ASTM E1691-95(2001)
(Guide)Standard Guide for Evaluation and Assessment of Analytical Chemistry Laboratories (Withdrawn 2007)
Standard Guide for Evaluation and Assessment of Analytical Chemistry Laboratories (Withdrawn 2007)
SCOPE
1.1 This guide sets the minimum requirements which an analytical chemistry laboratory should meet to be recognized as competent to carry out specific analytical procedures.
1.2 Additional requirements and information which have to be disclosed for assessing competence or for determining compliance with other criteria may be specified by the organization or authority granting the accreditation, depending upon the specific character of the task of the laboratory.
1.3 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This guide sets the minimum requirements which an analytical chemistry laboratory should meet to be recognized as competent to carry out specific analytical procedures.
Formerly under the jurisdiction of Committee E01 on Analytical Chemistry of Metals, Ores, and Related Materials, this guide was withdrawn in August 2007.
General Information
Relations
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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.
Designation:E1691–95 (Reapproved 2001)
Standard Guide for
Evaluation and Assessment of Analytical Chemistry
Laboratories
This standard is issued under the fixed designation E 1691; 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.
1. Scope 2.2 Other Documents:
ANSI/ASQCQ90 Quality Management and Quality Assur-
1.1 This guide sets the minimum requirements which an
ance Standards—Guidelines for Selection and Use
analytical chemistry laboratory should meet to be recognized
ISO/IECGuide 25 General Requirements for the Compe-
as competent to carry out specific analytical procedures.
tence of Calibration and Testing Laboratories
1.2 Additional requirements and information which have to
be disclosed for assessing competence or for determining
3. Terminology
compliance with other criteria may be specified by the orga-
3.1 Definitions—For definitions of terms used in this guide,
nization or authority granting the accreditation, depending
refer to Terminology E 1187.
upon the specific character of the task of the laboratory.
3.2 Definitions of Terms Specific to This Standard:
1.3 This standard does not purport to address all of the
3.2.1 audit—an examination of a laboratory’s operation and
safety concerns, if any, associated with its use. It is the
quality control to ascertain that it is able to obtain valid
responsibility of the user of this standard to establish appro-
analyses.
priate safety and health practices and determine the applica-
3.2.2 authority—an organization that evaluates the perfor-
bility of regulatory limitations prior to use.
mance of a laboratory; the authority may be a company that
2. Referenced Documents maintains the laboratory for its own analytical requirements.
3.2.3 client—an organization that requires a laboratory’s
2.1 ASTM Standards:
service.
E50 Practices forApparatus, Reagents, and Safety Consid-
3.2.4 protocol—a set of procedures which must be followed
erations for Chemical Analysis of Metals, Ores, and
to obtain acceptable analytical results.
Related Materials
3.2.5 traceability—the property of a result of a measure-
E 416 Practice for Planning and Safe Operation of a Spec-
mentwhereitcanberelatedtoappropriatestandards,generally
trochemical Laboratory
international or national standards, through an unbroken chain
E 548 Guide for Generic Criteria for Evaluating Laboratory
3 of comparisons.
Competence
3.2.6 valid analysis—analytical results obtained when a
E 876 Practice for Use of Statistics in the Evaluation of
2 procedure follows proper protocol and statistical control is
Spectrometric Data
verified.
E 882 Guide for Accountability and Quality Control in the
Chemical Analysis Laboratory
4. Significance and Use
E 994 Guide for Calibration and Testing Laboratory Ac-
4.1 This guide provides a mechanism for promoting confi-
creditation Systems General Requirements for Operation
3 dence in analytical chemistry laboratories by demonstrating
and Recognition
3 that they operate in accordance with the guide’s requirements.
E 1187 Terminology Relating to Conformaity Assessment
4.2 Thisguideisforusebyanalyticalchemistrylaboratories
E 1329 Practice for Verification and the Use of Control
in the development and implementation of their quality sys-
Charts in Spectrochemical Analysis
tems. It may also be used by accreditation bodies, certification
E 1581 Practice for Using Pre-Control in the Instrumental
bodies, and others concerned with the competence of labora-
Analysis Laboratory
tories.
4.3 It is intended that analytical chemistry laboratories
This guide is under the jurisdiction of ASTM Committee E01 on Analytical meeting the requirements of this guide will be in conformity
Chemistry for Metals, Ores, and Related Materials and is the direct responsibility of
with the relevant requirements of the ISO 9000 series of
Subcommittee E01.22 on Statistics and Quality Control .
