Regulatory Guide 7.10: Difference between revisions

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{{Adams
{{Adams
| number = ML14064A505
| number = ML003739404
| issue date = 06/30/2015
| issue date = 06/30/1986
| title = (Draft Was Issued as DG-7009, Dated May 2013), Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material
| title = Rev. 1, Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material
| author name = Glenny J
| author name =  
| author affiliation = NRC/RES
| author affiliation = NRC/RES
| addressee name =  
| addressee name =  
Line 9: Line 9:
| docket =  
| docket =  
| license number =  
| license number =  
| contact person = Bayssie M
| contact person =  
| case reference number = DG-7009
| document report number = RG-7.10 Rev 1
| document report number = RG 7.10
| package number = ML14064A494
| document type = Regulatory Guide
| document type = Regulatory Guide
| page count = 34
| page count = 25
}}
}}
{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION                                                                 June 2015 OFFICE OF NUCLEAR REGULATORY RESEARCH                                                                   Revision 3 REGULATORY GUIDE
{{#Wiki_filter:RevisionI
                                          REGULATORY GUIDE 7.10
                            U.S. NUCLEAR REGULATORY COMMISSION                                                                     June 1986
                                        ((Draft was issued as DG-7009, dated May 2013)
                      1REGULATORY GUIDE
          ESTABLISHING QUALITY ASSURANCE PROGRAMS
                            OFFICE OF NUCLEAR REGULATORY RESEARCH
                    FOR PACKAGING USED IN TRANSPORT OF
                                                          REGULATORY GUIDE 7.10
                                            RADIOACTIVE MATERIAL
                        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     


==A. INTRODUCTION==
===7. Transportation===
Purpose This regulatory guide describes an approach that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers acceptable for complying with the related regulatory requirements in Title 10 of the Code of Federal Regulations (10 CFR) Part 71, Packaging and Transportation of Radioactive Material (i.e., Type B and fissile radioactive materials) (Ref. 1). The regulations in 10 CFR
"lted  accidents. or to provIde guidance to applicants. Regulatory Guides are .not substitutes for regulations, and compliance
Part 71 apply to NRC licensees that transport licensed material or that deliver licensed material to a carrier for transport, and to certificate holders who design and fabricate packages for the transport of Type B and fissile radioactive materials. This guidance provides licensees, certificate holders, and applicants with an acceptable method to prepare and submit quality assurance (QA) program descriptions for NRC
                                                                      3.
staff review.


Applicable Rules and Regulations The 10 CFR Part 71 regulations define requirements for packaging of radioactive materials for transport. Specifically:
4.
      *    10 CFR 71.37(a) states that applicants requesting package design approval must describe, consistent with Subpart H of Part 71, Quality Assurance, the QA programs that they will apply in the design, fabrication, assembly, testing, maintenance, repair, modification, and use of the proposed packaging.


*    10 CFR 71.101, Quality Assurance Requirements, states that licensees, certificate holders, and applicants for a certificate of compliance (CoC) must implement and use a QA program that the NRC staff has previously approved.
Fuels and Materials Facilities Environmental and Siting


*    10 CFR 71.101(b) requires, in part, that QA programs of licensees, certificate holders, and applicants for a CoC satisfy each of the applicable criteria specified in 10 CFR 71.101-71.137.
===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.


Written suggestions regarding this guide or development of new guides may be submitted through the NRCs public Web site under the Regulatory Guides document collection of the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/reg-guides/contactus.html.
apProprlate, to accommodate comments and to reflect new Informa tion or experience.


Electronic copies of this regulatory guide, previous versions of this guide, and other recently issued guides are available through the NRCs public Web site under the Regulatory Guides document collection of the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/. The regulatory guide is also available through the NRCs Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under ADAMS Accession No. ML14064A505. The regulatory analysis may be found in ADAMS
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.
under Accession No. ML14064A504. DG-7009 was issued for public comments, and received no comments.


Related Guidance
TABLE OF CONTENTS
*        Terms used in this guide are consistent with those used in 10 CFR Part 71; and standards promulgated by the American National Standards Institute (ANSI) and the American Society of Mechanical Engineers (ASME), ANSI/ASME Standard NQA-1- 2008 and NQA-1a-2009 Addenda, Quality Assurance Requirements for Nuclear Facility Applications, (Ref. 2)
                                                                                                            Page
*        Regulatory Guide 7.6, Design Criteria for the Structural Analysis of Shipping Cask Containment Vessels, (Ref. 3) describes design criteria acceptable to the NRC staff for use in the structural analysis of the containment vessels of Type B packages used to transport irradiated nuclear fuel.


*        Regulatory Guide 7.7, Administrative Guide for Verifying Compliance With Packaging Requirements for Shipments of Radioactive Material, (Ref. 4) describes an approach that the staff considers acceptable for meeting the administrative requirements associated with transferring, shipping, and receiving radioactive material.
==A. INTRODUCTION==
 
.............................................................                     7.10-1
*        Regulatory Guide 7.9, Standard Format and Content of Part 71 Applications for Approval of Packages for Radioactive Material, (Ref. 5) provides guidance on preparing applications for approval of Type B and fissile material transportation packages. It is intended to assist applicants in preparing applications that thoroughly and completely demonstrate the ability of the given packages to meet the regulations.
 
Purpose of Regulatory Guides The NRC issues regulatory guides to describe to the public methods that the staff considers acceptable for use in implementing specific parts of the agencys regulations, to explain techniques that the staff uses in evaluating specific problems or postulated accidents, and to provide guidance to applicants. Regulatory guides are not substitutes for regulations and compliance with them is not required.
 
Information Collection Requirements This regulatory guide contains information collection requirements covered by 10 CFR Part 71, that Office of Management and Budget (OMB) approved under OMB control number 3150-0008. The NRC may neither conduct nor sponsor, and a person is not required to respond to, an information collection request or requirement unless the requesting document displays a currently valid OMB control number.
 
RG 7.10, Page 2


==B. DISCUSSION==
==B. DISCUSSION==
Reason for Revision This guide is being revised to address new and revised NRC regulatory requirements applicable to QA programs under 10 CFR Part 71. The regulatory revisions include, among other things, (1)
.................................................................                        7.10-1  
establishing requirements to allow some changes to be made to a previously approved QA program without obtaining additional NRC approval, and (2) removing the requirements for renewal of QA
program approvals. This updated guidance accompanies the final 10 CFR Part 71 rule. The amendments revise the regulations for the packaging and transportation of radioactive material to: (a) make the NRC
regulations compatible with the 2009 edition of the International Atomic Energy Agencys (IAEA)
transportation standards, Regulations for the Safe Transport of Radioactive Material, (TS-R-1), (Ref.


6), (b) maintain consistency with changes in the U.S. Department of Transportation (DOT) regulations, and (c) make other clarifying changes to the requirements for the packaging and transportation of radioactive material.
==C. REGULATORY POSITION==
. .......................................................                        7.10-1


Regulatory Framework for Transport of Radioactive Material The NRCs regulatory requirements for packaging and transporting radioactive materials are codified in 10 CFR Part 71. Those requirements state that the agency grants licenses to transport radioactive materials, under the provisions of 10 CFR Part 71, Subpart C, General Licenses, only to licensees whose QA programs the NRC has previously approved as satisfying the provisions of 10 CFR Part 71, Subpart H. The NRC also imposes QA requirements on those who submit applications for approval of package designs under the provisions of 10 CFR Part 71, Subpart D,
==D. IMPLEMENTATION==
Application for Package Approval. Specifically, in accordance with 10 CFR 71.31(a), an application for approval under Subpart D must include, for each proposed package design, a QA program description as required by Subpart H, or a reference to a QA program that the NRC has previously approved. If an applicant fails to include a QA program description or to reference a previously approved description, the NRC staff considers the application incomplete and may return it. As used in 10 CFR Part 71 Subpart H,
............................................................                  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
quality assurance comprises all planned and systematic actions necessary to provide adequate confidence that a system or component will perform satisfactorily in service. As such, QA includes quality control (QC), which comprises those quality assurance actions that relate to controlling the physical characteristics and quality of the materials or components in accordance with predetermined requirements.


Subpart H of 10 CFR Part 71 establishes QA requirements that apply to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of packaging of components important to safety (i.e., the features of a structure, component, or system under control of the QA program and necessary to ensure the integrity of the packaging and its capability to prevent or mitigate the consequences that could result from release of radioactive material). To meet those requirements, licensees, certificate holders and applicants (hereinafter referred to as QA program user) should control the quality of each of the above activities using a graded approach (i.e., the QA effort expended on an activity should be consistent with the importance to safety of the associated structures, systems, and components). For the purposes of this regulatory guide, structures, systems, and components important to safety mean the features of a Type B
==A. INTRODUCTION==
or fissile material package that are intended to (1) maintain the conditions required to safely transport the package contents, (2) prevent damage to the package during transport, or (3) provide reasonable assurance that the radioactive contents can be received, handled, transported, and retrieved without undue risk to the health and safety of the public or the environment. Appendix A to this guide, A Graded Approach to Developing Quality Assurance Programs for Packaging Radioactive Materials, describes a method for developing a QA program with a graded approach. Additional guidance on the graded approach for RG 7.10, Page 3
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                            


QA programs is available in NUREG/CR-6407, Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety (Ref. 7).
==C. REGULATORY POSITION==
        Pursuant to §71.101(c), before any package is used to ship licensed material, each licensee must obtain NRC approval of its QA program, along with a discussion of which Subpart H requirements apply and how those requirements will be satisfied . The licensee should address the regulations delineated in Subpart H to the extent they are applicable to its operations.
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.


