Resurrecting pharma plants from brazen culpability


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The response to brazen violation of quality requirements by pharma plants can best be said as patchy. Quality of products and service can not be improved in isolation of operational flow; rather the secret lies in improving operations to deliver quality. This document is the beginning of figuring out such an approach.

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Resurrecting pharma plants from brazen culpability

  1. 1. 1 Resurrecting Pharma Plants from Brazen Culpability (The Movement Begins) Dr. Shridhar Lolla Draft 0.0, Needs Editing 11-oct-2013 Anup Soans, editor of MedicinMan expressed in the October'13 issue of the magazine, how field force (read sales teams) feel helpless when they are not sure of the quality of products they are pitching in the market place. It is just like sending soldiers with guns but with empty shells. MedicinMan echoes the worries about culpability the back end of pharma industry - plants and factories has been surrounded with, now for over a couple of years. The attack on pharma industry has been the severest in the press, with titles like 'dirty medicines' appearing loud and bold. However, the response from Pharma Industry has thus far been varying from just callousness to taking it business as usual way to knee jerk reactions. Not a single company has come forward looking at the problem from the consumer (human) side and taking a vow to fight against dirty quality problems. In several industries where poor quality has far less dangerous consequences to customers, managements have gone all out to close the plants for months to ensure that boundary conditions for operations and product quality are assured before they begin operations. Why does not it happen in pharma companies? Is drug recall enough, is giving isolated justification to FDA notices enough and is stopping production of drugs for the US market but continuing to produce drugs in the same plant for other markets justified? It seems that pharma companies can afford most gross errors and yet continue to do profitable business. Perhaps, the state of the industry and the system provides for this. Otherwise, how do you explain growing chaos in pharma plants: 1. Untested and expired medicines being sold in the market 2. Wrong pills stuffed in a bottle with wrong label 3. Untidy manufacturing and storage locations 4. Falsifying documents 5. Non co-operation of staff with audit team 6. Hiding facts 7. Glass particles in vials The list can go on...You can check some of soul numbing lapses here: 'Urine spills stain..'. If you really want to get into the crux of the matter have a look at FDA site. Now think about you and your family taking medicines prescribed by doctors which are made under such dubious conditions. There is no doubt that what we see is just the tip of the iceberg (for the very reason that audit is based on extremely limited samples). No doubt, faith of consumer and society in the affairs of pharma industry is at all time low levels. Copyrights ©2013, Shridhar Lolla. All rights reserved.
  2. 2. 2 Fundamentals of organizational culture tells that people are good. Pharma Industry employs possibly the best talents and therefore, it is surprising that situation does not seem to get under control. The first action most of the organizations caught by regulators took was to sack people and thus act against the fundamental belief that people are good. If people were the cause of the problem then this problem would have been solved long back. It seems that the cause of the problem is somewhere else, elusive to the staff and management. In the language of management sciences, the core problem is hidden somewhere and speaking objectively, perhaps organizations need a new set of eyes to identify and solve the deep rooted problem. Did not Albert Einstein say, "We cannot solve our problems with the same thinking we used when we created them." Remember also what Deming, the father of quality movement said, "85% of the problems are systemic and come under management responsibility." Having said that, we must remember that most of the quality problems are not solvable by quality department or function. Last year, we begun to collaborate looking deeper into pharma operations. It was a collaboration to capture the changing business model of the industry amidst growing complexity and chaos. We have been looking at market conditions and trying to solve the twin problem of non availability and high price of drugs. We believed that the deep mistrust between pharma manufacturers on one hand and patients, society, regulators and government on the other hand has an answer in solving the problem business wise. Since then, a number of organizations have begun adopting the guidelines that came out of the above collaboration. The guidelines are in fact, presented in the form of a case study in the book 'The Path'. While we were co-creating 'The Path', the issue of poor quality levels in pharma operations came up as a major issue to be addressed but was parked for later consideration. We also realized that quality is actually integral to operations and its solution must lie in improving operations. Indeed, the approach adopted in 'the Path' did show that quality of product is to a large extent depends on how good the manufacturing operations is in its fundamental form. Which means that quality can't be improved in isolation, rather it must improve in the process of improving operations (by walking on the path of operational excellence). 'The Path' does mention a number of instances about how mismanaged operations leads to huge quality failures. We now feel that actually operations (manufacturing) in pharma industry is at a real culpable situation due to quality issues. Although we have not yet invested enough time to pin point the operational root cause of current culpability of pharma plants, we feel that continuing our study in this direction would bring out a major breakthrough in improving quality of plants without jeopardizing their business prospects. We feel that having a good operations will give good quality products and service. We also realize that the way Quality, specifically represented by QC and QA in today's organizations is an outsider policing function. Trying to solve quality issues or build quality culture by seeing quality in isolation to main operational flow can't give a sustainable quality culture. Copyrights ©2013, Shridhar Lolla. All rights reserved.
  3. 3. 3 We now intend to bring out a series of articles that tie quality to improvement in operations. In doing so, we will take significant inputs from the current state of pharma industry as well as the state of quality in other industries. _______________________ The author Shridhar Lolla is a practitioner of operational excellence and handholds pharmaceutical organizations in making operational improvements that directly impact business results. He is the author of a compelling business novel based on the current state of pharma industry, 'The Path - Leveraging Operations in a Complex and Chaotic World' (print and ebook). His another book, 'Building Manufacturing Competitiveness The TOC Way' (print and ebook) presents the technical aspect of 'The Path'. To know how dramatic improvements can be achieved quickly and sustainably without costly burn-out and trade-offs, check 'The Capacity Hunt Program'. Copyrights ©2013, Shridhar Lolla. All rights reserved.