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

2. 2 Disclaimers This material is for training and/or teaching purposes only. The views of the author do not necessarily represent that of EPA. 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. Mention of trade names, products, or services does not convey official EPA approval, endorsement, or recommendation.

3. 3 What is an S.O.P?

4. 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. 5 SOPs: the Good, the Bad, and the Ugly

6. 6 The Good

7. 7 EPA Guidance on QAPPs and SOPs Document EPA QA / G5 Document EPA QA / G5 Guidance for Quality Assurance Project Plans Guidance for Quality Assurance Project Plans Document EPA QA / R5 Document EPA QA / R5 Requirements for Quality Assurance Project Plans Requirements for Quality Assurance Project Plans Document EPA QA / G6 Document EPA QA / G6 Guidance for Preparing Standard Operating Procedures Guidance for Preparing Standard Operating Procedures

8. 8 A “GOOD” Standard Operating Procedure Should provide all the information necessary to perform a task Should provide all the information necessary to perform a task Is usually specific to the equipment used for the procedure Is usually specific to the equipment used for the procedure Should be detailed Should be detailed Should “stand alone” Should “stand alone” Should provide Quality Control information Should provide Quality Control information Should provide References Should provide References

9. 9 The bad

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

11. 11 The Ugly!

12. 12 Ugly SOPs No Title Page No Title Page No Revision Numbers or Approval Signatures No Revision Numbers or Approval Signatures No Table of Contents No Table of Contents No Page Numbers No Page Numbers No Quality Control (in a technical SOP) No Quality Control (in a technical SOP)

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

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

15. 15 QAPPs and SOPs Most QAPPs should have references to SOPs Most QAPPs should have references to SOPs Most QAPPs should use technical information in SOPs to set QC limits 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 Most QAPPs need referenced SOPs attached as appendices due to inaccessibility to the user

16. 16 QAPP Structure QAPPs are broken down into four major groups (A – D) QAPPs are broken down into four major groups (A – D) A: Project Management A: Project Management B: Data Generation and Acquisition B: Data Generation and Acquisition C: Assessment and Oversight C: Assessment and Oversight D: Data Validation and Usability D: Data Validation and Usability

17. 17 Group Sections that could reference SOPs Section A6: Project/Task Description Section A6: Project/Task Description Section A7: Quality Objectives and Criteria for Measurement Data Section A7: Quality Objectives and Criteria for Measurement Data Section A8: Special Training Requirements/Certification Listed Section A8: Special Training Requirements/Certification Listed All Sections in Group B All Sections in Group B Section C1: Assessments and Response Actions Section C1: Assessments and Response Actions All Sections in Group D All Sections in Group D

18. 18 Checklist for EPA/QA-R5 Breaks Down Each Major Group Breaks Down Each Major Group Covers All Aspects of the QAPP Covers All Aspects of the QAPP Is Redundant but Thorough Is Redundant but Thorough Helps Define Parts of EPA/QA-G5 Helps Define Parts of EPA/QA-G5

19. 19 Does the SOP have enough Quality Control?

20. 20 Common QC Missing From QAPPS Method IDs Method IDs Maximum Concentration Levels (MCLs) Maximum Concentration Levels (MCLs) Reporting Limits (RLs, QLs or MDLs) Reporting Limits (RLs, QLs or MDLs) Acceptance Limits for Precision and Accuracy Acceptance Limits for Precision and Accuracy Instrument and/or equipment lists Instrument and/or equipment lists

21. 21 Technical QAPP Document Support Technical QAPPs require more information regarding specific procedures/methods than administrative QAPPs 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. If results are used for compliance or public health decision making, EPA approved methods for sampling and analysis should be used.

22. 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. 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. Make sure these numbers will satisfy the goals of the QAPP.

23. 23 Laboratory Quality Assurance Manuals

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

25. 25 Questions?

26. 26 Thank You!

27. 27 Contacts Charlie Appleby – Chemist Charlie Appleby – Chemist (706) 355-8555 (706) 355-8555 appleby.charlie@epa. gov appleby.charlie@epa. gov appleby.charlie@epa. gov appleby.charlie@epa. gov Denise Goddard - Chemist Denise Goddard - Chemist (706) 355-8568 (706) 355-8568 goddard.denise@epa. gov goddard.denise@epa. gov goddard.denise@epa. gov goddard.denise@epa. gov Marilyn Maycock – Section Chief Marilyn Maycock – Section Chief (706) 355-8553 (706) 355-8553 maycock.marilyn@epa. gov maycock.marilyn@epa. gov maycock.marilyn@epa. gov maycock.marilyn@epa. gov Ray Terhune - Chemist Ray Terhune - Chemist (706) 355-8557 terhune.ray@epa.gov