Change Management and It’s Little Cousin Training

Training can be considered a change in what the learner knows now | can do now and what s/he knows and does afterward.  Training can close these gaps when knowledge and skill are lacking.  Thus, a trainer has a dual role: trainer and change agent. While on the surface, the actions a trainer takes looks like change management, it is a sub-part of the larger change management plan.  The scope is narrower.  It is focused only on the training content.  But the expectations for successful transfer back to the job and improved organizational results remain the same. One allocated and approved session designed and delivered by the training department is supposed to shift years of a mindset, alter behaviors and change the company’s culture.  Amazing!

This expectancy or shall I say management assumption is very real and prevalent in fast-moving start-up companies whose leaders claim to have a limited budget for “training” and no time to sit in frivolous meetings planning “the people side” of change.  I’m supposed to be grateful that I get an hour session.  What happens next also amazes me.  Training on the proposed system changes is reduced to an hour-long awareness session on the SOPs that have already gone into effect and folks are told – “Go with the flow. Change is part of our everyday life around here.  Get with it or get out”.  And here’s the rub for me, errors rise, deviations spike, users are annoyed, pissed off or disenfranchised and management blames the trainer for a failed change effort. Wow! Is this the management support that was promised to folks at the town hall meetings? 

The bigger the redesigned quality system changes are, the more you need to consider beyond just training awareness on the SOPs.  Assess the size of the change gap and the impact the new design will have on the culture; “the way we normally handle changes around here”.  Training rollout sessions are already time-crunched.  There is not enough time “allowable” to manage all the other non-training change issues like feelings, job security concerns, why the need for change retorts, lack of supervisory support post-training, etc. that actually get in the way of a successful learning transfer. And later create hurdles for improvement results.

Let’s look at the HPISC 5 Step Change Management Plan and apply it to quality system redesign projects.  (See the sidebar below.)

5 necessary parts of a Change Management Plan

QS Change Management Plan Considerations

1. Why is the change needed?

  • This may be really obvious when the site receives a Warning Letter.  But an explanation of how this became a driving force for the needed changes will do wonders for your employees to feel the urgency about the change.

2. What is really changing?

  • Will the changes be incremental or a huge transformational change such as “changing the quality culture”?
  • How are these SOP changes part of the GMP culture?

3. What are the pros and cons of the change?

  • Who benefits and who loses?
  • Are customers hurt or helped?
  • What are the stakeholder’s benefits from the change?
  • What about the benefits for the primary users?

4. What does success look like?

  • What will the outcomes of the change look like?
  • How will you and others know if the change has been successful?
  • What benchmarks will help you track progress?
  • When is the day or timepoint we get to declare success?

5. What other initiatives are we competing with

  • And how will adding the new change requirements impact already heavy workloads?

Will Awareness Training be the only vehicle for announcing the new changes?

Are the answers to the change management questions sitting with the trainer/training department or with the site leadership team?  Perhaps the answers can be found within the steering committee members?  Is the trainer supposed to address all of these questions in a 60-minute awareness session that also includes the SOP changes?  If successful user adoption is paramount to your strategic action plan, warning letter remediation plan, or CRL commitment response, you need to ensure that change management messages regarding these changes are included in the overall communication plan.  Don’t just rely on the design team members to deliver these messages casually at huddle updates.  That is not a communication plan. 

“The bigger the redesigned quality system changes are, the more you need to consider beyond just training awareness on the SOPs”.

Vivian Bringslimark, HPIS Consulting, Inc.

The design team with the aid of the project manager needs to schedule special change management sessions where the Affected Users are briefed on the status of the project and the answers to the questions listed above addressed.  Some leaders do not want to “waste time” on these sessions.  They are concerned that it will become a gripe session.  Instead, they think it’s better to just present the users with the revised procedures.  There’s less time to fret and grumble over it.

There is a false belief that once the Affected Users see the changes in a QA-locked down version, they will follow them “because it’s now in the approved SOP”.  Forced acceptance is not a change management strategy despite rampant practice in our industry. If awareness training will be the first time affected users are learning about significant system changes and the “Go-Live” date, be prepared to receive A LOT OF FEEDBACK FROM UPPER MANAGEMENT regarding how awful the awareness training sessions went. 

“Change is disturbing when it is done to us, exhilarating when it is done by us”.

Rosabeth Kanter, 1984, p. 64.

Who is Vivian Bringslimark?

This is 6th in the Redesigning Quality Systems series.

