From the present through 2020, the Indian pharmaceutical market is expected to develop and expand rapidly under the Indian government’s “pharma vision 2020.” This initiative presents significant opportunities for pharmaceutical companies, and the companies that serve them.
Working in India can be tough for a Westerner. The change in climate is nearly as significant as the change in culture.
I stepped off the plane in Mumbai at three in the morning and instantly felt a blast of heat like the hottest days in New York City. The airline pilot had made 37 ºC sound so pleasant. I would learn half a day later that 37 ºC is fairly cool compared to the 46 ºC midday temps. I was met at the airport by a driver from the hotel who told me that at this hour there would be no traffic; yet, two minutes after exiting the airport we were in bumper to bumper traffic, with vehicles from every direction trying to squeeze in wherever there was a sliver of space. We sailed through many red lights, drove against traffic, and veered much closer to other vehicles than comfortable on the 10 kilometer, hour long drive to the hotel. There were people everywhere — children, parents, even grandparents — packing the streets at four in the morning. Surely those who say New York City never sleeps have never been to India! It takes getting used to seeing the amount of people and animals walking and living in the streets. Villages of makeshift shelters can be seen on almost every street often times with large groups of cattle, oxen, goats, and dogs living among the people.
The aim of the project is to create a sense of urgency surrounding a fledgeling culture of continuous improvement for the quality control (QC) labs for one of the leading Indian pharmaceutical companies. Traveling to the client Monday I learned what the driver meant about traffic. During the day, the roads are a disorganized hurricane of people, scooters (typically transporting four or more), cars, buses, trucks, and livestock — all simultaneously trying to push through the madness with blatant disregard for traffic rules. This causes the ride to the site, eight kilometers, to take nearly twice as long as the drive from the airport. Amidst the constnant sound of beeping horns it is hard to imagine seeking tranquility here (it was not until visiting some of the religious and historical sites that I began to understand how peaceful India can be). Taking it all in for the first time, I feared it would be difficult to create a burning platform in such an atmosphere.
Even though the project scope is QC, ariving on site I am greeted not only by the QC lab managers but by the head of quality, the head of operations, and the managing director of the site. They treat me as if I am a friend they have not seen in years and do everything to make me feel welcome and comfortable. This hospitality includes bringing in special bland meals for my sensitive Western digestive system. Following an introductory presentation, the site’s managing director takes me on a tour of the facility, proudly showing off his organization. After a warm handshake, he leaves me to speak with the lab managers.
The discussion with the QC managers starts off unconventionally. Rather than speak about the labs, they ask about my personal life: “Are you married? Do you have a girlfriend? Why not?” Each question asked in rapid succession. It reminded me of Thanksgiving dinner interrogations by my aunt and uncle. I had been asked about my family status before, but nobody ever wanted to know why. To perfect the familial tone of the conversation, they urge me to learn how to cook, so I can find a wife. As they so delicately put it, I am not getting any younger after all. It became clear to me that a personal connection is a significant step in developing a professional relationship in India.
The managers were as eager to point out their department’s challenges as their strengths. They struggle to meet their cycle time expectations. They believe this stems from capacity constraints and a deficient right first time (RFT) rate, although neither are measured. Not having established key performance indicators (KPIs) would make it difficult to perform due diligence. Establishing KPIs is critical to the balanced scorecard the corporate office was developing. The conversation must be cut short as the plant management begins to gather for our kick-off presentation. I personally introduce myself to each of the meeting participants as they come in, noting that everyone is welcoming and respectful. I made sure to adapt to the more formal exchange of business cards. In India, people present and accept business cards with both hands, treating the cards as an object to be cherished.
The presentation starts well, but when I mention an example of a Kanban inventory management system that was rolled out at a similar facility, I notice a few people shaking their heads. I explain that by using Kanban they could optimize replenishment because for each item there is a clear signal of how much needs to be ordered — and when — to avoid shortages. Still I was met with head shakes. I continue to a different example and notice even more people shaking their heads. After the presentation, the managing director talks about how exciting the opportunity is for the site, and pledges that everyone will be available for the project. Everyone leaves echoing the sentiment of the managing director. I am confused. While presenting, everyone was shaking their heads — but afterward they promised support.
I approached the chemical manager and ask if she thought the message had been delivered effectively. She nodded and said it was very clear. I asked if she thought the other managers bought in. She began to shake her head, and added, “Oh yes, they are all very excited for the project to help our site improve.” Then it hit me. In India, nodding and shaking your head are both signs of agreement rather than opposites.
Next, we planned a very busy week, one filled with interviews. However, for some reason, when I checked my mail back at the hotel, I had no Outlook invites.
The next morning, I mentioned that I did not receive any Outlook invites for the interviews. The manager explained they do not use e-mail much and then handed me a printed schedule. I was concerned that people may forget. She told me not to worry. She would make sure everyone came. I was worried, but I smiled and went along with it. What else could I do?
