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
You might want to also read:

How committed to SOJT is your organization?

In this 2019 refreshed SOJT blog series, I’ve explored why curricula alone is not enough to call your OJT structured. And I shared what else needs to be incorporated into your OJT program to move from traditional OJT to SOJT.  These are all necessary components to provide direction and tools for the Qualified Trainer to deliver required training.  But what about management support for the QT’s and for delivering SOJT?  If only we were required to have a procedure for that! 

ICH Q10 – Pharmaceutical Quality System

While not mandatory, management needs to seriously take notice of ICHQ10 guidance document released in April 2009 (1).  In particular to the following:


“(d) Management should provide the appropriate resources and training to achieve the quality objectives”.


4.3 Outcomes of Management Review and Monitoring

The outcome of management review of the pharmaceutical quality system and monitoring of internal and external factors can include:

(b) Allocation or reallocation of resources and/ or personnel training.”

Under a Quality System: Managers Expectations for Training

Referencing the Sept. 2006 issue of Guidance Document for Quality Systems: IV. Management Responsibilities | B. Resources (2), we see alignment with the training CGMPs for continued training so “as to remain proficient in their operational functions and in their understanding of CGMP regulations.”  “Typical quality systems training should address the policies, processes, procedures, and written instructions related to operational activities, the product/service, the quality system, and the desired work culture (e.g., team building, communication, change, behavior).”

And my personal favorite, “When operating in a robust quality system environment, it is important that managers verify that skills gained from training are implemented in day-to-day performance.”  The responsibility for training under a quality system is not assigned to just one person or one function.  It is a shared responsibility across the entire organization.

Goals of the Train-the-Trainer Program (TTT) vs. OJT Program vs. Employee Qualification Program

In order to have qualified employees, they need to receive structured on the job training delivered by a qualified trainer who is content qualified and training process qualified via a TTT course.   Each of the three “programs” has defined outcomes that are dependent upon each other.  Unfortunately, the term program has been a bit overused throughout the years and can have a variety of meanings for folks.  For purposes of this blog, TTT program means OJT Qualified Trainers workshop, OJT Program means OJT methodology / procedure and Qualified Employee program means having a robust quality training system beyond the newest Learning Management System (LMS).

As you can see from the diagram, Qualified Trainers are at the core for all three “programs”.   I’ve previously blogged and written several resources on what’s involved.  The OJT QT Workshop is designed to prepare the QT’s for the realities of life as a Qualified Trainer. It includes the pre-work of familiarizing themselves with the training procedures and then in class: exploring basic learning theory and committing to what the QT signature means. The OJT Program is about delivering structuring on the job training consistently following the approved methodology as discussed in the previous blog.  An Employee Qualification Program is the ultimate validation of training effectiveness of the OJT methodology and the clarity of the underlying procedures.

Readiness Factors for SOJT and an Employee Qualification Program

Let’s start with a written purpose statement for having qualified employees beyond it’s required.  What is the company’s philosophy on achieving qualified status?  Is there agreement among the leadership for the level of rigor required to demonstrate performance and achieve a pass rating?  Where are the OJT program goals written?  Does a schedule exist for OJT and qualification events other than a LMS printout with required due dates.  That is not a schedule for OJT.  Do you have clearly defined objectives for the QT workshop captured in a document or perhaps a procedure?  Is there a single owner for all three programs or is responsibility and accountability assigned accordingly? Check out the HPISC Readiness Factors for SOJT/RTS/Employee Qualification Checklist.

Ronald Jacobs and Michael Jones, in their 1995 ground breaking book, Structuring on-the-Job Training, inform us that SOJT as a system functions within a larger context, namely the organization.  SOJT is not a standalone program.  Conflicts, competing priorities and mixed messages can influence the success of your SOJT program.  What else is going on in the organization that will compete for the same set of QTs? Remember they are also your most experienced and technical subject matter experts.  How is the overall Employee Qualification program aligned with the other quality systems? 

