ASTM C1009-96e1
(Guide)Standard Guide for Establishing a Quality Assurance Program for Analytical Chemistry Laboratories Within the Nuclear Industry (Withdrawn 2005)
Standard Guide for Establishing a Quality Assurance Program for Analytical Chemistry Laboratories Within the Nuclear Industry (Withdrawn 2005)
SCOPE
1.1 This guide covers the establishment of a Quality Assurance (QA) program for analytical chemistry laboratories within the nuclear industry. Reference to key elements of ANSI/ISO/ASQC Q9001-1994, Quality Systems, provides guidance to the functional aspects of analytical laboratory operation. When implemented, the recommended practices presented in this guide a comprehensive QA program for the laboratory. The recommended practices are grouped by functions, which are the basic elements of a QA program.
WITHDRAWN RATIONALE
This guide covers the establishment of a quality assurance (QA) program for analytical chemistry laboratories within the nuclear industry.
Formerly under the jurisdiction of ASTM Committee C26 on Nuclear Fuel Cycle, this guide was withdrawn in May 2005 in accordance with the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
e1
Designation:C1009–96
Standard Guide for
Establishing a Quality Assurance Program for Analytical
Chemistry Laboratories Within the Nuclear Industry
This standard is issued under the fixed designation C 1009; 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—Figure 1 was corrected editorially in February 1997.
1. Scope ratories Within the Nuclear Industry
C 1215 Guide for Preparing and Interpreting Precision and
1.1 This guide covers the establishment of a quality assur-
Bias Statements in Test Method Standards Used in the
ance(QA)programforanalyticalchemistrylaboratorieswithin
Nuclear Industry
the nuclear industry. Reference to key elements of ANSI/ISO/
C 1297 Guide for Laboratory Analysts for the Analysis of
ASQC Q9001-1994, Quality Systems, provides guidance to
Nuclear Fuel Cycle Materials
the functional aspects of analytical laboratory operation. When
D 1193 Specification for Reagent Water
implemented, the recommended practices presented in this
E 380 Practice for Use of the International System of Units
guide will provide a comprehensive QA program for the
(SI) (the Modernized Metric System)
laboratory. The recommended practices are grouped by func-
E 542 Practice for Calibration of Laboratory Volumetric
tions, which are the basic elements of a QA program.
Apparatus
1.2 The basic elements of a QA program appear in the
E 617 Specification for Laboratory Weights and Precision
following order:
Mass Standards
Section
E 694 Specification for Laboratory Glass VolumetricAppa-
Organization 5
Quality Assurance Program 6
ratus
Training and Qualification 7
2.2 ANSI Standard:
Procedures 8
Laboratory Records 9 ANSI/ISO/ASQC Q9001-1994 Quality Systems—Model
Control of Records 10
for Quality Assurance in Design, Development, Produc-
Control of Procurement 11
tion, Installation, and Servicing
Control of Measuring Equipment and Materials 12
2.3 NIST Standard:
Control of Measurements 13
Deficiencies and Corrective Actions 14
NIST IR74-461 The Calibration of Small Volumetric Labo-
ratory Glassware (1974)
2. Referenced Documents
2.4 Government Documents:
2.1 ASTM Standards:
10 CFR 830.120 Quality Assurance Requirements
C 986 Guide for Developing Training Programs in the
Nuclear Fuel Cycle
3. Terminology
C 1068 Guide for Qualification of Measurement Methods
3.1 Definitions:
by a Laboratory Within the Nuclear Industry
3.1.1 laboratory quality assurance, n—all those planned
C 1128 Guide for Preparation of Working Reference Mate-
and systematic actions necessary to provide adequate confi-
rials for Use in the Analysis of Nuclear Fuel Cycle
dence in each analytical result reported by a laboratory.
Materials
3.2 Definitions of Terms Specific to This Standard:
C 1156 Guide for Establishing Calibration for a Measure-
3.2.1 chain of custody, n—a procedure that documents
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
continuous sample control and security.
rials
C 1210 Guide for Establishing a Measurement System
Quality Control Program for Analytical Chemistry Labo-
Annual Book of ASTM Standards, Vol 11.01.
Annual Book of ASTM Standards, Vol 14.02.
Available from American National Standards Institute, 11 W. 42nd St., 13th
This guide is under the jurisdiction ofASTM Committee C-26 on Nuclear Fuel Floor, New York, NY 10036.
