is being presented by Bill White, Senior Consultant, with Quality System Strategies LLC and airs on Thursday, March 17th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Management of product risk is not addressed prominently either in the FDA’s Quality System Registration or in ISO 13485:2003. Nevertheless, in order to ensure the well being of customers and the company itself, each medical device company must incorporate product risk management concepts throughout its quality management system. The Global Harmonization Task Force issued a guidance document which provides an excellent starting point in identifying the processes that need to include risk management. However, going beyond the guidance document calls attention to both opportunities and pitfalls in product risk management.
This audio conference reviews senior management responsibilities and benefits related to product risk management. The speaker identifies the risk management principles to be incorporated throughout the quality management system, with particular emphasis on links between processes.
Showing posts with label quality manangement system. Show all posts
Showing posts with label quality manangement system. Show all posts
Friday, February 18, 2011
Wednesday, February 9, 2011
Correction and CAPA: What's the Difference?
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Thursday, March 10th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Do you know the difference between corrective action and preventive action? The difference between them is confusing because many practitioners don’t realize these terms have specific meaning in the quality profession. These two terms probably create more misunderstanding for quality professionals than any other pair of words.
There are two reasons for this problem. First, people tend to apply colloquial language without realizing they are defined technical terms. Second, corrective action prevents the recurrence of a problem, so the language leads us, incorrectly, to call it preventive action. With the term “correction”, the confusion can become a morass.
These two terms have clear meaning in a Quality Management System, and the formal definitions highlight the difference. This presentation uses the definitions found in ISO 9000:2005 to help attendees understand the terms, and illustrates the differences with examples that clarify each term.
Do you know the difference between corrective action and preventive action? The difference between them is confusing because many practitioners don’t realize these terms have specific meaning in the quality profession. These two terms probably create more misunderstanding for quality professionals than any other pair of words.
There are two reasons for this problem. First, people tend to apply colloquial language without realizing they are defined technical terms. Second, corrective action prevents the recurrence of a problem, so the language leads us, incorrectly, to call it preventive action. With the term “correction”, the confusion can become a morass.
These two terms have clear meaning in a Quality Management System, and the formal definitions highlight the difference. This presentation uses the definitions found in ISO 9000:2005 to help attendees understand the terms, and illustrates the differences with examples that clarify each term.
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