ASTM D5172-91(2010)e1
(Guide)Standard Guide for Documenting the Standard Operating Procedures Used for the Analysis of Water
Standard Guide for Documenting the Standard Operating Procedures Used for the Analysis of Water
SIGNIFICANCE AND USE
The exact analytical test methods and procedures used in any laboratory may be unique and affect the usability of their analytical results. A general reference to a book of standard analytical test methods, guides, and practices published by a reputable organization such as ASTM is not sufficient to guarantee acceptable results. As a point of clarification, a procedure may be part of a test method or it may be any other routine process the laboratory personnel must follow, for example, glassware cleaning, quality control, routine maintenance, or data reporting procedures.
A significant part of the variability of results generated by different laboratories analyzing the same samples and citing the same general reference is due to differences in the way the analytical test methods and procedures are actually performed in each laboratory. These differences are often caused by the slight changes or adjustments allowed by the general reference, but that can affect the final results.
The manual of SOPs is an important component of any laboratory's quality assurance program. As with all quality assurance activities, the importance of this manual lies in its impact on maintaining uniformity of test method performance and the utility of data generated by the laboratory.
Each laboratory should develop and maintain a loose-leaf manual containing an exact step-by-step description of how every test method and procedure is performed in the laboratory to help guarantee uniform performance among different analysts using them.
With adequate documentation of a laboratory's complete and exact analytical test methods and procedures, a laboratory will have improved confidence in its ability to reproduce analytical conditions exactly and thereby general reproducible results. This manual of SOPs is the cornerstone of a laboratory's creditability.
SCOPE
1.1 This guide addresses the need for each laboratory engaged in the analysis of water and wastewater to develop and maintain an up-to-date written manual that clearly and completely delineates the exact steps followed in performing every test method and procedure used in the laboratory, that is, a manual of their standard operating procedures (SOPs).
1.2 This guide details the practices necessary to provide clear in-house SOPs and a mechanism whereby the normal development and evolution of an analytical test method or procedure can be controlled and properly evaluated for incorporation into the SOP used in that laboratory.
1.3 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. Specific precautionary statements are given in the note.
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Designation: D5172 − 91(Reapproved 2010)
Standard Guide for
Documenting the Standard Operating Procedures Used for
the Analysis of Water
This standard is issued under the fixed designation D5172; 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.
ε NOTE—Editorially added Section 7.2 in March 2010.
1. Scope 4. Summary of Guide
1.1 This guide addresses the need for each laboratory 4.1 This guide describes suggested practices for developing
and maintaining a current compilation of the complete and
engagedintheanalysisofwaterandwastewatertodevelopand
maintain an up-to-date written manual that clearly and com- exact analytical test methods and procedures being used in a
particular laboratory.
pletely delineates the exact steps followed in performing every
test method and procedure used in the laboratory, that is, a
5. Significance and Use
manual of their standard operating procedures (SOPs).
5.1 The exact analytical test methods and procedures used
1.2 This guide details the practices necessary to provide
inanylaboratorymaybeuniqueandaffecttheusabilityoftheir
clear in-house SOPs and a mechanism whereby the normal
analytical results. A general reference to a book of standard
development and evolution of an analytical test method or
analytical test methods, guides, and practices published by a
procedure can be controlled and properly evaluated for incor-
reputable organization such as ASTM is not sufficient to
poration into the SOP used in that laboratory.
guarantee acceptable results. As a point of clarification, a
1.3 This standard does not purport to address all of the
procedure may be part of a test method or it may be any other
safety concerns, if any, associated with its use. It is the
routine process the laboratory personnel must follow, for
responsibility of the user of this standard to establish appro-
example, glassware cleaning, quality control, routine
priate safety and health practices and determine the applica-
maintenance, or data reporting procedures.
bility of regulatory limitations prior to use. Specific precau-
5.2 A significant part of the variability of results generated
tionary statements are given in the note.
by different laboratories analyzing the same samples and citing
the same general reference is due to differences in the way the
2. Referenced Documents
analytical test methods and procedures are actually performed
2.1 ASTM Standards:
in each laboratory. These differences are often caused by the
D1129 Terminology Relating to Water
slight changesoradjustmentsallowedbythegeneralreference,
but that can affect the final results.
