Quality Management 2.0 Blog

Common CAPA Pitfalls

Posted by Mary McAtee on Aug 27, 2014 @ 01:00 PM

One quality process that every company has but few are truly comfortable with is their Corrective and Preventive Action Program. People view it like the in-law that protocol demands you invite to Thanksgiving Dinner that no one really wants to deal with who doesn’t know when to leave. The biggest issue seems to be consensus about when and why to create CAPA's. Another inhibitor of effectiveness appears to be how CAPA's are viewed by senior management.

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Topics: IBS America, CAPA Software, CAPA, Mary McAtee, Corrective Actions and Preventive Actions, Corrective Action Software, corrective and preventative actions

The Impact of Context on Nonconformance, Corrective Actions and Complaints (CAPA)

Posted by Mary McAtee on Apr 23, 2014 @ 11:00 AM

“Who’s on First”: The Value of Clear and Accurate Communication

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Topics: IBS America, CAPA Software, CAPA, Mary McAtee, Corrective Actions and Preventive Actions, Corrective Action Software, Nonconforming Material Reports, NCMR, corrective and preventative actions

Data Overload: Obscuring the Forest with Trees with Risk Analysis

Posted by Mary McAtee on Apr 04, 2014 @ 11:00 AM

Statistical Analysis, Trending and Risk Assessment Pitfalls

One of the few gifts of being older is a sense of perspective. Interestingly it cuts both ways. For every situation where I am impressed by the immediate availability of Business Intelligence data I am equally perplexed by the seemingly conscious efforts of organizations to ignore or misread the data. There are all sorts of data collection systems that can keep a finger on the pulse of a process and the quality and risks associated with the outputs.

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Topics: IBS America, QSYS, Mary McAtee, Corrective Actions and Preventive Actions, Document Management Systems, Corrective Action Software, Risk Management Software, Risk Assessment & Analysis, corrective and preventative actions

How Education is Ruining Your Compliance Initiatives...

Posted by Jim Verzino on Aug 08, 2013 @ 02:52 PM

How Education is Ruining Your Compliance Initiatives - And What You Can Do About It

Over the last several weeks we dove into a series on “3 Keys to a Successful Integrated Management System,” and one of the sections focused on cooperation. A key part of cooperation is letting creativity flourish. Today, we will dive into both creativity and collaboration (in our school days known as cooperation).

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Topics: Document Management Solution, Jim Verzino, IBS America, Document Management Software, CAPA Software, CAPA, Corrective Actions and Preventive Actions, Document Management Systems, Compliance Software, document control, corrective and preventative actions, compliance

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