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pdfU.S. NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR REGULATORY RESEARCH
April 2013
Revision 3
DRAFT REGULATORY GUIDE
Contact: Jessica Glenny
(301) 492-3285
DRAFT REGULATORY GUIDE DG-7009
(Proposed Revision 3 of Regulatory Guide 7.10, dated March 2005)
ESTABLISHING QUALITY ASSURANCE PROGRAMS
FOR PACKAGING USED IN TRANSPORT OF
RADIOACTIVE MATERIAL
A. INTRODUCTION
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
Part 71 apply to NRC licensees that transport licensed material or that deliver licensed material to a
carrier for transport. This guidance provides licensees, certificate holders, and applicants with an
acceptable method to prepare and submit quality assurance (QA) program descriptions for NRC staff
review.
Applicable Rules and Regulations
The regulations established by the NRC in Title 10, Part 71, of the Code of Federal Regulations
(10 CFR Part 71), “Packaging and Transportation of Radioactive Material,” define requirements for
packaging of radioactive materials for transport. Specifically, 10 CFR 71.37(a) requires that applicants
requesting package design approval must describe, consistent with Subpart H of Part 71, “Quality
Assurance,” of 10 CFR Part 71, the QA programs that they will apply in design, fabrication, assembly,
testing, maintenance, repair, modification, and use of the proposed packaging. In addition,
10 CFR 71.101, “Quality Assurance Requirements,” requires that licensees, certificate holders, and
applicants for a certificate of compliance (CoC) must implement and use a QA program that the NRC
This regulatory guide is being issued in draft form to involve the public in the early stages of the development of a regulatory position in this
area. It has not received final staff review or approval and does not represent an official NRC final staff position. Public comments are being
solicited on this draft guide and its associated regulatory analysis. Comments should be accompanied by appropriate supporting data. Written
comments may be submitted through the federal government rulemaking Web site at http://www.regulations.gov. Alternatively, written
comments by be submitted to the Rules, Announcements, and Directives Branch, Office of Administration, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001; or faxed to (301) 492-3446. Copies of comments received may be examined at the NRC’s Public
Document Room, 11555 Rockville Pike, Rockville, MD. Comments will be most helpful if received by July 30, 2013.
Electronic copies of this draft regulatory guide and previous version of this guide and other recently issued guides are available through the
NRC’s public Web site under the Regulatory Guides document collection of the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/.
The draft regulatory guide is also available through the NRC’s Agencywide Documents Access and Management System (ADAMS) at
http://www.nrc.gov/reading-rm/adams.html, under Accession No. ML13079A004. The regulatory analysis may be found in ADAMS under
Accession No. ML13079A005.
staff has previously approved as satisfying the provision of Subpart H of 10 CFR Part 71. Specifically,
Subpart H requires, in part, that QA programs of licensees, certificate holders, and applicants for a CoC
must satisfy each of the applicable criteria specified in 10 CFR 71.101–71.137.
Related Guidance
•
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)
•
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.
•
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 agency’s 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.