CycleandisthedirectresponsibilityofSubcommitteeC26.08onQualityAssurance Available from National Institute of Standards and Technology, Gaithersburg,
Applications. MD 20899.
Current edition approved July 10, 1996. Published September 1996. AvailablefromSuperintendentofDocuments,P.O.Box371954,Pittsburgh,PA
Annual Book of ASTM Standards, Vol 12.01. 15250-7954.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
C1009
3.2.2 custody, n—analytical laboratories may prevent tam-
pering and secure possession of a sample by any of the
following means: (1) the sample is in actual physical posses-
sion, (2) the sample is in view after being in possession, (3) the
sample is in a locked area after being in possession, or (4) the
sample is in a designated secure area.
3.2.3 laboratory, n—an organization established to provide
analyses of materials for other organizations requiring those
analyses. In general, the laboratory exists within a larger,
parent organization, although it may exist as an independent
organization. It can range from an organization with a small
number of employees to a multi-group organization.
3.2.4 out-of-control, n—a system that fails to meet prese-
lected performance criteria.
3.2.5 requester, n—the person or organization from which
samples originate.
3.2.6 result, n—a qualitative or quantitative description of a
property obtained from an analysis and reported to a requester.
3.2.7 traveler, n—a laboratory record used to transmit
information and data through the laboratory.
4. Significance and Use
FIG. 1 Quality Assurance of Analytical Laboratory Data
4.1 The mission of an analytical chemistry laboratory is to
provide quality analyses on nuclear fuel cycle materials. An
5.2 Recommended Practices:
analytical chemistry laboratory QA program is comprised of
5.2.1 Organizational Structure—Eachlaboratoryshouldde-
planned and systematic actions needed to provide confidence
fine its internal structure and its position within the larger
that this mission is conducted in an acceptable and consistent
structure when the laboratory exists within a larger organiza-
manner.
tion. For a laboratory having only a few people, defining an
4.2 The analytical chemistry laboratories involved in the
internal structure may not be appropriate, but defining its
analysis of nuclear fuel cycle materials are required to use QA
position in a larger organization is relevant.
in their operations. Regulatory agencies may mandate some
5.2.2 Functional Responsibilities—Functional responsibili-
form of control requirements for all or a part of a laboratory’s
ties should be clearly established for job classifications and
operation. When not mandated, laboratory QA programs
functionalgroupswithinalaboratory.Functionalresponsibility
should be established as a sound and scientific technical
defines how work is accomplished in the laboratory in terms of
practice. This guide provides guidance for establishing a QA
who does it and where it is done. This helps to establish
program to control those analytical chemistry operations vital
relationships and interfaces within the laboratory.
to ensuring the quality of chemical analyses.
5.2.3 Levels of Authority—Authority to carry out work
4.3 Quality assurance programs should be designed to meet
responsibilities, particularly those involving technical and
the needs of the organization. The quality system is comple-
operational decisions, should be clearly established. Authority
mentary to specific technical requirements. Each laboratory
includes decision making and approval of actions, extending
should identify applicable program requirements and use
from the working level up to the manager of the laboratory and
standards to implement a quality program that meets the
beyond if the laboratory is a part of a larger organization. The
appropriate requirement. This guide may be used to develop
actions requiring approval and the types of decisions permitted
andimplementananalyticalchemistrylaboratoryQAprogram.
should be established for job classifications at each organiza-
Other useful implementation standards and documents are
tional level.
listed in Section 2 and Appendix X1.
5.2.4 Communications—Methods of communication, both
4.4 TheguidesforQAintheanalyticallaboratorywithinthe
formal and informal, should be clearly established between
nuclear fuel cycle have been written to provide guidance for
working groups within a laboratory and, particularly, between
each of the major activities in the laboratory and are displayed
the laboratory and outside organizations interacting with the
in Fig. 1. The applicable standard for each subject is noted in
laboratory.
the following sections.
