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Operational Excellence: Take Your CAPA to the Next Level With 8D

Quality professionals understand that the strength of an organization’s quality system can be determined by reviewing the corrective and preventive action (CAPA) system that has been established. ISO auditors and regulatory inspectors will assess an organization’s CAPA to evaluate the effectiveness of the quality system. Customers often use the mechanism of a corrective action request (CAR), which is part of the CAPA system, as the mechanism to request for a supplier to address a recurring quality issue that affects on-time delivery, product quality, or service performance. Given the visibility and attention this brings to an organization, it is an opportunity to shine by making the CAPA system best-in-class. And how can you do that? By using 8D methodology.

Before I introduce the 8D approach, it is important to understand the requirement of CAPAs. Every quality systems standard—from ISO 9001, AS9100, ISO 13485, and TS 16949 to regulatory clauses established by the FDA or other government agencies—defines corrective action requirements in their standards. One of the best definitions is provided by the FDA in its summary description of CAPA:

“The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures. One of the most important quality system elements is the corrective and preventive action subsystem.”

To read this entire column, which appeared in the December 2019 issue of SMT007 Magazine, click here.