Laboratory Quality Assurance and Management

LABORATORY QUALITY ASSURANCE AND MANAGEMENT
BY
Jackson I. OSUH, PhD, FISLT
Highlights
 Introduction
 What is Quality and Laboratory Quality
Management System (LQMS).
 Implementing LQMS.
 LQMS Basics/Definitions.
 Essential Requirements for Quality Systems.
 Case Study
 Critical Examination of the Components of LQMS.
 Current Trends in LQMS
 Conclusion
 References.
NISLT WORKSHOP, 10TH April, 2013

2
Learning Objectives
 At the end of this presentation, you should be able
to understand:
 The meaning of LQMS
 The components of LQMS
 The contribution of all the components to generating reliable

results
 The principles of Continuous Quality Improvement
 The Current trends in Laboratory Quality Management Systems.
NISLT WORKSHOP, 10TH April, 2013 3

Achieving a good quality data in any laboratory
analysis requires a careful planning and
documentation.

Introduction
 The focus of any laboratory analysis is to
produce accurate, reliable and effective
results and data which are fit for the purpose.
 Resources in every economy are limited and

any money invested into the laboratory
should be utilised to generate reliable and
accurate results. (1)

5
 Evidence-based science and
technology relies solely on the
generation of quality laboratory data
which are useful for:
 planning and budgeting.

 regulatory purposes
 formulation of policies at various levels of
government.

6
Definition of Quality
 A quality is a set of characteristics that a product

or service must have to satisfy needs and
expectations of the customer/client.
ISO 9000

7
What is Laboratory Quality Management
System?
 This implies the total (complete, unreserved)
implementation of the overall quality system
such as
 Quality Policy,
 structures,
 Procedures & processes,
 quality control,
 quality assurance
 quality improvement
which will enable an organization achieve her

quality goals
8
Facts about Quality
 It is a daily, on-going challenge contributing
to technological and scientific development
 Generating quality data from the laboratory is

premised on the proper understanding of the
basic concepts of quality management
systems.
 Errors emanating from laboratory are often

caused by systems and not humans.

9
Advocates of quality systems.
 Rapid strides have been made recently in
creating awareness about quality as well as in
articulating various components of a quality
system.
 The lead in this field has been taken by the

International Organization for
Standardization (ISO).
 ISO 9000 ( general requirement for lab accreditations)
 ISO 15189 (Medical Laboratory)

10
 LaboratoryQuality Management Systems
therefore means :
 the application of the principles of QMS in the laboratory setting.
 LQMS when applied in the day to day operational activities of the

laboratory results in producing reliable and satisfactory services
with client satisfaction
 For any organization to achieve her desired quality goals, quality

management system should be kept in place .

11
 Successful implementation of the principles
embedded in quality systems implies that all
stakeholders concerned should work in synergy to
achieve the set goals.
 In laboratory analysis, the product is achieving test

results that are correct within the stated limits.

12
Implications of Implementing QMS
 Generate accurate, precise, reproducible and
timely laboratory data
 Improve customer satisfaction
 Improve compliance with regulatory

requirements
 Help employee and management public

relation

13
 Reduce the generation of fallacious results
 Improve training and retraining of employees.
 Improve the comparability of laboratory data

between laboratories
 Establish the credibility of laboratory with

users of the laboratory

14
Total Quality Management Basics
Organization
Processes, procedures
Resources
Organogram Responsibilities
Equipment
Budget
Systems Staff,
Environment SOPs
validation
instruments.
Quality
TOTAL QUALITY Manual
MANAGEMENT SYSTEMS
Lab activities ,
Pre, analytical
& Post activities
EQA
Expressed in writing
by top Management.
Mission & vision.
Value Statement
15
Definition of terms associated with QMS
 Quality Policy:
 A written commitment by the top management put in place
as regards actualizing the quality objectives.
 Structures:
 in the laboratory contest it means putting up organizational
structures, responsibilities, procedures, processes and
resources necessary to achieve the quality objectives.
 Quality Control:
 this is related to operational techniques and activities which
occur mainly in the laboratory and are used to monitor
analytical performance in relation to accuracy and precision.

