Finishing third last year and fifth this year, the growth of Process Alliance is a testament to our working values, the hard work of everyone on the PA Team, and the trust we have formed with our clients and alliance partners. Process Alliance continues to grow, with a goal of helping more life science companies solve their problems.

With this growth additionally comes the opportunity to continue on our journey of growing and developing the next generation of pharmaceutical engineers and scientists. With a team of over 100 people, and over 30% of those being Early in Career, we’re well on our way. We’re proud of the work we’ve been doing, and are looking forward to where we’re headed!

To see the complete list of honorees and to read more about Process Alliance’s selection, visit https://www.ibj.com/fast25-2023.

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If you are a seasoned engineer, be it mid-career or later in career, you’ve likely faced and overcome a number of challenging technical problems. You have been on and led small and large teams in problem solving stints, managed cross-functional teams through projects and advised leadership in their decision making. Making things better, solving problems, and fixing “stuff” is part of what you do and it makes you feel good. It is satisfying. It is why you probably became and engineer, a scientist and a problem solver in the first place. Yet something is not quite right. Something is missing. You feel it. Maybe you can even articulate it. However, you cannot fix it, you know this to be true, and it frustrates you.

What’s not right? Maybe it is the organization in which you work. Maybe it is the company or its culture. Maybe it’s that guy in the next desk/cube (a sort of Dwight Schrute) that just does not take his work as serious as you. Regardless of the cause, it is impacting the level of satisfaction you know you should get from your vocation, your profession and your career. Well, isn’t it time for that career you’ve always wanted?

What most of us as scientists, engineers and problem solvers want is pretty simple: access to people, access to processes, a clear sense of purpose, partnerships, and problem solving tools. With permission to perform, and some problem solving tools, we can make things better; sometimes a lot better. As we coach and mentor those coming up the learning curve behind us, we are helping to develop the next generation of problem solvers. We have the training, skill, gusto and experience. We just need. . . everything else.

We need things like recognition, respect and trust. We need autonomy to investigate, explore, and to master our knowledge domain. Where are these things? They should be there. Sometimes they are, but rarely enough. So, Yes! At Process Alliance, we agree. There has to be a better way. In fact the phrase “there has got to be a better way” is how Process Alliance got started.

In 2018, a contingent of factory seasoned engineers who accepted early retirement, and were not satisfied that their careers had been fulfilled, created Process Alliance. Our purpose was, and it remains, to create a better model for how problems are solved and solutions are delivered. We provide capabilities and capacity to solve problems for our clients. Our experience and caring mindset brings calm to the chaos that sometimes enshrouds leaders and others in their organizations. Our people help our clients navigate change and achieve results.

What makes Process Alliance special is our culture, and thus our people. So many companies say this, but can they explain why? We can. Yes, we welcome into the Process Alliance (PA) family those with the right “technical chops”. But more importantly, we don’t just hire good technical people, we hire great character. We respect the humanity of each individual we evaluate, and we ultimately we hire the best personalities. Those individuals who put character above capabilities (a debatable choice for some institutions) are often PA material. Humility, caring, inextinguishable work ethic, self-awareness and awareness of those around them are all key PA attributes. We relish curiosity. We are a learning organization, and we practice this (internally) every day.

Our learning model of choice is familiar to some: Plan-Do-Study-Adjust (thank you Shewhart and Deming). Our leadership team actually begins each weekly meeting with a reflection on our people performance in the past week. We look for good and not-so-good stories of our employees performance from which we can learn. We look for evidence of our ability to, or failure to, live up to our Mission, Values and Purpose. We look for Praiseworthy Performance. In these stories, we act to hold up and recognize our PA family member’s performance or their impact on our clients. And, even more important, and with grace, we coach and develop our people to be better – sometimes we find it is us, the leadership (yes top leaders) that need to change and improve. Does this strike you as a better way? We believe so.

Process Alliance is made up of engineers, scientists and a diversely educated support staff. Like a rope made from many strands we find strength in the combination of our Early in Career professionals and our Advanced Consulting Experts, called ACE’s at PA (humbly referred to as gray-hairs and no-hairs internally). We learn from each other drawing upon each person’s unique experiences, knowledge and mental models. We love to share this with our clients to help them solve problems in unique and effective ways. We also value our allied partnerships with other consulting firms. This is how we arrived at our name: Process Alliance. We choose to partner with like-mined organizations that demonstrably share our values. We help each other out and, again, we learn from each other.

At Process Alliance our purpose is to develop a better model for solving problems and delivering solutions. We work every day to be a better model. Our culture is our primary differentiator. Our culture depends on the people we attract, keep, and cultivate. If you are a seasoned engineer and you feel the appeal of what you just learned about us at Process Alliance; if you agree that there has to be a better way; if you want to be part of a learning organization seeking to build a better model for consulting; and if you want to play a part in developing the next generation of problem solvers then perhaps your answer to the title question above is. “Yes – it is time for that career I’ve always wanted.” If that’s you, let’s talk.

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SOPs—Noun
Standard Operating Procedures

Practice—Noun
Actual performance; application of knowledge

Why is it important to review your facilities procedures (SOPs) against the actual laboratory execution practices? Per the definitions above, SOPs typically reflect the execution instructions derived from a validation or qualification protocol. Generally, the SOPs are written by Management or Senior Technical staff. While laboratory procedures are most often transmitted verbally between employees or found in notes “on the wall.” Laboratory practices tend to simplify workflow or use of equipment that the personnel have learned/picked up over their time performing the procedures.

Standard operating procedures (SOPs) are step-by-step instructions that function as guidelines for employee work processes. These are step by step instructions that are written to ensure the product that is produced is consistent and predictable over time.

As the laboratory business grows, the complexity of the work being performed increases, staffing increases, and training workload increases. Simultaneously, there is an increase in the number and types of analytical equipment used, SOPs, and Test Methods. During fast growth, it is stressful for laboratory staff, and it is easy for the executed tasks to start to diverge from the SOP.

Examples include:

OA Test Method was written while the lab was new and had a limited number of analytical equipment. The method describes a bioassay where the process has not changed, but specifically defines the plate reader to be used. At the time it was written, there was only one plate reader. Due to growth, now there are multiple plate readers available. There is now a deviation from the Test Method. Since this error probably will not influence the product (sample result), it can mistakenly be let go.

A second common error is when the process changes due to optimization at the bench. An example is a test method that has been validated and has hundreds of samples to analyze over a long period of time. The laboratory personnel started to optimize or streamline the procedure. For example, how long you leave a sample on a vortex mixer or only use a particular piece of equipment. These types of errors occur when the laboratory workers have been performing the assay for so long that they are able to optimize the method. Unfortunately, if the method is not properly updated, this is also a deviation that will need to be investigated.

A third scenario that can occur is when analysts train new analysts “by memory” and/or incorporate the “optimizations” into the training of the new person. This can perpetuate the gap between what is supposed to happen and what actually happens.

It is these perceived small and “unimportant” changes that build up over time until practice has diverged significantly from procedure.

Process Alliance has decades of experience in laboratory design, setup, SOP generation, process vs procedure audits, and management. We strive to provide high value and quick project turnaround to support our clients’ goals of competitive excellence.

Written by Rick Delhaye, Senior Science Consultant at Process Alliance. Rick has a 25+ year career in the lab, specializing in good lab procedure, implementation and design.

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