Implementing QSR and ISO 13485 requirements for CAPA and Corrections

Overview:

The difference between corrective action and preventive action is often confusing. There are, however, formal definitions that show the difference between them.

We use these definitions, found in ISO 9000:2005, to help the participant understand the terms. The concepts are illustrated with examples that help make the differences clear.

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. Correction deals with eliminating nonconformities. The need for correction arises in both internal auditing and in control of nonconforming material. Corrective action, in contrast, eliminates the cause of nonconformities, not the nonconformities themselves. Similarly, both audits and nonconforming material control need a corrective action system.

All managers involved in internal audits need to understand both correction and corrective action. ISO 9001:2008 requires:

• The management responsible for the area being audited must implement necessary corrections without undue delay
  
• The management responsible for the area being audited must take corrective actions without undue delay.

Quality professionals involved in the disposition of nonconforming material need to understand their options, including, based on ISO 9000:2005:

• Scrap, which precludes using an item for its intended use
  
• Correction, with its various options, to eliminate a detected nonconformity
• Rework, which makes an item conform to requirements
• Repair, which makes an item fit for use
• Regrade, which makes an item conform to a different set of requirements
• Concession, which allows the use of a product that doesn?t conform to requirements

Corrective action systems identify the cause of nonconformity, so it can be eliminated. This is a different (higher level) from correction. These systems must:

• Determine the cause
  
• Implement action
  
• Monitor effectiveness

Preventive action systems deal with potential problems – problems that haven’t happened yet. These systems must:

• Determine potential problems
  
• Implement actions
  
• Monitor effectiveness

Why should you attend:
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.

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

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
• Process definition
• 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 webinar 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