This is a collection of rules, procedure, and forms related to CAPA in a form consistent with the FDA QSR.
CAPA is the most frequently pointed out during QSR (Quality System Provision) inspections.

List of Forms
The following forms are included with your purchase.
・MD-QMS-K17 CAPA Provision
・MD-QMS-S1701 CAPA Procedure
・MD-QMS-F1701 CAPA Form
・MD-QMS-F1702 CAPA List
・MD-QMS-F1703 CAT Meeting Record

Table of Contents

CAPA Provision

1 Purpose
2 Scope
3 Definition of Terms
4 General rule of CAPA Management
5 Responsible department for CAPA management
6 CAPA Sources
7 Judgement standard for CAPA request
8 CAPA Severity Judgement
9 CAPA control numbering rules
10 CAPA Progress Management
10.1 List of Corrective and Preventive Actions
10.2 CAT (Corrective Action Team)
11 Implementation Procedure
11.1 Problem Identification
11.2 Cause Investigation
11.3 Plan and verification of actions
11.4 Implementation of Actions
11.5 Dissemination and education of relevant personnel
11.6 Termination Approval
11.7 Validation
11.8 Records
11.9 Data analysis and reporting
12 Reference
13 Appendence

CAPA Procedure

1 Purpose
2 Scope
3 Definition of Terms
4 Roles and Responsibilities
5 Procedure
5.1 Problem Identification
5.1.1 Corrective/preventive actions required
5.1.2 Preventive Action Requests
5.2 Cause Investigation
5.2.1 Determining necessity of Cause Investigation
5.2.2 Cause Investigation
5.3 Plan and verification of actions
5.3.1 Plan of Actions
5.3.2 Verification of Actions
5.4 Implementation of Actions
5.4.1 Dissemination and education of relevant personnel
5.5 Termination Approval
5.6 Validation
5.7 Creation of CAPA files and CAPA listings
5.8 Data analysis and reporting
6 CAPA Progress Management
6.1 Formation of CAT (Corrective Action Team)
6.2 CAPA Progress Management
7 Record keeping
8 Form
9 Reference
10 Appendence