QUALITY CONTROL IN MICROBIOLOGY

CHUKELU, CHISOM FAITH; MMADUEKWE, JANEFRANCES

CHIAMAKA; UDOYE IFUNANYA; EZEMBA, CHINYERE CONSTANCE.
ABSTRACT
Quality control (QC) is a process intended to review the quality of all factors involved
in production. It ensures manufactured products and means of service/production
strictly follows a defined set of quality criteria and meets the requirements of the
consumers. Quality control in microbiology is the process of recording what happens
throughout a process in a microbiology lab and pinpoint issues that affect those
processes. Each laboratory must have qualified supervisory and technical personnel,
standard operating procedures, be well lit, dust free and have an air conditioned
environment. All materials, equipment and procedures must be adequately controlled.
Quality of the media directly affects the observation and inferences drawn from the
cultural characteristics of microbiology, checking of different parameters of media such
as growth supporting characteristics, gel strength and batch contamination can help to
assess their quality. The meticulous performance of quality control of culture can assure
precision in reporting. Quality control is applied in almost all aspects of life and
activities such as Pharmaceutical, Agriculture, Medical, Food microbiology and other
areas involved in production and related to man. Hospital, industry and research are
fields in which microbiologists are active and are responsible for assuring quality of
products through all day to day operations. Microbiologists evaluate biomanufacturing
plants by assessing raw materials, other supplies and the finished/ packaged products.
Compliance to common Good Manufacturing Practices (GMP) is followed. Quality
control in a microbiology lab may be observed by outside regulatory bodies. The recall
of drugs, products or equipments are time consuming are some of the limitations
affecting quality control. Procedures to maintain quality control in microbiology are
setting quality standards, making improvements which reduce the risk to the consumer
and inadvertently to the manufacturer.

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 TABLE OF CONTENTS

Title page i

Dedication ii

Acknowledgements iii

Abstract v

Tables of contents vi

List of figures

List of tables

1.0 Introduction 1

2.0 Quality control in microbiology 3

2.1.1 Quality control in Pharmaceutical microbiology 7

2.1.2 Quality control in Industrial microbiology 7

2.1.3 Quality control in Medical microbiology 11

2.1.4 Quality control in Agricultural microbiology 16

2.1.5 Quality control in food microbiology 19

2.2 Benefits of quality control in microbiology to human activities 22

and environment

3.0 Limitations of quality control in microbiology 23

3.1 Organisations involved in adhering and fulfilling of rules and 23

regulations of quality control in microbiology

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4.0 Roles of the microbiologist in quality control 25

4.1 Ways to maintain quality control in microbiology 26

5.0 Conclusion 28

References 29

3
 LIST OF FIGURES

Figures Title Page

1 Quality management Techniques 6

2 Flowchart of a pharmaceutical quality control 10

3 Analysis on farm products 18

4
 LIST OF TABLES

Tables Title Page

1 Performance Tests On Commonly Used Media 15

2 Some do's and don'ts of personal hygiene for food handlers 21

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1.0 INTRODUCTION

Quality mean meeting the pre-determined requirements of users for a Particular substance or
service. Juran, J. M. (1970) who is considered the father of quality research has defined quality as
“the performance of the product as per the commitment made by the producer to the consumer.

Quality" originated from the Latin language meaning as much as "property or characteristics.".
According to the international Standards Organisation [ISO]" quality" is the entity of attributes
and characteristics of a product or service which are necessary to fulfill it's defined or assumed
requirement. As already indicated quality can be seen to be more or less comprehensive, for
which reason many organisations defines or describe their commitment to quality in a so-called
quality policy statement. A quality policy (ISO,2015) typically is based on three fundamental
principles.

 Ensuring that the costumers needs are identified and that these are confirmed.
 Examination of all production and services in order to identify the potential for errors and
to take necessary actions to eliminate them.
 Ensuring each employee understand how to do his/her job and is doing it right.

Control is the act to regulate, restrain, correct, or restore to normal or an influence or authority
over things. Control of an undertaking consists of seeing that everything is being carried out in
accordance with the plan which has been adopted, the orders which have been given, and the
principles which have been laid down, (Henri, 1916).

Quality control is an act of control, such as inspection or testing, introduced into an industrial or
business process to ensure quality and to meet requirements. Quality control can also be defined
as "part of quality management focused on fulfilling quality requirements". It is more the
inspection aspect of quality management. An alternate definition is " the operational techniques
and activities used to fulfill requirement for quality.

