LABORATORY QUALITY

MANAGEMENT SYSTEM-MLT06101
MR.SANGA ZABRON
DMLS,BMLS (MUHAS)
IHAS-RUCU
Learning Objectives
a) Understand the general concept of quality management system
b) Understand the major components of quality management system
Introduction to Quality
In every life aspect, man need the highest degree of successfulness
and to maintain the high degree of the set goals. This determines
quality of every life aspect.
As you can choose between which hospital to get treated, which super
market to shop, which country to travel, what type of food to eat etc.
 those decisions come to the point where one will consider some
aspects to be superior and reasonable compared to others.
Like wise, for every laboratory, the ultimate goal of all the processes
are accurate, reliable, and timely results.
• The laboratory results must be as accurate as possible, all aspects
of the laboratory operations must be reliable, and reporting must be
timely in order to be useful in a clinical or public health setting
Activity: Brainstorming (01 min)

Define Quality
What is Quality?
• Achieving a 99% level of quality

means

accepting a 1% error rate

1% failure
 Quality
• Quality -Degree to which a set of inherent(essential) characteristics
fulfils requirements.
Reference: ISO 9000:2005.)
Activity: Brainstorming (01 min)
Define- Quality assurance
A planned and systematic set of quality activities focused on providing
confidence that quality requirements will be fulfilled
Laboratory Quality

• Laboratory Quality is defined as the accuracy, reliability and timeliness

of reported test results
• The laboratory results must be as accurate as possible, all aspects of the
laboratory operations must be reliable, and reporting must be timely in
order to be useful in a clinical or public health setting
• When making measurements, there is always some level of inaccuracy.
So, our challenge is to reduce the level of inaccuracy as much as
possible.
• An accuracy level of 99% may at first glance appear acceptable, but the
resulting 1% error can become quite large in a system where many
events occur, such as laboratory testing.
Quality audit (also quality assessment or conformity
assessment)

• Is a systematic and independent examination and evaluation to

determine whether quality activities and results comply with
planned arrangements, and whether these arrangements are
implemented effectively and are suitable to achieve objectives.
Quality improvement
• Is a part of quality management focused on increasing the ability to
fulfil quality requirements.
(Reference: ISO 9000:2005)
Quality indicator
• Quality indicator- Is an established measure used to determine how
well an organization meets needs and operational and performance
expectations.
Quality control
• Quality control – Is a set of activities or techniques whose purpose is
to ensure that all quality requirements are being met.
• Simply, it is examining “control” materials of known
substances along with patient samples to monitor the accuracy and
precision of the complete examination process.
Quality management
• Quality management- These are Coordinated activities that managers
carry out in an effort to implement their quality policy.
These activities include
• Quality planning, quality control, quality assurance and
quality improvement.
Quality Management System

Quality Management System

• -This involves all Coordinated activities to direct and control an
organization with regard to quality (ISO,CLSI).
• That means, All aspects of the laboratory operation need to be
addressed to assure quality.
The definition is according to International Organization for
Standardization (ISO) and by the Clinical and Laboratory Standards
Institute (CLSI). All together are quality governing organizations
internationally
ISO 15189 Special for medical laboratories
Standards Organizations
ISO CLSI
International Organization for Clinical and Laboratory
Standardization Standards Institute
(formerly known as NCCLS)

Guidance for quality in Standards, guidelines, and best

manufacturing and service practices for quality in medical
industries laboratory testing
Broad applicability; used by Detailed; applies specifically to
many kinds of organizations medical laboratories
Uses consensus process in Uses consensus process in
developing standards developing standards
ISO standards group laboratory processes into three phrases namely
pre-examination, examination and post-examination
categories.
OR
Pre-analytic, Analytic, and Post-analytic
OR
Pre-test, test, and Post-test.
Path of workflow
• The entire set of operations that occur in testing is called the path of
workflow.
• The path of workflow begins with the patient and ends in reporting
and results interpretation, as shown in the figure below.
Path of workflow
Four Components of Quality Management System-1