The types of activities in which a given QA program user engages will determine which sections of the Subpart H regulations will need to be addressed and which activities the NRC staff will review before approving the QA program. The QA program activities may be divided into two major areas. The first area comprises activities associated with 10 CFR Part 71, Subpart D, which usually leads to issuance of a CoC and fabrication of the approved packaging. The activities normally authorized by an NRC-
Any information collection activities mentioned in this regulatory guide are contained as requirements in 10 CFR
approved QA program in this area are design, testing, repair, fabrication, procurement, modification, assembly, maintenance, and use. The second area comprises activities associated with 10 CFR Part 71, Subpart C, General Licenses. The activities normally authorized by an NRC approved QA program in this area are repair, procurement, maintenance, and use.
                                                                                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.


This regulatory guide includes information about commonly misinterpreted areas of
3150-0008.
10 CFR Part 71, such as (1) the level of detail required in QA program descriptions, (2) submittal of program descriptions based solely on other QA standards, and (3) requirements for changes to previously approved NRC QA program descriptions.


Level of Detail in QA Program Descriptions In their program description submittals, QA program users should identify how each regulation in
The recommendations of this guide apply to the gen
10 CFR Part 71, Subpart H, applies to their particular situation and how those regulations will be satisfied. Thus, the information supplied for NRC review varies as a function of the nature of the activities in which a given QA program user will engage. For example, a QA program user who has a general license solely to transport radioactive materials in packages purchased or leased for that purpose would be expected to address criteria governing such activities (e.g., procurement, shipment, and handling). By contrast, a QA program user who designs and fabricates a package would be expected to address criteria for design and testing, as well as activities related to procuring the component materials.


Elements that are common to all QA program descriptions include the quality organization and program, corrective actions, QA records, and audits (among others).
==B. DISCUSSION==
        In defining what the NRC staff considers to be an acceptable QA program description submittal, it is beneficial to discuss what the NRC considers an unacceptable submittal. Generally, in an unacceptable submittal, the QA program description may contain either too little or too much information.
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.


In terms of not providing enough information, this includes a QA program description that basically restates the QA program requirements in Subpart H of 10 CFR Part 71, fails to describe which elements of the NRCs QA program requirements apply to the QA program users activities, and fails to describe how the QA program user would satisfy those requirements. However, a QA program submittal may be extremely detailed, to the point that it contains actual implementing procedures, which the staff does not review. Thus, an acceptable QA program submittal addresses each regulation in Subpart H of 10 CFR
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.
Part 71 that applies to the QA program users activities and describes how the QA program user will comply with such requirements.


RG 7.10, Page 4
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.


Quality Assurance Program Submittals Based on Other Standards The NRC staff occasionally receives QA program descriptions that are based on QA standards other than 10 CFR Part 71 Subpart H, such as ANSI/ASME NQA-1-2008 with the NQA-1a-2009 Addenda (Ref. 2), or the standard promulgated by the International Organization for Standardization (ISO) 9000 series, Quality Management Systems (Ref. 8). While the staff may find such submittals acceptable upon review, QA program users should be aware that the QA regulations in 10 CFR Part 71 include requirements that other standards may not fully address. In general, programs based on certain NQA-1 revisions or the ISO 9000 standards will require supplementation to address all applicable Subpart H regulations. The only exception is the ANSI/ASME NQA-1-2008 with the NQA-1a-2009 Addenda, which the NRC has endorsed in its entirety. Without supplementation, the NRC may require the QA program user to submit additional information about how the applicable Subpart H regulations will be met, if standards other than ANSI/ASME NQA-1-2008 with the NQA-1a-2009 Addenda are being relied on. This may necessitate changes to the submitters underlying QA program and delay NRC
7.10-1
review and approval. Additional guidance may also be found in NRC Information Notice 86-21, Recognition of American Society of Mechanical Engineers Accreditation Program for N Stamp Holders, and its two supplements (Ref. 13, and 14).
Changes to Approved QA Program Descriptions Based on the applicable NRC regulations and the approved QA program, the QA program user should develop and implement lower-level (working-level) documents to govern the conduct of QA activities that are important to safety.


Previously, all changes to an approved QA program description required NRC approval.
==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.


Therefore, before implementing any change in the QA program description that was used as the basis for NRC approval, the QA program user was required to submit the proposed change for NRC review. That requirement was significantly changed under new provision §71.106. Specifically, new §71.106(a)
7.10-2
requires that the NRC only review and approve changes that reduce commitments to an approved QA
program description before they are implemented. Under new provision §71.106(a)(1), the NRC requires the following information for submitted changes that reduce commitments, made to an approved QA
program description: (1) a description of the proposed changes to the approved QA program description,
(2) the reason for the change, and (3) the basis for concluding that the revised program incorporating the change continues to satisfy the requirements of Subpart H. Requests for review and approval of such changes are handled through amendments to the QA program approvals.


In accordance with new §71.106(b), administrative changes (e.g., revisions to format, font size or style, paper size for drawings and graphics, or revised paper color) and clarifications, spelling corrections, and nonsubstantive editorial or punctuation changes will not require NRC approval. Changes to reporting responsibilities, functional responsibilities, and functional relationships, may be substantive and have the potential to reduce commitments made to the NRC and, in these instances, would require prior NRC
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
approval before being implemented. The new §71.106(b) lists the following changes that are not considered to reduce commitments made to the NRC:
I  same order as the criteria in Subpart H of 10 CFR Part 71.
        (1)      use of a QA standard that the NRC has approved, which is more recent than the QA
                  standard in the current QA program at the time of the change
        (2)      use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles RG 7.10, Page 5


(3)      use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text
program plan and implemented in QA manual
(4)      elimination of QAP information that duplicates language in QA regulatory guides and QA
        standards to which the holder of the QAP approval is committed
(5)      organizational revisions that ensure that personnel and organizations performing QA functions continue to have the requisite authority and organizational flexibility, including sufficient independence from cost and schedule when opposed to safety considerations All changes made to an approved QA program description must be reported to the NRC every 24 months. If the QA program approval holder has not made any changes to their approved QA program description during the preceding 24-month period, then the QA program approval holder would indicate to the NRC that no changes have been made. Additionally, each QA program approval holder must maintain records of all QA program changes, in accordance with new §71.106(c).
Harmonization with International Standards The International Atomic Energy Agency (IAEA) has established a series of safety standards and guides to provide for a high level of safety for protecting people and the environment. IAEA safety standards present a point of reference for international good practices to help users striving to achieve high levels of safety. This regulatory guide is compatible with the 2009 edition of the IAEA
transportation requirement, TS-R-1, Regulations for the Safe Transport of Radioactive Material (Ref.


6).
====s. The policy I====
        Also pertinent to this regulatory guide is IAEA Safety Standards Series no. GS-R-3, The Management System for Facilities and Activities (Ref. 9). The standard is broadly written, addressing quality of components and processes, as well as management and safety culture. It uses the term management system rather than quality assurance. The term management system reflects and includes the initial concept of quality control (controlling the quality of products) and its evolution through quality assurance (the system to ensure the quality of products) and quality management (the system to manage quality). The management system is defined as a set of interrelated or interacting elements that establishes policies and objectives and which enables those objectives to be achieved in a safe, efficient and effective manner. Implementing guidance is provided in an IAEA Safety Guide, IAEA Safety Standards Series No. GS-G-3.1, Application of the Management System for Facilities and Activities (Ref. 10). This regulatory guide is consistent with the basic safety principles outlined in IAEA Safety Standard GS-R-3 and Safety Guide GS-G-3.1.
                                                                      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.


Documents Endorsed in this Guide This regulatory guide endorses, in part, the use of one or more codes or standards developed by external organizations, and other third party guidance documents. These codes, standards and third party guidance documents may contain references to other codes, standards or third party guidance documents (secondary references). If a secondary reference has itself been incorporated by reference into NRC
The structure of the organization and the assignment of responsibility for each function should ensure that
regulations as a requirement, then licensees and applicants must comply with that standard as set forth in the regulation. If the secondary reference has been endorsed in a regulatory guide as an acceptable approach for meeting an NRC requirement, then the standard constitutes a method acceptable to the NRC
                                                                      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
staff for meeting that regulatory requirement as described in the specific regulatory guide. If the secondary reference has neither been incorporated by reference into NRC regulations nor endorsed in a regulatory guide, then the secondary reference is neither a legally-binding requirement nor generically approved as an acceptable approach for meeting an NRC requirement. However, licensees and applicants RG 7.10, Page 6


may consider and use the information in the secondary reference, if appropriately justified and consistent with current regulatory practice, consistent with applicable NRC requirements such as 10 CFR 50.54.
====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.


RG 7.10, Page 7
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.


C. STAFF REGULATORY GUIDANCE
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.,
          To evaluate compliance with the QA requirements of Subpart H of 10 CFR Part 71, the NRC staff typically reviews elements of a QA program that involve activities related to the design, fabrication, procurement, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, modification, and use of radioactive material packaging. The applicability of each element depends on the activities in which the QA program user is involved as well as the graded approach that the QA program user implements for items that are important to safety.
  engineering, procurement, inspection, testing, quality assur      written procedures and instructions and will be in place prior to engaging in these activities.


Individuals and organizations that are subject to Subpart H should submit their QA program descriptions to obtain NRC approval before engaging in any activity that is important to safety. Those who engage in activities important to safety before obtaining NRC approval of their QA programs are at risk of having to demonstrate that such activities were in compliance with the QA program submitted.
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.


