Unit 4: Quality assurance and quality control

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41 The concept of quality

What is meant by ‘quality’? There are many definitions – two that are relevant
in the analytical laboratory are ‘complies with specification’ and ‘fit for
purpose’.
A laboratory may test a product or substance to see whether it ‘complies
with specification’. The laboratory analytical procedure itself must be ‘fit for
purpose’ – it must be appropriate to the needs of the customer and it must
give the correct result. In this topic you will learn about the general principles
for ensuring quality.
On successful completion of this topic you will:
•• understand features of quality control and quality assurance (LO2)
•• understand quality management systems (LO3).
To achieve a Pass in this unit you will need to show that you can:
•• explain internal quality control measures (2.1)
•• discuss the features of quality assurance (2.3)
•• review the features of a quality management system (3.1).

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 Unit 4: Quality assurance and quality control
1 Introduction to quality control (QC)
Key terms
Quality control (QC): A formal
definition of quality control (QC) is
that it is ‘part of quality management
(QM) focused on fulfilling quality
requirements’ (ISO 9000). In practice,
this means carrying out checks to
determine whether manufactured
products or laboratory tests are ‘fit
for purpose’ and whether staff are
working correctly.
Quality assurance (QA): A
formal definition is ‘part of quality
management (QM) focused on
providing confidence that quality
requirements will be fulfilled’ (ISO
9000). In practice, this means having
a system (including appropriately
trained personnel) that is designed to
assure that analysis or manufacture is
carried out to an agreed standard.
2 Introduction to quality assurance (QA)
4.1: The concept of quality
In the manufacturing sector, for example, in the manufacture of pharmaceuticals,
quality control (QC) typically involves sampling and testing of products to ensure
that they are not released for sale until they have been judged to be of satisfactory
quality, i.e. to be within specification. Intermediate products are also tested to
ensure they are not used in the next stage of a process until they have met the
correct specification.
In analytical laboratories, e.g. forensic, environmental, trading standards or
hospital laboratories, QC is concerned with ensuring that the analytical procedure
is working correctly. QC procedures generally require that a proportion of
standards are included among the samples to be tested and checking that the
tests for the standard samples give the expected answers. If a test does not give
the expected answer, then the test procedure has to be examined to identify the
source of the error.
The main weakness in relying on QC alone to ensure quality is that it can be
wasteful. If a manufacturing process is not working correctly then QC will ensure
that the product is rejected, but the cost in time and money of manufacturing it
will have been wasted.
Similarly, in analytical laboratories if an instrument is not working correctly or an
analyst is making mistakes, QC will detect this at some point, but some or even
many samples may have to be reanalysed. This will waste time (frustrating when
a quick turnaround of results is needed) and cost money. Having to reanalyse
samples because of mistakes in analysis is a particular concern in a hospital
laboratory when decisions on patients’ treatments depend on test results.
Activity 4.1.1
Consider QC in your own workplace and your daily work routine.
•• Does your lab undertake QC work, for example, analysing samples taken from a production
plant prior to sale or the next step in production?
•• Is your work subject to QC checks, for example, having your own results checked by your
supervisor?
•• Are there QC checks performed in your laboratory, for example, to check that instruments are
working correctly?
Quality assurance (QA) is concerned with all matters that influence the quality
of a product or service. QA requires that the whole process, whether the design,
manufacture and sale of a product, or the supply of a service such as a laboratory
analysis, is carefully controlled so that the customer gets the correct product with
the appropriate specification, or the required service to an appropriate standard.
A QA system also includes appropriate QC procedures. QA can be summed up in
the phrase ‘right first time, every time’.
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 Unit 4: Quality assurance and quality control
Key terms
Standard operating procedure
(SOP): A detailed written instruction
to achieve uniformity in the
performance of a specific function.
Quality management system
(QMS): A set of procedures and
responsibilities that an organisation
puts in place to make sure that the
staff have the facilities, equipment
and resources to carry out their work
effectively (ISO 9001:2008).
Hospital microbiologist
3 Introduction to quality management systems
(QMS)
4.1: The concept of quality
An important aim of QA is ensuring customer satisfaction by making sure that
customers’ requirements are understood and agreed. For example, a laboratory
that was sent a sample of soil to be tested for sulfur would agree with the
