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.
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
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