So the event description is clarified and updated. The assigned investigator is up to speed on the details of “the story”. What happens next? What is supposed to happen? In most organizations, there is rush to find the root cause and get on with the investigation. A novice investigator will be anxious to conduct the root cause analysis (RCA). S/he can easily make early root cause mistakes like grabbing the first contributing factor as the root cause without being disciplined to explore all possible causes first.
Thus it makes sense to get the Investigators trained in root cause analysis. Unfortunately for many, this is the ONLY training they receive and it is not nearly enough. RCA is a subset of the investigation process and the training agenda is heavy on the tools, which is perfectly appropriate. But when do they receive training on the rest of the investigation stages like determining CAPA significance and writing the report? Given the amount of FD-483 observations and warning letter citations for inadequate investigations that continue to be captured, I’d say we need more training beyond RCA tools. As a result, we are starting to see FDA “recommendations” for trained and QUALIFIED Investigators. This means not only in how to conduct a root cause analysis, but also the Deviation and CAPA Process.
This goes beyond e-sign the Read and Understand procedures in your LMS
E-Doc systems are a great repository for storing controlled documents. Searching for SOPs has become very efficient. In terms of documenting “I’ve read the procedure”, very proficient and there’s no lost paperwork anymore! But learning isn’t complete if we’ve merely read through the steps. We also need to remember it. At best, we remember that we read it and we know where to find it when we need to look something up. Does that translate to understood? Maybe for some.
To help us remember the actual steps, we need to do something with the knowledge gained. This is where the responsibilities section of the procedure tells us who is to do what and when. But the LMS doesn’t include structured and guided practice as part of the assigned curricula. Unless your equipment and complex procedures are also flagged for Structured OJT and possible Qualification Events as in most Operations groups, practice happens incidentally as part of on the job experience. Feedback is typically provided when there’s a discrepancy or a deviation. This is reactionary learning and not deliberate practice.
If we want Deviation Investigators to understand and remember their tasks (procedures) so they can conduct investigations and write reports that get approved quickly, then we need to design learning experiences that build those skills and ensures accurate execution of assigned roles and responsibilities for Deviations and CAPAs. They need an interactive facilitated
More than just studying a set of procedures and filling out related forms
It’s about putting the learners; the assigned SMEs as Investigators and QA Reviewers, at the center of the whole learning experience. It’s about empowering them to take charge of their own learning by enabling them to experience real work deviations / CAPA investigations and to deliberately practice new skills in a safe environment with the assistance of adult learning facilitator(s) and coaches. Thereby bridging the “R & U Only Knowledge Gap”.
The look and feel of the program follows a Learn By Doing approach with customized learning content, using interactive techniques and offering more hands-on opportunities for them to engage with real work application that ensures learners are immediately using the knowledge and tools in class and for their homework assignments thus increasing the connections for knowledge transfer.
This requires a shift from the traditional mindset of a classroom course where the emphasis is on the expertise of the instructor and the content. The learners and their learning experience becomes the priority. The instructor’s task isn’t to deliver the content, it’s to help their learners acquire knowledge and skill.
Qualifying SMEs as Deviation Investigators Program
This unique curriculum uses a variety of teaching methods fostering more balanced and meaningful instruction over the duration of the program. It is not a single course or
“Spaced learning works, in part, because the brain needs resting time to process information, create pathways to related information, and finally place the new information into long-term memory – the main objective of learning.” (Singleton, Feb 2018, p.71).
Each module revisits the Investigation Stages and builds on the prior lessons by reviewing and debriefing the homework. Then, expanding on that content and including new lessons with increasing intensity of the activities and assignments.
By design, the program provides time and space to interact with the content as opposed to delivering content dumps and overwhelming the newbies; short-term memory gets maxed out and learning shuts down. The collaborative participation and contributions from the Investigators and Program Facilitator(s) result in better overall engagement. Everyone is focused on accomplishing the goal of the program; not just checking the box for root cause analysis tools.
The goal of the program is to prepare subject matter experts to conduct, write and defend investigations for deviations and CAPAs. The program also includes QA reviewers who will review, provide consistent critique and approve deviations, investigations, CAPAs. Attending together establishes relationships with peers and mutual agreement of the content. The learning objectives describe what the learners need from the Deviation and CAPA quality system procedures while the exercises and assignments verify comprehension and appropriate application.
“Learning happens when learners fire their neurons, not when the trainer gives a presentation or shows a set of Power-Point slides.” (Halls, Feb 2019, p.71).
Qualified, really? Isn’t the training enough?
Achieving “Qualified” status is the ultimate measure of the training program effectiveness. For newly assigned Investigators, it means the company is providing support with a program that builds their skills and confidence and possible optional career paths. Being QUALIFIED means that Investigators have undergone the rigor of an intensely focused investigations curriculum that aligns with the task and site challenges. That after completing additional qualification activities, Investigators have experienced a range of investigations and are now deemed competent to conduct proper investigations.
For the organization, this means two things. Yes, someone gets to check the FDA commitment box. And it also means strategically solving the issues. Better investigations lead to CAPAs that don’t fail their effectiveness checks. Now that’s significant performance improvement worthy of qualifying Investigators! -VB
- Campos,J. The Learner Centered Classroom. TD@Work, August, 2014, Issue 1408.
- Chopra,P. “give them what they WANT”, TD, May, 2016, p.36 – 40.
- Halls,J. “Move Beyond Words to Experience”, TD, February, 2019, p. 69 – 72 DL.
- Parker, A. “Built to Last: Interview with Mary Slaughter”, TD, May, 2016, p. 57.
- Singleton, K. “Incorporating a Spiral Curriculum Into L&D”, TD, February, 2018, 70 – 71.
HPISC Coaching Brief available here.