ASTM C1188-04(2011)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: C1188 − 04 (Reapproved 2011)
Standard Guide for
Establishing a Quality Assurance Program for Uranium
Conversion Facilities
This standard is issued under the fixed designation C1188; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.1.1 operation—the terms operation, operations, and op-
eration activities are used interchangeably to describe collec-
1.1 This guide provides guidance and recommended prac-
tively all activities and functions executed by the conversion
tices for establishing a comprehensive quality assurance pro-
facility.
gram for uranium conversion facilities.
3.1.2 special process—a process, the results of which are
1.2 This standard does not purport to address all of the
highly dependent on the control of the process or the skill of
safety concerns, if any, associated with its use. It is the
theoperators,orboth,andinwhichthespecifiedqualitycannot
responsibility of the user of this standard to establish appro-
be readily determined by inspection or test of the product.
priate health and safety practices and determine the applica-
3.1.3 uranium conversion facility—a chemical processing
bility of regulatory limitations prior to use.
plant whose primary function is to convert uranium ore
1.3 The basic elements of a quality assurance program
concentrates or uranium oxide to purified uranium hexafluo-
appear in the following order:
ride.
FUNCTION SECTION
4. Significance and Use
Organization 5
Quality Assurance Program 6
4.1 Quality assurance provides a planned and systematic
Design Control 7
Instructions, Procedures & Drawings 8 approach for establishing practices to meet requirements of
Document Control 9
safe facility operation and product quality.
Procurement 10
Identification and Traceability 11
4.2 In the operation of a uranium conversion facility there
Processes 12
aremanyrequirementsestablishedbyregulatorybodies,codes,
Inspection 13
customers, and the facility itself. These requirements are
Control of Measuring and Test Equipment 14
Handling, Storage and Shipping 15
identified by facility management and acted upon by various
Inspection, Test and Operating Status 16
facility groups. Implementation of the practices described in
Control of Nonconforming Items 17
this guide are intended to assist with compliance with these
Corrective Actions 18
Quality Assurance Records 19
requirements.
Audits 20
4.3 In the operation of a uranium conversion facility there is
a potential for both chemical and radiological exposure to
2. Referenced Documents
employees, the public, and the environment. This potential is
2.1 ANSI Standard:
reduced by implementation of the practices described in this
ANSI/ASME NQA-1 Quality Assurance Program Require-
guide. The development of this guide, as part of sound
ments for Nuclear Facility Applications
management practice, provides a means for ensuring consis-
tency between facilities, and documentation and formalization
3. Terminology
of existing practices.
3.1 Definitions:
4.4 To establish a quality assurance program for a uranium
conversion facility, the practices in use should be evaluated
against the recommended practices of this guide. Existing
This guide is under the jurisdiction ofASTM Committee C26 on Nuclear Fuel
practices may then be modified or new practices implemented
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality
to correct any identified deficiencies. This approach highlights
Assurance, Statistical Applications, and Reference Materials.
the fact that the basic foundation of a quality assurance
Current edition approved June 1, 2011. Published June 2011. Originally
approved in 1991. Last previous edition approved in 2004 as C1188 – 04. DOI: program is already present.
10.1520/C1188-04R11.
4.5 ANSI/ASME NQA-1 is a quality assurance standard
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. that is being applied broadly across the nuclear industry.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
C1188 − 04 (2011)
TABLE 1 NQA-1 Basic Requirements Related to Principles of Conversion Facility Quality Assurance
NQA-1 BASIC REQUIREMENTS
Elements of Conversion Facility Quality
123456789 10 11 12 13 14 15 16 17 18
Assurance
Organization X
Quality Assurance Program X
Design Control X
Document Control X X
Instructions, Procedures & Drawings X
Procurement X
Identification and Traceability X
Processes X
Inspection XX
Control of Measuring and Test Equipment X
Handling, Storage, and Shipping X
Inspection, Test and Operating Status X
Control of Non-conforming Items X
Corrective Actions X
Quality Assurance Records X
Audits X
NQA-1 was used as guidance in the development of the the completion or performance of an activity. Interfaces, both
program elements of this guide. internal and external to the facility, may be defined through
position descriptions. Specific interfaces may be detailed in the
4.6 The program functions detailed in this guide should be
quality assurance program in order to clarify or emphasize the
selected based on the particular needs and applications at the
proper protocol. It should be stressed that the quality assurance
facility. Those activities or programs to be included in a
personnel be formally given, via appropriate lines of
uranium conversion facility should be defined in that program.
