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CAPA (Corrective Action & Preventive Action)

The CAPA module is used to identify, investigate, and resolve issues that occur during production.

A CAPA is typically created when there is a gap between planned production and actual production results, or when significant downtime events affect production performance.

This module provides a structured workflow to assign responsibility, track corrective actions, and implement preventive measures.


1. CAPA Dashboard

The CAPA dashboard serves as the central location for monitoring all open and closed CAPA records.

Key Features

FeatureDescription
Search & FilterFind CAPAs using CAPA number, production line, or order
RefreshRetrieve the latest CAPA updates and status changes
Create CAPACreate a new CAPA record (restricted to authorized users such as supervisors)

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Dashboard Fields

FieldDescription
CAPA NoUnique identification number for the CAPA
Production ContextAssociated Production Line, Production Order, and Batch
Planned QtyPlanned production quantity
Actual QtyActual production quantity achieved
GapDifference between planned and actual quantities
AgeTime duration since the CAPA was created
StatusCurrent stage of the CAPA

Actions

ActionDescription
ReplyOpen the resolution screen where assigned persons record actions taken
EditModify CAPA details (available to the creator or supervisor)
DeleteRemove the CAPA record (available only to the creator)

2. Creating a CAPA

A CAPA should be created whenever a production gap or operational issue is identified.


FieldDescription
CAPA NoAuto-generated based on system sequence
Production LineSelect the production line where the issue occurred
Production OrderChoose the related production order
BatchSelect the affected batch

You may link the CAPA to specific downtime records.

FeatureDescription
Select DowntimeAttach one or more downtime events that contributed to the production gap

Step 2: Define the Gap

FieldDescription
Planned QtyTarget quantity planned for production
Actual QtyQuantity actually produced
GapAutomatically calculated by the system (Planned - Actual)
DescriptionDetailed explanation of the problem identified

Step 3: Assignment

FieldDescription
Responsible PersonsSelect one or more employees responsible for investigating the issue
Target DateDeadline for completing the corrective action

3. CAPA Reply & Resolution Workflow

After a CAPA is assigned, the responsible person must document the investigation and resolution steps.


View Master Details

The reply screen first displays a read-only summary of the CAPA:

FieldDescription
Planned QtyOriginal planned production
Actual QtyActual production achieved
GapCalculated production difference
StatusCurrent CAPA status

Adding a Resolution (Reply)

Click the Reply/Edit icon next to the responsible person to log actions taken.

FieldDescription
Corrective ActionAction taken to resolve the immediate problem
Preventive ActionSteps implemented to prevent the issue from recurring

Managing Status

StatusDescription
ClosedMarks the CAPA as resolved and completed
Re-assignedAssign the CAPA to another person for further investigation

When Re-assigned, the user must select:

  • New Responsible Person
  • Updated Target Date

4. CAPA Status Definitions

StatusDescription
AssignedCAPA created and assigned to responsible person
Re-assignedResponsibility transferred to another team member
CompletedCorrective and preventive actions recorded
ClosedIssue fully resolved and CAPA finalized

IMPORTANT

The Actual production quantity cannot exceed the Planned quantity when creating a CAPA.
If actual production exceeds planning, a CAPA may not be the appropriate transaction type.