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
(The Movement Begins)
Dr. Shridhar Lolla
lolla@cvmark.com
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.

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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.

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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.