1. Quality planning,
2. Quality control,
3. Quality assurance and
4. Quality improvement
Components of Quality Management System-2
1. Quality Planning- Develop quality policy, provide resources and
determines quality standards which are necessary to meet quality
2. Quality Assurance- Program used to provide assurance that quality
service is provided as planned, measure the effectiveness of agreed
plans and identify areas that need improvement
3. Quality Control- Part of Quality Assessment used for inspection,
testing, and quality measurement to verify that the services meet the
standards
4. Quality Improvement- Continuous adherence to quality
management
Factors to be addressed to assure quality in
the laboratory
• The laboratory environment
• Quality control procedures
• Communications
• Record keeping
• Competent and knowledgeable staff
• Good-quality reagents and equipment.
Elements of quality system
essentials
• Quality system essentials are a set of coordinated activities that serve
as building blocks for quality management.
• There are twelve(12) elements of quality system essentials.
• Each must be addressed if overall laboratory quality improvement is
to be achieved.
• This quality management system model was developed by CLSI, and
is fully compatible with ISO standards
Elements of quality system
essentials
1.Organization
• The term organization in the context of a quality management model is
used to indicate the management and the supporting organizational
structure of the laboratory.
• Organization is one of the essential elements of the quality system, and
is intimately related to all the other elements in the model.
• To have a functioning quality management system, the structure and
management of the laboratory must be organized so that quality policies
can be established and implemented.
• There must be a strong supporting organizational structure management
committed and there must be a mechanism for implementation and
monitoring
Key organizational component
• The important organizational requirements for achieving a successful
quality system include the following:
Leadership
• Laboratory leaders must be fully committed to implementation of the
system, and these leaders will also need vision, team-building and
motivational skills, good communication techniques, and the ability to
use resources responsibly.
Organizational structure
• The structure of the organization should be clearly defined, and this
should be reflected by a functional organizational chart with clear
assignment of responsibility.
An example of laboratory
organisational structure at a
regional hospital level
Laboratory organization
structure/Organogram for zonal hospitals
• Lab Director,
• Lab Manager,
• Safety/Quality Officer
• Head of sections,
• Deputy head of sections,
• Laboratory Staff
Implementation
• Implementation requires that a number of issues must be addressed
by the management staff.
• These include management of projects and activities, directing
resources to accomplish plans, and ensuring that timelines are met
and goals achieved.
Monitoring
• As components of the quality management system are put in place,
processes for monitoring will be needed to ensure that the system is
working, and that benchmarks and standards are being met.
• This element is essential to the primary goal of a quality system,
which is continuous Improvement.
Planning process
• Skills for planning are needed, and planning should address a time
frame, responsibility for conducting the activities, the availability and
use of human resources, management of workflow and financial
resources.
• As a part of the planning process, the laboratory will have established
a timeline for tasks to be performed, including a projected completion
date.
• This timeline is a critical part of the process, as it allows everyone in
the laboratory to observe progress.
• A Gantt chart (shown below) is a very useful tool for visually
representing the proposed timeline; it shows tasks to be done, with
times of beginning and completion.
Management roles of a leader
Important roles for a leader include:
i. Providing vision
ii. Giving a direction for goal-setting
iii. Motivating staff
iv. Providing encouragement
Laboratory directors role
I. Responsible for setting up an organization that can support the
quality system model.
II. Responsible for developing policies, assigning authority and
responsibility to the appropriate persons,
III. Ensuring resources and reviewing the organizational aspects of the
system for optimal functioning of quality processes.
IV. Laboratory directors must ensure that staff follow the quality
policies established by the quality manual.
Quality managers/officers
• The quality manager is the person most directly responsible for
ensuring that the quality policies and procedures are carried out.
Quality officers Responsibilities
Some responsibilities of the quality manager include:
1. Monitoring all aspects of the quality system;
2. Ensuring staff are following quality policies and procedures;
3. Regularly reviewing all records; for example, quality control and
external quality assessment that are part of the quality system;
4. Organizing internal audits and coordinating external audits;
5. Investigating any deficiencies identified in the audit process;
6. Informing management on all aspects of the quality system
monitoring.
Laboratory staff
Laboratory staff are responsible for understanding the organizational
structure of the laboratory, including where authority and responsibility
are assigned.
The laboratory staff will follow all of the quality policies in their daily
work routine
2. Personnel

• Personnel are the most important laboratory resource.

