Standard Operating Procedures

Presentation Transcript

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

Disclaimers This material is for preparing as well as showing purposes as it were. The perspectives of the creator don't really speak to that of EPA. Specify of exchange names, items, or administrations does not pass on authority EPA endorsement, support, or proposal.

What is a S.O.P?

Standard Operating Procedure Definition A Standard Operating Procedure (SOP) is an arrangement of composed directions that report a normal or dreary action took after by an association.

SOPs: the Good , the Bad , and the Ugly

The Good

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

A " GOOD " Standard Operating Procedure Should give all the data important to play out an assignment Is normally particular to the hardware utilized for the method Should be itemized Should "remain solitary" Should give Quality Control data Should give References

The terrible

BAD "Stuff" in a SOP DON'T sum up in a specialized strategy. Try not to accept that the peruser knows the procedure. Try not to allude to a strategy or investigation for the vast majority of the technique steps. Try not to drift on about pointless things. Be succinct.

The Ugly !

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

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

SOP Structure proceeded with Administrative SOP Title Page Table of Contents Procedures Quality Control and Quality Assurance Reference Section

QAPPs and SOPs Most QAPPs ought to have references to SOPs Most QAPPs ought to utilize specialized data in SOPs to set QC restrains Most QAPPs need referenced SOPs connected as supplements because of unavailability to the client

QAPP Structure QAPPs are separated into four noteworthy gatherings (A – D) A: Project Management B: Data Generation and Acquisition C: Assessment and Oversight D: Data Validation and Usability

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

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

Does the SOP have enough Quality Control?

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 additionally gear records

Technical QAPP Document Support Technical QAPPs require more data with respect to particular systems/strategies than managerial QAPPs If results are utilized for consistence or general wellbeing basic leadership, EPA endorsed techniques for testing and investigation ought to be utilized.

Technical QAPP Document Support proceeded with SOPs confirm that the research facility is utilizing EPA endorsed methodology. They ought to likewise demonstrate the QC acknowledgment ranges and the base discovery restrict (MDL) or reporting limit (RL) for each analyte of concern. Ensure these numbers will fulfill the objectives of the QAPP.

Laboratory Quality Assurance Manuals

Laboratory Quality Assurance Manuals QA Manuals are an awesome wellspring of data for a specialized QAPP Provide arrangements of instrumentation Analyst's preparation Tests and mixes broke down, their reporting cutoff points and techniques utilized QC acknowledgment ranges and other helpful data

Questions?

Thank You!

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