Ch 371 l 1 QUALITY ASSUARENCE AND CONTROL

2017/12/18
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CH 371
Quality Control andAssurance
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What is the course about?
Principles of quality assurance, quality control and
quality assessment
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Quality Control and Assurance
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Course Outline
1. Principles of quality systems, elements of quality
manuals, quality control and quality assurance activities
that provide confidence for a product or a service.
2. Good laboratory practices (GLP) and Good
Manufacturing Practices (GMP)
3 Control tools in monitoring quality
4. Quality management of sampling, records, personnel,
equipment, supplies, methods of analyses, instrument
performance, method validation, proficiency testing, and
audits.
5. Accreditation and International Organisation for
Standardization (ISO) documents (ISO 17025 and 9001)
as quality assurance requirements.
Text books
1. Tickle F. and Vorley G., Quality Management: Introduction to
Quality, 3rd Ed.,QM and T Publication. 2002.
2. Montgomery and Douglas C., Introduction to Statistical quality
Control, John Wiley, 2001.
Reference:
1. Garfield F.M., Klesta E. and Hirsch J., Quality Assurance
Principles for Analytical Laboratories, 3rd ed., AOAC
International, Gaithersburg, MD USA, 2000
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Assessments
Coursework: 40 %
Two Tests
University Examination: 60 %
Lecture & Tutorial Sessions
Lecture days: Thursdays; 17:00 – 19:00 HRS, (A 214)
(Discuss)
Tutorial Days: Wednesday; 07:00 – 08:00 HRS, (SC 111)

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Introduction
Definition of Terminologies associated with QA/QC
Quality
The totality of characteristics of an entity that bear on
its ability to satisfy stated and implied needs.
Quality System
Organisational structure, procedures, processes, and
resources needed to implement quality management
Quality Management
All activities of the overall management function that
determine the quality policy, objectives and
responsibilities, and implement them by means such
as quality planning, quality control, quality assurance,
and quality improvement within the quality system. 12/18/2017 Quality Control and Assurance 8
Introduction
Quality Assurance
All the planned and systematic activities implemented
within the quality system and demonstrated as
needed, to provide adequate confidence that an entity
will fulfil requirements for quality.
Quality Control
The operational technique and activities that are used
to satisfy quality requirement.
The overall system of activities whose purpose is to
control the quality of a product or service so that it
meets the needs of users.
Introduction
Quality Audit
Systematic and independent examination to determine
whether quality activities and related results comply with
planned arrangements and whether these arrangements
are implemented effectively and are suitable to achieve
objectives.
A Quality System sets out the standards that you are
working to, and how you are going to meet them.
The system should define what people, actions and
documents are going to be employed in order to carry
out the work in a consistent manner, leaving evidence
of what has happened.
It includes manuals, handbooks, procedures, policies,
records and templates.
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Quality System
It aims to ensure reproducibility and reconstructability,
and compliance with whatever standards you have
set.
The fundamentals of a quality system are the same
regardless of what your work is.
The same principles can be applied whether you are an
academic research laboratory, a medical device
manufacturer or a hospital clinical unit.
Quality System Principles of Quality Systems
Quality Systems are founded on four principles:
Managing:
Organisations must manage their physical and human
resources to ensure that plans can be converted to
delivery.
Planning:
All research and development should be a planned
process, not a series of random occurrences.
Planning is a continuous process, not an event.
It controls the predictable and reacts to the
unpredictable to ensure that the process is under control
at all times and that there is clear understanding of
cause and effect.
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Delivering:
Management and Plans come together to provide the
environment in which effective research and development
is delivered.
Delivery must ensure that inputs and processes are
controlled to minimise or remove variability and that outputs
(results, reports, papers, etc) are robust and reliable.
Measuring:
Quality system requires to measure the actual output
against the planned aims.
Equally important is the setting of acceptable standards
for the performance of the work and ensuring that there
are mechanisms to demonstrate that these are met or
exceeded.12/18/2017
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Principles of Quality Systems Quality System
Elements of quality system
Appropriate management support.
Development, implementation and management of QA/QC
system.
Clear documentation of quality methods, procedures and test
results.
Quality awareness and training of personnel.
Acceptance and testing of new materials.
Appropriate maintenance and testing of equipment,
materials and processes.
Calibration, and verification of the calibration facilities.
Reliable testing of the system performance.
Periodic performance testing of the system
Quality Assurance
Quality Assurance - planned and systematic actions
necessary to provide adequate confidence that a
product or service will satisfy given requirements for
quality.
It refers to the full range of practices employed to
ensure that laboratory results are reliable.
Examples of QA:
Type testing, performance testing, and quality audits
required by a regulatory body.
Blind testing and quality audits of the product service
provider performed by the user of the service.
Quality assurance may further be defined as the
system of documenting and cross referencing the
management procedures of the organization or
laboratory.
Quality Assurance
Why Quality Assurance?
To have clear and concise records of all
procedures which may have a bearing on the
quality of data, so that those procedures may be
monitored with a view to ensuring that quality is
maintained.
Details on the Concept of Quality
What is Quality?
A high standard or level.
Degree of excellence.
Distinguishing feature.
Skill, accomplishment.
Satisfaction of a customer’s needs or requirements
Quality is “totality of characteristics of an entity that
bear on its ability to satisfy stated and implied needs”

