Skip to main content

Quality Management System

"Quality is never an accident, it is always the result of high intentions, sincere effort, intelligent direction and skillfull execution; it represents the wise choice of many alternatives"- William A. Foster
Quality as a concept first evolved during the Industrial Revolution. In olden days goods were made by artisans or craftsmen manually or by using simple levers.Meeting the quality specifications of the product was more of an art rather than science. During Industrial revolution the concept of "Mass production" began to meet the huge demand of market. This inturn lead to the usage of machinery and a team of skilled technicians who were specially trained for a particular process. Thus the quality of end product was the outcome of scientific and systematic approach of the technicians as a team who were trained and made to follow the procedures which were standardised. Later on pioneers in Total Quality Management such as Frederick Winslow Taylor and Henry Ford recognized the shortcomings of the methods being used in mass production at the time and the subsequent variations in the final quality of end product. Taylor recommended and established Quality Departments to monitor the quality of production and minimise the errors, and Ford emphasized standardization of design and component standards to ensure a consistantancy and reliability in production. Assurance of quality was the sole responsibility of the Quality department and was believed to achieve by testing of product to find the defects (non conformance with the specified product quality standards).
"Quality in a product or service is not what supplier puts in, it is what the customer gets out and is willing to pay for. A product is not of quality beacuase it is hard to make and costs a lot of money, as manufacturers typically believe. This is incompetence. Customers pay only for what is of use to them and gives them value. Nothing else constitutes quality."- Peter F. Drucker

Subsequently statistical process control was implemented to ensure the sample was representative of the lot or population. Quality management systems evolved as a discipline of management only later when the world especially Japan started to look at it as a ray of hope to rejuvenite its automobile industry which was totally hampered by the competitive US automakers. It was only by the marvellous contribution of renowned Quality gurus like Juran, W. Edwards Deming, Peter Drucker, Crosby only to name a few the Quality revolution was undergone.
It has been quoted by many scholars that-"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 by leaps and bounds, from simple control, to total quality control, to quality by design. Only inspection was considered as Quality control(QC) in the initial days later on Quality assurance(QA), Quality by design(QoD) were the key concepts which were followed and know are the buzz word almost in every organization.

Quality Management System standards
ISO was the prime organization to publish the set of guidelines on design and development of QMS. But it was a concept limited only to a few large organizations which enjoyed the exclusivity of being called Quality Vision Factories. Nevertheless the quality concept percolated the world of globalization so fast that nobody could ever realize when it became a part of their organizational goal. The government bodies which were regulating the healtcare sectors like Pharmaceutical industry also started demanding the implementation of QMS across the organization to assure the level of confidence among the people using medicines as a reliable approach to achieve and maintain the required quality. With the publication of ICH Q10 guidelines for Pharmaceutical Quality System, the new era of regulatory requirement for QMS started. Today most of the Pharmaceutical industries small, medium and large have their own QMS designed, developed and implemented as per the international and national quality standards. Quality is no more the privilege of few aristocrats but a yardstick of every customer who pays for the required product.
The design and content of QMS has metamorphised drastically from just a docket of Quality Policy, Quality objective and Quality manual to Product realization, Operational excellence, Quality vision, Isolators and clean room concepts to PAT.

Plan – Do – Check – Act
Popularly known as Deming's cycle / wheel or Shewhart's cycle is one of the tools recommended by ISO.

Plan – What to do? (organizational goal, target of completion and plan ahead).

Do – Just do it (implementing the above plan to achieve the final output).

Check – Performance evalution(Key Performance Indicators).

Act – Corrective And Preventive Action (Continous improvement and consistency).

"Quality is like walking towards horizon, the distance always remains the same no matter how much you walk towards it."

Comments

Popular posts from this blog

Made in Japan

Made in Japan
Japan – the island nation is famous for many things. The first developed country in Asia despite adverse geographical conditions, the oldest empire existing on earth, the land of rising sun, Japanese tea ceremony Sado, Sushi the national dish, the great Samurai warriors, the gigantic Sumo wrestlers and above  all “Made in Japan” robots. Its technology had made it an iconic nation.
I was amazed to see many marvels of science and technology during my recent visit to Tokyo Science Center. What impressed me most was apart from being a research and training center for healthcare professionals it offers many novel modes of training like using realistic organ models for endoscopic surgery and cardiovascular disease treatment in an effort to introduce its cutting edge medical devices and technological advancement to the whole world enabling the healthcare professionals to enhance their knowledge and skills in treating patients across the globe for unmet medical needs making it a…

Dissolution - Theory and concepts

Theory of Dissolution

 Dissolution is the process by which a solid enters into solution.
 In 1897 Noyes and Whitney came up with: “The rate of solution of
solid substances in their own solution.”
 dc / dt = K (Cs-Ct)
 According to their research, rate of dissolution of solid substances is determined by rate of diffusion of a very thin layer of saturated solution that forms instantaneously around the solid particle. They developed the mathematical relationship that correlates the dissolution rate to the solubility gradient of the solid.

Diffusion layer model / film theory

 In 1904, Nerst and Brunner applied Fick’s law of diffusion to the
Noyes-Whitney equation. (Diffusion layer model / film theory)
 dc / dt = K D.S / v.h (Cs-Ct)

Cube root law of dissolution

 In 1931, Hixson and Crowell came up with Cube root law of
dissolution.
 W01/3-W1/3 = Kt

Scheme of dissolution

Later Wagner followed by Carstensen gave the scheme of dissolution.
 Initial mechanical lag
 Wetting of the …