ASTM E1691-95

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
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Designation: E 1691 – 95
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 ance Standards—Guidelines for Selection and Use
ISO/IECGuide 25 General Requirements for the Compe-
1.1 This guide sets the minimum requirements which an
tence of Calibration and Testing Laboratories
analytical chemistry laboratory should meet to be recognized
as competent to carry out specific analytical procedures.
3. Terminology
1.2 Additional requirements and information which have to
3.1 Definitions—For definitions of terms used in this guide,
be disclosed for assessing competence or for determining
refer to Terminology E 1187.
compliance with other criteria may be specified by the orga-
3.2 Definitions of Terms Specific to This Standard:
nization or authority granting the accreditation, depending
3.2.1 audit—an examination of a laboratory’s operation and
upon the specific character of the task of the laboratory.
quality control to ascertain that it is able to obtain valid
1.3 This standard does not purport to address all of the
analyses.
safety concerns, if any, associated with its use. It is the
3.2.2 authority—an organization that evaluates the perfor-
responsibility of the user of this standard to establish appro-
mance of a laboratory; the authority may be a company that
priate safety and health practices and determine the applica-
maintains the laboratory for its own analytical requirements.
bility of regulatory limitations prior to use.
3.2.3 client—an organization that requires a laboratory’s
2. Referenced Documents service.
3.2.4 protocol—a set of procedures which must be followed
2.1 ASTM Standards:
to obtain acceptable analytical results.
E 50 Practices for Apparatus, Reagents, and Safety Precau-
2 3.2.5 traceability—the property of a result of a measure-
tions for Chemical Analysis of Metals
ment where it can be related to appropriate standards, generally
E 416 Practice for Planning and Safe Operation of a Spec-
international or national standards, through an unbroken chain
trochemical Laboratory
of comparisons.
E 548 Guide for Generic Criteria for Evaluating Laboratory
3.2.6 valid analysis—analytical results obtained when a
Competence
procedure follows proper protocol and statistical control is
E 876 Practice for Use of Statistics in the Evaluation of
verified.
Spectrometric Data
E 882 Guide for Accountability and Quality Control in the
4. Significance and Use
Chemical Analysis Laboratory
4.1 This guide provides a mechanism for promoting confi-
E 994 Guide for Calibration and Testing Laboratory Ac-
dence in analytical chemistry laboratories by demonstrating
creditation Systems General Requirements for Operation
4 that they operate in accordance with the guide’s requirements.
and Recognition
4 4.2 This guide is for use by analytical chemistry laboratories
E 1187 Terminology Relating to Laboratory Accreditation
in the development and implementation of their quality sys-
E 1329 Practice for Verification and the Use of Control
3 tems. It may also be used by accreditation bodies, certification
Charts in Spectrochemical Analysis
bodies, and others concerned with the competence of labora-
E 1581 Practice for Using Pre-Control in the Instrumental
3 tories.
Analysis Laboratory
4.3 It is intended that analytical chemistry laboratories
2.2 Other Documents:
meeting the requirements of this guide will be in conformity
ANSI/ASQCQ90 Quality Management and Quality Assur-
with the relevant requirements of the ISO 9000 series of
standards, including those of the model described in ISO 9002
This guide is under the jurisdiction of ASTM Committee E-1 on Analytical when they are acting as suppliers producing test results. The
Chemistry for Metals, Ores, and Related Materials and is the direct responsibility of
ISO 9000 and ISO 9002 standards are identical to the standards
Subcommittee E01.22 on Statistics and Quality Control.
Current edition approved March 15, 1995. Published May 1995.
Annual Book of ASTM Standards, Vol 03.05.
3 5
Annual Book of ASTM Standards, Vol 03.06. Available from American National Standards Institute, 11 W. 42nd Street, 13th
Annual Book of ASTM Standards, Vol 14.02. Floor, New York, NY 10036.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
E 1691
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
resources to discharge their duties; 6.2.8 The laboratory’s scope of analytical services;
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,
6.2.10 Reference to the calibration, verification, or test
and interrelation of all personnel who manage, perform, or
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
services it provides. The elements of this system shall be
quality system. Such audits shall be carried out by trained and
documented. The quality documentation shall be available to qualified staff who are, wherever possible, independent of the
all laboratory personnel.
activity to be audited. Where the audit findings cast doubt on
6.1.1 The laboratory shall define and document its policies the correctness or validity of the laboratory’s analytical results,
and objectives for and its commitment to proper laboratory the laboratory shall take immediate corrective action and shall
practice and analytical services. immediately notify, in writing, any client whose work may
6.1.2 The laboratory management shall ensure that their have been affected.
policies and objectives are documented in a quality manual and
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.
6.2.1 A quality policy statement by top management, in- 6.6 In addition to periodic audits, the laboratory shall ensure
cluding objectives and commitments;
the quality of results provided to clients by implementing
6.2.2 The organization and management structure of the checks. These checks shall be reviewed and shall include, as
E 1691
appropriate, but not be limited to: equipment that has been subjected to overloading or mishan-
6.6.1 Internal quality control schemes using statistical tech- dling, gives suspect results, or has been shown to be defective,
niques, such as those presented in Practice E 876, Guide E 882, shall be taken out of service. Withdrawn equipment shall be
and Practice E 1329, whenever possible; clearly identified and, wherever possible, stored at a specified
6.6.2 Participation in proficiency testing or other interlabo- place until it has been repaired and shown by calibration,
ratory comparisons; verification, or test to perform satisfactorily. The laboratory
6.6.3 Regular use of certified reference materials or second- shall examine and determine if defective equipment affected
ary reference materials, or both; previous analyses.
6.6.4 Replicate testings using the same or different methods; 9.3 Records shall be maintained of each major item of
and equipment and all reference materials significant to the analy-
6.6.5 Retesting of retained samples; ses performed. The records shall include the following:
9.3.1 The name of the item of equipment;
7. Personnel
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
both, and date of the next calibration or verification, or both;
NOTE 1—Confidential records on an employee are not part of the
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
10. Measurement Traceability
sources, lighting, heating, and ventilation shall be such as to
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-
or both, before being put into service. The laboratory shall have
taken shall not invalidate the results or adversely affect the
an established program for the calibration and verification of its
required accuracy of measurement. Particular care shall be
analytical instrumentation.
taken when such activities are undertaken at sites other than the
10.2 The overall program of calibration or verification, or
permanent laboratory premises.
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 certified reference materials is
and vibration levels.
not applicable, the laboratory shall provide satisfactory evi-
8.4 There shall be effective separation between neighboring
dence of correlation of results (for example by participation in
areas when the activities therein are incompatible.
a suitable program of interlaboratory comparisons or profi-
8.5 Access to and use of all areas affecting the quality of
ciency testing).
these activities shall be defined and controlled.
11. Analytical Methods
8.6 Adequate measures shall be taken to ensure good
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