ASTM D3856-95(2006)
(Guide)Standard Guide for Good Laboratory Practices in Laboratories Engaged in Sampling and Analysis of Water
Standard Guide for Good Laboratory Practices in Laboratories Engaged in Sampling and Analysis of Water
SIGNIFICANCE AND USE
Data on the composition and characteristics of water are frequently used to evaluate the health and safety to humans and the environment.
Moreover, such data are frequently used for process control or to ascertain compliance with regulatory statutes that place limits on acceptable compositions and characteristics of waters.
Laboratories that conduct water sampling and generate analytical data, and those persons who have the responsibility for selecting a laboratory to perform water quality studies, need to use criteria, guidelines, and recommendations that have been developed by consensus and are well accepted in making this selection.
Demonstration and documentation by a laboratory that there was judicious selection and control of organization, facilities, resources, and operations will enhance the credibility of the data produced and promote its acceptance.
SCOPE
1.1 This guide provides information on consensus good laboratory practices for laboratories that provide services in the sampling and analysis of water. As consensus standards, these are the minimum criteria that all laboratories should consider in establishing their good laboratory practices.
1.2 This guide is designed to be used by those responsible for the selection, operation, or control of laboratory organizations engaged in sampling and analysis of water.
1.3 This guide presents features of organization, facilities, resources, and operations which affect the usefulness of the data generated.
1.4 This guide presents criteria for selection and control of the features described in and also makes recommendations for the correction of unacceptable performance.
1.5 This guide describes methodology and practices intended to be completely consistent with the International Organization for Standardization (ISO) 9000 series of standards and Guide 25 - 1990 ().
1.6 The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are for information only.
This standard does not purport to address all of the safety concerns, 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.
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: D3856 – 95 (Reapproved 2006)
Standard Guide for
Good Laboratory Practices in Laboratories Engaged in
Sampling and Analysis of Water
This standard is issued under the fixed designation D3856; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope D1193 Specification for Reagent Water
D2777 Practice for Determination of Precision and Bias of
1.1 This guide provides information on consensus good
Applicable Test Methods of Committee D19 on Water
laboratorypracticesforlaboratoriesthatprovideservicesinthe
D3370 Practices for Sampling Water from Closed Conduits
sampling and analysis of water. As consensus standards, these
D3694 Practices for Preparation of Sample Containers and
aretheminimumcriteriathatalllaboratoriesshouldconsiderin
for Preservation of Organic Constituents
establishing their good laboratory practices.
D4210 Practice for Intralaboratory Quality Control Proce-
1.2 This guide is designed to be used by those responsible
dures and a Discussion on Reporting Low-Level Data
for the selection, operation, or control of laboratory organiza-
D4375 Practice for Basic Statistics in Committee D19 on
tions engaged in sampling and analysis of water.
Water
1.3 This guide presents features of organization, facilities,
D4447 Guide for Disposal of Laboratory Chemicals and
resources, and operations which affect the usefulness of the
Samples
data generated.
D4840 Guide for Sample Chain-of-Custody Procedures
1.4 This guide presents criteria for selection and control of
D4841 Practice for Estimation of Holding Time for Water
the features described in 1.3 and also makes recommendations
Samples Containing Organic and Inorganic Constituents
for the correction of unacceptable performance.
D5172 Guide for Documenting the Standard Operating
1.5 This guide describes methodology and practices in-
Procedures Used for the Analysis of Water
tended to be completely consistent with the International
D5847 Practice for Writing Quality Control Specifications
Organization for Standardization (ISO) 9000 series of stan-
for Standard Test Methods for Water Analysis
dards and Guide 25 – 1990 (1).
E456 Terminology Relating to Quality and Statistics
1.6 The values stated in inch-pound units are to be regarded
E548 Guide for General Criteria Used for Evaluating Labo-
as the standard. The values given in parentheses are for
ratory Competence
information only.
1.7 This standard does not purport to address all of the
3. Terminology
safety concerns, if any, associated with its use. It is the
3.1 For definitions of terms used in this guide, refer to
responsibility of the user of this standard to establish appro-
Terminologies D1129, D4375, and E456, Guide E548, and
priate safety and health practices and determine the applica-
ASTM MNL 7(2).
bility of regulatory limitations prior to use.
4. Summary of Guide
2. Referenced Documents
3 4.1 This guide describes the criteria, guidelines, and recom-
2.1 ASTM Standards:
mendations for physical and human resources and data valida-
D1129 Terminology Relating to Water
tion for the operation of a laboratory.
