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                              October - December 2012

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?

I thought it would be enlightening to ask people who are in the quality field or function as organizational decision makers to address this question.

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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.

You only get what you want if you know what your requirements are for using the tool. Understand the native functionality of the tool when used "as is" and what needs to be configured or customized to get the performance you need. Document the tool's configurations and customizations. Review the native functions and the configurations and map them back to your intended uses to assure that you have covered all your needs.

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Cindy Fazzi

How to Build a Strong Supply Chain Team

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

In today's fiercely competitive global market, finding good suppliers that help create efficiencies, reduce cost, and support compliance efforts is critical to the success of manufacturers in regulated environments. Let's say you have found excellent suppliers, the question is: How do you maintain control over your suppliers and also keep good relations with them?

Walt Murray, MasterControl's director of quality and compliance services, cited some practical tips for guidance on supplier controls at the AdvaMed virtual seminar held on June 6. In his presentation on "Building Internal Support for Supplier Controls," Murray said there are two factors you must consider in deciding the appropriate level of supplier control.

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