Upon determining that a given QA program submittal is adequate, the NRC will issue a QA program approval Establishment of a QA program implies that all activities important to safety and applicable to the design, fabrication, procurement, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, modification, and use of packages are implemented with written procedures approved by appropriate levels of management. Certificate holders and applicants for a package approval are responsible for satisfying the QA requirements that apply to design, fabrication, testing, and modification of packaging. Licensees are responsible for satisfying the quality assurance requirements which apply to their use of a packaging for the transport of licensed material. The licensee will notify the NRC before its first use of any package, and certificate holders and applicants will notify the NRC before the fabrication, testing, or modification of a package.
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.


A previously approved quality assurance program that satisfies the applicable criteria of 10 CFR
procedures with an estimated date *for completion should be included. Table I of this annex shows a
Part 71 subpart H, 10 CFR Part 50 Appendix B, or 10 CFR Part 72 subpart G, and that is established, maintained, and executed regarding transport packages, will be accepted as satisfying the requirements of
      1.1.2 Top Management Endorsement of a Quality suitable format for listing procedures to demonstrate Assurance Program                                      implementation of a documented QA program.
71.101(b). Before first use, the licensee, certificate holder, or applicant for a CoC, shall notify the NRC
of its intent to apply its previously approved subpart H, Appendix B, or subpart G quality assurance program to transportation activities. The licensee, certificate holder, or applicant for a CoC shall identify the program by date of submittal, docket number, and date of approval. The NRC also has endorsed the use of ANSI/ASME NQA-1-2008 and the NQA-1a-2009 Addenda, Quality Assurance Requirements for Nuclear Facility Applications, as a standard that, when properly applied and supplemented (as necessary) to meet all applicable criteria, should result in the development of a QA program that is acceptable to the NRC staff.


1.       Guidance on 10 CFR 71.103, Quality Assurance Organization
Top management needs to maintain a continuing in
          1.1      Structure and Authority For each function, the structure of the organization and the assignment of responsibility should ensure that the following requirements are fulfilled:
                                                                        1.2.2 Personnel volvement in QA matters if the QA program is going to*
                  *        The formal structure of the organization is documented by organization charts that identify each organizational element that functions under the QA program.
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


*       The discussion specifies the required authority and organizational responsibility, including sufficient independence from influences of cost and schedule.
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.


*        The specified quality requirements are achieved and maintained by those who have been assigned the responsibility for performing the work.
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.


RG 7.10, Page 8
QAM, QP 3                              Design Control                3          Describes design control measures established for structures, systems, and components.


*        The QA program user has established measures to provide adequate control over activities important to safety (e.g., inspecting, cleaning, purchasing, and preparing the packaging for delivery).
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.
          *        The conformance to established requirements is verified by individuals and groups not directly responsible for performing the work.


Note: If, because of staffing limitations, the same individuals perform multiple functions (including QA), the QA program user should establish measures to ensure that the designated individuals performing QA and QC functions have the responsibility and authority to stop unsatisfactory work and delivery or installation of nonconforming material. These individuals also should have direct access to management levels that can ensure that QA procedures important to safety have been accomplished.
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.


In addition, the QA program user should establish and document the required duties and qualifications for (1) the individual who has overall authority and responsibility for the QA program, as well as (2) other personnel performing QA and QC functions.
*The information requested for all 18 aiteda would be fisted; the table shows examples for Criteria 1, 2, 3, 4, and 18 only.


Individuals with QA and QC functions should have the written endorsement of upper management.
7.10-4


1.2    Senior Management Endorsement of a QA Program Senior management, the company or corporate president or chief executive officer, should maintain a continuing involvement in QA matters to ensure that the QA program is effective. Senior management should establish a written company or corporate policy to perform work on items important to safety in accordance with the requirements of
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.
          10 CFR Part 71, Subpart H. This policy should be described in or incorporated into the QA program plan and implemented through the QA program procedures.


The policy statement should also identify the functions and positions that have delegated authority for the following tasks:
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.
          *        Implement and revise the provisions of the described QA program.


*        Regularly assess the scope, status, implementation, and effectiveness of the QA
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.
                  program.


2. Guidance on 10 CFR 71.105, Quality Assurance Program
ing and testing, should be qualified based on their abilities gained through education, training, and expe
  2.1    General Guidance on QA Programs In its program description submittal, the QA program user should describe to the NRC
                                                                        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.
          how each of the requirements in Subpart H of 10 CFR Part 71 applies to its particular situation and how each requirement will be satisfied. The information supplied for NRC
          review will vary as a function of the nature of activities in which the QA program user is involved. For example, an individual or organization using a general license solely for transportation of radioactive material in packages purchased or leased for that purpose would be expected to address regulations governing activities such as procurement, shipment, and handling. By contrast, someone who designs and fabricates packaging would be expected to address criteria for design and testing, as well as material RG 7.10, Page 9


procurement activities. Elements common to all QA program descriptions include the quality organization and program, corrective action, QA records, and audits.
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.


In developing its program, a prospective QA program user can refer to the NRCs guidance in this regulatory guide, as well as the additional guidance on graded QA approach in NUREG/CR-6407 (Ref. 7). In developing its program, a QA program user should apply each of the applicable Subpart H regulations in a graded approach (i.e., to an extent that is consistent with items important to safety).
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.
     Following the NRC staffs technical review and determination that the QA program submittal meets regulatory requirements, the Commission issues a QA program approval.


Changes to an approved QA program are specifically addressed in new §71.106 as described in Section B, DISCUSSON, of this Regulatory Guide.
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.


Based on NRC approval of its QA program description submittals, a QA program user will translate the regulations discussed in its submittals into lower-level (working-level)
conformance to these quality requirements should be documented.                                                          During the sequence of design verification, changes to the final design may result; consequently, measures
    implementing procedures that govern the conduct of QA activities important to safety.
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.


If the NRC staff reviews a QA program submittal and finds that it inadequately describes how the requirements will be met or fails to specifically address some Subpart H
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.
    regulation(s), the staff will either reject the QA program submittal or ask the QA program user to submit additional information to correct the deficiencies.


2.2 Scope of QA Program The QA program user should establish measures for identifying: (1) the components, structures, and systems that the QA program will cover, and (2) the approach for verifying that the applicable components, structures, and systems meet design objectives.
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


Although 10 CFR Part 71 allows the development of a graded QA program, this does not preclude the alternative of defining a program with additional measures if such a program is deemed necessary to attain the confidence needed for meeting design objectives. In particular, the QA program user should establish measures to ensure that the following requirements are fulfilled:
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.
    *        Activities important to safety are performed using specified equipment and under suitable environmental conditions.


*        QA and QC manuals specify the designated responsibilities for implementation of activities important to safety.
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.


*        The QA program user has established indoctrination programs to ensure that personnel performing activities important to safety are trained and qualified to perform those activities.
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.


2.3 Applicability of QA Program Measures that the QA program covers should be compatible with and emphasize characteristics identified in the manufacturers QA program. The QA program user should establish the rationale for identifying items classified as important to safety and subject to the users QA program.
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.


RG 7.10, Page 10
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.


2.4      Documentation The QA program user should ensure that written procedures and instructions:
acceptance criteria to verify that activities important to safety have been satisfactorily accomplished.
                  (1) describe all activities that are important to safety and applicable to the design, procurement, fabrication, and testing of packaging, and (2) will be in place before the QA
                  program user engages in those activities.


If the QA program user has not yet initiated activities important to safety, the user should identify the implementing procedures for such activities by title and procedure number and provide a brief description of the content of those procedures with an estimated date for their completion. The following table shows a suitable format for listing procedures to demonstrate implementation of a documented QA program.
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.


Table 1. Format for Listing Implementing Procedures*
QA organization reviews and concurs in inspection plans;
Implementing                  Title            Regulatory          Description Document                                        Position per Regulatory Guide 7.10
                                                                    test, calibration, and special process procedures; and
Quality Assurance              Organization     1                  Identifies the QA organization, its relationship Manual (QAM), Quality                                                to other organizations within the company, and its Procedure (QP) 1                                                    responsibilities for activities affecting quality.
     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.


QAM, QP 2                      QA Program        2                  Describes basic methods for establishing a documented QA program that implements requirements of Subpart H to Part 71.
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.


QAM, QP 3                      Design            4                  Describes design control measures established Control                              for structures, systems, and components.
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.


QAM, QP 4                      Procurement       5                   Describes procedures for ensuring that applicable Document                              regulatory requirements, design bases, and other Control                              requirements necessary to ensure adequate quality are suitably included or referenced in documents for procurement of material, equipment, and services.
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.


QAM, QP 18                    Audits            19                  Describes internal and external audit programs applicable to both in-house and major suppliers.
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.


* This table shows examples only for Regulatory Positions 1, 2, 4, 5, and 19; however, the QA program user should provide the requested information for all 18 regulatory positions, as applicable.
6. Nonconformance reports,
    7. Requirements for reporting        and approving dis position of nonconformances.                                            7. Design change requests, and
                                                              7.10-6


To demonstrate that written procedures fully implement and reflect the current status of the documented QA program, the QA program user should establish and maintain a master index of QA procedures related to all activities important to safety, as well as a matrix of the QA procedures that implement each section of 10 CFR Part 71, Subpart H.
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.


These written procedures should also address the use, management, and storage of electronic records and data.
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.


2.5      Controlled Conditions and Assignment of Responsibilities The QA program user should establish measures to ensure that activities important to safety are accomplished using appropriate production and test equipment, suitable environmental conditions, applicable codes and standards, and proper work instructions.
conform to procurement documents.


