Redesigning Quality Systems: Achieving Successful User Adoption

What really happens to “change initiatives” after the CAPA due dates are met? Is the project done because the consultants leave? Or is it when the new priority has been re-directed to another pressing issue? What kind of post-implementation support is there for the leader charged with the ultimate responsibility for the improved performance of the redesigned quality system(s)?

But how did we get here?

The Compliance Situation

Whether it was a Warning Letter, a series of problematic 483 Inspections, or an OAI letter from FDA, you are now facing a compliance situation that has become your #1 priority.  If you are like most companies in this situation, Quality Improvement (QIP) Teams or CAPA groups are formed and are typically managed with an outside Compliance Consulting firm that is leading the overall compliance strategy using a popular 5 phased project plan.  See the visual example below.

Commonly used project phases for quality systems stages

Congratulations on taking action to quickly rectify your status with the agency.  In most cases, the redesign of one of more quality systems is part of the commitments made to the FDA, sometimes with very aggressive due dates.

CAPA Teams Produce Good Work

The individuals assigned to these teams collaborate on the necessary decisions to redesign current procedures and produce streamlined processes that link the inputs and outputs of key critical quality systems.  Team members trace and re-trace the process several times to challenge their thinking and include steps for non-routine situations that are known to happen occasionally.  They examine how the current forms will be used to ensure that the right information is captured and forwarded on to the next system when required.  For some system redesigns, new forms need to be created or undergo significant modifications that result in better compliance to form requirements. 

When Due Dates Are Met

Is there a collective sigh of relief?  Is the project now completed?  It might appear that way since the consultants have left and the new SOPs are in effect.  The mindset at this point may be akin to: “So long as we met the due dates and everyone has been trained, the new system redesign should run smoothly, right?”  Ideally yes, but the reality is no.  I often hear comments like these: “even though we trained everyone and sent out GO-LIVE emails, there is still a lot of confusion.” Another classic one is “the learning curve for new system changes is expected to be high initially considering how many changes we made.”

So what happened?  Was there a rush to complete the awareness training and collect knowledge checks as evidence of effective training?  It is no surprise that training on the new procedures follows the redesign.  But what is a surprise is when the Training Group is notified to make it all happen just days before the due date. 

When is the Training Group invited to the project meetings?

Often the Training Group is late to the planning conversations and sometimes very late to the rollout discussions. There’s never enough time to deliver a proper training session, so in 60 minutes or less, folks are supposed to have all their concerns addressed and get “trained” on all the changes. 

Suggestions and new ideas are captured for the “next revision” because it’s “kind of too late” to revise the procedures at this point.  And when the deviations start racking up, we sigh, shrug our shoulders and check the box for human error/learning curve.  There is a better way to manage the rollout.

This new blog series will examine why “training only roll-outs” are not enough to gain 100% participation and compliance with changes associated with Quality Improvement Plans (QIP) / Continuous Improvement Plans  / Strategic Action Plans. 

I often hear comments like these: “even though we trained everyone and sent out GO-LIVE emails, there is still a lot of confusion.”

I will include descriptions of additional project tasks/actions that need to be designed, planned for and incorporated into the overall QIP that are often left out or neglected. One such area is Affected Users

In this blog series, I will also identify several opportunities for the inclusion of Affected Users and how best to include them throughout the project phases. The series will wrap up with additional blogs on suggestions for maintaining the new changes for sustained performance improvement. 

Sign up now at the left sidebar to ensure you don’t miss an issue!  -VB

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Who is Vivian Bringslimark?

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Will You Please Just Sign the Training Form!

For companies who are required to have standard operating procedures (SOPs), managing changes and ensuring affected employees are up to date is a constant challenge. Especially for companies whose weekly revision churn rate is from 10 to 150+ revisions. The standard approach is to “get ‘em done” in the fastest amount of time. The end goal for most people is the proverbial (√) and lots of records claiming “read and understood” the procedure.

What’s a Trainer now Performance Consultant to do? With all this focus on training effectiveness and return on stakeholder expectations, how does a Training / Performance Consultant demonstrate his/her worth when the real outcome is a rushed end-user who has less than 20 minutes to train on the changes?

According to Rummler and Morrill*, it comes down to how serious do the changes need to be? Performance consulting is about closing gaps in results, training is about closing gaps in knowledge and skill. So, consider analyzing what precipitated the SOP change. Was is it a significant CAPA issue or FDA commitment that requires a solution more than “Read and Understood”/ e-sign for the revised SOP?

