Corrective and Preventive Action (CAPA) plays a central role in quality management systems. Its customer and supplier processes include far more than just control of nonconformances; they also include customer feedback, audit findings, the management review, and even more. Inadequate CAPA is a predominant source of ISO 9001 and IATF 16949 audit findings, and FDA Form 483 observations. Inadequate CAPA leaves problems unresolved which leads in turn to even more audit findings as well as waste associated with the problems in question.
The Automotive Industry Action Group’s (AIAG’s) CQI-20, Effective Problem Solving, is however a recognized, off-the-shelf, and highly effective CAPA process that can address all seven Toyota production system wastes, as opposed to just poor quality.
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. MD3370
Areas Covered in the Session :
- CAPA is arguably the most important process in the quality management system because resolution of issues related not only to poor quality but also audit findings, customer complaints, opportunities for improvement, and inputs and outputs of the management review meeting depend on it.
- Inadequate CAPA and root cause analysis is a predominant source of ISO 9001 and IATF 16949 audit findings, and FDA Form 483 observations.
- 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.
- This includes a culture of problem-solving.
- Awareness of the problem; this can be extended to the other six TPS wastes as well
- Cross-functional team
- Definition of the problem
- Containment of the problem; containment is not, however, correction.
- Identify the root cause(s): (1) Occurrence root cause: why the problem occurred. (2) Escape root cause: why the problem was not caught. (3) Systemic root cause: why the system or planning process did not identify these issues ahead of time
- Select and test the corrective action(s)
- Implement the corrective actions
- Prevent recurrence of the problem. This includes deployment of the lessons learned to related processes that might benefit from the knowledge.
- Recognize the team
- Simple examples will be presented.
- 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 is an occupational health and safety near-miss report. 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. If MOC is an issue, the project must be handed off to the formal cross-functional CAPA process which assesses changes for unintended consequences.
- Simple examples will be presented.
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 Departments
- Manufacturing Departments
- Engineering Departments
- Production Departments