The QA program user should also document the assignment of responsibility for each task and method used to verify conformance to these quality requirements.
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


RG 7.10, Page 11
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.


3. Guidance on 10 CFR 71.107, Package Design Control Essential elements of adequate design control are (1) clearly-established working relationships among those responsible for preparing design disclosures, (2) conducting independent design analyses, (3) coordinating interfaces, and (4) maintaining lines of communication. To ensure an adequate commitment to control of design activities, applicants should consider the three principal areas of (1) control of the design process, (2) control of design input, and (3) control of design verification, as defined in regulatory positions 4.1 - 4.3.
preclude use of items whose shelf life or prescribed
                                                                        1.10.2.2 In-Process. Measures should be established to operation time has expired.


Computer-aided design (CAD) is extensively used in current design applications. Designs developed using CAD methods are prepared and stored electronically. Thus, applicable QA
ensure that process specifications and their supporting documentation provide for indirect control by monitor
  procedures for verification and validation, management of electronic records, and quality control of electronic data should address the control of electronic data in design applications to ensure authenticity and technical accuracy. The Nuclear Information and Records Management Association (NIRMA), ANSI, and the Electric Power Research Institute (EPRI) provide guidance for use in developing QA programs for managing electronic data. In addition, NRC Generic Letter 88-18, Plant Record Storage on Optical Disks (Ref. 11), and Regulatory Information Summary 00-18, Guidance on Managing Quality Assurance Records in Electronic Media (Ref. 13), provide guidance on the use of optical disc document imaging systems for retrieving record copies of QA records.
      1.8.2 ConditionalReleases ing processing methods, equipment, and personnel Measures should be established to facilitate con            if direct inspection is impractical.


3.1     Control of the Design Process The QA program user should establish measures such as classification of characteristics to ensure that packaging designs are reviewed to emphasize parameters important to safety that can be controlled by inspections or tests and to identify test and inspection criteria and quality standards.
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.


To control the preparation of drawings and specifications, the QA program user should establish recognized engineering practices. Engineering practices may include:
criteria:
            (1) prescribing drafting room standards, (2) checking methods, establishing review and approval and issuance and distribution requirements (including revisions to them),
                                                                        1.10.3 Inspectors
            (3) maintaining current as-built configurations, and (4) storing and controlling original and master copies.
      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.


3.2      Control of Design Input The QA program user should establish measures to ensure that appropriate codes and standards are used in the design of the packaging. In the absence of such codes and standards for formulation of the design activities, the QA program user should identify alternative approaches.
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.


The QA program user should establish measures to ensure that (1) the responsible design organization has properly considered, reviewed, and approved all design parameters (e.g., criticality physics, cooling, and decontamination of an item), (2) the parameters are in accordance with the applicable performance codes, standards, and regulatory requirements, and (3) design documents specify the related maintenance, repair, inservice inspection, handling, storage, and cleaning requirements.
evidence of verification.


RG 7.10, Page 12
3. Qualification records of procedures, equipment,            1.11 Test Control and personnel are established, filed, and kept current.


3.3    Control of Design Verification The QA program user should establish methods for use in verifying the adequacy of the design (e.g., qualification testing, design review, or alternative calculations, including use of computer programs). Technically qualified individuals or groups responsible for design verification should not be in the administrative line of authority of the original designer, with the exception that the designers immediate supervisor may perform the verification, provided that the following criteria are met:
1.11.1 Requirements
           *        The supervisor is the only technically qualified individual.
  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.


*        The supervisors management documents and approves the need in advance.
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.


*        The QA audits cover the effectiveness of the use of supervisors as design verifiers to guard against abuse of this practice.
test specimen, methods for documenting or recording test data, and criteria for acceptance) are properly trans
    1.10.2 Inspections                                          lated into test procedures.


Changes to the final design may arise during the sequence of design verification.
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.


Consequently, the QA program user should establish measures to ensure that drawing and specification changes are reviewed and approved by the same individuals or organizations that reviewed and approved the original documents. Changes in design that could result in conditions different from those prescribed in the CoC should be approved by the NRC prior to implementation.
7.10.8


Design verification, if other than by qualification testing of a prototype or lead production unit, should be satisfactorily completed before release (1) for procurement or fabrication and (2) to other organizations for use in other design activities, except when this timing cannot be met. In such cases, design verification may be deferred, provided that the justification for this action is documented and the unverified portion of the design output documents are appropriately identified and controlled. When a test program is used to verify the adequacy of a design, the prototype should be subjected to the most adverse design conditions.
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.


Even though users of packaging do not normally perform design activities, users should establish and verify that the packaging was designed under the control of an NRC-approved QA program.
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.


4. Guidance on 10 CFR 71.109, Procurement Document Control The QA program user should establish measures to control the preparation, review, concurrence, and approval of all procurement documents.
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.


4.1    Content of Procurement Documents The QA program user should establish measures to ensure that procurement documents include the following information (to the extent applicable to their respective operations):
Measures should be established to identify noncon
          *        The scope of work to be performed by the prospective supplier.
      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.


*        The design-basis technical requirements (or references thereto), including applicable regulatory requirements, material and component identification RG 7.10, Page 13
to be out of calibration. If any measuring equipment is consistently out of calibration, it should be repaired
                                                                          1.15.2 Segregation or replaced.


requirements, drawings, specifications, codes and standards, special process instructions, and test and inspection requirements.
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.


*        Applicable Subpart H requirements that should be complied with and described in the suppliers QA program (e.g., qualified QA personnel from the purchasers organization should review and provide review concurrence on the suppliers QA
1.13.1 Preservation
            program or portions thereof before the purchaser initiates activities that the program affects. Also, if subtier suppliers are involved, the QA program user should specify the QA provisions appropriate to those procurements. The extent of the suppliers and subtier suppliers QA programs will depend on the particular item or service being procured).
                                                                          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.
    *        Permission to gain access to the suppliers and subtier suppliers plant facilities and records for inspection and audit purposes (e.g., procurement documents should identify the type of verification activities required of any subtier suppliers for supplied materials, as well for any design, fabrication, assembly, testing, maintenance, and repair services or activities supplied).
    *        Identification of the documentation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, results of chemical and physical tests on material) that the supplier(s) must prepare, maintain, and submit to the purchaser for approval.


*        Requirements for reporting and approving disposition of nonconformances.
or special markings) to adequately identify and preserve packaging components or assemblies.


*        Identification of records that the supplier must retain, control, and maintain, as well as those records that the supplier must deliver to the purchaser before installation of hardware. These records should include the pertinent documentation to be furnished with the procured materials or services (e.g., CoC,
1.15.4 Evaluation
            as-built drawings, photographs, sketches, and use and maintenance manuals). If the pertinent documentation is in an electronic format, the QA program user also should maintain information on the specific software applications and storage or computing hardware.
      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.


4.2 Replacement Part Procurement Measures should be established to require that the QA program user reviews procurements of replacement parts important to safety to ensure that appropriate technical and QA requirements are included in purchase orders and that the purchase orders are placed with suppliers previously qualified during packaging fabrication. If replacement parts are purchased from suppliers not previously identified as qualified sources, the QA
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
    program user should ensure that the replacement parts meet requirements at least as stringent as the original criteria.
                                                                    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.


4.3 Review and Changes to Procurement Documents The QA program user should establish measures to ensure that review and approval of procurement documents are recorded before release, and that changes and revisions to those documents are subject to at least the same review and approval process as the original documents.
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.


RG 7.10, Page 14
7.10-9


5. Guidance on 10 CFR 71.111, Instructions, Procedures, and Drawings
L- -_____
  5.1    Quality Assurance Program Procedures The QA program user should establish measures to ensure that the following requirements are fulfilled:
      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
          *      Activities important to safety are prescribed and accomplished in accordance with current documented instructions, procedures, or drawings that have been approved by appropriate levels of management.
  1.17 Quality Assurance Records until prescribed conditions are satisfied.


*      Instructions, procedures, and drawings specify the methods for complying with each of the applicable sections of Subpart H of 10 CFR Part 71.
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.


*      All work activities are coordinated with QA personnel to ensure that the work- controlling documents incorporate appropriate inspection and hold points to verify that initial work, planned work, effective repairs, or rework have been performed satisfactorily.
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.


*      Instructions, procedures, and drawings include quantitative acceptance criteria (e.g., dimensions, tolerances, and operating limits) and qualitative acceptance criteria (e.g., workmanship samples) to verify that activities important to safety have been accomplished satisfactorily.
(4) conditions detrimental to quality, (5) names of inspectors, testers, or data recorders, and (6) evidence of
                                                                    1.18 Audits acceptability.


*      Written procedures address the use, management, storage, and protection of electronic records and data. The QA program user should also maintain information on the specific software applications and storage or computing hardware.
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.


5.2    QA Review and Concurrence The QA program user should establish measures to ensure that the QA organization reviews and concurs in inspection plans; test, calibration, and special process procedures;
while it is installed in the packaging or stored for future use. These are the records that demonstrate the
          and specifications as well as any changes thereto. Before fabrication of an item, the QA
                                                                      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.
          organization should review and concur in the related manufacturing plans, as they relate to scheduled witness and hold points during fabrication.


