(CAPA) Corrective and Preventive Actions FDA Inspectional Objectives Part-01.
- Does CAPA system framework that addresses the necessities of the quality system in your Organization have been scientifically defined and documented.
Key Questions in this subsection to answered are:
- Have your organization clearly defined terms such as “nonconforming product”, “correction”, “prevention” through documented procedures such as SOP?
- Does your CAPA methodology incorporate systems for meeting the prerequisites for all components of the CAPA subsystem?
- Do your CAPA system have sufficient documentation for identifying and incorporating quality data for improving CAPA subsystem?
2. Does your CAPA system have reliable sources of product and quality problems?
Key Questions in this subsection to answered are:
- Do your CAPA system have sufficient documentation for identifying and incorporating quality data for improving CAPA subsystem?
- Do your CAPA system capturing and analyzing data from specifications relating to product, In-Process, Intermediates and finished product testing?
- Is data obtained from subsequent events such as distribution, market complaints, customer complaints and returned products being captured, analyzed and documented?
3. Does your CAPA system identify sources that may show unfavorable trends?
Key Questions in this subsection to answered are:
• Do your CAPA system identifying product and quality problems that shall require
Preventive action?
4. Does your CAPA system have reliable
sources for Input data?
Key Questions in this subsection to answered are:
• Are all data complete, accurate and
entered into the CAPA system in a timely manner?
5. Does your CAPA use appropriate
statistical methods to detect recurring quality problems.
Key Questions in this subsection to answered are:
• Does your organization analysis of product and quality problems such as Annual Product Review include sufficient and scientifically correct statistical and non-statistical techniques.
• Does your organization after employing statistical tools generate trends across different data sources
•Does your organization employ sufficient time and resources to identify Root Cause Analysis, to identify the issue and prevent re-occurrence of the same quality issue again. (updated on 25.09.2020)