SMT007 Magazine

SMT007-Dec2019

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70 SMT007 MAGAZINE I DECEMBER 2019 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 sys- tem. 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, prod- uct quality, or service performance. Given the visibility and attention this brings to an organi- zation, 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 [1] in its summary description of CAPA: "The purpose of the corrective and preven- tive action subsystem is to collect informa- tion, analyze information, identify and inves- tigate product and quality problems, and take appropriate and effective corrective and/or pre- ventive action to prevent their recurrence. Ver- ifying or validating corrective and preventive actions, communicating corrective and preven- tive action activities to responsible people, pro- viding relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recur- Take Your CAPA to the Next Level With 8D Operational Excellence by Alfred Macha, AMT PARTNERS

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