6. Guidance on 10 CFR 71.113, Document Control
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
  6.1    Controlled Documents The QA program user should maintain control of each of the documents of the QA
                                                          7.10-10
          program to reflect the current status. As a minimum, the QA program user should exercise control over the following:
          *      design documents (e.g., drawings, specifications, and computer codes)
          *      procurement documents
          *      QA and QC manuals
          *      operating, maintenance, and modification procedures
          *      inspection and test procedures
          *      nonconformance reports RG 7.10, Page 15


*        design change requests
to safety (e.g., procurement, training of personnel) to be
          *        corrective action reports
                                                                            1.18.4 PreauditConference included in the audit program should be identified.
  6.2    Control of Document Generation and Issuance The QA program user should establish controls to ensure that all documents and any changes are adequately reviewed and approved before they are issued. These controls should include measures (e.g., the use of a master document list) to ensure that current issues of applicable documents are available at the location where the activity is being performed, to preclude use of obsolete or superseded documents. The QA program user also should check all packaging affected by design changes to verify that it is in accordance with the appropriate revision. In addition, the QA program user should identify (by function or position) the individuals or groups responsible for reviewing, approving, and issuing documents and revisions thereto.


6.3    Control of Document Changes The QA program user should establish measures to ensure that changes to documents are reviewed and approved by the same organization that performed the original review and approval, and the changes are in accordance with established configuration control procedures.
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.


6.4    Control of Electronic Documents If the documents are stored electronically, the QA program user should establish controls over access to the documents to ensure that the latest versions are available and changes are properly authorized and implemented. The software and hardware systems used to store electronic information should be reliable and secure to avoid alteration or corruption of the information.
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.


7. Guidance on 10 CFR 71.115, Control of Purchased Material, Equipment, and Services The QA program user should establish measures in the areas identified below to ensure that materials, equipment, and services conform to procurement documents.
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.


7.1     Procurement Document Planning The QA program user should establish procurement planning procedures that describe each procurement step leading to contract award for items and services. These procedures should identify the organizations responsible for each procurement step.
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.


7.2    Selection of Procurement Sources The QA program user should establish measures for evaluating and selecting procurement sources, including the extent of QA and engineering involvement.
scribed schedule.


Specifically, the QA program user should consider establishing the following provisions (if applicable):
7.10-11
          *        the suppliers capability to comply with applicable sections of Subpart H
          *        results of the survey of the suppliers facility and QA program
          *        review of the suppliers previous records and performance RG 7.10, Page 16


7.3 Bid Evaluation and Award The QA program user should establish measures to ensure that designated individuals or organizations evaluate proposed suppliers, as applicable to the type of procurement, based on technical considerations, conformance to QA requirements, production capability, and past performance. Before contract award, the QA program user should resolve (if possible) all unacceptable conditions identified during the bid evaluation. If any unacceptable conditions cannot be resolved before contract award, the QA program user should obtain the suppliers commitment that the conditions will be resolved at a mutually agreeable date during the contract period.
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.


7.4 Supplier Performance Control The QA program user should establish measures for pre- and post-award 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.


These activities may include meetings and other communications, to ensure that the supplier understands procurement requirements, including, if applicable, hold points (i.e., pre-established inspection points in the manufacturing process that require inspection approval and release by the QA organization before further processing) during manufacturing and testing and before shipment.
repair of packaging.


7.5 Verification Activities The QA program user should establish the extent to which source surveillance will be performed during fabrication, assembly, maintenance, modification, repair, inspection, testing, and shipment to ensure conformance with the purchase order requirements. The source surveillance should cover the following aspects:
This annex provides guidance on                                        2.3    Design Control the essential ele ments needed to develop, establish, and maintain a QA
    *        instructions specifying characteristics or processes to be witnessed, inspected, or verified
    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
    *         the documentation required
    2.1      Organization                                                      control of an NRC-approved QA program (see Sec tions 2.4.1 and 2.7 of this annex).
    *        identification of those responsible for implementing source surveillance The QA program user also should establish the extent to which inspection will be performed upon receipt of supplier-furnished hardware to ensure that items are properly identified and correspond with procurement documentation. When acceptance of an item is contingent on tests after installation in the package, the QA program user and item supplier should mutually establish the relevant acceptance documentation before its use.
          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.


In addition, the QA program user should take appropriate measures (such as source surveillance and audits of records) to ensure that the supplier performed the design and fabrication of packaging under the control of an NRC-approved QA program.
7.10-13


7.6 Controlling Nonconformances The QA program user should establish measures to ensure the proper disposition of items or services that do not meet procurement requirements. These measures should include evaluation of nonconforming items categorized by the supplier, along with technical justification and recommended disposition (e.g., use as is or repair).
2.5    Instructions, Procedures, and Drawings changes to documents are reviewed and approved by the same organization that performed the original review
                                  RG 7.10, Page 17
          2.-51 PreparationofPackagingfor Use                        and approval.


7.7      Records The QA program user should establish measures to ensure that the supplier furnishes the following records to the purchaser (as a minimum):
Procedures for meeting the requirements of of 10CFR Part71 for placing the packaging §in71.87  use
            *        documentation that identifies material or equipment and the specific procurement requirements (e.g., codes, standards, and specifications met by the items)
                                                                    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.
            *        documentation that identifies any procurement requirements that have not been met, along with a description of those nonconformances designated use as is or repair
            *        documentation that the supplied material and equipment meets the applicable procurement requirements before installation or use
            *        appropriate documentation, as identified in the purchase order, which will accompany the NRC-approved packaging during transport and be received at the destination by the user Such documents should (1) be referenced in the CoC, (2) relate to the use and maintenance of the packaging, and (3) identify necessary actions to be taken before delivery of the licensed material to a carrier for transport. If the pertinent documentation is in an electronic format, the QA program user should also maintain information on the specific software applications and storage or computing hardware that must be used to prepare and deliver the documentation.


The QA program user should retain the documentation at the facility or site of material or equipment use.
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.


8. Guidance on 10 CFR 71.117, Identification and Control of Materials, Parts, and Components The QA program user should establish measures to ensure that materials, parts, and components, including partially fabricated assemblies, are adequately identified to preclude the use of incorrect or defective items. These measures should provide the means for physical identification (e.g., stamping, tags, labels, or lot-follower cards) and traceability to appropriate documentation (e.g., mill reports, drawings, or specifications) throughout fabrication, installation, and use. Also, when replacement of limited-life items is specified, the QA program user should establish measures to preclude use of items for which the shelf life or prescribed operation time has expired.
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.


In addition, the QA program user should establish measures to facilitate continued processing, when required inspections or tests have not been completed, to maintain physical identity and control over affected materials.
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.


9. Guidance on 10 CFR 71.119, Control of Special Processes Special processes are not normally performed by the user of packaging. However, if packaging maintenance requires the use of special processes (e.g., welding or heat treating) or nondestructive testing, or if special processes are required to meet CoC requirements, the QA program user should establish measures to ensure that the special processes are controlled in accordance with the following suggested elements of process control:
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.
                                          RG 7.10, Page 18


*      Procedures, equipment, and personnel are qualified in accordance with applicable codes, standards, and specifications.
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.


*     The operations are performed by qualified personnel and accomplished in accordance with written process or procedure sheets that direct the recording of evidence of verification.
1. Procedures, equipment, and personnel are qual
  2.6     Document Control                                      ified in accordance with applicable codes, standards, and specifications.


*      Qualification records of procedures, equipment, and personnel are established, filed, and kept current.
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.


10. Guidance on 10 CFR 71.121, Internal Inspection
1. QA and QC Manuals,
    10.1   The QA program user should establish measures for internal inspection that consider the following recommendations:
      2. Operating Procedures,                                        3. Qualification records of procedures, equipment,
          *        The prerequisites to be satisfied before inspection are identified, including operator qualification and equipment calibration. Where sampling is used, the standard used as the basis for verifying acceptability of a group of items should be identified.
      3.  Maintenance Procedures, and personnel are established, filed, and kept current.


*        Inspection procedures, instructions, or checklists should be available for each work operation, where necessary to ensure quality.
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.


*        Documents developed should include methods for identifying characteristics and activities to be inspected, acceptance and rejection criteria, and the individuals or groups responsible for performing the inspection.
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


*        Hold or witness points should be identified.
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.


*        Inspection results should be recorded and objectively verifiable.
4. Shielding integrity, and
        2.10.2 Maintenance Measures should be established for an inspection                    5. Thermal integrity.


*        The appropriate personnel should approve data to ensure that all inspection requirements have been satisfied.
program to ensure adequate maintenance of packaging.


10.2  Inspections
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.
          10.2.1 Receiving Inspections The QA program user should establish measures to ensure that items that are important to safety meet the requirements specified on the purchase order when the items are received at the plant.


The QA program user should establish the criteria for acceptance of each of these inspections, as well as the action to be taken, if noncompliance is encountered.
ensure that packages remain usable and free of excessive radiation and contamination.


These visual inspections should include the following aspects:
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.
                    *        surface conditions
                    *        weld and structural integrity
                    *        the condition of flange faces or sealing areas, gaskets, seals, gauges, rupture disks, valves, and pressure relief devices RG 7.10, Page 19


*        the condition of tie-down members (if applicable)
have been complied with:
      *        labeling and marking
                                                                        2.12 Control of Measuring and Test Equipment
      *        leak-tightness of the packaging In addition, the QA program user should establish provisions to control accepted items until they are placed in stock or released for use, as well as provisions for the proper disposition of rejected items.
        1. Packages are properly assembled.


10.2.2 In-Process Inspections The QA program user should establish measures to ensure that process specifications and their supporting documentation provide for indirect control by monitoring processing methods, equipment, and personnel if direct inspection is impractical.
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.


10.2.3 Final Inspections The QA program user should establish measures to ensure the following:
characteristics) should be calibrated, adjusted, and main tained at prescribed intervals or prior to us
      (1) final inspections provide for resolution of nonconformances identified in earlier inspections, (2) the inspected item is identifiable and traceable to specific records and is adequately protected from physical or environmental damage, and
      (3) supervisors review inspection records to verify that all inspection requirements have been satisfied, as described in Section 11.2 of this document.


