Our last post discussed spending more time on fire prevention and less time on firefighting. Today, we will discuss how to think like a teacher rather than a dictator.
Dictators don’t engage people they don’t focus on the “why,” only the “what.” They demand action, no questions asked.
Educators, rather, engage people by focusing on helping them understand the “why” of quality so they are better prepared and equipped to work on the “how.” My latest true-to-life example is around Equipment Qualification (EQ). For those who are not typically involved in or familiar with EQ, it is a process by which an instrument’s operational and performance capability is established. So when data are generated using this instrument, we have confidence that said data are generated consistently.
Within large pharma companies, EQ is generally a task performed by engineers or vendors. In smaller companies where you wear many hats, the System Owner may perform these tasks and, as such, must understand what attributes need to be tested, how to design experiments to test these attributes, and ensure they meet acceptance criteria so you know the equipment is operating within specific parameters and its capability.
Who knows what EQ is … Anyone? Anyone?
A client was in the process of expanding its lab, which involved moving existing equipment and purchasing new equipment. I soon discovered that it hadn’t occurred to anyone to conduct any training on EQ, given tight implementation deadlines. Many documents (User Requirement Specifications, Configuration Specifications, Risk Assessments) were found not to be in place, adding to the complexity of this task.
The person in our lab tasked with EQ was neither an EQ specialist nor an engineer. New to this whole process, this individual became quite overwhelmed rather quickly and proceeded to get bogged down in the perceived morass of documentation and process. Seeing an opportunity to positively influence this situation, I approached the individual and arranged a brief one-on-one EQ training session (read: a crash course). We covered the following:
- What was the task he had been given;
- What was the end goal;
- What did he need to know and complete as the System Owner; and
- Why and how it mattered.
I began by explaining that the end goal was to ensure that we knew batch release data generated on this instrument were accurate and reliable. So the question to answer was: Is this instrument operating properly and within user requirements, configuration and functional specifications, so that we have confidence that data being produced are correct?
I used an example of a completed qualification package, walked through the elements of EQ, and how these elements all fit together to deliver an answer to the question above. And when it was clear that he understood the task, I ended our meeting, ensuring him that he could check back with me to confirm everything was in order and to answer any questions. If we had not talked live and in-person for 30 minutes (and he was just told what to do), he would be stuck in a maze of processes that had nothing to do with the task at hand… and we still may not have completed the needed EQ.
Sit-downs save time.
Many times, people overthink agency requirements and make it more complicated than it needs to be. It’s understandable because people want to do the right thing—they want to be compliant, but they may not know the best way to get there. A little one-on-one training and education can put an end to “overthink” and knee-jerk reactions that complicate Quality systems. In our case, a 30-minute discussion improved efficiency, understanding, consistency, while also encouraging compliance, personal accountability and confidence.
Teachers do sit-downs. Dictators don’t.
P.S. Here is a nice overview of what makes a great teacher in the classroom, but it has merit in Quality as well.