Current edition approved Dec. 29, 2003. Published May 1995.
Annual Book of ASTM Standards, Vol 03.05.
3 5
Annual Book of ASTM Standards, Vol 14.02. Available fromAmerican National Standards Institute, 11 W. 42nd Street, 13th
Discontinued 1998; see 1997 Annual Book of ASTM Standards, Vol 03.06. Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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.
E1691–95 (2001)
standards, including those of the model described in ISO 9002 6.2.1 A quality policy statement by top management, in-
when they are acting as suppliers producing test results. The cluding objectives and commitments;
ISO9000andISO9002standardsareidenticaltothestandards
6.2.2 The organization and management structure of the
appearing in the ANSI/ASQC Q90 Series. laboratory, its place in any parent organization, and relevant
4.4 This guide follows criteria of ISO/IEC Guide 25-1990,
organizational charts;
and Guides E 548 and E 994. It is intended as a generic guide
6.2.3 The relations between management, technical opera-
for analytical chemistry laboratories. Specific analytical tech-
tions, support services, and the quality system;
niques or instruments, or both, may require additional specific
6.2.4 Procedures for control and maintenace of documenta-
criteria.
tion;
6.2.5 Job descriptions of key staff and reference to the job
5. Organization and Management
descriptions of other staff;
6.2.6 Identification of the laboratory’s approved signatories,
5.1 The laboratory shall be legally identifiable, and orga-
where this concept is appropriate;
nized and operated in such a way that its facilities meet the
6.2.7 The laboratory’s procedures for achieving traceability
requirements of this guide, as follows:
of measurements;
5.1.1 Have managerial staff with the proper authority and
6.2.8 The laboratory’s scope of analytical services;
resources to discharge their duties;
6.2.9 Arrangements for ensuring that the laboratory reviews
5.1.2 Permit no pressure on personnel to obtain “favorable”
test results; all new work to ensure that it has the appropriate facilities and
resources;
5.1.3 Specify and document the responsibility, authority,
and interrelation of all personnel who manage, perform, or 6.2.10 Reference to the calibration, verification, or test
verify work affecting the quality of analysis; procedures, or combination thereof, used;
5.1.4 Provide supervision by persons familiar with the 6.2.11 Procedures for handling samples;
analytical methods, the objective of the methods, and the
6.2.12 Reference to the major equipment and reference
assessment of the results. The ratio of supervisory to nonsu- measurement standards used;
pervisory personnel shall ensure adequate supervision;
6.2.13 Reference to procedures for calibration, verification,
5.1.5 Have a technical manager (however named) who has and maintenance of equipment;
overall responsibility for the technical operations;
6.2.14 Reference to verification practices, including inter-
5.1.6 Have a quality manager (however named) who has
laboratory comparisons, proficiency testing programs, use of
responsibility for the system and its implementation. The
reference materials, and internal quality control schemes;
quality manager shall have access to the technical manager and
6.2.15 Procedures to be followed for feedback and correc-
to the highest level of management at which decisions are
tive action whenever testing discrepancies are detected, or
taken on laboratory policy and resources;
departures from documented policies and procedures occur;
5.1.7 Nominate deputies in case of absence of the technical
6.2.16 Procedures may be used by laboratory management
or quality manager;
to permit departures from documented policies and procedures
5.1.8 Where relevant, have documented policy and proce-
or from standard specifications under exceptional circum-
dures to ensure the protection of clients’ confidential informa-
stances;
tion and proprietary rights;
6.2.17 Procedures for dealing with complaints;
5.1.9 Participate in interlaboratory comparisons and profi-
6.2.18 Procedures for protecting confidentiality and propri-
ciency testing programs. See 6.2.14.
etary rights; and
6.2.19 Procedures for audit and review.
6. Quality System, Audit, and Review
6.3 The laboratory shall arrange for audits of its activities
6.1 The laboratory shall establish and maintain a quality annually or at some other appropriate interval to verify that its
system appropriate to the type, range, and volume of analytical operations continue to comply with the requirements of the
quality system. Such audits shall be carried out by trained and
services it provides. The elements of this system shall be
documented. The quality documentation shall be available to qualified staff who are, wherever possible, independent of the
activity to be audited. Where the audit findings cast doubt on
all laboratory personnel.
