Deviation and CAPA Management – Milestone Management for a Robust, Transparent and Efficient Process

It is an inescapable fact that deviations will occur at various points along the production cycle. An organization’s discrete approach to the management of such deviations will define how laborious and complicated the ensuing investigation and correction process is.

In this blog, we outline BSM’s approach for the simple and effective management of deviation and CAPA (Corrective and Preventive Action) systems.

Goals of our systems include:

Flow

Define and implement interim milestone steps with defined lead times. The discipline of this approach ensures that tasks (deviations or CAPAs) are dealt with in a timely manner, avoiding the often-encountered rush to close as the due date approaches. Operating in this way drives continuous and proactively focused efforts on important quality issues and can reduce the overall effort expended on each task.

Levelling

Level the workload for individuals to avoid overburdening people and creating delays. Where possible, it is advantageous to avoid dedication, e.g. product-specific resources for the tasks, as there will be a natural product volatility to the on-hand workload that will likely not match any static dedicated resourcing pattern. Regular review meetings of the workload are also an important habit to establish.     

Visual Management

Develop a facile visual management system that is visible to all stakeholders and clearly communicates the ownership, progress and status of each task. Simple systems such as a physical visual management board are very effective and provide a focal point for discussions at regular update meetings. Digital boards represent an advancement from the physical form and have several advantages that include:

• Accessibility – Digital boards can be accessed from multiple devices in multiple locations with configurable permissions for users.
• Visibility – Digital boards can create visibility for all levels of users across departments and even up to regional and global management teams.
• Real Time Information – Digital boards display real time information and avoid the update delays that physical boards can suffer due to their static location.
• Integration – Digital boards can be aligned to current task management systems (e.g. Trackwise).