The CAPA system is the cornerstone of a Quality Management System, especially in the Pharmaceutical/Medical Device Industry, and the backbone and driver for quality improvements. The CAPA system feeds the Quality System to improve processes, procedures, organization and business in a structured, well-documented and actionable way.
Operon Strategist audits the existing CAPA system of clients determines how effective it is in identifying & correcting quality problems. An effective Corrective And Preventive Action system enables easy collection & analysis of information. This information is used to identify & investigate existing; potential product & quality problems.
CAPA Process Flow Chart
There is a strong link between QUALITY and OPERATIONAL EXCELLENCE, as a well-established CAPA system will have its benefits for the business, for instance:
- Improved safety and security
- Improved customer satisfaction
- Increased productivity
- Infrastructure efficiency gains
- Better product quality
- Avoiding the cost of regulatory non-compliance
The risk-based CAPA requirements demand a well-documented system that determines the root cause of non-conformances, system failures or process problems, corrects the problems, and prevents them from recurring. The documentation must identify why something went wrong—or why it may go wrong—and what has been done to make sure it does not happen again. One of the most important quality system elements is the corrective and preventive action subsystem. And its purpose of this corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.
In an industry where patients’ health and wellness depends on products functioning properly, an organization cannot afford any weak areas that could lead to nonconformities or lower quality products
We help manufacturers to audit their current quality system reviews as per the standards to determine how effective it is in identifying quality problems. We carry out systematic and independent process audits to determine the conformity or nonconformity of your QMS Requirements. We also help you with an effective CAPA management system which enables easy collection & analysis of information, this information can be used further to identify & investigate existing, potential product and quality problems.