ASTM C1188-91(1997)e1

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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e1
Designation: C 1188 – 91 (Reapproved 1997)
Standard Guide for
Establishing a Quality Assurance Program for Uranium
Conversion Facilities
This standard is issued under the fixed designation C 1188; 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 (e) indicates an editorial change since the last revision or reapproval.
e NOTE—Keywords were added in May 1998.
1. Scope 3. Terminology
1.1 This guide provides guidance and recommended prac- 3.1 Definitions:
tices for establishing a comprehensive quality assurance pro- 3.1.1 operation—the terms operation, operations, and op-
gram for uranium conversion facilities. eration activities are used interchangeably to describe collec-
1.2 This standard does not purport to address all of the tively all activities and functions executed by the conversion
safety concerns, if any, associated with its use. It is the facility.
responsibility of the user of this standard to establish appro- 3.1.2 special process—a process, the results of which are
priate health and safety practices and determine the applica- highly dependent on the control of the process or the skill of
bility of regulatory limitations prior to use. the operators, or both, and in which the specified quality cannot
1.3 The basic elements of a quality assurance program be readily determined by inspection or test of the product.
appear in the following order: 3.1.3 uranium conversion facility—a chemical processing
plant whose primary function is to convert uranium ore
FUNCTION SECTION
concentrates or uranium oxide to purified uranium hexafluo-
Organization 5
ride.
Quality Assurance Program 6
Design Control 7
4. Significance and Use
Instructions, Procedures & Drawings 8
Document Control 9
4.1 Quality assurance provides a planned and systematic
Procurement 10
approach for establishing practices to meet requirements of
Identification and Traceability 11
Processes 12
safe facility operation and product quality.
Inspection 13
4.2 In the operation of a uranium conversion facility there
Control of Measuring and Test Equipment 14
are many requirements established by regulatory bodies, codes,
Handling, Storage and Shipping 15
Inspection, Test and Operating Status 16
customers, and the facility itself. These requirements are
Control of Nonconforming Items 17
identified by facility management and acted upon by various
Corrective Actions 18
facility groups. Implementation of the practices described in
Quality Assurance Records 19
Audits 20
this guide are intended to assist with compliance with these
requirements.
2. Referenced Documents
4.3 In the operation of a uranium conversion facility there is
2.1 ANSI Standard:
a potential for both chemical and radiological exposure to
ANSI/ASME NQA-1 Quality Assurance Program Require-
employees, the public, and the environment. This potential is
ments for Nuclear Facility Applications
reduced by implementation of the practices described in this
guide. The development of this guide, as part of sound
management practice, provides a means for ensuring consis-
tency between facilities, and documentation and formalization
This guide is under the jurisdiction of ASTM Committee C–26 on Nuclear Fuel
Cycle and is the direct responsibility of Subcommittee C26.08 on Quality Assurance
of existing practices.
Applications.
4.4 To establish a quality assurance program for a uranium
Current edition approved May 15, 1991. Published July 1991.
2 conversion facility, the practices in use should be evaluated
Available from American National Standards Institute, 11 W. 42nd St., 13th
Floor, New York, NY 10036. against the recommended practices of this guide. Existing
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
C 1188
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
practices may then be modified or new practices implemented This may be necessary in order to most efficiently or effectively
to correct any identified deficiencies. This approach highlights accomplish the assigned responsibilities.
the fact that the basic foundation of a quality assurance
5.2.4 Communication— Lines of communication for formal
program is already present.
interaction between groups should be defined. This is espe-
4.5 ANSI/ASME NQA-1 is a quality assurance standard
cially important when more than one group is responsible for
that is being applied broadly across the nuclear industry.
the completion or performance of an activity. Interfaces, both
NQA-1 was used as guidance in the development of the
internal and external to the facility, may be defined through
program elements of this guide.
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 commu-
uranium conversion facility should be defined in that program.
nication, the organizational freedom and access to management
to effectively perform quality assurance functions.
5. Organization
5.1 Summary—The organizational structure of a facility is
6. Quality Assurance Program
the basis from which authority, functional responsibility, lines
6.1 Summary—A quality assurance program should be es-
of communication and interfaces are derived. Since, in every
tablished, documented and implemented. The program should
case, facilities are composed of smaller organizations of
consist of suitable policies, programs, and written procedures
various functions, it is necessary to define the organizational
that provide for the planning and accomplishment of activities
structure and the controls and responsibilities delegated to each
affecting quality under controlled conditions. The program
component.
should provide for training, as necessary, of personnel to
5.2 Recommendations:
ensure that adequate proficiency is achieved and maintained.
5.2.1 Organizational Structure—All facilities have an inter-
The quality assurance program should provide for routine
nal organizational structure. The organizational structure
assessment of policies, programs, and procedures to ensure
should be defined and documented. This is necessary to define
their continued effectiveness and to ensure compliance.
relationships between groups and to assign responsibilities for
6.2 Recommendations:
the accomplishment of required activities. Without a defined
6.2.1 The uranium conversion facility should document the
organizational structure, the efficiency and quality of output of
quality assurance program in sufficient detail to demonstrate
the organization will be adversely affected. The most common
that the recommendations of this guide have been met. This is
method of documenting the organizational structure is via the
usually provided by means of a quality assurance manual,
organization chart.
which is approved and signed by senior facility management.
