Are you doing the Training 2 Step?

Has this situation ever happened to you? You are in a root cause meeting and the *CAPA Investigator is conducting an interview with the primary individual involved with the discrepancy. When questioned why did this happen, he shrugs first and then quietly mumbles I don’t know. When pushed further, he very slowly says I just kind of went brain dead for a moment.  And then silence.

While that may be the honest truth, the investigator must resist the temptation to label it as Operator Error and explore possible causes. One of my favorite root cause analysis tools for “I Don’t Know Why” response is to use the Fish Bone Diagram also known as the 4 M’s diagram. This tool provides a structured focus to explore many possibilities and not just stop at the first plausible cause; such as Operator Error. Aptly nicknamed, the 4 M’s are Man, Machine, Methods and Materials.   When the results of this exercise points to a training or operator related issue, don’t stop at “operator error –> retrain”.

Consider for a moment, what this retraining session would look like. Will re-reading the procedure be enough to “jog his memory”? Will repeating the procedure be a good use of precious time when s/he already knows what to do? More than likely it won’t prevent “going brain dead” from happening again. Instead, do the HPISC Training 2 Step:

Step 1 – confirm the results of the gap analysis

Ask: What task, what step(s) or actions are in question?

Step 2 – address why the original training did not transfer back to the job.

Using the 4 M’s diagram as the framework, explore Man, Machine, Methods and Materials questions with regards to the training this operator receives. See diagram below. The full set of questions can be found in the eBook Training Cause Analysis.

4msfortrca

Is this really worth it?

I think it is. Conducting these 2 steps will accomplish two objectives.   It will provide further evidence that some kind of training is needed. And it will highlight what areas are in need of revising either for the performer, the training program or course materials. Yet, there are some who will resist this added work because it’s easier to find blame than to uncover the cause. Fixing the true root cause could trigger a re-validation of the process or an FDA filing if it’s a major process change.   Why create more work? Isn’t it easier to just retrain ‘em? No, not really. Finding the true root cause is the only effective way of eliminating many of the costly, recurring problems that can plague manufacturers.

But what if

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Some folks will push back with the excuse – “this never caused a problem until now”, so it must be the operator’s fault! This may be the first time it was discovered but that does not mean the procedure is 100% accurate. Often, experienced operators know how to work around an incorrect step and don’t always report a misstep in the procedure while a less savvy operator follows the procedure and causes the non-conformance to occur. See Sidebar SOP Logic Rules. Is the procedure difficult, lengthy or requires weeks to become proficient let alone qualified? Was the qualification routine or performed as a simulation? Was the procedure written with support from a lead operator or qualified trainer? Did the draft version undergo some kind of field test or dry run prior to release? And the classic situation, are proposed changes hung up in change control awaiting effective release?

Understanding Why Human Errors Occur

Industry practice is evolving to explore why people make the decisions they do by looking at the Organization’s systems. It’s usually a poor decision made somewhere in the error chain. We must believe that the person who made the poor decision did not intend for the error to occur. As part of CAPA investigations, we need to explore their physical environment as well; the conditions under which they make those decisions. The Training Program Improvement Checklist can be requested using this link to capture your findings.

If you are going to spend time and money on training, at least identify what the gap is; fix that and then “train” or provide awareness on what was corrected to prevent the issue from re-occurring again.   That is after all, the intention of *Corrective Action Preventive Action investigations. -VB

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(c) HPIS Consulting, Inc.

When Does Change Control Get Invited to the Investigation Discussion?

Somewhere between “What is the solution? (#4)” and “The best way to implement the solution (#5)” but definitely before “Implement CAPA Solution” is another necessary quality system called Change Control. Where in your Deviation – CAPA process is the linkage or hand-off to Change Control? When does the Change Control request get initiated? Is it part of the Deviations SOP, built into the CAPA process or is it a separate stand-alone system? For novice investigators, this additional requirement is very easy to overlook by assuming that it falls within the boundaries of CAPA.

When CA’s require more than SOP revisions

Let’s examine typical corrective actions (CAs) more closely.  By far, rewriting SOPs to correct a procedural step or clarify the wording is the most common corrective action for a CAPA.  Initiating a document control request as per the SOP on SOPs is a pretty routine task and I generally don’t see deviations relating to “failure to open a doc control request for SOP revisions”.  But what about changes to batch records?  This gets a little bit trickier when rewriting a batch record step is a change to the process and most likely will require some kind of validation activity.  Some CAs involve changes to methods, materials or even vendors.  Again requiring change controls to be initiated.  Even changes to tech-enabled “GMP Systems” needs to be evaluated for a performance qualification under a change control protocol.

