ASTM D3856-95(2000)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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An American National Standard
Designation: D 3856 – 95 (Reapproval 2000)
Standard Guide for
Good Laboratory Practices in Laboratories Engaged in
Sampling and Analysis of Water
This standard is issued under the fixed designation D 3856; 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 D 1193 Specification for Reagent Water
D 2777 Practice for Determination of Precision and Bias of
1.1 This guide provides information on consensus good
Applicable Methods of Committee D-19 on Water
laboratorypracticesforlaboratoriesthatprovideservicesinthe
D 3370 Practices for Sampling Water from Closed Con-
sampling and analysis of water. As consensus standards, these
duits
aretheminimumcriteriathatalllaboratoriesshouldconsiderin
D 3694 Practices for Preparation of Sample Containers and
establishing their good laboratory practices.
for Preservation of Organic Constituents
1.2 This guide is designed to be used by those responsible
D 4210 Practice for Intralaboratory Quality Control Proce-
for the selection, operation, or control of laboratory organiza-
dures and a Discussion on Reporting Low-Level Data
tions engaged in sampling and analysis of water.
D4375 TerminologyforBasicStatisticsinCommitteeD-19
1.3 This guide presents features of organization, facilities,
on Water
resources, and operations which affect the usefulness of the
D 4447 Guide for the Disposal of Laboratory Chemicals
data generated.
and Samples
1.4 This guide presents criteria for selection and control of
D 4840 Guide for Sampling Chain-of-Custody Procedures
the features described in 1.3 and also makes recommendations
D 4841 Practice for Estimation of Holding Time for Water
for the correction of unacceptable performance.
Samples Containing Organic and Inorganic Constituents
1.5 This guide describes methodology and practices in-
D 5172 Guide for Documenting the Standard Operating
tended to be completely consistent with the International
Procedures Used for Analysis of Water
Organization for Standardization (ISO) 9000 series of stan-
D 5847 Practice for Writing Quality Control Specifications
dards and Guide 25 – 1990 (1).
for Standard Test Methods for Water Analysis
1.6 The values stated in inch-pound units are to be regarded
E 456 Terminology Relating to Quality and Statistics
as the standard. The values given in parentheses are for
E 548 Guide for General Criteria Used for Evaluating
information only.
Laboratory Competence
1.7 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
3. Terminology
responsibility of the user of this standard to establish appro-
3.1 For definitions of terms used in this guide, refer to
priate safety and health practices and determine the applica-
Terminologies D 1129, D 4375, and E 456, Guide E 548, and
bility of regulatory limitations prior to use.
ASTM MNL 7 (2).
2. Referenced Documents
4. Summary of Guide
2.1 ASTM Standards:
3 4.1 This guide describes the criteria, guidelines, and recom-
D 1129 Terminology Relating to Water
mendations for physical and human resources and data valida-
tion for the operation of a laboratory.
This guide is under the jurisdiction of ASTM Committee D19 on Water and is
the direct responsibility of Subcommittee D19.02 on General Specifications and
Technical Resources.
Current edition approved Oct. 10, 1995. Published December 1995. Last
previous edition D 3856 – 88.
2 4
The boldface numbers in parentheses refer to the list of references at the end of Annual Book of ASTM Standards, Vol 11.02.
this guide. Annual Book of ASTM Standards, Vol 11.04.
3 6
Annual Book of ASTM Standards, Vol 11.01. Annual Book of ASTM Standards, Vol 14.02.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
D 3856 – 95 (Reapproval 2000)
4.2 Although, philosophically, this guide is intended to 6.3.3 There should be a document control system to track
apply to all analyses of water, there may be certain test the currency and completeness of procedures.
methods to which parts of this guide are not applicable due to 6.4 Metrology—Systems for making measurements should
the nature of the samples, for example, microbiological analy- have the following:
ses. 6.4.1 Written calibration procedures, including traceability
and schedule.
6.4.2 Written preventive maintenance procedures with
5. Significance and Use
scheduled intervals.