Camp, RR, Blanchard, PN. & Huszczo. Toward a More Organizationally Effective Training Strategy & Practice. New Jersey: Prentice-Hall, 1986.

Kanter, RM. The Change Masters. New York: Simon and Schuster, 1984, 64.

© HPIS Consulting, Inc.  All rights reserved.

Gap Assessments are necessary for QS redesign projects but so is the right level of support

This is the 3rd blog in the on-going Redesign Quality Systems: Achieving Successful User Adoption series. Visit Blog 1 and 2 here.

Assessments – “Truth Be Told”

Assessing the current state of the targeted quality system is analogous to collecting the “voice of the customer” input.  Discovering what is and is not working is vital to ensuring a successful redesign and ultimately user adoption. This is more than a review of the SOPs and forms; however.  Interviews are key to this phase of the project.  From the system owner to primary users, QA staff and even the LMS or the eDoc administrator are essential.  The more cross functional the input, the better the confirmation of the “data” and the “evidence”.  Which in turn, provides a truer gap assessment.

Most interviewees know the system’s weaknesses and they know how to fix it.  But they are frustrated with ignored attempts to change it.  Many simply give up trying to get it changed on their own or within their circle of responsibility.  So, when quality systems interviews are being conducted with an external consultant, some are eager to share the “dirt” on just how broken the system really is.  And some of the “fixes” are political and can only be handled when trust has been earned or when the sponsor deems it so.

We recognize Training is important but …

A small vitamin and supplements company set out to become a commercial manufacturer of pharmaceutical drug products.  Naturally, their quality systems were not robust enough to meet 21CFR 211 code of regulations. So, assessments were conducted for the major quality systems.  The Training Quality System assessment revealed several positive activities that were enabling current success and a lot of gaps that would need to be addressed to meet regulatory expectations for today’s pharmaceuticals companies. 

The sponsor explained that without top leadership support (meaning physically show up and attend this debriefing meeting), no one else would show up nor take the project seriously.

The sponsor routed the Training Gap Assessment Report to his peers and the CEO with an invitation to attend the first in-person briefing.  No one showed up except the sponsor, his direct reports and the consultant.  The meeting was rescheduled for a month later when all executives’ schedules showed availability.  One month later, the sponsor learned that key executives would be out of office during the meeting, so he postponed the briefing indefinitely.

The sponsor then arranged for a one-on-one follow-up session with the CEO and explained that without top leadership support (meaning physically show up and attend this debriefing meeting), no one else would show up nor take the project seriously. He also reiterated that in order to grow the business as intended, resources needed to be hired and the quality systems including Training needed immediate prioritization.  Or else the company would not receive approval to manufacture and could further impact its current relationship with the agency.

Three months later the meeting was scheduled.  However, the agenda took on a different focus. Particularly, the collaboration benefits of working cross-functionally with department managers and the shared ownership for the Training Quality System.  More specifically, the training project was not just a QA program, but a robust training system that impacts all employees.  This time the meeting occurred and was fully attended by all invitees.  

Change Readiness for the Design Team

With the briefing finally conducted, the sponsor explained to the consultant, that the “Design Team of SMEs” had very limited experience working cross-functionally or as a team. They knew even less about project management concepts like scope and project charters and they lacked fundamental concepts like quality systems and systems-based inspections.  And they did not know how to process map. They had been silo’d far too long.

SME Readiness Curriculum
Design Team of SMEs Readiness Curriculum

The consultant’s background included curricula building, instructional design, and quality systems redesign experience. She sketched a brief outline of the mini-curriculum for the Design Team of SMEs and the Sponsor agreed.   Over the next few weeks, they used their meeting time to work through the 4 introductory lessons.  And as a team, they used the “live” aspects of the project work to illustrate the concept and apply its principles to the progress and development of their team.   In essence, they were taught just what they needed to know at the moment the project needed it, similar to learning in the flow of work.  Four weeks later, the team was ready to begin their process mapping sessions together.

How Big is the Change Readiness Gap?

Who is Vivian Bringslimark?

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

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.

Who is Vivian Bringslimark?

*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.

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.

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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Did we succeed as intended? Was the training effective?

When you think about evaluating training, what comes to mind? It’s usually a “smile sheet”/ feedback survey about the course, the instructor and what you found useful. As a presenter/instructor, I find the results from these surveys very helpful, so thank you for completing them. I can make changes to the course objectives, modify content or tweak activities based on the comments. I can even pay attention to my platform skills where noted. But does this information help us evaluate if the course was successful?

