Robert Bishop, CMRP, CRL, is plant manager at Toronto-based Chemtrade’s Syracuse, NY, sodium nitrite manufacturing plant. Last fall, the Society for Maintenance and Reliability Professionals (SMRP) named him one of the society’s two CMRP of the Year recipients; he was recognized in the Rising Leader category. Previously the manager of maintenance and reliability at Bristol-Myers Squibb Co., Bishop, who also chairs SMRP’s Pharma and Biotech Shared Interest Group, spoke with Plant Services about the compliance challenges in the pharmaceutical and food and beverage industries as well as the importance of strengthening interdepartment communication and collaboration.
PS: You have a bachelor’s in mechanical engineering from the University of Rochester and a master’s in bioengineering from Syracuse University – how did that background help lead you to a role as a maintenance and reliability manager at a pharmaceutical company like Bristol-Myers Squibb?
RB: I’ve always been an equipment-type person. I always feel comfortable around equipment. Like, this weekend I’ll be changing the brakes on my car. I decided to go for my undergraduate degree at the University of Rochester – I put myself in a little bit of an uncomfortable place because UR is more of a theory than an application type of school. I knew that going in, and I enjoyed the challenge of that. When I got out of school, with a mechanical engineering degree, you can pretty much do anything, which is kind of a challenge. I ended up working for a company in Rochester. That gave me exposure to the pharmaceutical industry, and it didn’t take me long to realize that I wanted to work in the pharmaceutical industry, and so I ended up going to work for Wyeth Pharmaceuticals.
I was still involved in the equipment side but on more of the compliance end, so computer validation, equipment qualification, cleaning validation (to ensure removal of residues from the pharmaceutical production process) and that kind of thing.
Back in ’06, Wyeth decided they were either going to close or sell the site that I worked at, so that prompted me to look proactively and not wait for that to happen. I ended up in Syracuse, New York (and at Bristol-Myers Squibb). So I was still dealing with equipment qualification, cleaning validation, that side of things – a lot of the compliance aspect – but I’ve always worked in more of a facilities and engineering group.
PS: How did working in the highly regulated pharmaceutical sector, with its strict compliance reporting requirements, affect your thinking about and approach to reliability?
RB: Within the pharmaceutical world, and I think if you carry it to food and beverages, too, a lot of the challenges have to do with making sure that you have the right certification in place. Having to deal with the documentation creates a mentality where your thought processes are more through, your documentation is more thorough, and so as you go through any kind of project, you tend to think it out a little bit more. When you do investigations, for example, if you have an equipment failure or something, those investigations tend to be more of a true root-cause (type of investigation). I would say that it’s still a step below a nuclear (facility) or industries like airlines, places where failure is not acceptable at all. Having a piece of equipment fail in a food or pharmaceutical type of environment doesn’t usually result in an injury to people. It’s usually an injury to your bottom line. Having that documentation (requirement), although it is a challenge, I think that it is a very unique benefit to those industries.
PS: You’ve made a move into the food and beverage world and are taking on a new position as plant manager – what challenges and opportunities do you see in your new role?
RB: Bringing, you know, the history that I have and applying some of those thought processes within a different context. Anytime you (shift) from one paradigm to another, making sure that you don’t assume that your experiences or your culture that you’re used to is better. You have to assess the culture where you’re going; you have to make sure that you have a thorough understanding before you start changing things on a whim. You have to make those decisions about where (potential) changes are and possibly admitting to yourself that a change isn’t necessary in some cases.
Some of my experiences in the past have led me to go very in-depth when it comes to some of the documentation. So for example in an equipment failure, historically I might have gone through and done Ishikawa [cause-and-effect] diagrams and 5 Whys and done a formal (investigation) that could end up taking 50 to 100 hours’ worth of people’s time to complete that investigation. That’s costly to do. And in reality a lot of times, a couple hours, two or three hours, without the rigor around it, can still give you that gut feeling and get you very close to the same endpoint. And so I think not necessarily not doing an investigation but more about the level that you take that investigation; I think that’s an example of where I went ahead and changed my expectation to still do the investigation to get to that (end)point but not necessarily through the same rigor.