5.1 Data on the composition and characteristics of water are
6.4.3 Recordsavailabletodocumentanyrepairorserviceof
frequentlyusedtoevaluatethehealthandsafetytohumansand
equipment, replacement or change of reagents, or modification
the environment.
of procedures.
5.2 Moreover, such data are frequently used for process
6.5 Data Recording— The laboratory should keep records
control or to ascertain compliance with regulatory statutes that
of sample source disposition and analyses to provide informa-
place limits on acceptable compositions and characteristics of
tion on sample collection and preservation, analytical proce-
waters.
dures and results, and the persons responsible for the sampling
5.3 Laboratories that conduct water sampling and generate
and analysis. All laboratory data sheets should be dated and
analytical data, and those persons who have the responsibility
signedbytheanalystandhissupervisororasuitablecolleague.
forselectingalaboratorytoperformwaterqualitystudies,need
6.6 Data Validation— To assess and demonstrate a suitable
tousecriteria,guidelines,andrecommendationsthathavebeen
level of analytical performance, the laboratory should keep
developed by consensus and are well accepted in making this
records of audit procedures, reference sample programs, and
selection.
interlaboratory tests. One criterion for measurement of analyti-
5.4 Demonstration and documentation by a laboratory that
cal performance should be the precision and bias data con-
there was judicious selection and control of organization,
tained in the analytical method being used. Where applicable,
facilities, resources, and operations will enhance the credibility
quality control charts as described in Practice D 4210 should
of the data produced and promote its acceptance.
be used.
6.7 TroubleShooting—Theorganizationshouldprovidethe
6. Aspects of Quality Assurance
authority and the responsibility to a designated person or
6.1 General—The function of a laboratory is to provide
persons for investigation of out-of-control results and for
analytical results and related information which are adequate
informing the laboratory management of any problems that
for the intended use. This function is achieved through effec-
occur.
tive use of a quality assurance program. Every laboratory
6.7.1 Acurrent log should be kept of analytical deficiencies
should develop a written quality assurance program, plan, or
and the action taken to correct them.
manual that demonstrates the effectiveness of its procedures
7. Organization
and practices in assuring this quality. In addition to addressing
any applicable regulatory requirements, the program should
7.1 General—The production of reliable data is effected
consider the following:
through the effort of everyone involved with the service. It is
6.2 Organizational Structure—A table of the organization
paramount, therefore, that personnel have a clear understand-
should be available which shows the lines of authority, areas of
ing of their duties and responsibilities and their relationship to
responsibility, and job functions. The laboratory should also
the product produced. Management has the responsibility for
provide a description of its capabilities. Laboratory manage-
defining function and goals as applied to the individual. A
ment should demonstrate and foster a positive quality assur-
formal document describing objectives, staff functions and
ance attitude and provide the analytical staff with a written
responsibilities, should be distributed and explained to all staff
policy to carry out a defined quality assurance program.
members.
6.2.1 Human Resources— The key personnel of the orga-
7.1.1 The personnel in a laboratory will vary with the
nization should be described by means of personal résumés
specific functions that are to be served, but minimal qualifica-
presenting the education and work experience appropriate to
tions and duties generally will be as described in 7.2 through
the table of organization and the qualifications of the position.
7.3.5.11.
For each employee, provision should be made for update of 7.2 Human Resources/Personnel Duties and Responsibili-
records to reflect additional education, work experience, and
ties:
continuing training. 7.2.1 The Director— The director should have a working
6.2.2 Physical Resources—The laboratory facilities should
knowledge of the laboratory and its scope of activities. The
provide a working environment that is clean, comfortable, and director should have earned a baccalaureate degree in science
safe. The instrumentation and equipment must be suitable for
or engineering from an accredited college or university or the
the operational needs of the laboratory. equivalent (Note 1) and have at least five years experience in
6.3 Methodology— Written procedures should be readily laboratory work.
available to personnel.
