Redesigned procedures impact all personnel, temporary employees, consultants, and contractors involved in the manufacture of GMP drug products. However, inviting all affected users to review the proposed changes is not practical; nor efficient. Neither is skipping the advanced review while hoping that the draft SOPs will be approved quickly. This is a surefire way to derail the project. And just might add to the resistance for changed behavior these procedures are seeking.
I’m amazed at all the feedback that surfaces after the procedures go into effect. A field test is an effective vehicle to generate user feedback that is constructive, timely and can be used to evaluate concerns before the procedures go live. It can be as simple as an “Open House” with silent feedback forms to a full-fledged Pilot Program with formal feedback.
A pilot would be ideal. What better way to gauge the impact of the desired state than to pilot it in the workflow? But, this would require two processes (the current one and the proposed one) to be executed simultaneously. What a documentation nightmare this would cause; not to mention the lack of approval for the plan. An alternative approach is to invite impacted department heads, business unit leaders and a handful of affected SMEs to briefing meetings.
- The scope of the meeting is focused on one task.
- The project manager (PM) controls the copies of draft SOPs and Forms.
- The PM provides a forum for discussion by providing the updates in advance and still has development time to consider the feedback before submitting to Change Control/ Document Control.
- Invited folks are “now in the know”.
- Expedites change control review and approval workflow later on.
An Open House Invitation to Field Test the Process Redesign
The goal of this Field Test was to provide targeted feedback sessions with identified internal customers before new procedures became effective. Three feedback rounds were delivered each designed to achieve targeted stakeholder and user feedback.
- Session # 1 – Formal Project Update and sharing of Communication Plan for the Project. The first feedback form was developed to capture participants’ observations in general.
- Session # 2 – Simulated Scenarios that challenged the future state process. Scenarios included routine processes and new situations such as major changes to an SOP for example. Two feedback forms were used: one for procedural steps and a second one for the proposed forms.
- Session # 3 – Silent Feedback where users provided their comments, questions, concerns and overall experience. Similar to a “brown paper exercise”, the entire process was pasted on the wall showing actual steps, decision points, documentation, and interfaces with other systems. The exercise got users involved and they commented on strengths, weaknesses and further opportunities. By enlarging the process maps to wall size, users literally walked through the process and used a feedback form specifically for this activity.
- The rounds were scheduled in advance to allow the design team to leverage the feedback from each round and make changes before the next round of feedback began. Participation in the previous round was a prerequisite for attending the next round to minimize having to brief new participants on the project; thus, keeping the sessions short and focused.
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