Recognition for QTs and Qualified Status

Most QTs are not fully dedicated to delivering training for departments.   There are pros and cons for this decision.  For now, I will leave them out.  Suffice it to say, they are tasked with both their “day” job and the responsibility for delivering training when needed.  They are at times, doing two jobs.  Whether or not they are compensated additionally for delivering OJT, acknowledging their contribution to the department and the organization is part of management support.   It takes more than “you are doing a good job, keep it up”. 

Often supervisors and managers don’t know what else they are supposed to do to show their support, other than allow them to attend the QT workshop.  The interested ones will “pop” in during lunch and chat with their direct reports.  Others will show up at the end for the poster activity (equivalent to a written test) and some will come to learn about the parking lot issues that need follow up.  The energy in the room when this happens is amazing. 

To help ease the knowledge gap between a manager and their now Qualified Trainer, I started delivering the Leadership Briefing module prior to the QT workshop delivery.  The purpose is to provide an overview of the content highlights, alignment with initiatives / CAPAs/ agency commitments and more importantly to secure agreement for the following:

  • criteria for nominating a QT
  • roles and responsibilities of QT
  • scope of work QT’s can be assigned
  • expectations for QT’s post launch
  • what happens day one after workshop is done
  • what is the status of the SOJT checklists
  • scheduling and budget concerns.

If the organization says they support the qualification program, then what happens when employees achieve qualification status?  Nothing?  A nonevent? Or is it announced in newsletters, plasma screens and other company announcements?  Is it a big deal to be able to perform independently and free up a much-needed QT for another learner?  I keep hearing over and over again about how there aren’t enough QT’s to deliver OJT the right way.  One would think qualification status on SOPs, especially big complex processes deserves SOME kind of recognition.   Just how committed are the managers and supervisors?  QTs and employees draw their own conclusions about the level of real management support for the programs.  

If truth be told, after launching many supervisors privately don’t support the program.  They lose their top performers for the workshop participation and during the hours it takes to train someone. Forget about giving QTs adequate time to complete the paperwork properly! And then leadership wonders why good documentation practice (GDP) issues continue to be a problem? The non-distracted performance observations that QT’s are expected to conduct for the qualification demonstration drive supervisors and line managers crazy the most – what, they can’t do anything else but observe?  Hence, many QT’s are asked to multi task just to get the work done: not enough resources they are told.  For supervisors, productivity and the workload will always trump OJT and qualification events, until their bonuses include completion of training and qualification events.

What Real Support Is Supposed To Look Like

My key take away message is that attending the TTT program is not the end of the OJT program or the Employee Qualification Program but rather the launching point.  Management support needs to go beyond just nominating QTs and allowing them to participate in the workshop.  The real support is in the alignment of goals, clarifying expectations continuously, allocating resources for training and budgeting time to deliver OJT using an approved OJT methodology that includes qualification events.  This commitment of time and sponsorship for qualified employees is a culture shift for many line managers and site leaders.  But actions do speak louder than words.  -VB

Alas, we have come to the end of this SOJT blog series. For a recap, visit the individual blog links below:

(1) Guidance for Industry Q10 Pharmaceutical Quality System | US Department of HHS | FDA
| CDER | CBER April2009 ICH

(2) Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP RegulationsU.S.Department of HHS | FDA | CDER | CBER | CVM | ORA| September 2006 Pharmaceutical CGMPs

Jacobs RL, Jones MJ. Structured on-the-job training: Unleashing employee expertise in the workplace.  San Francisco: Berrett-Koehler: 1995.

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.

Curricula Creation and Maintenance are NOT a “one and done event”!

Over the last few weeks, I’ve been blogging about structured on the job training (SOJT) with refreshed insights from my Life Sciences consulting projects.  Allow me to have a sidebar blog about the need for keeping curricula up to date.  I realize the work is tedious even painful at times.  That’s why donuts show up for meetings scheduled in the morning, pizza bribes if it’s lunchtime and quite possibly even cookies for a late afternoon discussion.  So I get it when folks don’t want to look at their curricula again or even have a conversation about them. 

