CAPA

CAPA (Corrective and Preventive Action) is a systematic process for identifying, investigating, and resolving quality issues. The CAPA module in RapidFacto allows you to track CAPAs from initiation through root cause analysis, corrective/preventive action planning, verification, validation, and closure with approval.

Overview

A CAPA follows a structured lifecycle:

1. Draft → CAPA is created with initial details
2. Open → CAPA is accepted and investigation begins
3. In Progress → Root cause analysis and actions are being developed
4. Root Cause Analysis → Root cause has been documented
5. Actions Defined → Corrective and preventive actions have been documented
6. Verification → Actions have been verified for effectiveness
7. Pending Approval → CAPA closure is submitted for approval
8. Closed → CAPA is approved and closed

CAPA Sources

CAPAs can originate from various sources:

CAPA Statuses

Creating a New CAPA

From the CAPA List

1. Navigate to QMS → CAPA from the sidebar
2. Click the Create CAPA button
3. Fill in the CAPA details:
   • Title (required) — A concise title describing the issue (e.g., "Labeling Error on Batch B-2026-001")
   • Description (required) — Detailed description of the issue or non-conformity
   • Source Type (required) — Select the source of the CAPA (Audit Finding, Customer Complaint, Deviation, etc.)
   • Source Reference — Reference to the source (e.g., audit finding number)
   • Owner — Select the user responsible for managing this CAPA
   • Due Date — Set a deadline for CAPA completion
   • Containment Actions / Adverse Implications — Describe any immediate containment actions taken or adverse implications
4. Click Create to save the CAPA

From an Audit Finding

You can create a CAPA directly from an audit finding:

1. Navigate to the audit detail page in Internal Audit
2. Find the finding and click the Create CAPA button
3. The CAPA form will be pre-filled with:
   • Source type set to "Audit Finding"
   • Title auto-generated from the finding number
   • Description from the finding details
4. Complete the remaining fields and click Create

Working on a CAPA

Step 1: Root Cause Analysis

1. Navigate to QMS → CAPA and click on the CAPA to view details
2. In the Root Cause Analysis section, click Add or Edit
3. Document the root cause analysis — describe the investigation methodology and identified root causes
4. Click Save

Step 2: Corrective Actions

1. In the Corrective Actions section, click Add or Edit
2. Document the corrective actions to be taken — describe what will be done to correct the identified issue
3. Click Save

Step 3: Preventive Actions

1. In the Preventive Actions section, click Add or Edit
2. Document the preventive actions — describe what will be done to prevent recurrence
3. Click Save

Step 4: Verification

1. In the Verification section, click Add or Edit
2. Document the verification results — confirm that the corrective and preventive actions were implemented effectively
3. Click Save

Step 5: Validation

1. In the Validation section, click Add or Edit
2. Document the validation results — confirm that the actions prevent recurrence over a defined period
3. Click Save

Linking Documents and Records

You can link relevant documents and records to a CAPA for traceability:

Linking a Document

1. On the CAPA detail page, click the Link Document button
2. Select a document from the available documents list
3. The document will be linked and shown on the CAPA detail page

Linking a Record

1. On the CAPA detail page, click the Link Record button
2. Select a record from the available records list
3. The record will be linked and shown on the CAPA detail page

You can unlink documents or records at any time by clicking the unlink button.

Submitting for Approval

Once all sections are completed (root cause analysis, corrective/preventive actions, and verification/validation):

1. Click the Submit for Approval button on the CAPA detail page
2. Select the Approval Workflow to use (workflows of entity type "CAPA")
3. Optionally add comments
4. Click Submit
5. The CAPA status changes to "Pending Approval"

Approvers will review and either approve (closing the CAPA) or reject (sending it back for rework).

If e-signatures are enabled, approvers will need to enter their password when approving or rejecting.

Filtering and Searching CAPAs

On the CAPA list page, you can:

• Search — Search by CAPA title or number
• Filter by Status — Filter by any CAPA status
• Filter by Source — Filter by CAPA source type
• View Overdue — See CAPAs that have passed their due date

Best Practices

• Act quickly — Initiate CAPAs promptly to prevent recurrence of issues
• Be thorough with root cause analysis — Use established techniques (5 Whys, Fishbone Diagram) to identify true root causes
• Define measurable actions — Corrective and preventive actions should be specific, measurable, and time-bound
• Verify and validate — Always verify that actions were implemented and validate their effectiveness
• Link to source — Always link CAPAs to their originating audit findings, complaints, or deviations for traceability
• Set realistic deadlines — Allow enough time for thorough investigation and action implementation
• Use approval workflows — Submit all CAPAs for formal approval before closure

Next Steps

• Set up Approval Workflows for CAPA closure approvals
• Learn how CAPAs integrate with Internal Audit and Complaints