Quality management is the totality of functions involved in the determination and achievement
of quality (includes quality assurance and quality control), (ASQ, 1983). Quality management
system (QMS) is a set of policies, processes and procedures required for planning and execution

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(production/development/service) in the core business area of an organization (i.e., areas that can
impact the organization’s ability to meet customer requirements). ISO 9001 is an example of a
Quality Management System.

Quality control in microbiology is the control of laboratory analytic error by monitoring

analytical performance with control sera and maintaining error within established limits around
the mean control values in microbiology. Important impact of quality control is that it ensures
both precision and accuracy in microbiology.

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2.0 Quality Control in Microbiology

Following the Industrial Revolution and the rise of mass production, it became important to
better define and control the quality of products. Originally, the goal of quality was to ensure that
engineering requirements were met in final products. Later, as manufacturing processes became
more complex, quality developed into a discipline for controlling process variation as a means of
producing quality products.

Quality management went along a constant evolution from the sixties to reach the current state of
practice (Bartlett, et al., 1994). It is now generally accepted (Arora, 2004) and legally prescribed
in Switzerland and in the USA (Laboratory requirement, 2012) that a minimal quality assurance
(QA) program is composed of quality control (QC), external quality assessment (EQA), standard
operating procedure (SOP) and competency assessment (CA) of coworkers. These procedures,
despite being needed and regulated by certification processes such as ISO 15189 (ISO, 2012).

Hospitals, industry, and research are fields in which microbiologists are active. In order to get the
most accurate results possible, he or she needs to follow rules. These rules ensure that materials
are fit for the purpose, that analysts are trained correctly, and that procedures are followed
properly. In this way, mistakes can be reduced, and the source of a problem can be identified.A
quality coordinator in a microbiology research facility needs to be meticulous about record
keeping. Microbiologists identify microorganisms, such as bacteria and fungi, for a living. The
importance of this depends on the field they work in, Food safety is one such example.
Manufacturers of food products may need a microbiology lab to check if any dangerous
microbes are present in the food. As an absolute minimum, procedures for the identification
and/or enumeration of the following organisms or groups of organisms should be taught in all
food microbiology laboratories: total aerobic microflora (standard plate count, aerobic total
coliforms, fecal coliforms, Escherichia coli. Salmonella, and Staphylococus aureus. Depending
on the commodities examined by the laboratory, additional training may be needed for the
following: Campylobacter (poultry, pork, and raw milk), Yersinia enterocolitica (refrigerated
meats, raw vegetables, seafood, and dairy products), Listeria monocytogenes (meats, dairy
products, and vegetables), Vibrio cholerae and Vibrio parahaemolvticus (seafoods), Shigella
(raw vegetables), yeasts and moulds (nuts, spices, grains, and canned foods), Bacillus cereus
(rice, wheat, and other grains), and Clostridium perfringens (meats). If the laboratory is

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responsible for the analysis of canned foods, the analyst should be trained in techniques for the
identification of spoilage organisms in canned foods.

Pharmaceutical companies make drugs to be used on humans or animals. If the product is

contaminated with microbes, this can adversely affect the patient. Contamination is especially
dangerous if the product is an injectable medication, where microbes can be introduced directly
into the body. Quality control related to microbes is extremely important for drug makers.
Hospital microbiologists test samples from ill patients. If they can find a microbe that is causing
a disease, then doctors can treat the patient effectively. Research microbiologists analyze
microbes for scientific purposes, and their findings may be important for public health or for
future research.

Correctly identifying a microbe that is present in a certain area is the aim of any microbiologist.
Once the microbe is identified, a microbiologist may also have to track down the source of
contamination and remove the problem. He or she may also have to advise on the correct method
to resolve the issue and prevent it happening in the future. Quality control in microbiology uses
documentation to record what happens throughout a process. Central to these responsibilities is
the accurate identification of the microbe involved. Microbiology tests are easily contaminated
with other, irrelevant microbes, which make the entire test inaccurate and all future actions
useless. QC focuses on the intrinsic performances of laboratory tests, reviewing their
performance (specificity and sensitivity), the regular maintenance of all used materials, the
constant quality of reactants and media, as well as the use of negative and positives controls
(Arora, 2004). Lab analysts need to know the right way to perform tasks. To learn these, they can
follow training procedures, which lay out in writing the best way to perform tasks. Each
procedure is the same for every analyst. Part of quality control in microbiology is to keep the
records of training to show that an analyst knew how to perform the task properly.

