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Equipment Maintenance and Use

Dr Anjali Hazarika
I/c Blood Transfusion Services
Cardiothoracic and Neurosciences Centre
AIIMS, New Delhi
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Why Equipment management?
Resource involving
Heavy capital investment
Tedious procurement
process
Critical to ensure nn
interrupted and quality
service
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Equipment management program
To :
Maintain a high level of performance
Lengthen life of instrument
Reduce interruption of services due to
breakdowns and failures
Improve customer satisfaction
Improve the technologists confidence and
knowledge
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Equipment management
It goes far beyond that of a person simply being able
to operate the equipment.
It also requires a specific person designated to deal
with all aspects of equipment management.
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Equipment Management
Need assessment List of critical equipment i.e.
Selection specifications when the result of any of its
Procurement functions is essential to
achieve a quality outcome
Installation
Devise a system to uniquely
Calibration / Validation identify equipment
User Responsibility Prepare labels for
Maintenance equipment
Troubleshooting
Service and repair
Retiring equipment /
 condemnation
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Need Assessment
Utilization Index:
Parameter to assess productivity of service of an equipment
Use co-efficient Index:
N / M x100
N = average number of hours the equipment is used / day
M = Maximum number of hours the equipment can be
used per day
< 50% considered to be under utilized
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Selection of equipment
A Selection Criteria Check List will assist in
purchasing the most appropriate piece of equipment
to meet the laboratories needs, e.g.
Cost
Manufacturer
Technical Support
Availability
Model (capacity, volume, warranty)
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Selection & Validation of Equipment
Blood bank/ Blood centre has a policy for selection,
procurement and installation
New equipment needs to be validated
Process should include
Design qualification
Installation qualification
Operational qualification
Performance qualification
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Design Qualification:
Documented verification that the design
(specifications) of the equipment and its
components satisfies the User Requirement
Specifications
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Installation Qualification
IQ demonstrates that the instrument is properly installed
in environmental conditions that meet the manufacturers
specifications
 IQ testing and documentation typically includes:
verification of the manufacturer
model no.
equipment no.
instrument calibration status,
equipment SOP verification &
verification of critical installation parameters eg
equipment location,
major components and utilities
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Operational Qualification:
An OQ is a validation protocol that provides documented
verification that equipment or a system functions according
to written & pre-approved specifications.
It demonstrates that the installed equipment operates as
intended.
It focuses on the capability of the equipment to operate
within the established limits and specifications supplied by
the manufacturer.
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Operational Qualification (contd)
OQ testing and documentation typically
includes
verification of the Operator Interface
Screen Menus
Alarms
Inputs and Outputs
Print Functions
Eventful & Uneventful Functions
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Performance Qualifications:
PQ demonstrates that the equipment performs as
expected for its intended use in the processes
established by the blood center and that the output
meets the centers specifications.
It evaluates the adequacy of equipment for use in a
specific process that uses the blood centers
personnel, procedures, and supplies in a normal
working environment.
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Performance Qualifications
(contd)
PQ testing and documentation typically
 includes:
verification of the operator training,
SOP approval
equipment or system process parameters.
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Procurement and Reception of Equipment
At time of delivery the equipment is inspected as per
specifications given in the supply order by the user
department.
On satisfactory receipt, installation certificate to that effect
is given by user department.
The operational manual is available to the User
department
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Installation
Prior to installation:
verify physical requirements have been met
safety checks, electrical, space, ventilation, water
supply, ambient temperature, etc.
confirm responsibility for installation
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Installation (contd)
Upon receipt:
Verify package contents
Do not attempt to use prior to proper
installation
If required, ensure the equipment is installed
by the manufacturer
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Installation (contd)
After installation:
Establish inventory record
Define conditions
Develop and implement protocols for calibration,
performance verification, and operating procedures
Establish maintenance program
Provide training for all operators
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Labeling of Equipment
Blood centre maintains labels on each equipment
 with the following details:
Identification (YY lab code- 0001, 2011-IH-012)
Serial number / Model number
Date of last calibration
Due date of calibration
Contact details of the service engineer
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Equipment Record, Unique Identification
Blood centre maintains records for each equipment for
life span or for any time period required by regulations
and may include:
Identification
Manufacturers name, type, serial no./ other unique id
Manufacturers contact person and telephone number
Date of receiving and date of putting into a service
Current location, where appropriate
Condition when received (new, used or reconditioned)
Manufacturers instructions,
Equipment performance records that confirm the equipment
suitability for use
Maintenance carried out and that planned for the future
Damage to or malfunction/modification/repair of equipment
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Proforma for History Sheet of the
Equipment
Name of the equipment
Model No.
