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Corrective and preventive action (CAPA) is a process of the quality management system which, like other processes, has suppliers (other processes of the QMS), inputs such as corrective action requests and audit findings, a series of clearly defined activities, outputs, and customers. Its deliverables (outputs) include identification of a problem's root causes, corrective or preventive actions to suppress or disable the root causes, and organizational knowledge (ISO 9001:2015 clause 7.1.6) that allows deployment of the lessons learned to related activities.
Corrective and preventive action (CAPA) is likely to be the most important process of any quality management system (QMS) because so many other activities depend on it. These include not just the traditional processes for handling poor quality, customer complaints, and audit findings but also outputs of the management review meeting and stakeholder-identified risks and opportunities.
Inadequate CAPA is a predominant source of ISO 9001 and IATF 16949 audit findings, and also FDA Form 483 observations. The good news is however that the Automotive Industry Action Group's CQI-20, Effective Problem Solving, and the related Eight Disciplines (8D) process, are proven off-the-shelf CAPA processes. They will work on waste (muda) other than poor quality as well as OH&S issues. They are easier to understand and apply than Six Sigma's DMAIC and work on a wider variety of problems.
When CQI-20 and 8D are too complicated for a simple issue—we don't have to convene a cross-functional team to decide to put a guard on a machine or move parts closer to the work station so the employee doesn't have to walk to get them—the much simpler Error Cause Removal (ECR) process can be used. ECR is often initiated by a worker or other relevant interested party, and it empowers everybody to identify risk and opportunities to drive continual improvement. Its application to OH&S in the context of near-miss reporting (hiyarihatto, "experience of almost accident situation") supports ISO 45001:2018's requirements for workforce participation in the OH&S management system, and supports OSHA requirements as well.
1. Supplier and customer processes of CAPA; the numerous processes of the quality management system that supply inputs and receive outputs from CAPA.
• Example: the internal audit process is a supplier of audit findings and observations to the CAPA process, whose resulting outputs are deliverables (inputs) for the management review of audit status reports.
• Example: the management review may itself initiate CAPA for risks or opportunities.
2. CAPA is a leading source of ISO 9001 and IATF 16949 findings, and FDA audit 483 observations.
3. CAPA is usable against all seven Toyota production system wastes and not just poor quality. All we need to do is treat the gap between the current performance state and a desirable future performance state as the problem or nonconformance.
4. Organizational support requirements for CAPA
5. Effective Problem Solving process per AIAG CQI-20. (The appendix of the handout provides an outline of the similar 8D process.)
• Recognize that there is a problem (awareness)
• Organize a suitable cross-functional team
• Define the problem; this is mandatory to ensure that the process addresses the real issue as opposed to a symptom or the wrong issue
• Contain poor quality (if poor quality is involved) to protect the customer
• Identify the problem's root causes, of which there are up to three.
(1) The occurrence root cause is why it happened.
(2) The escape root cause is why it reached the next internal or external customer, if it did.
(3) The systemic root cause is why the planning process did not identify the issue ahead of time, e.g. through failure to apply lessons learned from a related activity
• Identify, and test for effectiveness, corrective or preventive actions
• Implement the actions
• Prevent the problem's recurrence (or occurrence, if the action is preventive) not just for the process or activity in question, but for similar processes and activities throughout the organization. This is read across/replicate process, or best practice deployment
• Recognize the team to teach and encourage others to use the CAPA process
6. Error Cause Removal (ECR), as described by Halpin's (1966) Zero Defects, is a very simple CAPA process for issues that can be resolved on the shop floor by the process owner without the need for a cross-functional team or extensive root cause identification. Simple case studies will be given.
Attendees will receive a copy of the slides and accompanying notes, and also a simple draft ECR process they can modify to meet the needs of their own organization.
The webinar will provide a comprehensive overview of formal corrective and preventive action (CAPA) and also a much simpler process for issues that can be resolved by a process owner on the factory floor. Both processes are applicable not only to poor quality but also occupational health and safety (OH&S) and the other six Toyota production system wastes (muda).
ISO 9001:2015 and IATF 16949 users, including but not limited to manufacturing and quality managers, engineers, and technicians.
Years of Experience: 30+ years
Areas of Expertise: Statistical Process Control, Lean Manufacturing, Quality, ISO 9001, Design Of Experiments, Non-Normal Distributions, Quality Management Systems
William Levinson 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, ISO/Lean Six Sigma World Conference, and others.View all trainings by this speaker