For packaging use, the QA program user should establish checklists to ensure that inspections are performed to verify the following:
====e. The meas====
      *        Packages are properly assembled.
      4. Valves are set to specifications.


*        Moderators and neutron absorbers are present (if applicable).
uring and test equipment should be labeled or tagged to indicate the planned date of its next calibration, and
      *        Valves through which primary coolant flows are protected against tampering.
      5. All shipping papers are properly completed.


*        Valves are set to specifications.
the calibration records should be identified and traceable.


*        All shipping papers are properly completed.
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.


*        Packages are conspicuously and durably marked as required by the regulations set forth by the U.S. Department of Transportation (DOT).
for shipping.
      *        Measures are established to ensure that appropriate personnel designated by the package user sign the shipping tags or indicators before authorization for shipping.


RG 7.10, Page 20
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.


10.2.4 Maintenance Inspections The QA program user should establish measures for an inspection program to ensure adequate maintenance of packaging. This inspection program should identify the items to be maintained, criteria for acceptability or replacement, and the frequencies of inspection assigned to each item.
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.


10.2.5 Inspectors The QA program user should establish measures to ensure that (1) inspectors are qualified in accordance with applicable codes, standards, and company training programs, (2) such qualifications and certifications are kept current, and
1. Structural integrity,
                    (3) inspection personnel are independent from all individuals performing the activity being inspected.
    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.


10.2.6 Inspection Documentation The QA program user should maintain inspection records as QA records to document performance of inspection activities.
7.10-15


11. Guidance on 10 CFR 71.123, Test Control
3. Proper environmental conditions to preserve packag
    11.1  Requirements The QA program user should establish measures to ensure that applicable test programs, including prototype qualification tests, production tests, proof tests, and operational tests, are accomplished in accordance with written procedures. The QA program user should also establish measures to ensure that modifications, repairs, and replacements are tested in accordance with the original design and testing requirements.
                                                                          2.15.3 Disposition ing are maintained.


11.2  Procedures The QA program user should establish measures to ensure that test prerequisites identified in the appropriate design disclosures are properly translated into test procedures. For example, design closures may include instrument calibrations, monitoring to be performed, mandatory hold points, suitable environmental conditions to be maintained, condition of the test equipment, methods for physical identification of test specimen, methods for documenting or recording test data, and criteria for acceptance of the package.
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.


11.3  Acceptance Tests The QA program user should establish measures, as appropriate, to ensure that acceptance tests are conducted before delivering packages for transport to a carrier.
inspecting or retesting the item against the original requirements after designated repair or rewor


These measures should identify the basis for acceptance criteria (e.g., CoC, maintenance and operational manuals furnished by the packaging manufacturers). Tests should typically include the following considerations:
====k. Final====
                                        RG 7.10, Page 21
        2.13.2 Preparationfor Release and Shipment disposition of nonconformances should be identified and documented.


*        structural integrity
Measures should be established to ensure that:
          *        leak-tightness (on containment vessel as well as auxiliary equipment and shield tanks)
        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
          *        component performance for valves, gaskets, and fluid transport devices
                                                                      personnel to determine quality trends for appropriate management review and assessment.
          *        shielding integrity
          *        thermal integrity
    11.4   Maintenance Tests The QA program user should establish maintenance test programs to ensure that packages remain usable and free of excessive radiation and contamination. These test programs should include measures to ensure that qualified and responsible individuals document, evaluate, and assess the acceptability of all test results.


11.5  Results The QA program user should establish measures to ensure that test results are documented, evaluated, and maintained as QA records. These records should be readily available if questions arise concerning operational aspects of the packages. In addition, a qualified individual or group should determine the acceptability of the records.
2. All conditions, including specified operations, in spections, and tests, have been completed prior to
                                                                      2.16 Corrective Action delivery to a carrier.


12. Guidance on 10 CFR 71.125, Control of Measuring and Test Equipment
3. All NRC and DOT requirements have been satis                    2.16.1 Reportink fied prior to delivery to a carrier.
    12.1   Calibration Control The QA program user should establish guidelines to ensure that measurement and test equipment (e.g., gauges, fixtures, and devices used to measure product characteristics) is calibrated, adjusted, and maintained at prescribed intervals or before use. Such equipment should be labeled or tagged to indicate the planned date of its next calibration.


Calibration records should be identified, traceable, and maintained as QA records. The QA program user should also establish measures to ensure that in-house reference or transfer standards used in calibrating measuring and test equipment are traceable to nationally recognized standards. Calibrating standards should have known valid relationships to nationally recognized standards. If no known recognized standard exists, the QA program user should document the basis for calibration.
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.


12.2  Out-Of-Calibration Equipment When test and measuring equipment is found to be out of calibration, the QA program user should take measures to validate previous inspection and test results up to the time of previous calibration.
sible for assurance of quality.


In addition, the QA program user should repair or replace any measuring equipment that is consistently out of calibration.
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.


RG 7.10, Page 22
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.


13. Guidance on 10 CFR 71.127, Handling, Storage, and Shipping Control
individuals or groups responsible for approval of the disposition of nonconforming items.
    13.1    Preservation The QA program user should establish measures to ensure that cleaning, handling, storage, and shipping are accomplished in accordance with design requirements to preclude damage or deterioration by environmental conditions such as temperature and humidity. When necessary, the QA program user also should establish provisions for the use of special handling, lifting, or storage devices (e.g., cranes, shock absorbers, or special markings) to adequately identify and preserve packaging components or assemblies. In addition, the QA program user should ensure that conditions identified in the CoC are adhered to when unloading packaging.


13.2   Preparation, Release, and Delivery to Purchaser The QA program user should establish measures to ensure that a final pre-release review has been completed. This review should ensure that the packaging (1) is prepared for delivery to the purchaser in accordance with NRC-approved drawings, specifications, and government regulations, (2) has passed all applicable inspections and tests, (3) is properly identified by physical markings or tags, and (4) contains operating manuals, maintenance manuals, and generic procedures relating to its use.
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.


In addition, the QA program user should establish measures to ensure that the following requirements are fulfilled:
needed.
            *        Cavities within gas-cooled package containments have been adequately dried, and cavities within liquid-cooled packages have been drained to allow adequate void space.


*        All conditions (including specified operations, inspections, and tests) have been completed before delivery to a carrier.
7.10-16


*        All NRC and DOT requirements have been satisfied before delivery to a carrier.
2.1 7.3 Receipt, Retrieval and Disposition of Records          established for prompt replacement of a record that is lost or damaged.


*        All necessary shipping papers have been prepared as required and reviewed by qualified personnel to verify completeness and accuracy.
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.


14. Guidance on 10 CFR 71.129, Inspection, Test, and Operating Status The QA program user should establish measures to ensure that the status of inspections, tests, and operating conditions (including maintenance of items) is known by organizations responsible for ensuring quality. The QA program user should also establish measures to control the application and removal of status indicators (e.g., tags, markings, stamps) and to ensure that bypassing a required inspection or test or any other required operation is procedurally controlled under the cognizance of the QA organization.
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.


15. Guidance on 10 CFR 71.131, Nonconforming Materials, Parts, or Components An acceptable program for controlling nonconforming items should include the following principal elements:
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
                                          RG 7.10, Page 23
remote from each other to preclude damage to both                program approved by NRC.


*      proper identification
facilities from a single event such as a fire or flood.
    *      segregation of discrepant or nonconforming items
    *      evaluation of the nonconforming items
    *      disposition of the nonconforming items
16. Guidance on 10 CFR 71.133, Corrective Action
    16.1  Reporting The QA program user should establish measures to ensure that the causes of conditions detrimental to quality (e.g., those resulting from failures, malfunctions, deficiencies, deviations, or defective material and equipment) are identified promptly and reported to appropriate levels of management. In addition, the QA program user should establish measures to obtain corrective actions from suppliers and ensure that followup actions are documented to verify that the corrective actions were implemented and effective.


16.2  Closeout, Retrieval, and Disposition of Records The QA program user should establish measures to ensure that corrective actions designated by cognizant individuals have been implemented to preclude recurrence. In addition, the QA program user should identify (by function or position) the individuals or organizations responsible for closing out corrective actions and documenting their resolution.
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.


17. Guidance on 10 CFR 71.135, Quality Assurance Records
7.10-17
    17.1  General QA records should furnish documentary evidence of the activities that affect quality and should provide sufficient information to allow each record to be identified with the items or activities to which it applies. In accordance with 10 CFR 71.135, QA records shall be retained for 3 years beyond the date when the QA program user last engaged in the activity for which the QA program was developed. If any portion of the written procedures or instructions is superseded, the QA program user shall retain the superseded material for 3 years after it is superseded. As a minimum, QA records should include the following information:
          *        design, procurement, manufacturing, and installation records
          *        supplier evaluations
          *        nonconformance reports
          *        results of inspections and tests
          *        failure analyses
          *        as-built drawings and specifications
          *        qualification of personnel, procedures, and equipment
          *        calibration procedures
          *        training and retraining records
          *        corrective action reports
          *        records demonstrating evidence of operational capability
          *        records verifying repair, rework, and replacement
          *        audit plans, audit reports, and corrective actions
          *        records that are used as a baseline for maintenance RG 7.10, Page 24


*        maintain records documenting changes to the QA program as required by 10
ANNEX 3 Quality Assurance Programs Applicable to Procurement, Use, Maintenance, and Repair of Packages Designed to Transport Radiographic Exposure Devices
              CFR 71.106 In addition, the QA program user should retain records that show evidence of package delivery to a carrier and proof that all NRC and DOT requirements have been satisfied (with their retention times identified).
      3.1  Organization of packages to supply appropriate certifications verifying Organization charts identifying each organizational                  that the designated (model and serial number)
    Where applicable, inspection and test records should contain the following information:
                                                                                                                                        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).
    *        a description of the observation
     delegated authority to stop unsatisfactory work, unsatis factory processing, or the installation of                                  3.3.2 Replacement PartsProcurement(If Applicable)
    *        evidence of completion of the inspection or test operation
                                                  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.
    *        results of inspections or tests with appropriate data
     *        conditions detrimental to quality
    *        names of inspectors, testers, or data recorders
    *        evidence of acceptability
17.2 Generating Records The QA program user should establish measures to ensure that methods employed to generate and manage documents that are designated as QA records result in information that is retrievable, intelligible, and reliable. Such records should reflect the work accomplished and should be stored in a manner that avoids unnecessary delay when access to the record is needed. In addition, procedures for generating QA records should address both hard copy records and electronic information.


