What to expect when process mapping with SMEs as teammates

Process Mapping the Redesign

While there is value in mapping the current state of the quality system, teams can often get bogged down in disagreements over the level of detail and the sequence of explicit steps.  They miss the point that a future state design is our desired outcome from this stage.  The danger lies in members becoming so entrenched in the current state, that they have difficulty envisioning any other possibilities including a better future process for the named quality system.  The gap assessment interviews and report findings were the opportunity to focus on the current state of affairs.

To keep the project moving forward and team members engaged, begin the process mapping sessions with a marked-up, “proposed” future state model and have the design team members identify what needs to change, be eliminated or added using the gap assessment report.  During these discussions, another layer of discovery is often revealed.  The project manager frequently learns that recommended steps suggested forms, etc. were previously included in the SOPs only to have been removed in later change control requests with limited or no rationale provided.

Use process maps to work out the process conceptually first

Occasionally, one or two members will find themselves stuck in “the way we do it here” mindset and cannot embrace the change(s) being proposed.  This is when the project manager needs to switch roles and become a facilitator (or hire one) to put into practice the training concepts from team-building like staying open-minded, respecting different viewpoints, actively listening to each other and reaching consensus.

Change is a process.  As a project manager, I could just come in and tell the design team “this is the future state and these are the SOPs and new forms you will be following.  Now, will someone help me get this packet of documents into the change control queue? We have FDA due dates to meet”.  I don’t envision any of my team will raise their hand.  Would you?  And yet, most Quality Systems redesign projects are executed this way under the guise of the SME team.  If the design team isn’t buying the need for changes, how can I expect the rest of the users to embrace it, let alone comply with the new design?

“This Will Never Work Here!”

Another barrier to staying focused on future state mindset is succumbing to the fear that “management will never buy into any of this”. A good project manager will maintain a project issues log that becomes the agenda for weekly check-ins with the sponsor.  This is why it so crucial to keep the sponsor up to date with anticipated barriers and challenges sooner rather than later during the implementation stage.  It is also wise to reflect the tracking of these items in the written project status updates.  It is the responsibility of the project manager to track resolution and report back to the team in order to keep momentum, encouragement and continued trust within the team.

If the design team isn’t buying the need for changes, how can I expect the rest of the users to embrace it, let alone comply with the new design?

Vivian Bringslimark, HPIS Consulting, Inc.

But we’ve already got our process in place!”

Once in a while, I am presented with a range of progress on implementing a Robust Training System, where some departments are very far along with their executed tasks and some departments haven’t even begun.  It’s like a race to see who crosses the finish line first.  Being first allows the department to carve its way as the best practice and the process for the rest of the organization to follow.  AKA – they like to think they can influence the policy and/or SOPs with little regard for the nuances of other department’s unique processes. So, be mindful of resistance to adapt, adjust, or even participate in design team meetings, when one group is heavily entrenched in their departmental training practices, especially the unwritten ones.

Spend the team’s meeting time wisely and focus on the process maps first.  Get a consensus on the flow diagrams before proceeding to the SOPs.  This accomplishes a number of benefits.  Having a process flow diagram keeps the discussion centered on the process conceptually and not hung up in SOP semantics.  Wordsmithing comes after an agreement for the future state has been achieved. 

Another barrier to staying focused on future state mindset is succumbing to the fear that “management will never buy into any of this”.

Vivian Bringslimark, HPIS Consulting, Inc.

Include your sponsor and select executive stakeholders on the update.  This is the opportunity to inform them about major changes and anticipated impact on the organization. Be sure to speak about eliminated redundancies and/or any anticipated efficiencies gained from the future state.  Keep the discussion at the conceptual level for now.  But also be prepared to field specific or detailed concerns i.e. will this result in a change of headcount?  Note: If your sponsor or key executive stakeholder prefers “seeing” the process via printed SOP steps, accommodate this preference and have a good working draft prepared.

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Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

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 in 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.

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

Is Documenting Your OJT Methodology Worth It?