Then, an analyst needs to follow the rules for each particular test he or she does on samples.
These rules prevent the test from being contaminated and ensure that, if relevant microbes are
present in the sample, the test will identify them. A typical test procedure, which is called a
standard operating procedure (SOP) in some fields, spells out the way to handle the sample, how
to work the equipment, and at what temperatures and times a sample is incubated. All steps of
the test also need to be recorded in detail by the analyst. Equipment in the laboratory also needs

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to do its job properly. Analysts and engineers record in writing if the equipment is functioning
and remove it from use if it is not. Pipettes and other equipment must be calibrated regularly to
ensure they are working as expected. In an industry such as pharmaceuticals, the term quality
control also refer to an entire department. People working in the quality control (QC) department
check the products and raw materials for contamination. They also check the parts of the factory
involved in making the product for possible sources of contamination. If a microbiologist finds
contamination in a sample, then he or she can look back through the quality documentation to
ensure that nothing went wrong or was done incorrectly in the testing process. If this
documentation is not present, an analyst cannot rule out mistakes as a cause of the contamination.
All of the rules also give analysts good procedures to follow so that they can do the work to a
high quality.

Quality control in a microbiology lab may be checked by outside regulatory bodies. The U.S.
Food and Drug Agency is one such organization that checks the documentation of many
companies such as those that produce pharmaceuticals. Each country generally has its own
regulatory bodies for laboratories operating in various fields. Quality control comprises of
internal and external sections. Internal quality control is limited only in the laboratory within.
With less restriction on trade throughout the world the comparability of data among testing
laboratories becomes all the more important. In the past the differences in quality programmes
operated in laboratories made this difficult. Laboratory accreditation to quality standards such as
EN 45000 series and ISO Guide 25 (Tille, 2014) has given creditability to data produced by
laboratories and has ensured wider acceptability of the data. Many European countries with
national accreditation bodies now have multilateral recognition agreements.

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Figure 1: Quality management Techniques.

Source: Chapman [2007]

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2.1. APPLICATIONS OF QUALITY CONTROL

2.1.1. Quality Control on Pharmaceutical Microbiology

Contamination of pharmaceutical products by objectionable microorganisms is a major risk

within the pharmaceutical industry as it may impact product integrity and patient safety. To
prevent contamination events from occurring, licensed pharmaceutical manufacturing companies
worldwide are required to adhere to strict regulations and robust quality control procedures
issued by their respective government agencies. In recent years, major number of drugs have
been recalled among the pharmaceutical industry. Even more alarming is the increase in drug
recalls due to microbial contamination, which are among the most dangerous as they can result in
serious illness or death in general.

A recent example is the January 2011 recall of Alcohol Prep Pads, Alcohol Swabs and Alcohol
Swabsticks, manufactured by the (Triad Group, 2011). This recall was initiated due to potential
contamination of Bacillus cereus. Another pharmaceutical product that was recently recalled due
to microbial contamination included two brands of antiseptic-antiplaque mouthwash that were
contaminated with Burkholderia cepacia. This recall took place in November 2010, and was
issued by the Health Sciences Authority in Singapore.

Undoubtedly, a company suffers enormous damage when a drug product is recalled. The direct
hit will include loss of product sales, decreased customer confidence, damage to the brand and
company name, and in many cases, legal proceedings. The costs associated with a major drug
recall are almost immeasurable.

Quality Control is an essential function of the Pharmaceutical industry. Drug manufacturers must
thoroughly test materials, processes, equipment, techniques, environments and personnel in order
to ensure their final products are consistent, safe, effective and predictable.

Pharmacopeias

In addition to their local government authorities, many pharmaceutical manufacturers look to a

Pharmacopeia for guidance on ensuring the quality, safety and benefit of the medicines they
produce. A Pharmacopeia is an organization that develops and publishes standards for
manufacturing prescription and over-the-counter medicines as well as other healthcare products.

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Three major Pharmacopeias throughout the world include: the United States Pharmacopeia
(USP), the European Pharmacopoeia (Ph. Eur.) and the Japanese Pharmacopoeia (JP). Each of
these organizations has their own set of standards, however the International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
(ICH) is working to facilitate international harmonization in the interpretation and application of
technical guidelines and requirements for the pharmaceutical industry.