communication, the organizational freedom and access to
management to effectively perform quality assurance func-
5. Organization
tions.
5.1 Summary—The organizational structure of a facility is
the basis from which authority, functional responsibility, lines
6. Quality Assurance Program
of communication and interfaces are derived. Since, in every
6.1 Summary—A quality assurance program should be
case, facilities are composed of smaller organizations of
various functions, it is necessary to define the organizational established, documented and implemented. The program
should consist of suitable policies, programs, and written
structure and the controls and responsibilities delegated to each
component. procedures that provide for the planning and accomplishment
of activities affecting quality under controlled conditions. The
5.2 Recommendations:
program should provide for training, as necessary, of personnel
5.2.1 Organizational Structure—All facilities have an inter-
to ensure that adequate proficiency is achieved and maintained.
nal organizational structure. The organizational structure
The quality assurance program should provide for routine
should be defined and documented. This is necessary to define
assessment of policies, programs, and procedures to ensure
relationships between groups and to assign responsibilities for
their continued effectiveness, to ensure compliance, and to
the accomplishment of required activities. Without a defined
identify opportunities for improvements.
organizational structure, the efficiency and quality of output of
the organization will be adversely affected. The most common 6.2 Recommendations:
6.2.1 The uranium conversion facility should document the
method of documenting the organizational structure is via the
organization chart. quality assurance program in sufficient detail to demonstrate
5.2.2 Functional Responsibilities—Each position detailed that the recommendations of this guide have been met. This is
on the organization chart should be defined. This can be done usually provided by means of a quality assurance manual,
via a position description or other method. The job description which is approved and signed by senior facility management.
should include the functional responsibilities and relationship 6.2.2 The quality assurance function should be staffed by
to the organization. personnel who are independent of the organizations respon-
5.2.3 Levels of Authority—Included with functional respon- sible for performing quality related functions.
sibilities should be the authority level of the position. This 6.2.3 Personnel involved in quality assurance activities
authority should include decision making and approval of should have training or experience commensurate with the
actions necessary to carry out the assigned functional respon- scope of the activities. This training and experience should be
sibility. The delegation of authority should also be addressed. documented.
Thismaybenecessaryinordertomostefficientlyoreffectively 6.2.4 Quality assurance activities may utilize other person-
accomplish the assigned responsibilities. nel in order to obtain the necessary knowledge or expertise to
5.2.4 Communication— Lines of communication for formal properly perform the function in question. The quality assur-
interaction between groups should be defined. This is espe- ance organization should maintain ultimate responsibility for
cially important when more than one group is responsible for the results of the actions of the other persons.
C1188 − 04 (2011)
6.2.5 Quality assurance program documentation should be 7.2.3.2 Extent of design verification should be commensu-
submitted, if so required, to the appropriate regulatory body, rate with the scope and complexity of the design.
customer or other jurisdiction for approval prior to implemen-
7.2.3.3 Acceptable verification methods include, but are not
tation.Any substantive changes made after receipt of approval
limited to, any one or a combination of the following: design
should be approved in the same manner.
reviews, alternate calculation and verification testing.