Change Control during a CAPA Investigation is not an afterthought

How is this managed where you work?  Is there any evidence in the Deviation –Investigation CAPA file that points to or includes the change control request, protocol, a/o final report?  How does the Lead Investigator ensure that this “big step” is being managed? Is it the responsibility of the CAPA team, the Lead Investigator or the Change Control Manager who happens to hear about it at a morning huddle discussion?

So instead of treating Change Control as an afterthought like an unwanted guest to a party, why not add one more tool to the problem-solving toolbox?  It’s called a Process Change Analysis.  The purpose of this tool is to explore identified process steps being considered for change.  (Available to Mailing List subscribers).

Add one more tool to the problem-solving toolbox

As part of steps 4 and 5 of the Problem Solving Model Approach, the investigation team examines the effect of the proposed change might have on the individual performer, other processes and systems.  Using the Process Change Analysis worksheet not only captures the implications of the proposed change but also provides the proper documentation for both the CAPA Investigation File and the Change Control Request.  Asking team members to consider what else might have to change allows for a more comprehensive change control project that gets coordinated alongside CAPA implementations.

Quality systems were never intended to stand alone and function as siloed departments.  A sign of a good functioning Quality Management System is how well the linkages (handoffs) are integrated and understood by employees and not duplicated by mistake or as a result of not knowing enough about other site quality systems procedures.

Summary of the HPISC Deviation – CAPA Blog Series

Alas, I have come to the end of the Deviation –CAPA blog series.  Thank you for allowing me to share my thoughts, air my frustrations and suggest ideas for expanding the problem-solving tool kit while staying within the boundaries of Quality Systems expectations.

1st in the series – The Big Why for Deviations – where I proposed that deviations and investigations provide rich learning opportunities to find out what’s going with our Quality Systems.

2nd in the series – Why Do CAPAs Fail Their ECs? – where I introduced the HPISC CAPA Performance Chain and suggested that the Effectiveness Check must map back to the CAPA that maps back to the root cause.

3rd in the series – The Investigation Hand Off: Is it a Handshake or a Missed Step? – where I urged QA personnel to clearly define the roles of the Initiator and the Investigator.

4th in the series – Investigations 101: Welcome Newbies – where I highly recommended a dedicated program to qualify Deviation Investigators.

5th in the series – Conducting Root Cause Meetings vs. Facilitating Problem Solving Discussions – where I suggested a broader problem- solving approach to get better at fixing our repeat problems.

6th in the series – Please Tell Me There Are More Tools Than 5 Whys and Fish Bone Diagrams – where I advised investigators to consider which tool to use to help make the right choice to maximize the tool results based on the investigation stage.

7th in the series – When Does Change Control Get Invited to the Discussion.

The next blog series is currently being mapped out.  Stay tuned for more updates by subscribing to the Theory vs. Blog.  Reach out to me if you wish to see a QA or Training subject be developed into a future blog series.

Until then visit the HPISC library for published articles, eBooks, white papers and impact stories.  I will not add your name to the mailing list without your permission. 

© HPIS Consulting, Inc.

Who is Vivian Bringslimark?

Please Tell Me There Are More Quality Tools Than Fish Bone and the 5 Whys!

Don’t get me wrong.  I am a huge fan of both these methods especially for training related errors.  However, there are a lot of other quality tools in the problem solving toolbox that aren’t as popularly used.  In this blog, I will continue part two of the previous blog, RCA Meetings vs. Problem Solving Discussions in which I presented an alternative problem-solving model that helps investigators take a deeper dive into understanding the problem first (#1), then asking a series of questions to generate possible causes (#2) that move from the event trigger to patterns to systems glitches.

So many tools, so little time!

Before Google became a verb, the best way to learn about a problem-solving tool was to ask someone, ask to borrow his or her “The Memory Jogger” pocket guide, or wait patiently to take your course.  Getting information at your fingertips instantly is no longer a barrier.  But the consequence of too many available tools can lead to confusion and indecision resulting in sticking to what is familiar instead. One way to mitigate the bewilderment is to choose these tools by which stage the investigation is in and whether the team needs to analyze the process or the collected data.

Where are you in the investigation?

Are you exploring and just learning more about the triggering event?  Are you generating possible causes and need an organized decision making technique?  Or are you verifying and eliminating causes?  Refreshing on the purpose of the tool helps the Lead Investigator make the right tool choice.  Consider the Job Aid: Which Tool to Use When?

WHAT IS THE ASSIGNABLE CAUSE?

Just because the team has generated more than one possible cause does not mean that one of them has to be the root cause by default.  Has the team asked the “second right answer”?  Charles “Chic” Thompson, in his book, What a Great Idea, explains that we’ve been trained to look for the right answer, to seek the one and only answer, ever since we started school.  Instead, he suggests that we ease “into a new frame of mind” by asking a host of questions in search of potential solutions.  Included in this perspective, is asking, “dumb” but penetrating questions that lead to finding “the true source of bottlenecks buried deep in habitual routines of the firm”.  