• Critical to the implementation of the quality management system are people who
possess integrity, recognize the importance of their work and participate in continuous
improvement.
• Well trained and committed personnel are needed for quality implementation (for
example: interpreting data, and calibrating instrument).
• Each new staff must be oriented in the work area
Orientation is the process of introducing a new staff member to the new work
environment and to their specific tasks or duties
-There should be regular checking of competency and performing competency assessment
to staff members
The Quality Management System

Organization Personnel Equipment

Purchasing Process Information

& Management Management
Inventory

Documents Non-
Assessment
& conforming
Records Event Mgmt

Continual Customer Facilities

Improvement Focus &
Safety

45
Personnel
Personnel…
• Under personnel elements we should consider:
• Recruitment and orientation
• Competency and competency assessment
• Training and continuing education
• Employee performance appraisal
• Personnel records
Laboratory Staff
• laboratory’s greatest asset
• critical to quality
• partners in public health
• qualified professionals
 Staff Equals Job
Workload Qualifications

Performance Job
Appraisal Descriptions
Personnel
Management
Continuing Orientation
Education

Competency
Assessment Training

Personnel-Module 49
49
 Personnel Qualifications
Qualifications
 required education
 required certificates
 required degrees
 required prior training
 required prior experiences
 required abilities
Laboratory director roles to lab personnel (1)
Hire an appropriate number of staff to cover workload.

Verify that items on the job application are correct.

Develop complete and thorough job descriptions for each employee.

Train each employee in their specific duties.

laboratory director roles to lab personnel (2)
Provide orientation and training for new employees.

Conduct and record competency assessments on all personnel.

Provide opportunities for continuing education; new techniques or

updates for existing methods

Conduct annual employee performance appraisals

Quality Officer roles to lab personnel
Provide employees with orientation and training.

Keep track of employee records and make sure they are confidential.

Include policies relevant to personnel in the quality manual.

Roles of the laboratory personnel
Participate in training and continuing education opportunities.

Request training that may be needed as job responsibilities increase.

Maintain records of personal professional development.

Job description
Is a written narrative document that describes the general tasks, or other
related duties and responsibilities of a position.
Job descriptions give a clear and accurate picture of responsibilities and
authorities for each staff position.
A Job description should:
Lay out all activities and tasks that should be performed;
Specify responsibilities for conducting testing and implementing the quality
system (policies and activities);
Reflect the employee’s background and training;
Be kept current and be available for all people working in the laboratory
Job Descriptions

“5.1.3- Laboratory Management

shall have job descriptions that
describe responsibilities,
authorities and task for all
personnel.”

ISO 15189:2012

Personnel-Module 56
Job Descriptions

Job Descriptions

 specify lines of authority

 specify responsibilities
 all roles
 all duties
 all responsibilities
 reporting structure
 Qualified New Employee

Job Description

Orientation Task-specific Training

Retraining

Competency Assessment

Competency Recognition

58
Orientation (1)
• Orientation is the process of introducing a new staff member to the
new work environment and to their specific tasks or duties
Orientation aspects (1)
• Orientation Aspects of laboratory personnel iclude
1. General orientation
• A tour of the workplace and introduction to all management and staff.
Information about key personnel and lines of authority the policies and
procedures regarding facilities and safety
2. Personnel policies
• Includes
 Ethics,
Confidentiality,
Employee benefits,
Work schedules.
3. An employee handbook that outlines the policies of the organization
and information about the laboratory quality system.

4. A copy of the employee’s job description and a detailed review of its

contents.