customer whether the customer wanted the total amount of sulfur to be
determined, or the amount of extractable sulfur, or both.
As part of the QA process for ensuring the quality of an analysis, staff must be
trained to do it correctly, there must be written standard operating procedures
(SOPs) that are adhered to, and the analytical method must be validated to show it
gives the correct result. Instruments must be calibrated (calibration is determining
the response of the instrument for specific concentrations of analyte) and used
correctly, reagents made up correctly, the correct grade and concentration of
purchased reagents used, and glassware and benches kept clean and free from
contaminants.
The QA process also needs to be regularly audited, for example, by assessors
from another part of the organisation reviewing how well it is being adhered to,
to ensure it is being implemented properly.
Activity 4.1.2
Consider QA in your own workplace.
•• Does your lab work to a specific QA standard?
•• How do you ensure your work is of a suitable standard?
•• Have you been trained to do your work correctly?
•• Are there written SOPs that you have to follow?
•• Do you have the necessary laboratory facilities and equipment, and does the equipment work
correctly?
•• Do you have the time to do your work with due care or are you rushed because of the level
of workload?
•• Does your workplace get audited by other members of your organisation?
Peter works in a hospital laboratory as a microbiologist, identifying different microbial species and
strains obtained from swabs taken from patients for diagnostic purposes, and also determining
whether the strains are resistant to antibiotics. He started his job after getting his A levels, and
is currently studying for a degree in Biomedical Science on a part-time basis. He is undertaking
a work-based training programme, which will be verified by an assessor from the Institute of
Biomedical Science (IBMS). This, together with successful completion of his degree, will complete
his portfolio of evidence required to gain a Certificate of Competence, which is required to join the
Health Professions Council (HPC) Register as a Biomedical Scientist.
The organisation of which the laboratory is a part needs to have a quality
management system (QMS) to implement and maintain its QA processes. A QMS
is the set of procedures and organisational responsibilities that an organisation
establishes to ensure effective QA.
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 Unit 4: Quality assurance and quality control
Activity 4.1.3
•• Do you know if your organisation
has a QMS?
•• Do you know who has overall
responsibility for QA in your
organisation?
•• How do they pass on the
importance of quality to more
junior employees?
Forensic scientist
4.1: The concept of quality
The International Organization for Standardization (ISO) lists eight requirements
for a QMS – these include customer focus, leadership, involvement of people, a
process approach, continual improvement and a factual approach to decision
making. Leadership is key, and the management system must include senior
managers (as well as senior laboratory staff ) who have specific responsibilities for
overseeing the QA processes.
The role of senior managers is important in ensuring that an ethos of quality runs
right through the organisation, while staff at all levels have responsibilities for
implementing QA processes. The organisation must not consider each activity in
isolation, but as interconnected parts of one whole process – this is the process
approach. An organisation committed to quality should also aim to improve
its service to its customers by identifying and promoting good practice while
eliminating errors and poor practices (continual improvement). All decisions taken
in the organisation should be based as far as possible on solid information and
data (the factual approach).
Jenny is a forensic scientist working in DNA analysis. After getting a degree in Biochemistry she
joined the Forensic Science Service (FSS) where she spent 2½ years working as an assistant in
different divisions, including toxicology, footmarks and fibres before specialising in DNA analysis.
Following the closure of the FSS she joined the DNA section of an independent forensic science
provider. She had to start again at assistant level and demonstrate her competence in all aspects
of DNA analysis (including extraction of DNA from evidence samples, analysis and interpretation)
before being allowed to work at the level she had already reached in the FSS. She is currently
training to be a reporting officer, learning how to compile a case file, draft court reports and
present evidence in court.
Checklist
At the end of this topic you should:
 understand the concepts of quality control (QC) and quality assurance (QA)
 know what is meant by a quality management system.
Further reading
Biomedical Science Practice: Experimental and professional skills, (H. Glencross, N. Ahmed and
Q. Wang, 2010), OUP
Quality Assurance in Analytical Chemistry (E. Pritchard and V. Barwick, 2007), Wiley
Acknowledgements
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Shutterstock.com: Olivier
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Every effort has been made to trace the copyright holders and we apologise in advance for any
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