AZ Puts Proactive in Reliability

Biopharmaceutical manufacturing company AstraZeneca redefines reliability to streamline more-effective maintenance processes.

Even though the AstraZeneca manufacturing facility in Mt. Vernon, IN, looks like a hospital surgical unit—with key equipment separated into concentrated clean rooms—for years it operated like an emergency room. When an equipment breakdown occurred, personnel jumped into action, triaging the issue and not always looking into the true symptoms to prevent future occurrences.

At AstraZeneca, separating the reliability people from the day-to-day commotion, defining the difference between reliability and maintenance, and management support were keys to a successful transition to a reliability-oriented operation. Photo: AstraZeneca

The company acquired the Mt. Vernon facility in August 2015. With a new reliability unit in place and an Operations Excellence Team, the site now has teams focused on preventing emergencies, instead of addressing them.

Reliability and maintenance can be a challenge when maintaining a high standard for the pharmaceutical environment. As you walk through the facility, the white walls and floors glisten against the shiny, almost mirror-like, stainless-steel equipment. Equipment and personnel rooms serve as airlocks between the corridors and the manufacturing rooms. The airlocks are guards against dust, dander, allergens, or other elements that could contaminate the critical medicine that is being manufactured. The switch from a reactive to a proactive, risk-based, approach has taken reliability in the 700,000-sq.-ft. manufacturing area to a new level.

“Our first step was to separate our reliability team from the day-to-day commotion,” explained facilities engineer Andrew Carpenter. “We had to be sure they understood that reliability is different than maintenance, and we had to all take this seriously. We had many people who were specialists and were relied upon for troubleshooting and fixing emergency issues. It was a complete mindset change.”

The new reliability team received support from upper management and buy-in from the team. Although some roles changed, the team remained headcount neutral. This, along with clear alignment of goals, became the keys to a successful transition.

“If you are starting a reliability program in your plant, call it what it is,” senior building and reliability manager Chris Nolan said. “Reliability is different than maintenance. The goal is to get to a certain utopia. As your group grows, you all become more focused on that reliability side, but when you are starting out with a reactive-maintenance program, and you want to transition to one that is reliability based, there is a different vision. This must be explained and understood.  Now we have processes in place to aid in the prevention of emergencies and more organized efforts to quickly respond should the need arise.”

With an investment in new tools and technology, including additional vibration, infrared thermography, and ultrasound training, the newly structured, two-year-old team measures its return on investment in high-quality performance and products.

“A key driver within our business is quality,” Nolan said.

AstraZeneca is a science-led, biopharmaceutical business that discovers, develops, manufactures, and supplies innovative medicines for millions worldwide—primarily in the areas of respiratory, cardiovascular and metabolic, and oncology. The Mt. Vernon site manufactures oral-solids medicines—primarily for Type 2 diabetes treatment.

The maintenance and reliability group focuses on maintaining the utilities, purified water, HVAC, manufacturing equipment, and all Good Manufacturing Practice (GMP) maintenance.

Maintenance technician Dan Guth concentrates on a detailed work request in the maintenance shop.

A new process

The Mt. Vernon-site reliability team adopted a common mission statement from the industry. “Anyone who improves a process or a piece of equipment is a reliability leader.”

The simple vision was broken down into specific goals and targets. Nolan explained that 2015 was all about building a foundation, while 2016 was the year to focus on root-cause analysis. The team received early help from consultant group Life Cycle Engineering (LCE, Charleston, SC, LCE.com).

“In pharma, when somebody uses the word ‘criticality’ they go straight to quality,” Nolan said. “LCE helped us identify the tools we needed to show overall criticality—business cost, quality, mean time between failure. Andrew [Carpenter] led us through a criticality assessment at our site and we banked that into different categories, including equipment, water purification, parts redundancy, and packaging items. Now we do an assessment and re-rank our critical categories that need attention every year. We are in the process of doing that now. This helps us focus our efforts and has become a game-changer for us.”

The reliability group became its own entity within the plant’s maintenance organization.

“We were doing a really good job of fixing issues, but needed to work on following up after the issue, getting to the root cause, and putting processes in place to prevent the issue from happening again,” Carpenter said.

Two years in, Carpenter and Nolan are beginning to see the fruits of the team’s labor. “We can see that it is working and we have come a long way.”

Maintaining the reverse-osmosis purified- water-generation system at the AstraZeneca plant is critical to ongoing production.

Early wins

Redefining the maintenance and reliability functions was an anchor in achieving some early wins for the new team.

“We are all here to get the product out of the door, but the difference is simply the things we focus on,” Nolan said. “Maintenance right now focuses on the day-to-day activities—the preventive maintenance piece and execution of that at a high level. But when you are executing you are challenged on the day-to-day things, so it is hard to find that balance of time to take a look back on the long-term items, like the vision. For us, the difference between maintenance and reliability is that reliability is getting into the data mining of the maintenance activities. Particularly in the pharma environment, that is a big piece that ties back to the quality culture, as well. The maintenance piece is very tactical, while reliability centers around more planning and vision.”

Carpenter said the team’s vision began to take shape when it zoomed in on the root-cause analysis program. About six months into the program’s launch, Nolan began to notice a distinct change in the culture.

“It was a Friday afternoon before a three-day holiday weekend and normally everybody was ready to scoot,” he said. “We had one of our metrology calibration technicians and engineering technicians having a serious conversation about a particular problem. It turned into an hour-and-a-half discussion of digging into really finding the problem, turning it into a root-cause analysis. That is the first time when I really thought this whole program began to click. These guys were looking beyond the fix and they were passionate about preventing it from happening again.”

Andrew Carpenter, Neil Reichel, Chris Nolan, and author Michelle Segrest (l-r), discuss reliability and maintenance operations in the AstraZeneca maintenance shop.

Carpenter explained that the change involved a clear switch from simply fixing a problem to a focus on the big picture. “We are better at documenting the data and finding ways to prevent failures,” he said.

One of the areas the team focused on heavily at the start of the reliability program was predictive maintenance. Engineering technicians and predictive-maintenance technicians were sent to Level I vibration, infrared, ultrasound, and laser-alignment training. It didn’t take long to see the return on investment.

Nolan said another key win was bringing the storeroom into the reliability discussion.

“The storeroom is a key to reliability,” Nolan said. “Paying attention to what is going on in the storeroom tells you what is going on in the plant. What goes out of your storeroom is a huge check and balance of your maintenance process.”

Realizing how much can be learned from problems and mistakes also made a big difference.

“Problems are gold,” Nolan said. “Problems within your processes give you ‘aha’ moments. This allows you to bring people together to look at what is going on and talk about how can it be better. Don’t ever be afraid to share a problem because usually it can positively impact you, your group, or someone else.”