Equipment Qualification

Equipment Management Training-

Labs for Life Project

Dr Anu George
15 Feb 2016
 Reliability of Analytical Data
Methods
Instruments/
equipment
Analysts
Environment
Why EQ?
ISO: 15189 Clause 5:3:1

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 Qualification
Qualification
Action of proving that any premises, systems &
items of equipment work correctly and
actually lead to the expected results
Validation usually incorporates the concept of
qualification
A process of establishing confidence that the
equipment is capable of consistently operating
within established limits & tolerances. Studies
therefore done prior to use
Equipment Qualification (EQ)…
Steps
1. Design Qualification (DQ)
2. Installation Qualification (IQ)
3. Operational Qualification (OQ)
4. Performance Qualification (PQ)
5. Maintenance Qualification (PQ)

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 Pre-purchase Planning
Identification of needs
What is the requirement?

Increased productivity

Regulatory requirement

Enhancing laboratory capabilities

Replacing an existing equipment

 Why DQ?
Some equipment issues we can avoid
Poor design
Lack of safety
Poor quality finishes
Too sensitive to environmental changes
No usage log or record
Frequent breakdowns
Need highly trained Analysts
No tech support
No spare parts
What are the steps in DQ
URS (User Requirement Specification)
Technical Requirements
Operational Requirements
Commercial Requirements

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DQ (Contd.…….)
Vendor Qualification

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URS vs Vendor Specification

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 Vendor Qualification
Does the vendor have a documented & certified
quality system, (e.g. ISO 9001. ISO 9002 or 9003)
Is equipment hardware & computer software
developed & validated according to a documented
procedure?
Does the vendor provide?
Declaration of conformity
Assistance in qualification, maintenance &
timely repair through qualified employees
Training on the equipment
 Performance Specifications
Are the analyte performances like precision and
accuracy within stipulated quality specifications as per
available databases (BV, CLIA)?
Are the linearity of all analytes acceptable?
Are the Sensitivity and Specificity of all anlaytes
acceptable?

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 Operational Specifications
Do you have the specified infrastructure in terms of
space and accommodation needs for the equipment?
Will the vendor give you engineering as well as
application support?
Are spare parts supplied for authorized maintenance
steps?
How hard is it to get spare parts?
What is the assured downtime control policy offered?

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Pre-installation checks (Post purchase)

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Pre-installation…. Verify
Verify that all physical requirements (electrical, space,
doors, ventilation, and water supply) have been met.
Verify Spares
Verify Software

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 Site Preparation
Location
Physical dimensions of the instrument
Suitable operating environment - temperature,
humidity and vibration control
Utilities - voltage, current, special electrical
plug, gas supplies, computer network
connection, special ventilation/enclosure, water
supply, drainage etc.
IT & safety requirements
Take vendor’s / manufacturer’s
recommendations
Pre-installation …Sign-off

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Installation Qualification

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IQ….(cont.….)
Ensure that the equipment in the condition delivered
meets DQ specifications and is correctly set up in
customer plant as planned.
Special attention must be paid to the completeness
and correct installation of the equipment supplied.
Verify that sub-systems and ancillary systems have
been delivered, installed and configured

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 IQ….(cont.….)… Protocol
The IQ protocol could be in the form or a check
list and shall capture the entire activities
performed as part of installation verification. The
IQ protocol shall also have:
Protocol no.
Name of the vendor & contact details
Date received (and Date of Installation)
Location of installation
Any damages or deficiencies shall be documented
& reported to the vendor for corrective action
IQ…..Sign off

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Operational Qualification (OQ)

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Operational Qualification (OQ)
Make inventory records
Calibrate all parameters
Verification with samples, IQCs
Define and program all operating procedures
Define a maintenance program
Train all operators
Give authorization

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 Operational Qualification (OQ)…..
Test all functional specifications
Check for all normal operation controls, all alarm
points, all switches/displays interacting controls &
any other indications of operations & functions
Functional challenge tests shall also be performed
in OQ to test the system software operation &
security
Challenges equipment functionally to verify
compliance with manufacturer’s specifications &
end-user defined requirements(i.e. “worst case
conditions”)
All what was asked in the URS should be validated
OQ (cont.…..) Spares

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OQ (cont.…..) Labeling
Equipment Name : ___________________ Model No :____________________________

Manufacturer Name : ________________ Date of Installation : _________________

Contact Number: Tech Support Application: Serial No.: ____________________________

Contact Numbers: Tech Support: Service- Lab/Hospital Equipment ID: ______________

_________________________

Last PM Done : ______________________ Last Calibration Done : __________________

Next PM Due : _______________________ Next Calibration Due :___________________

Authorization for Use:_________________________________________________________

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OQ…….Sign-off

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Performance Qualification (PQ)

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PQ……CLSI guidelines
1. Precision
2. Accuracy (measured bias) or comparability (measured
differences)
3. Linearity over the measuring interval or analytical
measurement range (AMR)
4. Limit of detection (LoD) and limit of quantitation (LoQ or
analytical sensitivity)
5. Specificity or interference
6. Reagent or sample (analyte) carryover
7. Biological Reference Interval or decision value (interpretive
information)
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PQ….Cont.………..

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PQ..Cont…
Precision Check against claim

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PQ… Cont.……Accuracy..
Check against claim

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Recap: Advantages of EQ
 Change control
Requalification
Required for:
Change in operating parameters
Component specifications have changed
New accessories or components are added to
previously qualified equipment
Process changes that potentially impact product
effectiveness or quality
Equipment has been shifted