Corrective and Preventive Action; Our Most Important Quality Process

Corrective and preventive action (CAPA) is a process of the quality management system that begins with the identification of a problem (or opportunity), goes through a series of steps including identification of the root causes and deployment and verification of a solution, and documentation and deployment of lessons learned. The deliverables include not only elimination of the problem at hand, or realization of the opportunity, but application of the best practices learned to related activities.

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Why Should You Attend:

Attendees will learn that CAPA applies to far more than its traditional context of poor quality. The same process is used to handle audit findings, outputs of the management review meeting, all seven Toyota production system wastes, and opportunities (in the form of gaps between the current state and desired future state) that are identified by employees and other stakeholders. The AIAG's CAPA process, which is related to the 8D (Eight Disciplines) process, is usable for all these applications and addresses all the root causes (occurrence, detection, and systemic) involved.

Areas Covered in the Webinar:
  • Role of CAPA in the quality management system
    • CAPA applies to a very wide variety of activities as opposed to just reaction to poor quality. These activities include internal audits, outputs of the management review meeting, and stakeholder-identified opportunities.
    • Inadequate CAPA processes are among the foremost causes of ISO 9001 and IATF 16949 findings, and FDA 483 citations. This is not surprising because, if the CAPA process is deficient, then audit findings and other problems will not be corrected which lead to additional quality system nonconformances.
  • CAPA is applicable to all seven Toyota production system wastes as opposed to just poor quality. Treat the other wastes as gaps between the current state and a desired future state, and the gaps as problems with root causes that can be identified and removed.
  • The organization and its culture must support CAPA.
  • AIAG's CQI-20, Effective Problem Solving, is probably the most up-to-date reference. It is roughly similar to the Ford Motor Company's proven 8D problem solving process. Both are easier to understand than Six Sigma's DMAIC (Define, Measure, Analyze, Improve, Control) process and apply to a much wider variety of problems.
  • CQI-20 process:
    • Awareness of the problem. This can come from many sources including quality audit findings, the management review process, or stakeholder observations as well as the traditional sources of scrap, rework, and customer complaints. Any gap between the current state and an ideal future state can initiate the CAPA process.
    • Form an appropriate cross-functional team.
    • Define the problem. It is vital to define the problem accurately.
    • Contain the problem. This applies only to poor quality, and its purpose is to protect the customer. Containment is however not correction.
    • Identify the root causes. The traditional one is the occurrence root cause, which is why the problem happened. This relates to failure of the prevention controls, if any, in failure mode effects analysis. The escape root cause is why the problem escaped without detection from where it was created (if it did), and this ties in with the detection controls in FMEA. The systemic root cause is why the planning process did not identify the issue in the first place.
    • Select and test corrective or preventive actions.
    • Implement the selected actions.
    • Prevent recurrence. Apply the lessons learned to similar activities throughout the organization. Read across/replicate process means application of the corrective or preventive action to similar processes and activities.
    • Recognize the team
  • Case studies:
    • Quality example adapted from Shingo, Shigeo. 1986. Zero Quality Control: Source Inspection and the Poka-Yoke System.
    • CAPA for waste motion adapted from Frank Gilbreth's work
  • Hatto ("sudden awareness") or ECR (Error Cause Removal per J.F. Halpin's Zero Defects) is a stakeholder-initiated CAPA that can often be resolved by the process owner without the need for a formal CAPA process. A hiyari hatto ("experience of almost accident situation") is for example an employee-initiated near-miss report that supports the ISO 45001 occupational health and safety management system as well as OSHA requirements.
    • Muda hatto (awareness of waste) case study adapted from Edward Mott Woolley's How Scientific Management is Applied. In this case, the solution was so simple and obvious, and could not have unintended consequences, that it could be deployed immediately and without the need for extensive study.
    • Hiyari hatto adapted from a more recent situation in which enteric feeding tubes were attached to intravenous lines by mistake, thus causing patient fatalities. The actual error-proofing solution was from the manufacturer, but the example shows how a nurse or other stakeholder might have initiated the process.

    Attendees will receive a pdf copy of the slides and accompanying notes, and also an appendix that provides a brief overview of the similar 8D process.

Who Will Benefit:
  • All ISO 9001:2015 and IATF 16949 users, including but not limited to manufacturing and quality managers, engineers, and technicians.
Instructor Profile:
William Levinson William Levinson

Principal Consultant, Levinson Productivity Systems

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.

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