Context Matters

Progress is impossible without the ability to admit mistakes. – Masaaki Imai

My path to project management is only clear in hindsight. I grew up just southwest of Bloomington and just north of the poverty line, in rural Indiana where basketball is king and girls in those days typically become teachers or nurses. This was good, necessary, and compassionate work, but I didn’t have that calling.  My Mom had stayed home with me through elementary school and eventually she started cooking for minimum wage and tips at local diners.  We scraped by. Even as a kid, I was keenly aware of our finances.  It was one of the reasons I started serving ice cream at fourteen.

I was a freshman in high school when in a desperate effort to stabilize our home life, Mom drove into the big city and got herself a factory job. I was old enough to find my own way to school, so she worked the first shift, 7:00 am to 3:30 pm. She punched a clock, took a thirty-minute lunch, and told me stories about making specialized in vitro fertilization catheters by hand in a small, gleaming white lab space, gowned up in clean Tyvek coveralls and latex gloves. It might as well have been a different planet from the hot, steamy kitchens she was used to. 

I was immensely proud of Mom, even my immature teenage brain could see that this type of work was meaningful. I could sense her growing self-confidence as she started to move in the wider world. She met new fascinating people and took on increasing responsibilities. It didn’t solve all of our troubles at home, but she became the role model I was searching for.  She demonstrated how to see a problem and address it with whatever resources you’ve got.   

It was through Mom that I entered the world of pharmaceutical contract manufacturing.  Knowing that such places existed, and seeing the pride she took in her work, I almost couldn’t imagine doing anything different.  I didn’t want to spend a career making widgets or gizmos, I wanted to make drugs. Well, let me clarify because sometimes that statement gets me in trouble. I wanted to make medicine.  I wanted my nerdy love of spreadsheets and Gantt charts to benefit others in a real, tangible and direct way.

I may have avoided traditional manufacturing, but that’s precisely where many of my favorite operational planning concepts originated: automotive manufacturing and telecommunications. Without the foundations built by Walter Shewhart and W. Edwards Deming, such as control systems, tolerance limits, and total quality management, the CDMO industry would not have been able to produce 200 million doses of Modern’s mRNA covid-19 vaccine in unprecedented time. Shewhart and Deming’s work, applied to pharmaceutical manufacturing almost a century later, saved lives.  

In my opinion, it is the simplest of Shewhart’s contributions that ultimately has had the most outsized impact.  Shewhart, a physicist, engineer and statistician, developed the iterative design and management methodology, called the PDSA (Plan, Do, Study, Act) during his time at Western Electric and Bell Laboratories in the 1920s.  His work greatly influenced Deming, the “Father of Quality Control” who incorporated Shewhart’s model into his operational management principles and used them to revolutionize manufacturing in post WWII Japan.  

The PDSA cycle provides the underpinning of the final step of the Conceptual Gantt Planning System (CGPS) approach to project management: Iterate.  For a brief recap, project managers using this approach are operating within the context of their project’s reality.  They oriented by defining where they are, and where they want to go.  The scope, or all of the steps from here to there, are identified and written down in the form of a list or outline.  They have sequenced each step, placing them in position based on their relationship to the other steps within the project.  The project manager then considered and applied the known constraints and documented planning assumptions.  Where possible, these constraints have been reconciled to the project through adjustments in resources, time or project goals. 

Finally, we come to iteration.  This step is the application of the Shewhart cycle to the project in an iterative, repeated cycle.  We set the plan, execute the plan, study ourselves against the plan, and then we take action to adjust the plan.  The ongoing process of continuously, methodically, checking into the plan and adjusting for reality is conducted periodically throughout the project execution phase. The iteration step is like a flashlight, first pointing backwards to appreciate where we have come from and then pointing forward to illuminate the next step on our critical path. Iteration requires that we take in what we see, as feedback, and then adjust the plan accordingly.   