5. Organization 6. Quality Assurance Program
5.1 Summary—An organizational structure is the frame- 6.1 Summary—QAbecomes a formal, visible program for a
work within which functional responsibilities, authorities, and laboratory when a document is prepared and approved that
interfaces are established. From a QA viewpoint, the subjects prescribes the QA requirements applicable to operation of the
included as recommended practices in 5.2 are areas in which laboratory and that describes how those requirements are
administrative controls should be defined. This is particularly implemented.
true for laboratories having multiple functional groups. 6.2 Recommendations:
C1009
6.2.1 Quality Assurance Program Description—Once QA attend seminars, courses, and professional meetings as appro-
requirements have been selected and existing laboratory prac- priate. Closely associated with training is the concept of
tices evaluated with respect to those requirements, procedures qualifying analysts before beginning the analysis of samples.
should be written that describe how those QArequirements are 7.1.2 Qualification includes not only specific training, but
implemented in laboratory operations. These QA procedures, also the review and verification of applicable education and
either added to existing laboratory documents or assembled experience.Aprerequisite for performing all laboratory opera-
intoaseparatelaboratoryQAmanual,definethelaboratoryQA tions should be the use of adequately trained and qualified
program. people. The requirements for qualification of each person
6.2.2 Implementation—Once the QA program documenta- performing analyses should be defined by management (see
tion has been prepared, reviewed, and approved, new or Fig. 1).
modified practices should be implemented by training person- 7.2 Recommendations:
nel in their use. In addition, personnel should receive general 7.2.1 Training—Providing training is a basic management
instruction in the overall contents of the QA program. responsibility. The need for training and the type of training
6.2.3 Assessment Program—There should be a procedure used should be a management decision, which is based on the
established whereby the adequacy of laboratory management factors mentioned previously. Management should establish a
and operations is assessed regularly. This procedure should documented training system to ensure that persons are trained
ensure that problems and deficiencies are identified, docu- adequately and that they remain trained as changes in work
mented, analyzed, resolved, and followed up. Assessment practices occur. Such a program should be developed based on
programs should consist of at least two components: manage- job requirements relating to skills, knowledge, and levels of
ment and independent assessment. Personnel performing as- competency required for adequate job performance. Quality
sessments must be technically qualified and knowledgeable in assurance training should be included. Guide C 986 provides
the areas assessed. guidance on developing training programs.
6.2.3.1 Management Assessment—All levels of manage- 7.2.2 Qualification—The concept of qualifying analysts to
ment should critically assess work under their cognizance and perform analyses implies that qualification requirements are
determine whether they are meeting established quality objec- established for each method. As with training, management is
tives. responsible for the qualification process, which can range from
6.2.3.2 IndependentAssessment—QAauditingshouldfoster a simple practice of stating that an analyst is qualified by
independent assessment and focus on real issues that affect the reasonofeducation,experience,andjobknowledgetoaformal
organization’s performance. Independent assessments should system requiring passing tests and routinely demonstrating
be planned and conducted to measure item and service quality, proficiency in required job skills. Guide C 1297 provides
to measure the adequacy of work performance, and to promote guidance on the qualification of analysts (see Fig. 1).
improvement. Independent assessment personnel should have 7.2.3 Records—Trainingandqualificationrecordsshouldbe
sufficient authority and organizational independence to carry maintained to give visibility to the training program and to
out their responsibility. Independent assessment personnel may show the past and current qualification status of each person
act as advisors to senior management to assess quality and trained. The extent of the records required will depend on the
process effectiveness. scope of the qualification process.
6.2.3.3 Reporting—Assessment procedures should include 7.2.3.1 The qualification record should consist of at least a
provisions for reporting the results to those responsible for single-page form on which the basis of an analyst’s qualifica-
ensuring correction of the problems identified. tion is stated, along with those methods for which that analyst
6.2.4 Quality Improvement—Processes to detect and pre- is qualified to perform. Management should verify qualifica-
vent quality problems should be established and implemented. tion before assigning work.
The processes should include identification of the causes of 7.2.3.2 Qualification should be reviewed and updated, if
problems and work to prevent recurrence. Quality-related required, on at least a yearly basis.
information should be reviewed and data analyzed to identify 7.2.3.3 Training and qualification records are QA records,
areas of needed improvement, according to the importance of and they should be controlled as prescribed in Section 10.
the problem and the work affected.
8. Procedures
7. Training and Qualification
8.1 Summary:
7.1 Summary: 8.1.1 Analyses are conducted in a planned, systematic, and
7.1.1 An important factor affecting all laboratory activities controlled manner so that the results produced will be valid,
is the training and qualification of those doing the work, that is, based on sound technology. An analysis involves
including the chemist, technician, and clerical workers. Train- discrete actions taken in a specific order. Any change in an
ing can vary from direct, on-the-job training by a more action or in the order without a valid reason probably will
experienced person to a formal program involving both class- produce an unsatisfactory result.To control analyses and avoid
room and on-the-job training. The extent
...
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