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

Does having curricula make OJT structured?

The Evolution

First there was “Just go follow Joe around” training …

And then came “and it shall be documented” …

Next the follow up question:  “Are they trained in everything they need to know?”

So line managers used the SOP Binder Index and “Read and Understand Training” became a training method…

But alas, they complained that it was much too much training and errors were still occurring …

So training requirements were created and curricula were born.

Soon afterwards, LMS vendors showed up in our lobbies and promised us with a click and a report, we could have a training system!

But upper management called forth for METRICS! So dashboards became a visible tool. Leaderboards helped create friendly competition among colleagues while “walls of shame” made folks hang their heads and ask for leniency, exemptions and extensions  … 

But just having curricula doesn’t necessarily make OJT structured.  During the HPISC Qualified Trainers workshop, I present the difference between t-ojt (traditional) and s-ojt (structured). 

Moving from t-ojt to s-ojt

When I ask the QT’s where they feel their organization is, most of them will say still in t-ojt box but closer to the middle of the range.  Why I ask?  Invariably, they’ll tell me OJT is not scheduled.  “Just because I have the list (curricula requirements) doesn’t mean the training gets scheduled or that qualification events get conducted”.  But rather, it happens when someone makes it a priority, an inspection is coming or a CAPA includes it as part of corrective actions. So what else makes it structured?

In the next blog, I’ll continue the “discussion”.  In the meantime, feel free to share your thoughts regarding how OJT is handled at your site.  -VB

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Why Knowledge Checks are Measuring the Wrong Thing

When I taught middle school math, tests were used to assess knowledge comprehension and some application with word problems and a few complex questions requiring logic proofs. Results were captured via a score; a metric if you will as to how well you answered the questions and very appropriate in academia.

In our quest for training evaluation metrics, we have borrowed the idea of testing someone’s knowledge as a measure of effectiveness. This implies that a corporate classroom mirrors an educational classroom and testing means the same thing – a measure of knowledge comprehension. However, professors, colleges, universities and academic institutions are not held to the same results oriented standard. In the business world, results need to be performance oriented, not knowledge gained.

So why are we still using tests?

Call it a quiz, a knowledge check or any other name it is still assessing some form of knowledge comprehension. In training effectiveness parlance, it is also known as a level 2 evaluation. Having the knowledge is no guarantee that it will be used correctly back on the job. Two very common situations occur in the life science arena where “the quiz” and knowledge checks are heavily used: Annual GMP Refresher and Read & Understand Approach for SOPs.

Life sciences companies are required by law to conduct annual regulations training (GMP Refreshers) so as to remain current. To address the training effectiveness challenge, a quiz / questionnaire / knowledge assessment (KA) is added to the event. But what is the KA measuring? Is it mapped to the course /session objectives or are the questions so general that they can be answered correctly without having to attend the sessions? Or worse yet, are the questions being recycled from year to year / event-to-event? What does it mean for the employee to pass the knowledge check or receive 80% or better? When does s/he learn of the results? In most sessions, there is no more time left to debrief the answers. This is a lost opportunity to leverage feedback into a learning activity. How do employees know if they are leaving the session with the “correct information”?

The other common practice is to include a 5 multiple choice as a knowledge check for Read & Understood (R & U) SOPs especially for revisions. What does it mean if employees get all 5 questions right? That they will not make a mistake? That the R & U method of SOP training is effective? The search function in most e-doc systems is really good at finding the answers. It doesn’t necessarily mean that they read the entire procedure and retained the information correctly. What does it mean for the organization if human errors and deviations from procedures are still occurring? Does it really mean the training is ineffective?

What should we be measuring?

The conditions under which employees are expected to perform need to be the same conditions under which we “test” them. So it makes sense to train ‘em under those same conditions as well. What do you want/need your employees (learners) to do after the instruction is finished? What do you want them to remember and use from the instruction in the heat of their work moments? Both the design and assessment need to mirror these expectations. And that means developing objectives that guide the instruction and form the basis of the assessment. (See Performance Objectives are not the same as Learning Objectives.)

So ask yourself, when in their day to day activities will employees need to use this GMP concept? Or, where in the employees’ workflow will this procedure change need to be applied? Isn’t this what we are training them for? Your knowledge checks need to ensure that employees have the knowledge, confidence and capability to perform as trained. It’s time to re-think what knowledge checks are supposed to do for you. – VB

Need to write better Knowledge Check questions?  Need to advise peers and colleagues on the Do’s and Don’ts for writing test questions?

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.

Are all your SMEs Qualified Trainers?

I got a phone call from my Lead SME’s boss one morning. “How many more sessions do you need”, I asked him. I had already delivered 4 back-to-back workshops with class sizes of 25-30 SMEs; which was beyond optimal. So I asked him why. I needed to find out what was driving the surge in identified Qualified Trainers (QTs). I learned that a retrospective qualification needed to take place in order to close out an inspection observation. The total number of SMEs needing “proper paperwork” was well over 700. Since the redesigned training system was now in effect, these undocumented SMEs as Trainers would have to follow the new procedure. Or would they? Our discussion shifted to what type of training these SMEs will be delivering.