When the team has really explored all possible causes, then it’s time to switch tools and use data analysis tools such as histograms, run/control charts, and/or scatter diagrams.

“A fishbone represents opinions.  Opinions must be verified with facts before action to change is taken.”  

Waste Chasers: A Pocket Companion to Quality and Productivity, p.43.

Pareto charts can be very helpful when you need to display the relative importance of all of the conditions in order to identify the basic cause of the problem.  It helps the team to focus on those causes that will have the greatest impact if solved.  The team has to agree on the most probable cause aka the root cause.  One of the best decision making tools I’ve experienced is Nominal Group Technique.  NGT provides a way to give everyone in the group/team an equal voice in the selection.  Team members rank the items without being pressured by others.  Therefore, it builds commitment to the team’s choice through equal participation in the process.

What is the solution?

One of the most versatile tools in the arsenal is brainstorming.  It’s quick; it’s easy to administer and almost everyone has experienced a session or two.  We like it because it is an efficient way to generate a lot of ideas that are free of criticism and judgment when facilitated properly. 

At this point in the investigation, some members on the team finally get to share their ideas on how to solve the problem.  For teams pressed for time, having already made ideas sounds like a gift ready to be opened.  And yet, there can be a tendency to allow the eager problem solvers to dominate the discussion and solution path forward. 

A nice warm up exercise prior to the solution brainstorm, is to assign an individual idea map first.  By mapping individuals’ own thoughts first, they are not lost to the group’s brainstorming results when the time comes to participate in the session. The original ideas, thoughts, and even impulses can be easily shared since they have already been captured in their own idea map.

For teams stuck in the “same old way” mindset or wrestling with a frustrating repeat problem, try switching up the brainstorm trigger word.  For example, the trigger word “when solved” can help us work backwards.  Or use the opposite trigger word and brainstorm on ideas to make it true.  Try a random trigger word or a metaphorical trigger phrase such as (the problem …) is like … the day after a vacation when … .  I’ve seen amazing idea maps resulting from stepping up the brainstorming trigger words.  If the team is still stuck, compare all of the maps to look for commonalities or common themes.  And sometimes you just have to change your shoes or take a walk outside to shift your thoughts.

What is the best way to implement the solution?

Now, the team is responsible for bringing their ideas into reality aka the corrective actions / CAPA Plan.  One of my favorite tools is the Force Field Analysis when the team is working on corrective actions.  The tool helps team members to identify forces and factors that will support or work against the solution of an issue so that the positives can be reinforced and /or the negatives eliminated or reduced. It forces the team to think through all the aspects of making the desired change a permanent one. 

“After falling in love with your idea, you must also be prepared to fall out of love.”

Charles Thompson, What A Great Idea, p.161.

Now Just Do It

Implementing the corrective action(s) may be the longest duration depending upon the scope of the project and therefore needs to be managed using project management techniques.  And that could be the basis of another blog series. 

Close the Investigation

Before the investigation can be closed, the effectiveness check needs to be performed and evaluated as described in the CAPA plan. Over the course of the incident and its CAPA, the story evolves.  This is normal and expected especially as we learn more.  To an outsider reviewing the investigation report, the story and all the supporting evidence has to be understandable, even to someone internal to the organization but not involved in the investigation, the CAPA or the project. 

The Lead Investigator must review the entire file one more time to finalize the problem statement and confirm the cause statement given what is known at this final point of the investigation.  The following is a list of questions to ask:

  • Is the report easy to follow? Is there a logical flow?
  • Is the report free of unnecessary documentation? Is it uncluttered?
  • Is there sufficient information to back up the investigation, results and the outcome?
  • Does the report support decisions about product disposition?

Conclusion

Part One of this blog suggested the use of a more creative problem-solving approach to help us see our problems using systems thinking perspective.  Systems Thinkers understand complex relationships and their interdependencies. They step up and take responsibility to fix the problem.

In part two, I suggested different problem solving tools to use depending on the investigation stage and the team’s task.  As a Performance Consultant, the problem solving approach and the plethora of “quality” tools has me excited about identifying the true root cause and implementing systematic solutions as the corrective actions because we have to get better at solving our problems.  System Thinking,

  • puts a problem into a context of the larger whole with the objective of finding the most effective place to make an appropriate change and
  • it can help us identify and respond to a series of changes before those changes lead to more unwanted deviations and CAPAs. 

Isn’t that the purpose of the PA in CAPA, the preventive actions? -VB

Root Cause Analysis and Qualifying Investigators Coaching Briefs
  • Charles “Chic” Thompson, What A Great Idea: Key Steps Creative People Take, HarperPerennial, 1992.
  • The Memory Jogger: A Pocket Guide of Tools For Continuous Improvement, GOAL/QPC, 2nd 1988.
  • Waste Chasers: A Pocket Companion to Quality and Productivity, Conway Quality, Inc.

