2018

QUALITY IN THE FIRST PERSON

Against the Grain

Standing your ground when the senior majority rules

by Allan Marinelli

In 1993, I introduced the concept of open door studies at my organization without ever having heard of it. At the time, the job requirement for someone in my position, assistant clinical supply scientist, was a bachelor’s or master’s degree in chemistry or pharmacy and a minimum of five years of experience. When I interviewed for the position, there was a pool of 2,000 candidates pursuing the job. Only one candidate was selected, and I was fortunate to be chosen. That made me the youngest scientist on my team working in a clinical phase-three setting for a cancer parenteral injectable drug formulation.

I noticed that the cold room door was being opened several times a day. I was not surprised to hear that stored samples in the cold room were becoming invalid as far as obtaining input information.

Troubled by the observation, I decided to bring up this issue with fellow scientists and engineers. I simply asked, "How do you know for sure about the stability of our product if you open the door more than a hundred times a day, with just a few minutes between each door opening?" I added that conducting a complete open door thermo-kinetic study and tracking product degradation and defects could provide us with data to modify or justify our practices.

Know-nothing or know-it-all?

The team did not want to listen. A senior scientist barked, "Who do you think you are? No one has ever claimed such ridiculous conjectures." The mindset of staff members was that if you challenged anyone above you on the totem pole, you either "lacked experience" or were viewed as a "meddler." Speaking out didn’t help my future at the organization—two years later I was no longer employed there. I couldn’t bring myself to go with the flow when I knew they may not be correct.

I continued working in the clinical science realm, but I never forgot the experience or my idea. Unfortunately, I found similar attitudes wherever I went. Clients and colleagues would respond in a variety of ways. They would:

  • Refuse any open door studies since it is a waste of time, money and resources.
  • Test only the open door phase. Testing the other phases was not necessary and there was not enough time.
  • Test only the phase prior to opening the door and the open door and closed door phases since this pretty much captures all phases.

But testing all phases, the 360 approach, is the only way to ensure complete data inputs. It allows you to subsequently conclude how fast the cold room returns to equilibrium, determine efficiency and explain where product discrepancies result based on cold spot and hot spot analyses.

In 2004, when I became a senior validation engineer and scientist at a pharmaceutical organization, I again mentioned the idea of conducting an open door thermo-kinetic study. I still encountered some resistance, but I was relieved that I piqued the interest of some of the other scientists. I attribute this to now having more seniority and a greater degree of quality adoption in the industry.

Recently, it became standard practice to perform open door studies. Conducting open door thermo-kinetic studies is relative to current good manufacturing practices. When it comes to cold rooms used to store pharmaceutical products, quality is a factor that must be accounted for. Often, the U.S. Food and Drug Administration will request reports from these studies. 

The funny thing is, 25 years later, some of my former colleagues that I kept in touch with at the organization where I first introduced this idea eventually apologized. They said they unfairly judged my ideas because people were more resistant to change. They also didn’t like the fact that I was younger than most members of the team by at least 15 years.

My advice to young people with big ideas is to have conviction and to believe in yourself. W. Edwards Deming suggested to Americans in the 1950s to build quality into the product, and no one wanted to listen—but they did in Japan where his teachings became widely endorsed and adopted long before they were instituted in America.

If they don’t want to listen or acknowledge your perspective, it doesn’t mean that your idea is bad. It could mean you’re forward thinking and the rest of the group isn’t there yet. Reflecting on my experiences and possible missteps, speak up in a way that advances the organization’s goals. Come well prepared to meetings and be armed with informed opinions, recommendations and data. Address your colleagues with honesty, curiosity and passion. Leave the ego at the door and present yourself as an advocate for the team and the organization.


Allan Marinelli is an international quality validation engineer and senior consultant at Quality Validation 360 Inc. in Zephyr Cove, NV. He holds a bachelor’s degree in chemistry from Concordia University in Montreal, Quebec.



Hi Allan,
Nice Article. I can very well relate with what you said as I too faced similar situations ! Your example & analogy with Deming & Japan is absolutely bang on. Thanks & regards, Shrikant.
--Shrikant Mehta, 08-30-2014

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