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Chapter 4
Implementation of Quality Control
Irfan Ahmad
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http://dx.doi.org/10.5772/intechopen.77060
Abstract
Quality control is a procedure for examining the problems, work processes as well as
making improvements preceding to transport of products. In the global markets, the ris-
ing competition between manufacturers and producers has guided irms in recognizing
the competitive beneits. However, in the previous eras, the importance has been aten-
tive on the continuous upgrading of quality for the success of several kinds of business
in present and future. Employing a universal quality assurance background will help in
more efective organization and improve the quality of statistical output in international
organizations. Quality values are an essential part of the quality system. They are delib-
erated to support regulatory requirements of the laboratories, including monitor labora-
tory functions and local health regulations, thus conirming the safety of the local health
regulations and reliability of performance. This chapter highlights the elements essential
for efective implementation of quality control.
Keywords: quality control, implementation, essential elements, quality management,
improvement, six sigma
1. Introduction
Quality is a worldwide value and now has converted a universal concern. The burden of
globalization has built manufacturing organizations afecting to three main competitive areas
such as cost, responsiveness and quality. For the beter survival, it is necessary to ofer cli-
enteles with good quality stuf, so necessary for manufacturing organizations to ensure that
their procedures are constantly supervised and quality of the product is enhanced. The manu-
facturing company applies several techniques for quality control (QC) to increase the quality
of the progression by decreasing its variability [1].
© 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons
© 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative
Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use,
Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly cited.
distribution, and reproduction in any medium, provided the original work is properly cited.
40 Quality Control in Laboratory
A variety of methods exist to control the products or process quality. Seven statistical pro-
cess control (SPC) tools are included such as plan, do, check, act (PDCA), quality function
deployment (QFD), acceptance sampling, failure mode and efects analysis (FMEA), a design
of experiments (DoE) and six sigma [2]. This chapter emphasizes the implementation of qual-
ity control in companies and categorizes the factors applying for quality control techniques,
the techniques used in the implementation. The inspiring factors for the companies to relate
quality control and tasks challenge by companies in implementing the quality control [3–5].
Laboratory facilities are an important constituent of quality health care. It can be employed
eiciently at each level of health care system, involving point-of-care and primary health care
testing. Results of the quality laboratory are requisite to support justify, monitor, treatment
and clinical diagnosis, for the purposes of epidemiology, surveillance and control of disease
at public health importance, and to deliver the initial warning of disease epidemics. This
increases the accuracy of health evidence and endorses the national health planning efec-
tively. The aim of establishing laboratory quality standards is to conirm the conidence of
patients, increase the accuracy of test results, communities and clinicians in the importance of
laboratory testing, and to update patient management [6]. Entirely laboratory activities might
be subject to errors, and many studies have exposed that errors in the laboratory can appear
in all the phases of diagnostic processes. The examples of errors that may occur in all phase
are given below.
1.1. Pre-analytical phase
• Incorrect test selection or test request
• Incomplete request forms of laboratory
• Incorrect collection of specimen, inadequate quantity, improper labeling and transportation
1.2. Analytical phase
• Use of defective equipment, inappropriate use of an equipment
• Use of expired or substandard reagents
• Incorrect storage and reagent preparation
• Incorrect procedures; non-adherence to internal quality control (IQC) or standard operat-
ing procedures (SOPs)
1.3. Post-analytical phase
• Inappropriate reporting or recording
• Incorrect calculations, transcription or computation
• Send the results too late to the clinician
• Inappropriate interpretation of the results
Implementation of Quality Control 41
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2. Quality control
Quality can be described as achieving customer requirement or speciication, without any
deiciency. A product is considered to be great in quality if it is working as reliable and
expected. Quality control denotes to activities to conirm that produced articles are achieving
the highest promising quality. Furthermost of tools and techniques to control the quality are
statistical procedures. The techniques for the quality control can be categorized into the basic,
intermediate and advanced level, although there is no unanimity amongst researchers about
it. For example, Xie et al. [7] deliberate the DoE as an intermediary level technique while
Antony et al. [8] classiied that technique as advanced. Nonetheless, the contents are more
signiicant rather than the classiication. Amongst the basic techniques, SPC is a statistical
method for supporting the supervisors, operators and managers to accomplish quality and
to remove special causes of inconsistency in the process [9]. The early role of SPC is to stop
rather than process deterioration or recognize the product, but Xie et al. [7] propose for its
new role to vigorously identifying prospects for the improvement of the process. The fore-
most tools in SPC are control charts. An essential knowledge of the control charts is to analyze
the hypothesis that there are few common reasons of alternative versus variability, that there
are exceptional causes by continuously observing the process. The manufacturing company
could avoid defect items to be administered in the subsequent stage and to take instant cor-
rective action while the process exists to be out of control [10].
