Correction-corrective Action and preventive action

Correction-corrective action and preventive action in pharma:

Correction-corrective action and preventive action are the 3 key definitions used in the pharmaceutical industry while investigating.

Let’s understand the definitions of all with examples.

Correction:

Action to eliminate the detected nonconformity.

Nonconformity is nothing but the non-fulfillment of a specified requirement.

A correction is when you fix the thing that went wrong ( the non-conformity) or to contain the problem.

For Example, Reworking, repair or replacement are corrections.

Corrective Action:

Action to eliminate the cause of a detected nonconformity.

A corrective action (CA) deals with a nonconformity that has occurred i.e. the corrective action is performed on detected non-conformity.

The objective of CA is to prevent a recurrence.

For Example: Installing the filter after an incidence of filter choking.

Corrective action is a reaction that can be made along with the correction.

Preventive Action:

Action to eliminate a cause of a potential nonconformity.

Preventive action determines and eliminates the cause of potential non-conformities to prevent occurrence.

The objective of PA is to prevent its occurrence.

For Example: Installing an alarm to warn you when your process is drifting out of the acceptance range.

Preventive action is proactive.

Quick Recap & key Insights of CAPA:

Corrective ActionPreventive Action
Deals with a nonconformity that has occurredDeals with potential
nonconformities- no failure has yet occurred.
The objective of CA is to prevent a recurrenceThe objective of PA is to prevent the occurrence
Focuses on past eventsFocuses on potential future events
Requires root cause analysisRequires risk/or trend analysis
Eg. Installing a backup filter after an incidence of filter chokingEg. Installing an alarm to warn
you when your process is drifting out of acceptable range.
Difference Between CA/PA
Correction-corrective action and preventive action
Difference Between CA/PA

The ratio of CA/PA provides insights into the maturity of the Quality Management System of any organization.

Also Read:

Refer YT Channel: Pharmabeej

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