CAPA: Your Most Important Process
Duration: 90 Minutes
Corrective and Preventive Action (CAPA) is a key process of the quality management system, and arguably the most important one. It is useful, and even mandatory, for far more than its traditional application to poor quality. It is also useful for the resolution of audit findings, actions on outputs of management review meetings, resolution of customer complaints, and realization of opportunities. The Automotive Industry Action Group's CQI-20, Effective Problem Solving is a generally accepted and highly effective off-the-shelf CAPA process that should meet and exceed any organization's needs.
1. Know the central role of CAPA in the quality management system and its interactions with other processes of the quality management system.
2. Know that inadequate CAPA is a principal source of ISO 9001 and IATF 16949 audit findings, and FDA
3. Form 483 observations and warning letters.
4. Know how CAPA applies to all seven Toyota production system wastes and not just poor quality.
5. Know and apply the elements of AIAG’s Effective Problem-Solving process. (Purchase of the manual from AIAG is highly recommended.)
6. Recognize the need to look for three rather than one root cause of any problem: the occurrence root cause (why it happened), the escape root cause (how the problem escaped to an internal or external customer), and the systemic root cause (why the planning process didn't anticipate the problem in advance). This goes well beyond the traditional approach of looking only for an occurrence's root cause.
• This is synergistic with process failure mode effects analysis (PFMEA) because the escape root cause relates to a deficiency in the process’ detection controls and the occurrence root cause to a deficiency in the process’ prevention controls. Removal of the root causes should usually update the PFMEA to reflect new or improved controls.
7. Deploy a separate process for problems that can be easily resolved on the shop floor by the process owner. The Japanese hatto (“recognition or awareness” of a problem or opportunity) and identical Error Cause Removal processes are available off the shelf.
8. The handout will include an appendix with an overview of the related 8D (Eight Disciplines) process; this is very similar to CQI-20.
2. Know that inadequate CAPA is a principal source of ISO 9001 and IATF 16949 audit findings, and FDA
3. Form 483 observations and warning letters.
4. Know how CAPA applies to all seven Toyota production system wastes and not just poor quality.
5. Know and apply the elements of AIAG’s Effective Problem-Solving process. (Purchase of the manual from AIAG is highly recommended.)
6. Recognize the need to look for three rather than one root cause of any problem: the occurrence root cause (why it happened), the escape root cause (how the problem escaped to an internal or external customer), and the systemic root cause (why the planning process didn't anticipate the problem in advance). This goes well beyond the traditional approach of looking only for an occurrence's root cause.
• This is synergistic with process failure mode effects analysis (PFMEA) because the escape root cause relates to a deficiency in the process’ detection controls and the occurrence root cause to a deficiency in the process’ prevention controls. Removal of the root causes should usually update the PFMEA to reflect new or improved controls.
7. Deploy a separate process for problems that can be easily resolved on the shop floor by the process owner. The Japanese hatto (“recognition or awareness” of a problem or opportunity) and identical Error Cause Removal processes are available off the shelf.
8. The handout will include an appendix with an overview of the related 8D (Eight Disciplines) process; this is very similar to CQI-20.
1. CAPA is a major source of ISO 9001 and IATF 16949 findings, and FDA Form 483 observations.
2. Supplier and customer processes of the CAPA process such as management review, internal audit, and external customers.
3. Application of CAPA to all seven wastes of the Toyota production system allows the removal of these wastes with consequent bottom-line financial and performance-related results.
4. CAPA requires organizational support as depicted in Appendix A of CQI-20. An overview of this will be provided.
5. CQI-20 is arguably more effective than Six Sigma’s DMAIC process and will work on a much wider range of problems and opportunities.
6. CQI-20 is a nine-step process, the elements of which will be provided.
7. The hatto (awareness or recognition), or Error Cause Removal (ECR) process is a much simpler process for problems or opportunities that can be resolved on the shop floor by the process owner.
8. Examples will be provided.
2. Supplier and customer processes of the CAPA process such as management review, internal audit, and external customers.
3. Application of CAPA to all seven wastes of the Toyota production system allows the removal of these wastes with consequent bottom-line financial and performance-related results.
4. CAPA requires organizational support as depicted in Appendix A of CQI-20. An overview of this will be provided.
5. CQI-20 is arguably more effective than Six Sigma’s DMAIC process and will work on a much wider range of problems and opportunities.
6. CQI-20 is a nine-step process, the elements of which will be provided.
- The process begins with awareness of the problem. We can expand widely its range of applications by treating any gap between current performance and desired performance as a "nonperformance" thus allowing its application to any of the seven wastes of the Toyota production system. (Visser, Chris. 8D Problem Solving Explained, refers to a performance gap in this context.)
- Containment (step 4) is required only for poor quality.
- Look for three root causes. The escape root cause is why the problem reached an internal or external customer (assuming that it was not caught by the process that generated it). The occurrence root cause is why the defect was generated, or why there is some other gap between current and desired performance. The systemic root cause is why the planning process did not identify the issue previously.
- Select, test, and implement a corrective or preventive action. Apply the action to the related processes that might benefit from it (read across/ replicate, or best practice deployment).
7. The hatto (awareness or recognition), or Error Cause Removal (ECR) process is a much simpler process for problems or opportunities that can be resolved on the shop floor by the process owner.
8. Examples will be provided.
A good CAPA process can make the quality management system, and an inadequate one can break it. Deficient CAPA is a leading cause of ISO 9001 and IATF 16949 audit findings, as well as FDA Form 483 observations, and warning letter citations for medical device companies. The latter are escalations of observations, and deficient or absent CAPA is cited frequently in them. This comes as no surprise because, if the CAPA process is not adequate, comprehensive corrective action including identification and removal of root causes will not be taken for quality issues, audit findings (and failure to resolve an audit finding is itself a quality system nonconformance), customer complaints, and other issues. Actions to address risks and opportunities will also fall short. A good CAPA process will, on the other hand, help to not only resolve problems but also to drive continual improvement and contribute to the bottom line.
- Managers.
- Executives.
- Engineers, and others with responsibility for the quality management system.
- Also, all manufacturing, users of ISO 9001 and IATF 16949, and FDA-regulated industries. Services also might benefit.
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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