4.2 Although, philosophically, this guide is intended to
This guide is under the jurisdiction of ASTM Committee D19 on Water and is
apply to all analyses of water, there may be certain test
thedirectresponsibilityofSubcommitteeD19.02onQualitySystems,Specification,
methods to which parts of this guide are not applicable due to
and Statistics.
the nature of the samples, for example, microbiological analy-
Current edition approved Feb. 15, 2006. Published February 2006. Originally
approved in 1988. Last previous edition approved in 2000 as D3856 – 95 (2000).
ses.
DOI: 10.1520/D3856-95R06.
The boldface numbers in parentheses refer to the list of references at the end of
this guide.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on Withdrawn. The last approved version of this historical standard is referenced
the ASTM website. on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
D3856 – 95 (2006)
5. Significance and Use 6.4.2 Written preventive maintenance procedures with
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 D4210 should be
of the data produced and promote its acceptance.
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
and practices in assuring this quality. In addition to addressing
7. Organization
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.
6.3.1 Written sample collection, handling and storage re-
NOTE 1—The purpose of the “equivalent” requirement is to allow the
quirements should be followed.
assignment of persons who have comparable skills obtained through
6.3.2 Analytical procedures should be written. qualified training which did not result in the award of a baccalaureate
degree. Interpretation of the term “equivalent” will necessarily require
6.3.3 There should be a document control system to track
careful judgment by the user of these guidelines. Certification by
the currency and completeness of procedures.
professional boards is to be encouraged.
6.4 Metrology—Systems for making measurements should
have the following: The laboratory director or manager should be a full-time
6.4.1 Written calibration procedures, including traceability employee that operates the laboratory with at least the respon-
and schedule. sibilities outlined in 7.2.1.1-7.2.1.6.
D3856 – 95 (2006)
7.2.1.1 Establishment of long-term program plans and 7.2.3.2 Technical staff may be required to satisfactorily
shorter term work plans and assignments to meet the program complete analytical tests to qualify initially and to periodically
objectives.
requalify throughout their work career. Qualification should be
7.2.1.2 Operation and maintenance of the physical plant based on the generation of analytical results with precision and
(building, equipment, instrumentation, services, etc.). bias recovery within limits known to be possible for the
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
analyses. technical workers who perform routine field and laboratory
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
from the laboratory operation. This includes ensuring staff and other field equipment.
participation in appropriate interlaboratory quality control
7.2.4.1 In the laboratory, they wash glassware, operate
activities,intercalibrationchecks,performanceauditprograms,
laboratory reagent water systems, autoclaves, drying ovens,
etc. Such interlaboratory checks are the most effective measure
and incubators. The support staff also receives, stores, and
of comparative performance and should demonstrate the worth
ships samples, materials, and laboratory equipment.
of a good quality assurance program to upper management or
7.2.5 Offıce Support Staff—The office staff are nontechnical
regulator agencies. A QA program also provides each labora-
clerical or secretarial personnel who are trained either on the
tory staff member with a copy of the quality assurance plan for
job or by formal schooling in keyboarding, filing, recordkeep-
the laboratory, which documents responsibilities and kind and
ing, communications by telephone or personal visits, payroll,
frequency of quality control checks. The plan should also
travel, or some combination thereof.
specify the monitoring and overview responsibilities of man-
agement. 7.2.5.1 The laboratory or office support staff may be an
integral part of the laboratory or may be provided as part of the
7.2.1.6 Establishment of a development and operational
administrative function in a larger organization.
performance appraisal system for the staff and an individual
career development plan for each staff member. Performance
7.3 Physical Resources and Related Operating Procedures:
standards should be developed and agreed to jointly by each
7.3.1 General—The laboratory environment can signifi-
staff member and their supervisor. The director should be
cantly affect the results of water analyses; therefore, the
responsibleforassuringaperiodicreviewofperformanceofall
laboratory facility should be carefully designed and periodi-
staff members by supervisors, for rewarding good quality
cally inspected and reevaluated. In general, the physical
performance, and for implementing and encouraging on-the-
conditions in the laboratory should comply with the applicable
job or off-site training. This joint development of performance
U.S. OSHArequirements, or their equivalent, and other safety
standards is key to obtaining an understanding between the
and legal requirements. For further information seeLaboratory
worker and the supervisor, as to what is expected for satisfac-
Planning for Chemistry and Chemical Engineering (3).
tory performance. It also paves the way for rewarding out-
7.3.2 Equipment and Supplies—The specific instrumenta-
standing performance or identifying unsatisfactory perfor-
tion, equipment, materials, and supplies needed for the perfor-
mance. These standards should be used to evaluate
mance of a standard test method are usually described in the
performance frequently but informally, and formally on a le
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.