DG-7009, Page 2
TABLE OF CONTENTS
Page
A. INTRODUCTION .................................................................................................................................. 1
B. DISCUSSION ......................................................................................................................................... 4
Reason for Revision ......................................................................................................................... 4
Regulatory Framework for Transport of Radioactive Material ....................................................... 4
Level of Detail in QA Program Descriptions................................................................................... 5
Quality Assurance Program Submittals Based on Other Standards................................................. 5
Changes to Approved QA Program Descriptions ............................................................................ 6
Documents Endorsed in this Guide
Harmonization with International Standards
C. STAFF REGULATORY GUIDANCE ................................................................................................... 6
1. Guidance on 10 CFR 71.103, “Quality Assurance Organization” ............................................... 7
2. Guidance on 10 CFR 71.105, “Quality Assurance Program” ...................................................... 8
3. Guidance on 10 CFR 71.106, “Changes to Quality Assurance Program” ................................. 10
4. Guidance on 10 CFR 71.107, “Package Design Control” ......................................................... 11
5. Guidance on 10 CFR 71.109, “Procurement Document Control” ............................................. 13
6. Guidance on 10 CFR 71.111, “Instructions, Procedures, and Drawings” ................................. 14
7. Guidance on 10 CFR 71.113, “Document Control” .................................................................. 15
8. Guidance on 10 CFR 71.115, “Control of Purchased Material, Equipment, and Services” ...... 16
9. Guidance on 10 CFR 71.117, “Identification and Control of Materials, Parts,
and Components” ...................................................................................................................... 18
10. Guidance on 10 CFR 71.119, “Control of Special Processes” ................................................ 18
11. Guidance on 10 CFR 71.121, “Internal Inspection” ................................................................ 18
12. Guidance on 10 CFR 71.123, “Test Control” .......................................................................... 21
13. Guidance on 10 CFR 71.125, “Control of Measuring and Test Equipment”........................... 22
14. Guidance on 10 CFR 71.127, “Handling, Storage, and Shipping Control” ............................. 20
15. Guidance on 10 CFR 71.129, “Inspection, Test, and Operating Status” ................................. 23
16. Guidance on 10 CFR 71.131, “Nonconforming Materials, Parts, or Components” ................ 23
17. Guidance on 10 CFR 71.133, “Corrective Action”.................................................................. 23
18. Guidance on 10 CFR 71.135, “Quality Assurance Records”................................................... 24
19. Guidance on 10 CFR 71.137, “Audits”.................................................................................... 26
D. IMPLEMENTATION ........................................................................................................................... 28
REFERENCES ........................................................................................................................................... 29
APPENDIX A: A GRADED APPROACH TO DEVELOPING QUALITY ASSURANCE PROGRAMS
FOR PACKAGING RADIOACTIVE MATERIAL ................................................................................ A-1
DG-7009, Page 3
B. DISCUSSION
Reason for Revision
This guide is being revised to address regulatory requirements applicable to QA programs
required pursuant to 10 CFR Part 71. These changes include, among other things, (1) establishing
requirements to allow some changes to be made to a previously approved QA program without obtaining
NRC approval, and (2) removing the requirements for renewal of QA program approvals. This updated
guidance accompanies a proposed revision to 10 CFR Part 71. The proposed amendments would revise
the regulations for the packaging and transportation of radioactive material to: make the U.S. Nuclear
Regulatory Commission (NRC) regulations compatible with the 2009 edition of the International Atomic
Energy Agency’s (IAEA) transportation standards, “Regulations for the Safe Transport of Radioactive
Material,” (TS-R-1), (Ref. 6), maintain consistency with changes in the U.S. Department of
Transportation (DOT) regulations, and make other changes to the requirements for the packaging and
transportation of radioactive material.
Regulatory Framework for Transport of Radioactive Material
The NRC’s 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, “Quality Assurance.” 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, “Application for Package Approval.” Specifically, an application for approval under
Subpart D shall 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,
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 should control the quality of each of the
above activities using a graded approach (i.e., the QA effort that a licensee expends 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 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
DG-7009, Page 4
graded approach for 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).
The NRC explicitly requires that each licensee or package design applicant (hereinafter referred
to as a “QA program user”) must submit a description of its QA program, along with a discussion of
which Subpart H requirements apply and how those requirements will be satisfied. The QA program
users should address the regulations delineated in Subpart H to the extent they are applicable to their
respective operations.
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, “Application for Package
Approval,” which usually leads to issuance of a CoC and fabrication of the approved packaging. The
activities normally authorized by an NRC-approved QA program 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 second area are repair, procurement, maintenance, and use.
This regulatory guide includes information about commonly misinterpreted areas of
10 CFR Part 71, such as (1) the extent 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
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 packaging 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).
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.