6.2.6 The quality assurance program documentation should
7.2.4 Documentation— Sufficient records should be gener-
contain the following as a minimum:
atedtoprovideevidencethatdesignprocessesareperformedin
6.2.6.1 Policy statement by senior executive, directing com-
accordancewiththerequirementsofthisguide.Documentation
pliance to the quality assurance program,
should include such items as drawings, specifications, design
6.2.6.2 Organizational description meeting the requirements bases and design input that support the final design. Documen-
of Section 5, Organization, of this guide,
tation should also include any revisions to the design including
6.2.6.3 A description or reference of the program proce- the appropriate review and verification documentation.
dures that implement the requirements of this guide,
6.2.6.4 Identification of the interrelationship and hierarchy 8. Instructions, Procedures and Drawings
of documents used in the program,
8.1 Summary—Typically, in industry, there are many activi-
6.2.6.5 Identification of programs items, procedures, and
ties that, when performed incorrectly, could adversely affect
services to which the program applies, and
thequalityoftheproducts,thehealthandsafetyofworkersand
6.2.6.6 Provision for the periodic review of the program to
the public, the environment, or a combination thereof. It is
determine its adequacy, effectiveness, and opportunities for
widely accepted that the best way to ensure that these activities
improvement.The method of review, frequency, and documen-
areconsistentlyperformedinthepropermanneristodefinethe
tation should be stated.
requirements and the actions to be taken. This is done in
appropriate documents such as instructions, procedures, and
7. Design Control
drawings. For simplicity, when the term procedure is used in
this guide, it will refer to any of these types of documents.
7.1 Summary—This section describes design control mea-
sures required to ensure that design bases, design calculations,
8.2 Recommendations:
and specifications are correct. It also provides the means for
8.2.1 In the operation of a uranium conversion facility,
ensuring that new or modified designs are in compliance with
procedures should be used to help ensure the proper perfor-
applicable codes, standards, and regulations.
mance tasks by employees. The following activities are some
7.1.1 Uranium conversion facilities, based on proven design
candidate areas for the development of procedures. Note that
and technology, have been in operation for many years. As
when procedures are designated “appropriate to” these
such, the application of design control should focus on changes
activities, the activity often defines a category or type of
made to these original designs based on facility operating
procedure (for example, operating procedures.)
experiences, changes in process technology, emissions
8.2.1.1 Process operations,
requirements, etc.
8.2.1.2 Maintenance and calibration,
7.2 Recommendations:
8.2.1.3 Laboratory analyses,
7.2.1 Change Control— Changes to approved designs that
8.2.1.4 Emergency actions, and
may alter the performance of the design should be subject to
8.2.1.5 Quality assurance (including inspections, tests,
review and verification similar to that used for the original
audits, etc.).
design. Changes should be requested and documented in a
8.2.2 Procedures should be written to ensure consistency in
formal change request letter or form.
the operation of a facility. For operating procedures (and as
7.2.2 Design Analysis— Design input should be solicited
appropriate for other types of procedures) the following should
from each affected organization in order to provide for ad-
be considered as the minimum to be included:
equateinitialdesign.Informationfordesignshouldbeobtained
8.2.2.1 Start-up and shutdown sequences,
from appropriate production, maintenance, technical, or other
8.2.2.2 Normal conditions and monitoring activities,
personnel to ensure that all requirements are anticipated and
8.2.2.3 Emergency conditions and expected responses,
satisfied.
8.2.2.4 Identification of chemical and radiological hazards,
7.2.3 Design Verification:
and
7.2.3.1 Designs, including pertinent drawings,
specifications, and calculations should be reviewed according 8.2.2.5 Identification of significant environmental aspects of
to any or all of the following, as appropriate: the operation.
(a) Upon completion of the design and prior to construction 8.2.3 Procedures should be designed to match the way they
or implementation, will be used. Consideration should be given to the use of
(b) By a competent individual or group not directly in- specialdocumentssuchasoperatingchecklists,logbooks,shift
reports, etc.
volved in the preparation or selection of the design methods,
and
8.2.4 Whenever possible, quantitative or qualitative criteria
(c) For accuracy, compliance with regulatory stipulations, that help dete
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