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

Allow me to have a 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.

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?

Who is Vivian Bringslimark?

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Will You Please Just Sign the Training Form!

For companies who are required to have standard operating procedures (SOPs), managing changes and ensuring affected employees are up to date is a constant challenge. Especially for companies whose weekly revision churn rate is from 10 to 150+ revisions. The standard approach is to “get ‘em done” in the fastest amount of time. The end goal for most people is the proverbial (√) and lots of records claiming “read and understood” the procedure.

What’s a Trainer now Performance Consultant to do? With all this focus on training effectiveness and return on stakeholder expectations, how does a Training / Performance Consultant demonstrate his/her worth when the real outcome is a rushed end-user who has less than 20 minutes to train on the changes?

According to Rummler and Morrill*, it comes down to how serious do the changes need to be? Performance consulting is about closing gaps in results, training is about closing gaps in knowledge and skill. So, 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?

In other words, isolate the underlying issue that prompted the change. How significant is the change in the procedure? Is it vital enough to improve performance results?  Then take a performance consulting approach for these changes. Don’t fret about the others requiring only knowledge. Those SOP revisions can be managed using routine training techniques whose goal is numbers trained.

What Do They Really Need to Know About the Revised SOP?

The HPI/HPT approach ties the results back to the business outcomes. If the end goal is truly a √ for SOP revision training, you have met the expectations. But as Trainer/ Performance Consultants, we know this is not an acceptable measure for any type of formal review. (Human Performance Improvement / Human Performance Technology).

What we can do is use a modified root-cause approach to address why the procedure changed and then incorporate the what, the where and the when into the training session. Take advantage of the revision history page if available. 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.

  • Will it 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 OJT or new hire SOP Training.

SOP Revisions Needing Real OJT: Will Management Agree with Your 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 your Qualified Trainers in redirecting this discussion with management regarding the most effective method to use, despite that it will take longer to complete the training notification flags?
Some SOP Revisions require more than a R & U checkmark.

First and foremost, the QT signature means that learners were 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?  Again, it comes down to how critical-to-quality is the new change?  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”? After the fact, many managers have “a case of amnesia” about their original directive regarding the SOP revisions. “Just tell them what the changes are, better yet, have them R & U and sign the darn form already!”  With more deviations being opened, these same managers now question why they have QTs in the first place.  Funny how there’s time to do the training properly a second time?

I realize this is easier said than done especially for new QT graduates.  A directive is a directive, I understand.  In these cases, documentation matters and needs to be explicit that demonstration requirements were waived by “Management Decision”.  When the investigation points back to a QT, the documentation will provide what content was covered and to what level of demonstration and practice was included; if any.  If none are required, then the risk for mistakes is minimal.  These questions, as painful as they are can be excellent references for future events where OJT is really needed for a significant SOP revision.  -VB

*Rummler, G. and Morrill, K. “The Results Chain”. T & D, Feb 05; 26—37.

ASTD HPI— www. Astd.org/content/education/ certificateprogram/HPI

Robinson, DG and Robinson, JC. Performance Consulting: Moving Beyond Training; 1995.

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

Who is Vivian Bringslimark?

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Calling ALL User Generated Tools Home

What do I mean?  You know, job aids, tools users have created, and SME cheat sheets.  I’ve even seen task instruction sheets, quick reference guides for completing forms, and process flow diagrams.  But I’m not talking about posters on the wall describing how to turn on the projector in the conference room.  In this 3rd issue of Making It Work for Compliance Trainers series, I blog about why creating and openly sharing user-generated tools may not be a good thing in a regulated environment.

The Dilemma

As a Performance Consultant (PC) or HPT specialist, works with SMEs, Key Performers, or STAR employees, s/he invariably uncovers or discovers that their SMEs have “other” tools they’ve developed that help them be so good at what they do.  While these are helpful to the key performers, it presents a dilemma for the PC who is also a Compliance Trainer or a QA Manager.  “If I expose the source of their secret sauce, will I break trust and create a barrier to the relationship?  On the other hand, if I don’t speak up about this tool, what assurance do I have that the content is approved by the Quality Control Unit (per GMP) and is version controlled?

Why create them in the first place?

To get grounded, the PC/Compliance Trainer needs to perform a quick cause analysis upon the discovery of the tool.  Why was it created in the first place?  Is there information or steps missing from the standard operating procedure (SOP)?  Was this tool created to “chunk up” the steps or create bite-sized training materials that evolved into a job aid?  Or is it a maneuver to bypass the change control system?  The answers to the questions could provide the basis for a more user-friendly revision or at least be officially approved as a supporting tool to the SOP upon the next version release.

What’s the big deal?

Rejection of product, deviation from approved written instruction that could result in adulterated product, additional follow up testing, and rework are all forms of waste to the organization.  Not to mention that consistency is the key to compliance and assuring public confidence in approved marketed products.  If folks are not using the approved procedure, then there’s an issue somewhere.

To what level of control is needed?

That is the most sought after question regarding job aids and user tools.  The answer lies in each company’s level of risk and its document hierarchy.  I’ve seen extreme cases where “NO Paper” on the floor means not even an SOP is allowed to be in hand.  I do believe that some level of control is needed to ensure that the content is valid, is in sync with the current procedure and users have the most current version of the tool.  Can your organization defend the level of control?  Are you sure about that?  Or do you use a “don’t tell and we won’t ask policy”?  Are folks making errors because they followed an uncontrolled worksheet vs. the approved procedure?

Tips for Establishing Level of Control

  • If the tool /job aid is tied to a procedure, it needs to become a required tool and included in the SOP.
  • Job aids should not be a standalone orphan.  It needs to have a procedure that it supports.  The use of the job aid is included in the hands-on training so folks know how to use it properly and where to access it if it is not “attached” to the SOP.

o   For example, some companies have a separate numbering system for these exhibits and the storage location may not be in the same folder directory as the parent SOP.

  • If more than one tool / job aid / worksheet exists per procedure, then an appendix or reference section needs to highlight the existence of these “tools in use”.
  • Establish an amnesty initiative to raise awareness for the quality and compliance consequences of using uncontrolled tools.

Calling all User Generated Tools Home

The purpose of the initiative is to allow users to admit that they have these tools and that no performance consequences will follow when they surrender them.  The second focus of the program is to find a proper home for these tools once they are deemed valuable.  They need proper care and nourishment.  In other words, content is valid, accurate, up to date and approved for use.  The PC/Compliance Trainer is the ideal conduit to make this happen.

One company that I visited did just that and more.  Once it was discovered that a series of mistakes were coming from an old tool that had been downloaded and copied to their desktop, a team of auditors was dispatched to observe the removal of all tools from employee’s desktops.  The 2nd phase of their program was the identification of an owner for the share-point site who now manages access and content revisions.  The 3rd phase includes a content/tool submission process that is vetted by a designated users group of SMEs.

Is it time for a Job Aid/Users Tool Amnesty Project where you work? – VB