5. An overview of standard operating procedures (SOPs).

Orientation

63
Take a minute…..
• NEW EMPLOYEE ORIENTATION

Write 1 or 2 things you would want to know as a new

employee

64
Sample Orientation Checklist
NAME: START DATE:

POSITION: MANAGER:


Laboratory
Laboratorytour
tour


Introductions
Introductionstotomanagement
management


Laboratory
Laboratorytechnical
technicaloverview
overview


Personnel
Personnelkey
keypolicies
policies


Laboratory
LaboratoryQuality
QualityManagement
ManagementSystem
System


Job
Jobdescription
description

65
Competency and competency
assessment(1)
Competency
• Is the application of knowledge, skills and behavior's used in
performing specific job tasks.

Accurate laboratory test results depend on staff being competent in

performing a range of procedures that occur throughout the entire
examination process.
Competency assessment
• Is a system for measuring and documenting personnel competency.

The goal of competency assessment is to identify problems with

employee performance and to correct these issues before they affect
patient care.
Competency assessment methods (1)
1. Direct observation
• Techniques are watched during the examination process to see if
the employee is following the SOP.
• To avoid subjectivity during a competency assessment, the
observer uses a custom-designed checklist

2.Monitor records
• prepared by the employee (e.g. review worksheets and logs).
Competency assessment methods (2)
3. Review and analyze quality control records and results of
proficiency tests performed by the employee being evaluated.

4. Retest or recheck results to compare results among personnel;

discrepancies should be resolved.

5. Assess knowledge or problem-solving skills using case studies.

Employees are asked to respond orally or in writing to simulated
technical problems
Competency assessment methods (3)
All competency assessments must be recorded, showing date and
results, and should be kept in a place where they remain confidential.

These records are part of a laboratory’s quality documents, and should

be periodically reviewed and used for continuous improvement
Competency Assessment

“5.1.6 - The laboratory shall assess the

competence of each person to perform
assigned managerial or technical tasks
according to established criteria.
Reassessment shall take place at regular
intervals. Retraining shall occur when
necessary.
ISO 15189:2012
71
 Job Description

Task-specific Training
Retraining

Competency Assessment

Competency Recognition
72
72
Competency Assessment Methods

• Direct Observation Technologist Name Technologist Title

checklists
Procedure for Evaluation Date Evaluator
Evaluation

Procedure item Accept Partial No Comment

• Indirect Observations Read procedure

manual
• monitoring records Equipment set up

• re-testing appropriately
Work area neat

• case studies Reagent preparation

Perform task
accurately
Perform task timely

Other: Specify

73
Competency Assessment Documentation

• use standard forms

• date and keep
confidential

74
Competency Assessment Checklist (top)

Technologist Name Technologist Title

Procedure for Evaluation Evaluation Date Evaluator

Procedure item Accept Partial No Comment

Read procedure manual
Sign manual read log
Equipment available
Work area neat
Reagent preparation
Perform task accurately
Perform task timely

75
Competency Assessment Checklist (bottom)
Accept Partial No Comments
Assessment summary

Re-training required to address deficiencies:

Recommended activities:

Re-assessment to occur in _____ days

Comments:

Signed:

Assessed Technologist Date Evaluator

76
Training

• Is a process aimed to provide and develop knowledge, skills, and

behaviours to meet requirements.
Training addresses identified gaps in specific tasks to be performed by
the employee.
Competency should be reassessed after any job-specific training.
Retraining

Is a training process done when competency assessment reveals the

need for improving an employee’s knowledge and skills.
Cross-training

• Is a training that provides an opportunity for staff to acquire skills

outside their own discipline.

• This allows for flexibility in shifting or reassigning personnel

whenever needed; this may occur in crisis situations or with absences
of staff due to illness or vacation
Continuing education

• Is an educational programme that brings employees up-to-date in a

particular area of knowledge or skills.
• Since laboratory medicine is constantly changing, keeping current
takes effort on the part of both employee and management.
 Training

Continuing Education

81
81
Training

work related Examples:

reviewing
task specific operator manuals
reviewing manual
linked to updates
competency manufacturers’
assessment equipment training…

82
Training

“5.1.5 laboratory shall provide training

for all personnel which includes quality
management system, processes and
procedures, safety, ethics, information
system and confidentiality.”