Manufacturer
Name of supplier with contact No.
Mode of purchase Hospital supply/NACO/UPSACS/Other
Cost of equipment
User manual
List of accessories
List of repairs
Warranty
AMC
Date of installation & demo
Calibration
Validation
Operational qualification
Performance qualification
Status of the equipment
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 Use of equipment
Only authorized person should operate the
equipment.
Equipment used in the collection, processing, testing,
storage and distribution of blood and its components
should be maintained in a clean and proper manner
and so placed as to facilitate cleaning and
maintenance.
Instructions for use and daily maintenance of all
equipment should be available to personnel.
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User Responsibilities
The user has the major responsibility to ensure the
equipment is used properly and services regularly
Need well trained staff
Understand how equipment works
Have been trained to maintain equipment
Understand possible problems and their
prevention
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Training of User Staff
All relevant staff are trained on the use of equipment.
Training should include the following modules:
Use & practice of equipment including proper handling of equipment
Preventive maintenance and trouble shooting
Following instruction manual in day-to-day use of equipment
Common and recurrent causes of break-down
Common spare parts responsible for frequent break-downs
Inspection and routine maintenance
Calibration
Testing and safety guidelines
Basic concepts of physics and electronics as relevant to equipment
Documentation of procedures (SOPs)
Refresher training when new equipment is procured, is provided.
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Programme for calibration and
maintenance of equipment
It includes establishing a programme that regularly monitors
and demonstrates proper calibration and function of
instruments, reagents and analytical system
Established or implemented procedure for calibration and
regular monitoring
Program of preventive maintenance which contains
recommendations of manufacturers / service report.
Frequency of calibration of equipments as per
recommendation of manufacturer, or as per prevalent
 standards.
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Calibration & Validation
Blood centre should have a policy and procedure for
calibration and validation of equipment to achieve the
required performance that complies with standards
What is calibration?
What is validation?
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Calibration
Definition
Comparison of measurements performed by an
instrument to those made by a more accurate
instrument (traceable to national or international
standard) for the purpose of detecting, reporting &
eliminating errors in measurement
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Equipment Calibration
Perform initial calibration
Calibrators or standards
Follow manufacturers instructions
Determine frequency of routine calibrations
Calibration certificate / due date for next calibration
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Calibration
When to calibrate?
At regular intervals based on usage
When equipment is new and no calibration certificate
provided
When equipment undergoes traumatic events e.g.
moving over long distance
When routine maintaining shows functioning outside
specifications
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 Validation
Confirmation and provision of objective evidence
that requirements for a specific intended use or
application have been fulfilled
Assurance that a specific process will consistently
produce an outcome that meets its pre- established
quality and performance specifications
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Validation: General Principle
It is a key part of quality system
It needs to be carefully & clearly thought out or
planned
You validate something before you use it
You can validate something while you are using it
Prevention is better than cure
Failing to plan is planning to fail
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What can be validated?
Any process, piece of equipment or software
Processes
Is the output correct?
Does it meet specification?
Is it documented?
Does it affect another process?
Is it safe to use?
Is there defined maintenance/ repair?
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Validation of equipment
When to do?
On commissioning of the equipment, based
on full validation data supplied by the
manufacturer
After any repair or adjustments which may
potentially alter the function of equipment
If ever a doubt arises that the machine is not
functioning properly
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Performance Validation
Validate the performance of new
equipment prior to use
 Test known samples, analyze data
Establish stability/uniformity of temperature
controlled equipment
Check accuracy/precision for pipettes
Check centrifuge rpms/ rcf
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Implementing a Maintenance Program
Assign responsibility
Oversight of all laboratory equipment
Individual responsibilities
Develop written policies and procedures
Train staff
Keep records
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Implementing a Maintenance Program:
Types of maintenance contracts:
Annual maintenance contract (AMC)
Comprehensive maintenance contract (CMC).
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Annual maintenance contract
A manufacturer company provides the service through AMC
by themselves or with the help of service providers.
The contract is usually for the period of 1 year after the
warranty period is over and can be extended up to three years
or five years as per the mutual understanding of both the
parties.
Usually the service providers give only service support and
would charge separately for every part under AMC.
However, in some cases, few parts are replaced during the
visit by service engineer when it is mentioned in AMC
contract that limited parts will be replaced.
