QA audit program, including work areas, activities, and processes to be audited to ensure cluding specified operations, inspections and tests, and NRC and DOT shipping requirements, and that all necessary the objective evaluation of practices, procedures, and shipping papers have been completed prior to delivery instructions important to safety and the effectiveness of their implementation should be established. (If the orga to a carrier. nization is so small that independence of the auditing personnel is impractical, a checklist of the activities to
3.7 be audited should be prepared.)
Inspection, Test, and Operating Status Frequencies for the audits listed in the paragraph Subpart B of Part 34 identifies specific inspections and certain tests to be conducted during use and maintenance above should be established.
of radiographic devices. Measures should be established to ensure that identification of the status of these inspec Individuals or organizations responsible for performing tions and tests through use of tags, labels, markings, etc., external audits of the QA program to determine its over is known by organizations responsible for assurance of all effectiveness and compliance with management policies and procedures should have no responsibility in the areas quality. being audited.
7.10-20
APPENDIX A
A Graded Approach to Developing Quality Assurance Programs for Packaging of Radioactive Material The design effort and the requirements for a quality in a condition adversely affecting public health and safety.
assurance program are interrelated and should be developed This would include such conditions as loss of primary simultaneously. Addressing them as independent functions containment with subsequent release of radioactive mate may result in an overly stringent QA program (i~e., one rial, loss of shielding, or an unsafe geometry ccmupronising that imposes unnecessary QA activities to verify attain-. criticality control Category B items could be structures, ment of design objectives) or the development of an components, and systems whose failure or malfunction inadequate quality assurance program (ie., one that could indirectly result in a condition adversely affecting imposes too few QA activities to verify attainment of public health and safety. An unsafe condition could design objectives). To develop a quality assurance program result only if the primary event occurs in conjunction in which the application of QA requirenents is commensu with a secondary event or other failure or environmental rate with their safety significance, it is essential that occurrence. Category C items could be those structures, engineering personnel perform a systematic analysis of components, and systems whose failure or malfunction each component, structure, and system of packages to would not significantly reduce the packaging effectiveness assess the consequence to the public health and safety and would be unlikely to create a condition adversely and the environment resulting from malfunction or affecting public health and safety.
failure of such items. This engineering assessment and quality assurance program development should be initi 3. Level of Quality Assurance Effort ated as early in the design process as practicable and should be in accordance with approved procedures.
The last step would be to assign an appropriate Establishment of an engineering basis for the formula degree of quality assurance effort to each quality cate tion of a quality assurance program early in the design gory. For example, quality requirements for Category A
process enables a uniform, consistent application of QA items would specify the following:
requirements during fabrication, use, and maintenance of packaging. a. The design would be based on the most stringent industrial codes or standards, and design verification A logical sequence leading to identifying realistic would be accomplished by prototype testing or formal quality assurance requirements would be by (1) classifying. design review;
each component, structure, and system as important to safety or not important to safety ("Q" or "non-Q"),
b. The procurement documentation for materials or
(2) grouping items classified as important to safety into services would specify that only suppliers from qualified quality categories, and (3)specifying a level of quality vendor lists be used;
assurance effort applicable to each category. To ensure a better understanding of the process, each step is further c. The suppliers and subtler suppliers would have a detailed below:
1. Clasification QA program based on applicable criteria in Subpart H
to Part 71; I
d. The manufacturing planning would specify complete All components, structures, and systems appearing traceability of raw materials and the use of certified on the latest list of packaging parts would first be welders and processes;
analyzed to determine whether their functions or physi cal characteristics are essential to safety. Those items e. The verification planning (test and inspection) would identified as essential to safety (often referred to as require use of qualified inspectors (i.e., personnel per
"Q" items) are then subject to a QA program based an forming nondestructive examinations such as radiography the requirements of Subpart H to 10 CFR Part 71. and ultrasonic testing would be qualified in accordance with recommended practices described in such documents
2. Qualy Categores as SNT-TC-lA,* Section IX of the ASME Boiler and Pressure Vessel Code,** or other industrial standards);
Quality categories would then be established based on the relative safety significance of each Q item and, where appropriate, their subcomponent parts. .Categories could OCopim of "Pursonnel Qualification and Crtification for Non be identified as A for items that are critical to safe opera d ucte Exmination, Recommended Practice No. SNT-TC-1A,"
tion, B for items with a major impact on safety, and C we available from the American Society for Nondestructiv Test ing, 3200 Riverside Dri*%, Columbus, OH 43221.