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 NRC’s QA program requirements apply to the QA program user’s 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
Part 71 that applies to the QA program user’s activities and describes how the QA program user will carry
out and satisfy each regulation. It is important to consider the limitations described in the previous
paragraph, and that the extent of detail is at the QA program user’s discretion.
DG-7009, Page 5
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 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 used. This
may necessitate changes to the submitter’s underlying QA program and delay NRC 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, 14 and 15).
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.
Any changes that reduce commitments to the approved QA program description require NRC
approval. Therefore, before implementing any change that constitutes a reduction in commitments in the
QA program description that was used as the basis for NRC approval, the QA program user should
submit the proposed change for NRC review and approval. Under new provision §71.106(a)(1), the NRC
would require the following information for changes that reduce commitments, made to an approved QA
program description for its review: (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.
Harmonization with International Standards
The International Atomic Energy Agency (IAEA) has established a series of safety standards and
guides constituting 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).
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
DG-7009, Page 6
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.
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
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
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
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.
C. STAFF REGULATORY GUIDANCE
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.
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.
Upon determining that a given QA program submittal is adequate, the NRC will issue a QA program
approval. Under proposed §71.106(b), while the approval does not expire, the NRC expects the user to
review its QA program periodically to ensure it is adequately maintained. The NRC also expects that the
user will notify the NRC when the QA program approval is no longer needed. Note that QA program
approval holders are expected to report changes to their approved QA program that do not reduce any
commitments in the QA program description approved by the NRC every 24 months. The licensee has to
obtain NRC approval before making any changes to their QA program description that would reduce the
commitments made to the NRC.
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
DG-7009, Page 7
requirements which apply to their use of a packaging for the shipment 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.
A previously approved quality assurance program that satisfies the applicable criteria of 10 CFR
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
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”
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:
•
The formal structure of the organization is documented by organization charts
that identify each organizational element that functions under the QA program.
•
The discussion specifies the required authority and organizational responsibility,
including sufficient independence from influences of cost and schedule.
•
The specified quality requirements are achieved and maintained by those who
have been assigned the responsibility for performing the work.
•
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).
•
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.
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.
Individuals with QA and QC functions should have the written endorsement of upper
management.
DG-7009, Page 8
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
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:
2.
•
Implement and revise the provisions of the described QA program.
•
Regularly assess the scope, status, implementation, and effectiveness of the QA
program.
Guidance on 10 CFR 71.105, “Quality Assurance Program”
2.1
General Guidance on QA Programs
In its program description submittal, the QA program user should describe to the NRC
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
procurement activities. Elements common to all QA program descriptions include the
quality organization and program, corrective action, QA records, and audits.
In developing its program, a prospective QA program user can refer to the NRC’s
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).
Following the NRC staff’s technical review and determination that the QA program
submittal meets regulatory requirements, the Commission issues a QA program approval.
While the approval does not expire, the NRC expects the user to periodically review its
QA program to ensure it is adequately maintained. The NRC also expects the user to
notify the NRC when the approved QA program is no longer needed.
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)
implementing procedures that govern the conduct of QA activities important to safety.
DG-7009, Page 9
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
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.
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:
2.3
•
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.
•
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.
Applicability of QA Program
Measures that the QA program covers should be compatible with and emphasize
characteristics identified in the manufacturer’s QA program. The QA program user
should establish the rationale for identifying items classified as important to safety and
subject to the user’s QA program.
2.4
Documentation
The QA program user should ensure that written procedures and instructions:
(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.
DG-7009, Page 10
Table 1. Format for Listing Implementing Procedures*
Implementing
Document
Title
Regulatory
Position per
Regulatory
Guide 7.10
Description
Quality Assurance
Manual (QAM), Quality
Procedure (QP) 1
QAM, QP 2
Organization
1
QA Program
2
QAM, QP 3
4
QAM, QP 4
Design
Control
Procurement
Document
Control
QAM, QP 18
Audits
19
Identifies the QA organization, its relationship
to other organizations within the company, and its
responsibilities for activities affecting quality.
