Dan O’Leary 2012 - Avoid the common confusion surrounding Corrections and CAPA

Why you should attend

As part of their improvement activities, companies need effective Corrective Action 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 affect 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

Description of the topic:

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

Areas Covered in the Session

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 (Titles)

The webinar is 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

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