A root cause is a factor that causes a non-conformance or deviation from a defined path and should be permanently eliminated through process improvement and analysis. Root Cause Analysis (RCA) is a tool to help identify what, how and why an event has occurred so that proper steps can be taken to prevent future occurrence.
RC can also be to target opportunities for system improvement. It can be attested that root causes are specific underlying causes that can be reasonably located and are mostly management’s control to amend and it helps generate effective recommendations to prevent recurrences.
RC Analysis process involves data collection, causal factor charting, root cause identification, recommendation generation etc.
Resolving a quality problem could be done with correction, correction action or preventive action! These actions under regulations also require proper identification, documentation, evaluation.
Correction: is a type of action, correction is a change that makes something right, true, accurate or better. It is also defined as an action taken to eliminate a detected nonconformity.
Correction Action: is action taken to eliminate the causes of a detected nonconformity or quality problem. The deemed action is intended to eliminate the recurrence of a quality problem that has occurred. Post applying correction actions to confirm the issues is not being faced again. This is called verification of effectiveness, which manifests that the actions have addressed the root causes of the problem to reduce or eliminate their effect, depending on the goal of the CAPA.
Preventive Action: is action taken to avoid occurrence of a potential issue.
What action is being taken to amend the issue is of utmost importance in ensuring safe and effective products.
RC & CAPA is a team effort that should be address properly in most of the cases. Leaving the same unaddressed may worsen the issue(s) and later may require lots of description and time digging up the bugs and relevant parts that has been impacted.