Dr.Mrs.Nalini Ramamurty King Institute of Preventive Medicine, Chennai. Quality assurance. Quality is…. Invisible when GOOD Impossible to ignore when BAD. Quality assurance. Definition
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King Institute of Preventive Medicine, Chennai
Invisible when GOOD
Impossible to ignore when BAD
To ensure credibility of the lab and generate confidence in lab results
How : By establishing a quality manual defining
Standard Operating Procedures
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).
Code : Number relating to procedure and revisions
Objective : Aim of the procedure clearly described
Scope : The operating unit and field of application
Definitions: Meaning of principle terms used
Description : Operating instructions clearly described without any ambiguity, understood by all staff with flow diagrams
Safety : Measures to be kept in mind when executing the SOP
Documentation : Protocol, Data sheets and measurements
References : Used to draw up the SOP
King Institute of Preventive Medicine,
National Polio Laboratory - Department of Virology,
Standard Operating Procedure - 001
RECEIPT OF STOOL SPECIMENS
Date of issue of this version:1/4/2003 Page Number 1/4
Objectives: Procedure to be followed for receiving and storing stool samples of AFP Cases.
Scope: This document contains the procedure that is adopted when stool specimens are received from
cases of AFP from Tamilnadu, Andhra Pradesh, Pondicherry, Andaman & Nicobar.
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:
Tech/Scientist incharge Checked by Authorized by
to establish, monitor and record “Quality” for all aspects of Good Laboratory Practices and Quality Control”.
Type of documents
Standard operating procedures
Protocols of tests, results
SOP for Reagent and Standards Quality ControlThe accuracy and precision of test results and test methods is dependant on the reliability, authenticity and control over reference standards, reagents and stock solutions..Similarly the retrospective testing of materials and product is dependant on the protection and storage of retention samples
SOP for control over Standards(reference material)
SOP for Standard Solutions & Reagents
It is a journey
towards the destination
Quality assurance Equipment Criteria
Purchase / Acquisition
Maintenance - Service and repair
Sales personnel are trained to sell a refrigerator to an eskimo, so beware.
check the fine print!!!
Equipment performance degrades over time.
- Monthly validation by BI
Maintenance is a costly activity.
- Should maintenance be done only by out side contractors.
For each piece of equipment:
Establish and maintain an inventory of most frequently used spare parts. Include in record of inventory:
Develop a problem log record for each piece of equipment
Retiring Equipment / Disposal