Iteration requires discipline, time and data to be effective.  Project managers who systematically iterate add strategic value by identifying new information, enabling rapid objective decisions and implementing effective adaptations. When organizations talk about being “nimble,” it is the PDSA cycle of continual iteration that they have perfected.   

Through Mom, my first pharmaceutical manufacturing job was also on the production floor. I could be found in my Tyvek bunny-suit, buried in the basement of the cavernous manufacturing building, washing dishes in “Prep”.  We prepared materials, and equipment, for entry into the clean and controlled production spaces. Part of my role was to clean stainless steel equipment, pipes and valves and various connection pieces, in giant sinks with high pressure water for injection and isopropyl alcohol.

The Prep room was spotless, immaculate, everything in its place. A Supervisor handed me the batch records each morning, and I carefully documented every bit and bob that I scrubbed. Sometimes we wiped down cardboard dust from pallets of glass destined for the clean rooms.  It was my first direct exposure to current Good Manufacturing Practices (cGMP).  Our small crew of summer temps was allowed to play music and chat while we worked. I made new friends and good money for a college kid. 

I met Mom’s friends from the IVF catheter lab, learned to read the step-by-step standard operating procedures, observed routine microbiology testing of the water facets, and learned to pronounce “bromobutyl” rubber. I watched the Formulation crew, in full sterile gowning, move within the clean rooms, their faces obscured by foggy safety goggles and every inch of skin hidden by Tyvek. When we needed supplies, I searched in the maze of racking running through the warehouse. The cafeteria was full of maintenance technicians, operators, buyers, chemists, microbiologists, and IT specialists. The facility was a buzzing hive of activity, every worker bee knowing their role and operating in service of the patients.

One morning, after clocking in and receiving my daily pages, I found myself face to face with an unfamiliar white-haired gentleman. He politely greeted me, and asked if he could spend the morning learning how I perform my tasks. This was new, but my midwestern manners told me not to ask too many questions. Together, we donned our bunny suits, booties, hair nets and gloves, then stepped over the management line and into the clean production space. He watched me closely and mirrored my movements, as if it were his first day on the job.

We spent the morning together, measuring tiny rubber stoppers into the stopper hopper, adding the cleaning agent, and setting the wash cycle. We retrieved a tray of stainless-steel bits and pieces, equipment whose purpose I really could only guess at. He helped me carry the heavier parts, and together we dumped everything into the sink basin. We blasted each piece carefully with hot water, ensuring every surface was rinsed clean and gleaming. Finally, the drying racks were packed, and we tidied up the Prep Room, wiping down each tabletop to a shine, refilling the IPA bottles and hanging them neatly in a row. We dated our paperwork and de-gowned out of the room to clock out for lunch. The kind guy thanked me for my time and headed off down the corridor, I turned the opposite way and rushed to catch up with my Mom so that we could eat together. 

It’s halfway through our meal before I think to share about my unexpected sidekick.  I described his features and our morning, emphasizing how eager he seemed to learn from me, which struck me as a little weird given my lowly position and barely a month of experience. Mom looked at me closely, her expression one of bemused shock, clearly, she was surprised at my naivete and ignorance to the matter. “Melissa,” she says, “you spent the morning with the President of the company.” 

I learned a lot that summer.  I learned how work can be meaningful, no matter what your title is, even if you’re just washing the dishes.  I learned that it takes everyone working together to accomplish big goals.  I saw the value of a plan in and the even greater impact of a plan that was adaptable.  These experiences are the seeds, the context from which my approach to project management, and the CGPS methodology, has grown. Iteration is the final step in the model, but not the final word on successful application.  In the coming weeks we’ll move beyond the process and dive into the practice of CGPS.  The next series of posts will dive into the CGMP tenets for success: Simple, Intuitive, Visual, Objective, Service Minded and Action Oriented.  If you are enjoying the series, please drop me a line! I’d love to hear about how the CGMP process is helping you in your work!

#Iteration