Formative vs. Summative Distinction

Formative assessments provide data about the course design. Think form-ative; form-at of the course. The big question to address is whether the course as designed met the objectives. For example, the type of feedback I receive from surveys gives me comments and suggestions about the course.

Summative assessments are less about the course design and more about the results and impact. Think summative; think summary. It’s more focused on the learner; not the instructional design. But when the performance expectations are not met or the “test” scores are marginal, then the focus shifts back to the course, instructor/trainer and instructional designer with the intent to find out what happened? What went wrong? When root cause analysis fails to find the cause, it’s time to look a little deeper at the objectives.

Objectives drive the design and the assessment

Instructional Design 101 begins with well-developed objective statements for the course, event, or program. These statements aka objectives determine the content and they also drive the assessment. For example, a written test or knowledge check is typically used for classroom sessions that ask questions about the content. In order for learners to be successful, the course must include the content whether delivered in class or as pre-work. But what are the assessments really measuring? How much of the content they remember and maybe how much of the content they can apply when they return to work?

Training effectiveness on the other hand is really an evaluation of whether we achieved the desired outcome. So I ask you, what is the desired outcome for your training: to gain knowledge (new content) or to use the content correctly back in the workplace? The objectives need to reflect the desired outcome in order to determine the effectiveness of training.

What is your desired outcome from training?

Levels of objectives, who knew?

Many training professionals have become familiar with Kirkpatrick’s 4 Levels of Evaluation over the course of their careers, but less are acquainted with Bloom’s Taxonomy of Objectives. Yes, objectives have levels of increasing complexity resulting in higher levels of performance. Revised in 2001, the levels were renamed for better description of what’s required of the learner to be successful in meeting the objective. Take note, remembering and understanding are the lowest levels of cognitive load while applying and analyzing are mid range. Evaluating and creating are at the highest levels.

If your end in mind is knowledge gained ONLY, continue to use the lower level objectives. If however, your desired outcome is to improve performance or apply a compliant workaround in the heat of a GMP moment, your objectives need to shift to a higher level of reasoning in order to be effective with the training design and meet performance expectations. They need to become more performance based. Fortunately, much has been written about writing effective objective statements and resources are available to help today’s trainers.

Accuracy of the assessment tools

The tools associated with the 4 levels of evaluation can be effective when used for the right type of assessment. For example, Level 1 (Reaction) surveys are very helpful for Formative Assessments. Level 2 (Learning) are effective in measuring retention and minimum comprehension and go hand in hand with learning based objectives. But when the desired outcomes are actually performance based, Level 2 knowledge checks need to shift up to become more application oriented such as “what if situations” and scenarios requiring analysis, evaluating, and even problem solving. Or shift altogether to Level 3 (Behavior) and develop a new level of assessments such as demonstrations and samples of finished work products.

Trainers are left out of the loop

But, today’s trainers don’t always have the instructional design skill set developed. They do the best they can with the resources given including reading books and scouring the Internet. For the most part, their training courses are decent and the assessments reflect passing scores. But when it comes to Level 4 (Results) impact questions from leadership, it becomes evident that trainers are left out of the business analysis loop and therefore are missing the performance expectations. This is where the gap exists. Trainers build courses based on knowledge / content instead and develop learning objectives that determine what learners should learn. They create assessments to determine whether attendees have learned the content; but this does not automatically confirm learners can apply the content back on the job in various situations under authentic conditions.

Performance objectives drive a higher level of course design

When you begin with the end in mind namely, the desired performance outcomes, the objective statements truly describe what the learners are expected to accomplish. While the content may be the same or very similar, how we determine whether employees are able to execute post training requires more thought about the accuracy of the assessment. It must be developed from the performance objectives in order for it to be a valid “instrument”. The learner must perform (do something observable) so that it is evident s/he can carry out the task according to the real work place conditions.

To ensure learner success with the assessment, the training activities must also be aligned with the level of the objectives. This requires the design of the training event to shift from passive lecture to active engagement intended to prepare learners to transfer back in their workspace what they experienced in the event.   This includes making mistakes and how to recognize a deviation is occurring. Michael Allen refers to this as “building an authentic performance environment”. Thus, trainers and subject matter experts will need to upgrade their instructional design skills if you really want to succeed with training as intended. Are you willing to step up and do what it takes to ensure training is truly effective? – VB

 

Allen,M. Design Better Design Backward, Training Industry Quarterly, Content Development, Special Issue, 2017, p.17.