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October 2012


Dennis Arter

Corrective Action and Preventive Action: What's the Difference?

by Dennis Arter
Independent Consultant and Trainer

This is a common question for many people, both inside and outside of the quality community. It periodically appears every few months in virtual discussion groups and electronic bulletin boards. The question is difficult because the concepts have evolved over several decades, without adequate explanation from the core standards and regulations.

A problem happened. It might have been a defective part, or an incorrect decision, or a sprained back. But it happened. That is called a "nonconformance" because an action or thing did not meet specified requirements.1 Those requirements may have come from a drawing, a safety plan, a standard operating procedure, or a supervisor's instruction. The principles of nonconformance control have been around since the early days of manufacturing. Nonconformance control is a system. It consists of three processes working in harmony:

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Janis Olson

Can You Use Automated Testing Tools as an FDA-Regulated Company?

by Janis Olson
Vice President of Quality and Regulatory Services, EduQuest, Inc.

Software test tools help development and testing teams verify functionality, ensure both the reliability and security of the software they develop, and investigate software bugs. Off-the-shelf tools are available for all stages of software development. Examples include static code analyzers, record and replay, regression testing, and bug tracking. Some software testing tool vendors offer an integrated suite that starts with the gathering of requirements and continues through software development and testing throughout the life of a project, including supporting the live system. Other vendors concentrate on a single part of the application development life cycle, such as just testing.

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Seth Mailhot

Five CAPA Tips that Help Ensure Compliance

by Seth Mailhot
Special Counsel, Sheppard Mullin Richter & Hampton LLP

Having been intimately involved in how the U.S. Food and Drug Administration ("FDA") inspects current Good Manufacturing Practice ("cGMP") requirements for nearly two decades, I find myself repeating certain things to companies. Most often, the issues I repeat relate to Corrective and Preventive Action ("CAPA") systems. CAPA systems are a focal point in FDA inspections precisely because they are the process that manufacturers follow in case something goes wrong. In the same way that a person's character may be understood by trial through adversity, quality system auditors and FDA investigators understand a company's operations through its CAPA system.

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Deborah Mackin

How to "Sell" Quality

by Deborah Mackin
Performance Strategy Consultant, New Directions Consulting

ASQ CEO Paul Borawski asked us to comment on the question, "How do you 'sell' quality to decision makers?" While everyone theoretically believes in the importance of quality, there are times when the demands of the customer cause the focus to shift to speed and cost. Probably many quality heads of departments have been asked to compromise quality requirements at some point to get product out the door. Others find that they have to "sell" the rationale for their very existence as quality departments, with leaders eager to cut costs on staffing for quality. Why do we need so much money for labor that doesn't make product/service? Why can't we just build quality into what we do, so quality auditors are unnecessary?

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RAPS
October 26-30, 2012, Seattle, WA

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Did you know that scientists levitate liquid in order to develop better pharmaceuticals? In a new development which on first glance resembles a storyline plucked from the pages of Harry Potter, researchers at the U.S. Department of Energy’s (DOE) Argonne National Laboratory, Illinois, have adopted a system of levitation in order to more effectively develop pharmaceuticals - no magic wand required.
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