Once a year curricula upkeep?

It’s like having a fichus hedge on your property.  If you keep it trimmed, pruning is easier than hacking off the major overgrowth that’s gone awry a year later.  And yet, I continue to get push back when I recommend quarterly curricula updates.  Even semi-annual intervals are met with disdain.  In the end we settle for once a year and I cringe on the inside.  Why?  Because once a year review can be like starting all over again.

Don’t all databases know the difference between new and revised SOPs?

Consider for a moment the number of revisions your procedures go through in a year.  If your learning management system (LMS) is mature enough to manage revisions with a click to revise and auto-update all affected curricula, then once a year may be the right time span for your company. 

Others in our industry don’t have that functionality within their training database.  For these administrators, revisions mean manual creation into the “course catalog” each time with a deactivation/retirement of the previous version; some may be able to perform batch uploads with a confirmation activity post submission.  And then, the manual search for all curricula so that the old SOP number can be removed and replaced with the next revision.  Followed by a manual notification to all employees assigned to either that SOP or to the curricula depending on how the database is configured.  I’m exhausted just thinking about this workload.  

Over the course of a year, how many corrective actions have resulted in major SOP revisions that require a new OJT session and quite possibly a new qualification event?  What impact do all these changes have on the accuracy of your curricula? Can your administrator click the revision button for these as well?   And then there’s the periodic review of SOPs, which in most companies is two years.  What is the impact of SOP’s that become deleted as a result of the review?  Can your LMS / training database search for affected curricula and automatically remove these SOPs as well? 

The Real Purpose for Curricula

Let’s not lose sight of why we have curricula in the first place.  So that folks are trained in the “particular operations that the employee performs” (21CFR§211.25).  And “each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities” (21CFR§820.25).  Today’s LMSes perform reconciliation of training completion against curricula requirements.  So I’m grateful that this task is now automated.  But it depends on the level of functionality of the database in use.  Imagine having to manually reconcile each individual in your company against their curricula requirements.  There are not enough hours in a normal workday for one person to keep this up to date!  And yet in some organizations, this is the only way they know who is trained.  Their database is woefully limited in functionality.

The quality system regulation for training is quite clear regarding a procedure for identifying training needs.  To meet that expectation, industry practice is to have a process for creating curricula and maintaining the accuracy and completeness of curricula requirements.  Yes, it feels like a lot of paperwork.  §820.25 also states “Training shall be documented”.   For me, it’s not just the completion of the Read & Understood for SOPs.  It includes the OJT process, the qualification event AND the ownership for curricula creation and maintenance. (Stay tuned for a future blog on documenting OJT.)

Whose responsibility is it, anyway?

Who owns curricula in your company?  Who has the responsibility to ensure that curricula are accurate and up to date?  What does your procedure include?  Interestingly enough, I have seen companies who get cited with training observations often have outdated and inaccurate curricula!  Their documentation for curricula frequently shows reviews overdue by 2 – 3 years, not performed since original creation and in some places, no specialized curricula at all!   “They were set up wrong.”  “The system doesn’t allow us to differentiate enough.”  “Oh, we were in the process of redoing them, but then the project was put on the back burner.”  Are you waiting to be cited by an agency investigator during biennial GMP inspection or Pre-Approval Inspection?

The longer we wait to conduct a curricula review, the bigger the training gap becomes.  And that can snowball into missing training requirements, which leads to employees performing duties without being trained and qualified.  Next thing you know, you have a bunch of Training CAPA notifications sitting in your inbox.  Not to mention a FD-483 and quite possibly a warning letter.  How sophisticated is your training database?  Will once a year result in a “light trim” of curricula requirements or a “hack job” of removing outdated requirements and inaccurate revision numbers? Will you be rebuilding curricula all over again?  Better bring on the donuts and coffee!  -VB

How many procedures does it take to describe a training program?

From Traditional OJT to SOJT: What else makes OJT structured?