The short answer is yes!  In this blog post, I intend to share with you how I came to this answer and to make the case for you to also say yes.  I will also explore the challenges of documenting OJT as promised in a previous blog post.

Years ago, during the Qualified Trainers (QT) workshop, I would ask QTs the following two questions:

  • What is OJT?
  • How do you deliver OJT?

Invariably, all would answer the first question the same way: on the job training.  And then I would ask the attendees to form into groups to discuss the second question among fellow peers.  I purposely mixed the groups so that there was equal representation of manufacturing trainers and QC analytical laboratory trainers and a fascinating exchange occurred between the attendees.  During the debriefing activity, we learned that there was a lot of variability in how the trainers were conducting OJT.  How can that be when they all answered the first question so consistently? “Well”, one of them said, “we don’t have a procedure on it so I just go about it the way I think it should be done.  I’ve had success so far, so I keep on doing what I’ve done in the past.”

How many ways is there to train on this procedure?

In the blog post, “When SMEs have too much secret sauce”, I share the story about a Director of Operations who had to find out from an FDA Investigator, that his SMEs were teaching techniques for a critical process procedure that 1) were not written down nor were they approved (aka their secret sauce) and 2) were not at all consistent with each other.  Which lead to a FD-483 observation, a high visibility corrective action project with global impact and a phone call to HPISC.

In order to get consistent OJT, you need to define the process and you need to approve the content from which QTs will be using to deliver OJT.  I’m not proposing a cookie cutter approach for QTs to become all the same.  I am advocating a clear distinction between each step / stage / phase so that both the learner and the QT know exactly where they are in the process, what is expected of them in that step and why it is needed.  This is no longer just go follow Joe or Jane around which is how traditional OJT happened in the past.  

Declaring your OJT Model

I’m less focused on what you call these steps or how many there are.   I am looking to see how these steps move a new hire along the journey to becoming qualified prior to being released to task.  For me, this is what makes OJT really structured.  And that model needs to be captured in a standard operating procedure or embedded in a training procedure so that all employees are informed and aware of how they will receive their OJT.  The last step has to include the final evaluation of performance, not to be confused with demonstrating proficiency as in practice sessions. 

How many times does a learner have to practice an SOP before s/he is ready for the qualification event (Q-Event)? 

The nature of the SOP or the complexity of the task at hand determines this.  But, how do I proceduralize that, you ask?  It starts by not arbitrarily picking the magic number 3.  I have engaged in countless discussions regarding the exhaustive list of exceptions to forcing the rule of 3 times to practice.  And some QT’s will argue for more than 3 sessions especially when the procedure is so infrequently performed.  It’s not about the number of times, folks. 

Documenting OJT sessions presents a challenge for many trainers and document control staff.  Are we required to capture every OJT session or just one?  What is considered an OJT session?  My favorite lament is – “Do you know what that will do to our database not to mention the amount of paperwork that would create!” A workaround to all these questions and concerns is to capture at least one session along the progression of each OJT step as per the OJT Model, thus documenting adherence to the procedure.  For example, the first step is to Read SOP 123456.  As mentioned in other HPISC blogs and white papers, we are pretty good at this already.  Then, the next step is to discuss / introduce the SOP, so capture when that discussion occurred if it’s different from Step 1 READ.  The “trainer demonstrates” portion can also be captured.  Where it gets tricky is when we ask the learner to demonstrate and practice.  Why not capture the last instance when it is confirmed the learner is ready to qualify?  If we keep it simple and document that our learners have experienced each step /stage, then we are complying with our OJT methodology and minimally documenting their OJT progression.

Is one qualification session enough to pass?

At some point in these documentation discussions, we have to let the QT evaluate the outcome of the learner’s demonstration(s).  Does the performance meet “business as usual” expectations?  If it does, the learner is ready to qualify in order to perform independently.  If not, feedback is provided and the learner undergoes more practice.  How many times is enough? Until both the learner and the QT are confident that s/he is not going to have an operator error deviation a week after going solo.  The QT is ultimately the one who has to assess progress and determine that “with a few more sessions”, my learner will get this or no, s/he may never get it and it’s time to have a discussion with the supervisor.