5.2.2 Functional Responsibilities—Each position detailed
6.2.2 The quality assurance function should be staffed by
on the organization chart should be defined. This can be done
personnel who are independent of the organizations respon-
via a position description or other method. The job description
sible for performing quality related functions.
should include the functional responsibilities and relationship
6.2.3 Personnel involved in quality assurance activities
to the organization.
should have training or experience commensurate with the
5.2.3 Levels of Authority—Included with functional respon-
scope of the activities. This training and experience should be
sibilities should be the authority level of the position. This
documented.
authority should include decision making and approval of
actions necessary to carry out the assigned functional respon- 6.2.4 Quality assurance activities may utilize other person-
sibility. The delegation of authority should also be addressed. nel in order to obtain the necessary knowledge or expertise to
C 1188
properly perform the function in question. The quality assur- 7.2.3.2 Extent of design verification should be commensu-
ance organization should maintain ultimate responsibility for rate with the scope and complexity of the design.
the results of the actions of the other persons. 7.2.3.3 Acceptable verification methods include, but are not
6.2.5 Quality assurance program documentation should be limited to, any one or a combination of the following: design
submitted, if so required, to the appropriate regulatory body, reviews, alternate calculation and verification testing.
customer or other jurisdiction for approval prior to implemen- 7.2.4 Documentation— Sufficient records should be gener-
tation. Any substantive changes made after receipt of approval ated to provide evidence that design processes are performed in
should be approved in the same manner. accordance with the requirements of this guide. Documentation
6.2.6 The quality assurance program documentation should should include such items as drawings, specifications, design
contain the following as a minimum: bases and design input that support the final design. Documen-
6.2.6.1 Policy statement by senior executive, directing com- tation should also include any revisions to the design including
pliance to the quality assurance program, the appropriate review and verification documentation.
6.2.6.2 Organizational description meeting the requirements
8. Instructions, Procedures and Drawings
of Section 5, Organization, of this guide,
8.1 Summary—Typically, in industry, there are many activi-
6.2.6.3 A description or reference of the program proce-
ties that, when performed incorrectly, could adversely affect
dures that implement the requirements of this guide,
the quality of the products, the health and safety of workers and
6.2.6.4 Identification of the interrelationship and hierarchy
the public, the environment, or a combination thereof. It is
of documents used in the program,
widely accepted that the best way to ensure that these activities
6.2.6.5 Identification of programs items, procedures, and
are consistently performed in the proper manner is to define the
services to which the program applies, and
requirements and the actions to be taken. This is done in
6.2.6.6 Provision for the periodic review of the program to
appropriate documents such as instructions, procedures, and
determine its adequacy and effectiveness. The method of
drawings. For simplicity, when the term procedure is used in
review, frequency, and documentation should be stated.
this guide, it will refer to any of these types of documents.
7. Design Control
8.2 Recommendations:
7.1 Summary—This section describes design control mea- 8.2.1 In the operation of a uranium conversion facility,
sures required to ensure that design bases, design calculations, procedures should be used to help ensure the proper perfor-
and specifications are correct. It also provides the means for mance tasks by employees. The following activities are some
ensuring that new or modified designs are in compliance with candidate areas for the development of procedures. Note that
applicable codes, standards, and regulations. when procedures are designated “appropriate to” these activi-
7.1.1 Uranium conversion facilities, based on proven design ties, the activity often defines a category or type of procedure
and technology, have been in operation for many years. As (for example, operating procedures.)
such, the application of design control should focus on changes 8.2.1.1 Process operations,
made to these original designs based on facility operating 8.2.1.2 Maintenance and calibration,
experiences, changes in process technology, emissions require- 8.2.1.3 Laboratory analyses,
ments, etc. 8.2.1.4 Emergency actions, and
7.2 Recommendations: 8.2.1.5 Quality assurance (including inspections, tests, au-
7.2.1 Change Control— Changes to approved designs that dits, etc.).
may alter the performance of the design should be subject to 8.2.2 Procedures should be written to ensure consistency in
review and verification similar to that used for the original the operation of a facility. For operating procedures (and as
design. Changes should be requested and documented in a appropriate for other types of procedures) the following should
formal change request letter or form. be considered as the minimum to be included:
7.2.2 Design Analysis— Design input should be solicited 8.2.2.1 Start-up and shutdown sequences,
from each affected organization in order to provide for ad- 8.2.2.2 Normal conditions and monitoring activities,
equate initial design. Information for design should be obtained 8.2.2.3 Emergency conditions and expected responses, and
from appropriate production, maintenance, technical, or other 8.2.2.4 Identification of chemical and radiological hazards.
personnel to ensure that all requirements are anticipated and 8.2.3 Procedures should be designed to match the way they
satisfied. will be used. Consideration should be given to the use of
7.2.3 Design Verification: special documents such as operating checklists, log books, shift
7.2.3.1 Designs, including pertinent drawings, specifica- reports, etc.
tions, and calculations should be reviewed according to any or 8.2.4 Whenever possible, quantitative or qualitative criteria
all of the following, as appropriate: that help determine the proper course of action or define the
(a) Upon completion of the design and prior to construction result of step or process should be included in procedures.
or implementation, 8.2.5 The requirement to follow procedures should be
(b) By a competent individual or group not directly in- documented and employees should be made aware of this
volved in the preparation or selection of the design methods, requirement.
and 8.2.6 The system for development of proce
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