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

Internal Assessments Best Practices in QMS

Posted by Mary McAtee on Jul 30, 2014 @ 11:00 AM

Old School Basics Utilizing High Tech Tools

 I would have to say that one of my favorite Quality activities is performing audits and training auditors.

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Topics: Quality Management Systems, Supply Chain Management, Quality Management Software, IBS America, QMS, CAPA, Mary McAtee, Audit Management, Corrective Actions and Preventive Actions, Supply Management Software, Auditing Software, ISO9001

Risk Management - Depend on your QMS Tools

Posted by Mary McAtee on Jul 02, 2014 @ 03:15 PM

Risk Management as a Career Tool

In the last blog I vented my most annoying compliance issue. This week I thought I would switch gears to my most amusing and embarrassing Quality moments.

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Topics: Quality Management Software, QMS, Mary McAtee, Corrective Actions and Preventive Actions, Risk Management Software, Risk Management, FMEA, Risk Assessment Software, Risk Assessment & Analysis

Using Meetings & Action Items to Monitor QMS Performance & Progress

Posted by Mary McAtee on May 07, 2014 @ 11:00 AM

Separating Contributors from Inhibitors: Using Meetings and Action Items to Monitor Performance and Progress

My Grandfather was a wise old farmer and he once made an observation I have never forgotten. We were at a barn raising. Yes, they do still actually have them in the part of Kentucky I come from. There was one young man, in particular, who seemed to be everywhere yelling instructions and searching through tool boxes and kegs of nails. My Grandfather pointed him out and said “Mary, never confuse motion with accomplishment”.  I quickly began to see what he meant. For all his exhortations and constant motion he was actually contributing nothing to the work taking place and was impeding progress in some situations.

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Topics: Quality Management Systems, Quality Management Software, QMS, CAPA, Mary McAtee, Corrective Actions and Preventive 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

Using your QMS to Empower Change Agents

Posted by Mary McAtee on Mar 24, 2014 @ 12:00 PM

“Give the people a light and they will see their way."  It was an unlikely source that brought this message home to me.

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Topics: Quality Management Systems, Quality Management Software, QMS, CAPA Software, CompliantPro, CAPA, Mary McAtee, Corrective Actions and Preventive Actions, Nonconforming Material Reports, NCMR

Quality Control Risks in Ignoring or Misreading Data...?

Posted by Mary McAtee on Dec 11, 2013 @ 11:00 AM

“Lies, Damned Lies and Statistics”

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Topics: IBS America, CAPA, Mary McAtee, Quality Assurance and Quality Control, Corrective Actions and Preventive Actions, Quality, Risk Management Software, Risk Management

Quality, Environmental and Health & Safety: Shaken not Stirred

Posted by Mary McAtee on Oct 16, 2013 @ 01:00 AM

It was the end of a long and frustrating day. My long-time colleague, Tisha Tomlinson and I were discussing the situation and trying to plan a strategy that met the needs of all involved parties, over dirty martinis with extra olives. We had spent the day with various Quality and EH&S personnel at one of our large, long-time clients. The company senior management was pushing to expand their product usage to include EH&S.

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Topics: Quality Management Systems, Quality Management Software, CAPA Software, CAPA, Tisha Tomlinson, Mary McAtee, Environmental Quality Management, Corrective Actions and Preventive Actions, Quality, Environmental Management System, Environmental Management Software, Environmental Compliance Software, EH&S, Environmental, Auditing Software

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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