I began this Deviation and CAPA series with the intent to share what I call the human performance improvement (HPI)
If you perform a Google search on CAPA process and the ensuing steps, the results are varied but in general, industry follows a routine process that looks like the following:
“CAPA” Program includes procedures for:
- Discovery and Notification
- Impact Assessment
- Product Investigation
- RC Investigation
- Corrective Actions (CA)
- Prevention Actions (PA)
- Effectiveness Checks (EC)
If you are satisfied with the results you are getting, great, more success to you! One of the misconceptions about today’s CAPA process is that it suggests the steps start and end cleanly and the process moves in a linear fashion. I have one of those theory vs. practice moments where what is supposed to happen “if you correctly follow this process” does not happen in reality. That somehow it’s the fault of the lead investigator if it’s not progressing as described.
Deviations and CAPA investigations are not theoretical. As the investigation unfolds and the true story is discovered, we learn quickly that the process is really iterative. Often we find ourselves back at the beginning, rewriting the event details and fine tuning the problem statement or re-examining the root cause because a repeat deviation occurred. Frustrated that the clock is ticking and the pressure to get ‘em closed is always in the forefront of the investigation, there is no time allowed to think outside this process; no room for creatively solving the problems. The mere mention of creativity makes some compliance professionals break out in hives.
I get it. The intention of the process is to provide a structured approach to conduct the investigation and manage the related CAPA when assigned. Otherwise, it’s too overwhelming and unwieldy. We could go down a rabbit hole and never close an investigation or come up with totally out of the question corrections. However, it seems to me that we’ve ingrained these steps into routine habit, that our root cause investigation meetings have also become check the boxes to get the CAPA closed on time! Hence, our industry is still getting “inadequate investigation” observations. Could there be a causal relationship?
So, if you seek something else, I am proposing a problem-solving model below that mirrors very closely with CAPA. The following problem-solving steps give us the freedom to consider new ideas and new possibilities for solving the same repeated problems without violating our Deviation and CAPA procedures.
DEFINING THE PROBLEM
It sounds simple enough to do. Collect the event details. Answer the universal questions. And lo behold, the problem should be evident. SMEs unwittingly suffer from the curse of too much knowledge and as they learn more about the event, they tend to form early hypothesis about the problem especially if they’ve seen a similar event. They tend to collect evidence about problems they are familiar with and understand. Unfortunately for most, they seldom go beyond their current knowledge base.
In the Qualifying SMEs as Investigators Program, nominees are asked to discuss and prepare their response to the following question: Is the problem different from the cause? Initially, everyone nods his or her head yes with a baffled look as to why further discussion is needed. In their break out groups, I ask them to prepare their group rationale. And then it happens, a few will inadvertently slip in the cause with the problem explanation and to their amazement they are stunned at hearing these words. Alas, that’s the point. Before you can assign the root cause, you need to know what the problem really is.
WHAT DO I ASK TO FIND THE CAUSES?
“To find the answer, ask a lot of questions first”. The discovery of a non-conformance, deviation or discrepancy is usually triggered by an event and thus the investigation begins here. In the event stage, not only are investigators collecting details they also interview the individual performers who are involved. However, there are three levels of interaction that can influence performance:
- The individual performer level
- The process level
- The systems level.
To identify the possible causes not just the obvious one, the investigation team needs to move beyond just the event triggers.
Moving from Events to Patterns and Systems Influences
If we keep the scope limited to the event and performers involved “as an isolated incident”, we often find that the easy way out (aka the fastest way to close the investigation) will often lead back in with more repeat deviations. So, we need to expand the investigation to include other individuals and /or other similar incidents to look for a pattern or a reoccurring theme.
As investigators, we need to keep asking questions that enable information sharing to drive a deeper understanding of what the individuals were/are experiencing when performing their part of the tasks within the process.
Mapping the task/process helps SMEs to re-trace the steps or sub-tasks rather
Within this process analysis/review, ask are there other procedures that have been implicated in other deviations? What about the hand offs; the linkages between the procedures and other quality systems? Are these clearly defined and understood or are these the basis of “miscommunication” causes between other groups? The big question to ask is what would happen if we left it alone? What other systems would be impacted? When investigation teams are given the time to explore (investigate) enough, they often find these system glitches just waiting to contribute to another deviation.
Problem Solving ala Systems Thinking
Peter Senge in his 1990 ground breaking book, The Fifth Discipline: The Art and Practice of the Learning Organization, describes a system as being perceived whole whose elements “hang together” because they continually affect each other over time and operate toward a common purpose. There’s a pattern of interrelationships among the key components of the system, including the ways decisions are made. Often invisible until someone points them out.
Systems thinking allows problem solvers to see the event in the context of the whole system
The next blog will continue describing the problem-solving model and explore other quality tools investigation teams can use. – VB
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(c) HPIS Consulting, Inc.