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SOPs Overview

SOPs are documents that include:
A set of step-by-step instructions
that laboratory staff shouldt meticulously follow when performing a procedure
.

  • These SOPs are complied to laboratory management system
  • Tohelp lab staff to carry out → complex routine Operations
SOPs Overview
  • In quality management it is important that You do what you say and say what you do
  • By recording all the major processes in the laboratory in SOPs You assure that these processes are carried out in Exactly the same way every time. Which means that you have Standardized the process.
  • As the SOPs need to be reviewed and authorized by different persons. You anso assured the quality of the procedures.
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SOPs is one of the components of the laboratory quality System

The 1st Step in standardizing the primary process is: The documentation of the procedures of all the tests currently performed in the Laboratory in SOPs.

WHO Laboratory Quality Stepwise Implementation Tool

  • Make Procedures for all tests
    • Develop a request form for laboratory testing
    • Write a master sop
    • Make a list of all tests performed in the laboratory
    • Make SOP for all tests performed by the laboratory

Also in Quality management : SOPs are subject to regular review and revision by setting up a document control system.

We need SOPs for 7 Reasons:

  1. SOPs Facilitate Communication
    • Well written SOPs clearly communicate responsibilities to Laboratory staff
    • They dont have to relay on there memories
  2. SOPs provide a Total Quality System
    • Quality Items = How SOPs provide this Item
    • Quality Policy = Mission Statement
    • Quality Plan = Implementation of Policies
    • Quality Manual = Application of Standards
    • Procedure = Implementation of SOPs
    • Training = Using SOPs for Self-Training
    • Auditing = Documenting Errors and failures
    • Quality Improvement= Corrective Actions
  3. SOPs help to Increase Productivity
    • More Likely to achieve Peak Performance
    • Also manager Productivity by Saving there time
      • Not have to re-train Lab Staff
      • Not have a remind them of what needs to be done
  4. SOPs Facilitate Cross-Training
    • SOPs allow to other lab staff to fill in and complete tasks they don’t normally perform if those key players are on vacation or out sick.
  5. SOPs are essential to the lab Staff
    • Performance Eveluation Process
    • How can you hold laboratory staff responsible for task and processes that are not documented?
    • Whithout SOPs job performance offen becomes a matter of openion.
    • With SOPs Manager can clearly identify Successes
    • With SOPs Manager can Communicate Deficiencies
    • With SOPs Manager can be able to justify his disciplinary actions and Termination actions
  6. SOPs help to lab staff to support each others
    1. When learning new processes, Lab staff can help and train eachother, rether then relying on a manager to do so.
    2. Lab Staff opportunity to correct/ redirect each other when tasks are not being performed correctly.
  7. SOPs help to create a safe work Environment.
    1. Clearly written SOPs along with proper training Reduce legal liability when an incident occure.

SOPs Road Map

  1. Sop Introduction:
    1. Overview
    1. Purpose
    2. Benifits
    3. Writing Styles
  2. General Formates:
    1. Title Page
    2. TOC
    3. Text
  3. SOPs Types:
    1. Master SOPs
    2. Administrative SOps
    3. Technical SOPs
      1. Procedure
      2. Equipments
      3. Analysis
  4. SOPs Process:
    1. Preparation
    2. Revision and Approval
    3. Frequency of Reviewing
    4. Checklists
    5. Document Controls
    6. Document Tracking and Archival
    7. How to apply a SOP system ?

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