Let’s begin with why we have curricula in the first place. So that folks are trained in the “particular operations that the employee performs” (§21CFR 211.25). Having this “list” is a huge improvement from the previous practice years ago.
I was once told, “If an SOP is sitting in a binder in my department, then everybody is going to train on it”. He had the entire SOP binder collection sitting on a shelf in his office. He routinely required that all his direct reports sign the training form to back up his statement. I congratulated him on documenting the READ part. But when I asked him if his folks were trained on how to conduct the preventative maintenance procedure for cleaning the HVAC air ducts on the roof, he extolled, “that’s not our responsibility!” “Yes, you are right, but you all signed for the UNDERSTOOD part of those SOPs as well!” I replied. He didn’t take my comment very well.
The quality system regulation for training is quite clear regarding a procedure for also identifying training needs. And “each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities” (§21CFR820.25). To meet that expectation, industry practice is to have a process for creating curricula, maintaining the accuracy and completeness of curricula requirements.
Once I explained the purpose of curricula and how this manager could determine which procedures his folks should train on rather than using the SOP Index, he stopped the unrequired R & U for SOPs that were outside of their responsibilities. Then I jokingly said, “Now you have time to send them to Annual GMP Training!” He frowned and walked away.
§820.25 also states “Training shall be documented”. Yes, it feels like a lot of paperwork. Thank goodness today’s LMSes can perform reconciliation of training completion against curricula requirements. So, I’m grateful that this task can be executed with a click for simple reports. And with just a few key search words, more advanced reports can be compiled. No more excel spreadsheets filled with matrix like set ups cross referencing SOPs, attendance and employees! But there’s more to training curricula than setting them up and earning 100% Training Complete.
Who is Really Responsible for Employee Training?
Almost every training SOP I read will include a statement that Department Managers are responsible for training of their direct reports. Managing SOP changes and ensuring affected employees are up to date is a constant challenge for everyone. Especially for companies whose weekly revision churn rate is anywhere from 10 to 150+ revisions.
First, we rely on the LMS to automatically revise curricula or at least expect the LMS Admin to click [Revised] function. Then we wait for the notifications either automatically from the LMS or the Admin. And then we begin the huddle brow beating to “get ‘em done” before or by the effective date. The end goal for most people is the proverbial check mark (√) and lots of line items claiming “Read and Understood” the revised procedure. This is when we hate the LMS because the notifications won’t go away until we sign off. Btw, this isn’t training at all when the real outcome is a rushed end-user who has less than 15 minutes to “train on the changes”.
What Do They Really Need to Know About the Revised SOP?
Training is about closing gaps in knowledge and skills. Consider analyzing what precipitated the SOP change. Was is it a significant CAPA issue or FDA commitment that requires a solution more than “Read and Understood”/ e-sign for the revised SOP? How significant is the change in the procedure?
The SOP Author has listed what changed. Call him/her and ask why the change was made. Perhaps it is related to a deviation or audit observation that other employees need to know about. Find out when the changes will go into effect and how will folks be notified. Take advantage of the revision history page if available. And then incorporate the what, the where and the when into the training session:
- Will the changes be upon an effective date?
- Or a trigger condition that now has a different decision path?
- Or is it a completely overhauled FORM to be used?
Include these notes as part of your preparation for end-users to recognize when to make the changes in their tasks. PLEASE NOTE: Revision training is not to be used as a substitute for planned On Job Training or new hire SOP Training.
SOP Revisions Needing Real OJT: Will Management Agree with the Recommendation?
But what if the SOP revision requires more than a “tell and forget” discussion? Are the changes significant enough to require a demonstration? Will a one-time demo by the Qualified Trainer (QT) be enough to call it OJT? Does the revision require some practice to unlearn the old way and learn the new steps? How confident are the Qualified Trainers in redirecting the discussion with management regarding the most effective method to use, despite that it will take longer to satisfy the LMS requirement?
First and foremost, the QT signature means that employees were trained and assessed as having learned the content of what was delivered. Can the QT confidently say their colleagues are trained in the revision and can perform the revision without errors? Can the department / site / organization incur waste as in mistakes, scrap work, delayed release of product, and/or re-work as a result of “lack of proper training for the revision”? It comes down to how critical to quality is the new change.
So, Who Owns Curricula In Your Company?
In those same Training SOPs that I mentioned earlier, I usually find a responsibility statement about determining training requirements as well. Who has the responsibility to ensure that curricula are accurate and up to date as well as no overdue training for SOP revisions? Is it QA L&D because they manage the LMS or is it Dept Management as per the Training SOP?
What is the frequency for curricula review in your procedure? I realize that curricula requirements 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.
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. If your LMS is mature enough to manage revisions via 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.
What about 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 without intervention from the LMS administrator as well?
And then there’s the corrective actions that 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?
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 or 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 can become. And that gap snowballs 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 inspection report and quite possibly a warning letter. So why does QA L&D continue to experience pushback for this required activity? Maybe folks really like morning bagels or the pizza bribes?
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? It’s a self-fulfilling prophecy. Can we please change this already? You just might be surprised at how many SOPs are no longer required and that you may reduce the time needed to train on SOPs. In the meantime, better bring the donuts and coffee! -VB
Tired of bloated and over-allocated curricula?
Who is Vivian Bringslimark?