17.3 Indexing and Classification of Records The QA program user should classify QA records as either lifetime or nonpermanent:
QA/QC func tions should also be identified.
    *        Lifetime records include those pertaining to package fabrication and those associated with a particular item while it is installed in the packaging or stored for future use. These records (1) demonstrate the capability for safe operation,
              (2) provide evidence of repair, rework, replacement, or modification, (3) aid in determining the cause of an accident or malfunction of an item, and (4) provide a baseline for inservice inspection.


*        Nonpermanent records are those that show evidence that an activity has been performed but do not meet the criteria for lifetime records. Records pertaining to use of a package should be retained for a period of 3 years after each shipment.
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.


17.4 Receipt, Retrieval, and Disposition of Records The QA program user should establish measures to provide a receipt control system, including identification of functions or positions in each organization responsible for receiving records and assessing the current status of records in their possession. The QA program user should also establish measures to ensure that records maintained in- house or at other locations are identifiable and retrievable, and are not disposed of until prescribed conditions are satisfied. For electronic records, the software systems used to image and store information should be compatible with new hardware as current technologies are implemented. In addition, the QA program user should have a RG 7.10, Page 25
that are identified in the manufacturer's QA program.


procedure in place before installing any new hardware systems to ensure that the new systems can reliably store and retrieve information from existing software systems.
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.


17.5  Storage, Preservation, and Safekeeping The QA program user should establish measures to ensure that the following outcomes are fulfilled:
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:
          *        Facilities used to store records should be constructed to minimize the risk from damage or destruction by severe natural conditions, such as wind, flood, fire, temperature, humidity, mold, or infestation by insects or rodents.
                                                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.


*        Records should be firmly attached in binders or placed in folders or envelopes for storage in steel file cabinets.
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


*        Electronic records should be maintained in facilities that minimize or eliminate the potential for destruction of information as a result of demagnetization (Ref.
6. Packaging for Transport Procedures, and
                                                                    3.8    Quality Assurance Records
      7. Repair Procedures.


12).
A list of records to be controlled under the QA program and identification of retention times for each record
          *        Electronic records should be backed up daily to eliminate the potential for loss of information as a result of equipment failure or human error (Ref. 12).
  3.6    Handling, Storage, and Shipping should be established. These records should include, as a minimum, procurement documentation; inspection, test,
          *        If dual storage facilities are used to ensure the record integrity, the storage facilities should be sufficiently remote from each other to preclude a single event (such as a fire or flood) from damaging both facilities.
    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.


*        The QA program user should take measures to protect special records (e.g., radiographs and microfilm) from excessive light, electromagnetic fields, and temperature.
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.


*        The QA program user should take measures to prevent unauthorized personnel from entering record storage areas.
vide for their safekeeping, and prevent their deterioration.


*        Electronic information storage systems should be accessible only through security measures such as passwords, and the number of personnel who have authorized access should be limited. In addition, personnel who have authorized access should have identified privileges, such as read only or read and add only.
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.


*        The QA program user should establish measures to ensure prompt replacement of lost or damaged records.
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.


18. Guidance on 10 CFR 71.137, Audits
7.10-20
    18.1  Elements of an Audit Program A comprehensive audit program should include the following elements:
          *        assurance of the authority and organizational independence of the auditors
          *        a commitment to adequate manpower, funding, and facilities to implement the audit RG 7.10, Page 26


*      identification of audit personnel and their qualifications
APPENDIX A
    *      provisions for reasonable and timely access of audit personnel to facilities, documents, and qualified personnel necessary for performing audits
                        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.
    *      use of established procedures and checklists
    *      methods for reporting audit findings to responsible management of both the audited and auditing organizations
    *      provisions for the audit team to gain access to levels of management that have responsibility and authority for corrective action
    *      methods for verifying that effective corrective action has been accomplished on a timely basis
    *      The QA program user also should establish and maintain a list to reflect the current status of the activities important to safety that are to be audited and the frequency at which each quality criterion is to be audited. The frequency of audits should be based on each activitys importance to safety; however, each quality criterion should be audited at least once each year.
 
*      The QA program user also should establish measures to ensure that packaging manufacturers are audited to assess the extent of their compliance with purchase orders and to verify that their work is controlled under an NRC-approved QA
            program. In addition, the QA program user also should identify (by function or position) the individuals or groups that have the responsibility and authority to ensure that corrective actions resulting from audit findings are accomplished on a timely basis. The QA program user should re-audit deficient areas on a timely basis to verify implementation of corrective actions.
 
18.2 Scheduling of Audits
    *      The QA program user should establish schedules for internal audits, external audits, and audits performed by management. These schedules should ensure that key activities of the QA program (e.g., design, fabrication) receive priority consideration.
 
*      For audits performed by management, the schedules should identify the level of management (usually from the corporate office or another division) designated to assess the overall effectiveness of the implementation of the described in-house QA program. The QA program user should also identify the activities important to safety (e.g., procurement, training of personnel) that should be included in the audit program. Management audits should be conducted at least once every
            12 months.
 
*      For internal audits, the schedules should ensure that applicable elements of the QA program are audited annually or at least once within the life of the activity, whichever is shorter.


RG 7.10, Page 27
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.


*        For external audits, the schedules should ensure that all elements of a major suppliers (or major contractors) QA program are audited on a triennial basis.
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 3-year period should begin with performance of an audit when sufficient work is in progress to demonstrate implementation of a QA program that has the required scope for purchases placed during the 3-year period.
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.


18.3    Team Selection
for items with a minor impact on safety. For example,
        *       The QA program user should establish the qualifications of the lead auditor and audit team members and specify their respective responsibilities for evaluating and issuing audit reports. The auditing organizations should be responsible for establishing qualifications for prospective audit personnel and the requirements for the use of technical specialists to accomplish auditing activities that are important to safety. The QA program user should select the lead auditor and audit team members from personnel who do not have direct responsibility in the areas being audited.
                                                                      "*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.


*        Specific guidance for determining qualifications for the lead auditor and individual audit team members may be obtained from ANSI/ASME NQA-1-
7.10-21
                2008 with the NQA-1a-2009 Addenda, Quality Assurance Requirements for Nuclear Facility Applications (QA) (Ref. 2).
18.4    Pre-Audit Conference Before an audit, the QA program user should specify the nature and scope of the pre-audit conference between management of the organizations being audited and the team conducting the audit. The purpose of the pre-audit conference should be to (1) meet counterparts,
(2) confirm the audit scope and dates, (3) establish channels of communication, (4) discuss the sequence and duration of the audit, (5) prepare an agreed-upon agenda for the audit, and (6) set the time for the post-audit conference.


18.5    Post-Audit Conference The QA program user should establish measures to conduct a post-audit conference between management of the organizations being audited and the team conducting the audit to present the results and clarify any questions that may arise.
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.


18.6    Reporting and Response The QA program user should establish measures to identify time constraints imposed for issuing audit reports and the requested date for a corrective action response by the audited organization. The response should clearly state the corrective action taken to prevent recurrence of nonconformances. If corrective action cannot be taken immediately, the response of the audited organization should include scheduled dates for initiation and completion of the corrective action.
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.


18.7   Followup Action The audit team leader should verify that (1) the audited organization provides a timely response to the audit report, (2) the response is adequate, and (3) the corrective action has been accomplished within the prescribed schedule.
7.10-22


RG 7.10, Page 28
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.


==D. IMPLEMENTATION==
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.
The purpose of this section is to provide information to licensees, certificate holders and applicants regarding the NRCs plans for using this regulatory guide.


Methods or solutions that differ from those described in this regulatory guide may be deemed acceptable if they provide sufficient basis and information for the NRC staff to verify that the proposed alternative demonstrates compliance with the appropriate NRC regulations. Current licensees may continue to use guidance the NRC found acceptable for complying with the identified regulations as long as their current licensing basis remains unchanged. Backfit and issue finality considerations do not apply to licensees and applicants under 10 CFR Part 71.
Part 71.
 
RG 7.10, Page 29
 
REFERENCES1
1. U.S. Code of Federal Regulations (CFR), Packaging and Transportation of Radioactive Material, Part 71, Title 10, Energy.
 
2  American National Standard Institute/American Society of Mechanical Engineers (ANSI/ASME)
  NQA-1- 2008 with the NQA-1a-2009 Addenda, Quality Assurance Requirements for Nuclear Facility Applications, ASME, New York, NY, 2008.2
3  NRC, Regulatory Guide (RG) 7.6, Design Criteria for the Structural Analysis of Shipping Cask Containment Vessels, Washington, DC.
 