Describes basic methods for establishing
a documented QA program that implements
requirements of Subpart H to Part 71.
Describes design control measures established
for structures, systems, and components.
Describes procedures for ensuring that applicable
regulatory requirements, design bases, and other
requirements necessary to ensure adequate quality
are suitably included or referenced in documents for
procurement of material, equipment, and services.
Describes internal and external audit programs
applicable to both in-house and major suppliers.
5
* 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.
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.
These written procedures should also address the use, management, and storage of
electronic records and data.
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.
The QA program user should also document the assignment of responsibility for each
task and method used to verify conformance to these quality requirements.
3.
Guidance on 10 CFR 71.106, “Changes to Quality Assurance Program”
As stated in 10 CFR 71.106, the NRC must review and approve any changes that reduce
commitments to an approved QA program description before they are implemented. Therefore,
to make a change in the QA program description that reduces commitments made in the NRC
approval, the QA program user must submit the change for NRC review and approval before
implementing the change. 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 would not require NRC
approval. Changes to reporting responsibilities, functional responsibilities, functional
relationships, and some editorial or punctuation changes may be substantive and have the
potential to reduce commitments made to the NRC and, in these instances, would require prior
NRC approval before being implemented. The following are some changes not considered to
reduce commitments made to the NRC:
DG-7009, Page 11
(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
(3)
use of generic organizational charts to indicate functional relationships, authorities, and
responsibilities, or alternatively, the use of descriptive text
(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
Changes that consist of administrative improvements and clarifications, spelling corrections,
changes to punctuation, or editorial changes would not require NRC approval. In accordance
with 10 CFR 71.106, the NRC would require the following information to be provided for
changes reducing commitments made in an NRC-approved QA program description for its
review: (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. 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 shall
maintain records of QA program changes.
4.
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.
Computer-aided design (CAD) is extensively used in current design applications. Designs
developed using CAD methods are prepared and stored electronically. Thus, applicable QA
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.
DG-7009, Page 12
4.1
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.
To control the preparation of drawings and specifications, the QA program user should
establish recognized engineering practices. Engineering practices may include:
(1) prescribing drafting room standards, (2) checking methods, establishing review and
approval and issuance and distribution requirements (including revisions to them),
(3) maintaining current “as-built” configurations, and (4) storing and controlling original
and master copies.
4.2
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.
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.
4.3
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 designer’s immediate supervisor may perform the
verification, provided that the following criteria are met:
•
The supervisor is the only technically qualified individual.
•
The supervisor’s management documents and approves the need in advance.
•
The QA audits cover the effectiveness of the use of supervisors as design
verifiers to guard against abuse of this practice.
Changes to the final design may arise during the sequence of design verification.
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.
DG-7009, Page 13
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.
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.
5.
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.
5.1
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):
•
The scope of work to be performed by the prospective supplier.
•
The design-basis technical requirements (or references thereto), including
applicable regulatory requirements, material and component identification
requirements, drawings, specifications, codes and standards, special process
instructions, and test and inspection requirements.
•
Applicable Subpart H requirements that should be complied with and described
in the supplier’s QA program (e.g., qualified QA personnel from the purchaser’s
organization should review and provide review concurrence on the supplier’s QA
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 supplier’s and subtier supplier’s QA programs will depend on the
particular item or service being procured).
•
Permission to gain access to the supplier’s and subtier supplier’s 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.
DG-7009, Page 14
•
5.2
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,
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.
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
program user should ensure that the replacement parts meet requirements at least as
stringent as the original criteria.
5.3
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.
6.
Guidance on 10 CFR 71.111, “Instructions, Procedures, and Drawings”
6.1
Quality Assurance Program Procedures
The QA program user should establish measures to ensure that the following
requirements are fulfilled:
•
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.
