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Standard Operating Procedures

Standard Operating Procedures. Their Development and Use with Quality Assurance Project Plans. Disclaimers . This material is for training and/or teaching purposes only. The views of the author do not necessarily represent that of EPA.

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Standard Operating Procedures

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  1. Standard Operating Procedures Their Development and Use with Quality Assurance Project Plans

  2. 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.

  3. What is an S.O.P?

  4. 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.

  5. SOPs: the Good, the Bad, and theUgly

  6. The Good

  7. 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

  8. 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

  9. The bad

  10. BAD “Stuff” in an SOP • DON’T generalize in a technical procedure. • DON’T assume that the reader knows the process. • DON’T refer to a method or analysis for most of the procedure steps. • DON’T ramble on about unnecessary things. Be concise.

  11. The Ugly!

  12. 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)

  13. Typical Structure for SOPs • Technical SOP • Title Page • Table of Contents • Procedures • Quality Control and Quality Assurance • Reference Section

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

  15. 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

  16. 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

  17. 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

  18. 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

  19. Does the SOP have enough Quality Control?

  20. 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

  21. 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.

  22. 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.

  23. Laboratory Quality Assurance Manuals

  24. Laboratory Quality Assurance Manuals • QA Manuals are a great source of information for a technical QAPP • Provide lists of instrumentation • Analyst’s training • Tests and compounds analyzed, their reporting limits and methods used • QC acceptance ranges and other useful information

  25. Questions?

  26. Thank You!

  27. 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 Contacts

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