Training assessment as part of change management

One of the key parts of any change (process improvement, project, etc) is preparing people to actually do the work effectively. Every change needs to train.

Building valid and reliable training at the right level for the change is critical. Training is valid when it is tied to the requirements of the job – the objectives; and when it includes evaluations that are linked to the skills and knowledge started in the objectives. Reliability means that the training clearly differentiates between those who can perform the task and those who cannot.

A lot of changes default to read-and-understand training. This quite bluntly is the bane of valid and reliable training with about zero value and would be removed from our toolkit if I had my way.

There are a lot of training models, but I hold there is no single or best method. The most effective and efficient combination of methods should be chosen depending on the training material to be covered and the specific needs of the target group.

For my purposes I’ll draw from Edgar Dale’s Cone of Experience, which incorporates several theories related to instructional design and learning processes. Dale theorized that how a learner retained information is based on what they “do” as opposed to what is “heard,” “read” or “observed.” This is often called experiential or action learning.

dalescone

Based on this understanding we can break the training types down. For example:

Structured discussions are Verbal and some Visual, and lives within the Abstract
Computer Based Trainings are mostly Iconic, with a few concrete
Instructor Led Trainings are a lot about Concrete
On-the-job training is all about the Concrete

Once we have our agreed upon training methods and understand what makes them a good training we can then determine what criteria of a change leads to the best outcome for training. Some example criteria include:

Is a change in knowledge or skills needed to execute the procedure?
Is the process or change complex? Are there multiple changes?
Criticality of Process and risk of performance error? What is the difficulty in detecting errors?
What is the identified audience (e.g., location, size, department, single site vs. multiple sites)?
Is the goal to change workers‘ conditioned behavior

This sort of questioning gets us to risk based thinking. We are determining where the biggest bang from our training is.

Building training is a different set of skills. I keep threatening a training peer with doing a podcast episode (probably more than one) on the subject (do I really want to do podcasts?).

The last thing I want to leave you is build training evaluations into this. Kilpatrick’s model is a favorite – Level 4 Results evaluations which tell us how effective our training was overtime actually makes a darn good effectiveness review. I strongly recommend building that into a change management process.

Change Management and Communication

All changes need to be communicated to internal and external stakeholders. The development of the communication plan should be part of the change management system.

One of the better models I’ve used is Prosci’s ADKAR.

This is a good model because it matches very nicely to the 4 major phases of change.

In Propose we focus on Awareness and Desire
In Evaluate we focus on Knowledge and Ability
in Implement we focus on Ability and Reinforcement
And in Close, we focus on sustained Reinforcement and perhaps Awareness of a new change.

Not every change is the same size, and not every change uses the same tactics of communication. Often these tactics are training.

A table, such as the one below, can help.

Item	Description of What it is	Audience	Publication Date
List each of the proposed elements of your communication plan	Be sure to include key stakeholder outreach along with all other tactics	Who	List the date you want the communication delivered

There are lots of good tools out there for communicating. This post was prompted by this post on elevator pitches, which are one of my favorite items in my toolkit. Every change, big or small, should have an elevator pitch ready to go. And make sure it evolves according to the change/process improvement lifecycle.

Communication of Changes between sites

Yesterday, the FDA finalized the ICH Q7 Q&A Guidance on GMPs following its endorsement by the regulatory agencies participating in the ICH in June 2015.

Two-and-a-half-years. And I sometimes wonder why the ICHs aren’t more broadly adopted or why some of my colleagues are a little pessimistic about their impact on this industry

However, re-reading these questions and answers gave me a good topic.

QA on Q7 change management

With complex and virtual supply chains, with world wide distribution, it is important to understand who needs to be communicated about what changes.

This communication should be evaluated for it’s directionality. It helps to break down your types of changes and determine what are:

Consult – those changes where the other site needs to provide an assessment. For example, if a change impacts testing that is conducted at another site, or it impacts the way the next site will receive the material (don’t forget ERP changes). These communications are always push.
Inform – the other site needs to be aware but will not need to take any action. A great example of this notifying the QP.

Include your suppliers in this process as well, and ensure your suppliers are also appropriately communicating. Include this in your quality/technical agreements or contract terms.