2009 05 11 Methods Qaqc-Part136methods

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
MEMORANDUM
SUBJECT: Quality Assurance and Quality Control Requirements in Metho~~c;.i~F

Not Published by EPA ~
FROM: Richard Reding, Chief t\!
Engineering and Analyti upp0r! Branch, EAO, OST
TO: Regional Quality Assurance Managers
DATE: May 7, 2009
Auditors, our co·regulators, laboratory personnel, and the regulated community

have noted the different amount and type of quality assurance (QA) and quality control
(QC) procedures practiced by laboratories that use 40 C.F.R. Part 136 methods. Some of
these methods are published by voluntary consensus standard bodies, such as "Standard
Methods for the Examination of Water and Wastewater", and the ASTM, International
compendiums, 11.0 I and 11.02. These compendiums can be in print, electronic or web-
based media, and have unique structures.
The subject of this memorandum is to address problems encountered in
conducting analyses, or auditing laboratory practices when the:
• QAJQC requirements are sufficient, but published in other parts of an
organization's compendium rather than within the Part 136 method, or
• QAlQC instructions in a Part 136 method are insufficient.
For example, the Standard Methods Committee consolidates general QAJQC
requirements for all methods in Part 1000 of their compendiums. Other Parts (and
Sections) may contain additional QAJQC requirements that are relevant to the pollutants
(e.g., metals, nutrients, organic solvents) measured by the methods in that Part or Section.
In ASTM methods, the QAJQC requirements are specified in the method's Referenced
Documents section, and in the pollutant method. Both organizations publish QAJQC
instructions so that analysts can achieve acceptable results. Consequently, EPA expects
that an analyst using these consensus body methods for reporting under the CWA will
also comply with the quali ty assurance and quality control requirements listed in the
appropriate sections in the consensus body compendium. EPA's approval of use of these
voluntary consensus standard body methods clearly contemplated that any analysis using
such methods would also meet the quality assurance and quality control requirements
prescribed for the particular method. As a result, neither an analysis using a specific 40
C.F.R. Part 136 method or one using a voluntary consensus body standard approved for
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Part 136 that fai led to meet the applicable quality assurance and quality control
requirements of the respecti ve methods would comply with EPA' s NPDES regulations
requirements to monitor in accordance with the procedures of 40 C.F.R. Part 136 for
analysis of pollutants.
In subsequent editions of their compendiums, the Standard Methods Committee
has modified their QNQC sections to strengthen the procedures, and conform more to
the QAlQC procedures in methods publi shed by EPA. In rules publ ished March 12 and
26, 2007, EPA approved use of the Part 136 methods published in the most recent edition
of Standard Methods, but did not withdraw approval of previous editions of these
compendiums. This has allowed analysts to choose which edition to fo llow, and in some
cases has led to significant differences in the amount or type ofQNQC used. In some
cases, analysts have di sregarded some procedures with the rationale that the compendium
QAfQC procedures are not sufficiently prescribed within the approved method.
Regardless of the publisher, edition or so urce of an analytical method approved
for CWA compliance monitoring, QA and QC procedures are to be employed whether
they are specified in the Part 136 method, or referenced by other means. For a method
that is approved in more than one edition of a compendium an analyst should, at a
minimum, fo llow the QAfQC in that edition. To improve consistency, labs should
consider phasing.in and adopting the QAlQC procedures specified in the most recent,
approved editions of that compendium.
An internal or extemallab auditor or regul atory authority may identify Part 136
methods or laboratory standard operating procedures (SOPs) with insufficient QAlQC
instructions. For example, some Part 136 methods that were developed before EPA and
other organizations standardized QAlQC practices and method formats have insufficient
instructions. For these methods analysts have three options:
a) Refer to and follow the QC published in the "equivalent" EPA method that has
such QC; or
b) Refer to National Environmental Laboratory Accreditation Conference (NELAC)
2003 Standard as outlined in chapter 5 and appropriate appendices, or any update
of the Standard; or
c) Refer to the appropriate sections of the 40 CFR listed consensus body methods.
The following twelve quality control checks are to be considered essential and
must be incorporated into the laboratory' s documented quality system unless a written
rati onale is provided that indicates why these controls are inappropriate for a speci fic
analytical method. These essential QC checks are:
1. Demonstration of Capability (DOC),
2. Method Detection Limit (MOL),
3. Reagent blank (also referred to as method blank),
4. Laboratory fort ifi ed blank (LFB, also referred to as a spiked blank, or laboratory
control sample (LCS)),
2
5. Matrix spike (MS), matrix spike duplicate (MSD), or laboratory fortified blank
duplicate (LFBD) for suspected difficult matrices,
6. Internal standard/s, surrogate standard/s (for organic analysis) or tracer (for
radiochemistry),
7. Calibration (initial and continuing)~
8. Control charts (or other trend analyses of quality control results), and
9. Corrective action (root cause analyses),
10. Specific frequency of QC checks,
11 . QC acceptance criteria, and
12. Definitions of a batch (preparation and analytical).
Please share this memo with your co-regulators, and other appropriate parties, and
contact me with any questions or suggestions at [email protected]. Your ATP
coordinators or QA staff may contact Lemuel Walker at [email protected].
cc: Regional QA Coordinators

Gregory Carroll, GGWDW

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

SUBJECT: Quality Assurance and Quality Control Requirements in Metho~~c;.i~F

Auditors, our co·regulators, laboratory personnel, and the regulated community

IflIemel Address (URL) • hnp:/.w-.epa .gov

cc: Regional QA Coordinators

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