Real Lean Transformation

Deviations / CAPA

Deviations and CAPAs typically have long target lead times. Deviations are typically 30 days and CAPAs are typcially from 30 to 90 days.
However, in order to level and manage task execution it is good practice to visually manage Deviations and CAPAs based on shorter (interim milestone) target process lead-times. 
  • Contrary to popular belief, shorter process lead-times do not increase the effort required.
  • In fact when individual Deviations or CAPAs are processed quicker there is less ‘picking up’ and ‘putting down’, less re-familarisation and less duplication of effort . 
  • Faster processing lead-times result in less open Deviations or CAPAs at any given time.

Deviations and CAPA Visual Management

Management of Deviations and CAPAs impacts workload for many stakeholders (e.g. Site Management, Global Management, QA and Tech Ops), both inside and outside the area where the Deviation originated.
Visibility of Deviations and CAPA volume and timelines is a key feature of a BSM daily visual management system. 
  • Key process ‘milestones’ should be clearly visualised
  • Current status of individual deviations should be instantly visible
  • Overall progress of individual deviations should be clearly visualised and easy to follow
  • The current milestone owner should be clearly visualised
  • Simpler is better – the simpler the layout and the less elements required the better (e.g. magnets etc.).