Quality Management Systems (QMS)
Contents
• Quality management
& Certifications: Concept of Quality, Total Quality Management
• Quality by Design (QbD)
• Six Sigma concept
• Out of Specifications (OOS)
• Change control
• Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Quality Management Systems (QMS)
• QMS is a collection of business processes focused on
consistently meeting customer requirements and enhancing their satisfaction
• It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it
Quality
management & Certifications
• The term "Quality Management System" and the
initialism "QMS" were invented in 1991 by Ken Croucher, a British
management consultant working on designing and implementing a generic model of
a QMS within the IT industry
Concept of quality –
historical background
• The concept of a quality as we think of it now first
emerged from the Industrial Revolution
• Previously goods had been made from start to finish by the
same person or team of people, with handcrafting and tweaking the product to
meet 'quality criteria’
• Mass production brought huge teams of people together to
work on specific stages of production where one person would not necessarily
complete a product from start to finish
• In the late 19th century pioneers such as Frederick
Winslow Taylor and Henry Ford recognized the limitations of the methods being
used in mass production at the time and the subsequent varying quality of
output
• Management of quality was the responsibility of the
Quality department and was implemented by Inspection of product output to
'catch' defects
• Application of statistical control came later as a result
of World War production methods, which were advanced by the work done of W.
Edwards Deming, a statistician, after whom the Deming Prize for quality is
named
• Joseph M. Juran focused more on managing for quality
• He developed the "Juran's trilogy", an approach
to cross- functional management that is composed of 3 managerial processes:
quality planning, quality control, and quality improvement
• Quality, as a profession and the managerial process
associated with the quality function, was introduced during the second half of
the 20th century and has evolved since then
• Over this period, few other disciplines have seen as many
changes as the quality profession
• The quality profession grew from simple control to
engineering, to systems engineering
• Quality control activities were predominant in the 1940s,
1950s, and 1960s
• The 1970s were an era of quality engineering and the 1990s
saw quality systems as an emerging field
• Like medicine, accounting, and engineering, quality has
achieved status as a recognized profession
ISO
Standards
• ISO Standards Is a formula that describes the best way of
doing something
• It could be about making a product, managing a process,
delivering a service or supplying materials – standards cover a huge range of
activities
• The International Organization for Standardization (ISO)
is an international standard-setting body composed of representatives from
various national standards organizations.
• Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial, and commercial standards. It is headquartered in Geneva, Switzerland and works in 165 countries
ISO 9001 is a Quality Management System (QMS) which gives organizations a systematic approach for meeting customer objectives and providing consistent quality
ISO 14001 is an Environmental Management System (EMS) which gives organizations a systematic approach for measuring and improving their environmental impact
Total
Quality Management (TQM)
• TQM is a managerial approach used by pharmaceutical
manufacturers in ensuring pharmaceutical products meets the required quality
with regard to their uses
• It is a potentially beneficial approach to manufacturing
pharmaceutical products, as it ensures they exceed customers' expectations in
relation to quality standards, efficiency and also effectiveness
• Pharmaceutical manufacturers play a key role in the system
of health care and for that case, they are heavily regulated by the relevant
authorities since; any slight mistakes in pharmaceuticals manufacturing can have
fatal consequences.
• In this case, pharmaceutical manufacturers need to
maintain and improve continuously on their products through TQM system process
implementation
Major
Components of the TQM Approach
1. Customer Focus:
It is beneficial to recognize product consumers
2. Involvement of
Employees: All employees are involved in the quality production process,
and so they should as well take part in the innovation and improvement of
quality
3. Constant Improvement: The mission for quality is an endless process in which individuals are constantly attempting to improve on the product’s features
7 Important
Principles of TQM
1. Quality can and
must be managed
• Many companies have wallowed in a repetitive cycle of
chaos and customer complaints
• They believe that their operations are simply too large to
effectively manage the level of quality
• The first step in the TQM process, then, is to realize
there is a problem and that it can be controlled
2. Processes, not
people, are the problem
• If your process is causing problems, it won’t matter how
many times you hire new employees or how many training sessions you put them
through
• Correct the process and then train your people on these
new procedures
3. Don’t treat
symptoms, look for the cure
If you just patch over the underlying problems in the
process, you will never be able to fully reach your potential. If, for example,
your shipping department is falling behind, you may find that it is because of
holdups in manufacturing. Go for the source to correct the problem.
4. Every employee is
responsible for quality
• Everyone in the company, from the workers on the line to
the upper management, must realize that they have an important part to play in
ensuring high levels of quality in their products and services
• Everyone has a customer to delight, and they must all step
up and take responsibility for them.
5. Quality must be
measurable
• A quality management system is only effective when you can
quantify the results
• You need to see how the process is implemented and if it
is having the desired effect
• This will help you set your goals for the future and
ensure that every department is working toward the same result
6. Quality
improvements must be continuous
• Total Quality Management is not something that can be done
once and then forgotten
• It’s not a management “phase” that will end after a
problem has been corrected
• Real improvements must occur frequently and continually in
order to increase customer satisfaction and loyalty
7. Quality is a
long-term investment
• Quality management is not a quick fix
• You can purchase QMS software that will help you get
things started, but you should understand that real results won’t occur
immediately
• TQM is a long-term investment, and it is designed to help you find long-term success
Six Sigma concept
• It is a set of tools and techniques used for the
improvement of the product
• It can be termed as a cornerstone principle used by
leading corporations of the world
• It is so because it has proven itself by giving rise to
substantial business returns
• The thrust on the Six Sigma policy caused 50% process cost
reduction along with the less waste of that materials.
