In Part 1 of this two-part article, we explored a troubling trend in the life sciences industry — a tendency to teach our personnel to blindly follow standard operating procedures (SOPs), without an understanding of why we are asking them to do what they do. As a result, we essentially tell them “we don't want you to think” and leave them ill-equipped to respond intelligently and appropriately when something out of the ordinary occurs. This leads to siloed corporate cultures that are driven by fear and that use widespread lack of knowledge to keep personnel under control.
Compare this to the organization that supports a strong quality culture, and the situation becomes very different. This organization believes in knowledge sharing, which starts as soon as personnel start working for the company. New personnel are welcomed into an onboarding program that provides them a broad understanding of the business and their role in it; information about the product and how their role impacts it and patients; basics of the quality systems that govern processes and what is expected of them within these systems; and the importance of training and the quality of the operations. Managers focus on ensuring tasks are performed correctly and have regular communication meetings with personnel to increase understanding and improve job performance. Personnel are empowered to provide improvement ideas that come from a position of understanding the operation, and those ideas are discussed openly.
Because of this level of understanding, personnel are also encouraged to work above their level — engaging in problem-solving activities and engineering or other technical activities to further their knowledge. Managers recognize that it’s OK to not know everything, and that surrounding themselves with technically strong personnel is beneficial, including those who may know more than they do. When problems are encountered, personnel can rely on their understanding of the operation and the requirements — at both the task and big-picture levels — to take appropriate action, plan changes, and present those plans to their management and quality team. Improvements and knowledge sharing are encouraged and seen as an investment in the business’ future. And members of management regularly — and with personnel — discuss quality and doing things right, as well as what those look like in the organization, so that all can recognize their importance.
Sounds like a good place to be, right? So how do we get there?
First, we need to teach people how to think again. Then, we need to encourage them to think on a day-to-day basis so that they’re comfortable with it when a problem arises that requires out-of-the-box, beyond-the-SOP thinking. And we need to foster ongoing day-to-day conversations with people and mentor them through thinking about these situations and how to approach them.
One of the simplest examples of what we need personnel to be able to do is akin to what happens when we need to be somewhere at a certain time, but discover an accident has occurred along the route and is causing delays. In this situation, we think through possible route options and scenarios, considering how many alternate routes exist, our knowledge of traffic levels and transit times, and other alternatives — even whether we can postpone our scheduled meeting. Then we make the best decision we can about which route to take, based on the available information, and we compose the story we’ll tell our meeting partner, either to warn them we might be late, or to explain what happened when we get there or why it might be appropriate to reschedule.
Convert this into our GMP environment, where we need our personnel to be able to recognize situations that are — or may become — problematic, and formulate options for how to deal with them that align with existing procedures, policies, and GMP expectations. We need them to be able to use their accumulated knowledge of the task, GMP expectations, and procedural requirements to identify the most appropriate path to follow in these situations. Then, they must understand the importance of telling the story and how they arrived at their decisions — and be prepared to discuss that with management, quality staff, and potentially regulators.
How we get there is to build these nine elements into an organization:
1. First, find value in innovation and do not be afraid of change. The paradigm of “control at all costs” is old and outdated, but some organizations still try to work that way. Continuous improvement is expected across the industry — it’s high time we step up and staff our organizations with personnel interested in working that way. Control is good, but quality is better — and part of quality is recognizing that change will always be necessary to improve.
2. Put in place experienced managers and leaders who believe that training and mentoring are valuable activities. Having that belief isn’t enough, though — they must display it in day-to-day operations. They should be on the floor monitoring operational activities and talking to personnel about issues and concerns, improvements, theories behind operations, business strategy, quality, and more. Managers shouldn’t be stuck in meetings talking to each other — their true value lies in leading the organization, and the most valuable managers are those who can lead from behind.
3. Hire personnel who are passionate, curious, and interested in learning and growing, preferably with a strong sense of responsibility or a history of providing service to others. People with strong “service” backgrounds understand what it means to have responsibility placed on them, and they take their responsibilities seriously. An organization should engage their minds by giving them learning opportunities: Allow them to work on projects they’d like to do, so long as what they need to do gets done correctly, and encourage them to identify anomalies or things that don’t make sense — and when that happens, listen and talk through their concerns. Prior experience and specific background will be required in some areas more than others — but personnel who are motivated and willing to learn are absolutely essential.