How do you know if someone is qualified to perform task?

Ideally, the answer would be because we can look it up in our LMS history.  And that of course depends on how well the critical steps and behaviors are captured in the documentation tool. The tool is supposed to help the QT be as objective as possible and consistently evaluate performance as demonstrated. In the article, “A Better Way to Measure Soft Skills”, author Judith Hale explains the difference between a checklist and a rubric.

            “Checklists only record whether a behavior occurred, though, and not the quality of the behavior.  Rubrics, on the other hand, measure how well the learner executed the behavior.”  p. 62.

Yes, but was it tolerable, adequate or exemplary?

What I typically see are checklists with varying levels of tasks, steps and/or behaviors with a column for Yes, No and Comments.  What I don’t see is a column to mark how well the learner performed!  Is it enough to mark Yes or No for each item since most Q Events are Pass or “needs more practice”?  Maybe.  But consider the following situation.  A human error deviation has occurred and the LMS indicates the technician has earned qualified status.  The document used to qualify this individual shows all Yeses.  Yes s/he was able to demonstrate the step, critical task, and/or behavior, but what we don’t know is how well?  Are we to assume that No means “No, not at all” and Yes means performed “Well” or it is “As Expected” or “Adequate” or maybe in this case it was “Sort of”? 

An additional column describing what it means to score low, medium, high or in our situation: Poor, Adequate, As Expected, and even Exemplar could provide much needed insight for the root cause analysis and investigation that will follow this deviation.  It provides a level of detail about the performance that goes beyond Yes, No, or Comment.  In most checklists I’ve reviewed, the comments column is hardly ever used.

In future posts, I will blog about what the QT signature means.  Until then, is documenting your OJT methodology worth it?  What is your answer? – VB  

Hale,JA Better Way to Measure Soft Skills, TD, ATD, August, 2018, pps. 61-64.

Instructional Design: Not Just for Full Time Trainers Anymore

When I left the manufacturing shop floor and moved into training, full time trainers presented in the classroom using a host of techniques, tools, and relied on their platform skills to present content. Subject matter experts (or the most senior person) conducted technical training on the shop floor in front of a piece of equipment, at a laboratory station or a work bench.

For years, this distinction was clearly practiced where I worked. Trainers were in the classroom and SMEs delivered OJT. Occasionally a “full time” trainer would consult with a SME on content or request his/her presence in the room during delivery as a back-up or for the Q & A portion of a “presentation”. It seemed that the boundaries at the time, were so well understood, that one could determine the type of training simply by where it was delivered.

Training boundaries are limitless today

Today, that’s all changed. No longer confined to location or delivery methods, full time trainers can be found on the shop floor fully gowned delivering GMP (Good Manufacturing Practices) content for example. And SMEs are now in the classroom more each day with some of the very tools used by full time trainers! What defines a full time trainer from a SME is less important, what is imperative however is what defines effective instruction.

Instructional Design is a recognized profession

What goes into good instructional design?

Believe it or not, instruction design (ID) / instructional technology is a degreed program offered at numerous colleges and universities. Underlying the design, is a methodology for “good” course design and really good instructional designers will confess that there is a bit of an art form to it as well. Unfortunately, with shrinking budgets and downsized L&D staffs, there are less resources available to develop training materials. Not to mention, shrinking time lines for the deliverables. So it makes sense to tap SMEs for more training opportunities since many are already involved in training at their site. But, pasting their expert content into a power point slide deck is not instructional design. Nor is asking a SME to “deliver training” using a previously created power point presentation effective delivery.

What is effective design?

To me, effective design is when learners not only meet the learning objectives during training but also transfer that learning experience back on the job and achieve performance objectives / outcomes. That’s a tall order for a SME, even for full time trainers who have not had course design training. The methodology a course designer follows be that ADDIE, Agile, SAM (Successive Approximation Model), Gagne’s 9 Principles, etc., provides a process with steps to facilitate the design rationale and then development of content including implementation and evaluation of effectiveness. It ensures that key elements are not unintentionally left out or forgotten about until after the fact like evaluation/ effectiveness or needs assessment. In an attempt to expedite training, these methodology driven elements are easily skipped without fully understanding the impact the consequences can have on overall training effectiveness. There is a science to instructional design.