After the first three interviews, I was impressed. Everyone showed up on time even without electronic reminders. Unfortunately, I did not get much information from anyone. I asked openended questions, so the interviewee could speak more freely; however, it was not fruitful. Most responses consisted of only a few words. The first few believed that the only challenge was meeting the cycle time expectations. They gave the same reasons as the managers: There are capacity constraints, and the struggling RFT rate would improve as newer hires gained expeireince. Contrary to my intuition, I decided to try asking less open-ended questions and found this technique elicited more robust responses.
The quality assurance (QA) manager responded particularly well to this style of interview and provided additional insights. He believed that performance management was difficult for the QC managers because they had little in the way of KPIs for their teams, making it a challenge to identify and remediate weaker performers. He also believed that the analysts might struggle working together on project teams because the site as a whole had not embraced team-building initiatives proposed by human resources.
I applied the same technique, starting open ended and moving to more direct questioning, when I started speaking with the analysts, but it was very
difficult to coax information from them. This was partly related to weaker English skills, but even those who spoke very well struggled to envision their workplace differently. Following the interviews I realized I needed to spend extra time in the lab to find answers.
I knew the supervisors gave out the day’s testing assignments when they arrived in the labs. What I did not know was this: The analysts arrived 20 to 60 minutes prior to their supervisors. As I walked through the labs I noticed most of the analysts were idle until their supervisor’s arrival. Some supervisors would assign work during group meetings, but others met individually with their analysts, which occurred about 20 minutes before the start of any testing.
After assignments were given out, I asked a supervisor about what he says to his team. He tells them the test method(s) they will perform that day. I ask what the analysts do prior to the supervisor’s arrival. He informs me they are to work on corrections, preventative maintenance, or sample prep. I had observed mostly conversation.
I am bewildered that this had not come out in the interviews. The scheduling process was causing them to lose their workforce for somewhere between 40 and 80 minutes daily. Most of the analysts work a minimum of one hour of overtime daily, meaning a predetermined schedule could result in significant reduction.
I spoke with the supervisors to check up on the assignment I had given them — to begin tracking the RFT. Each supervisor told me it was going well and there were no problems. This was great news because I needed baseline RFT information to make a proper assessment.
With the second week coming to a close, the last thing I needed to create a comprehensive list of potential improvements is the RFT data. I head to the labs to discover that only four of the 10 supervisors actually had the data. I was disappointed because I had spoken to each three times and always heard they were recording the data and everything was okay.
Some of the culture shock subsides during my third week in India. It is no longer terrifying when the driver goes through red lights — on the wrong side of the road.
This week at the site we are discussing which recommendations will be part of the first wave of ongoing improvements. I have meetings set up to speak with relevant supervisors to shore up recommendations and to review with the managers before presenting to the steering committee.
The first thing on my agenda is scheduling, clearly in need of reform. I present the current state and recommend how it would be more effective to plan in advance and use visual boards to assign testing on a weekly basis. The supervisors, however, do not believe that the current process is ineffective, and they are concerned that change means more work for them. I try to explain the value by showing how many hours the team will save every week. For some supervisors this is enough motivation to give it a try; others remain skeptical.
The next topic I address is the frequency with which they prepared the mobile phase. For every test that required the mobile phase, analysts would prepare the amount needed for that test. In my experience, it was prepared in bulk to be shared until expiry. When I proposed the idea to shift to a bulk preparation model, they claimed they needed to prepare daily because the mobile phase would expire the next day. We consulted the SOP for the creation of the mobile phase — an expiry of three weeks from the date it was made. We debated the value of having one person create a large quantity to be shared, but I still had trouble convincing them. I brought the chemical lab manager into the discussion. Upon understanding the time savings by switching to bulk preparation, the manager decreed that this is how it would be done going forward. The supervisors conformed by simply shaking their heads in agreement once the manager became involved.
Observing the immediate compliance from the manager’s directive, I decided to have the manager speak to the supervisors about the RFT data. As a result, 10 out of 10 supervisors dropped off data that Friday. I understood that there was a much more hierarchical organizational structure in India than in the States, but I assumed people who were used to directive management would be empowered by being given more autonomy. So far I was wrong.
Presenting the findings and recommendations encouraged a lot more discussion at our steering committee meeting. It was much less perplexing giving a presentation to a room full of people shaking their heads this time around, despite my Western instincts. The chemical manager was proud to announce she had already introduced the change to the mobile phase preparation, claiming it would save at least 20 hours per week for her team. After the meeting ended, the managing director and head of quality stayed behind to personally thank me for my efforts and to let me know how happy they were to have an outsider helping them improve.
With a handful of initiatives to work on, we started on the journey toward change. I would need to involve myself to a greater extent for two of the initiatives — 5S implementation and the scheduling reform — that required paradigm shifts, moving away from inefficient internal practices that weren’t considered problematic.
5S is essentially what our parents asked us to do with our bedrooms growing up.
• 1st S: Sort. Remove all unnecessary items and clutter.
• 2nd S: Set in order. Organize all items close to their point of use maximizing space and working efficiency.