for items with a minor impact on safety. For example,
"*Copim of Section D1,'Qualification Standard for Weldiand Category A items could be structures, components, and hazin Procedues, Welders, Bazes and Welding and Brazing systems whose failure or malfunction could result directly Operators," are xaaiable from the American Society of Mechanical Enghners, 345 East 47th Street, New York, NY 10017.
7.10-21
f. Only qualified auditors and lead auditors would c. The manufacturing planning need not require perform audits; and traceability of materials, and only specified welds would be done by qualified welders;
g. A representative of the buyer would be present at a supplier's facility to approve the final acceptance d. Verification activities would still require use of test and to authorize shipment. inspectors qualified to appropriate codes, standards, or other industrial specifications; and Category B quality requirements would include the e. Only the lead auditor need meet certain quali following: fication requirements.
a. The design would be based on the most strin With respect to Category C items, the only quality gent industrial codes and standards, but design verifica requirements enforced would include the following:
tion could be through use of calculations or computer codes; a. Items would be purchased
"off the shelf'; and from a catalog or b. The procurement of materials need not be from b. When the itein is received, the material would a qualified vendor list; be identified and checked for damage.
7.10-22
VALUE/IMPACT STATEMENT
1. BACKGROUND develop, establish, and maintain quality assurance pro grams in accordance with the requirements of Appendix E
Assurance that packaging used to transport radioactive (now Subpart H) to 10 CFR Part 71 for packaging used materials will not be hazardous to public health and to transport radioactive materials.
safety depends greatly on the integrity of the features of the container that are important to safety. The NRC revised 10 CFR Part 71 on September 6, 1983, to be consistent with the International Atomic Energy To increase confidence that designated features impor Agency regulations (Safety Series No. 6) in effect at tant to safety of particular packaging are designed, built, that time. In addition, the format of 10 CFR Part 71 and used so as to minimize the risk to the public from was changed to be compatible with new guidelines exposure to radioactivity, prescribed systematic manage issued by the Office of Federal Regulations concerning ment and administrative controls need to be invoked use of appendices. These format changes resulted in a during each phase of their design, production, and use. nonsubstantive incorporation of Appendix E into the regulation as a new Subpart H. Consequently, for com These management controls are embodied in the' 18 patability, all references in Regulatory Guide 7.10 to criteria of Subpart H, "Quality Assurance," of 10 CFR Appendix E have been changed to Subpart H.
Part 71.
2.2 Need Prior to October 1977, when Appendix E (now Subpart H) became effective, quality assurance (QA) pro According to paragraph 71.37(a), applicants for pack grams were required by approval condition (1972) only age approval are required to identify their quality for packaging designed to transport plutonium, high-level assurance programs, and, according to Subpart H, licensees waste, and irradiated fuel The description of the quality are required to establish and maintain a quality assurance assurance program was to be included in the application program.
for package approval and was reviewed against the cri teria identified in Appendix E to Part 71. Guidance is needed by persons establishing QA pro grams and by persons having NRC-approved QA programs After Appendix E (now Subpart H) became effective who need to maintain them. Guidance is also needed by and pursuant to paragraph 71.24(a) (now paragraph the NRC staff to develop inspection plans and proce
71.37(a)) and § 71.51 (now § 71.101), "Establishment dures.
and Maintenance of a Quality Assurance Program," all applicants for and holders of licenses to use, possess, Furthermore, because there is a wide disparity of design, or build packages to transport radioactive material applicability of the requirements of Subpart H, specific in excess of Type A quantities as defined in paragraph guidance concerning grading of a particular QA program
71.4(g) have been required to provide documented to fit its potential impact on safety is needed. The evidence of a QA program acceptable to the NRC A economic penalties for overcommitment to QA require special provision of the rule allows any licensee with an ments resulting from uniform application of quality NRC-approved QA program covering activities under assurance without regard to its specific impact on safety
10 CFR Part 50, "Domestic Licensing of Production and can be as severe as not applying any quality require Utilization Facilities," as delineated in Appendix B to ments at all to achieve design objectives.