In other words, isolate the underlying issue that prompted the change. How significant is the change in the procedure? Is it vital enough to improve performance results?  Then take a performance consulting approach for these changes. Don’t fret about the others requiring only knowledge. Those SOP revisions can be managed using routine training techniques whose goal is numbers trained.

What Do They Really Need to Know About the Revised SOP?

The HPI/HPT approach ties the results back to the business outcomes. If the end goal is truly a √ for SOP revision training, you have met the expectations. But as Trainer/ Performance Consultants, we know this is not an acceptable measure for any type of formal review. (Human Performance Improvement / Human Performance Technology).

What we can do is use a modified root-cause approach to address why the procedure changed and then incorporate the what, the where and the when into the training session. Take advantage of the revision history page if available. The SOP Author has listed what changed. Call him/her and ask why the change was made. Perhaps it is related to a deviation or audit observation that other employees need to know about. Find out when the changes will go into effect and how will folks be notified.

  • Will it be upon an effective date?
  • Or a trigger condition that now has a different decision path?
  • Or is it a completely overhauled FORM to be used?

Include these notes as part of your preparation for end-users to recognize when to make the changes in their tasks. PLEASE NOTE: Revision training is not to be used as a substitute for planned OJT or new hire SOP Training.

SOP Revisions Needing Real OJT: Will Management Agree with Your Recommendation?

But what if the SOP revision requires more than a “tell and forget” discussion?

  • Are the changes significant enough to require a demonstration? 
  • Will a one-time demo by the Qualified Trainer (QT) be enough to call it OJT?  
  • Does the revision require some practice to unlearn the old way and learn the new steps? 
  • How confident are your Qualified Trainers in redirecting this discussion with management regarding the most effective method to use, despite that it will take longer to complete the training notification flags?
Some SOP Revisions require more than a R & U checkmark.

First and foremost, the QT signature means that learners were assessed as having learned the content of what was delivered.  Can the QT confidently say their colleagues are trained in the revision and can perform the revision without errors?  Again, it comes down to how critical-to-quality is the new change?  Can the department / site / organization incur waste as in mistakes, scrap work, delayed release of product, and/or re-work as a result of “lack of proper training for the revision”? After the fact, many managers have “a case of amnesia” about their original directive regarding the SOP revisions. “Just tell them what the changes are, better yet, have them R & U and sign the darn form already!”  With more deviations being opened, these same managers now question why they have QTs in the first place.  Funny how there’s time to do the training properly a second time?

I realize this is easier said than done especially for new QT graduates.  A directive is a directive, I understand.  In these cases, documentation matters and needs to be explicit that demonstration requirements were waived by “Management Decision”.  When the investigation points back to a QT, the documentation will provide what content was covered and to what level of demonstration and practice was included; if any.  If none are required, then the risk for mistakes is minimal.  These questions, as painful as they are can be excellent references for future events where OJT is really needed for a significant SOP revision.  -VB

(c) HPIS Consulting, Inc. All rights reserved.

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*Rummler, G. and Morrill, K. “The Results Chain”. T & D, Feb 05; 26—37.

ASTD HPI— www. Astd.org/content/education/ certificateprogram/HPI

Robinson, DG and Robinson, JC. Performance Consulting: Moving Beyond Training; 1995.

HPIS C. has articles, impact stories and white papers.

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

Why Do CAPAs Fail Their Effectiveness Checks?

When we start talking about deviations and CAPAs, we can’t help having a sidebar discussion about root causes and more specifically the rant about finding the true root cause.  I intentionally skipped that content in the previous blog.  It was my intention to kick off the new Deviation and CAPAs blog series by first looking at deviations by themselves.  And the learning opportunities deviations can provide us about the state of control for our quality systems.  From those deviations and ensuing CAPA investigations, I ask you this: are we improving anything for the long term (aka prevention).  Are we making any progress towards sustaining those improvements?

Corrective Actions Preventive Actions (CAPA) Steps

Let’s step back a moment and quickly review typical steps for CAPAs:

CAPA Components

The purpose of an Effectiveness Check (EC) is for verifying or validating that actions taken were effective and do not adversely affect product, device or process.  It goes beyond the statement in the investigation form to include a follow-up activity that closes the loop on the specific CAPA.  If an effectiveness check fails meaning the CA/PA was not effective or another deviation /nonconforming incident has occurred, we go back to the beginning and either start again or in most cases, we re-open the investigation.  The pressing question is why did the EC fail?  Almost instinctively, we believe that we did not find the true root cause.  Perhaps.  Was there a rush to close the investigation?  Probably.  Did the investigation team grab the first probable cause as the root cause because the “problem” felt familiar?  Maybe. Or is it a case of a fix that backfired into unintended consequences? Possibly. I will also suggest that the CA/PA may not have been aligned properly.

