HPIS Means Human Performance Improvement Solutions

Welcome to the “official” HPIS C. Blogspot.  

Back in March of 2008, I was completing my second course in the ATD Human Performance Improvement Certificate series in Alexandria, VA.  ATD had recently moved into their new HQ home and the building was filled with a lot of excitement, energy, and promise.  Having been a national member since 1990, I was kind of in awe with being at the center of such a publicly accredited resource center.

 The course did not disappoint.  Somewhere on the morning of the 1st day, I had an epiphany that changed the path of my career.  Actually, it was when we were knee-deep into cause analysis of performance problems that I declared that I wanted to do this full time. 

The HPI approach is much more than a fancy training fix, or an excuse to buy more time.  Yes, it’s true that often the solution has a training component to it, but often the focus has evolved into something much more appropriate.  What appeals to me with Human Performance Improvement, is that a trainer’s toolbox of solutions is so much bigger.  The old expression, “when the only tool you have is a hammer, you tend to see everything as a nail” couldn’t be truer for trainers who deliver only courses.  The cause analysis step in the HPI Methodology gives credence to conducting a root cause analysis specifically for humans and their work environment.   The results of the analysis then provide insight as to how to resolve the gap(s).  Notice I didn’t say that it provides the learning objectives for the course that management wants delivered.  It is solution-agnostic until the end of the analysis period.

The HPI toolbox has 6 categories from which learning solutions typically are derived from.  Not to be confused with Carl Binder’s 6 boxes, the ATD HPI Model adapted these categories from the 1996 work of Dean, Dean, and Rebalsky; albeit, both have strong origins to the father of human performance improvement, Thomas Gilbert who first captured the concept as Engineering Worthy Behavior.  I highly recommend reading his work. See reference at the end.

The *1996 study focused on analyzing employee perceptions about which workplace factors would most improve their performance.  They categorized these factors into 6 key areas:

1.) PHYSICAL RESOURCES (the tangible tools and resources)

2.) STRUCTURE & PROCESS (Workflow factors of who and how)

3.) INFORMATION (effectiveness of data exchange between people a/o machines)

4.) KNOWLEDGE (skill related)

5.) MOTIVES (intrinsic to the performer; may or may not affect performance)

6.) WELLNESS (physical or emotional factors affecting performance)

HPIS Consulting was created on the basis of the HPI methodology.  Using a structured process to uncover what gets in the way of employees performing their jobs, a true “training” root cause analysis can be conducted.   The solutions are then project managed to fruition and evaluated for impact results.

So how does HPISC’s Robust Training Systems and HPI mesh?

The following diagram illustrates just how expansive today’s Performance Consultants toolbox can be.  It was this vision back in March 2008 that got me so excited about where the Learning and Performance field can go.  I say bring it on!  -VB

HPIS C uses 6 boxes of solutions
HPIS C uses 6 boxes of solutions

References:

Dean, PJ, Dean,MR, Rebalsky,RM. (1996) Performance Improvement Quarterly, 9(2), 75-89.

Gilbert, T.  Engineering Worthy Behavior,

Wilmoth, Prigmore, Bray “HPT Models”, Performance improvement 41(8), 16-23.

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Isn’t this still training?

To the newly minted and seasoned performance consultant, the answer is NO.  But for your client, internal customer or the VP of Quality, or whomever is your requestor, it still may look like “a training solution”, so don’t argue with them.  You do however, want to be able to explain why it is more than a classroom instructor led session or a quick and dirty PPT slide with audio recording.

If it looks like, smells like, tastes like training …

Then it must be training, right? Not exactly, but nod your head anyway; at least they are still engaged with you!  Any one of the elements of a Robust Training System is “training-related”.  So for the less informed, this connection makes sense to them.  If your client/sponsor/requestor is more comfortable with calling it training, let them do so.  Don’t push the HPI label at this point.  First, we work on raising their awareness of our early projects and successes.  Understanding and hopefully appreciation will come later.

What’s your company’s definition of training, anyway?

Most folks will envision instruction either classroom based, virtual instructor led or even formal eLearning course.  Their reasoning is that the gap must be a lack of knowledge and training is used to close that gap.  Is closing a skill based gap also considered training?  Most companies would define that as OJT.  What about “awareness training” and communication “training” sessions; are these considered training?  It is a form of closing a knowledge gap, the depth of the gap and the degree of required proficiency is the differentiator.  Again, what’s your company’s definition of training?

Closing Performance Gaps with the Right Solutions

The essence of HPI methodology is all about the right solution based on the data (evidence) and making an impact on the bottom line when the performance gap closes.  Is this training, you tell me?  How would you explain it to your sponsor?

