Training can be considered a change in what the learner knows now | can do now and what s/he knows and does afterward. Training can close these gaps when knowledge and skill are lacking. Thus, a trainer has a dual role: trainer and change agent. While on the surface, the actions a trainer takes looks like change management, it is a sub-part of the larger change management plan. The scope is narrower. It is focused only on the training content. But the expectations for successful transfer back to the job and improved organizational results remain the same. One allocated and approved session designed and delivered by the training department is supposed to shift years of a mindset, alter behaviors and change the company’s culture. Amazing!
This expectancy or shall I say management assumption is very real and prevalent in fast-moving start-up companies whose leaders claim to have a limited budget for “training” and no time to sit in frivolous meetings planning “the people side” of change. I’m supposed to be grateful that I get an hour session. What happens next also amazes me. Training on the proposed system changes is reduced to an hour-long awareness session on the SOPs that have already gone into effect and folks are told – “Go with the flow. Change is part of our everyday life around here. Get with it or get out”. And here’s the rub for me, errors rise, deviations spike, users are annoyed, pissed off or disenfranchised and management blames the trainer for a failed change effort. Wow! Is this the management support that was promised to folks at the town hall meetings?
The bigger the redesigned quality system changes are, the more you need to consider beyond just training awareness on the SOPs. Assess the size of the change gap and the impact the new design will have on the culture; “the way we normally handle changes around here”. Training rollout sessions are already time-crunched. There is not enough time “allowable” to manage all the other non-training change issues like feelings, job security concerns, why the need for change retorts, lack of supervisory support post-training, etc. that actually get in the way of a successful learning transfer. And later create hurdles for improvement results.
Let’s look at the HPISC 5 Step Change Management Plan and apply it to quality system redesign projects. (See the sidebar below.)
QS Change Management Plan Considerations
1. Why is the change needed?
- This may be really obvious when the site receives a Warning Letter. But an explanation of how this became a driving force for the needed changes will do wonders for your employees to feel the urgency about the change.
2. What is really changing?
- Will the changes be incremental or a huge transformational change such as “changing the quality culture”?
- How are these SOP changes part of the GMP culture?
3. What are the pros and cons of the change?
- Who benefits and who loses?
- Are customers hurt or helped?
- What are the stakeholder’s benefits from the change?
- What about the benefits for the primary users?
4. What does success look like?
- What will the outcomes of the change look like?
- How will you and others know if the change has been successful?
- What benchmarks will help you track progress?
- When is the day or timepoint we get to declare success?
5. What other initiatives are we competing with?
- And how will adding the new change requirements impact already heavy workloads?
Will Awareness Training be the only vehicle for announcing the new changes?
Are the answers to the change management questions sitting with the trainer/training department or with the site leadership team? Perhaps the answers can be found within the steering committee members? Is the trainer supposed to address all of these questions in a 60-minute awareness session that also includes the SOP changes? If successful user adoption is paramount to your strategic action plan, warning letter remediation plan, or CRL commitment response, you need to ensure that change management messages regarding these changes are included in the overall communication plan. Don’t just rely on the design team members to deliver these messages casually at huddle updates. That is not a communication plan.
“The bigger the redesigned quality system changes are, the more you need to consider beyond just training awareness on the SOPs”.Vivian Bringslimark, HPIS Consulting, Inc.
The design team with the aid of the project manager needs to schedule special change management sessions where the Affected Users are briefed on the status of the project and the answers to the questions listed above addressed. Some leaders do not want to “waste time” on these sessions. They are concerned that it will become a gripe session. Instead, they think it’s better to just present the users with the revised procedures. There’s less time to fret and grumble over it.
There is a false belief that once the Affected Users see the changes in a QA-locked down version, they will follow them “because it’s now in the approved SOP”. Forced acceptance is not a change management strategy despite rampant practice in our industry. If awareness training will be the first time affected users are learning about significant system changes and the “Go-Live” date, be prepared to receive A LOT OF FEEDBACK FROM UPPER MANAGEMENT regarding how awful the awareness training sessions went.
“Change is disturbing when it is done to us, exhilarating when it is done by us”.Rosabeth Kanter, 1984, p. 64.
Who is Vivian Bringslimark?
This is 6th in the Redesigning Quality Systems series.
Camp, RR, Blanchard, PN. & Huszczo. Toward a More Organizationally Effective Training Strategy & Practice. New Jersey: Prentice-Hall, 1986.
Kanter, RM. The Change Masters. New York: Simon and Schuster, 1984, 64.
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