Ask these 3 questions about CA/PAs

  • Is the CA/PA Appropriate? The focus of this question is about the affected people.  What is the size of this audience? Is it mainly one person or groups of people?

Can the CA/PA be executed efficiently?  Is it for one site or multiple sites?

  • Is the CA/PA Economical? What budget is available?

Is it a “cheap” fix or a 3 – 6 month project? Or an expensive solution of more than 6 months and will need capital expenditure funding?

  • Is the CA/PA Feasible? The real question is about the timeline.

            Need it fast – within 3 months or

            Have time – don’t need until more than 3 months from now.

And then there is the unspoken 4th question – is the CA/PA “political”?  I experienced first hand what happens to CAPAs that are politically oriented.  Most of them failed their ECs.  Request “Can You Stay a Little While Longer”. The best CAPAs are the ones that map back to the root cause.

Introducing the HPISC CAPA Performance Chain

On the left hand side, you will recognize the 3 traditional tasks to complete.  After the EC is written, trace upwards to ensure that the EC maps back to the CA/PA and that the CA/PA maps back to the root cause; hence, the bottom up arrow.  On the right hand side are performance improvement activities that I use as a Performance Consultant (PC) to bring another dimension to the CAPA investigation, namely, Human Performance Improvement (HPI). 

Before I can write the root cause statement, I examine the “problem” also known as a Performance Discrepancy or an incident and I conduct a Cause Analysis that forces me to take a three tiered approach (the worker, the work tasks, the workplace) for the possible causes and not get bogged down in observable symptoms only.  The Performance Solution is more appropriately matched to the identified gap. In theory, this is what the corrective action(s) is supposed to do as well. During the performance solution planning, determination of success and what forms of evidence will be used happens with key stakeholders.  So that collecting the data happens as planned, not as an after thought, and the effectiveness is evaluated as discussed.    

What can we really control?

In RCA/CAPA meetings, I often hear about what management should do to fix the working conditions or how most of the operator errors are really managements’ fault for not taking the culture factor seriously enough.  While there may be some evidence to back that up, can we really control, reduce or eliminate the human factor?  Perhaps a future blog on understanding human errors will be released.

Management Can:

  • Design work situations that are compatible with human needs, capabilities and limitations
  • Carefully match employees with job requirements
  • Reward positive behaviors
  • Create conditions that optimize performance
  • Create opportunities to learn and grow professionally.

Clues for Failed Effectiveness Checks

One of the first activities to perform for a failed EC is to evaluate the effectiveness check statement.  I have read some pretty bizarre statements that challenge whether the EC was realistic to achieve at all. The conditions under which we expect people to perform must be the same as the conditions we evaluate them during an EC review.  So why would we set ourselves up to fail by writing ECs that don’t match normal workplace routines? What, because it looked good in the investigation report and it got the CAPA approved quicker?

Next, trace back each of the CAPA tasks to identify where to begin the re-investigation.  I also suggest that a different root cause analysis tool be used. And this is exactly what we did while I was coaching a cohort of Deviations Investigators.  Future blogs will discuss RCA tools in more detail. -VB

The Big Why for Deviations

As part of my #intentionsfor2019, I conducted a review of the past 10 years of HPIS Consulting.  Yes, HPISC turned 10 in August of 2018, and I was knee deep in PAI activities.  So there was no time for celebrations or any kind of reflections until January 2019, when I could realistically evaluate HPISC: vision, mission, and the big strategic stuff.  My best reflection exercise had me remembering the moment I created HPIS Consulting in my mind.

Human Performance Improvement (HPI) and Quality Systems

One of the phases for HPI work is a cause analysis for performance discrepancies.  The more I learned how the HPI methodology manages this phase the more I remarked on how similar it is to the Deviation /CAPA Quality System requirements.  And I found the first touch point between the two methodologies.  My formal education background and my current quality systems work finally united.  And HPIS Consulting (HPISC) became an INC.  