SOJT needs a clearly defined scope.  If you don’t articulate the boundaries, you can end up hearing statements like “only a Qualified Trainer (QT) can deliver deviation related training sessions” and wonder how in the world did this get so out of hand?  It comes back to how well you define the scope of their responsibilities.  More specifically, are there different categories of QT’s or is it strictly a manufacturing program/ initiative?  For example, do you have qualified trainers who deliver OJT (on the job training) and SMEs as Classroom Trainers who are qualified to deliver warning letter corrective actions for overhauled quality systems? The scope will clarify who is responsible for what kind of training situation.

SOJT includes a deliberate review of regulatory, departmental and positional /functional requirements.  Yes, this is curricula.  But having curricula is not enough to call it SOJT as discussed in the previous blog.  It also includes a TRAINING SCHEDULE for the curricula requirements and an individualized learning plan for new hires; not just a matrix with their name highlighted in yellow marker. 

SOJT is formal and it’s documented.  For years, we have been documenting that we’ve read and understood our required SOPs, so that part is covered.  QT’s need “Quality Control Unit” approved documents (aka SOPs) to use as the main document to train with and the proper documentation to record an OJT session.  But documenting OJT sessions has been a bit of a challenge for the life sciences industry.  Perhaps a future blog can reveal some of the issues. 

Even more challenging is adding the OJT requirement to curricula.  Unfortunately, it generates almost double the requirements. So for companies who focus solely on the number of requirements, this is daunting.  What helps is differentiating between R & U stage and completion of the actual OJT events.  Some organizations go one step further and also add the Qualification Event as a final requirement unless their LMS can be configured to mimic the OJT Methodology steps; thus reducing the number of times the same procedure is listed albeit for a different training step.  HPISC Robust Training System also includes the OJT methodology that delineates the steps to conducting OJT and the qualification process.  Stay tuned for a future blog about OJT Methodologies.

SOJT is also delivered by a department SME qualified to deliver OJT.  The old adage for selecting department trainers based on seniority and documented R & U SOP paperwork no longer meets regulatory expectations.  You need a QA approved process for qualifying SMEs that includes a train-the-trainer workshop that focuses on hands on training and NOT how to develop power point slides.   In future blog(s), I will provide more discussion points regarding Qualified Trainer requirements.

So it’s as easy as that, right?

Moving from T-OJT to Structured OJT

Actually no. Last time, I blogged about QT’s indicating that their organizations are just at the brink of SOJT and that scheduling seems to be the barrier to moving into SOJT.  In future posts, I will share with you some organizational issues to manage as well as shifting the managers’ mindset that all we need is a LMS

Until then, you might enjoy the HPISC Impact Story below:

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

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

Impact Story: Reduce Training by 10%

The Journey of a New Hire to Qualified Employee: What really happens at your company?

After weeks if not months of waiting for your new hire, she is finally here, finishing up 1st day orientation. Day 2, she’s all yours. Are you excited or anxious? The LMS printout of training requirements is overwhelming; even for you. Bottom line question running through your mind — when can she be released to task? Isn’t there a faster way to expedite this training, you ask? There is, it is called S – OJT.

Structured on the job training (S-OJT) is an organized and planned approach for completing training requirements. Yet for many line managers, they want their trainees now. Ironically, the faster you “push” trainees through their training matrix, the slower the learning curve. This in turn often leads to more errors, deviations, and quite possibly CAPA investigations for numerous training incidents. It’s a classic case of pay now or pay later.

This proactive vs. reactive dilemma is not new. Traditional OJT aka “follow Joe around” looks like a win – win for everyone on the surface. The new hire gets OJT experience, a SME is “supervising” for mistakes, and supervisors are keeping up with the production schedule. So what’s wrong, you ask?