DoE and Taguchi approaches are inluential tools for the development of product and pro-
cess. Taguchi methods, for example, the purpose of manufacturing products or process that
vigorous to non-desirable turbulences such as manufacturing and environmental variations.
Though, the request of these two approaches by industries is inadequate [11]. Antony et al.
[8] delineate the problems in the application including the inappropriate understanding of
statistical ideas in the procedures; therefore recommend an approach for the implementation.
Procedure ability study is an efective technique to examine the ability of a procedure to pro-
duce items that meet speciications.
The process gains fast raising atention because of increased utilization of the quality system
(QS9000), where to take advantage of method capability study are demanded [12]. The out-
come obtains from capability study may want some modiication of process employing some
other statistical technique, for example, DoE or SPC. Furthermore, Motorcu and Gullu [13]
and Srikaeo et al. [14] conducted a capability study in which process capability production
and stability machine tool were assessed and crucial procedure to diminish poor quality pro-
duction was carried out employing other statistical methods.
Failure mode and efects analysis (FMEA) is a well-known technique to identify the point
where precisely problems can take place as well as to urgencies feasible problems in the order
of their diiculty [15]. This tool is valuable to troubleshoot problems in the process, i.e. pro-
cess FMEA and to recognize problems in the product, i.e. design FMEA [7]. Additionally, six
sigma is also a known statistical device for conirming the fault-free products via nonstop
progress and six sigma application has been chiely employed in manufacturing industry.
However, use of six sigma in the software development is a case of the non-manufacturing
42 Quality Control in Laboratory
industry [16]. The term six sigma instigated by Motorola as well as various motivated inter-
national organizations have ixed goal concerning a six sigma level of implementation [17].
Moreover, acceptance sampling is alternative statistical techniques that concluded whether to
take or refuse a quota based on the information from the sample. The request for the approval
of sampling permits industries to minimize the product demolition through examination
and to raise the inspection capacity and eiciency. The request of geting sampling has been
chiely employed in manufacturing industry; however, Slatery [18] reported its application
in non-manufacturing industry.
3. Implementation of the quality control system
Quality standards are an integral part of the quality system. They are designed to help labora-
tories meet regulatory requirements, including local health regulations, and monitor labora-
tory functions, thereby ensuring laboratory safety and consistency of performance. A quality
system can be developed in a step-wise manner and implementation (Table 1).
The methodologies for the implementation of quality control can be difer in diverse organi-
zations. Irrespective the methodologies of the continuous improvement program, each orga-
nization desire to use the proper tools and techniques in the process of implementation. The
selection of tools and techniques is depend on the demands and applied appropriately to the
approach and process.
The PDCA is an essential concept for quality improvement processes, easy to understand
and followed by most of the organizations. The most signiicant characteristic of PDCA
lies in the “act” phase after the completion [19]. The six-sigma procedure is consistent and
delivers a rigorous outline of results concerned with management. It must be distinguished
that the greatest results from six-sigma are accomplished and eradicating unproductive
procedures, especially when the members of the team are new to the concerned tools and
techniques [20, 21].
3.1. Implementation of laboratory quality standards
The implementation process for laboratory quality standards must follow a stepwise atitude
conferring to an implementation strategy drawn up by the national laboratory, in discussion
with the National Laboratory Coordinating Commitee. Certain countries can desire to prog-
ress national laboratory quality standards for all level of health care system.
Implementing laboratory quality standards guidelines are as follows.
3.1.1. National level
1. Achieve nationwide agreement for established standards through peer review.
2. Achieve consent to established standards via the suitable nationwide experts.
Implementation of Quality Control 43
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Table 1. Key steps in implementing a quality system.
44 Quality Control in Laboratory
3. Make a short-term, medium-term and long-term implementation plan for objectives, time-
lines and activities, and revealing yearly budgets.
