GCLP WORKSHOP

EQUIPMENT
MANAGEMENT
The Quality Management System

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•GCLP requirements
4. Definitions
Facility Records: records that confirm and support non-trial activities
essential to the reconstruction of the work performed. This may include
supporting data such as fridge/ freezer temperature records, equipment
service, maintenance and calibration records.
7. Equipment, materials & reagents
7.1.2 Equipment used should be periodically inspected, cleaned,
maintained, and calibrated, as appropriate. Records of such
maintenance and any unscheduled maintenance or calibration should
be retained.
7.1.3 An equipment service schedule listing all relevant equipment and
the schedule of planned service and calibration activities should be
maintained.
GCLP requirements
8. Standard operating procedures
8.2.1 Standard operating procedures should be available for:
b) Equipment: Operation, maintenance, cleaning, calibration of
equipment
16. Storage and retention of records
16.1 The following should be retained for the period specified by the
appropriate authorities or as defined by the trial protocol:
d) Records and reports of the maintenance and calibration of
equipment;
EQUIPMENT MANAGEMENT

Acquisition & Implementation

Selection & Installation

Equipment
Life Cycle

End of Life Use

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LEARNING OBJECTIVES

At the end of this module, you will be able to:

• Provide a rationale for equipment management
• List items to consider prior to selection/purchase of
laboratory equipment
• List main reasons of equipment failure
• describe requirements for a preventive maintenance
program
• to develop a maintenance program in their laboratory

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ACQUISITION AND SELECTION

Scenario:

• Purchase of an autoclave..

1. which factors to consider

2. which information you need in order to
make an appropriate decision?

• 4 different models …
but which one will you select to buy?

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 Autoclave.. 4 different models

1. which factors to consider

2. which information you need in order
to make an appropriate decision?

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SELECTION AND ACQUISITION

Equipment Facility
needs requirements

Performance needs

Total cost

Ease of use

Purchase conditions
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You bought your autoclave
It’s delivered ..
so what’s next?

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IMPLEMENTATION AND INSTALLATION

• Perform equipment validation:

documented evidence that the equipment performs
conform the specified requirements
= does it do what it is meant to do?

• When?
 before routine use

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IMPLEMENTATION AND INSTALLATION

1. Verify delivery of correct equipment

Document:
 The supplier and manufacturer
 System or equipment name, model and serial number
 Spare parts, relevant procedures and certificates
 Date of installation
Uniquely number (traceability)
Verify “User Requirements Specifications”

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IMPLEMENTATION AND INSTALLATION

2. User Requirement Specifications (URS)

what do you want the instrument to do for me?

 Focus on intended use within the lab

 Clear and verifiable

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IMPLEMENTATION AND INSTALLATION

2. User Requirement Specifications (URS)

Example autoclave
Req-1: Cycle temperature can be adjusted from 0-140°C
Req-2: Cycle time can be adjusted from 0-120min.
Req-3: The instrument input and output voltage must be 230V.
Req-4: The instrument must contain a manometer
Req-5: The instrument must contain an overpressure safety valve.
Req-6: The instrument must be delivered with European Standard AC power
plugs.
Req-7: The user manual must be delivered in an English and French version.
…..

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IMPLEMENTATION AND INSTALLATION

3. Installation Qualification
 Documented evidence that equipment is installed conform the
manufacturer’s specifications.
- Follow installation steps as specified in the user manual
- Verify the environmental conditions (space, temperature,
humidity,…)
- Verify availability of utilities (power supply,..)
- Verify the installation of the equipment.

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IMPLEMENTATION AND INSTALLATION

4. Operational Qualification
 Documented evidence that equipment functions in
accordance to the user requirements and user manual.
– Test all functionalities essential for the intended use
– Include studies on critical variables under their limits
(worst-case conditions)

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IMPLEMENTATION AND INSTALLATION

4. Operational Qualification
 Documented evidence that equipment functions in
accordance to the user requirements and user manual.
– Perform a calibration of the instrument

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IMPLEMENTATION AND INSTALLATION

4. Operational Qualification
 Documented evidence that equipment functions in
accordance to the user requirements and user manual.
– Finalize and approve SOP for operation.
based on manual but also personalize
– Provide a training for ALL operators.

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IMPLEMENTATION AND INSTALLATION

Take home messages - VALIDATION

1. Focus on the most critical (parts of) systems in your lab
 goal is to control measurement errors
2. Focus on the intended use of your system
 User Requirement Specifications (URS)
3. Perform and document qualification tests related to URS
(IQ and OQ)
4. Draw conclusions with traceability between URS and
qualification tests

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 IMPLEMENTATION AND INSTALLATION
RECEPTION

EQUIPMENT INSTALLATION

INVENTORY RECORD

Verification
Calibration
Procedures

Train ALL Operators

Use
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Scenario:

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Scenario:
You want to do microscopy, you have two
microscopes
but today all of them are out of work ?
1. no light
2. impossible to keep the focus

What should you do?

What should you have done earlier ?
MAINTENANCE

DOCUMENTS ?

Manufacturer’s instructions/manual are missing

No documented procedure for troubleshooting

Maintenance log book has not been updated for 4 years

MAINTENANCE
Key words
FIND INFORMATION: Microscope
Olympus
User manual
INTERNET ?
 MAINTENANCE

FIND INFORMATION:
INTERNET ?
http://www.alanwood.net/photography/olympus/downloads.html

Troubleshooting guide ?
MAINTENANCE

Spare parts are essential…

Proper documentation will prevent or reduce problems!
Proper storage of the microscope will help to solve problems!
Proper daily maintenance will prevent or reduce problems!