Conducting Root Cause Investigation Meetings vs. Facilitating Problem Solving Discussions

I began this Deviation and CAPA series with the intent to share what I call the human performance improvement (HPI) touch points; where HPI and the CAPA quality system have cross -over connections.  See The Big Why of Deviations and Why Do CAPAs Fail Their ECs.  In this two-part blog, I will reveal another noteworthy HPI crossover connection.

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:

  • Compliant “CAPA” Program includes procedures for:
    • Discovery and Notification
    • Containment
    • Impact Assessment
    • Product Investigation
    • RC Investigation
    • Corrective Actions (CA)
    • Prevention Actions (PA)
    • Effectiveness Checks (EC)
    • Close

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.

(c) HPIS Consulting, Inc.

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 then rely on their memory (their expertise reservoir).  Many SMEs think they know the procedure and will often state a step from an older version of the SOP or will be surprised to see new changes in the most current version of the procedure.  In this group review, SMEs can look for weaknesses and offer their insights about the point of discovery. 

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 not just individual performers or procedure.  They see patterns of recurring problems that deepen their understanding of the situation and leads them to reframe the problem, thus providing a new framework from which to generate an additional set of possible causes.

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.

Investigations 101: Welcome Newbies

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 learner centered qualification program.

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.

Shifting the priority to a more engaging Learning Experience

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 2-day training event.  It is delivered in modules, with weekly “homework” assignments consisting of active deviations and open investigations.

“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

References:

  • 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.

The Investigation Hand-off: Is it a handshake or missed step?

Upon discovery and containment of a deviation or non-conformity, the investigation begins.  Whose responsibility is it, the one who discovers it or the one who gets assigned to investigate it?  In most organizations, it is not the one who discovers the performance discrepancy.  It usually gets assigned to an SME or a dedicated investigator if QA has the resources. 

The hand-off between the discoverer and the assigned investigator is not always clearly defined and is often vaguely described in the CAPA procedures. And here is where the first misstep has potential to delay the start of the investigation clock. In this third blog of the Deviation and CAPA series, I intend to argue for the importance of the “hand-off” especially if investigations are assigned to SMEs and staff who were not present during initial discovery, containment and notification activities.

Making the Hand-off Formal

The purpose of the hand-off is to acknowledge responsibility for the investigation and review all actions taken up to the current point in time.  Given the nature of the event, the significance and urgency to move forward, there can be a lot of confusion, misinformation and misunderstanding of roles, responsibilities and authority.

One misconception that can occur with novice investigators is the lack of awareness that the investigation details can change and should be revised as the investigation unfolds especially the event description.

Please Tell Me the Story (again)

There are 3 main elements in every “story”.  Usually a cause and effect flow to the story unfolds and becomes the basis of the narrative that is told or captured in the investigation form.   Next are the key variables that reveal the impact.  The trick is to recognize and capture them and not get bogged down or distracted in the extra details.  And then, there are the two sides of every story.  The investigators job is to find the similarities among the interviews especially if there has been a long chain of events occurring before the hand-off.

A second misconception with new investigators is to park all the information in the investigation form as possible drafts and then revise and revise and revise again until they are finished.  Alternatively, they could use a tool that is designed to capture and review the details for the event.

The Investigators Hand-Off Tool – Tell Me the Story

The tool is essentially a worksheet to capture, review and collate the answers to the “Universal Problem Solving Questions”. 

  • What Happened?
  • Where did it happen?
  • Who was involved?
  • When did it happen?
  • How did it happen?
  • How big is the scope of the problem?

Notice that “why did it happen” is not included. How it happened can easily morph into why it happened if not carefully checked.  At this stage of the investigation, root cause analysis is way too early and can misguide the investigation.  Investigators in a rush to get their assignments done, need to stay true to the CAPA process and confirm the event details and then finalize the problem as they know it; more about problem statements in a future blog. 

“How it happened” is more about how it was found and how it was discovered?  “Where it happened” is seeking clues about a breakdown in the process, the procedures, paperwork and/or batch records.  Something happened somewhere and the investigation has to first identify what and where before the why.  Having these questions answered accurately allows for a richer probable cause identification step and eventual determination of the true root cause(s). 

Until the next blog is released, I have a homework assignment for you.  Reread your Deviation and CAPA SOPs specifically looking for the roles and responsibilities for the Initiator and the Investigator.  Are they clearly written? Ask your assigned Investigators (if this applies at your site) if they follow a hand-off guide or use any kind of fact-finding/event description worksheet.  If you are interested in the HPISC Tell Me the Story worksheet, you can find it here.  May all your CAPAs map back to the true root causes.  -VB