Not all HPI Solutions are Classroom Based

HPI Solutions

Talk about using knowledge to improve KPIs for a business unit

A team of site leaders met to discuss (problem solve) what to do about lagging metrics for a business unit.  The idea of studying SMEs (aka key performers) to learn what they needed to do to meet or beat the numbers was brought up.  I applaud them.  In fact, conducting Key Performer Analyses is part of the HPI methodology and is an excellent way to gather real data from experts.  However, the outcome was already biased with a set of “knowledge based” assumptions unbeknownst to the Performance Consultant (PC).  During the Key Performer Interviews, it turned out that those assumptions were brutally flawed and put this HPI project and another highly visible project in serious jeopardy.    The PC was able to uncover the right knowledge from the SMEs and successfully deliver a solution.  However, it was far from a traditional classroom training session.  Yet, it had everything to do with capturing secret sauce learned on the job.

Is this still training?  You tell me after you read the impact story.  -VB

NOTE: A more detailed version of this case –“Capturing Secret Sauce of Senior Equipment Operators?” is available. 

Next blog: “If it’s not training, then what is the right fix?”

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

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.

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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I’m in love with my own content!

Many QA /HR Training Managers have the responsibility for providing a train-the-trainer course for their designated trainers.  While some companies send their folks to public workshop offerings, many chose to keep the program in-house.   And then an interesting phenomenon occurs.  The course content grows with an exciting and overwhelming list of learning objectives.

The supervisors of the SMEs struggle with the loss of productivity for the 2 – 3 day duration and quickly develop a “one and done” mindset.   Given the opening to “train” newly identified SMEs as Trainers, the instructional designer gets one opportunity to teach them how to be trainers.  So s/he tends to add “a lot of really cool stuff” to the course in the genuine spirit of sharing, all justifiable in the eyes of the designer.  However, there is no hope in breaking this adversarial cycle if the Training Manager doesn’t know how to cut content.

I used to deliver a two-day (16 hour) workshop for OJT Trainers. I included all my favorite topics.  Yes, the workshop was long.  Yes, I loved teaching these concepts.  I honestly believed that knowing these “extra” learning theory concepts would make my OJT Trainers better trainers.  Yes, I was in love with own my content.  And then one day, that all changed.

 

Do they really need to know Maslow’s Hierarchy of Needs?

During a rapid design session I was leading, I got questioned on the need to know Maslow’s Hierarchy of Needs.  As I began to deliver my auto-explanation, I stopped mid-sentence.  I had an epiphany.  My challenger was right.  Before I continued with my response, I feverishly racked my brain thinking about the training Standard Operating Procedures (SOPs) we revised, the forms we created, and reminded myself of the overall goal of the OJT Program.  I was searching for that one moment during an OJT session when Maslow was really needed.  When would an OJT Qualified Trainer use this information back on the job, if ever I asked myself?

It belongs in the Intermediate Qualified Trainers Workshop, I said out loud.  In that moment, that one question exercise was like a laser beam cutting out all nice-to-know content.  I eventually removed up to 50% of the content from the workshop.

 

Oh, but what content do we keep?

Begin with the overall goal of the training program: a defendable and reproducible methodology for OJT.  The process is captured in the redesigned SOPs and does not need to be repeated in the workshop.  See Have you flipped your OJT TTT Classroom yet?

Seek agreement with key stakeholders on what the OJT QTs are expected to do after the workshop is completed.  If these responsibilities are not strategic or high priority, then the course will not add any business value.  Participation remains simply a means to check the compliance box.  Capture these expectations as performance objectives.

How to align purpose of a course to business goals

Once there is agreement with the stated performance objectives, align the content to match these. Yes, there is still ample room in the course for learning theory, but it is tailored for the need to know only topics.

In essence, the learning objectives become evident.  When challenged to add certain topics, the instructional designer now refers to the performance objectives and ranks the consequences of not including the content in the workshop against the objectives and business goal for the overall program.

 

What is the value of the written assessment?

With the growing demand for training effectiveness, the addition of a written test was supposed to illustrate the commitment for compliance expectations around effectiveness and evaluation.  To meet this client need, I put on my former teacher hat and created a 10 question open book written assessment.  This proved to need additional time to execute and hence, more content was cut to accommodate the classroom duration.

My second epiphany occurred during the same rapid design project, albeit a few weeks later.   What is the purpose of the classroom written assessment when back on the job the OJT QTs are expected to deliver (perform) OJT; not just know it from memory? The true measure of effectiveness for the workshop is whether they can deliver OJT according to the methodology, not whether they retained 100% of the course content!   So I removed the knowledge test and created a qualification activity for the OJT QTs to demonstrate their retained knowledge in a simulated demonstration using their newly redesigned OJT checklist.  Now the OJT QT Workshop is value added and management keeps asking for another round of the workshop to be scheduled.  -VB

Are you ready to update your OJT TTT Course?