•
Instructions, procedures, and drawings specify the methods for complying with
each of the applicable sections of Subpart H of 10 CFR Part 71.
•
All work activities are coordinated with QA personnel to ensure that the workcontrolling documents incorporate appropriate inspection and hold points to
verify that initial work, planned work, effective repairs, or rework have been
performed satisfactorily.
•
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.
DG-7009, Page 15
•
6.2
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.
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;
and specifications as well as any changes thereto. Before fabrication of an item, the QA
organization should review and concur in the related manufacturing plans, as they relate
to scheduled witness and hold points during fabrication.
7.
Guidance on 10 CFR 71.113, “Document Control”
7.1
Controlled Documents
The QA program user should maintain control of each of the documents of the QA
program to reflect the current status. As a minimum, the QA program user should
exercise control over the following:
•
•
•
•
•
•
•
•
7.2
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
design change requests
corrective action reports
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.
7.3
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.
DG-7009, Page 16
7.4
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.
8.
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.
8.1
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.
8.2
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.
Specifically, the QA program user should consider establishing the following provisions
(if applicable):
•
•
•
8.3
the supplier’s capability to comply with applicable sections of Subpart H
results of the survey of the supplier’s facility and QA program
review of the supplier’s previous records and performance
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 supplier’s commitment that the conditions will be resolved at a
mutually agreeable date during the contract period.
8.4
Supplier Performance Control
The QA program user should establish measures for pre- and post-award activities.
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.
DG-7009, Page 17
8.5
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:
•
instructions specifying characteristics or processes to be witnessed, inspected, or
verified
•
the documentation required
•
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.
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.
8.6
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”).
8.7
Records
The QA program user should establish measures to ensure that the supplier furnishes the
following records to the purchaser (as a minimum):
•
documentation that identifies material or equipment and the specific procurement
requirements (e.g., codes, standards, and specifications met by the items)
•
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
DG-7009, Page 18
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.
9.
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.
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.
10.
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:
11.
•
Procedures, equipment, and personnel are qualified in accordance with applicable codes,
standards, and specifications.
•
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.
•
Qualification records of procedures, equipment, and personnel are established, filed, and
kept current.
Guidance on 10 CFR 71.121, “Internal Inspection”
11.1
The QA program user should establish measures for internal inspection that consider the
following recommendations:
•
The prerequisites to be satisfied before inspection are identified, including
operator qualification and equipment calibration. Where sampling is used, the
DG-7009, Page 19
standard used as the basis for verifying acceptability of a group of items should
be identified.
11.2
•
Inspection procedures, instructions, or checklists should be available for each
work operation, where necessary to ensure quality.
•
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.
•
“Hold” or witness points should be identified.
•
Inspection results should be recorded and objectively verifiable.
•
The appropriate personnel should approve data to ensure that all inspection
requirements have been satisfied.
Inspections
11.2.1 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.
These visual inspections should include the following aspects:
•
surface conditions
•
weld and structural integrity
•
the condition of flange faces or sealing areas, gaskets, seals, gauges,
rupture disks, valves, and pressure relief devices
•
the condition of tie-down members (if applicable)
•
labeling and marking
•
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.
11.2.2 In-Process Inspections
The QA program user should establish measures to ensure that process
DG-7009, Page 20
specifications and their supporting documentation provide for indirect control by
monitoring processing methods, equipment, and personnel if direct inspection is
impractical.
11.2.3 Final Inspections
The QA program user should establish measures to ensure the following:
(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:
•
Packages are properly assembled.
•
Moderators and neutron absorbers are present (if applicable).
•
Valves through which primary coolant flows are protected against
tampering.
•
Valves are set to specifications.
•
All shipping papers are properly completed.
•
Packages are conspicuously and durably marked as required by the
regulations set forth by the U.S. Department of Transportation (DOT).
