Standard Operating Procedures

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Standard Operating Procedures

• 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/Certific
  ation 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
• [phone]
• appleby.charlie_at_epa.gov
• Denise Goddard - Chemist
• [phone]
• goddard.denise_at_epa.gov

• Marilyn Maycock Section Chief
• [phone]
• maycock.marilyn_at_epa.gov
• Ray Terhune - Chemist
• [phone]
• terhune.ray_at_epa.gov