ISO 15189:2012

Personnel-Module 83
Continuing Education

work related
may not be task specific
may not be linked to competency
assessment
Examples:
 conferences
 workshops
 journal clubs
 journals and literature…

84
Continuing Education

“5.1.8 personnel Shall take part in

continuing education and regular
professional development or other
professional liaison activities

ISO 15189:2012

Personnel-Module 85
Training/CE
Methods and Resources

86
86
Summary
• Well trained and committed personnel are needed for quality
implementation (for example: interpreting data, and calibrating
instrument)
Key Messages
• Lab staff are a key input into the testing process
• Laboratory managers must assure staff competency
prior to authorizing the staff to perform testing.
• Competency must be validated routinely
• Reviewing competency includes reviewing safety
practices in all aspects of testing.
• Competency must be documented in the personnel
file
Causes for Poor Performance:
Personal Systemic
• personal health • worksite distractions
• excessive workload
• personal distractions
• poor orientation
• misunderstandings
• insufficient training
• miscommunications • absent competency
assessment
• absent or invalid SOPs
• Ect…….
Personnel Records

Training Records Performance

Performance
Appraisal
Appraisal

Competency
Assessment
John Smith
Competency Assessmen

CONFIDENTIAL

90
Personnel Records
“5.1.9 - Records of the relevant
educational and professional qualifications,
training and experience, and assessments
of competence of all personnel shall be
maintained.
ISO 15189:2012

91
Cont…
• Personnel management is critical to success of a quality management
system.
• Job descriptions should accurately describe tasks and authorities.
• Training will help to assure competent staff.
• Competency must be assessed.
• Methods for attracting and retaining personnel must be addressed.
• Personnel are the most important resource in the laboratory.
• Managers must create an environment that will fully support all laboratory
personnel in order to maintain a high quality of laboratory performance.
Thank you for listening !
Any question?
Evaluation
1.Define the following terms
• Orientation, Training, Cross training, Retraining, continuing
education, competency, competency assessment,
2. Mention the competency assessment methods
3. Mention the orientation aspects
4. Describe Job description
The Quality Management System

Organization Personnel Equipment

Purchasing Process Information

& Management Management
Inventory

Documents Non-
Assessment
& conforming
Records Event Mgmt

Continual Customer Facilities

Improvement Focus &
Safety

96
Equipment
 acquisition
 installation
 validation
 maintenance
 calibration
 troubleshooting
 service and repair
 records
Introduction Laboratory Quality Management
97
System-Module 1
3. Equipment
Choosing the right equipment, installing it correctly, ensuring that
new equipment works properly, and having a system for maintenance
are all part of the equipment management programme in a quality
management system.

Proper management of the equipment in the laboratory is necessary to

ensure accurate, reliable and timely testing.
Importance of good equipment
management
The benefits of a good equipment management programme are: -
• Helps to maintain a high level of laboratory performance
• Reduces variation in test results, And improves the technologist’s
confidence in the accuracy of testing results
• Lowers repair costs, as fewer repairs will be needed for a well-maintained
instrument.
• Lengthens instrument life
• Reduces interruption of services due to breakdowns and failures
• Increases safety for workers
• Produces greater customer satisfaction.
Program considerations IN GOOD EQUIPMENT
MANAGEMENT