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The History of Quality (Q)
Customer - Craft Q relation
Design and build each product for a particular customer.
Producer knows the customer directly.
Mass production and inspection Q relation
focus on designing and building products for mass consumption.
larger volumes will reduce costs and increases profits.
push products on the customer (limit choices).
quality is maintained by inspecting and detecting bad products.
Total Quality Management or “Customer Driven Quality”
potential customers determine what to design and build.
higher quality will be obtained by preventing problems.
Need for a New Strategy; Why?
Foreign markets have grown
Import barriers and produce protection are not the
answer.
Consumers are offered more choices
They have become more discriminating.
Consumers are more sophisticated
They demand newer and better products
Why Improvement in Quality?
1. Global Competition
Economic and political boundaries are slowly
vanishing.
Global trade has been accepted.
The 1990’s slogan “Built by Africans for Africans” is
very far from reality in the 2000’s.
“We need to export – satisfy wider markets”.
2. It pays
Less rework, fewer mistakes, fewer delays, and better
use of personnel, time and materials.
In United States today, 15 to 20% of the production
costs are incurred in finding and correcting mistakes
Why Improvement in Quality?
How do organizations compete?
Most common competitive measures:
Quality (both real and perceived)
Cost
Delivery (amounts, lead time and accuracy)
Awards given with sale
Other measures:
Safety,
Employee morale,
Product development (time-to-market, innovative
products)
Any others ?????
The Quality Hierarchy
Inspection
Quality Control
Quality Assurance
Total Quality
Management
Incorporates QA/QC activities
into company-wide system
aimed at satisfying the
customer.
Actions to insure products or
services conform to company
Requirements.
Operational techniques to make
inspection more efficient and to
reduce the costs of quality.
Inspect raw materials and
products
Prevention
Detection