•
Measures are established to ensure that appropriate personnel designated
by the package user sign the shipping tags or indicators before
authorization for shipping.
11.2.4 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.
11.2.5 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
(3) inspection personnel are independent from all individuals performing the
activity being inspected.
11.2.6 Inspection Documentation
DG-7009, Page 21
The QA program user should maintain inspection records as QA records to
document performance of inspection activities.
12.
Guidance on 10 CFR 71.123, “Test Control”
12.1
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.
12.2
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.
12.3
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.
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:
12.4
•
structural integrity
•
leak-tightness (on containment vessel as well as auxiliary equipment and shield
tanks)
•
component performance for valves, gaskets, and fluid transport devices
•
shielding integrity
•
thermal integrity
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.
DG-7009, Page 22
12.5
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.
13.
Guidance on 10 CFR 71.125, “Control of Measuring and Test Equipment”
13.1
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.
13.2
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.
In addition, the QA program user should repair or replace any measuring equipment that
is consistently out of calibration.
14.
Guidance on 10 CFR 71.127, “Handling, Storage, and Shipping Control”
14.1
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.
14.2
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
DG-7009, Page 23
identified by physical markings or tags, and (4) contains operating manuals, maintenance
manuals, and generic procedures relating to its use.
In addition, the QA program user should establish measures to ensure that the following
requirements are fulfilled:
15.
•
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.
•
All NRC and DOT requirements have been satisfied before delivery to a carrier.
•
All necessary shipping papers have been prepared as required and reviewed by
qualified personnel to verify completeness and accuracy.
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.
16.
Guidance on 10 CFR 71.131, “Nonconforming Materials, Parts, or Components”
An acceptable program for controlling nonconforming items should include the following
principal elements:
•
•
•
•
17.
proper identification
segregation of discrepant or nonconforming items
evaluation of the nonconforming items
disposition of the nonconforming items
Guidance on 10 CFR 71.133, “Corrective Action”
17.1
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.
17.2
Closeout, Retrieval, and Disposition of Records
DG-7009, Page 24
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.
18.
Guidance on 10 CFR 71.135, “Quality Assurance Records”
18.1
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
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). The QA program user should also maintain
records documenting changes to the QA program as required by 10 CFR 71.106.
Where applicable, inspection and test records should contain the following information:
•
•
•
•
•
•
a description of the observation
evidence of completion of the inspection or test operation
results of inspections or tests with appropriate data
conditions detrimental to quality
names of inspectors, testers, or data recorders
evidence of acceptability
DG-7009, Page 25
18.2
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.
18.3
Indexing and Classification of Records
The QA program user should classify QA records as either “lifetime” or “nonpermanent”:
18.4
•
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.
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 inhouse 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
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.
18.5
Storage, Preservation, and Safekeeping
The QA program user should establish measures to ensure that the following outcomes
are fulfilled:
•
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.
•
Records should be firmly attached in binders or placed in folders or envelopes for
storage in steel file cabinets.
DG-7009, Page 26
19.
•
Electronic records should be maintained in facilities that minimize or eliminate
the potential for destruction of information as a result of demagnetization (Ref.
12).
•
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).
•
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.
•
The QA program user should take measures to protect special records
(e.g., radiographs and microfilm) from excessive light, electromagnetic fields,
and temperature.
•
The QA program user should take measures to prevent unauthorized personnel
from entering record storage areas.
•
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.”
•
The QA program user should establish measures to ensure prompt replacement of
lost or damaged records.
Guidance on 10 CFR 71.137, “Audits”
19.1
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
•
identification of audit personnel and their qualifications
•
provisions for reasonable and timely access of audit personnel to facilities,
documents, and qualified personnel necessary for performing audits
•
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
DG-7009, Page 27
•
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
activity’s 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.
19.2
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.
For external audits, the schedules should ensure that all elements of a major supplier’s (or
major contractor’s) QA program are audited on a triennial basis. 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.
