27 February, 2014 by James Jardine, Marketing Communications, MasterControl Inc.
Quality guru Ken Peterson has dedicated his career to helping organizations like Abbott Laboratories, Kodak, and IBM devise better quality management solutions that allow them to maximize efficiency and resolve problems faster. In the first of a three-part series of complimentary webinars available from MasterControl, Peterson breaks down quality management into three distinct segments: quality events, issue review, and corrective and preventive actions (CAPA). You can view the free webinar in its entirety here. No registration is required to access the recorded presentation—just click and play!
The opening section of the first webinar features Peterson discussing the handling of quality events—how to take an occurrence (such as a customer complaint, a nonconformance, an audit finding, etc.) and determine the most efficient way to resolve the issue.
The webinar provides a demonstration of how a quality event should pass through a risk-based issue review process for the best possible outcome. Peterson explains how different situations require different actions and how the impact and frequency of quality events can dictate what actions should be taken. A correction, for example, is an immediate fix that can be made to eliminate an existing undesirable situation. For issues that can’t be resolved immediately, he explains how a corrective action—step(s) that can be taken to eliminate a root cause and prevent the reoccurrence of problems—may be required. Peterson also delves into preventive actions, the processes of identifying and eliminating the causes of potentially problematic occurrences.
The webinar goes into detail about what regulatory bodies refer to as “closed loop” quality management systems for identifying and eliminating problems. Such systems require all issues and events to be carefully tracked and addressed during the entire life cycle of a product. Ken thoroughly explains the closed loop system by outlining the benefits of a “three loops in one” quality system. The first loop in such a system is closed at the initial level; the undesirable situation is immediately resolved. The second loop of this system, as Ken demonstrates, refers to an issue review process where data is gathered and assessed and a determination is made as to whether or not the event should be pushed through the CAPA process. The third loop comes into play when the issue review escalates to a CAPA where the event is investigated, root causes are determined, actions are implemented, and there is closure of the event after appropriate effectiveness checks have been made.
The complimentary webinar is an exceptional resource that can help companies ensure their quality actions are successful and devise CAPA systems that ultimately result in safer and
better products on the market. Best of all, the free recording is only a click away!
Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.
James Jardine is a Marketing Communications Specialist for MasterControl Inc. He has a bachelor’s degree in journalism from the University of Utah and is based in MasterControl’s headquarters in Salt Lake City, Utah.