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Quality Management 2.0 Blog

IBS America Exhibiting at AIAG Quality Summit - Sept 24 & 25

Posted by IBS America on Sep 12, 2014 @ 09:00 AM

2014 Quality Summit - Quality for Emerging Technologies

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Topics: Process Control, IBS America, Quality Assurance Management, Quality Assurance Software, AIAG

ISO 9001 as a Leadership Tool

Posted by Mary McAtee on Sep 04, 2014 @ 03:00 PM

Not long ago I wrote about people’s attitude and work ethic. I think Labor Day is a good time to take a look at how and why people extend themselves as part of how they approach their work.

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Topics: IBS America, Mary McAtee, Quality, quality management, Management Review, Management Review and Quality Objectives, Quality Objectives, ISO 9001, ISO 14000, ISO 13485

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

Quality Management Software Tools: An Evolution

Posted by Mary McAtee on Aug 22, 2014 @ 01:00 PM

It’s the end of summer and Labor Day is rapidly approaching. Many folks are squeezing in that last drop of vacation time before the kids head back to school. In that vacation mindset, let’s take a little lighter look at the quality profession.

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Topics: Quality Management Software, IBS America, QMS, Mary McAtee

Assuring Transparency in Your Quality Management System

Posted by Mary McAtee on Aug 06, 2014 @ 11:00 AM

Okay, I am officially outing myself as an old fart!  I knew what I wanted to talk about this week but no matter what title or description I came up with it screamed crotchety old person. The subject this week is personal investment and responsibility in one’s job. In my opinion, based on decades of walking shop floors and talking to all kinds of people, I’ve reached the following conclusions. In general people have a real and significant investment and pride of accomplishment in their job. This seems to remain a truism no matter how dirty, dangerous and thankless the job appeared to me. It was still “their job”. Formal education seemed to have little or nothing to do with the work ethic and pride of accomplishment demonstrated by the people I have encountered.

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Topics: Quality Management Systems, Document Management Solution, Quality Management Software, IBS America, Document Management Software, Mary McAtee

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

Overlooked Supply Chain Management Areas?

Posted by Mary McAtee on Jul 15, 2014 @ 04:00 PM

Mitigation and Contingency Controls

My colleagues and I have addressed various approaches to formal Risk Assessment. We have talked about the methodology for utilizing Risk Assessment tools for overlooked areas such as Supply Chain Management. We even conducted a webinar on best practice for assessing and managing risk.

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Topics: Supply Chain Management, IBS America, Mary McAtee, Risk Assessment Software, Risk Assessment & Analysis, Supply Chain Risk

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

Quality Compliance - Calibration Pet Peeves

Posted by Mary McAtee on Jun 25, 2014 @ 01:00 PM

Calibration and Metrology: Old School Ain’t All Bad

I started out my day with a quick chat with a colleague concerning a client project she is working on. It concerns calibration and I could hear the tone of a righteous lecturer creeping into my voice. After a very long career in Quality, I realized there are certain subjects that really get my blood pressure up and yank my chain. I began thinking about all the different Quality Compliance issues that have me talking to myself.

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Topics: IBS America, Mary McAtee, Gage Management, quality and compliance, calibration best practices

IBS 2014 User Forum – Grand Slam Event

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

Motivation, Education and Innovation

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Topics: Jim Verzino, IBS America, QSYS, Siemens’ SIMATIC IT, Michael Rennell, SPC, CAPA, Tisha Tomlinson, Mary McAtee, Daniel Schmitt, APQP, IBS User Forum 2014, IBS AG, Pete Bassney, ATS, Incoming and Outgoing Goods, V&V Toolkit for Life Sciences, Brian Kohn

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