Being a part of the industry, we come across various news articles on industry, and one such article which caught my attention, was titled,“ Beware of ‘Made in India’ medicine” published in The Hindu Business Line, on August 12, 2015. The author had opined on the current status of the Indian pharmaceutical organizations, while article was not representing the facts completely, it did trigger the curiosity to understand, what are the threats we have as an industry, and what we need to do to mitigate them.
Most of my colleagues, who are either regulators or are working with the industry, are unanimous on one such threat, of supply chain continuity. This sounded a little surprising to me. As the industry exists to provide affordable and quality medicine and regulators are more than happy to allow more players into the market to bring quality medicines into the patient reach. Quality and affordability are a motto for both sides. Patient safety is “the priority” for all, regulators and industry. The number of plants and their capacities are increasing, spending on R&D(1) has increased, and number of people joining the pharma industry has gone multifold. Then where is the threat to “supply chain continuity”.
Apparently most, were worried about, regulatory action, which stems out of deficiency in the quality management system, that makes a site or facility, incapable of supplying medicines into the market, till remediation is completed and is verified by regulatory agency(ies). This process when kicks in takes a lot of effort and time from both the sides, till the process is brought on to the track and the trust is re-established, through all protocols being followed.
Going deeper, one realizes that this stopping of a site to supply medicines, by a regulatory agency, should not have happened at first place, because, patient safety and quality are the two wheels on which the industry rides. Secondly, no organization would want to deliberately create a situation, which will call for such a harsh regulatory action, one which will prevent them from providing medicines into the market. Regulators on the other hand are working assiduously to safeguard patient interest. They will not be happy to stop supply of a medicine, if they find it to be safe, efficacious and meeting the quality standards. Most of the recent, “import alerts” or “regulatory actions” seen by Indian industry comes from deficient or unsustainable quality management systems.
So why are we finding it difficult to sustain “quality”. One clue is in the attrition rate of employees in the pharmaceutical sector. If one looks at the attrition rate in the pharmaceutical industry, it is 30 to 40 percent at the bottom of the pyramid (2). This bottom consists of people who are at the R&D bench, running experiments, or at shop-floor, manufacturing these medicines, or in the field, selling them.
While manufacturing plants have increased capacity to produce more drugs, the manufacturing processes are becoming complex, and sourcing of materials to manufacture drugs has gone global. All this and high attrition at shop-floor, has increased pressure on “quality manufacturing”. The organization is stretched at the core to produce drugs, and at the same time is struggling to keep the required positions filled. Thus, we hear a high performing organization, suddenly is in the news for all the wrong reasons.
Taking its toll on the capability building of the personnel, who are manning operations. The current learning and development departments are still operating under traditional concepts of class room trainings or “read and learn”, collectively called as “apprenticeship model”. This model coupled with high attrition at the bottom, besides the increased complexity of manufacturing operations, is totally out of the sync with the current realities. These classical approaches of capacity building need a lot of time and effort to produce a slow and difficult to evaluate improvements; whereas, the need of the hour is to have a paradigm shift in our technical training methodologies.
Let us take a classical example, where a trainee is trained on a standard operating procedure (SOP). The apprenticeship model of training process which is currently followed in the pharmaceutical industry is described in the following chart:
The success of this SOP training is dependent on following factors:
1.
Complexity/simplicity of the task
2.
Learning ability of the trainee
3.
Resources available to learn
4.
Availability and time of “trained” personnel
5.
Availability of infrastructure to teach
6.
Time and its quality spent on teaching
This classical apprenticeship (class room training) model, though is
rigorous, but on an average takes several weeks to months, for an apprentice to
complete the training. The expansion of manufacturing capacity, has led to increased
requirement of trained manpower. Ironically, the current trained manpower is
stretched not only to complete the increased manufacturing activities, but also
is expected to train and qualify new operators and analysts. Over and above a high
attrition of these trained operators and analysts has left this model
completely ineffective.Therefore the current challenge, that the industry
faces, has to rethink and strategize, on how we train and qualify our personnel,
to match pace with the growth.
