In “Change Management – Post Change Evaluation and Action” John Hunter (of CuriousCat) writes a nice post on the The W. Edwards Deming Institute Blog on linking change management to the PDSA (PDCA) lifecycle focusing on Act.
Post Change Evaluation is often called the effectiveness review, and is a critical part of change in the pharmaceutical quality system, and frankly is important no matter the industry.
An effectiveness review is the success criteria of the change viewed over enough data points based on a methodology informed by the nature of the change and risk.
The success criteria should be achieved. If not, reasons why they have not been achieved should be assessed along with the mitigation steps to address the reasons why, including reverting to the previous operating state where appropriate. This may require the proposal of a subsequent change or amendment of the implementation plan to ensure success. Here we see the loop aspects of the PDSA lifecycle.
All changes should have a way back into knowledge management. The knowledge gathered from implementation of the change should be shared with the development function and other locations, as appropriate, to ensure that learning can be applied in products under development or to similar products manufactured at the same or other locations.
When choosing success criteria always strive for leading indicators that tell you how the change is working. Deviations are an awful way to judge the effectiveness of the change. Instead look for walkthroughs, checklists, audits, data gathering. Direct observation and real-time gathering and analysis of data of any sort is the best.
As mentioned above, ensure the change management/change control system is set up to deal with the inevitable change that does not work. Have a clear set of instructions on how to make that decision (returning to the success criteria), what steps to take to mitigate and what to do next. For example having guidance of when to create a deviation and on how to make a decision to rollback versus implement another change.
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