• A great deal of thought and planning should go into equipment

management.
• As the laboratory puts an equipment management programme in
place, the following elements should be considered:
• Selection and purchasing
• When obtaining new equipment, what criteria should be used to
select equipment?
• Should equipment be purchased or would it be better to lease?
• Installation
• For new equipment, what are the installation requirements and who
will install the new instrument?
• Calibration and performance evaluation
• What is needed to calibrate the equipment and validate that it is
operating correctly?
• How will these important procedures be conducted for both old and
new instruments?
• Maintenance
• What maintenance schedule is recommended by the manufacturer?
• Will the laboratory need additional preventive maintenance
procedures?
• Are current maintenance procedures being conducted properly?
• Troubleshooting
• Is there a clear procedure for troubleshooting for each instrument?
• Service and repair
• What is the cost?
• Can the laboratory obtain the necessary service and repair in its
geographical area?
• Retiring and disposing of equipment
• What must be done to dispose of old equipment?
• When it needs to be replaced?
Program Considerations
Installation

Retiring Calibration/
equipment/ performance
disposition evaluation

Selection
and
acquisitio
n

Service
and Maintenance
repair

Trouble-
shooting

Equipment-Module 3 104
Selecting and Acquiring Equipment

Equipment Facility
needs requirements

 performance characteristics
 cost
 reagents

Equipment-Module 3 105
Selecting and Acquiring
Equipment
 easy to use
 language

 warranty
 safety

will it fit?

Equipment-Module 3 106
Acquiring Equipment
• purchase, lease, rent, donations
• central acquisition
• bulk procurement
conditions of contract

Equipment-Module 3 107
Negotiating Equipment Acquisition

Request:
• wiring diagrams
• software information
• parts list
• operator manual
• installation by manufacturer
• trial period

Equipment-Module 3 108
Before Equipment
Installation
 confirm vendor’s responsibilities in writing

 establish checklist

Equipment-Module 3 109
Equipment Installation
• when possible, have manufacturer install
and set up
• do not attempt to
use prior to
proper installation

Equipment-Module 3 110
Equipment Installation

 verify package contents

 copy software,
if part of system

Equipment-Module 3 111
 After Equipment Installation

Maintenance Program

Train ALL Operators

Equipment-Module 3 112
Equipment Calibration
• perform initial calibration
• use calibrators or standards
• follow manufacturer’s
instructions
• determine frequency of routine
calibrations

Equipment-Module 3 113
Performance
Evaluation Test known samples,
analyze data

Establish stability
for temperature-
controlled
equipment

Validate
performance with
parallel samples

Equipment-Module 3 114
• Equipment documents and records are an essential part of the quality
system.
• The policies and procedures for maintenance should be defined in
appropriate documents, and keeping good equipment records will
allow for thorough evaluation of any problems that arise.
• Each major piece of equipment will have its own equipment
maintenance document.
• Smaller, commonly used equipment such as centrifuges and pipettes
may be managed with an equipment maintenance document or
manual that deals with all such equipment in the laboratory
• An equipment maintenance document should include:
• Step-by-step instructions for routine maintenance, including
frequency of performance and how to keep records of maintenance
• Instructions for carrying out function checks, frequency of
performance, and how to record the results
• Directions for calibrating the instrument
• Guide for troubleshooting.
• Any required manufacturer’s service and repair
• List of any specific items needed for use and maintenance, such as spare parts
• For major equipment, include identification of the specific instrument and perhaps
information on its performance.
• In recording problems, be sure to record:
• Date problem occurred and when equipment was removed from service
• Reason for breakdown or failure
• Corrective action taken, including a note about any service provided by the manufacturer
• Date returned to use
• Any changes to procedure for maintenance or function checks as a result of the problem.
• Some of the tools that are helpful for keeping records of
equipment management are:
• Charts
• Logs
• Checklists
• Graphs
• Service reports.
• The logbook should be available for review during the entire life of
the equipment.
The benefits of a good equipment
management programme
1.Helps to maintain a high level of laboratory performance;
2. Reduces variation in test results, and improves the technologist’s
confidence in the accuracy of testing results;
3. Lowers repair costs, as fewer repairs will be needed for a well-
maintained instrument;
4. lengthens instrument life;
5. Reduces interruption of services due to breakdowns and failures;
6. Increases safety for workers;
7. Produces greater customer satisfaction
Equipment Management Benefits

Test results
Variation/
Time

Performance
high level

Lowers
Lengthens
repair costs
lifespan
Equipment-Module 3 120
Equipment Management Benefits
Increases safety

