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Root Cause Analysis and CAPA using 8-D Problem Solving Method


OVERVIEW While preventive action is now covered by ISO 9001:2015 clause 6.1, Actions to address risks and opportunities, no change to existing CAPA processes is necessary to fulfill this requirement. These processes can also be extended to address opportunities by treating gaps between the current and desired states as 'non-conformances' that the CAPA process can easily address.
WHY SHOULD YOU ATTEND
Corrective and Preventive Action (CAPA) has been a mandatory element of quality management systems for decades. Identification and elimination of a problem's root cause makes it unnecessary to solve the same problem more than once, and preventive action makes it unnecessary to deal with a quality or safety issue even once. The only difference between corrective and preventive action is, in fact, the need for containment of a quality problem that has already occurred.
AREAS COVERED
• ISO 9001:2015 and IATF 16949 require CAPA, and CAPA plays a key role in deployment of ISO 9001 clause 6.1, Actions to address risks and opportunities. Risks and opportunities, however, include not only the traditional ones related to poor quality but also the Toyota production system's other six wastes. These also are removable by the CAPA process.
• Ford's Team Oriented Problem Solving, 8 Disciplines (8D) method (TOPS-8D), AIAG's similar Effective Problem Solving process, and Toyota's A3 process use similar structured plan-do-check-act (PDCA) approaches to identify and then remove a problem's root cause.
LEARNING OBJECTIVES
The webinar will stress the superiority of engineering controls (error-proofing, poka yoke) over administrative controls that rely on worker vigilance for effectiveness.
WHO WILL BENEFIT
Quality and manufacturing engineers and technicians, and everybody with CAPA responsibilities under ISO 9001:2015 or IATF 16949.

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