Change Management and It’s Little Cousin Training

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.)

5 necessary parts of a Change Management Plan

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.

© HPIS Consulting, Inc.  All rights reserved.

Tired of repeat errors – ask a Performance Consultant to help you design a better corrective action

In this last “Making HPI Work for Compliance Trainers” series, I blog about one of the biggest complaints I hear over and over again from Compliance Trainers – management doesn’t really support training.  It’s hard to ask for “more of the same” even though you know your programs are now different.  In previous blogs, I shared why management hasn’t totally bought into the HPI methodology yet. See the blog Isn’t this still training?

 

Given the constant pressure to shrink budgets and improve the bottom line, managers don’t usually allow themselves the luxury of being proactive especially when it comes to training.  So they tend to fall back on quick fix solutions that give them a check mark and “clears their desk” momentarily.  For the few times this strategy works, there are twice as many times when those fixes back fire and the unintended consequences are worse.

 

In the article, “Why the Band Aids Keep Falling Off”, I provide an alternate strategy that emphasizes moving away from events-only focus to exploring the three levels of interaction that influence performance: individual performer, task/process, organizational quality systems.  These same three levels are where performance consultants carry out their best work when supported by their internal customers.  The good news is that the first step is the same; it begins with a cause analysis.  See the blog Analysis du jour  for more thoughts on why these are essentially the same approach.

 

The difference is that the corrective action is not a reactive quick fix but a systems approach to correcting the issue and preventing it from showing up again.  System based solutions are the foundation of many HPI/HPT projects that require cross functional support and collaborative participation across the site / organization.  And this is where a PC needs support from senior leaders.

 

We wrap up this series here and introduce the next series – Gaining Management Support – where I blog about credibility, trust, and access and how these 3 concepts impact relationship management.

From a pair of hands to trusted business partner

In this second blog from the “HPI: Making it Work for Compliance Trainers” series, I continue the business partner exploration.  Need the first one?  Get caught up: What’s the difference between Trainers and Performance Consultants?

Three Consulting Styles Let’s start with the Pair of Hands.  This style of consulting resembles more or less the contractor for hire or long term temporary employee; sometimes referred to as the permanent temp much to the chagrin of those who hold those positions.  Here the client (or internal customer) retains control of the project from problem identification to solution deployment.  The consultant implements those decisions as if s/he were an extension of the client’s staff.  Hence the expression, an extra pair of hands to delegate the work to.

There’s the Expert.  Here the consultant assumes most of the control for the project.  The client can still make suggestions while the consultant makes recommendations for the best solution selection.  Ultimately, the expert-consultant decides on the course of action and tells the client what’s the best path forward.  In this type of consulting relationship, the client wants the expertise of the consultant.

The third is Collaborator.  This is where the consultant utilizes his/her specialized knowledge and field experience and leverages the client’s knowledge of the operations, including processes and procedures, and the cultural factors.  In this relationship style,  1 + 1 = 3, representing a more synergistic approach to problem solving.  Decisions and implementation plans become shared responsibilities.  This style is often referred to as a business partnership and it is really the only one the changes performance.

Internal vs. External Consultant I’ve been both and have had success in implementing HPI projects in both environments.  There are pros and cons and tradeoffs.  Whether you are internal to the organization or external (an outsider), Compliance Trainers need to expand their skills sets if they are going to move from a “pair of hands” to expert and eventually to trusted business partner.  The new competencies to be developed are:

  • Analysis (both Training Needs and Performance Needs) – See If Training Isn’t the Right Answer
  • Implementing Performance Solutions (not just training solutions) – See Isn’t This Still Training?
  • Change Management (not just Change Control/Doc Control but how to manage what I call the “People Side of Change”
  • Measurement and Evaluation (recognizing that these are not the same thing)

Learn more about how to assess yourself against these competencies.

Take ACTion Now! In their 2005 book, Strategic Business Partners, Dana Gaines Robinson and Jim Robinson, recommend that transitioning trainers take ACTion now.  ACT stands for Access, Credibility and Trust.  However, from my experience, the steps don’t necessarily follow in that order.  It’s more like establishing your Credibility first, earning their Trust next, and then you’ll be granted Access to strategic opportunities.

Oh, but where to start? A good place is to show your performance worth.  Recall earlier I listed developing performance solutions as a new competency? A training solution closes a knowledge and skill gap, wonderful.  A performance solution may include a training piece, but it also closes a gap in Job Performance which in turn can close a gap in a Process Performance and resolve a gap in Business Results.   That’s what a HPI project/solution does differently than a training solution and it certainly illustrates why those new competencies are needed.  Being able to show this kind of impact on the business as a result of the work a Performance Consultant does goes a long way to earning business leaders trust.  –VB

With a little help from my Validation Colleagues – The Training Protocol

In the blog, “Learning on the Fly“, I blogged about an urgent learning need requiring instructor-led classroom delivery that needed to be facilitated among a group of talented SMEs.  During the needs assessment portion, I hit a huge barrier.

“I teach GMP Basics and conduct Annual GMP Refreshers several times a year and preach to audiences that you must follow the procedure otherwise it’s a deviation.  And in less than two weeks, I am expected to teach a process that is changing daily!   Yet on the other hand, how could I teach a work instruction that is known to be broken; is being re-designed and not yet finalized?”

My dilemma challenged the essence of my “learned” compliance belief system about following the 1st basic GMP principle – “thou shall follow written procedures”!  The instructional designer side of me screamed – how can you teach flawed content?  That’s wasted training that results in scrap learning. How is that training going to be effective beyond a check in the box?

And then it hit me – validation engineers use protocols to capture their “change in process” work.  Whether it’s experimental batches, 3 batches for process validation or *IQ-OQ-PQ protocols for equipment qualifications.  They are validating the procedure or the new process before it can become the standard operating procedure by developing the plan, developing acceptance criteria, managing the unexpected deviations and capturing the results.  So why couldn’t I borrow the concept and adapt it to my situation?

While it was the intention of the business unit leader to deviate from the approved set of work instructions, a planned deviation would not be appropriate in this case.  The purpose of the training sessions was to test the new sequence of steps and confirm the robustness of the criteria to make correct decisions where needed.  The learners would still be in compliance with the quality policy document and would still meet the intention of the quality system regulation.  They were essentially testing the future “how-to steps” for the proposed new work instructions.

Now before you fire off a rant of emails to me, I did not copy and paste the validation protocol template.  I did however, include a “please pardon our appearance while we are under construction” paragraph in the training plan to document the departure from the current set of work instructions.  This protocol like section also included our intentions for the outcomes of the sessions and stipulated required SOP training of all affected users once the finalized set of work instructions were approved and went into effect.

Sometimes the very solution can be found around the next cubicle.  –VB

*Installation Qualification, Operational Qualification, Performance Qualification

(c) HPIS Consulting, Inc.