Upon discovery and containment of a deviation or non-conformity, the
investigation begins. Whose
responsibility is it, the one who discovers it or the one who gets assigned to
investigate it? In most organizations,
it is not the one who discovers the performance discrepancy. It usually gets assigned to an SME or a
dedicated investigator if QA has the resources.
The hand-off between the discoverer and the assigned investigator is not always clearly defined and is often vaguely described in the CAPA procedures. And here is where the first misstep has potential to delay the start of the investigation clock. In this third blog of the Deviation and CAPA series, I intend to argue for the importance of the “hand-off” especially if investigations are assigned to SMEs and staff who were not present during initial discovery, containment and notification activities.
Making the Hand-off Formal
The purpose of the hand-off is to acknowledge responsibility for the
investigation and review all actions taken up to the current point in time. Given the nature of the event, the
significance and urgency to move forward, there can be a lot of confusion,
misinformation and misunderstanding of roles, responsibilities and authority.
One misconception that can occur with novice investigators is the lack
of awareness that the investigation details can change and should be revised as
the investigation unfolds especially the event description.
Please Tell Me the Story
There are 3 main elements in every “story”. Usually a cause and effect flow to the story
unfolds and becomes the basis of the narrative that is told or captured in the
investigation form. Next are the key
variables that reveal the impact. The
trick is to recognize and capture them and not get bogged down or distracted in
the extra details. And then, there are
the two sides of every story. The investigators
job is to find the similarities among the interviews especially if there has been
a long chain of events occurring before the hand-off.
A second misconception with new investigators is to park all the
information in the investigation form as possible drafts and then revise and
revise and revise again until they are finished. Alternatively, they could use a tool that is
designed to capture and review the details for the event.
The Investigators Hand-Off
Tool – Tell Me the Story
The tool is essentially a worksheet to capture, review and collate the
answers to the “Universal Problem Solving Questions”.
Where did it happen?
Who was involved?
When did it happen?
How did it happen?
How big is the scope of the problem?
Notice that “why did it happen” is not included. How it happened can easily morph into why it happened if not carefully checked. At this stage of the investigation, root cause analysis is way too early and can misguide the investigation. Investigators in a rush to get their assignments done, need to stay true to the CAPA process and confirm the event details and then finalize the problem as they know it; more about problem statements in a future blog.
“How it happened” is more
about how it was found and how it was discovered? “Where
it happened” is seeking clues about a breakdown in the process, the
procedures, paperwork and/or batch records.
somewhere and the investigation has to first identify what and where before the
why. Having these
questions answered accurately allows for a richer probable cause identification
step and eventual determination of the true root cause(s).
Until the next blog is released, I have a homework assignment for you. Reread your Deviation and CAPA SOPs specifically looking for the roles and responsibilities for the Initiator and the Investigator. Are they clearly written? Ask your assigned Investigators (if this applies at your site) if they follow a hand-off guide or use any kind of fact-finding/event description worksheet. If you are interested in the HPISC Tell Me the Story worksheet, you can find it here. May all your CAPAs map back to the true root causes. -VB
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?
Let’s step back a moment and quickly review typical steps for CAPAs:
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
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
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
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.
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
Clues for Failed
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
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.
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.
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 andhope” 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
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 workenvironment 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
Rossett, First Things Fast: a handbook for Performance Analysis; 2nd
Gilbert, Human Competence: Engineering Worthy Performance
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
While not mandatory, management needs to seriously take notice of ICHQ10 guidance document released in April
2009 (1). In particular to the following:
RESPONSIBILITY 2.3 Quality Planning
“(d) Management should provide the appropriate resources and training to achieve the quality objectives”.
“CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM
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
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
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:
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.
during the Qualified Trainers (QT) workshop, I would ask QTs the following two
do you deliver OJT?
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
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
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?
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.
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,J. A Better Way to Measure Soft Skills, TD, ATD, August, 2018, pps. 61-64.
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.
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.
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?
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
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
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
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?
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:
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 HPISCQualified Trainers workshop, I present the difference between t-ojt (traditional) and s-ojt (structured).
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
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