• 3rd S: Shine. Perform a deep clean of the area.
• 4th S: Standardize. Put into place regular upkeep habits, and make sure like workstations are equally equipped.
• 5th S: Sustain. Measure upkeep in the form of periodic audits while searching for further improvements.
In the workplace, 5S boosts productivity by keeping items organized close to their point of use to maximize space.
I changed my approach to be more directive during the initial meetings. For the 5S group, a supervisor was assigned to oversee the other four members of the team (analysts). The analysts were each assigned a quadrant of the lab to start tagging items for removal. The scheduling revamp involves creating visual boards for the labs, having supervisors prepare weekly schedules, and having a brief meeting to kick off the shifts. The supervisors did not really want to go through with this because they doubted they would see improvement.
I instructed the supervisors to prepare the schedule for the following week by Thursday, so we could update the boards on Friday.I made sure to check in with the supervisors toward the end of each day to ensure compliance. Thursday afternoon came around. Only one supervisor had prepared the schedule; others promised it would be ready the next day. I took the opportunity to try to galvanize them into action. I reiterated the significance of this initiative, assuring them that scheduling would become effortless with practice. I asked if they would be able to produce the schedule prior to a Friday morning meeting where we would put the assignments on boards.
“Yes,” they told me definitively.
Friday morning, I decided to check the raw materials lab where we started our 5S initiative. Based on the feedback form, supervisor items should be tagged ready to start setting in order. I walked into the lab and did not see a single tag. There were two analysts present, so I asked why there were no tags. They informed me a malfunctioning piece of equipment caused them to get behind on testing. I found the tags and worked with them until the supervisor arrived to assign their testing. I spoke to the supervisor. He said they had too much work this week to get to 5S.
When I asked why, he explained that they had been working on it the whole week, and he expected they would have time before today.
As the supervisors arrived and assigned testing for the analysts, I worked on the scheduling boards. Of the 10, seven showed up for our meeting prepared to put assignments on the boards. We worked together in one room and finished the boards very quickly. I asked how long it took put together the plans, and was pleasantly surprised when they told me it took less than two hours for the largest team. I reminded them that each morning it takes at least 20 minutes to individually hand out assignments, so their workload was not impacted this week, and it would only become easier as they adjusted to the new practice. With the posted schedule, the analysts would no longer need to ask their supervisors if they forgot about what their second assignment was or which sample to test, currently a common occurrence.
The other three supervisors told me they would be ready on Monday. Instead, I instructed them to gather what they needed and start working on it, with my help. They were impressed that developing a schedule and posting it took under two hours. Once they personally experienced that this was not the undertaking they dreaded, they became more optimistic.
At the end of the day, I spoke with the managers about the project progress. Unfortunately, they had not heard many specifics about the other initiatives
because they were busy with an internal audit. I had that heard things were progressing when I spoke to supervisors, but after today I knew I had to see it with my own eyes.
I was a little apprehensive on the way to the site Monday morning. The initiatives I was most directly involved with were not moving at the speed I expected. What about the other ones?
I decided that this week I would relocate to the labs to make sure everything kept moving. It proved to be the right decision. My increased presence (even before I could speak to everyone) inspired renewed efforts. My previous approach worked well in the States where people prefer autonomy at work, but here I needed to adapt to the culture by being more directive and visible to keep things moving.
As the weeks flew by, most initiatives were a few days behind where I had planned, but the teams were putting forth appropriate effort. A significant challenge was substandard infrastructure and hardware: sporadic Wi-Fi, space at a premium, and not many computers. These factors worked to limit collaboration especially for non-testing work.
Even with the infrastructure working against them, they maintained momentum once they got started. It is amazing how resourceful the people are. No matter what, they will accomplish a task assigned to them by their superior. This was something I learned to leverage as time went on. As long as the task is well defined with many touchpoints, and administered by the person’s direct superior, there will be continuous progress. The people have an amazing work ethic and a strong desire to impress their managers and their peer group.
Seemingly out of nowhere, it was the night before my departure. The final presentation had been a big success earlier in the day, and I was starting to pack my bags. The project had succeeded in instilling a culture of continuous improvement in the labs. Supervisors who had once been reluctant participants were now champions of change management, effectively leading the initiatives on their own. The cycle times were also starting to come down thanks to some optimized processes and superior organization. With an understanding of the value change can bring, the site lit the burning platform, taking action today instead of accepting today’s problem as tomorrow’s reality.
I would be very excited to come back and work in India. If I had another assignment there, I would arrive with this knowledge:
• Things may take slightly longer than expected.
• Interpersonal communication can be challenging with shop floor employees due to the language barrier and a reluctance to question a person of perceived authority.
• There needs to be constant touchpoints to review in-progress deliverables.
• I must adapt to the culture by utilizing the hierarchy to my advantage and assigning very specific tasks.
The people are not only incredibly hospitable but have a strong work ethic and are uniquely resourceful. No matter what brings you to India, it will be the people that bring you back.
By Thomas Ambrogio, Consultant, Tefen USA