standard operating procedures l.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Standard Operating Procedures PowerPoint Presentation
Download Presentation
Standard Operating Procedures

Loading in 2 Seconds...

play fullscreen
1 / 27

Standard Operating Procedures - PowerPoint PPT Presentation


  • 834 Views
  • Uploaded on

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.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Standard Operating Procedures' - issac


Download Now An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
standard operating procedures

Standard Operating Procedures

Their Development and Use with Quality Assurance Project Plans

disclaimers
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.
standard operating procedure definition
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.
epa guidance on qapps and sops
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
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
bad stuff in an sop
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.
ugly sops
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)
typical structure for sops
Typical Structure for SOPs
  • Technical SOP
    • Title Page
    • Table of Contents
    • Procedures
    • Quality Control and Quality Assurance
    • Reference Section
sop structure continued
SOP Structure continued
  • Administrative SOP
    • Title Page
    • Table of Contents
    • Procedures
    • Quality Control and Quality Assurance
    • Reference Section
qapps and sops
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
qapp structure
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
group sections that could reference sops
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
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
common qc missing from qapps
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
technical qapp document support
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.
technical qapp document support continued
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.
laboratory quality assurance manuals24
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
contacts
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