NOTE 1—The purpose of the “equivalent” requirement is to allow the
6.3.1 Written sample collection, handling and storage re-
assignment of persons who have comparable skills obtained through
quirements should be followed.
qualified training which did not result in the award of a baccalaureate
6.3.2 Analytical procedures should be written. degree. Interpretation of the term “equivalent” will necessarily require
D 3856 – 95 (Reapproval 2000)
careful judgment by the user of these guidelines. Certification by
7.2.3.1 Where appropriate, technical staff members should
professional boards is to be encouraged.
have formal training in the sampling and analytical methodol-
ogy, and quality control, as applied to the specific sample types
The laboratory director or manager should be a full-time
and concentration levels of analytes which are of interest to the
employee that operates the laboratory with at least the respon-
laboratory.
sibilities outlined in 7.2.1.1-7.2.1.6.
7.2.3.2 Technical staff may be required to satisfactorily
7.2.1.1 Establishment of long-term program plans and
complete analytical tests to qualify initially and to periodically
shorter term work plans and assignments to meet the program
requalify throughout their work career. Qualification should be
objectives.
based on the generation of analytical results with precision and
7.2.1.2 Operation and maintenance of the physical plant
bias recovery within limits known to be possible for the
(building, equipment, instrumentation, services, etc.).
particularmethodandwhichmeetthedatauser’srequirements.
7.2.1.3 Selection, training, and development of personnel.
7.2.4 Laboratory Support Staff—The support staff are non-
7.2.1.4 Overview and approval of methods of sampling and
technical workers who perform routine field and laboratory
analyses.
services in support of the professional and technical staff. In
7.2.1.5 Development and implementation of a quality assur-
the field, they may collect samples, and they may transport,
ance (QA) program to monitor and maintain the quality of
handle and maintain records of collection and storage, includ-
laboratory performance. In larger laboratories, this function is
ing chain of custody.The support staff also maintains sampling
frequently delegated to an individual or organization separate
and other field equipment.
from the laboratory operation. This includes ensuring staff
7.2.4.1 In the laboratory, they wash glassware, operate
participation in appropriate interlaboratory quality control
laboratory reagent water systems, autoclaves, drying ovens,
activities, intercalibration checks, performance audit programs,
and incubators. The support staff also receives, stores, and
etc. Such interlaboratory checks are the most effective measure
ships samples, materials, and laboratory equipment.
of comparative performance and should demonstrate the worth
7.2.5 Offıce Support Staff—The office staff are nontechnical
of a good quality assurance program to upper management or
clerical or secretarial personnel who are trained either on the
regulator agencies. A QA program also provides each labora-
job or by formal schooling in keyboarding, filing, recordkeep-
tory staff member with a copy of the quality assurance plan for
ing, communications by telephone or personal visits, payroll,
the laboratory, which documents responsibilities and kind and
travel, or some combination thereof.
frequency of quality control checks. The plan should also
specify the monitoring and overview responsibilities of man-
7.2.5.1 The laboratory or office support staff may be an
agement. integral part of the laboratory or may be provided as part of the
administrative function in a larger organization.
7.2.1.6 Establishment of a development and operational
performance appraisal system for the staff and an individual
7.3 Physical Resources and Related Operating Procedures:
career development plan for each staff member. Performance
7.3.1 General—The laboratory environment can signifi-
standards should be developed and agreed to jointly by each
cantly affect the results of water analyses; therefore, the
staff member and their supervisor. The director should be
laboratory facility should be carefully designed and periodi-
responsibleforassuringaperiodicreviewofperformanceofall
cally inspected and reevaluated. In general, the physical
staff members by supervisors, for rewarding good quality
conditions in the laboratory should comply with the applicable
performance, and for implementing and encouraging on-the-
U.S. OSHArequirements, or their equivalent, and other safety
job or off-site training. This joint development of performance
and legal requirements. For further information seeLaboratory
standards is key to obtaining an understanding between the
Planning for Chemistry and Chemical Engineering (3).
worker and the supervisor, as to what is expected for satisfac-
7.3.2 Equipment and Supplies—The specific instrumenta-
tory performance. It also paves the way for rewarding out-
tion, equipment, materials, and supplies needed for the perfor-
standing performance or identifying unsatisfactory perfor-
mance of a standard test method are usually descr
...