Closing deviations and CAPAs on time can be challenging, with late closure meaning delays in batch release and disruption to the supply of crucial medicines. Such delays can cause stress and anxiety to the patients who depend on them. Adoption of effective management tools is thus essential to ensure minimal disruption to the patient. When managing CAPAs and deviations, it is important to consider each like a mini-project that will require cross-functional input and expertise to close out. In managing them, there are three key elements that aid timely closure:

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• Visibility is fundamental when planning any project. You need to know the resources available, what other projects are coming up, and where the finish line is. Well-designed trackers are a great way to manage CAPAs and deviations as they can enable re-time status updates rapid response to a changing landscape.

 

• Regular accountability meetings with representatives from across value-streams provides multiple benefits:

  • It allows for the raising of key issues or technical knowledge to be rapidly shared, allowing the reallocation of resources as priorities shift

  • Regular meetings build intra-team relations, lowering social barriers which can preclude the transfer of vital information.

  • Create a nurturing environment that fosters teamwork. Key to the success of accountability meetings is the environment created; What do you need for this to succeed? How can we help? and not, Why isn't this done?

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• Consistency in approach, such as the use of well-designed investigation templates, not only speed up the delivery deviations and CAPA implementation, but it improves investigation accuracy, integrity, and transparency.

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