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Before you can think of Quality
You need to know the standard for the product or
service.
What is the standard for the service or product or
package whose quality you want to improve?
E.g. Shirt, car, bicycle, mobile phone, trouser, book,
BSc degree, etc.
What is a standard?
NOUN
a level of quality or attainment.
Equivalent to: excellence, worth, merit, grade, level
e.g. "the standard of work is very good“
"this restaurant offers a high standard of service"
something used as a measure, norm, or model in
comparative evaluations.
e.g. “the wages are low by today's standards"
ADJECTIVE
used or accepted as normal or average.
Equivalent to: normal, typical, customary
e.g. "the standard rate of income tax is ......."
Standard
A ‘standard’ is a document that provides requirements,
specifications, guidelines or characteristics that can be
used consistently to ensure that materials, products,
processes and services are fit for their purpose.
A ‘standard’ is a published specification that
establishes a common language, and contains a
technical specification or other precise criteria and is
designed to be used consistently, as a rule, a guideline,
or a definition
Standards are applied to many materials, products,
methods and services. They help to make life simpler,
and increase the reliability and the effectiveness of
many goods and services we use.
Standards are designed for voluntary use and do not
impose any regulations.
However, regulations and laws may refer to certain
standards making compliance with them compulsory.
These are universally or widely accepted, agreed
upon, or established means of determining what
something should be.12/18/2017
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Standard
Categories of standards
In the global environment there are three different
official categories of standards:
International standard – a standard adopted by an
international organization for standardization e.g. ISO,
WHO, USEPA, (and accepted globally)
Regional standard - a standard adopted by a regional
standardization body or area such as European,
Asian, African, American standard – e.g. SANAS
(South African National Accreditation System),
National standard – a standard adopted by a national
standardization body and made available to the public
e.g. TZS, KES,
What is a quality standard?
A system for ensuring the maintenance of proper
standards in manufactured goods, especially by periodic
random inspection of the product.
Ensuring quality means, making sure that products are
made to a minimum standard or better.
The British Standards Institute (BSI, and (International
Equivalent) ISO) publishes standards for many kinds of
product and services that can be seen as a badge
of quality.
BS5750 is a British Standard for quality assurance and ISO
9000 is the international equivalent.