The growth promotion test

The Growth Promotion Test is a very important Quality Control function in the Pharmaceutical
industry. It is imperative for establishing the nutritive properties of the microbiological culture
medium that will be used in a pharmacopeial procedure, such as a test for specified
microorganisms. Culture medium (or media) refers to a liquid or gel substance that is used to
support the growth of microorganism or cell. The Growth Promotion Test is necessary to ensure
that the culture medium is able to support the growth of small numbers of microorganisms, and
that selective medium will grow specified microorganisms. If the new batch of media is not able
to properly support growth, the pharmacopeial tests for which it is used will fail. “The overall
costs associated with a major drug recall are almost immeasurable.”

There are three key tests in the pharmacopeias that outline growth promotion testing. These
chapters have been harmonized in the United States Pharmacopeia (USP), the European
Pharmacopoeia (Ph. Eur.) and the Japanese Pharmacopoeia (JP).

a) Microbial enumeration tests

This test establishes the ability of the new lots of medium to support growth when the inoculum
contains a small number of microorganisms. This test is used for both solid and liquid media.

b) Tests for specified microorganisms

This test establishes the ability of the selective medium to meet three criteria:

 Growth promoting properties – the growth of selected microorganism is supported

 Indicative properties – the colonies have specific morphological characteristics

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 Inhibitory properties – organisms that should be inhibited on the medium should not
grow

C) Sterility tests

This test establishes the ability of new lots of medium to support growth when the inoculum
contains a small number of microorganisms. This test is used for liquid medium only.

Further, as reported in the 2003 progress report of the Pharmaceutical GMPs, the initiative
included a focus on the science of manufacturing in order to identify “...efficient approaches for
characterizing and controlling critical manufacturing process parameters and quality assurance.”
Implementation of new process monitoring and control methods will bring the industry closer to
this quality goal. Whereas the latest PAT technologies encompass “real time” and “at-, on- or in-
line” process assessments, most rapid microbiology tests are, at present, “off-line” laboratory
tests. However, FDA continues to support the development of new microbiology methods and
recognizes that appropriate new microbiology technologies will be part of up-to-date quality
systems. The microbiological aspects of product safety must be considered early in
manufacturing process design. Regulators and pharmaceutical industry scientists similarly view
the goals of drug product quality in microbiology in the following simplified terms:

 limit adventitious microbial contamination and prevent the presence of harmful

organisms (and their byproducts) in non-sterile products (e.g., component and process
control tests)
 minimize the chance of microbial contamination in products purporting to be sterile (e.g.,
component, process controls, and validation of the sterilization process)
 maximize product safety and quality by controlling the presence of microbes that gain
entry inadvertently (i.e., preservatives effectiveness)

Overall, to ensure product safety, pharmaceutical companies must be versed in the important
role of microbiological testing in product research and development, process validation,
manufacturing, and quality control.

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Figure 2: Flowchart of a Pharmaceutical Quality Control.

Source: Rashed (2015).

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2.1.2 Quality Control in Industrial Microbiology

During the last two decades the term “quality” has become one of the most stressed words in the
field of production. The facts behind this are, on the one hand, the traditionally different
meanings of the word “quality” and, on the other hand, the advanced importance of quality and
quality management systems as tools for an economical and safe production. In relation to food
it originally was used as a synonym for “freshness” and “unspoilt”.

Quality control is very necessary for the industrial sector, ranging from manufacturing,
production activities to the results of production. Quality control is a process of checking and
testing conducted by a business or a company. Measuring and ensuring that the quality of the
product meets the standard. This process can make an entity in quality assessment of various
factors involved in production activities. From antiquity up to now, many philosophers, scientists
and economists have tackled with the sense and the meaning of the term “quality”, leading to
numerous quality models, for example metaphysical, product management, economical,
ecological and cognitive approaches. To get an overview of the major quality models, see (Terry
and Teranishi, 1993).

Raw materials Microbiological quality is important in prevention and management of spoilage

yeast due to higher contamination increase the risk of technological control process failure.
Natural raw materials (Eg fruit and sugar cane) have an external microbial flora which is not
performing in foods after processing having been easily controlled through GMP. Quality control
is an important aspect in producing products or services, in order to ensure quality in accordance
with company standards so that it can meet consumer expectations.

2.1.3. Quality control in medical microbiology

The issue of quality control (QC) in the medical microbiology laboratory is complex. Quality
control is defined as all measures put in place to ensure the medical reliability of laboratory data.
Quality control is now recognized as being a part of a larger program referred to as ‘Quality
assurance’ (WHO,1991).

Quality control activities that take place must be recorded to prove their existence. The
responsibility for QC usually rest with one person, but in reality, everybody in the laboratory
must participate if a program is to be successful (WHO, 1991). QC programs for the medical

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microbiology laboratory should include procedures for control of media, temperature, reagents,
equipment, susceptibility testing, and all personnel.

a) Temperature

Temperature checks should be done daily on all temperature dependent equipments like water
bathes, incubators, refrigerators, heating blocks and freezers.

