Introducing and Dealing With Changes in Documentation Work Practices

As business pressures, increasing regulatory demands, and competitive forces impact pharmaceutical and medical device companies worldwide, change is becoming the norm rather than the exception. This is not only true on the marketing and manufacturing sides of the business, but this is also becoming the watchword on the development side of the house. We are seeing plenty of this is in our McCulley/Cuppan consulting practice. What we also see is considerable reluctance to engage in work practice change. This is especially true for the work practices that people “see” as being straightforward and something they effectively mastered many years ago—like scientific writing and reviewing.

What we also see is considerable reluctance to engage in work practice change. This is especially true for the work practices that people “see” as being straightforward and something they effectively mastered many years ago—like scientific writing and reviewing.

Over time as we become experts in a specific job or a specific context, we develop theories of practice and heuristics that provide mental shortcuts for us to quickly evaluate familiar problem sets and develop solutions without exerting the kind of mental energy required for novel tasks. In essence, we can operate on a kind of workplace‐triggered autopilot.  However, these theories of practice can lead to “cognitive distortions” when the situation changes or is different than we had anticipated. Furthermore, these theories of practice can actually cause the distortion in judgment, as we attempt to apply our expertise to arenas in which they are not effective or relevant.

This is what we see in many workplaces where the organization wants to move to more collaborative writing models and optimize review practices. At its worst, we see large-scale resistance due to these distortions. At its best, knowing that there is a need to think differently is not enough to help many to do so. In these situations, the subject experts must develop a new framework for looking at the same issues as before. This can be a painful and long process and the “old ways” of solving problems—like how to write and what to say in a document—can severely hinder an expert’s ability to acquire a new framework for quite some time.

We have found, like others trying to bring change to work practices, that success follows a relatively standard pattern:

  1. The first step consists of “unfreezing” the current way of doing things. This is the phase where the underlying cause driving change is realized and the vision for a new way of operating is created/shared.
  2. The second phase involves getting more people in the change process to take ownership stakes in the final outcome. This is where you need to build project wins to use as news fodder and models of how reformed practices can play out.
  3. The third phase consists of redefining the workplace infrastructure so as to make the change successful.
  4. The final phase is measure, measure, measure to make sure the changed work practices are yielding the intended benefits/outcomes.

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