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Overview
A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end result. An authorized written procedure giving instructions for performing operations not necessarily specific to a given process, product or material (e.g. equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection).
Importance:
Standard operating procedures describe in a detailed form the activities performed in the laboratory Provide uniformity, consistency and reliability in each of the activities performed in the laboratory Reduce systematic errors Provide training and guidance for new staff development and use of SOPs promotes quality through consistent implementation of a process or procedure within the organization reduced work effort, along with improved data comparability, credibility, and legal defensibility
Writing Style
concise, step-by-step, easy-to-read format information presented should be unambiguous and not overly complicated active voice and present verb tense should be used should not be wordy, redundant, or overly lengthy
General: Document Preparation (SOP for SOP) Preparation and maintenance of work area
Washing and sterilization Decontamination Testing area Recording and labeling Storage and discarding
Receipt of samples,
Laboratory operations
Receipt of reagents, standards, etc storage Preparation of reagents labeling and storage Test procedures Reference material identification,handling,storage and use Results results, deviations, errors Reports generation, distribution Archives maintenance
Staff Training, GLP, staffing pattern Equipments Indent, purchase, installation and validation Maintenance Daily checks and records Periodic calibration and validation Trouble shooting and action to be taken Annual maintenance In case of accidents action to be taken Deviations Planned deviations Unplanned deviations Variance Errors Record of all the above Action taken
SOP Process(steps)
Preparation
written by individuals knowledgeable with the activity and the organization's internal structure written with sufficient detail so that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised
Checklists
Many activities use checklists to ensure that steps are followed in order.
SOPs should describe how the checklist is to be prepared or on what it is to be based.
Title Page
Title that clearly identifies the procedure/activity Date of issue and/or revision Name of the association Signatures and signature dates of those individuals who prepared Code : Number relating to procedure and revisions
Table of Contents
Quick reference Denotes changes or revisions made only to certain sections of a SOP Objective : Aim of the procedure clearly described
Eg
Date of issue of this version:1/4/2003
Objectives Scope
: Procedure to be followed for receiving and storing stool samples of AFP Cases. : This document contains the procedure that is adopted when stool specimens are received from cases of AFP from Tamilnadu, Andhra Pradesh, Pondicherry, Andaman & Nicobar.
Definition: Stool sample carrier marked with red for stool samples only Deep freezer 20 (1) preparation of ice pack Refrigerator No.3 for pre processing storage of samples LRF Lab request form. AFP Acute flaccid paralysis. Place of testing: Requirements: Equipment
Consumables
Registers
Tech/Scientist incharge
Checked by
Authorized by
Material Control
Specification For Raw Materials Specification For Supplies/Disposables Inspection & Acceptance Criteria For Supplies/ Disposables/Raw Material. Inventory Control Procedures For Supplies/Disposables.
Labelled
complete description (name, source, Lot number) strength, activity and confidence interval storage conditions
Protected (heat, light, humidity, irradiation, vibration) Custodian of Standards SOP for Standards Management
selection, standardisation, change, and control Standard Lot Number must appear in testing record
Standard Name Batch Number Date of preparation Date of expiry Storage conditions Strength
EQUIPMENT Material needed ( Pipette, incubator, water bath). Daily-start up Machine Daily maintenance Weekly maintenance Monthly maintenance Temperature monitoring
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