4. Provide solid SOPs and increase — rather than decrease — training time. Ensure procedural content covers processes and critical activities to the appropriate levels of detail. Then pair those procedures with training that enables performance and includes learning the “why’s” behind what personnel are asked to do, as addressed in depth in this article. Establish a competency-based training program (see my previous CBT article) that focuses on teaching personnel to execute the process/activity correctly, through the use of the procedures and demonstration of an appropriate level of operational knowledge — including how the task can go wrong, and what to do if it does. If training enables better performance and fewer errors, the business will buy into it. And if the training isn’t accomplishing these things, fix it.
5. Find ways to challenge and empower people to use what they know by working on special projects or on teams addressing items of interest to them. Give them opportunities to grow by pairing them with more experienced people to help guide them. When possible, let qualified personnel take the lead on dealing with issues — just make sure appropriate and timely oversight and reviews are in place to ensure important items haven’t been missed. Then provide them feedback on any errors or misjudgments they made, talking through what should have happened and why, as preparation for next time.
6. Develop personnel’s troubleshooting skills by spending time as a group, discussing common problems that happen (including how, why, and what to do about them when/if they occur), areas of concern, issues seen in regulatory agency inspections, and hot topics. Talk about the “what ifs.” Encourage people to ask questions they may have in relation to their practices or why these items are a concern, and discuss any that are raised
7. Teach — and practice — proactive risk analysis and risk management. Teaching people to think through where things can go wrong, and then what in the process can keep it from happening, has long-term benefits to the entire business, not just situations each individual may face.
8. When problems or failures do occur (which they will), treat them as learning opportunities, while driving to and fixing root causes. And if there is a business reason to not fix or change something, explain that to personnel, so they understand the decision and can potentially identify some other type of improvement that can be put in place. Drive out the human error/blame culture — but when someone does make a mistake, address it with them, have them correct it, and then use that as a learning opportunity for others.
9. Mentor, mentor, mentor. Never underestimate the importance of sharing knowledge when you have the opportunity. Create a mentoring program, or simply encourage individuals to mentor others, and just watch the magic that can happen.
Or, you can end up with a situation like this, as described in a 2017 FDA warning letter:
“During the inspection, our investigator … observed the introduction of a bottle of sterile water with a shrink-wrapped plastic tamper-resistant seal into the isolator material transfer chamber … specifically prohibited by your firm’s isolator SOP. Our inspection documented that at least two, and possibly four, of your operators observed the presence of this sealed bottle in the chamber, despite the explicit prohibition in the SOP … and you were unable to explain why your operators did not recognize this problem.”
Notice this doesn’t say one of these operators was responsible for introducing the shrink-wrapped bottle into the isolator — just that they didn’t recognize that it was there in violation of the SOP that they likely were all trained on. Not one of them reacted to what they all should have been able to identify as at least an anomaly, if not an outright problem. “We don’t want you to think” rears its ugly head in the worst possible situation — in front of an FDA investigator.
I’ve always found that if you let people know you expect them to think, they step up. (Just ask those who have taken my quizzes after training courses.) If you want your operators to act like engineers, treat them like engineers. If you want your personnel to think, encourage them to do so. They may surprise you.
Where would you rather be?
About The Author:
Joanna Gallant is an experienced, solutions-driven quality and training professional who has spent more than 23 years in pharmaceutical, biotechnology, tissue culture, and medical device development and manufacturing environments. Over her career, she has provided regulatory, technical, skill, and management development training support to all operations functions, as well as IT, R&D, customer service, and senior management. Now, as a training system consultant, she works with clients to design and deliver custom training and build/remediate training systems, including in support of regulatory audit observations and commitments.
Joanna has been a GMP TEA member since 2001, and now serves on the Board of Directors as an advisor. She is one of the founders of the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine's Biotechnology degree program in 2011.