Is Your Quality Training SOP Sufficient?

Is your response, “Yes!” or is it “Yea, I think so. How can I be sure?”

  • 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?

There shall be written procedures even for training!

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.

Yet, training root cause analyses involving operator or human error often yields some contributing factors around how the individual was trained.  On the Job Training is not that simple after all and requires more than a check on someone’s to-do list.  Find out why in the e-Book, Training Root Cause Analysis. In spite of this, the level of detail in Training SOPs 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 conduct 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
6 Elements of a Robust Training System

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 elements 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; every time 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. multiple tailored work instructions will always bring comments after the latest version goes into effect. This includes non-QT end-user feedback criticizing how complicated and confusing the procedures are!  When pressed further for specifics, most admit that they just want to train themselves and not deal with the documentation requirements. So, addressing one set of concerns can actually create more complaints around the very changes. See the table below for pros and cons.

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Pros and Cons for One AP Training SOP vs. Smaller, Multiple Work Instructions

Remind me again who these procedures are for?

The real question is to what level of detail is appropriate.  And the answer lies in the culture of the department and the company’s history with the FDA.  I once worked in an organization where the procedures were stripped to bare essentials, even the definitions were removed!  A recent warning letter left battle scars for the General Manager.

But seriously, how much is enough? Another way to answer this question is by looking at your document control hierarchy of documents.  If your site differentiates between SOPs and Work Instructions, the need for detail can be relocated into a suitable work instruction that is designed to provide detailed how-to steps.  AKA Level 3 type documents.  Refer to the diagram below.  The SOP (Level 2) can then provide a broader high-level overview addressing “the what” without getting encumbered into the “how-to execute” steps.  Some document pyramids include a Level 4 in which much detail can be used for training purposes.

A screenshot of text

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Referring to Document Pyramid determines level of appropriate detail

Back to the opening question

While addressing ease of navigation and use concerns is laudable, it is not always realistic to satisfy all users.  You need to explain what your Training “Program” contains, a high level policy that answers “the what”.  But you also need to describe how your training is conducted.  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 consider some Level 3 Work Instructions.
  • Do you have too many standalone task-focused SOPs (or Level 3 Work Instructions) that could be grouped into a few larger processes?  Recall the 3 Big Blocks of Training

From experience working with SME teams, three “how-to” procedures are usually sufficient: preparation process, delivery and documentation process, and measuring training effectiveness process.  So the next time you find yourself in the level of detail discussion, consider which of the levels (1,2,3,4) is the best place to park your “detailed” content. – VB

Who is Vivian Bringslimark?

Think your Training SOP could use a makeover? How about a document review?

Interested to see how the 3 Big Blocks of Training and the 6 Elements of a Robust Training System all interface with each other? Send your email request above.

(c) HPIS Consulting, Inc.