In my role of Performance Consultant (PC), I leverage the best techniques and tools from both methodologies.  Not just for deviations but for implementing the corrective actions sometimes known as HPI solutions.  In this new HPISC blog series about deviations, CAPAs, and HPI, I will be sharing more thoughts about HPISC touch points within the Quality Systems. For now, lets get back to Big Why for deviations.

Why are so many deviations still occurring? Have our revisions to SOPs and processes brought us farther from a “State of Control”? I don’t believe that is the intention. As a Performance Consultant, I consider deviations and the ensuing investigations rich learning opportunities to find out what’s really going on with our Quality Systems.

The 4 cross functional quality systems

At the core of the “HPISC Quality Systems Integration Triangle” is the Change Control system.  It is the heartbeat of the Quality Management System providing direction, guidance and establishing the boundaries for our processes.  The Internal Auditing System is the health check similar to our annual physicals; the read outs indicate the health of the systems.  Deviations/CAPAs are analogous to a pulse check where we check in at the current moment and determine whether we are within acceptable ranges or reaching action levels requiring corrections to bring us back into “a state of control”.  And then there is the Training Quality System, which in my opinion is the most cross-functional system of all.  It interfaces with all employees; not just the Quality Management System.  And so, it functions like food nourishing our systems and fueling sustainability for corrections and new programs.

Whether you are following 21CFR211.192 (Production Record Review) or ICHQ7 Section 2 or  820.100 (Corrective and Preventive Action), thou shall investigate any unexplained discrepancy and a written record of the investigation shall be made that includes the conclusion and the follow up. Really good investigations tell the story of what happen and include a solid root cause analysis revealing the true root cause(s) for which the corrective actions map back to nicely.  Thus, making the effectiveness checks credible. In theory, all these components flow together smoothly.  However, with the continual rise of deviations and CAPAs, the application of the Deviation /CAPA Management system is a bit more challenging for all of us.  

Remember the PA in C-A-P-A?

Are we so focused on the corrective part and the looming due dates we’ve committed to, that we are losing sight of the preventive actions? Are we rushing through the process to meet imposed time intervals and due dates that we kind of “cross our fingers and hope” that the corrective actions fix the problem without really tracing the impact of the proposed corrective solutions on the other integrated systems? Allison Rossett, author of First Things Fast: a handbook for performance analysis, explains that performance occurs within organizational systems and the ability to achieve, improve and maintain excellent performance, depends on integrated components of other systems that involve people. 

Are we likewise convincing ourselves that those fixes should also prevent re-occurrence? Well, that is until a repeat deviation occurs and we’re sitting in another root cause analysis meeting searching for the real root cause.  Thomas Gilbert, in his groundbreaking book, Human Competence: engineering worthy performance tells us, that it’s about creating valuable results without using excessive cost.  In other words, “worthy performance” happens when the value of business outcomes exceeds the cost of doing the tasks.  The ROI of a 3-tiered approach to solving the problem the first time, happens when employees achieve their assigned outcomes that produce results greater than the cost of “the fix”. 

Performance occurs within three tiers

So, donning my Performance Consulting “glasses”, I cross back over to the HPI methodology and open up the HPI solutions toolbox.  One of those tools is called a Performance Analysis (PA). This tool points us in the direction of what’s not working for the employee, the job tasks a/or the workplace. The outcome of a performance analysis produces a 3 tiered picture of what’s encouraging or blocking performance for the worker, work tasks, and/or the work environment and what must be done about it at these same three levels.  

Root cause analysis (RCA) helps us understand why the issues are occurring and provides the specific gaps that need fixing.  Hence, if PA recognizes that performance occurs within a system, then performance solutions need to be developed within those same “systems” in order to ensure sustainable performance improvement.  Otherwise, you have a fragment of the solution with high expectations for solving “the problem”.  You might achieve short-term value initially, but suffer a long-term loss when performance does not change or worsens. Confused between PA, Cause Analysis and RCA? Read the blog – analysis du jour.

Thank goodness Training is not the only tool in the HPI toolbox!   With corrective actions /HPI solutions designed with input from the 3 tiered PA approach, the focus shifts away from the need to automatically re-train the individual(s), to implementing a solution targeted for workers, the work processes and the workplace environment that will ultimately allow a successful user adoption for the changes/improvements.   What a richer learning opportunity than just re-reading the SOP! -VB

  • Allison Rossett, First Things Fast: a handbook for Performance Analysis; 2nd edition 
  • Thomas F. Gilbert, Human Competence: Engineering Worthy Performance
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