4  NRC, Regulatory Guide (RG) 7.7, Administrative Guide for Verifying Compliance With Packaging Requirements for Shipping and Receiving of Radioactive Material, Washington, DC.
 
5  NRC, Regulatory Guide (RG) 7.9, Standard Format and Content of Part 71 Applications for Approval of Packages for Radioactive Material, Washington, DC.
 
6  International Atomic Energy Agency (IAEA), Regulations for the Safe Transport of Radioactive Material, (TS-R-1), Vienna, Austria, 2009. 3
7  U.S. Nuclear Regulatory Commission, Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety, NRC NUREG/CR-
  6407, Washington, DC, February 1996.
 
8  International Organization for Standardization (ISO) 9000, Quality Management Systems, Geneva, Switzerland, 2000.4
9  IAEA, The Management System for Facilities and Activities, Vienna, Austria, 2006.
 
10 IAEA, Application of the Management System for Facilities and Activities, IAEA Safety Standards Series No. GS-G-3.1, Vienna, Austria, 2006.
 
1 Publicly available documents from the U.S. Nuclear Regulatory Commission (NRC) are available electronically through the NRC Library on the NRCs public Web site at http://www.nrc.gov/reading-rm/doc-collections/. The documents can also be viewed on-line for free or printed for a fee in the NRCs Public Document Room (PDR) at
  11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR, Washington, DC 20555; telephone (301)
  415-4737 or (800) 397-4209; fax (301) 415 3548; and e-mail pdr.resource@nrc.gov.
 
2 Copies of American Society of Mechanical Engineers (ASME) standards may be purchased from ASME, Two Park Avenue, New York, New York 10016-5990; Telephone (800) 843-2763. Purchase information is available through the ASME Web site store at http://www.asme.org/Codes/Publications/.
3 Copies of International Atomic Energy Agency (IAEA) documents may be obtained through their Web site WWW.IAEA.Org/ or by writing the International Atomic Energy Agency P.O. Box 100 Wagramer Strasse 5, A-1400
  Vienna, Austria. Telephone (+431) 2600-0, Fax (+431) 2600-7, or E-Mail at Official.Mail@IAEA.org
4 Copies of International Organization for Standardization (ISO) documents may be obtained by writing to the International Organization for Standardization, 1, ch. de la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, Telephone: +41 22 749 01 11, Fax: +41 22 749 09 47, by E-mail at sales@iso.org, or on-line at the ISO Store Web site:
  http://www.iso.org/iso/store.htm.
 
RG 7.10, Page 30
 
11 NRC, Generic Letter 88-18, Plant Record Storage on Optical Disks, Washington, DC, October
  20, 1988. (ADAMS accession number: 8810250164)
12 NRC, Regulatory Issue Summary (RIS) 00-18, Guidance on Managing Quality Assurance Records in Electronic Media, Washington, DC, October 23, 2000. (ADAMS accession number:
  ML003739359)
13 NRC, Information Notice (IN) 86-21, Recognition of American Society of Mechanical Engineers Accreditation Program for N Stamp Holders, Washington, DC, March 31, 1986.
 
(ADAMS accession number: 031220635)
14 NRC, IN 86-21 supplement 2, Recognition of American Society of Mechanical Engineers Accreditation Program for N Stamp Holders, Washington, DC, April 16, 1991. (ADAMS
  accession number: 031220630).
                                    RG 7.10, Page 31
 
APPENDIX A
    A GRADED APPROACH TO DEVELOPING QUALITY ASSURANCE
          PROGRAMS FOR PACKAGING RADIOACTIVE MATERIAL
        The design effort and requirements for a QA program are interrelated and should be developed simultaneously. Addressing them as independent functions may result in an overly stringent QA program (i.e., one that imposes unnecessary QA activities to verify attainment of design objectives) or an inadequate QA program (i.e., one that imposes too few QA activities to verify attainment of design objectives). To develop a QA program in which the application of QA requirements is commensurate with their safety significance, it is essential that engineering personnel perform a systematic analysis of each component, structure, and system of packages to assess the consequences to the health and safety of the public and the environment that would result from malfunction or failure of such items. This engineering assessment and development of the QA program should be initiated as early in the design process as practicable and should be in accordance with approved procedures. Establishment of an engineering basis for the formulation of a QA program early in the design process enables a uniform, consistent application of QA requirements during the fabrication, use, and maintenance of packaging.


A logical sequence leading to the identification of realistic QA requirements would involve (1)
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.
classifying each structure, system, and component as important to safety or not important to safety (Q
or non Q); (2) grouping items classified as important to safety into quality categories; and (3)
specifying the applicable level of QA effort for each category. To ensure a better understanding of the process, the remaining sections of this appendix provide additional detail concerning each of these three steps.


1.      Classifying Structures, Systems, and Components To begin the process of identifying realistic QA requirements, the QA program user should first analyze all structures, systems, and components that appear on the latest packaging parts list to determine whether their functions or physical characteristics are important to safety. Items identified as essential to safety (often referred to as Q items) should then be subjected to a QA program based on the requirements of Subpart H of 10 CFR Part 71.
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.


2.      Grouping Items into Quality Categories After classifying the structures, systems, and components that appear on the latest packaging parts list, the QA program user should establish quality categories based on the relative safety significance of each Q item and, where appropriate, their subcomponent parts. In doing so, the QA program user could identify the categories as A for items that are critical to safe operation, B for items that have a major impact on safety, and C for items that have only a minor impact on safety. For example, Category A items could include structures, systems, and components for which a failure or malfunction could directly result in a condition that would adversely affect public health and safety. This would include such conditions as loss of primary containment with subsequent release of radioactive material, loss of shielding, or an unsafe geometry compromising criticality control. Category B items could include structures, systems, and components for which a failure or malfunction could indirectly result in a condition that would adversely affect public health and safety. However, an unsafe condition could result only if the primary event occurs in conjunction with a secondary event or other failure or environmental occurrence. Finally, Category C items could include the structures, systems, and components for which a failure or malfunction would not significantly reduce packaging effectiveness and would be unlikely to Appendix A to RG 7.10, Page A-1
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.


create a condition that would adversely affect public health and safety such as the dunnage, packaging hardware, protective cover, security lockwire and seals, and skids or forklift channels for low specific activity and Type A (fissile) shipments as well as all of the previously mentioned items and vent and drain port plug and pressure relief device outer seals, vent, drain and leak check port plug cover plates for Type B shipments.
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.


3. Specifying the Applicable Level of QA Effort The last step in the process of identifying realistic QA requirements would be to assign an appropriate degree of QA effort to each quality category. For example, QA requirements for Category A items would include the following specifications:
23      Value/Impact Ame    enent I
  *        The design should be based on the most stringent industrial codes or standards, and design verification would be accomplished by prototype testing or formal design review.
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.


*        The procurement documentation for materials or services should specify that the QA
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.
            program user should use only suppliers from qualified vendor lists.


*        The suppliers and subtier suppliers should have QA programs based on the applicable criteria in Subpart H to 10 CFR Part 71.
7.10-23


*        The manufacturing planning should specify complete traceability of raw materials and the use of certified welders and processes.
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.


*        The verification planning (test and inspection) should require use of qualified inspectors (i.e., personnel performing nondestructive examinations such as radiography and ultrasonic testing would be qualified in accordance with recommended practices described in such documents as ASNT-TC-1A1 and Section IX of the ASME Boiler and Pressure Vessel Code or other industrial standards).
that would be acceptable to the NRC. In addition, this regulatory guide exists, and updating to changes in
  *        Only qualified auditors and lead auditors should perform audits.
      2.3.3 Industry
                                                                      10 CFR Part 71 is a relatively simple procedure.


*        A representative of the buyer would be present at a suppliers facility to approve the final acceptance test and to authorize shipment.
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.


Category B quality requirements should include the following specifications:
lent in industry should be reduced.
  *        The design should be based on the most stringent industrial codes and standards, but design verification could be achieved through use of calculations or computer codes.


*        Materials need not be procured from a qualified vendor list.
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.


*        Manufacturing planning need not require traceability of materials, and only specified welds would be done by qualified welders.
required for this action.


*        Verification activities would still require use of inspectors qualified to appropriate codes, standards, or other industrial specifications.
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


1 ASNT-SNT-TC-1A, Recommended Practice for Personnel Qualification and Certification for Nondestructive Testing, American Society for Nondestructive Testing (ASNT), Columbus, Ohio, 2001.
===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.


Appendix A to RG 7.10, Page A-2
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


*      Only the lead auditor need meet certain qualification requirements.
====e.    I====
                                                                  be prepared and issued.


With respect to Category C items, the only enforced quality requirements include the following specifications:
7.10-24
*      Items should be purchased from a catalog or off the shelf.


*       When the item is received, the material should be identified and checked for damage.
UNITED STATES
NUCLEAR REGULATORY COMMISSION        FIRST CLASS MAIL
                                  POSTAGE & FEES PAID
       WASHINGTON, D.C. 20555              USNRC
                                        WASH. D.C.


Appendix A to RG 7.10, Page A-3}}
PERMIT No. G47 OFFICIAL BUSINESS
    PENALTY FOR PRIVATE USE, $300}}


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Latest revision as of 11:39, 28 March 2020

Rev. 1, Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material
ML003739404
Person / Time
Issue date: 06/30/1986
From:
Office of Nuclear Regulatory Research
To:
References
RG-7.10 Rev 1
Download: ML003739404 (25)
v • d • e


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.

1. QA and QC Manuals,

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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