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StandardStandard Operating Operating

ProceduresProceduresTheir Development and Use with Their Development and Use with QualityQuality Assurance Project Plans Assurance Project Plans

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Disclaimers Disclaimers This material is for training and/or teaching This material is for training and/or teaching

purposes only. The views of the author do not purposes only. The views of the author do not necessarily represent that of EPA.necessarily represent that of EPA.

Mention of trade names, products, or services Mention of trade names, products, or services does not convey official EPA approval, does not convey official EPA approval, endorsement, or recommendation.endorsement, or recommendation.

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

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Standard Operating Procedure Standard Operating Procedure DefinitionDefinition

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 SOPs: the GoodGood, the , the BadBad, and the, and the UglyUgly

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The The GoodGood

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EPA Guidance on QAPPs and EPA Guidance on QAPPs and SOPsSOPs

Document EPA QA / G5Document EPA QA / G5Guidance for Quality Assurance Project PlansGuidance for Quality Assurance Project Plans

Document EPA QA / R5Document EPA QA / R5Requirements for Quality Assurance Project Requirements for Quality Assurance Project

PlansPlansDocument EPA QA / G6Document EPA QA / G6

Guidance for Preparing Standard Operating Guidance for Preparing Standard Operating ProceduresProcedures

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A “A “GOODGOOD” Standard Operating ” Standard Operating ProcedureProcedure

Should provide all the information Should provide all the information necessary to perform a tasknecessary to perform a task

Is usually specific to the equipment used Is usually specific to the equipment used for the procedurefor the procedure

Should be detailedShould be detailedShould “stand alone”Should “stand alone”Should provide Quality Control informationShould provide Quality Control informationShould provide ReferencesShould provide References

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The The badbad

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BADBAD “Stuff” “Stuff” in an SOP in an SOPDON’T generalize in a technical DON’T generalize in a technical

procedure.procedure.DON’T assume that the reader knows the DON’T assume that the reader knows the

process.process.DON’T refer to a method or analysis for DON’T refer to a method or analysis for

most of the procedure steps.most of the procedure steps.DON’T ramble on about unnecessary DON’T ramble on about unnecessary

things. Be concise.things. Be concise.

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The The UglyUgly!!

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UglyUgly SOPs SOPs No Title PageNo Title PageNo Revision Numbers or Approval No Revision Numbers or Approval

SignaturesSignaturesNo Table of ContentsNo Table of ContentsNo Page NumbersNo Page NumbersNo Quality Control (in a technical SOP)No Quality Control (in a technical SOP)

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Typical Structure for SOPsTypical Structure for SOPsTechnical SOPTechnical SOP

Title PageTitle PageTable of ContentsTable of ContentsProceduresProceduresQuality Control and Quality AssuranceQuality Control and Quality AssuranceReference SectionReference Section

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SOP Structure continuedSOP Structure continuedAdministrative SOPAdministrative SOP

Title PageTitle PageTable of ContentsTable of ContentsProceduresProceduresQuality Control and Quality AssuranceQuality Control and Quality AssuranceReference SectionReference Section

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QAPPs and SOPsQAPPs and SOPsMost QAPPs should have references to Most QAPPs should have references to

SOPsSOPsMost QAPPs should use technical Most QAPPs should use technical

information in SOPs to set QC limitsinformation in SOPs to set QC limitsMost QAPPs need referenced SOPs Most QAPPs need referenced SOPs

attached as appendices due to attached as appendices due to inaccessibility to the userinaccessibility to the user

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QAPP Structure QAPP Structure QAPPs are broken down into four major QAPPs are broken down into four major

groups (A – D)groups (A – D)A: Project ManagementA: Project ManagementB: Data Generation and AcquisitionB: Data Generation and AcquisitionC: Assessment and OversightC: Assessment and OversightD: Data Validation and Usability D: Data Validation and Usability

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Group Sections that could Group Sections that could reference SOPsreference SOPs

Section A6: Project/Task DescriptionSection A6: Project/Task Description Section A7: Quality Objectives and Criteria Section A7: Quality Objectives and Criteria

for Measurement Datafor Measurement Data Section A8: Special Training Section A8: Special Training

Requirements/Certification ListedRequirements/Certification Listed All Sections in Group BAll Sections in Group B Section C1: Assessments and Response Section C1: Assessments and Response

ActionsActions All Sections in Group DAll Sections in Group D

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Checklist for EPA/QA-R5Checklist for EPA/QA-R5Breaks Down Each Major GroupBreaks Down Each Major GroupCovers All Aspects of the QAPPCovers All Aspects of the QAPP Is Redundant but ThoroughIs Redundant but ThoroughHelps Define Parts of EPA/QA-G5Helps Define Parts of EPA/QA-G5

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Does the SOP have enough Quality Does the SOP have enough Quality Control?Control?

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Common QC Missing From QAPPSCommon QC Missing From QAPPS

Method IDsMethod IDsMaximum Concentration Levels (MCLs)Maximum Concentration Levels (MCLs)Reporting Limits (RLs, QLs or MDLs)Reporting Limits (RLs, QLs or MDLs)Acceptance Limits for Precision and Acceptance Limits for Precision and

AccuracyAccuracy Instrument and/or equipment listsInstrument and/or equipment lists

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Technical QAPP Document Technical QAPP Document SupportSupport

Technical QAPPs require more Technical QAPPs require more information regarding specific information regarding specific procedures/methods than administrative procedures/methods than administrative QAPPsQAPPs

If results are used for compliance or public If results are used for compliance or public health decision making, EPA approved health decision making, EPA approved methods for sampling and analysis should methods for sampling and analysis should be used.be used.

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Technical QAPP Document Technical QAPP Document Support continuedSupport continued

SOPs verify that the laboratory is using SOPs verify that the laboratory is using EPA approved procedures. They should EPA approved procedures. They should also show the QC acceptance ranges and also show the QC acceptance ranges and the minimum detection limit (MDL) or the minimum detection limit (MDL) or reporting limit (RL) for each analyte of reporting limit (RL) for each analyte of concern.concern.

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

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Laboratory Quality Assurance Laboratory Quality Assurance ManualsManuals

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Laboratory Quality Assurance Laboratory Quality Assurance ManualsManuals

QA Manuals are a great source of QA Manuals are a great source of information for a technical QAPPinformation for a technical QAPPProvide lists of instrumentation Provide lists of instrumentation Analyst’s trainingAnalyst’s trainingTests and compounds analyzed, their Tests and compounds analyzed, their

reporting limits and methods usedreporting limits and methods usedQC acceptance ranges and other useful QC acceptance ranges and other useful

informationinformation

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Questions?Questions?

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Thank You!Thank You!

2727

ContactsContacts Charlie Appleby – Charlie Appleby –

ChemistChemist (706) 355-8555(706) 355-8555 appleby.charlie@epa.appleby.charlie@epa.

govgov

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

govgov

Marilyn Maycock – Marilyn Maycock – Section ChiefSection Chief

(706) 355-8553(706) 355-8553 maycock.marilyn@epa.maycock.marilyn@epa.

govgov

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