3. Terminology
5.3 The manual of SOPs is an important component of any
3.1 Definitions—For definitions of terms used in this guide, laboratory’s quality assurance program. As with all quality
refer to Terminology D1129.
assurance activities, the importance of this manual lies in its
impact on maintaining uniformity of test method performance
3.2 Definitions of Terms Specific to This Standard:
and the utility of data generated by the laboratory.
3.2.1 procedure— any process involving sequential steps
5.4 Each laboratory should develop and maintain a loose-
conducted to achieve a specific objective.
leaf manual containing an exact step-by-step description of
how every test method and procedure is performed in the
1 laboratory to help guarantee uniform performance among
This guide is under the jurisdiction of ASTM Committee D19 on Water and is
thedirectresponsibilityofSubcommitteeD19.02onQualitySystems,Specification, different analysts using them.
and Statistics.
5.5 With adequate documentation of a laboratory’s com-
Current edition approved Feb. 1, 2010. Published March 2010. Originally
plete and exact analytical test methods and procedures, a
approved in 1991. Last previous edition approved in 2004 as D5172 – 91 (2004).
DOI: 10.1520/D5172-91R10E01.
laboratory will have improved confidence in its ability to
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
reproduce analytical conditions exactly and thereby general
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
reproducible results.This manual of SOPs is the cornerstone of
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. a laboratory’s creditability.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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D5172 − 91 (2010)
6. Suggested Steps for Generating a Manual of SOPs pages, and the author(s). The effective date is the date when it
was first used to produce actual data. The final version and all
6.1 The manual should begin with specification of the
subsequent revisions should be approved and signed by the
published references from a standard-setting organization or
laboratory manager and the quality assurance officer or their
regulatory agency. An adequate written SOP should then be
designees, and distributed to all analysts for bench use.
drafted in-house for each test method or procedure performed
by the laboratory. A standard format should be used that is
7. Centralized Files
appropriate to the SOP and is similar in scope to the formats
included in this guide as AnnexA1 and AnnexA2.All aspects
7.1 A master copy of the laboratory’s SOPs should be kept
of the test method or procedure as actually applied in the
on-file under the control of the quality assurance officer.
laboratory should be addressed in detail.
Whenever a procedure is modified, the revised version should
NOTE 1—Caution: When a laboratory is performing an analytical be documented and the changes highlighted. Copies of the
procedure in a regulatory or legal environment, it is of vital importance
revised SOP should be distributed to the staff to replace the
that the in-house version be maintained within the technical allowances of
previous version, that they should destroy, and a new effective
the mandated procedure. Technical departures from the mandated proce-
date for the revision and a revised copy of the SOP should be
dure may result in a legal liability. One way to demonstrate consistency
with the mandated procedure is to copy the standard procedure as added to the master file along with an explanation of why the
published and add footnotes to fully document the specific in-house
revision was necessary. Out-of-date versions of an SOPshould
version.
be filed separately by the QA officer for future reference.
6.2 The basic structure and elements of a test method are
Through use of such an updating mechanism, the laboratory
typically present in consensus standards published by groups
will be able to identify the exact procedure being followed at
such as ASTM. But, invariably, these published test methods
the time a particular result was generated.
and procedures must be interpreted for application in each
7.2 Alaboratory’sSOPsmaybemanagedthroughtheuseof
laboratory. Published versions of other test methods and
electronic documents. Whether through a paper system or
procedures are often very general or completely unavailable.
electronic files, the key issue is that there is one, and only one,
6.3 In generating a draft SOP, it is often helpful to solicit
official SOP document at any moment. “Bench” copies of an
input from analysts experienced with a test method or proce-
SOP or analytical practice in the Lab should be referenced to
dure who are familiar with its vagaries and pitfalls, and can
this official document. If electronic or “computerized” SOP
provide valuable assistance in writing a complete and exact
documents are employed, they must be adequately controlled
document on how the procedure is done in the laboratory. It is
with limited access to assure their integrity.
often useful to have all of the analytical staff review the final
draft.
8. Suggested Use and Maintenance
6.4 After an initial draft to identify the pertinent details of
8.1 While performing an SOP, the analyst should have a
an SOP, the laboratory should conduct a study to verify its
copy of the current documentation readily at-hand and follow
applicability to the sample matrices encountered in that par-
it to the letter. If the SOP allows for multiple options, the
ticular laboratory. In addition, the laboratory should verify that
option employed should be noted with the final results.
it can, at a minimum, obtain results with precision and bias
equivalent to those in published references (if available for
8.2 When an analyst encounters a situation for which no
similar matrices). The precision and
...
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