Recognize that CAPA is arguably the most important process in the quality management system because so much else depends on it. CAPA is used to handle not only poor quality (the traditional application) but also audit findings, customer complaints, and outputs of the management review. It can even be deployed against the other six Toyota production system wastes by treating them as "nonconformances" or, more precisely, gaps between the current state and the desired level of performance

Know the organizational support requirements for effective CAPA. Apply the AIAG's CQI-20, Effective Problem Solving, to resolve quality issues, audit findings, and other problems, and take preventive action for trouble before it occurs.

The handout includes an appendix with an overview of the related 8D process.

Areas Covered

• CAPA is arguably the most important process of the quality management system because so much else depends on it.
    - CAPA has numerous supplier and customer processes including but not limited to the management review, segregation of nonconforming output, internal audits, and customer complaints.
     -  Inadequate CAPA and root cause analysis are leading sources of ISO 9001 and IATF 16949 findings, and FDA Form 483 citations.
• CAPA and the Seven Wastes; the CAPA process can be used against all seven Toyota production system wastes as opposed to just poor quality. This is achieved by treating as a "nonconformance" the gap between current performance and desired performance.
• Organizational support requirements for CAPA; this ranges from management support to worker buy-in and empowerment.
• AIAG CQI-20, Effective Problem Solving, is an outstanding off-the-shelf CAPA and root cause analysis process.
• The first step is to become aware of a problem, and there are numerous ways to do this. Employees can often be the best source of information about potential sources of poor quality, safety issues, and waste. Methods that support ISO 14001  and ISO 50001 can reveal material and energy wastes to which the CAPA process can be applied.
    - Establish an appropriate cross-functional team with the resources and authority necessary to address the problem.
    - Define the problem; this is perhaps the most important step.
    - Contain the symptoms to protect the customer. (This step can be omitted for the other six TPS wastes as there is no poor quality to contain.) Containment is not however correction because it doesn't get rid of the problem's root cause.
    - Identify the root causes, of which there are more than one. The traditional occurrence root cause is why the poor quality was generated, which could expose inadequate prevention controls as described in failure mode effects analysis. The escape root cause is why it reached the next internal or external customer (if it did), and this is related to the process detection controls. The systemic root cause is why the planning process did not identify the issue proactively.
    - Select and test the corrective or preventive action for the root causes, and make sure it works.
    - Implement the corrective or preventive action to make it permanent. The entire CAPA project should become part of the organization's knowledge (ISO 9001:2015 clause 7.1.6) and work instructions and FMEAs also must be updated.
    - Prevent recurrence by deploying the lessons learned to related processes and activities (read across/replicate process).
    - Recognize the team.
• Examples
   - CAPA for poor quality, drawn from Shigeo Shingo's Zero Quality Control. (Shingo did not use CQI-20 but the application is a real workplace example.)
   - CAPA for motion efficiency, as might have been applied to Frank Gilbreth's brick-laying example.
• Hatto (Japanese for recognition or sudden awareness) or Error Cause Removal (Halpin, 1966, Zero Defects) = employee-initiated CAPA resolvable at the shop floor level without the need for the formal CQI-20 or 8D process. This is for use when the assembly of a cross-functional team would be an unnecessary use of resources when the process owner can implement the solution himself or herself.
   - Hiyari Hatto ("Experience of almost accident situation") = a near-miss report that supports ISO 45001:2018 and OSHA requirements for near-miss reporting
   - Poka hatto = "almost error situation" or poor quality in general; somebody recognizes a situation that could result in poor quality.
   - Muda hatto = recognition of waste.
   - Two examples based on real-world situations will be provided.