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Their Development and Use with

Quality Assurance Project Plans
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Disclaimers
This material is for training and/or teaching
purposes only. The views of the author do not
necessarily represent that of EPA.
Mention of trade names, products, or services
does not convey official EPA approval,
endorsement, or recommendation.
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What is an S.O.P?
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Standard Operating Procedure
Definition
A Standard Operating
Procedure (SOP) is a
set of written
instructions that
document a routine or
repetitive activity
followed by an
organization.
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SOPs: the Good, the Bad, and the
Ugly
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The Good
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EPA Guidance on QAPPs and
SOPs
Document EPA QA / G5
Guidance for Quality Assurance Project Plans
Document EPA QA / R5
Requirements for Quality Assurance Project
Plans
Document EPA QA / G6
Guidance for Preparing Standard Operating
Procedures


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A GOOD Standard Operating
Procedure
Should provide all the information
necessary to perform a task
Is usually specific to the equipment used
for the procedure
Should be detailed
Should stand alone
Should provide Quality Control information
Should provide References
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The bad
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BAD Stuff in an SOP
DONT generalize in a technical
procedure.
DONT assume that the reader knows the
process.
DONT refer to a method or analysis for
most of the procedure steps.
DONT ramble on about unnecessary
things. Be concise.
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The Ugly!
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Ugly SOPs
No Title Page
No Revision Numbers or Approval
Signatures
No Table of Contents
No Page Numbers
No Quality Control (in a technical SOP)
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Typical Structure for SOPs
Technical SOP
Title Page
Table of Contents
Procedures
Quality Control and Quality Assurance
Reference Section

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SOP Structure continued
Administrative SOP
Title Page
Table of Contents
Procedures
Quality Control and Quality Assurance
Reference Section

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QAPPs and SOPs
Most QAPPs should have references to
SOPs
Most QAPPs should use technical
information in SOPs to set QC limits
Most QAPPs need referenced SOPs
attached as appendices due to
inaccessibility to the user

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QAPP Structure
QAPPs are broken down into four major
groups (A D)
A: Project Management
B: Data Generation and Acquisition
C: Assessment and Oversight
D: Data Validation and Usability
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Group Sections that could
reference SOPs
Section A6: Project/Task Description
Section A7: Quality Objectives and Criteria
for Measurement Data
Section A8: Special Training
Requirements/Certification Listed
All Sections in Group B
Section C1: Assessments and Response
Actions
All Sections in Group D
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Checklist for EPA/QA-R5
Breaks Down Each Major Group
Covers All Aspects of the QAPP
Is Redundant but Thorough
Helps Define Parts of EPA/QA-G5
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Does the SOP have enough
Quality Control?
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Common QC Missing From QAPPS
Method IDs
Maximum Concentration Levels (MCLs)
Reporting Limits (RLs, QLs or MDLs)
Acceptance Limits for Precision and
Accuracy
Instrument and/or equipment lists

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Technical QAPP Document
Support
Technical QAPPs require more
information regarding specific
procedures/methods than administrative
QAPPs
If results are used for compliance or public
health decision making, EPA approved
methods for sampling and analysis should
be used.
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Technical QAPP Document
Support continued
SOPs verify that the laboratory is using
EPA approved procedures. They should
also show the QC acceptance ranges and
the minimum detection limit (MDL) or
reporting limit (RL) for each analyte of
concern.
Make sure these numbers will satisfy the
goals of the QAPP.
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Laboratory Quality Assurance
Manuals
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Laboratory Quality Assurance
Manuals
QA Manuals are a great source of
information for a technical QAPP
Provide lists of instrumentation
Analysts training
Tests and compounds analyzed, their
reporting limits and methods used
QC acceptance ranges and other useful
information
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Questions?
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Thank You!
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Contacts
Charlie Appleby
Chemist
(706) 355-8555
appleby.charlie@epa.
gov

Denise Goddard -
Chemist
(706) 355-8568
goddard.denise@epa.
gov

Marilyn Maycock
Section Chief
(706) 355-8553
maycock.marilyn@epa.
gov

Ray Terhune - Chemist
(706) 355-8557
terhune.ray@epa.gov