Standard Operating Procedures Writing - …...• Standard Operating Procedure • Recognized...

Standard Operating Procedures (SOPs) Writing

Dr Naheda AlkazemiJuly 2018

Content

• What is an SOP?• SOP benefits• Tips before creating SOP• When do we review SOPs?• SOP Structure

Standard Operating Procedure (SOP) writing - Dr Naheda Alkazemi - 2018

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What is an SOP?

• Standard Operating Procedure• Recognized internationally as a vital part of a laboratory quality

assurance program• Part of successful quality system in the laboratory• Step-by-step detailed instructions on how to perform a

laboratory assay/ procedures, including: • Pre-analytical [Specimen receipt & processing]• Analytical [Testing procedures (e.g. CBC)]• Post-analytical [Interpreting & reporting test results]

• Made specific to each laboratoryStandard Operating Procedure (SOP) writing - Dr Naheda Alkazemi - 2018

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What is an SOP? … cont

• Ensure reproducible and correct performance of laboratory tests• Requires a system for:

• Preparation• Approval• Distribution• Revision• Training

• Uniform • Accurate• Ensures results validityStandard Operating Procedure (SOP) writing - Dr Naheda Alkazemi - 2018

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Content

• What is an SOP?• SOP benefits


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SOP benefits

• Important for training new staff• Efficient workflow• Address safety and quality concerns• Minimize opportunities for

misunderstanding/miscommunication• Minimize variability in test results• Minimize failed test runs


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Content

• What is an SOP?• SOP benefits• Tips before creating SOP


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Tips before creating SOP

• SOP’s should be concise, step-by-step, and easy to read• Include pre-analytical, analytical and post-analytical phases• Use active voice and present verb tense (Never use “you”) (e.g.

Add 5ml of H20 and vortex)• Avoid using names; instead use titles if possible• Abbreviated step-by-step instructions• Consider using illustrations if possible• You can use pictures, tables & flowcharts to illustrate actions

• Especially useful for software instructionsStandard Operating Procedure (SOP) writing - Dr Naheda Alkazemi - 2018

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Tips creating SOP … cont

• Drafts should be reviewed by testing staff • Avoid unnecessary details• Document all dates (issue, review)• Kit/package inserts are NOT SOP’s• Never rely solely on manufacturer’s instructions for SOP’s• Information from the kit/package insert can help in the writing

of SOP.• Illustrations from kit/package inserts can be used/attached to

SOPsStandard Operating Procedure (SOP) writing - Dr Naheda Alkazemi - 2018

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Content

• What is an SOP?• SOP benefits• Tips before creating SOP• When do we review SOPs?


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When do we review SOPs?

• Regular update• Improvements in workflow• Change of reagents• Changes in reporting• Revised kit package inserts

IMPORTANT NOTE:When SOPs are revised, you must document these changes!Standard Operating Procedure (SOP) writing - Dr Naheda Alkazemi - 2018

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Content

• What is an SOP?• SOP benefits• Tips before creating SOP• When do we review SOPs?• SOP Structure


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SOP Manual Table of Contents


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SOP Structure

The SOP should include the following information• Title• Introduction/Purpose• Definitions• Equipment• Supplies• Sample (for testing procedures only)• Safety / Quality• Procedure

• Troubleshooting• Calculations • Interpretation/ Results• References• Related Documents• Appendices


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• Font: Times New Roman• Font size:

• Titles: 12 BOLD• Paragraphs: 12• Footer: 10

• Line Spacing: 1.5 Line

SOP Template


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Header / Footer

Title: Code:Section: Issue date:Issued by: Revision date:Approved by: Approved by:

• Header

• Footer:


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Introduction / Purpose

• Background information about the assay / machine / process

• Sensitivity/specificity data if appropriate• Diagnostic information • Justification of importance (include references)• Don’t forget citation!


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Definitions

• Abbreviations• e.g. CBC: Complete Blood Count

• Scientific terms


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Equipment / Supplies

• List all the equipment used• List all supplies needed

• Tables attached / index • Reagents used preparation recipe (if any)


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Sample

• Specimen collection • Acceptable specimen criteria; including:

• Received after collection time• Transportation• Storage

• Specimen rejection criteria• Biosafety


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Safety / Quality

• Quality • Quality controls

• Positive, negative, extraction, controls• Define acceptable/failure criteria• Define actions taken following test results (if any)

• Safety• Equipment needed• Important precautions• Test environment


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Procedure

• Step-by-step detailed instructions (simple & concise)• Sample processing• Sample testing• Data acquisition, calculations, software


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Troubleshooting

• Equipment• Refer to the manufacturer manual

• Test• Refer to the kit/package insert


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Calculations

• Results• Reporting • Dilutions


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Interpretation criteria

• Define positive, negative and equivocal/inconclusive results

• Define other tests needed (if any)• Table format?


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Resulting & Reporting

• When to report the results• How to report the test performed• Who has the authority to report• Documentation storage and retention (how, when,

where, who)• Electronic• Manual


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References / Related Documents

• Literatures cited (e.g. in the introduction)• Package inserts (if any)• Any document that interfaces with the SOP


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Appendices

• Package inserts• Flowcharts• Tables• Instrument operation & maintenance• Supporting documents


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Questions?

References

• CLSI (2006) Laboratory Documents: Development and Control; Approved guideline-5thEdition. GP2-A5

• WHO (2011) Laboratory Quality Standards and their Implementation. Available at: http://www.searo.who.int/LinkFiles/Publications_Laboratory_Quality_Standards_and_Impl.pdf

• WHO (n.d.) Laboratory Quality Management System Tool Kit. Available at: http://www.who.int/ihr/training/laboratory_quality/documents/en/index.html

• ISO 15189 (2007) Medical Laboratory Standards-2ndEdition• Rick Alexander-Orange County (CA) Public Health Lab• Erik Reisdorf (2012) Standard Operating Procedures (SOPs). Surveillance & Team

Leader-Virology Laboratory


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Date post:	29-Dec-2019
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