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Standards
The ISO 9000 series of international Quality
Management Standards was developed to help organizations
establish an effective quality management system capable of
inspiring confidence among consumers and business
partners that products/services are quality compliant.
Examples:
National Ambient Air Quality Standards (NAAQS)
TZS 789:2004 Drinking(potable) water-Specification
TZS 760:2002 (Part 2) Methods of testing cement: Chemical
analysis
TZS 102:2010 White bread – Specification. (Prescribes the
requirements and methods of sampling and test for white bread,
whole meal (brown) bread, enriched bread, fortified bread, fruit
bread and composite bread)
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Stages of Quality - Hierarchy
QUALITY MANAGEMENTQUALITY MANAGEMENTQUALITY MANAGEMENTQUALITY MANAGEMENT
QUALITY SYSTEMQUALITY SYSTEMQUALITY SYSTEMQUALITY SYSTEM
QUALITY ASSURANCEQUALITY ASSURANCEQUALITY ASSURANCEQUALITY ASSURANCE
QUALITY CONTROLQUALITY CONTROLQUALITY CONTROLQUALITY CONTROL
Components of quality assurance
1. Management:
One of the most important components of the quality
assurance programme in the organisation/laboratory
are the comprehensive management documents which
should describe, in detail, the management structure of
the organisation/laboratory. Such documentation
should provide clearly defined communication
channels and a clear reporting structure.
Within that structure each member of staff should be
able to locate his or her own job description and
responsibilities and their relationship with other staff
members who are subordinate or superior
2. Training:
It is important that all staff are adequately trained for
the task they have to perform.
Training must be documented in order that
management and other personnel can verify that staff
are competent to conduct the duties required.
The level of training required for each procedure
should also be clearly defined to ensure that staff
ability and training are matched to procedural
requirements.
3. Standard Operating Procedures:
Standard Operating Procedures (SOPs) provide the core
of most of the day to day running of any quality
assurance programme.
They are the documents describing in detail every
procedure conducted by the laboratory including:
Sampling, transportation, analysis, use of equipment, quality
control, calibration, production of reports, etc.
They are the laboratory’s internal reference manual for
the particular procedure to which they are dedicated and,
for that reason, SOPs must document every relevant step
in the procedure.
An SOP should be clear, concise and contain all the
relevant information to perform the procedure it describes
4. Laboratory facilities:
These are resources required for regular laboratory
work.
It is essential that these resources, i.e. space, staff,
equipment and supplies, are sufficient for the volume
of work to be done.
Equipment should be available to allow the procedures
performed in the laboratory to be conducted efficiently.
The environment in which the work is conducted must
be clean and tidy, have adequate space to work
without risk to personnel or to the analytical sample,
and there should be sufficient storage space for
glassware, chemicals, samples and consumables.
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5. Equipment maintenance and calibration:
All equipment must be maintained on a regular basis,
consistent with the documented criteria of the laboratory
and normally accepted codes of practice.
The care and cleaning of the equipment is extremely
important to ensure quality.
Frequent checks on the reliability of equipment including
calibration checks on all relevant equipment, such
as balances, pipettes, etc.
6. Sampling:
Procedures for sampling operations should be carefully
documented.
Clear details should be given for precautions to be taken
while sampling and the sampling strategies.
Careful documentation during sampling is required so that
all relevant information on the nature of the sample (when
it was taken, where it was taken and under what
conditions it was taken) are clearly recorded on site by the
person conducting the sampling.
This is necessary because variations in sampling
procedures can have a marked effect on the results of
analysis.
Quality assurance of sampling can be achieved in the
following ways:
Strictly adhere to standard operating procedures for
sampling.
Ensure all equipment is clean and in working order.
Record all conditions which applied during sampling.
Take strict precautions to avoid contamination.
By observing those simple procedures will ensure that
the quality of samples matches the quality of analysis.
7. Sample receipt, storage and disposal:
Proper storage of samples prior to analysis is as
important as proper sampling.
It is important to ensure that the passage of a sample
through the laboratory’s analytical systems is fully
documented, and corresponds to the practices laid down
in the relevant SOPs.
Arrangements for disposal of samples when exceed their
stable storage time.
With some forms of analysis which are required for legal
or for regulatory reasons there may be a requirement to
store a suitable aliquot of a sample safely, for a given
time, to allow for re-examination when necessary.
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Procedures for sample handling should ensure that the
sample is not compromised. The sample should be
logged in and stored in such a way as to minimise its
deterioration. The condition of each sample and its
storage location should be recorded.
8. Reporting of results:
The final products of the laboratory are the data that it
reports.
Therefore, the efforts of quality assurance are directed
towards seeing that these data are suitable for use in an
assessment.
This includes the final stage of reporting and interpreting
the results which have been generated.
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The first stage in this process is examination of the
data to determine whether the results are fit to report.
Data should be examined at many stages in the quality
assurance system and no data should be reported
from assays that are out of control.

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Implementation of quality assurance
The ultimate objective of a QA programme is to ensure that
the laboratory functions efficiently and effectively.
One logical way to tackle the task is first to write the Quality
Manual, then to put in place documentation such as SOPs
and laboratory records, then to test run the system for a
limited period (i.e. three to six months) and finally, to conduct
a detailed review which identifies successes and failures
within the system.
This is best done by inspection of key areas such as laboratory
records and by conducting audits.
An efficient auditing system is to pick data at random and then
trace the documentation pertaining to those data back to
sampling and sample receipt.
Implementation of quality assurance
A common method of implementing a QA programme
is to apply for accreditation.
Accreditation is the implementation of a QA
programme in conformity with a recognised QA
system.
Alternatively, QA can be implemented by reference to
international standards such as ISO 9000 without
necessarily going to the expense of accreditation.
Checking compliance
In order to maintain the quality assurance system it is
necessary to check periodically each area of the
laboratory for compliance with the QA system.
This involves auditing of the component parts to assess
whether they continue to meet the original criteria.
Reports on all audits should be made available to
management, and to the individuals responsible for the
work concerned.
Deviations from required standards must be corrected
immediately.

Ch 371 l 1 QUALITY ASSUARENCE AND CONTROL

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