Corrective and preventive action (CAPA) requirements for ISO 9001:2000 registered/compliant companies must be understood and implemented effectively. CAPA systems should provide critical input to top management relative to the status of the continuing effectiveness of the Quality Management System (QMS) and the efficiency and profitability of the organization.

Corrective and Preventive Action for ISO 9001 Quality Management Systems Objectives

• Understand the ISO 9001:2000 requirements for corrective and preventive action
• Understand the differences between corrective and preventive action and their relationship to continual improvement
• Understand internal and competitive external data sources that may generate the need for both formal and informal corrective action
• Stop putting out fires and learn to extinguish the source
• Understand how to identify and state a problem
• Understand the critical steps in the corrective and preventive action processes
• Develop competence in taking a problem through the CAPA process
• Understand how to use formal root cause analysis methodology
• Develop familiarity in initiating and completing the mandatory CAPA record
• Learn not only what is expected from your organization, but also how you can use it to impact the bottom line

Corrective and Preventive Action for ISO 9001 Quality Management Systems Topics

• What is the CAPA relationship to ISO 9001:2000 requirements?
• Sources for CAPA requests (internal/external); day-to-day CA
• CAPA and the process approach
• Problem identification and analysis
• Prioritizing problems
• Preventive action
• The steps of corrective and preventive action
• Formal methods for determining root cause
• Implementation effectiveness
• Case studies in corrective and preventive action
• Communication/documentation of results

Who Should Attend Corrective and Preventive Action for ISO 9001 Quality Management Systems?

Recommended for an organization's senior staff, management representative, and staff in:

• Quality management (QA/QC/QE)
• Manufacturing operations
• Internal audit
• CAPA management
• Information systems/technology
• Documentation management

CEUs: 1.5
Number of Days: 2