Paradigm shift in Pharma: Quality by Design (QbD)

Posted by |Apr 28, 2012|1 comment

Introduction to Quality   Pharmaceutical industry is guided by very stringent norms and guidelines that are laid down by FDA and the regulatory bodies. It is very crucial for the pharma companies to adhere to these guidelines as the stakes are very high. Pharma companies have to follow Good Manufacturing Practice (GMP) procedures and guidelines laid down by the regulatory bodies to assure a good quality end product. The ultimate aim of these guidelines is to safeguard the health of the patients/ consumers by producing good quality medicines or pharmaceutical products. It is mandatory for the pharmaceuticals to comply with GMP and hence, all the pharma companies put a lot of emphasis on quality.   There are 3 approaches to quality: Quality Control Quality Assurance Quality Management.   Quality Control is an inspection based approach. QC is used to assure a certain level of quality in a product or service. Quality Control is a process by which the product quality is...

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Dr. Ritu Bhattacharyya, Director – MGM Institute of Management talks about Lean Six Sigma

Posted by |Apr 27, 2012|0 comments

                                    Dr. Ritu Bhattacharyya, Director – MGM Institute of Management talks about Lean Six Sigma training to management students   “We generally conduct 2-years MBA courses from Mumbai University. As we are aware, the main aim of the management course is to ensure that the students get placed. With 85000 students doing MBA in Maharashtra alone, it’s a little difficult for the industry to choose from among the lot. Therefore, it is very essential for the institutes to do something different.   At MGM, we have done a lot of innovative programs and one such venture has been tying up with SSA Business Solutions for Lean Six Sigma. Mr. Narayanan of SSA was very kind to come down to our institute and ensure that the teaching-learning pattern was changed from what it was in the industry, mainly to suit or students who had no exposure. For the last 2...

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DMAIC Way!!

Posted by |Apr 5, 2012|1 comment

                              In this blog, am presenting the problem solving approach using DMAIC and my own perspective. I am not going to explain or deal with the DMAIC process steps which everyone already knows, but I am sharing and highlighting my perspective of the same and the common pitfalls where people don’t focus enough on the critical steps in the journey of DMAIC implementation.   DEFINE                         DMAIC is a problem solving methodology. When we say “problem”, whose problem we means?   The success of the DMAIC journey is possible only when we incorporate the pain points from the “Customer”. It is the customer problem because of our process design. It may appear very simple to state that we need to include the customer’s voice here but it has to become a part of culture / attitude of the people who are...

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TRIZ MANIA

Posted by |Apr 4, 2012|2 comments

In the 1970s, the United States and the Soviet Union fiercely competed in the area of moon exploration. Unable to afford the costs of an APOLLO like project for landing astronauts on the moon, the Soviet Union decided to launch an unmanned lunar probe to deliver an autonomous vehicle to the dark side of the moon’s surface. The vehicle was to transmit TV pictures of that not-yet seen side to earth. The incandescent light bulb was found to be the best light source; however existing light bulbs would not have survived the impact of landing on the lunar surface. Even the most durable bulbs, those used in military tanks, cracked at the joint between the glass and the socket during test. There was not a single way out. It was a dead end.   This dead end situation is not new. Such a dead end situation is always been seen in all the industries where the project teams have carried out huge research but they could not go beyond certain limits of thinking the solutions. In these...

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BPMS

Posted by |Apr 3, 2012|4 comments

Introduction   In this era of globalization, both the manufacturing and service industries face the challenge of meeting and exceeding the customers’ expectations. As far as the employees are concerned, all the routine activities they perform on the job on a day-to-day basis constitutes “work” for them. A collection of such activities (work) that delivers the final output and outcome to the customers is often called a ‘process’. Say for example in a McDonald outlet, while one of the employees makes the burger, the other services the customer and yet another collects the money. As far as these employees are concerned, it is the “work” they do, day in and day out, without really realizing that they are one of the links in the chain of activities called a “process”. In manufacturing parlance, we call this as ‘process capability’, and is often expressed as Cp or Cpk. It indicates the capability of a manufacturing process to deliver a defect free product or a...

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Excellence in Training

Posted by |Apr 2, 2012|2 comments

Being in the training industry for around half a decade, marketing training programs and also attending quite a few trainings myself has given me the eligibility and the inspiration to write this blog on ‘Excellence in Training’.  Credit should be given to my profession that has put me in a position where I can better understand the customer’s expectations including myself (VOC) from a training program’ especially from the trainer and how the trainer fulfils their desire and hunger for knowledge. A trainer possesses the power to empower others; thereby making a difference to probably millions of lives. This blog is to point out what are those powers/unique qualities of an effective trainer that make him/her irresistibly charismatic and that compels people to follow the directions provided by the trainer and eventually reach their destination for success.   Unlike the relationship between  mentor – mentee or coach – coacher, the trainer and the trainee share a...

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Profitability Improvement through Process Improvement: By reducing cost of warranty

Posted by |Mar 29, 2012|1 comment

The fundamental purpose of any business is to make profit. A business makes profit if the price it can charge for its output is greater than the costs of producing that output. One way of making profits, is by adding the customer’s perceived value to the product and the other way is by reducing the cost of value creation by performing value creation activities more efficiently. One of the ripe areas for saving costs is Cost of Warranty. Warranties are an important ingredient to competitive success. Effective warranty planning can ensure success, but lack of attention to cost analyses can spell disaster.  Until now, Warranty was perceived as simply another necessary expense to be controlled, and no value creation was expected from this process. Hence, a reactive rather than pro-active approach was followed when it came to managing warranty processes.   One of the most important aspects of Warranty cost management is to understand what contributes to the overall Cost of...

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