Designing a Bulletproof CAPA Process: Key Components and Implementation

Some say, that CAPA – Corrective and Preventive Actions – are the most important process of any Quality Management System. This is more intensified in the Medical Devices industry where the ability of an organization to ensure that failures do not reoccur is one of the most important goals of Quality Systems and hence reducing. FDA, EU Notified Bodies, and other regulatory authorities investigate the capability of organizations to identify processes that require corrective and preventive actions. Organizations should provide evidence that they have the required means and abilities to analyze failures and nonconformities, then set up corrections, corrective actions, and corrective actions in a duly manner.

This webinar shall provide insight into how to establish CAPAs that shall provide the organization the confidence that the organization is mature enough to handle its failures and avoid future non-conformities. Mr. Yuval Shapiro will discuss the requirements for Corrective and Preventive actions as required by medical devices standards (ISO13485, etc.), and the common practice. The difference between Correction, Corrective Action, and Preventive Action will be discussed. Mr. Shapiro will also discuss common sources for CAPA and root-cause analysis tools, such as Why diagrams, cause-and-effect diagrams, Pareto charts, etc. An efficient CAPA management system will also be presented.

Quality management systems are built on the principle of Corrective and Preventive Action (CAPA). Daily challenges for quality managers include implementing CAPA as an organization-wide standard procedure. Failure to identify, locate, and address the fundamental issue(s) or root cause is one of the most frequently mentioned 483 observations. This means that CAPA documents were not closed out and the main underlying problem was not identified and resolved on time.

The use of a few straightforward but effective tools on a regular, defined, and systematic basis can make a significant impact on efforts to cut costs, reduce product liability, lower the likelihood of recalls, and boost profitability.
The purpose of this webinar is to present what are the requirements for a robust CAPA process. The webinar shall provide tools and examples of how to analyze and identify root causes and provide a mechanism to mitigate them. Also, the webinar shall provide insights into how to manage CAPA in a daily manner.

• Correction, Corrective Action, and Preventive Action and how they differ from each other.
• Sources that can trigger a CAPA process
  • Customer complaints
  • Internal audits
  • Regulatory inspections
  • Process deviations
  • Equipment failures
  • Nonconformances
• Situations necessitating a Corrective and Preventive Actions (CAPA) process.
• Identifying root causes using practical tools.
• How to manage a CAPA
  • Identify the problem
  • Investigate the root cause
  • Develop corrective and preventive actions
  • Assign responsibilities and timelines
  • Implement the actions & Verify the effectiveness
  • Monitor and review
• Common pitfalls in implementing CAPA processes

• Senior and Middle Management.
• Quality Assurance
• Regulatory Affairs
• R&D Engineers and Managers
• Quality Managers
• Quality Engineers
• Engineering Managers
• Operations / Production
• Production Engineers, Production Managers
• Complaint Handling Personnel