[SOJT] is the planned process of developing task level expertise by having an experienced employee train a novice employee at our near the actual work setting.” Jacobs & Jones, 1995

After 6 months or so, the trainee isn’t new anymore and everyone “expects” your new employee to be fully qualified by then with no performance issues and no deviations resulting from operator error. Without attentive monitoring of the trainee’s progress, the trainee is at the mercy of the daily schedule.  S/he is expected to dive right in to whatever process or part of the process is running that day without taking into account where the trainee is on their learning curve.  The assigned SME or perhaps the “buddy” for the day is tasked with not only trying to perform the procedure correctly but explain what he’s doing and why it may be out of sequence in some cases.  The burden of the learning gap falls to the SME who does his best to answer the why.  

The structured approach puts the trainee’s needs center stage. What makes sense for him/her to learn what and when? The result is a learning plan individualized for this new hire that includes realistic time frames. Added to the plan is a Qualified Trainer who can monitor the progression towards more complex procedures and increase success for first time qualification success. Still too much time to execute? How many hours will you spend investigating errors, counseling the employee and repeating the training? Seems worth it to me. – VB

You may also like: Moving Beyond R & U SOPs

Jacobs RL, Jones MJ. Structured on – the – job training: Unleashing employee expertise in the workplace. San Francisco: Berrett – Koehler,1995.

What’s Your Training Effectiveness Strategy? It needs to be more than a survey or knowledge checks

When every training event is delivered using the same method, it’s easy to standardize the evaluation approach and the tool. Just answer these three questions:

  • What did they learn?
  • Did it transfer back to job?
  • Was the training effective?

In this day and age of personalized learning and engaging experiences, one-size training for all may be efficient for an organizational roll out but not the most effective for organizational impact or even change in behavior. The standard knowledge check can indicate how much they remembered. It might be able to predict what will be used back on the job. But be able to evaluate how effective the training was? That’s asking a lot from a 10 question multiple choice/ true false “quiz”. Given the level of complexity of the task or the significance of improvement for the organization such as addressing a consent decree or closing a warning letter, it would seem that allocating budget for proper training evaluation techniques would not be challenged.

Do you have a procedure for that?

Perhaps the sticking point is explaining to regulators how decisions are made using what criteria. Naturally documentation is expected and this also requires defining the process in a written procedure. It can be done. It means being in tune with training curricula, awareness of the types of training content being delivered and recognizing the implication of the evaluation results. And of course, following the execution plan as described in the SOP.   Three central components frame a Training Effectiveness Strategy: Focus, Timing and Tools.


Our tendency is to look at the scope (the what) first. I ask that you pause long enough to consider your audience, identify your stakeholders; determine who wants to know what. This analysis shapes the span and level of your evaluation policy. For example, C-Suite stakeholders ask very different questions about training effectiveness than participants.

The all purpose standard evaluation tool weakens the results and disappoints most stakeholders. While it can provide interesting statistics, the real question is what will “they” do with the results? What are stakeholders prepared to do except cut training budget or stop sending employees to training? Identify what will be useful to whom by creating a stakeholder matrix.

Will your scope also include the training program (aka Training Quality System) especially if it is not included in the Internal Audit Quality System? Is the quality system designed efficiently to process feedback and make the necessary changes that result from the evaluation results? Assessing how efficiently the function performs is another opportunity to improve the workflow by reducing redundancies thus increasing form completion speed and humanizing the overall user experience. What is not in scope? Is it clearly articulated?

TRAINING EFFECTIVENESS STRATEGY: Timing is of course, everything

Your strategy needs to include when to administer your evaluation studies. With course feedback surveys, we are used to immediately after otherwise, the return rate drops significantly. For knowledge checks we also “test” at the end of the session. Logistically it’s easier to administer because participants are still in the event and we also increase the likelihood of higher “retention” scores.

But when does it make more sense to conduct the evaluation? Again, it depends on what the purpose is.

  • Will you be comparing before and after results? Then baseline data needs to be collected before the event begins. I.e. current set of Key Performing Indicators, Performance Metrics
  • How much time do the learners need to become proficient enough so that the evaluation is accurate? I.e. immediately after, 3 months or realistically 6 months after?
  • When are metrics calculated and reported? Quarterly?
  • When will they be expected to perform back on the job?