4. Recognize suitable implementing agencies such as non-government, governmental agen-
cies, and the private sectors.
5. Explain partaking health facilities and institutions.
6. Use existing SOPs, checklists, record forms, guidelines and appraisal forms, audit check-
lists, recording formats etc. or develop the documents for the country speciic.
7. Establish the national procedures for the referral of samples and laboratory networking.
8. Establish the annual plans with budgets.
3.1.2. Laboratory level
A similar procedure will be mandatory by diferent laboratories. The head of the laboratory
will require taking a leadership role and involving all the staf. Several changes are informal
to implement and some are extra expensive or tougher to implement.
The changes that make the implementation of quality control simple and easy:
1. Introduction of SOPs for speciic activities or procedures. This can be the collection of the
sample, comprising phlebotomy for the investigation of a speciic analysis.
2. Arrange meetings with the users consistently. This will inform the users of the service to
upgrade the quality of laboratory.
4. Challenges and future trends in QC implementation
Quality control by manual approach could be established in several companies, such as, to
observe cuprum pipe pressing procedure, speciic control chart is employed to identify the
existence of precise distinctions in the process. Furthermore, the chart is made by hand hence
it needs a large amount of time period for chart preparation. However, the workers appear
found to be more comfy with hard copy records as well as the manual process in making a
record for the created items. The absence of conident in soft copy ile supposed to be dread
that someone may interfere and alter the data that can depreciate the company reputation.
Earlier studies have been showed comparable diiculties in applying quality control between
native manufacturing institutes. Among the serious diiculties are concerning insigniicant
process observing, incapability to accomplish data analysis, the accomplishment of control
chart just on the completed products and not in a real-time approach [22, 23]. Additionally,
real-time quality control additionally afords countless competence to the management since
it takes time to make manual control charts as well as the time permited to accomplish sig-
niicant data analysis, is reduced [24]. Study by Mohd Nizam et al. [25, 26] and Rosmaizura
et al. [27] show obstacles in developing an online Statistical Process Control (SPC) system
Implementation of Quality Control 45
http://dx.doi.org/10.5772/intechopen.77060
and the outcome of the study illustrate that aspects associated with highest management
support, inter-departmental correlation, budgets to improve the system and education on
SPC are hindering manufacturing institutes via showing real-time process censoring. It is
well documented that strong obligation by top management is very important for the fruitful
accomplishment of SPC [28, 29].
In forthcoming days, it is supposed that manufacturers will face a progressively undeined
exterior atmosphere through an increasing consequence of alterations in worldwide competi-
tion, technological improvement and customer necessities. Flexibility, cost, time and qual-
ity are considered as amongst the very signiicant competitive weaponry for the success of
manufacturing companies. Manufacturers face the task of reining the eicacy and lower-
ing prices. Hence, QC techniques would be constantly used to support the organizations to
develop, revolutionize their goods and progression in order to be acknowledged by custom-
ers. Because of the rising concern on maintainable place and source for the upcoming genera-
tion, manufacturers are expected to give more consideration to the environmental efect from
their operations. So, application of environment preservation, atmosphere friendly industrial
practices and green technology seem to be dominant.
5. Conclusions
All the employees incorporate the concepts for implementation of quality control in a labora-
tory or organization. That will give massive beneits for the improvement of quality control.
Though the program of quality assurance is still independent to monitor the process of quality
control. Implementation of QC may require a change during the setup of quality management
system. The encouraging features for the companies to concern quality control arise inside from
the organization, parental company and/or externally from the customer. The companies use
widely SPC and acceptance sampling. DOE, Taguchi methods, Six Sigma, and capability studies
are missing to be used by the industries, because of the lack of knowledge in the technique. They
fulill the criteria for the laboratories requirement such as health regulation, consistency in per-
formance, laboratory functions and safety. Three aspects inluence the quality control procedure
in the irms, such as the capability to quantify product speciication contentment; simplicity
in the use of the technique; and capability to progress acute characteristic and yield diiculty.
Hence QC technique will combine all these environmental concerns like its signiicant elements
and ease and quickness for use would be the probability for QC techniques of the future.
Author details
Irfan Ahmad
Department of Clinical Laboratory Sciences, College of Applied Medical Sciences,
King Khalid University, KSA
46 Quality Control in Laboratory
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