Part 50 to apply it without further approvals to activ ities covered by Part 71. The revision to Regulatory Guide 7.10 is needed to An NRC licensee camot use packaging subject to 10 CFR Part 71 if its use is not covered by an NRC-approved QA program. Also, the rule clarified NRC's position as provide consistency between the guide and 10CFR
Part 71.
23 Value/Impact Ame enent I
to responsibility for quality assurance by stating that it was the licensee who delivers a package to a carrier for 2.3.1 NRC
transport who must ensure that all quality assurance provisions for the package have been followed. Staff time required for evaluation and inspection should be reduced because standardized QA programs
2. PROPOSED ACTION should allow the use of standard review plans and uni form inspection plans and procedures.
2.1 Description Other than the allocation of staff resources to develop The proposed action provides guidance to persons ing, reviewing, and issuing this guide, no impact on the needing information on the essential elements needed to NRC is anticipated.
7.10-23
2.3.2 Other Government Agencies 3.2 Discussion Impact on other government agencies would be essen A regulatory guide is the most efficient way to tially the same as that on industry to the extent that transmit information about the subject QA programs these agencies are regulated by NRC.
that would be acceptable to the NRC. In addition, this regulatory guide exists, and updating to changes in
2.3.3 Industry
10 CFR Part 71 is a relatively simple procedure.
Specific guidance on QA criteria applicable to par
4. STATUTORY CONSIDERATIONS
ticular packaging should aid in developing, establish ing, and maintaining a QA program that meets the spirit
4.1 NRC Authority and intent of the so-called "graded approach." Formu lating a program in which the QA effort expended on The proposed guide provides guidance for the imple an activity is consistent with its importance to safety mentation of regulations promulgated in paragraph 71.101 can be interpreted quite differently by different and described in Subpart H to 10 CFR Part 71. Authority licensees. Spelling out only the applicable criteria as well for these regulations is derived from the Atomic Energy as the specific applicable safety elements will result in a Act of 1954, as amended, and from the Energy Reorga graded approach. Proliferation of documentation preva nization Act of 1974.
lent in industry should be reduced.
4.2 Need for NEPA Assessment
2.3.4 Public No impact on the public is foreseen. Issuance or amendment of guides for the implementa tion of regulations in Title 10, Chapter I, of the Code of Federal Regulations is a categorical exclusion under
2.3.5 Worker paragraphS1.22(c)(16) of 10CFR PartSl. Thus, an environmental impact statement or assessment is not No impact on the worker is foreseen.
required for this action.
2.4 Decision 5. RELATIONSHIP TO OTHER EXISTING OR PRO
The proposed action, developing and issuing a re PROSED REGULATIONS OR POLICIES
vised regulatory guide, should be completed because of the benefits previously discussed. The structure of SubpartH to 10CFR Part 71 is identical to that of Appendix B to 10 CFR Part 50,
which describes quality assurance criteria now in effect
3. PROCEDURAL APPROACH
for nuclear power plants and certain fuel cycle facilities;
the only changes were made to accommodate terminology
3.1 Alternatives specific to transportation.
No meaningful alternative exists. Use of the gener al description of the QA criteria of Subpart H without 6. SUMMARY AND CONCLUSIONS
further amplification would place too much responsibili ty on licensees for judging what constitutes an accept The proposed action will provide persons involved able commitment. The ANSI N14.4 Subcommittee is -in activities related to the packaging for transporta tion of radioactive material much needed information on chartered to produce a standard based but its ongoing effort is not expected to on Subpart H,
be completed the essential elements of QA programs acceptable to the NRC. The revised regulatory guide discussed herein should in the near futur
e. I
be prepared and issued.
7.10-24
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