Online Webinar 2019 - Live Webinar Clinical Trial Master File Compliance

Description
Corrective and preventive action (CAPA) plays a central role in quality management systems, and not just in its traditional function of removing the root causes of poor quality. The same CAPA process can be used to address audit findings, outputs of the management review meeting, customer complaints, and even actions to address opportunities as well as risks. The Automotive Industry Action Group's CQI-20, Effective Problem Solving, is a proven off-the-shelf CAPA process that can be easily integrated into a quality management system, as can the related 8D (Eight Disciplines) process.
Why Should You Attend
CAPA is arguably the most important process in a quality management system, and it is the primary source of audit findings in ISO 9001 and IATF 16949, along with FDA Form 483 observations for medical device companies. Inadequate CAPA, including failure to address all root causes of a problem as opposed to just the immediate root cause, will lead to unresolved quality problems, audit findings, and other issues which will lead in turn to quality system nonconformances. Effective CAPA will on the other hand resolve problems effectively and permanently, and even drive continual improvement by realizing opportunities as well as dealing with risks.
Learning Objective
Recognize the role of the CAPA process as a customer of, and/or supplier to, many other processes of the quality management system.
Know that ineffective CAPA is a principal source of ISO 9001 and IATF 16949 findings, and also FDA Form 483 Observations.
Recognize how the CAPA process is applicable to all seven Toyota production system wastes and not just poor quality. The CAPA process can play a central role in continual improvement by addressing opportunities as well as risks and problems.
Know the organizational support requirements for effective CAPA.
Apply AIAG's CQI-20, Effective Problem Solving, to any risk or opportunity.
Recognize the importance of identifying not only the problem's occurrence root cause (why the poor quality or other waste was produced) but also its escape root cause (how it reached the next internal or external customer) and the systemic root cause (why the quality management system did not anticipate it in advance).
Know the availability of a simpler worker-initiated CAPA process for issues that can be easily resolved on the shop floor without the need for a cross-functional team or other formal activity.
Session Highlights
Role of CAPA in the quality management system, including its supplier and customer processes. These include the internal audit process, management review process, and even continual improvement process as well as the traditional process for handling poor quality and customer complaints.
CAPA as an enormous risk (as a principal source of ISO 9001 and IATF 16949 findings) and opportunity, if used to its fullest capability, to drive continual improvement as well as resolve quality problems and audit findings.
"CAPA and the Seven Wastes." If we treat any of the Toyota production system's Seven Wastes as a gap between the current state and an ideal future state, and therefore as a "nonconformance," we can apply the CAPA process to all of them rather than just poor quality.
Organizational support requirements for CAPA including workforce engagement and empowerment.
The CAPA Process; AIAG's CQI-20, Effective Problem Solving
Recognize that problems often have three rather than one root cause. These include the traditional occurrence root cause (why the problem happened), the escape root cause (why it reached the next internal or external customer, assuming it was not caught at the point of origin) and systemic root cause, or why the quality system did not prevent it.
Many problems and opportunities are sufficiently simple to be resolved on the shop floor without application of the formal CAPA process (or a cross-functional team). The Error Cause Removal (ECR) process from J.F. Halpin's Zero Defects (1966) explains how this works, and the Japanese hatto ("sudden awareness or recognition") process works similarly.
It is vital to record the lessons learned to support organizational knowledge (ISO 9001:2015 clause 7.1.6) and deploy them to related processes (read across/replicate process, or best practice deployment).
Who will Benefit
Manufacturing
Quality engineer
Manager
Technician
Speaker Profile
William Levinson
Areas of Expertise: Statistical Process Control, Lean Manufacturing, Quality, ISO 9001, Design Of Experiments, Non-Normal Distributions, Quality Management Systems
William Levinson is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt. He holds degrees in chemistry and chemical engineering from Penn State and Cornell Universities, and night school degrees in business administration and applied statistics from Union College, and he has given presentations at the ASQ World Conference, ISO/Lean Six Sigma World Conference, and others.