16
 Quality Assessment:
 All the planned and systematic activities comprising the
entire system, pre, analytical, post analytical and
external quality assessment.
 Procedure:
 A specified way of carrying out an activity in the laboratory.
 When it is documented, it is referred to as the Standard.
Operating Procedure (SOP).
 A documented procedure usually contains: what shall be
done and by whom, when, where and how it shall be
performed; what materials, equipment and how it shall be
controlled and recorded.

17
 Processes:
 This entails following a documented procedure to
achieve the required results.
 Quality Improvement:
 This implies the outcome of QC and QA. When
deviations occur, the cause is investigated and
corrective measures effected to improve results

18
Case Study
 A postgraduate student working on the effect of hypertension

on vitamin A submitted his samples for analysis in laboratory
Q. The samples were adequately received and kept in the
fridge as required. Two days later, the laboratory workers
helping him to analyse the samples estimated the level of
vitamin A on some of the samples. On the fifth day, the
student visited the laboratory and collected the results of the
samples which have been analysed. On checking the results,
he noticed some discrepancies and requested that the
laboratory workers recheck the values of the sample showing
discordant results . The next day, one of the laboratory
workers went to the fridge to retrieve the samples, but to his
surprise, the samples were nowhere to be found.
Analysis
 Questions:
 Who is in charge of sample arrangement/movement?
 How long are samples kept in that laboratory?
 Is the movement of the sample documented?
 No record of sample log in that laboratory.
 Poor Implementation of LQMS.

20
Essential requirements for quality system
Quality Policy
 It is the responsibility of the Management to formulate
the quality policy of any laboratory.
 This is a written document highlighting the quality

objectives of an organization.
 Implementing quality system in the laboratory is the

responsibility of all laboratory staff.

21
 After the quality policy is formulated and announced, it
is the responsibility of all laboratory staff to ensure that
they adhere to the policy statement.
 A policy statement without a willing staff results in

ineffective statement. The involvement of relevant
personnel is one of the key successes in the
implementation quality systems
22
 Structures:
 Most organizations fail because the required
structures to make them succeed are not put in
place.
 Structures refer to the operational guidelines of

any organization
 should describe, in detail, the management

structure of the laboratory.
 A chaotic, unstructured and unplanned

laboratory has no need discussing quality.
23
 Structures should define:
 Communication channels
 Reporting structure among the laboratory personnel
 Responsibilities and job description of each members of
staff
 Structures should also identify the records that

should be kept for routine operations such as :
 equipment calibration and maintenance (equipment log),
 sample handling, reporting of results, handling of
inconsistent results,
 resolution of conflicts,
 disposing of treated samples,
 training and retraining of staff, thus ensuring that a
logical and coherent system of record keeping is adopted.

24
 All these should constitute a single Quality
Manual which will act as a reference text for
the whole laboratory.
 A well documented quality manual is a key to

actualizing quality management objectives of
any laboratory.

25
Quality Control: Errors in laboratory
 Random (common with all measurements-
unavoidable)
 Systematic (e.g. wrong entry of data, calibration error

-avoidable)
 Gross ( absolute falsification- avoidable)

26
 Quality Control
 Operational techniques and activities (mainly within the
laboratory) that are used to fulfil requirements for
quality.
 The terms internal quality control” (IQC) and “external

quality assessment” (EQA) are commonly used.
 Quality control monitors analytical performance in

relation to accuracy (closeness of measured values to
the target value) and precision (closeness of repeated
measured values to one another).