Thermometers in incubators and refrigerators are easier to read when they are permanently
immersed in glycerol (Mahon et al.,2015). Glycerol helps prevent temperature fluctuations that
occurs when the door is opened to read the thermometer. Each thermometer must be checked
against a reference thermometer from the National Institute of Standards and Technology (NIST)
before each use (Procop et al., 2017). A large batch of thermometers can be checked at the same
time and at the temperature range likely to be used.

b) Equipment Quality Control

Equipment used in the clinical microbiology laboratory are usually tested for proper performance
at intervals as appropriate. The frequency of testing can vary from daily to yearly depending on
the equipment in question. A concept termed preventive maintenance is put in place to as an
additional control measure. It involves things like replacing filters, oiling and cleaning and
instrument recalibration

c) Media Quality Control

Media prepared in the medical microbiology department must be quality controlled with
documentation on their performance and sterility (Procop et al., 2017). Records of these
documentation must be kept for at least 2 years. Criteria used are generated by the Clinical and
Laboratory Standards Institute (CLSI). Conditions such as moisture; to be sure that plates are
moisture free before use and also, ensure that there are no signs of drying around the edges of the
media. Culture plates should be free of any form of contaminants. Petri dishes should not be
cracked or broken. The appearance of media, blood-based plates for example, should not show
signs of hemolysis, and also, other plate should not deviate from the normal color and should this
happen, it should not be used .

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The current understanding of which clinical media to test was based on a survey performed in the
early 1980’s of 1,164 laboratories. From their reported experiences it was determined that most
media could be accepted safely on the manufacturer’s data (Krishner,1999). This result
confirmed an earlier study (Nagel and Kunz, 1973) that called into question the need for
excessive growth-promotion testing of commercially prepared media. See performance test on
commonly used media in table:1.

d) Reagent Quality Control

Reagents like oxidase, kovacs, all stains, catalase, X and V strips, Voges-Proskauer and optochin
should be checked regularly using negative and positive controls.

e) Antimicrobial Susceptibility Quality Control

Guidelines for the control of susceptibility testing is provided by CLSI, also provided, is a list of
control strains from the American Type Culture Collection (ATCC). The variables that need to
be quality controlled to ensure release of quality reports include instrument failure, antibiotic
potency, agar depth, pH evaporation, inoculum concentration, temperature, moisture, difficulty
in determining endpoints.

f) Personnel Competency

Proficiency testing is usually done to ascertain the level of competence of each personnel for
each test he or she is expected to perform. Review of work sheet, written examination and direct
observation are also ways to determine personnel competence. Tests done on patient samples
must pass through proficiency testing at least twice a year Mahon et al.,2015), Procop et al.,
(2017). Another form of quality control is the act of reviewing the work of a technologist by
another, usually a senior technologist. Encouraging this practice ensures that mistakes are easily
caught prior to release of a result.

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g) Stock Cultures

These can be obtained from various sources including commercial sources, patient isolates,
ATCC and proficiency testing isolates. Stock cultures are best grown in large volume and
divided into small quantities that can be stored for at least a year in order to achieve best results.
This reduces the risk of organisms mutating during repeated subculturing. Stock cultures can also
be stored using storage beads.

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TABLE 1: Performance Test on Commonly used Media

Medium Control organism Incubation Expected results

conditions and
duration
Chocolate Agar H. influenza CO2, 24hrs Growth
Blood Agar S. pyogene CO2, 24hrs Growth and β-

haemolysis
S.pneumonia CO2, 24hrs Growth and α-

haemolysis
Salmonella- E.coli 24hrs No growth
Shigella agar or
Deoxycholate

citrate agar
S. Typhimurium 24hrs Colourless colony
Selenite broth S. Typhimurium 24hrs Growth after
subculture
E. coli 24hrs No growth after
subculture
Bile-aesculin agar E. Faecalis 24hrs Growth and
blackening
S. pyogene 24hrs No growth

Source:Basic Laboratory Procedure in Clinical Bacteriology(1991)

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2.1.4 Quality control in Agricultural microbiology

The prevalence of microorganisms within a range of crops is a major public

health concern round the globe (Noor, 2015). Implementation of the concepts of food
safety, food quality and food security are significant in the field of agriculture.
Microbiological contaminations of agricultural crops may often occur due to several
events, including weather variations, possible climate change effects, over usage of lands,
crop management anomalies during harvest and post-harvest periods. Health concerns
have recently emerged regarding the safety of consuming fresh produces (especially with
the fresh, leafy salad vegetables), which are often found to trigger disease outbreaks due
to bacterial contamination. Microbial contamination of the agricultural products at the
pre-harvest stages is known to occur directly or indirectly via water, soil, fertilizers,
unhygienic handling, vectors (animals, birds and insects), etc.