• Six sigma is a process which is a combination of 4Ms that
is man, machine, materials and methods for producing products or services which
meets customer’s expectation these are evaluated by statistical methods and
must have inherent statistical variability
• This process yield nearly ideal products and services
• It is a philosophy of quality and the way of surpassing
accomplishment by determining where you are and where you could be
Six Sigma simply means a measure of quality
Six Sigma is a data-driven approach and methodology for
eliminating defects in any process from manufacturing to transactional and from
product to service
History of
Six Sigma
• The concept of Six Sigma was started at Motorola during
the 1980’s as a response to lost market share which made the company realize
that an increase in quality was necessary to be able to compete with primarily
the Japanese manufacturer who was growing rapidly
• An engineer at Motorola called Bill Smith spent a lot of
time convincing higher management at Motorola that his new quality control
system Six Sigma, would provide significant benefits for the company
• On the advice of Bill smith, CEO Robert Galvin then looked
at the Japanese models for their quality work and realized that total
involvement of himself and his senior management team would be crucial for the
success of this new quality control system and the improvement work
• The implementation was very successful
• Further in the year 1995, the concept of Six Sigma was
implemented as a central business strategy by Jack Welch in his company General
Electric
• Their version of Six Sigma is focused on six key
principles which are summarized as:
Six Sigma-
Key principles
• Critical to
Quality: The customer is the start and what is important for the customer
needs to be identified
• Defect:
Anything that does not deliver exactly what the customer wants
• Process Capability:
The processes need to be able to deliver what the customer wants
• Variation: As
it is experienced by the customer
• Stable Operations:
The goal is to secure reliable, robust processes that improve the customer’s
experience.
Goals of
Six Sigma
• Enhancing customer satisfaction
• Enhance competitiveness
• Change organizational culture
• Enhance quality of product and services
• Decreasing defects
• Controlling variation and improving predictability
• Lessen costs – without unintended consequences
• To develop organizational competencies
• To improve organizational performance
• Reducing process cycle times and time-to market
• Boosting end-to-end process management and measurement
• Less equipment and human are needed
Lean- Six
Sigma concept
• Lean Six Sigma is a method that relies on a collaborative
team effort to improve performance by systematically removing waste and
reducing variation
• It combines lean manufacturing/lean enterprise and Six
Sigma to eliminate the eight kinds of waste (muda): Defects, Over-Production,
Waiting, Non-Utilized Talent, Transportation, Inventory, Motion, and
Extra-Processing
• During the 2000s Lean Six Sigma forked from Six Sigma and
became its own unique process
• While Lean Six Sigma developed as a specific process of
Six Sigma, it also incorporates ideas from lean manufacturing, which was
developed as a part of the Toyota Production System in the 1950
• Originally called "just-in-time production", it
builds on the approach created by the founder of Toyota, Sakichi Toyoda, his
son Kiichiro Toyoda, and the engineer Taiichi Ohno
“Just-in-time production"
• Just-in-time (JIT) manufacturing, also known as
just-in-time production or the Toyota Production System (TPS), is a methodology
aimed primarily at reducing times within the production system as well as
response times from suppliers and to customers
Lean manufacturing
• Lean manufacturing, or lean production, is a production
method derived from Toyota's 1930 operating model "The Toyota Way"
• The term "Lean" was coined in 1988 by John
Krafcik, and defined in 1996 by James Womack and Daniel Jones to consist of
five key principles; 'Precisely specify value by specific product, identify the
value stream for each product, make value flow without interruptions, let
customer pull value from the producer, and pursue perfection
• In the early 2000s Six Sigma principles expanded into
other sectors of the economy, such as Healthcare, Finance, Supply Chain, etc.
• While different sectors of the economy sell different
"products" and have different "customers", Lean Six Sigma
principles can still be applied with slight alterations in wording and
processes
D = Define
• The Define Phase is the first phase, in this phase, the
leaders of the project begin to understand the needs of the customers or simply
what new business objective or customer demand
• Define the project goals and customer deliverables
M = Measurement
• Measure the process to determine current performance and
quantify the problem
• Develop a data collection plan for the process
• Collect data from many sources to determine types of
defects and metrics
• Compare to customer survey results to determine shortfall
A = Analyse
• In this step the team has to analyse what is causing the
problem and where there will be the opportunity to improve the process or
service quality or cost or product
• In this step team spend their time on discovering root
causes of problem and constructing the solution as per the results
I = Improvement
• In this step the team has to accumulate data to check if
there is measurable improvement
• Create innovate solutions using technology and discipline
• Develop and deploy implementation plan
C = Control
• This is the step in which team has to control the process
and sustain the changes and improvement they made in the process or service
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