27
 Quality Control
 The use of quality control in the laboratory

ensures that errors are monitored, checked and
prevented.
 It is therefore an integral part of sound quality

management system.
28
Quality Assurance
 Analytical Process:
 Pre-analytical phase (Out side the lab). This usually includes-

selection of test, sampling and transportation to the lab. It contributes
of about 20% of the entire phase)
 The pre-analytical phase (inside the lab). This usually includes

sample registration, centrifugation, distribution and preparation. It
contributes about 37% of the entire phase
 Analytical Phase- Comprise activities within the analytical process.

(15% of TAT)
 Post analytical Phase (20% of TAT)

29
Quality Assurance
 Quality assurance encompasses all the
planned activities within the pre analytical,
analytical and post analytical processes which
if implemented within the quality system and
demonstrated as needed, will result in
generating quality data.
 EQA measures the reproducibility of lab data.
 Every lab should join an EQA programme.

30
Factors Affecting QA
Management factors
 Creating professional disharmony and salary

dichotomy
 Poor motivated and ill-encouraged staff
 Poor remuneration of staff
 Employment process based on bias leading to

recruiting poorly trained professionals
31
Personnel factors
 Poorly trained professional

 Lack of re-training of the entire workforce
 Wrong selection of staff
 Poor commitment and dedication to duty
 Lack of adequate knowledge about laboratory
operations.
 Carelessness
 Poor concentration
 Distractions
 GSM

32
 Environment:
 Poor illumination of laboratory
 Crowded environment
 High Humidity
 High Lab temperature

33
 Glassware
 Poorly cleaned glassware
 Use of wrong solution for washing
 The quality of water used for washing

34
 Instrument:
 Calibration errors
 Wrong purchase of instruments with wrong

specifications
 Faulty equipment
 Poorly calibrated balances, spectrophotometer

and automatic pipettes
35
 Reagents
 Poorly prepared reagents
 Poorly Stored reagents, controls and chemical
 Poorly revalidated reagents and instruments

prior to use
36
Quality Improvement
 Achieving quality laboratory data is not a- one- for- all
practice.
 It requires putting systems in place which will ensure a

continuous quality improvement.
 Continuous quality improvement does not only focus on

creating a corporate quality culture, but more on the
process of quality improvement.
 Continuous Quality Improvement (CQI) allows individuals

involved in the day-to-day operations to change and
improve processes and work flows as they deem fit.

37
 CQI implementation attempts to develop a
quality system that is never satisfied
 it strives for constant innovation to improve

work processes and systems by reducing TAT
and low value-added activities.
 The time and resource saved can now be

devoted to planning and coordination

38
Quality improvement is driven by the following
acronym
Find
Select
to Organize
Improve
CQI:
FOCUS
Understand
Variations Clarify

39
After Selecting then:
PLAN
CQI:
ACT DO
PDCA
CHECK
40
The Six Sigma Principle
 Current component of LQMS
 Six sigma was developed at Motorola in the 1980s as

a method to measure and improve high-volume
production processes
 Its overall goal was to measure and eliminate waste

by attempting to achieve near perfect or perfect
results
 The term six sigma refers to a statistical measure

with not more than 3.4 defects per million
productions. (2)
41
The Six Sigma Approach

 It utilises the following approach;
 statistical process control (SPC)
 total quality management (TQM),
 design of experiments (DOE).
 It can also be coordinated with other major initiatives and

systems, such as new product development and materials
requirement planning (MRP).

43
 Uses the following approach:
 Break down business process flow into
individual steps.
 Define what defects there are.
 Measure the number of defects.
 Probe for the root cause.
 Implement changes to improve.
 Remeasure.
 Take a long-term view of goals
44
Lean Simply Defined:
 Lean is a philosophy and a proven long-term
approach that aligns everything in the business
to deliver increasing customer value.
 It’s about orienting people and systems to

deliver a continuous stream of value to the
customer, and eliminate waste and deficiencies
in the process.
 Lean is an everyday practice at all levels to

perform consistently, as well as to consistently
improve performance

45
Lean :
 Eliminates waste
 looks to remove repetition of function
 Looks to standardize actions
 is an ongoing process
46
Achieves:
 Eliminate possibility of error
 Replace processes with more reliable ones
 Facilitate to make work easier to perform
 Detect errors when it occurs

