Corrective and Preventive Action; Your Most Important Process

  • 14
  • August 2024
  • 10:00 AM PDT | 01:00 PM EDT

    Duration:  90  Mins


Basic & Advanced

Webinar ID


  • The importance of CAPA cannot be overemphasized as inadequate CAPA is a major source of ISO 9001 and IATF 16949 findings, and FDA Form 483 observations. ISO 9001 users also need to be aware that IATF 16949 adds requirements that do not appear in ISO 9001 but are extremely useful in reinforcing the CAPA process.
  • CAPA has a very wide range of internal and external supplier and customer processes such as, as but two examples, internal audits and the management review.
  • CAPA can and should be extended to the six Toyota Production System wastes that do not involve poor quality. The trick is to define any waste (or gap between the current and desired state) as a nonconformance or deficiency to which the CAPA process can be applied. The only difference is that the containment step is omitted when there is no poor quality to contain.
  • Organizational support requirements for CAPA will be covered.
  • AIAG's CQI-20, Effective Problem Solving
  • Awareness of the problem; can be initiated by stakeholders and also processes for the identification of waste
  • Cross functional team
  • Define the problem
  • Contain the problem to protect the customer, but containment is not correction.
  • Identify the root causes: occurrence, escape, and systemic
  • Select and test corrective actions
  • Implement the corrective action
  • Prevent recurrence. Deploy the solution to relevant processes that might benefit (Read across/ replicate process). Henry Ford (Today and Tomorrow, 1926): "…the benefit of our experience cannot be thrown away."
  • Recognize the team
  • Hatto ("sudden awareness or recognition" of poor quality, a safety problem, or waste) or Error Cause Removal (Halpin, Zero Defects, 1966) empowers relevant interested parties to initiate CAPA. If the solution is obvious and easy to implement, formal CAPA is not required but the solution should still become part of the organizational knowledge data base.
  • Attendees will receive an ECR process description and form they can modify to meet their needs.
  • Simple case studies will be provided
  • The appendix of the handout will provide an overview of 8D (Eight Disciplines) which is similar to Effective Problem Solving and also works very well.

Overview of the webinar

While ISO 9001:2015 assigns corrective and preventive action to clauses 8.7 and 6.1 respectively, the same process can handle both activities and support other ISO requirements such as the organizational knowledge data base. It can also be extended to exploit opportunities to remove waste or muda from the workplace. 

It is vital to recognize that poor quality (the traditional focus of ISO 9001:2015) is the only one of the Toyota Production System's Seven Wastes that makes its presence known. The other six are often asymptomatic, or lacking in symptoms. This means that the workforce must act proactively to identify them, which supports Actions to Address Risks and Opportunities.

The Automotive Industry Action Group's Effective Problem Solving process (CQI-20) is a highly effective form of the Plan-Do-Check-Act (PDCA) continual improvement cycle. The presenter regards it as superior to other approaches including Six Sigma's DMAIC approach. It can be used not only for poor quality but also other gaps between the current state of a process and an achievable or desirable future state. It includes definition of the problem, containment (in the case of corrective action), root cause analysis, testing and verification of actions to eliminate or prevent the problem, and standardization and best practice deployment of the solution. The completed project becomes part of the organizational knowledge (ISO 9001:2015 clause 7.1.6) and can be used as reference in the future. 

CQI-20 stresses that there are actually three root causes for any problem. The traditional occurrence root cause is why the problem happened. The escape root cause is why it reached the next internal or external customer (if it did). The systemic root cause is why the planning system failed to address it in advance. This is synergistic with process failure mode effects analysis (PFMEA) because the escape root cause is related to inadequate detection controls, and the occurrence root cause to inadequate prevention controls.

The hatto ("sudden recognition or awareness," e.g. of a safety or quality risk, or waste) or Error Cause Removal (ECR) allows employees (or other relevant interested parties) to initiate CAPA for potential safety or quality problems or, by implication, waste or muda. This may, for a sufficiently complex problem, require handoff to a formal CAPA process. If the problem can easily be solved at the shop floor level, though, this is what happens and the solution becomes part of the organizational knowledge resource. Examples will be provided to illustrate how this works.

Who should attend?

Manufacturing and quality management professionals, quality practitioners, and executives responsible for the quality management system

Why should you attend?

Corrective and Preventive Action (CAPA) is arguably the most important process in the quality management system because so much else depends on it. Its numerous internal and external customer processes include not just poor quality but also customer complaints, internal audit findings, outputs of the management review meeting, and even opportunities for improvement as identified by internal and external stakeholders.  

Inadequate CAPA and root cause analysis is a predominant source of ISO 9001 and IATF 16949 findings as well as FDA Form 483 observations, and also warnings which are escalations for inadequate responses to observations. In addition, inadequate CAPA will result in unresolved audit findings and other unresolved deficiencies that will, in turn, lead to even more findings and, even worse, the consequences of the unresolved issues. Effective CAPA will on the other hand resolve the issues and also address their systemic root causes to prevent recurrence throughout the organization.

Formal CAPA is not required for issues that can be resolved by the process owner on the shop floor. The webinar will include a simple procedure for doing this.

Faculty - Mr.William A. 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 is also the author of several books on quality, productivity and management, of which the most recent is The Expanded and Annotated My Life and Work: Henry Ford's Universal Code for World-Class Success.

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