In the blog, “Learning on the Fly“, I blogged about an urgent learning need requiring instructor-led classroom delivery that needed to be facilitated among a group of talented SMEs. During the needs assessment portion, I hit a huge barrier.
“I teach GMP Basics and conduct Annual GMP Refreshers several times a year and preach to audiences that you must follow the procedure otherwise it’s a deviation. And in less than two weeks, I am expected to teach a process that is changing daily! Yet on the other hand, how could I teach a work instruction that is known to be broken; is being re-designed and not yet finalized?”
My dilemma challenged the essence of my “learned” compliance belief system about following the 1st basic GMP principle – “thou shall follow written procedures”! The instructional designer side of me screamed – how can you teach flawed content? That’s wasted training that results in scrap learning. How is that training going to be effective beyond a check in the box?
And then it hit me – validation engineers use protocols to capture their “change in process” work. Whether it’s experimental batches, 3 batches for process validation or *IQ-OQ-PQ protocols for equipment qualifications. They are validating the procedure or the new process before it can become the standard operating procedure by developing the plan, developing acceptance criteria, managing the unexpected deviations and capturing the results. So why couldn’t I borrow the concept and adapt it to my situation?
While it was the intention of the business unit leader to deviate from the approved set of work instructions, a planned deviation would not be appropriate in this case. The purpose of the training sessions was to test the new sequence of steps and confirm the robustness of the criteria to make correct decisions where needed. The learners would still be in compliance with the quality policy document and would still meet the intention of the quality system regulation. They were essentially testing the future “how-to steps” for the proposed new work instructions.
Now before you fire off a rant of emails to me, I did not copy and paste the validation protocol template. I did however, include a “please pardon our appearance while we are under construction” paragraph in the training plan to document the departure from the current set of work instructions. This protocol like section also included our intentions for the outcomes of the sessions and stipulated required SOP training of all affected users once the finalized set of work instructions were approved and went into effect.
Sometimes the very solution can be found around the next cubicle. –VB
*Installation Qualification, Operational Qualification, Performance Qualification
(c) HPIS Consulting, Inc.