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Annual Maintenance Contract
The Annual Maintenance Contract should include:
Regular service and maintenance after the warranty period
Warranty with spares
Continuous supply of consumables
Training of staff to handle the equipment
Reliable and prompt after-sale service
Suppliers contact details and emergency telephone number is
 available in Blood Bank.
Breakdown time / Uptime / Penalty clause
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Comprehensive maintenance contract.
It includes prompt service from the company or service
providers.
The contract is usually for the period of 1 year and can be
extended up to three years or five years as per the mutual
understanding of both the parties.
It includes repairs and replacements of faulty parts. Having
the contracts gives the benefits such as consumables (which
are not part of contract) being available at reduced costs.
CMC is costlier than AMC because it includes the costs of
spares as well.
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Essential components of
AMC & CMC:
Name and address of both the parties
Details of the equipment under contract
Duration of contract
Nature of AMC (comprehensive or non
comprehensive)
Cost of the contract
Number of visits and breakdown calls by the service
engineer
Payment terms
Penalty clause
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Maintenance
Types of maintenance
Routine
Preventive
Corrective
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Routine Maintenance
To ensure their long life and reliability of performance.
Routine maintenance includes both preventive as well as
corrective maintenance.
Any electronic product requires timely service to function
properly.
In a blood bank, there is always a danger of undesirable
machine breakdown.
Preventive maintenance can save a lot of time and money.
 With PMS, it is possible to predict and identify parts which are
at verge of collapse.
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Preventive Equipment Maintenance
Definition
Measures to ensure proper equipment functioning
and to minimize risk or equipment or breakdown
Written procedures must exist for planned
maintenance of blood bank equipment.
Documents
Develop written procedures for all equipment
Step-by-step instructions for performing maintenance
and function checks
Include guide for troubleshooting
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Preventive/planned maintenance
(contd)
Develop a Problem Log Record for each piece of
equipment
Date problem occurred, removed from service
Reason for breakdown or failure
Corrective action taken
Date returned to use
Change in maintenance or function checks
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Other safeguards
Warranty of new equipment for a sufficient time period to
test performance of equipment.
Safeguards for electronic equipment e.g. voltage stabilizer
automatic switch over for emergency (generator) are ensured
Periodic checks and repairs according to guidelines provided
in the operational manual
A logbook for all critical equipment
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Preventive Maintenance Schedule of
Equipment
Name of the equipment
Manufacturer & Model No.
Name of supplier with contact No.
Name of company to whom AMC given
Contact person with phone no.
Visit for Status of Any Equipment checked Next AM
C due
AMC on equipment on visit recommendation by on

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Breakdown of the Equipment
Blood centre has SOP for replacement/ repairing of defective
equipment.
The defective equipment is labeled and taken out of service.
Once repaired it should be calibrated before put in use and the
procedure is specified in a laid down SOP .
For equipment which are non-functional a prominent label stating
OUT OF ORDER is affixed.
For equipment not in use a prominent label stating CURRENTLY
NOT IN USE is affixed.
Blood bank has a back up policy for shifting and storage of blood
components in the event of breakdown of equipment.
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Corrective Maintenance
There is a system for communicating defects in equipment
which is known to all staff.
Written procedures exist for corrective maintenance of all
essential blood bank equipment
Procedures are described for repair of equipment by outside
agencies and in house
Records of external repair workshops are kept.
Response time of the supplier in case of repairs necessary is
recorded.
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Proforma for repairing of an equipment
Name of the equipment
Model No.
Manufacturer
Date of fault reported
Description of fault/malfunction
Date of information to the vendor
Date of visit by service engineer
Details of repairs to be done
Estimate of repairs
Date of reporting to TEMD
Repairs done on
Duration of breakdown of the equipment
Status of equipment after repairs
Calibration & Validation
Remarks
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Retiring Equipment / Condemnation
When?
When service engineer indicate not repairable
Outmoded, will replace with new equipment
Why?
Prevent inaccurate test results
Free up valuable space
Hazardous
How?
Condemnation
Salvage any useable parts
Consider biohazard, follow safety disposal
procedures (example: blood irradiator)
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Condemnation of Equipment
Procedures for condemnation and disposal of obsolete
equipment are laid down.
Criteria for condemnation and disposal of equipment should
be defined, such as:
Non-functional and beyond economical repair
Non-functional and obsolete
Functional but obsolete
Functional but hazardous
Functional but no-longer required
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To Summarize
Importance of Equipment Management Program :
Ensures a high level of performance
Reduces interruption of services due to breakdowns and
failures
Lowers repair costs
Lengthens life of instrument
Provides greater reliability of results
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