Transmission of microorganisms into the crops may be mediated by the seed itself,
during crop growth in the field, during harvesting and post-harvest handling or during
storage and distribution, soil particles, air-borne spores and irrigation water.

Spoilage microorganisms may also be present on harvesting equipment, on handling

equipment in the packing house, in the storage facility and on food contact surfaces
throughout the distribution chain. Identification of the specific spoilage microorganisms
for different types of fresh crops, vegetables and fruit products by means of traditional,
low-cost microbiological and biochemical methods would be helpful for indexing the
types of spoilage microorganisms. There is a need for investigation of not only for the
existence of the pathogenic microorganisms in agricultural products but also for chalking
out the spoilage patterns and the estimation of possible means it can be eradicated and
controlled. In ways to prevent contamination of farm produce, farmers should always
wash, scrub, rise, sanitize container and discard damage ones. Spoilt produce should not
be harvested together with good ones to avoid further contamination. For agricultural
quality control to be effectively implemented, farmers should be educated on the need
and efficiency on why quality control on farm produce should be adopted.

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Implementation of good agricultural practices (GAPs) in the agricultural fields, with the
food handlers, in case of the associated equipments, and with the distributors would
address the common microbiological hazards. HACCP management system in which
food safety is addressed through the analysis and control of biological, chemical, and
physical hazards from raw material production, procurement and handling, to
manufacturing, distribution and consumption of the finished product should be adopted.

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Figure 3: Analysis on Farm Products

Source: Alex(2019)

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2.1.5. Quality control in Food microbiology

Microbiological quality is a major concern in the food industry because of the acute risk to health
posed by bacteria, mold, and yeast (Milani, 2002).Microbiological quality control programs are
needed throughout the food production chain to minimize safety risks for the consumers.
Classical microbiological methods in foods involve, in general, enrichment and isolation of
presumptive colonies of bacteria on solid media of the food analysis and final confirmation by
biochemical or serological identification (Lazaro, Hernandez,2014).

Thus, they are laborious, time-consuming, and not always reliable but it will help in identifying
and choosing a better means of eradication and control. The greatest challenge to food safety is
microorganisms that account for more than 200 diseases caused by bacteria, viruses, protozoa,
and fungi. Recent-time statistics have shown that nearly 420,000 people die every year due to
foodborne illnesses. The case is even severe in children, especially those who are below 5 years,
which alone counts for 40% of the total burden caused by foodborne diseases.

Foodborne illnesses are primarily classified as food infection and food intoxication. While in the
first case, live microorganism enters the body, multiplies and damages host tissue, the later can
cause damage by the production of toxin in food, despite being absent in the body.
Microbiological quality control programs are needed throughout the food production chain to
minimize safety risks for the consumers. Consumer can also minimize food contamination by
placing raw meat, poultry, and seafood in containers or sealed plastic bags to prevent their juices
from dripping onto other foods when buying and refrigerating. Raw juices often contain harmful
bacteria.

Store eggs in their original carton and refrigerate as soon as possible. Rinse fresh fruits and
vegetables in running tap water to remove visible dirt and grime. With all this measure, quality
of food can be controlled. Regulatory Aspect of Food: Several food regulatory systems enforce

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Quality control Plan for food safety. A few of them are:

1. Good Agricultural Practices (GAP).

2. Good Manufacturing Practices (GMP).
3. Good Hygienic Practices (GHP).
4. Good Laboratory Practices (GLP).
5. Hazard Analysis and Critical Control Point (HACCP).
6. International Standard Organization (ISO).

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Table 2: Some do's and don'ts of personal hygiene for food handlers

Do's Don't

Wash your hands regularly throughout Do not smoke, chew gum, tobacco, betel
the day especially nuts, fingernails or anything else.

After going to the toilet

On entering a food room and
before handling food or
equipment.
After handling raw food
After combing or touching the
hair.
After eating, smoking, coughing
or blowing the nose.
After handling waste food, refuse
or chemical.

Keep fingernails short and clean. Do not taste food.

