A formal correction process can help you better manage defect reporting and improve related workflow. Find out about the key elements for an integrated corrective and preventive action system, which includes continuous monitoring based on documented procedures, prioritization and risk management, verification and validation, and well-defined procedures.
The define, measure, analyze, improve, and control (DMAIC) framework is a business methodology that helps track down and mitigate the root causes of defects. Using DMAIC, you define a problem, measure performance of an area or process, analyze the process, make improvements based on the analysis, and control the amended process.
In today’s competitive environment, a majority of industries are facing increasing pressure from regulatory bodies, big players in their respective industries, the latest customer mandates, and internal quality initiatives to take a proactive and automated approach for managing non-conformity, process deviations, and critical observations in relation to the defined quality procedures across their supply chains.
Corrective action and preventive action (CAPA) is one such process that has become a formal requirement by regulatory authorities for categorizing the various types of issues a company may encounter. The CAPA process I describe is based on the define, measure, analyze, improve, and control (DMAIC) framework, which can improve supply chain performance considerably by containing critical-to-quality problems, including:
- Nonconformity incidents, which are deviations from processes and procedures that get detected during audits (audits can be conducted internally or by external regulatory bodies)
- Process-related incidents resulting from an internal or external audit at a supplier premise
- Complaints from customers