I then shared a related story with him. Several years prior, I got entangled with a “CAPA crisis” that involved QTs. No sooner did we launched the QT program and put the new procedure into effect, the CAPA quality system temporarily shut down shipping over a weekend. Upon return to the site, I was summoned to an emergency meeting from the security gate. Amazingly, a new practice/rule that only a Qualified Trainer can conduct training evolved from “only OJT QT’s can deliver OJT and perform Qualification Events” as per the SOP! This was clearly a case of misunderstood scope.

Does every SME need to be qualified as a Trainer?

In the Life Sciences arena, there are 5 recurring situations that require training: Self, Corrective Actions, Classroom (ILT), Structured OJT, and Qualification Events (Performance Demos).

Self can be achieved by the individual reading the procedure and the signing the training record. This is also known as Read & Understand (R & U) for SOPs.

Deviations/ Corrective Actions stemming from a Corrective Action Preventive Action incident. Minimally a SME or the SOP Author is needed to ensure credibility of the content.

Classroom (Instructor Led Training) is preferred for knowledge-based content affecting a wide range of employees. The skill set needed is facilitation / managing the classroom and delivering content as designed by the instructor. A new trend is emerging for SMEs to deliver this training. And, they need to be qualified to deliver classroom sessions especially if the event is related to a significant CAPA or regulatory inspection observation. This is NOT the same course as the OJT-QT Workshop.

Structured OJT is On the Job Training delivered by a Qualified OJT SME using the approved OJT Methodology. OJT QT’s attend the Qualified Trainers Workshop.

Qualification Events (Performance Demonstrations) are formally documented observations of learners performing the procedure/task at hand in front of a Qualified OJT SME.

Can having too many QTs be a problem?

It can be when there is no one else to train; to deliver OJT steps. While many of you may be wishing for this situation, it can eventually happen if staffing levels are adequate, shifts are normalized and SOPs revisions are managed via R & U only with the LMS.   How do you keep your QTs engaged and fresh if there are no opportunities for OJT sessions? I have some ideas for you to explore.

When this situation occurs, it’s an appropriate time to administer the Trainer Mojo Assessment. Based on the QTs scores, it might be time to say thank you for a job well done for the low scoring QTs. You may be pleasantly surprised by who is ready to walk away from the training role? Or you may have a cadre of QTs who legitimately need more training and hence, the need for some new modules is now justified.

Another activity to pursue is re-examining the practice of online R & U only for SOP revisions. I bet some of those revisions were worthy of a face to face discussion and there is probably at least one in the past year that required a demonstration of task for optimum transfer of learning back on the job. *Just because all employees are now qualified, doesn’t mean the program sits in hiatus waiting for new hires to join the company.

What else can you offer bored and under utilized QTs? What about a 30 minute refresher series or developmental assignments that expand their subject matter expertise or advances their training repertoire into a classroom facilitators? Just an idea or is it a viable solution? – VB

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

Have you flipped your OJT Train the Trainer Classroom yet?

When I got introduced to the flipped classroom back in 2012, I fell in love with the concept immediately. But I was stymied on how to sell the mind shift to management. And then it occurred to me that I was already delivering the flipped classroom for my TTT course and have been for quite some time.

In the academic model, students study the concept at home using video instructions and other learning technologies. Then they come to class to do the homework in a collaborative and mentor style environment. The corporate approach can be tweaked if you rethink when and where learners (aka employees) access the content. If the content exists elsewhere, why waste valuable classroom time lecturing on it when you can create a facilitative and experiential learning lab?

But what content are we talking about?

As part of a Robust Training System, procedures are established that describe how to execute the many elements of a training system including how to quality a department SME as trainer and the OJT Methodology. These standard operating procedures (SOPs) become the basis of the Qualified Trainer (QT) curriculum, for LMS tracking purposes. Upon release (or by the effective date), flagged employees read the required Training SOPs and become aware of implementation timelines. The “Read and Understood” portion is completed in advance and outside of the classroom. Hence, the content of the QT workshop is not a slide deck repeat of the curriculum content.

OJT TTT Workshop is NOT SOP Training

Recently I was challenged about why I was working with the company SMEs at all. If I didn’t work at this company, wasn’t engaged with day to day processing activities or involved in writing their SOPs, how could I possibly teach the SMEs anything about teaching their processes, my contender demanded. Furthermore, he marveled at my audacity to assist with rebuilding their quality training system.

