Course Description

Corrective and preventive action (CAPA) is a process for the identification and resolution of customer complaints, nonconforming products, audit findings, safety problems, and even more. It consists of definition and identification of the problem and its root causes, and permanent actions to eliminate the problem and prevent it from coming back. The lessons learned must also be deployed to similar activities so we don't end up having to solve the same problem, or a similar one, more than once.

Areas Covered

• CAPA applies to a very wide range of activities in the quality management system, as opposed to only nonconforming products and customer complaints. It is also vital for internal and external audit findings, and outputs of the management review meeting. It can even be used on other Toyota production system wastes that do not involve poor quality if we treat as a problem any gap between the current state and a desirable future state. Inadequate CAPA for complaints, nonconforming products, and audit findings is meanwhile a major source of ISO 9001 and IATF 16949 (automotive) audit findings, and FDA Form 483 citations.
• AIAG's CQI-20, Effective Problem Solving, is an evolution of the excellent 8D (Eight Disciplines) approach and may well be the best CAPA system ever devised. Levinson Productivity Systems recommends this manual (available from AIAG) and has no financial interest in resulting sales.
• Simplified approach when full-scale CAPA is not necessary; this works when the problem (or opportunity) can be addressed by the process owner on the shop floor without any worries about the management of change (MOC) issue. MOC applies when seemingly innocent changes in a process can have undesirable side effects.