 

 

 

I’ve fired my [TTT] Vendor!  

Sustaining Qualified Trainer’s Momentum Post Launch

The Silver Bullet for Performance Problems Doesn’t Exist

Oh but if it did, life for a supervisor would be easier, right? Let’s face it, “people” problems are a big deal for management. Working with humans does present its challenges, such as miscommunications between staff, data entry errors, or rushing verification checks. Sometimes, the task at hand is so repetitive that the result is assumed to be okay and gets “a pass”.  Add constant interruptions to the list and it becomes even harder not to get distracted and lose focus or attention to the detail.

Actual behavior vs. performing as expected

In their book, Performance Consulting: Moving Beyond Training, Dana Gaines Robinson and James C. Robinson describe performance as what the performer should be able to do. A performance problem occurs when the actual behavior does not meet expectation (as in should have been able to do).   Why don’t employees perform as expected? Root cause analysis helps problem solvers and investigators uncover a myriad of possible reasons.   For Life Sciences companies, correcting mistakes and preventing them from occurring again is at the heart of CAPA systems (Corrective Actions Preventive Actions).

A closer look at performance gaps

Dana and James Robinson conducted research regarding performer actions and sorted their results into three categories of obstacles:

  • Conditions of performers
  • Conditions of the immediate managers
  • Conditions of the organization

A checklist for common Performance Causes  – scroll down for the Tool.

But, weren’t they trained and qualified?

Hopefully, employees are trained using an approved OJT (On the Job Training) Methodology in which they are shown how to execute the task and then given opportunities to practice multiple times to become proficient. During these sessions, they are coached by Qualified Trainers and given feedback on what’s right (as expected) and given specific instructions to correct what’s not right with suggestions for tweaking their performance so that their final performance demonstration is on par with their peer group. At the conclusion of the qualification event, employees must accept that they now own their deviations (mistakes) from this point forward. So what gets in the way of performing “as they should” or in compliance speak – according to the procedure?

Is it a lack of knowledge, skill or is it something else?

The Robinson’s explain that performance is more than the training event. It’s combination of the overall learning experience and the workplace environment that yields performance results. Breaking that down into a formula per se, they suggest the following: learning experience x workplace environment = performance results.

The root cause investigation will include a review of training and the qualification event as well as a discussion with the performer.

  • Is it a lack of frequency; not a task often performed?
  • Is it a lack of feedback or delayed feedback in which the deviation occurred without their awareness?
  • Is it task interference?

The work environment includes organizational systems and business unit processes that together enable the performer to produce the outcomes as “expected”.   These workplace factors don’t always work in perfect harmony resulting in obstacles that get in the way of “expected” performance:

  • Lack of authority – unclear roles, confusing responsibilities?
  • Lack of time – schedule conflicts; multi-tasking faux pas?
  • Lack of tools – reduced budgets?
  • Lack of poorly stored equipment/tools – lost time searching?

Isn’t it just human nature?

Once the root cause investigation takes on a human element attention, it’s easy to focus on the performer and stop there.   If it’s the first time for the performer or first instance related to the task, it’s tempting to label the event as an isolated incident. But when it comes back around again, it becomes apparent there was a “failure to conduct an in-depth investigation” to correct and prevent. Not surprisingly, a push back of “Operator Error as Root Cause” has forced organizations to look deeper into the root causes involving Humans.

Who’s human nature?

Recall that one of the categories of the researched obstacles was “conditions of the immediate managers”. This makes managers uncomfortable. With so much on their plates, managing a people performance problem is not what they want to see. A silver bullet like a re-training event is a nice activity that gets a big red check mark on their to-do list. However, Robert Mager and Peter Pipe, in their book, Analyzing Performance Problems, provide insights to managing direct reports that may lead to unintended consequences. A brief list can be found here – scroll to Tool: Performance Causes.  (It’s not always the performer’s fault.)

It takes all three to correct a performance problem

soln-people-performance-problemThe third category of researched obstacles clustered around “conditions of the organization”.  I’ve already discussed task interference above. To suggest that organizations are setting up their employees to fail is pushing it just a bit too far.   So I won’t go there, but it is painful for some leaders to come to terms with the implication. In order to prevent issues from reoccurring, an examination of the incidents and quite possibly a restructuring of systems have to occur, because automatic re-training is not the only solution to a “people performance problem”. –VB

Robinson DG, Robinson JC. Performance Consulting: Moving beyond training. San Francisco: Berrett-Koehler; 1995.

Mager R, Pipe P. Analyzing performance problems. Belmont: Lake Publishing; 1984.