How many procedures does it take to describe your Quality Training System?

The short answer should be as many as it takes. 

Are you trying to explain what you do for training or describe how your site handles the quality training system?

Who is your audience?

Who are the procedures being written for?

Step back and take a big view of training from start to finish. There are three distinct segments: (1) preparation, (2) delivery, and (3) measuring effectiveness. To some leaders, the idea of creating more than one training procedure for these three segments is baffling.  Training isn’t that hard. Why are you making this so complicated, they ask?  The simpler the process is, the easier it is to follow and administer, is what they are really thinking.

Upon a root cause analysis involving operator errors, the impact of this rationale can be quite a surprise.  Investigators uncover a lot of interpretations on how training was conducted.  So, training is not that simple to deliver and requires more than a check on someone’s to-do list.  There is a reason why “there shall be written procedures” can be found throughout the regulations.   In spite of this, the level of detail is always a concern for both SOP Author and approver.

But SMEs like KISS for Training

From an end-user perspective, I need enough detail so I can accomplish what I need to do without over-complicating my task, stay within compliance, and be effective as a qualified trainer. Since most qualified trainers are not full-time training professionals, the training procedures become their how-to tools not just a bunch of QA or HR rules about training. Without defining what your program includes and how to execute it, qualified trainers and other SMEs will complete their training delivery assignments in a manner that is as simple as possible and may not be 100% compliant. Administrative procedures are not for them, they argue.

It takes 6 elements to make a training system robust

The big view of training may have 3 Big Blocks (preparation, delivery, and measuring effectiveness), but it takes 6 elements to execute it well.   They are:

  • GxP and Training Curricula
  • Planned OJT for Procedures
  • Use of Qualified Trainers
  • Employee Qualification and Training Effectiveness Measures
  • On-Going GxP Refresher Series
  • Training Documentation Process

For each of these elements, there needs to be a set of “how-to-execute” instructions. However, it is not enough to describe what these are. That leaves a lot of room for interpretation and inconsistent documentation or no documentation at all. For example, are you documenting on-the-job training; all of them or just select sessions? Does your organization complain about over-allocated curricula? Do they understand the documentation requirements for your LMS? Does your training document explain how to conduct OJT? You’d be surprised just how many different techniques SMEs have for conducting OJT on their watch. Can anyone who has a signed training record be a department trainer? If yes, you need to upgrade your criteria and create a process around nominating and qualifying SMEs for OJT. Training is on the top 10 list for inspections.

So how is this not complicating Training?

The debate for the 1 All Encompassing SOP (standard operating procedure) vs. many smaller, but tailored work instructions is still being negotiated when end user feedback criticizes about complicated, confusing and not-so-user friendly documents!   Addressing one set of concerns actually creates more complaints around the very changes. See table below for pros and cons.

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Remind me again who these procedures are for?

The answer to the number of SOPs argument lies in determining what is appropriate for your end users. While addressing the ease of navigation and use concerns is laudable, it is not always realistic to satisfy all users. It comes down to a combination of appropriateness and acceptance with a little cultural history mix in. When you find yourself in the middle of this debate, ask yourself the following two questions:

  • Does the “Training SOP” contain many pages detailing steps for each of the 6 elements? This is an indicator that you need to break it up.
  • Do you have too many standalone task focused SOPs that could be grouped into a few larger processes? Recall the 3 Big Blocks of Training.  Will this satisfy the end users concerns?

Back to the opening question

If you need to explain what your GxP Training “Program” contains, a high-level policy can be used as long as it answers “the what”. If you also need to describe how your training is conducted, three “how-to” procedures are usually sufficient: preparation process, delivery and documentation process, and measuring training effectiveness process.  V-

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.