Seemingly, there is still some confusion about the purpose of an OJT TTT workshop. This stakeholder’s frame of reference was entirely research oriented and analytical in execution. In his experience, train the trainer meant true expert trains others on the subject matter (technical SOPs) via a knowledge transfer session. See graphic below. It took multiple conversations and an invitation to join the training design team for him to embrace the notion that SMEs should and could be taught learning theory. Also see The Real Meaning of TTT. ttt-infographic

The “flip” is in the instructional design

If I am asking for 8 hours of participation from SMEs in a classroom setting, then it MUST BE value added. The focus of the workshop design is “Life as a Qualified Trainer” and the realities of delivering OJT on the shop floor and/or in the analytical QC lab. Attendees will not find this content in their curriculum or in the e-DOC system for SOPs. And this is precisely why the classroom is the most effective environment to come together in a structured, guided and facilitated learning experience.

It means that the instructor-trainer is no longer the sage on the stage, but becomes a guide on the side, where the QTs are doing most of the talking. This switch in learning design reinforces collaboration among the QTs and better transfers the knowledge building so that scrap learning is significantly reduced. Activities are designed to be active and participatory thus promoting “learning by doing” practice and honing their learning for each step of the OJT Methodology while recognizing robust training system key concepts in action. The final activity requires engagement and participation of each nominated QT in order to complete the course.

A community of internal QT graduates

During the experiential activities, QT’s will share anecdotes or a “war story” from their past. Listening to those stories creates a connection and often the insights gained forms a bond with each other. A wonderful consequence of the TTT flipped classroom design is the community of internal QT graduates that grows after the workshop is over. QTs leave the classroom able to articulate and share what they learned and experienced together. This does not happen when the course is delivered as eLearning/CBT or self advanced power point slides.

Today’s classroom is still viable

The modern learner needs a modern learning experience. And while modern tech tools are fast on the rise, let’s not dismiss what a flipped classroom can produce – confident, competent and valued Qualified Trainers. Are you ready to flip your learning design to meet today’s modern learners? – VB

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.

Retraining and Refresher Training: Aren’t they one in the same?

I say no, not at all. Ask an Operations Manager and he’ll acknowledge that what it’s called is less important than getting the “assignment” done and entered into the LMS. He’s usually more concerned about the loss of productivity during the training than the effectiveness of the training at that time. It isn’t until later when the training may have to be delivered again (repeated), that the comment “training doesn’t really work” is heard.

Retraining is typically delivered as repeat training. Corrective Actions from *CAPAs usually trigger these types of required training events. In the context of the specific CAPA, we uncover the error, mistake, non-conformance or what I like to call performance discrepancy from expected outcome. It is believed that by delivering the training again, the cause of the discrepancy will be resolved. That is if the root cause was determined to be a lack of knowledge, skill or not enough practice.

Some folks believe that more is better and that with several repeated training sessions, employees will eventually get it right. It always amazes me that we find time to do repeat training over and over again but complain very loudly for refresher training, significant **SOP revision training or even new content training.   (*Corrective Actions Preventive Actions, **Standard Operating Procedures).Retraining Quote

Refresher Training implies that training was already provided at least once. The intention here is to review on that content.   A lot of regulatory training requirements are generated to satisfy this need. Common examples are Annual GMP Refreshers and several OSHA standards such as Blood Borne Pathogens training. While the aim is to refresh on the content, it is not necessarily meant to just repeat the training. Also included is the part – “so as to remain current” with current practice, trends and new updates. Hence, refresher training needs to include new material based on familiar content.

Upon Biennial SOP Review

There are some folks who would like to use this required SOP activity to coincide with the need to “refresh” on SOPs already read and/or trained. The rationale being that if the SOP hasn’t revved in 2 or 3 years time, more than likely the training hasn’t been repeated either. So, it sounds like a good idea to require that SOPs be “refreshed” upon using the same SOP cycle. One could argue for the prevention of errors; thus, in theory, this sounds very proactive.

But donning my Instructional Designer Hat, I ask you, what is the definition of training – to close a knowledge gap or skill gap. What value is there for forcing a mandatory “refresher reading” on SOPs just because the procedure is due for technical review? In practice, this becomes one huge check mark exercise leading to a paper work /LMS backlog and might actually increase errors due to “information overload”! Again, what gap are you trying to solve? In the above refresher scenario, we are avoiding a compliance gap by satisfying regulatory requirements.

Refresher Retraining

Defending Your Training Process

For those of you who have fielded questions from regulators, you can appreciate how the very training record produced generates follow up questions.   How you describe the conditions under which the training occurred or is “labeled” can impact the message you are sending as well. Calling it retraining instead of refresher training implies that training had to be repeated as a result of a performance problem not meeting expectations or standards. Whereas refresher training occurs at a defined cycle to ensure that the forgetting curve or lack of practice is not a factor of poor performance. It is a routine activity for satisfying regulatory expectations.

For end users, clarifying the difference between refresher training and “repeat” training in your Policy/SOP not only defines the purpose of the training session, it also provides the proper sequence of steps to follow to ensure maximum effectiveness of the training. There’s a difference between training content that is new /updated vs. delivered as a repeat of the same materials.   Yes, new and/or updated design takes resources and time.   How many times do you want to sit through the same old same old and get nothing new from it? Recall the definition of insanity – doing more of the same while hoping for change.   You just might want to review your Training SOP right about now. – VB