The “art form” occurs when a designer creates visually appealing slides and eLearning scenes as well as aligned activities and engaging exercises designed to provide exploration, practice and proficiency for the performance task back on the job. The course materials “package” is complete when a leader’s guide is also created that spells out the design rationale and vision for delivery, especially when someone else will be delivering the course such as SMEs as Classroom Facilitators.

The Leaders Guide

Speaker notes embedded at the bottom of the notes pages within power point slides is not a leader’s guide. While handy for scripting what to say for the above slide, it does not provide ample space for facilitating other aspects of the course such as visual cues, tips for “trainer only” and managing handouts, etc. A well-designed leader’s guide has the key objectives identified and the essential learning points to cover. These learning points are appropriately sequenced with developed discussion questions to be used with activities; thus removing the need for the facilitator to think on demand while facilitating the activity. This also reduces the temptation to skip over the exercise/activity if s/he is nervous or not confident with interactive activities.

A really good guide will also include how to segue to the next slide and manage seamless transitions to next topic sections. Most helpful, are additional notes about what content MUST be covered, tips about expected responses for activities and clock time duration comments for keeping to the classroom schedule. Given all the time and effort to produce the leaders guide, it is wasted if the course designer and SME as Facilitator do not have a knowledge transfer session. Emailing the guide or downloading it from a share point site will not help the SME in following the guide during delivery unless an exchange occurs in which SMEs can begin to mark up his/her copy.

Using previously developed materials

I am not criticizing previous course materials if they were effective. But replacing clip art with new images and updating the slide deck to incorporate the new company background is not going to change the effectiveness of the course unless content was revised and activities were improved. For many SMEs, having a previous slide deck is both a gift and a curse.

While they are not starting with a blank storyboard, there is a tendency to use as-is and try to embellish it with speaker notes because the original producer of the power point slide did not include them or worse, provided no leader’s guide. The SME has the burden to make content decisions such as what content is critical; what content can be cut if no time. Perhaps even more crucial is how to adapt content and activities to different learner groups or off-shift needs. SMEs who attend a HPISC. ID basics course learn how to use design checklists for previously developed materials.   These checklists allow them to confidently assess the quality of the materials and justify what needs to be removed, revised or added; thus truly upgrading previously developed materials.

What’s so special about SMEs as Course Designers?

They have expertise and experience and are expected to share it via training their peers. But now the venue is the classroom as well. It’s training on course design methodology that is needed. SMEs and most trainers do not automatically have this knowledge. Some develop it by reading A LOT, attending well-designed courses, and over time with trial and error and painful feedback. The faster way is to provide funds to get SMEs as Course Designers at least exposed to how to effectively design for learning experiences so that they can influence the outcome of the objectives. This is management support for SMEs as Trainers. -VB

Facilitating the Shift from Passive Listening to Active Learning

On the one end of “The Learner Participation Continuum” is lecture which is a one way communication and requires very little participation.  At the other end, we have experiential learning and now immersive learning environments with the introduction of 3D graphics, virtual simulations and augmented reality.

In the middle of the range are effective “lectures” and alternate methods such as:

  • Demonstrations
  • Case Study
  • Guided Teaching
  • Group Inquiry
  • Read and Discuss
  • Information Search.

Shift one step to right to begin the move to active learningNow before you insist that the SME as Facilitator move to the far right and conduct only immersive sessions, a word of caution is in order. It’s really about starting with the learners’ expectations and the current organizational culture and then moving one step to the right. If they are used to lectures from SMEs, then work on delivering effective lectures before experimenting with alternate training methods. The overnight shift may be too big of a change for the attendees to adjust to despite their desire for no more boring lectures. Small incremental steps is the key.