21 CFR 211. 25, USFDA states, “Each person engaged in the manufacture,
processing, packing, or holding of a drug product shall have education, training,
and experience, or any combination thereof, to enable that person to perform
the assigned functions.” (Highlight is done by author)
The focus of apprenticeship model is on education, training and experience,
which are very crucial for sustained quality manufacturing and operations.
However no consideration is given on the “assigned functions”. These functions
are taken “as is” and no thought is given on rationalizing these functions,
with current manpower and their competence.
Rationalization of function:
Delving into history, the answer was discovered by Henry Ford, around a
hundred years back, where he quotes, “I have heard
it said, in fact, I believe it's quite a current thought, that we have taken
skill out of work. We have not. We have put a higher skill into planning,
management, and tool building, and the results of that skill are enjoyed by the
man who is not skilled." In-line to
what Ford said, we cannot reduce the expectation of reaching bigger markets with quality
standards and lower costs. In-fact, that will be counter intuitive to
innovation and development. We also need to be prepared to face the current
challenges and realities, of a people turn-over due to the exploding employment
opportunities.
What we need is to invest in:
1. Designing our processes; for example if we consider explaining this, using a simple process of data
collection or documentation, which needs to be designed for manufacturing or
testing functions. The key questions, that seek answers are:
a.
Do we have the right people, who understand what critical data is?
b.
Do the people have information on what needs to be collected?
c.
Do they know how it will be collected in real life situations?
d.
Do they know who will collect this data, and what are the realities at the shop-floor?
e.
Do they know why it is important to collect a specific data and what may go
wrong?
If we have, a “Yes” as an answer to all the
above questions, we have our dream team, which can design the documentation
process. If not, we need to invest in capacity building of this team, before
launching on any documentation process, which will be handed off to the manufacturing
or testing department.
2. Understanding the functions, we expect people to perform; while drug
manufacturing process is designed by Scientists who are better read than the people,
who actually manufacture the drug, the information cascade does not always take
this difference into consideration. Therefore what appears obvious to many may
not be obvious to people, who are at the doing domain. The key questions, that
seek answers are:
a.
How is the current man-power (with all its turn-over etc.) going to handle the
documentation process, besides being involved with the manufacturing function?
b.
Are the documentation processes easy enough for every doer, (with little or
no telling/teaching) to be completing the data collection activity accurately
every time?
Remember Ford, when he said“I'm going to democratize the automobile,
when I'm through, everybody will be able to afford one, and about everybody
will have one." This thought
changed the way automobiles were manufactured before Ford(3). Ford
inaugurated the era of “mass production” and the car was transformed from a
luxury item to a necessity. What is
required in today’s pharmaceutical industry is to do a Henry Ford for our Human
resource capability building processes.
3. Process
Management Tools for today and
tomorrow: Quoting one of
Ford's maxims: "Everything can
always be done better than it is being done." The key questions, that
seek answers are:
a.
Are our tools (formats, documentation controls) for documentation processes
apt for the current requirements and for the foreseeable future?
b.
Have we challenged our documentation processes to fail?
c.
Are there better and simpler tools, which can be applied?
The classical apprenticeship approach focuses on telling operators and
analysts about ideal processes (documentation process, as we took the example),
which is both cumbersome and perhaps time consuming, while the radical thinking
approach focuses on the real life processes and how these processes will integrate
in the current infrastructure and in parallel build people capability. This in
the experience of the author has provided exponential results.
Today, the Indian pharmaceutical organizations are at the same cross-roads,
where Henry Ford was a hundred year ago. The path we choose to tread on today,
will take us to the next level, of creating a human infrastructure that will cradle
the physical infrastructure for the next hundred years and beyond. Henry Ford’s
concepts are testimonial to this.
Contributed by Vishal Sharma
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