6.1.1 The laboratory shall define and document its policies the correctness or validity of the laboratory’s analytical results,
the laboratory shall take immediate corrective action and shall
and objectives for and its commitment to proper laboratory
practice and analytical services. immediately notify, in writing, any client whose work may
have been affected.
6.1.2 The laboratory management shall ensure that their
policiesandobjectivesaredocumentedinaqualitymanualand 6.4 The quality system adopted to satisfy the requirements
communicated to, understood by, and implemented by all of this guide shall be reviewed at least once a year by the
laboratory personnel concerned. management to ensure its continuing suitability and effective-
6.1.3 The quality manual shall be maintained current under ness and to introduce any necessary changes or improvements.
the responsibility of the quality manager.
6.5 All audit and review findings and any corrective actions
6.2 The quality manual and related quality documentation that arise from them shall be documented. The person respon-
shall state the laboratory’s policies, established operational sible for quality shall ensure that these actions are discharged
procedures, and shall also contain: within the agreed time schedule.
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.
E1691–95 (2001)
6.6 Inadditiontoperiodicaudits,thelaboratoryshallensure control, the laboratory shall ensure that the relevant require-
the quality of results provided to clients by implementing ments of this guide are met.
checks. These checks shall be reviewed and shall include, as 9.2 All equipment shall be properly maintained. Mainte-
appropriate, but not be limited to: nance procedures shall be documented. Any item of the
6.6.1 Internal quality control schemes using statistical tech- equipment that has been subjected to overloading or mishan-
niques,suchasthosepresentedinPracticeE 876,GuideE 882, dling, gives suspect results, or has been shown to be defective,
and Practice E 1329, whenever possible; shall be taken out of service. Withdrawn equipment shall be
6.6.2 Participation in proficiency testing or other interlabo- clearly identified and, wherever possible, stored at a specified
ratory comparisons; place until it has been repaired and shown by calibration,
6.6.3 Regular use of certified reference materials or second- verification, or test to perform satisfactorily. The laboratory
ary reference materials, or both; shall examine and determine if defective equipment affected
6.6.4 Replicatetestingsusingthesameordifferentmethods; previous analyses.
and 9.3 Records shall be maintained of each major item of
6.6.5 Retesting of retained samples; equipment and all reference materials significant to the analy-
ses performed. The records shall include the following:
7. Personnel 9.3.1 The name of the item of equipment;
9.3.2 The manufacturer’s name, type identification, serial
7.1 The laboratory shall have sufficient personnel who have
number, or other unique identification;
the necessary education, training, technical knowledge, and
9.3.3 Date received and placed in service;
experience for their assigned functions.
9.3.4 Current location, where appropriate;
7.2 The laboratory shall ensure that the training of its
9.3.5 Condition when received (for example, new, used,
personnel is kept up-to-date.
reconditioned);
7.3 Records on the relevant qualifications, training, skills,
9.3.6 Copy of the manufacturer’s instruction, where avail-
and experience of the technical personnel shall be maintained
able;
by the laboratory.
9.3.7 Dates and results of calibrations or verifications, or
NOTE 1—Confidential records on an employee are not part of the
both, and date of the next calibration or verification, or both;
technical qualifications that are to be maintained by the laboratory for the
9.3.8 Details of maintenance carried out to date and planned
purpose of the evaluation and assessment of a laboratory.
for the future; and
9.3.9 History of any damage, malfunction, modification or
8. Facilities and Environment
repair.
8.1 Laboratory facilities, including work areas, energy
sources, lighting, heating, and ventilation shall be such as to
10. Measurement Traceability
facilitate proper performance of the analytical procedures. See
10.1 All measuring and testing equipment that affect the
Practices E 50 and E 416.
accuracy or validity of analyses shall be calibrated or verified,
8.2 The environment in which these activities are under-
orboth,beforebeingputintoservice.Thelaboratoryshallhave
taken shall not invalidate the results or adversely affect the
anestablishedprogramforthecalibrationandverificationofits
required accuracy of measurement. Particular care shall be
analytical instrumentation.
takenwhensuchactivitiesareundertakenatsitesotherthanthe
permanent laboratory premises. 10.2 The overall program of calibration or verification, or
both, and validation of equipment shall be designed and
8.3 The laboratory shall provide facilities for the effective
operated in a manner that will ensure that measurements made
monitoring, control, and recording of environmental condi-
by the laboratory are traceable to certified reference materials,
tions, as appropriate. This may include dust, electromagnetic
if they are available.
interference, humidity, line voltage, temperature, and sound
10.3 Where traceability to cer
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