Cover any cuts, spots or boils with a Do not spit or sneeze or cough over
waterproof dressing. food.

Keep hair clean and covered to prevent Do not pick nose, ear or any other body
hair/dandruff entering the food. site

Always wear clean protective clothing Do not wear jewellery when handling
(including footwear) in food processing food and protective clothing outside the
area. production area.

Source: Bermudez-Millan, (2001)

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2.2 Benefit of Quality Control in Microbiology to Human Activities and Environment.

 Production of quality products and reliable services.

 Motivation factor for the staff to work better.
 Creation of good reputation for the laboratory.
 Prevention of legal suits and associated complications.
 Protects your customers.
 Ensures testing procedures, equipment, instrumentation and materials are working
properly.
 Ensures personnel competence.
 Improves daily workflow and produces consistent and reliable results.

3.0 Limitations on Quality control in microbiology.

 It does not prevent waste of resources when products are faulty.

 The process of inspecting the goods or service costs money, e.g. the wages paid to the
inspectors, the cost of testing goods in the laboratory.
 It does not encourage all workers to be responsible for quality.
 Time consuming.
 Costs a lot of money to train staff.
 Time consuming to train staff.

3.1 Organisations Involved In Adhering And Fullfilling of the rules and regulation of
Quality control in microbiology

(a). The Federal Ministry of Health (FMOH)

 The Federal Ministry of Health is responsible for the formulation of national policies,
guidelines and regulations on food safety including monitoring and evaluation.

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  It is also responsible for the assessment of the nutritive value of food, environmental
sanitation, food environment and handlers, control of food borne disease, quality of
public water from taps, as well as national and international matters relating to food.

b) The National Agency For Food And Drug Administration and Control (NAFDAC)

 NAFDAC is responsible for the regulation and control of the importation, exportation,
manufacture, advertisement, distribution, sale and use of food, drug, cosmetics, medical
devices, chemicals, packaged water and detergent at Federal and State levels in Nigeria.
 Appropriate tests are conducted and compliance with standard specifications for the
effective control of the quality of food, bottled water and the raw materials as well as
their production processes in factories and other establishments is ensured.
 The Agency undertakes appropriate investigations into production premises and raw
materials for food and establishes relevant quality assurance systems including
certification of the production sites and the regulated products and pronounces on the
quality and safety of food, bottled water and chemicals.
 The role of the Agency also includes the inspection of imported food facilities to
ascertain relevant quality assurance systems necessary for certification of the imported
products

c) Standards Organization of Nigeria (SON)

 The Standards Organisation of Nigeria is responsible for the formulation and

enforcement of set standards on the composition of imported and locally manufactured
products.
 Responsible for investigating the quality of facilities, materials and products in Nigeria.
They also establish a quality assurance system, including certification of factories,
products and laboratories and to promote consumer confidence and global
competitiveness of Nigerian products and services through standardisation and quality
assurance

28
 The mandate of the Organisation includes preparation of Standards relating products,
measurements, materials, processes and services amongst others and their promotion at
National, Regional and International levels; certification of products, assistance in the
production of quality goods and services; improvement of measurement accuracies and
circulation of information relating to standards

c) The Federal Ministry of Agriculture and Rural Development (FMA&RD)

The Federal Ministry of Agriculture and Rural Development is responsible for

formulating policies on primary agricultural production and practices which cover plants,
animals, pests and diseases etc.; supervising and overseeing its departments and
parastatals i.e. research institutes, colleges of agriculture, college of fishery.

29
4.0 ROLES OF THE MICROBIOLOGISTS IN QUALITY CONTROL

Microbiologists play vital roles in the industry, especially in controlling the quality (QC) of
products. The job responsibilities of a Microbiologist include:

