Learning from Failure – Closing the loop with Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) workflows

“The only real mistake is the one from which we learn nothing.”
- Henry Ford

To err is human. However, not learning about and addressing the root causes of the error would be the real mistake. Learning about the root cause is often accomplished via Root Cause Analysis (RCA). The Root Cause Analysis should lead to Corrective and Preventive Actions (CAPA).





It is often the case that many quality events result in corrective actions/countermeasures. While cross-functional teams identify and prioritize corrective actions and countermeasures, ensuring implementation of corrective actions and validating their impact is anything but easy. That is where Digital Workflows for corrective action/countermeasure implementation can make a difference.

Take, for example, the following quality issue and related workflow.


Below is the workflow for the quality issue.


Closing the loop with Corrective Action and Countermeasures


Following the root cause analysis the team created a corrective action request as shown below to determine and implement appropriate countermeasures.



Workflows for implementing Countermeasures

Documenting countermeasures is often not the same as implementing countermeasures. Based on our experience many organizations and cross-functional teams find it difficult to diligently implement corrective actions / countermeasures on a timely basis due to the practical difficulty of coordination, handoffs and ensuring implementations are happening on a timely and reliable basis.

Digital workflows that are automatically triggered and involve the right people and systems for corrective action / countermeasure implementation.

Continuing our example from above, the 2 countermeasures involve updating Standard Operating Procedures (SOP) and following it up with a process audit to ensure that the changes are being practiced.