47
Conclusion:
 In science , that which is not written is not done.
In achieving quality laboratory service and data
having client satisfaction, the adherence to LQMS
is inevitable.
 The key word in implementing the principles of

LQMS is therefore the full documentation of all the
laboratory activities.
 The cost of quality is devastating and therefore

laboratory professionals should make every effort
to generate reliable and quality laboratory data by
applying the recommended standards

48
References
 1. Onyeaghala Augustine (2009) Principles of

Total Quality Management for Biomedical an
Analytical Scientists, First Edition, Change
Publishers, Lagos, PP 52.
 2. American Society for Quality. www.asq.org,
NISLT WORKSHOP, 10TH April,

2013 49

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LABORATORY QUALITY ASSURANCE AND MANAGEMENT

NISLT WORKSHOP, 10TH April, 2013

 The meaning of LQMS

 The components of LQMS

 The contribution of all the components to generating reliable

 The principles of Continuous Quality Improvement

 The Current trends in Laboratory Quality Management Systems.

NISLT WORKSHOP, 10TH April, 2013 3

NISLT WORKSHOP, 10TH April, 2013 4

 Resources in every economy are limited and

NISLT WORKSHOP, 10TH April, 2013

 planning and budgeting.

NISLT WORKSHOP, 10TH April, 2013

 A quality is a set of characteristics that a product

NISLT WORKSHOP, 10TH April, 2013

which will enable an organization achieve her

 Generating quality data from the laboratory is

 Errors emanating from laboratory are often

NISLT WORKSHOP, 10TH April, 2013

 The lead in this field has been taken by the

NISLT WORKSHOP, 10TH April, 2013

 the application of the principles of QMS in the laboratory setting.

 LQMS when applied in the day to day operational activities of the

 For any organization to achieve her desired quality goals, quality

NISLT WORKSHOP, 10TH April, 2013

 In laboratory analysis, the product is achieving test

NISLT WORKSHOP, 10TH April, 2013

 Improve customer satisfaction

 Improve compliance with regulatory

 Help employee and management public

NISLT WORKSHOP, 10TH April, 2013

 Improve training and retraining of employees.

 Improve the comparability of laboratory data

 Establish the credibility of laboratory with

NISLT WORKSHOP, 10TH April, 2013

NISLT WORKSHOP, 10TH April, 2013

NISLT WORKSHOP, 10TH April, 2013

NISLT WORKSHOP, 10TH April, 2013

 A postgraduate student working on the effect of hypertension

 No record of sample log in that laboratory.

 Poor Implementation of LQMS.

NISLT WORKSHOP, 10TH April, 2013

 This is a written document highlighting the quality

 Implementing quality system in the laboratory is the

NISLT WORKSHOP, 10TH April, 2013

 A policy statement without a willing staff results in

NISLT WORKSHOP, 10TH April, 2013

 Structures refer to the operational guidelines of

 should describe, in detail, the management

 A chaotic, unstructured and unplanned

 Structures should also identify the records that

NISLT WORKSHOP, 10TH April, 2013

 A well documented quality manual is a key to

NISLT WORKSHOP, 10TH April, 2013

 Systematic (e.g. wrong entry of data, calibration error

 Gross ( absolute falsification- avoidable)

NISLT WORKSHOP, 10TH April, 2013

 The terms internal quality control” (IQC) and “external

 Quality control monitors analytical performance in

NISLT WORKSHOP, 10TH April, 2013

 The use of quality control in the laboratory

 It is therefore an integral part of sound quality

NISLT WORKSHOP, 10TH April, 2013

 Pre-analytical phase (Out side the lab). This usually includes-