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Corrective and preventive action (CAPA) is probably the most important process of any quality management system (QMS). The CAPA process is a customer and supplier of many other processes including corrective action for poor quality, customer complaints, and audit findings, as well as actions to address risks and opportunities as identified by the management review meeting.
Inadequate CAPA is among the leading sources of ISO 9001 and IATF 16949 audit findings, and FDA Form 483 observations. It is in fact the foremost source of IATF 16949 findings. If CAPA for poor quality, customer complaints, and audit findings is ineffective, these issues will persist, findings will remain unclosed, and poor quality and customer satisfaction will continue.
The good news is however that the Automotive Industry Action Group's CQI-20, Effective Problem Solving, is a highly effective, authoritative, off the shelf 9-step process for CAPA. This webinar will focus on CQI-20 although the similar 8D (Eight Disciplines) process also has a long history of delivering proven results. Both processes can be used for preventive as well as corrective action and, just as importantly, they will work on any of the Toyota production system's Seven Wastes as opposed to just poor quality. They can also be used to handle occupational health and safety (OH&S) issues in support of safety in general and ISO 45001:2018. They apply to a wider variety of problems, and are easier to understand and use, than the Six Sigma DMAIC process.
CQI-20 and 8D might, however, be excessively complex for issues that can be resolved by the process owner on the shop floor. The Error Cause Removal (ECR) process from Halpin's (1966) Zero Defects offers an alternative for quality, safety, and waste-related issues that do not need the participation of a cross-functional team to resolve.
Attendees will learn and be able to describe the role of CAPA as the most important process of the quality management system, recognize how it can be deployed against all seven Toyota production system wastes as opposed to just poor quality, and gain a comprehensive overview of AIAG's Effective Problem Solving process. A simpler process for issues that can be resolved by the process owner on the shop floor also will be provided.
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