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Quality Management 2.0 Blog

Proactive Threat Assessment and Risk Mitigation

Posted by Mary McAtee on Nov 19, 2014 @ 12:46 PM

Contingency Planning

Proactive Threat Assessment and Risk Mitigation

Maybe it is because I am a New Yorker and lived through both 9/11 and Superstorm Sandy but I have an ingrained set of memories related to both events. I remember the scramble to pluck people off of the shoreline after the Towers had fallen. Thousands of people were crammed between the Hudson River and safety. Everything that floated and could get close to shore became a rescue vessel. It was the most massive water evacuation since Dunkirk. Among the responding vessels were ferries, tugs, recreational crafts, Police and Fire Boats not to mention everything that the USCG could deploy for the effort. With the exception of the professional rescue vessels, all the responders were pretty much making it up as they went along, yet they still managed to save thousands. What emerged from the experience was the realization that there needed to be coordinated rescue plans and training for urban water disasters. Less than a decade later that training and contingency planning effort was put to good use. Within three minutes of Sully hitting the water in what became known as the “Miracle on the Hudson” a very well-coordinated flotilla of ferries and working vessels were off-loading survivors. During Superstorm Sandy, no one expected a storm surge that would flood the Midtown and Battery Tunnels all the way to their ceilings. The same inundation of floodwaters swamped the basements of hospitals and other critical infrastructure facilities. The unforeseen consequence of 30 feet of floodwater in the basements of major hospitals and emergency planning facilities was the total submerging and destruction of emergency power generation equipment. Every critical building had redundant power generating equipment and thousands of gallons of fuel all of which was located in basements and sub-basements and were totally rendered useless and in many cases added fuel spills to compound the problem. Millions have been spent to relocate generators and fuel supplies to roofs and underground tank systems. These are just two cautionary tales about the failure to identify and mitigate risk.

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Topics: Risk Assessment & Analysis, risk mitigation

A Quality Management System for Those Who Served

Posted by Mary McAtee on Nov 11, 2014 @ 10:00 AM

Duty, Honor, Country

Veteran’s Day is this week. I always find myself thinking about family, friends and colleagues that have or are currently serving in our military. I think about my father John, a Merchant Marine in WWII and a Sargent in the Army during the Korean War. I think about my Father-in-law, Stanley who was a decorated B17 Navigator. His plane was called the Vargas Virgin and the photo of the smiling crew kneeling under the racy nose art and mission markings is a view back to another era. They were emblematic of the young citizen soldiers that have routinely gone above and beyond what anyone has a right to expect in defense of our freedom.

Yesterday, I watched an interview with John McDonald, the recently appointed Veteran Affairs Secretary.  He is a West Point graduate and was serving as CEO of Proctor & Gamble at the time of his appointment. The mindset and perspective he displayed during the interview really grabbed my attention. Perhaps the most thought provoking point in the interview was his very intentional decision to change Veterans Affairs nomenclature to begin referring to veterans as “customers”. This fundamental altering of the relationship between the veteran, the service providers and the actual way in which the Government and public view each other, realigns the balance and respect inherent in the exchange. I think this is a sensibility that McDonald brings to the office from his CEO leadership style at P&G.  

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Topics: quality and compliance

An Ocean Can’t Protect You from Compliance Fallout

Posted by Mary McAtee on Nov 05, 2014 @ 10:00 AM

REACH

There is a great book by a fellow named SQuire Rushnell called “When God Winks”.  He and I share prettyflaming_shots
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Topics: Compliance Software

Quality Assurance Documentation and Communication

Posted by Mary McAtee on Oct 30, 2014 @ 03:00 PM

Teams: Life’s Lessons

My CEO sent around an interesting email that centered around a couple of my favorite subjects; personal and peer responsibility and assessing one’s impact or lack of it on the greater company good. I think that more than money or recognition the most important and soul satisfying aspect of work for me is having an impact on the broader view and the ultimate outcome of situations.

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Topics: Quality Management Systems, Quality Management Software, Quality, quality management

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

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