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Quality Records - PPT (Compatibility Mode)

The document outlines the design and implementation of quality records in accordance with ISO/IEC 17025:2005 standards. It details various types of records, including personnel files, equipment logs, and performance check records, emphasizing their importance as evidence in quality control and assurance. Additionally, it discusses record approval, maintenance, and disposal mechanisms to ensure compliance and integrity.

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Mohammed Elsinnari
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43 views12 pages

Quality Records - PPT (Compatibility Mode)

The document outlines the design and implementation of quality records in accordance with ISO/IEC 17025:2005 standards. It details various types of records, including personnel files, equipment logs, and performance check records, emphasizing their importance as evidence in quality control and assurance. Additionally, it discusses record approval, maintenance, and disposal mechanisms to ensure compliance and integrity.

Uploaded by

Mohammed Elsinnari
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

DAL ISO/IEC 17025:2005 TRAINING COURSE

QUALITY RECORDS - DESIGN AND


IMPLEMENTATION

Dr. M.V. Rao

Technical Workshop on
Laboratory Quality Management & Analytical Quality Assurance
(ISO 17025:2005)
May, 2014
QUALITY RECORDS
DESIGN AND IMPLEMENTATION
What is a Record ?

Document generated during the operation of


a system

Ø Out put of work carried out


Ø Contains data

vRecords constitute the evidence


vPillars of QC & QA
QUALITY RECORDS
DESIGN AND IMPLEMENTATION

Types of Records

ØHard copy (Printed/hand written)


ØElectronic Record (Digital/Analogue)
ØPhotograph
QUALITY RECORDS
DESIGN AND IMPLEMENTATION
Basic Records
ØPersonnel files- Include Academic &
Technical qualifications, Skills, Experience,
Training etc.
ØEquipment Files- Technical literature,
Installation, Calibration, Repairs and re-
calibration
ØReference Certificates - Identity, Traceability
Manufacturer’s details, Unique number,
Expiry date. Add purchase details ( purchase
date, LPO etc.)
QUALITY RECORDS
DESIGN AND IMPLEMENTATION

Cleaning and Maintenance Records


Ø Equipment Log books
Ø Equipment Maintenance Records
Ø Room cleaning Record
Ø Room Temperature, humidity records
Ø Glassware Cleaning Records
Ø Laboratory Waste (Collection & Disposal)
Records
QUALITY RECORDS
DESIGN AND IMPLEMENTATION
Performance Check Records
Ø Performance checks on instruments
Ø Performance checks and balances
Ø Temp. of ovens, water baths, incubators etc.
Ø Temperature records of freezers/refrigerators
Ø Performance checks on volumetric apparatus/
micropipettes/automatic titrators
Ø Other checks
QUALITY RECORDS
DESIGN AND IMPLEMENTATION

Work Records
ØWork sheets
ØReagents/Standards/Reference Materials
preparation records [ Description, prep. date,
expiry date, analyst, security]
QUALITY RECORDS
DESIGN AND IMPLEMENTATION

Date: xx/xx/2008 Xx-xx-00x, Rev. x


QUALITY RECORDS
DESIGN AND IMPLEMENTATION

Date: xx/xx/2008 Xx-xx-00x, Rev. x


QUALITY RECORDS
Log of Use of Equipment

Date: xx/xx/2008 Xx-xx-00x, Rev. x


QUALITY RECORDS
DESIGN AND IMPLEMENTATION

Record Approval
Ø Signature
Ø Electronic Approval
Ø Stamping
QUALITY RECORDS
DESIGN AND IMPLEMENTATION

Record Maintenance
Ø Security
Ø Retrieval Authorization
Ø Back up (Electronic Records)
Ø Holding Periods
Hard copy – 5 years (Min. 3 years)
Soft copy – 7 years (Min. 5 years)
Ø Disposal Mechanism

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