1) Draw the transformation process of an existing company and define/ label

it. Indicate where improvements in the flow could be introduced.

2) Compare/contrast quality control and quality assurance. How to improve
QC/QA?
The definition of Quality control (QC) is that part of quality management focused on
fulfilling quality requirements (ISO 9000:2000). In other words, QC is the operational
techniques and activities that are used to fulfill requirements for quality. It is the amount
of supervision that a product is subjected to so as to be sure that the workmanship
associated with that product meets the quality level required by the design. In other
words, it is the control exercised by the manufacturer to certify that all aspects of their
activities during the design, production, installation and in-service stages are to the
desired standards. Quality control is exercised at all levels and as all personnel are
responsible for the particular task they are doing, they are all quality controllers to some
degree or other.
Quality assurance (QA) is that part of quality management focused on providing
confidence that quality requirements are fulfilled (ISO 9000:2000). In other words, QA
is all those planned and systematic actions necessary to provide adequate confidence
that a product or service will satisfy given requirements for quality. Quality assurance is,
therefore, a declaration given to inspire confidence that a product has achieved the
highest standards and that its manufacture, modification or repair has been completed
in an efficient and timely manner. Quality Assurance in a product (or service) is a
declaration given to inspire confidence that a particular organization is capable of
consistently satisfying need and achieving stated objectives, as well as being a
managerial process designed to increase confidence.
The International Standard for Quality Management (ISO 9001:2008) has identified
several principles which can help the organization to improve their performance. Among
these are the ff:

Involvement of employees in decision making : This brings a sense loyalty

among the employees towards the organization and they become more
responsible.

Leadership Qualities : An organization needs to inculcate leadership

qualities among its people so that they establish unity of purpose.

Customer Centric : Customers satisfaction is of utmost importance for the

overall growth of an organization. All the members of an organization
should know about the requirements of the external as well as the internal
customers and also resolve ways to meet those requirements.

System Approach to Management : This approach implies identifying,

understanding and managing all systems which are interrelated as a

process. Quality control involves checking transformed and transforming

resources in all stages of production process.

Continual Improvement : It is one of the most important quality improvement

functions and helps in gaining insights about the overall performance,
leveraging clear and concise Process Performance Measures (PPMs).

3) What are the components of good manufacturing practices (GMP)?

Good manufacturing practices (GMP) is a part of quality assurance which ensures that
products are consistently produced and controlled to the quality standards appropriate
to their intended use and as required by the marketing authorization. GMP guidelines
provide minimum requirements for pharmaceutical or a food product manufacturer must
meet to assure that the products are of high quality and do not pose any risk to the
consumer or public.
4) Give substantial examples and definitions of statistical process techniques
used in quality control.
There are two statistical methods used in quality control. The first method, statistical
process control, uses graphical displays known as control charts to monitor a production
process; the goal is to determine whether the process can be continued or whether it
should be adjusted to achieve a desired quality level. The second method, acceptance
sampling, is used in situations where a decision to accept or reject a group of items
must be based on the quality found in a sample.
Control charts provides a basis for deciding whether the variation in the output is due to
common causes (in control) or assignable causes (out of control). Whenever an out-ofcontrol situation is detected, adjustments and/or other corrective action will be taken to
bring the process back into control. Control charts can be classified by the type of data
they contain. An x chart is used if the quality of the output is measured in terms of a
variable such as length, weight, temperature and so on. Other control charts can be
used to monitor the range of the measurements in the sample (R chart), the proportion
of defective items in the sample (p chart), and the number of defective items in the
sample (np chart).

References:
Tricker, R. 2006. ISO 9001:2000: The Quality Management Process. 3 rd edition.
NL: Van Haren Publishing
How to Improve Quality Management Consistently. Accessed on December 03,
2016.
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at
https://www.simplilearn.com/improving-quality-managementconsistently-article