Reduces
interruption
of services

Greater
customer
satisfaction

Equipment-Module 3 121
Performance evaluation
Prior to testing patient specimens, it is important to evaluate the
performance of new equipment to ensure it is working correctly with
respect to accuracy and precision.
In addition, test methods using kits or laboratory instruments need to
be evaluated for the ability to detect disease (sensitivity, specificity,
positive and negative predictive value) and to determine normal
and reportable ranges.
Function Checks
Monitor instrument parameters:
• periodically, daily, weekly, monthly
• after major instrument repair

Examples:
• incubator temperatures
• wavelength calibration
• autoclave temperature chart

Equipment-Module 3 123
Equipment Verification
• Verification can be done by
i. Testing samples with known values and comparing the results to the
expected or certified value;
ii. If equipment is temperature controlled, establishing the stability and
uniformity of the temperature.
Equipment Validation
Validation can be carried out by running samples in parallel using
both old and new equipment and methods for a period of time to
determine that the expected results can be obtained.

These validation procedures should be completely recorded.

Equipment inventory
The laboratory should keep an inventory log of all equipment in the
laboratory.

The log should be updated with information on new equipment and

include documentation of when old equipment is retired.
Items on Equipment inventory log
1. Instrument type, make, model number, and serial number for easy discussion
with the manufacturer;
2. Purchasing Date and whether it was purchased new, used or reconditioned;
3. Manufacturer/vendor contact information;
4. Presence or absence of documentation, spare parts and maintenance contract;
5.Warranty’s expiration date;
6. Specific inventory number indicating the year of acquisition
• For example, “YY-number” (04- 001, 04-002,) where “YY-number” equals the
last two numbers of the year followed by a number attributed in the year.
Create an Equipment Inventory Log
Record:
 instrument type, model number,
serial number
 location in laboratory
 date purchased
 manufacturer and
vendor contact information
 warranty, note expiration date
 spare parts

Equipment-Module 3 128
Spare Parts Inventory
Include:
• record of spare parts
• log to track stock
• cost and ordering information

Equipment-Module 3 129
Preventive Maintenance

• routine cleaning
• adjustment,
replacement of
equipment parts

Equipment-Module 3 130
 Implementing a Maintenance
Program
• assign responsibility
• develop written
policies and
procedures
• maintain records
• train staff

Equipment-Module 3 131
Develop a Maintenance Plan
For each piece of equipment establish routine
maintenance plan to include:
• frequency of all maintenance tasks
• function checks
• routine replacement of parts

Equipment-Module 3 132
Troubleshooting: What is the
source of the problem?
• Sample?
• Reagent?
• Water, Electricity?
• Equipment?

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 When in-house efforts fail:

• call manufacturer or
other technical expert

• look for options to continue service

 obtain back-up instrument from central
stores or manufacturer
 refer sample to nearby laboratory

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Do NOT use equipment that does not function
properly

WARNING
OUT OF ORDER

DO NOT
USE

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Retiring Equipment /
Disposal

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Retiring Equipment / Disposal

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Recording Problems
date problem occurred, equipment removed
from service

reason for breakdown or failure

corrective actions taken

date returned to use

change in maintenance or in function checks

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Example of logbook 1

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Summary
• An equipment management program will address:
• equipment selection
• preventive maintenance
• procedures for troubleshooting and repair

• Documents and records will include:

• inventory of all laboratory equipment
• Information provided by the manufacturer on operation,
maintenance, and troubleshooting
• records of all preventive maintenance and repair
activities

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Key Messages

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.

A major part of equipment maintenance

is PREVENTIVE maintenance

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Any Question?
Scenario
“The reader fails while performing ELISA / EIA
tests. There isn’t a documented procedure
for troubleshooting, the maintenance log has
not been updated for 2 years, and the
manufacturer’s instructions are missing.”

What should you do? Why?

What should you have done earlier ?
What you would do if this happened in
your laboratory?

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