Measuring Training Transfer: 3, 6 and maybe 9 months later

We can observe whether a behavior occurs and record the number of people who are demonstrating the new set of expected behaviors on the job. We can evaluate the quality of a work product (such as a completed form or executed batch record) by recording the number of people whose work product satisfies the appropriate standard or target criteria. We can record the frequency with which target audience promotes the preferred behaviors in dialogue with peers and supervisors and in their observed actions.

It is possible to do this; however, the time, people and budget to design the tools and capture the incidents are at the core of management support for a more vigorous training effectiveness strategy. How important is it to the organization to determine if your training efforts are effectively transferring back to the job? How critical is it to mitigate the barriers that get in the way when the evaluation results show that performance improved only marginally? It is cheaper to criticize the training event(s) rather than address the real root cause(s). See Training Does Not Stand Alone (Transfer Failure Section).

TRAINING EFFECTIVENESS STRATEGY: Right tool for the right evaluation type

How will success be defined for each “training” event or category of training content? Are you using tools/techniques that meet your stakeholders’ expectations for training effectiveness? If performance improvement is the business goal, how are you going to measure it? What are the performance goals that “training” is supposed to support? Seek confirmation on what will be accepted as proof of learning, evidence of transfer to the workplace, and identification of leading indicators of organizational improvement. These become the criteria by which the evaluation has value for your stakeholders. Ideally, the choice of tool should be decided after the performance analysis is discussed and before content development begins.

Performance Analysis first; then possibly a training needs analysis

Starting with a performance analysis recognizes that performance occurs within organizational systems. The analysis provides a 3-tiered picture of what’s encouraging/blocking performance for the worker, work tasks, and/or the workplace and what must be in place for these same three levels in order to achieve sustained improvement. The “solutions” are tailored to the situation based on the collected data and not on an assumption that training is needed. Otherwise, you have a fragment of the solution with high expectations for solving “the problem” and relying on the evaluation tool to provide effective “training” results. Only when the cause analysis reveals a true lack of knowledge, will training be effective.

Why aren’t more Performance Analyses being conducted?
For starters, most managers want the quick fix of training because it’s a highly visible activity that everyone is familiar and comfortable with. The second possibility lies in the inherent nature of performance improvement work. Very often the recommended solution resides outside of the initiating department and requires the cooperation of others.   Would a request to fix someone else’s system go over well where you work? A third and most probable reason is that it takes time, resources, and a performance consulting skill set to identify the behaviors, decisions and “outputs” that are expected as a result of the solution. How important will it be for you to determine training effectiveness for strategic corrective actions?

You need an execution plan

Given the variety of training events and level of strategic importance occurring within your organization, one standard evaluation tool may no longer be suitable. Does every training event need to be evaluated at the same level of rigor? Generally speaking, the more strategic the focus is, the more tedious and timely the data collection will be. Again, review your purpose and scope for the evaluation. Refer to your stakeholder matrix and determine what evaluation tool(s) is better suited to meet their expectations.

For example, completing an after-training survey for every event is laudable; however, executive leadership values this data the least. According to Jack and Patricia Phillips (2010), they want to see business impact the most. Tools like balanced scorecards can be customized to capture and report on key performing indicators and meaningful metrics. Develop your plan wisely, generate a representative sample size initially and seek stakeholder agreement to conduct the evaluation study.

Life after the evaluation: What are you doing with the data collected?

Did performance improve? How will the evaluation results change future behavior and/or influence design decisions? Or perhaps the results will be used for budget justification, support for additional programs or even a corporate case study? Evaluation comes at the end but in reality, it is continuous throughout. Training effectiveness means evaluating the effectiveness of your training: your process, your content and your training quality system. It’s a continuous and cyclical process that doesn’t end when the training is over. – VB


Jack J. Phillips and Patricia P. Phillips, “How Executives View Learning Metrics”, CLO, December 2010.

Recommend Reading:

Jean-Simon Leclerc and Odette Mercier, “How to Make Training Evaluation a Useful Tool for Improving L &D”, Training Industry Quarterly, May-June, 2017.