Corrective and Preventive Action (CAPA): Key Process of The Quality Management System

Live Webinar

  • 90 minutes

Corrective and preventive action (CAPA) is arguably the most important process of any quality management system because the organization relies on it to resolve issues relating not only to poor quality (only one of the Toyota production system's Seven Wastes) but also audit findings, outputs of the management review meeting, customer feedback, and even opportunities for improvement. It is also a leading source of ISO 9001 and IATF 16949 findings, and FDA Form 483 observations. Inadequate CAPA will also result in uncorrected problems (such as poor quality and audit findings) which will result in even more audit findings and, of course, costs associated with the unresolved issues.

The Automotive Industry Action Group's Effective Problem Solving (CQI-20) is, however, a comprehensive, generally accepted, and extremely effective off-the-shelf CAPA process. This webinar will cover the highlights of CQI-20, and the handout (slides and notes) will also provide an overview of the similar 8D (Eight Disciplines) approach. Both can be deployed against not just poor quality, but also against any other waste (Muda) if the waste is treated as a gap between current and desired performance.

Join this session by expert speaker William Levinson,  the webinar will also offer a much simpler CAPA process that can be used by a process owner when the issue or opportunity can be resolved on the shop floor without the need for a cross-functional team or extensive root cause investigation.

Session Highlights

  1. Know how CAPA plays a central role in the quality management system as a customer and supplier of numerous other processes ranging from internal audit to the management review meeting, customer feedback, and opportunities for improvement.

  2. Know that CAPA is a predominant source of ISO 9001 and IATF 16949 findings, and FDA Form 483 observations. In addition, IATF 16949 adds CAPA and root cause analysis considerations that do not appear in ISO 9001:2015 but are nonetheless useful and important.

  3. CAPA is applicable to all seven Toyota production system wastes, as opposed to just poor quality, if we treat waste as a gap between current performance and potential or ideal performance. The same closed-loop problem-solving process applies in all cases, with the only exception being that containment is required only for poor quality.

  4. Organizational support requirements for CAPA will be covered.

  • An overview of AIAG's Effective Problem Solving process will be provided.

  • Awareness of the problem

  • Cross-functional team

  • Problem description

  • Containment (of poor quality) to protect the internal or external customer; containment is not, however, correction.

  • Root cause analysis: occurrence root cause (why it happened), the escape root cause (why it reached the next process if it did), and systemic root cause (why the planning process did not identify the issue in the first place)

  • Select and test a corrective action

  • Verify the action (ensure that it works)

  • Implement and standardize the improvement (read-across/replicate process)

  • Recognize the team

  • Simple examples will be provided.

  • Hatto (recognition or awareness, e.g. of poor quality, waste, or safety risk) or Error Cause Removal (ECR); a simple stakeholder-initiated process for issues that can be resolved by the process owner on the shop floor.

  • Management of change (MOC) issue; any change, such as a purported improvement, incurs risks of unintended consequences. This must be considered during the formal CAPA process (such as CQI-20 or 8D) and also the ECR process. If the proposed change might have unintended effects, the formal CAPA process with cross-functional input should probably be used.

Why You Should Attend:

The webinar will a much simpler CAPA process that can be used by a process owner when the issue or opportunity can be resolved on the shop floor without the need for a cross-functional team or extensive root cause investigation. This empowers the entire workforce (and other stakeholders) to contribute to the removal of all forms of waste from the organization, which enables lower prices, higher wages, and higher profits simultaneously.

Who Should Attend:

  • All ISO 9001:2015 and IATF 16949 users

  • Manufactures

  • Quality managers

  • Engineers

  • Technicians

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it at your convenience.

William Levinson

William Levinson

William A. Levinson, P.E., 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, TOC World 2004, and other national conferences on productivity and quality.

Levinson is also the author of several books on quality, productivity, and management. Henry Ford's Lean Vision is a comprehensive overview of the lean manufacturing and organizational management methods that Ford employed to achieve unprecedented bottom line results, and Beyond the Theory of Constraints describes how Ford's elimination of variation from material transfer and processing times allowed him to come close to running a balanced factory at full capacity. Statistical Process Control for Real-World Applications shows what to do when the process doesn't conform to the traditional bell curve assumption.

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