Root Cause Analysis and CAPA

ISO 9001:2015 assigns preventive action to clause 6.1 (Actions to address risks and opportunities) and corrective action to clause 8.7 (Control of nonconforming outputs), but the same process can be used for both activities; the only difference is that corrective action requires containment for an existing problem, while preventive action does not.

Poor quality is meanwhile only one of the Toyota production system’s Seven Wastes. The other six often hide in plain view, are present 100 percent of the time because they are built into the job, and can often be far more costly than poor quality. Off the shelf CAPA processes such as 8D (8 Disciplines) and AIAG’s Effective Problem Solving can address the other six wastes as well, thus comprehensively addressing risks and opportunities that are not related to poor quality while improving bottom line financial performance.

When formal CAPA is too complex for an issue that can be resolved on the shop floor by the process owner, a simplified and generally accepted approach can be used instead. This is Error Cause Removal (ECR) as depicted by J.F. Halpin’s Zero Defects or, with regard to occupational health and safety, hiyari hatto (“experience of almost accident situation”). These are generally initiated by workers or other relevant interested parties who are often in the best position to identify the risk or opportunity in question.

Areas Covered in the Session :

  1. CAPA has related traditionally to poor quality and its prevention, but it is applicable to any of the TPS’s Seven Wastes. The waste is treated like a nonconformance or, more specifically, a gap between the current performance state and an achievable performance state.* The CAPA process then identifies the root cause, and then implements, verifies, and deploys a solution in the usual manner.
    • It is to be noted that poor quality, the traditional focus of CAPA, is the only TPS waste that announces its presence. The other six are usually asymptomatic, are built into the job, and can often be far more costly than poor quality. As but one example, brick laying, as practiced for thousands of years, wasted 64 percent of the workers’ labor until the early 20th century.
    • Audit findings and management review outputs also can invoke the CAPA process to resolve the issues in question.
  2. All CAPA processes follow the plan, do, check, act (PDCA) cycle. These include:
    • The Ford Motor Company’s Team Oriented Problem Solving, 8 Disciplines (TOPS-8D)
    • AIAG’s Effective Problem Solving Process (CQI-20)
    • Toyota A3 process
  3. CAPA processes, like other processes, interact with other processes of the quality management system such as organizational knowledge (ISO 9001:2015 clause 7.1.6).
    • CAPA is in fact both a customer of, and a supplier to, existing Lessons Learned data bases.
    • CAPA is also a form of communication (ISO 9001:2015 clause 7.4) with workers and other relevant interested parties. Completed CAPAs become case studies that encourage imitation.
  4. Automotive Industry Action Group. 2018. CQI-20: Effective Problem Solving Guide is very similar in structure to 8D and adds some very important concepts.
    • Occurrence root cause: why the problem occurred
    • Escape root cause: why the problem was not caught (Detection issue in FMEA)
    • Systemic root cause: why the system or planning process did not identify these issues ahead of time
  5. Formal CAPA processes are, however, too complicated and time consuming for issues that can be resolved on the shop floor. The hatto (“recognition” or “awareness”), or error cause removal (ECR) process empowers front-line workers and others to identify potential quality, safety, or waste-related issues that the owner of the activity—the person with the resources and authority necessary to implement a solution—can deploy quickly.
    • Poka hatto (“awareness of opportunities for error”) relates to quality, although it encompasses root causes other than error as well.
    • Hiyari hatto (“experience of almost accident situation,” with hiyari meaning “incident”) relates to safety. This supports ISO 45001’s clauses on workforce participation, and also the right of employees to report safety issues.
    • Muda hatto (“recognition of waste”) means recognition of one of the other six TPS wastes. Workers might suddenly realize, for example, that a poor job design wastes 50% or more of their labor, or that scrap from machining operations along with consumables that are thrown away are forms of waste.
    • Hatto or ECR must consider, however, whether management of change (MOC) issues are involved. We never want our process to generate “new” or “changed” outputs for our internal or external customers without review for potential unintended consequences. Installation of a machine guard or error-proofing (poka yoke) device is unlikely to do this, but a change in materials, methods, machines, and so on could.

* AIAG’s CQI-20 uses the phrase, “what should be but is not being met.”

Attendees will receive a pdf copy of the slides and accompanying notes for the presentation, as well as an appendix that describes the 8D process.

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Everybody with CAPA responsibilities under ISO 9001:2015 or IATF 16949


William Levinson

William (Bill) 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 Pennsylvania 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.

Mr. 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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