Avoid the common confusion surrounding Corrections and CAPA

As part of their improvement activities, companies need effective Corrective and Preventive Action (CAPA) systems. To implement an effective system you must understand the requirements, including the difference between corrective action and preventive action.

This course provides the participant with a clear and simple explanation of corrective action and preventive action systems. It cuts through the confusion by explaining the technical definitions of correction, corrective action, and preventive action. By laying a clear foundation, the presentation offers a solid approach to system implementation.

In addition, correction and corrective action are often confused. Correction deals with eliminating a problem, while corrective action deals with eliminating the cause of a problem. This confusion can create difficulty in both audit programs and nonconforming material control.

These confusions can impact the systems, create endless discussions, and increase cost.

• Failure to implement an effective system can waste resources, increase cost.
• Systems to control and disposition nonconforming material have long cycle times when they confuse correction and corrective action.
• Companies without good preventive action systems miss improvement opportunities.
• Regulated industries have even more stringent requirements. In medical devices, for example, the FDA cites CAPA systems most often.

Learning objectives:

The participant will understand the difference among correction, corrective action, and preventive action. This understanding leads to more effective implementation.

Based on the ISO 9000 series, the participant will learn how to establish and measure processes in general and apply these methods to specific processes including: disposition of nonconforming material, correction (including audits), corrective action, and preventive action. At the conclusion the participant will be well versed in the terms and associated process implementation.

Areas Covered in the seminar:

• ISO 9000:2005 as a dictionary .
  • Concept diagram for conformity
    • Symbols used in the concept diagrams
  • Definitions and contrasting terms.
    • Corrective action v. preventive action
    • Correction v. corrective action
    • Rework v. repair
    • Regrade v. rework
• Sampling plans.
  • ISO concept of a process .
  • Process expectations.
    • Process owner
  • Process inputs
  • Process steps
  • Process outputs
  • Process indicators
  • Process customer
  • SIPOC Diagram
• Key process indicators (KPIs)
  • Effectiveness, Efficiency, Cycle time
• Nonconforming material control.
  • Correction
    • Rework, Repair, Regrade
  • Concession
  • Scrap
• CAPA as an integrated process
  • Relationships with other processes
• Corrective action process elements
  • Reviewing nonconformities
  • Determining the causes of nonconformities
• Establishing the need for action
• Determining and implementing action
• Creating records of the results
• Reviewing effectiveness
• Preventive action process elements
  • Determining potential nonconformities and their causes
  • Evaluating the need for action
  • Determining and implementing action
  • Creating records of the results
  • Reviewing effectiveness

Who will benefit:

This seminar is designed for people who manage and improve processes. By understanding the relationship between requirements and nonconformity, process owners can help plan and implement better processes. This typically includes:

• Quality Directors
• Quality Managers
• Quality Engineers
• Production and Process Engineers
• Manufacturing Engineers
• Design Engineers
• Supplier Quality Engineers
• Quality Supervisors
• Quality Inspectors
• Quality Managers

Instructor Profile:
Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.