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effective root cause analysis and corrective action process

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aggressively enforced. In order to be successful in this <strong>process</strong>, it is necessary to implement thefollowing steps:• Establishment <strong>and</strong> maintenance of documented procedures for implementing <strong>corrective</strong><strong>and</strong> preventive <strong>action</strong>;• Corrective or preventive <strong>action</strong> taken to eliminate the <strong>cause</strong>s of actual or potentialnonconformities to a degree appropriate to the magnitude of the problems <strong>and</strong>commensurate with the risks encountered;• Implementation <strong>and</strong> recording of changes to the documented procedures resulting from<strong>corrective</strong> <strong>and</strong> preventive <strong>action</strong>;• Effective h<strong>and</strong>ling of customer complaints <strong>and</strong> reports of product nonconformities.• Investigation of the <strong>cause</strong> of nonconformities relating to product, <strong>process</strong> <strong>and</strong> qualitysystem, <strong>and</strong> recording the results of the investigation;• Determination of the <strong>corrective</strong> <strong>action</strong> needed to eliminate the <strong>cause</strong> of nonconformities;• Application of controls to ensure that <strong>corrective</strong> <strong>action</strong> is taken <strong>and</strong> that it is <strong>effective</strong>.Effectiveness of RCCA <strong>process</strong> must demonstrate compliance with each of these requirements.Following the <strong>process</strong> described herein <strong>and</strong> documenting these steps will allow demonstrating thiscompliance. All of these requirements are met within a <strong>root</strong> <strong>cause</strong> <strong>corrective</strong> <strong>action</strong> <strong>process</strong> thataddresses:• Containment <strong>action</strong>s;• Problem definition;• Root Cause Analysis;• Possible Solutions <strong>and</strong> the selection of the right one(s);• Assessment <strong>and</strong> Effectiveness of the RCCA <strong>process</strong>.Root Cause Analysis <strong>and</strong> Corrective Action <strong>process</strong> are absolutely essential for the improvement ofthe quality management system <strong>and</strong> increasing the quality of the final product or service.REFERENCESLee N. V<strong>and</strong>en Heuvel et al., (2010), Root Cause Analysis H<strong>and</strong>book: A Guide to Efficient <strong>and</strong> EffectiveIncident Investigation, Third Edition ABS Consulting.Andersen B <strong>and</strong> Fagerhaug T., (2009), Root Cause Analysis: Simplified Tools <strong>and</strong> Techniques, SecondEdition, Milwaukee, American Society for Quality Press.Rooney J. <strong>and</strong> Heuvel N., (2004), Root Cause Analysis For Beginners, Quality Progress, American Societyfor Quality, July 2004, 45-53.Ingram S. T., (1997), QS-9000 Corrective <strong>and</strong> Preventive Action System, Annual Quality Congress, Orl<strong>and</strong>o,FL, Vol. 51, No. 0, May 1997, 463-469.Performance Review Institute, (2006), Root Cause Corrective Action Booklet, Pittsburgh, PAG. Dennis Beecroft, et al., (2003), The Executive Guide to Improvement <strong>and</strong> Change, Milwaukee, AmericanSociety for Quality Press.48

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