19.3
Team Selection
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.
DG-7009, Page 28
Specific guidance for determining qualifications for the lead auditor and individual audit
team members may be obtained from ANSI/ASME NQA-1- 2008 with the NQA-1a-2009
Addenda, “Quality Assurance Requirements for Nuclear Facility Applications (QA)”
(Ref. 2).
19.4
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.
19.5
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.
19.6
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.
19.7
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.
D. IMPLEMENTATION
The purpose of this section is to provide information to licensees, certificate holders and
applicants regarding the NRC’s 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.
DG-7009, Page 29
REFERENCES1
1.
Title 10 of the Code of Federal Regulations (10 CFR) Part 71, “Packaging and Transportation of
Radioactive Material,” U.S. Nuclear Regulatory Commission, Washington, DC.
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.
U.S. Nuclear Regulatory Commission (NRC) Regulatory Guide (RG) 7.6, “Design Criteria for
the Structural Analysis of Shipping Cask Containment Vessels,” Washington , DC.
4.
NRC, RG 7.7, “Administrative Guide for Verifying Compliance With Packaging Requirements
for Shipping and Receiving of Radioactive Material,” Washington , DC.
5.
NRC, 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.
NRC NUREG/CR-6407, “Classification of Transportation Packaging and Dry Spent Fuel Storage
System Components According to Importance to Safety,” 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.
11.
NRC, Generic Letter 88-18, “Plant Record Storage on Optical Disks,” NRC, Washington , DC,
October 20, 1988 (ADAMS accession number: 8810250164).
1
Publicly available documents from the U.S. Nuclear Regulatory Commission (NRC) are available electronically
through the NRC Library on the NRC’s 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 NRC’s 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 [email protected].
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 [email protected]
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 [email protected], or on-line at the ISO Store Web site:
http://www.iso.org/iso/store.htm.
DG-7009, Page 30
12.
NRC, Regulatory Issue Summary (RIS) 00-18, “Guidance on Managing Quality Assurance
Records in Electronic Media,” NRC, Washington , DC, October 23, 2000 (ML003739359).
13.
NRC, IN 86-21, “Recognition of American Society of Mechanical Engineers Accreditation
Program for N Stamp Holders,” Washington, DC, March 31, 1986 (8603260277).
14.
NRC, IN RIS 86-21, supplement 1, “Recognition of American Society of Mechanical Engineers
Accreditation Program for N Stamp Holders,” Washington, DC, December 4, 1986
(8612010331).
15.
NRC, IN RIS 86-21 supplement 2, “Recognition of American Society of Mechanical Engineers
Accreditation Program for N Stamp Holders,” Washington, DC, April 16, 1991 (9104100050).
DG-7009, 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)
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.
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
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.
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:
•
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.
•
The procurement documentation for materials or services should specify that the QA
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.
•
The manufacturing planning should specify complete traceability of raw materials and
the use of certified welders and processes.
•
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).
•
Only qualified auditors and lead auditors should perform audits.
•
A representative of the buyer would be present at a supplier’s facility to approve the final
acceptance test and to authorize shipment.
Category B quality requirements should include the following specifications:
1
•
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.
•
Manufacturing planning need not require traceability of materials, and only specified
welds would be done by qualified welders.
•
Verification activities would still require use of inspectors qualified to appropriate codes,
standards, or other industrial specifications.
•
Only the lead auditor need meet certain qualification requirements.
ASNT-SNT-TC-1A, “Recommended Practice for Personnel Qualification and Certification for Nondestructive
Testing,” American Society for Nondestructive Testing (ASNT), Columbus, Ohio, 2001.
Appendix A to RG 7.10, Page A-2
With respect to Category C items, the only enforced quality requirements include the following
specifications:
•
•
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.
Appendix A to RG 7.10, Page A-3
| File Type | application/pdf |
| File Modified | 2013-05-16 |
| File Created | 2013-05-16 |