 Routine Quality Control: Regular monitoring of the raw materials, process intermediates
as well as the finished products in terms of microbiological quality and practicing good
manufacturing practices (GMP)
 Risk Analysis, Assessment, Communication & Management: Any substance, action, and
method that increases the probability of adverse effects on the health of the consumers or
leads to hazards are termed as risk. The scientific process of analyzing risk using tools
like Hazard Analysis and Critical Control Point (HACCP) followed by an assessment of
the grade of risk with proper communication, to manage the process through scientific
intervention, is one of the major job-roles of the microbiologist.
 Environmental Monitoring: The safety of the product largely depends on the
environment of production and subsequent packaging. Therefore, a safe environment is a
prerequisite to maintain the sterility of products or at least a safe level for ensuring
safety. Environmental monitoring of the storage area, production area, instruments and
packaging area, etc. are carried out to determine the microbial load, adhering to the
policy and regulatory guidelines.
 Products Hygiene: The roles of microbiologists also include the maintenance of all
conditions and necessary measures to ensure the safety and suitability of products at all
stages of the production and supply; commonly referred to as Product hygiene.
 Food Inspection & Surveillance: Microbiologists are required to conduct routine
examinations, empowered by the regulations of food products and system, to confirm the
regulatory compliance and adhere to the norms associated with food safety. This
functionality is known as food inspection while continuous monitoring is termed as food
surveillance.
 Quality Management System (QMS): Microbiologists, as part of the entire management,
are involved in designing the process and formulating the ‘Quality Policy Document’ to
be followed. Routine monitoring of quality and survey based on HACCP are important
job roles.

30
  Product Regulatory Compliance: Microbiologists are involved in regulatory affairs in
maintaining the safety of products, adhering to the regulatory guidelines.

4.1 WAYS TO MAINTAIN QUALITY CONTROL IN MICROBIOLOGY

 Set your quality standards and decide which quality standards to focus on.

In some industries, you may have to meet quality standards set by an outside body, such as an
industry association, the local health and safety inspector, or a government regulatory agency. In
others, there aren't any official quality standards, so you'll need to set your own. Each department
of your business will have different quality control standards. However, they must all be
objectively measurable.

Of course, you want to ensure quality in all aspects of your operation. However, begin by
focusing on the most important measures — those that have the biggest effect on your profits and
your customer experience. This will enable you to get results quickly and also keeps you and
your team from becoming overwhelmed.

 Documentation

Refrences have already been made to the importance of record-keeping and documentation, in
particular SOPs. Under the demands of QA within Good Manufacturing Practice it is essential
that accurate documentary evidence is taken throughout the manufacturing and quality control
processes to ensure the product meets the required specification and enable fault tracking in the
event of product failure. Records should be made with sufficient rigour to ensure that they
withstand self audit and external inspection, for example by the Medicines Inspectorate. Central
to any manufacturing process is the SOP, since it is adherence to these procedures which is the
basis of QA. Within the pharmaceutical microbiology QA laboratory, there should be

SOPs for all of the following:

• All laboratory equipment, including operation, calibration and the maintenance schedule;

• Training of all staff;

• Reception of visitors;

31
• Laboratory housekeeping and hygiene, including cleaning and environmental monitoring;

• Sample receipt, record-keeping, handling and disposal;

• Reagents and microbiological media—preparation, shelf-life and methods of sterilization.

 Create operational processes to deliver quality.

W. Edwards Deming, the founder of modern quality control, believed that well-designed
processes lead to high-quality products and services. If you create good processes, continually
measure the results of the processes, and work to consistently improve the process, your product
or service will get better and better.

 Review your results.

Review your data regularly to see how well your company is meeting its quality standards.

 Get feedback.

Use measurable feedback from external sources, such as customer surveys, online ratings and
reviews and net promoter scores (NPS), to get a fuller picture of product and service quality.
Also, get regular feedback from employees. How well are the operational processes working to
deliver quality? How could they be improved?

 Make improvements.

Once you’re meeting your quality control standards, don't stop there. Make advances to further
improve the already existing quality standards. For example, if you own a brewery don't ever
reduce your quality standards. That will really boost your bottom line.

32
5.0 CONCLUSION

Quality Control may be considered the combination of system, procedures, activities,

instructions and management review that control and improve the quality of work performed.
The main purpose of this department in an organisation is to reduce risk by "looking at new and
better technologies or a different way to execute and get quality. It also ensures that
microbiology criterion are effectively followed during the process of production or analysis.
Quality control covers the part of quality assurance that ensures all standard operating
procedures are adhered to avoid errors in production. Some of the critical test performed incude
Bioburden, Endotoxin, Vible count etc to see the biological load or organism on the
manufactured products or equipment. It ensures both precision and accuracy of work. Quality
control does not become an integral part of an organisation activities without commitment and
effort by management both internal and external. There is a great deal of work to be done
initially in writing a quality manual, generating quality control data and commissioning the
quality system. Management support at this stage is essential and can be demonstrated by
encouragement, counseling and provision of adequate resources. Management can also express
their commitment to the programme very effectively by insisting on strict adherence to the
schedule of audits and review and taking keen interest in any follow up action. The audit and
action resulting from them represent the mechanism of change built into quality control and this
largely reflect the effectiveness of the programme.

33
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