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Risk Assessment - What Could Possibly Go Wrong?

Posted by Mary McAtee on Oct 22, 2014 @ 04:00 PM

Like pretty much everyone else with a pulse I have watched the sad spectacle of Ebola marching into my living room on every news outlet. Much like an anvil hitting a cartoon character repeatedly, I am gob smacked by the cascading series of lousy decisions made at every level.

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Topics: CAPA, APQP, Risk Management Software, FMEA, Risk Assessment & Analysis

Business Intelligence and SPC Reporting Traps

Posted by Mary McAtee on Oct 08, 2014 @ 11:00 AM

Metric Killers: Avoiding Traps in your Business Intelligence SPC Reporting

Gathering and reporting on data and trends can be an invaluable tool if it is approached with a solid foundation for the results.  You might think that any data report is better than nothing. In reality poorly structured reports with shaky and shady source data can waste valuable time and damage your credibility. Here are just a few data traps to avoid when gathering metrics:

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Topics: SPC, CAPA

FMEA as a Business Process Tool

Posted by Mary McAtee on Oct 03, 2014 @ 12:00 PM

More and more industries are discovering what the Automotive and Heavy Equipment companies have known for years. The same tools they use and trust to define, quantify and control risk around manufacturing design and associated processes can be used for defining, analyzing and controlling risk for any business process. Investing in the education, structure and discipline of a Design and process centric approach to developing and refining your company’s strategy to almost anything you need to do reliably and repeatedly can yield huge and immediate benefits.

If the entire concept of Design and Process FMEAs (Failure Mode Effects Analysis) is new to you here is the Cliff Notes explanation of the basics.

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Topics: IBS America, CAPA, Mary McAtee, APQP, FMEA

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

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