The Right CAPA - Systems Based Solutions - Checklist Example
Eldon Kao
Deciding on the appropriate level of response for a Corrective and Preventive Action (CAPA) is not always straight forward. The most idealistic solutions are often not the most realistic. There are always other factors that come into play such as capital constraints, insufficient labor, or geographical barriers to name a few. Furthermore, as many CAPAs require cross-functional support, it brings the complexities of priority conflicts, corporate communications, and general office diplomacy.
How can we navigate these waters and reach a compromise without "watering down" CAPAs to the point that they become ineffective or even worse, detrimental to the organization? A good CAPA improves on operations, processes, and quality. A bad CAPA will do none of these while burdening those involved with added work.
Where CAPAs usually falter is based on long term sustainability. An action is created or a process is revised for improvement but the integration and support system has not been evaluated. The right CAPA is a Systems Based Solution. Consider the below example to illustrate my point:
Problem:
Equipment breakdown at a confectionery manufacturer contributed to downtime which affected the productivity of the production department.
Solution:
As a result, the identified part along with auxiliary components were added to a daily checklist as part of a preventive maintenance program.
The Challenge:
Although checklists are helpful, changes to the frequency can greatly influence the workload, compliance, and ultimately the effectiveness of the checks. What is the appropriate frequency for this check? by shift? day? batch? week? month? This depends on the level of risk involved with the production between checks and breakdown but there should be a balanced approach. Too frequent checklists contribute to complacency. While their strength lies in their simplicity it also its weakness. Checklists are limited to what's in the checklist. Due to their format, they limit the scope of analysis and deter against critical thinking. Which means while checklists can be effective, there should also be effort made to communicate that they are representative of the bare minimum requirements and that thinking "outside the box" is encouraged. The systems based approach goes beyond just employing a tool and considers how the cog fits into the overall machine.
The system includes evaluation of standard procedures, operational practices, work culture and how departments interface with each other. These everyday habits are indicative of the future success of proposed CAPAs.
Discussion
What Systems Based solutions have you implemented and what challenges did you face?