Microscope maintenance on powerpoint :

http://www.google.be/search?hl=nl&q=microscope+maintenan
ce+module+9&meta=
MAINTENANCE
What should you do? Why?

What should you have done earlier ?

 EQUIPMENT MANAGEMENT

INSTALLATION

RETIREMENT CALIBRATION
SELECTION
AQUISITION VALIDATION

SERVICE AND
MAINTENANCE
REPAIR

TROUBLE-
SHOOTING
MAINTENANCE
What is it?
various processes used to keep equipment
functioning

What for?
- remain capable of producing the desired
output
- in compliance with any safety regulations
MAINTENANCE
Different Terms:
Preventive maintenance:
to keep equipment working and/or extend the life of
the equipment e.g. defrosting of freezer, etc.

Corrective Maintenance:
Also known as repair
to get equipment working again
MAINTENANCE
Preventive maintenance:
- routine cleaning

- adjustment, replacement of equipment parts

MAINTENANCE
Benefits:
- lifespan and reliability of equipment

- cost of repairs Test results

- test results: less variation in time Variation/

Time

- level of performance

- safety will increase – prevent accidents

- interruption of services
MAINTENANCE

How do you start a maintenance program?

• Identify equipment
• Assign responsibilities
• Develop written policies and procedures
• Maintain records
• Train staff
Monitor: e.g. review of records routinely, update
of procedures, etc.
MAINTENANCE
1. Identify essential equipment
• Focus on essential equipment
• Equipment Inventory Log:
- instrument type, model number, serial number
- location in laboratory
- purchase date
- manufacturer and vendor contact information
- warranty (not expiration date)
- spare parts
MAINTENANCE

Equipment Log Book:

- Keep next to your equipment – retained for life
• Equipment inventory sheet/log
• Manuals: user & technical/service – KEEP A COPY in office
• All problems
• Calibration, maintenance & service
• …..
MAINTENANCE
Logbook examples: maintenance & incidents
AUTOCLAVE
MAINTENANCE
Recording of problems:
• date problem occurred, equipment removed from
service

• what has happened/reason for breakdown or failure

• corrective actions taken

• date returned to use

• changes in maintenance or service

MAINTENANCE
Written procedures of maintenance based on:
• Manufacturer’s recommendations, as specified in the
operator’s manual
Be aware that there is a great variability in format and
effectiveness of instructions provided by manufacturers e.g.
not meaningful are sentences like “daily cleaning process is
required.”

BUT PERSONALIZE TO:

• Instructions given in training classes
• Experience in the lab
MAINTENANCE
Develop a Maintenance Plan which includes:
– frequency of all maintenance tasks

– function checks

– routine replacement of parts

exact maintenance tasks depends on the type of

equipment involved
MAINTENANCE
• Service and Repair
- Manufacturers:
o Laboratory can schedule routine manufacturer’s
maintenance
o Warranty may require repair handled by manufacturer
o Service contract: example
 MAINTENANCE
Example 1: HemoCue Hb 201+
Use: hemoglobin measurement
Principle: Red blood cells are lysed and haemoglobin
is released and converted to azidemethaemoglobin. This is
read by spectrophotometry at 570nm and 880 nm.
Maintenance:

TASKS FREQUENCY
Clean the cuvette holder with alcohol or mild detergent 1x/day
Clean the cover with alcohol or mild detergent After spills
Clean the optical unit with a HemoCue cleaner (cleaning swab) 1x/month or after 50 measurements
(whatever comes first)
When an error message is shown
(see manual)
MAINTENANCE
Operator’s manual of HemoCue Hb 201+
MAINTENANCE
MAINTENANCE
Example 2: Biological safety cabinet
Maintenance:
TASKS FREQUENCY
As described in the service contract with external party: 1x/6-months?
-Control of exterior e.g.window, gas tube of burner, etc.
-Inspection of filters: dust, damage
-Control of electrical parts e.g. switches, lights
-Control of functioning e.g. leak test of filter, alarms, airflow velocity
measurements
Cleaning of the bench of the cabinet with 0.5% bleach or 70% alcohol After each use

Changing of UV lamps After 2000 hours

Disinfection of cabinet with H2O2/formaldehyde Before external

maintenance + after spills
MAINTENANCE
• Example Out of service labels
System must be in place to prevent use of an instrument
that is not qualified, unusable due to damage or
malfunction, or has exceeded its established calibration
interval
Out of Service
Equipment ID:
Out of service from:
Cause:
Initials:
MAINTENANCE
Conclusion:
A well-organized equipment maintenance program
provides:
• High level of performance and greater confidence in
the reliability of results.
• Fewer interruptions in test performance, lower repair
costs, and elimination of premature replacement of
equipment.
• Increased safety for laboratory workers will result
from well-maintained equipment.
MAINTENANCE
References:
UTLM, ITM (2009)
LQM website
www.labquality.be

• WHO Laboratory Quality Management System (LQMS) training toolkit

equipment
http://www.who.int/ihr/training/laboratory_quality/equipment/en/
References:
• CDC Module 9 Microscope Maintenance:
wwwn.cdc.gov/dls/ila/.../Module9Presentation.ppt

• WHO Maintenance Manual for equipment 2nd edition

OMS Manuel d’entretien et de maintenance 2e édition

PAHO Manual de mantinemiento para equipo de laboratorio

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RETIREMENT OF EQUIPMENT

8/18/2015 51
 EQUIPMENT MANAGEMENT
Calibration
Needs Acquisition & Implementation Verification
Facility requirements Selection & Installation Documentation
Ease of use Training
Consummables Responsible
Service
$$$

Equiment
Life Cycle
Monitor
Salvaging spare parts
Maintenance
Safety issues
Troubleshooting
Recycling potential
Service / Repair
End of Life Use

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