Quality Management Systems (QMS) - Industrial Pharmacy II B. Pharma 7th semester PDF Notes

Quality Management Systems (QMS)


• 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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