How is this done? Upfront in the design of the course materials. The course designers have spent time and budget to prepare a leaders guide that captures their vision for delivering the course.  SMEs as Facilitators (Classroom SMEs) need to study the leader’s guide and pay attention to the icons and notes provided there. These cues indicate the differentiation from lecture, to an activity whether that be self, small group, or large group. While it may be tempting to skip exercises to make up for lost time, it is better for learner participation to skip lecture and modify an activity if possible.

During the knowledge transfer session/ discussion with the course designer and/or instructor, Classroom SMEs make notes of how the instructor transitions from one slide to the next and how s/he provided instruction for the activity. This is a good time for Classroom SMEs to ask how to modify content or an activity if certain conditions should occur. Especially important for SMEs to ask is what content is critical and what content can be skipped if time runs short. It is always a good idea for the Classroom SME to mark-up his/her copy of the materials. And then again after the first delivery to really make it their own leader’s guide. -VB

Speaking of personalizing their leaders’ guide, SMEs may want to experiment with different ways to “open a session” to get experience with a variety of techniques and observe which ones yield better results.

Moving from Lecture to Delivering an EFFECTIVE Lecture

While lecture has its merits, today’s learners want engaging content that is timely, relevant and meaningful. Yet, most SMEs tend to suffer from the “curse of too much knowledge” and find it difficult to separate the need-to- know from the nice-to-know content.

Presenting for them takes on a lecture style format. The thought of facilitating an activity gives most SME a case of jitters and anxiety.  So, in the HPISC. “SME as Facilitator” workshop, attendees are encouraged to step away from the podium and use their eyes, hands and voice to engage with their audience. Easier said than done, yes. That’s why the course is designed to allow them to take small steps within the safety of a workshop environment.

But rather than trying to pull off a fully immersive session, SMEs as Facilitators are introduced to techniques that “liven up” the lecture. They are shown how to move back and forth from passive (sit, hear, see) to active involvement (write, construct, discuss, move, speak). This requires the ability to:

  • follow a well organized design plan
  • capture and hold attention of learners
  • use relevant examples and deviations if possible
  • show authentic enthusiasm
  • involve audience both directly and indirectly
  • respond to questions with patience and respect.

Great presentations are like great movies. They open with an attention-seeking scene, have drama and conflict in the middle so you stick around long enough to see the hero survive and they close on a memorable note. Using the movie analogy, a SME as Facilitator can open the session with something more than his/her bio. They can pick a notable career achievement that most folks aren’t aware of.  Keeping the interest alive, the SME can then draw the connection of content to the audience and address the WIIFM question on everyone’s mind. (WIIFM = What’s in it for me?)

While we don’t need to add to anyone’s stress load, overcoming conflict makes for great story telling. Case studies, major CAPAs, deviations and audit observations make it real life. Use of visuals especially diagrams is visually appealing to learners and keeps them engaged. (CAPA= Corrective Actions Preventive Action Investigations)

Thoroughness in the preparation reflects care and thoughtfulness. Learners appreciate the personal desire to deliver a more lively lecture. Therefore, I like to use the concept of a lecturette; 10 minute blocks of time to chunk up complex topics. Interspersing a 10—15 minute lecture segment with an activity whether self, small group or stand up at the flipchart, gives learners the opportunity to engage with new and/or more complex content in smaller doses.

Stepping away from the podium forces the SME to take action and allow the learners to “get up close” with the SME as Facilitator. This in turn is reflected in the learners desire to respond to questions and dialogue during a facilitated discussion. The rule of thumb for lecturing is approximately 20 minutes max. But with today’s technology buzzing away at your fingertips or on the tabletop, I’d say more like 10 or 15 minutes max if you are an engaging facilitator.

difference between a novice and wise teacher

Remember, the goal of a session is to maximize retention of the audience, not just tell them the content. Attendees learn more if the SME as Facilitator can focus their attention on the topic and deliver content that is relevant to their work situation. Involving the learners in a variety of ways is the key to effective lectures and great presentations. – VB

You might also want to get up to speed with current trend for SMEs – check out the blog post – Are your SMEs becoming duo purposed? Comments welcomed.