Quality Management 2.0 Blog

ISO 9001:2008 Surveillance Audits

Posted by Mary McAtee on Dec 19, 2014 @ 11:06 AM

Old Dog, New Tricksold-dog-new-tricks

Last week was our annual ISO 9001:2008 surveillance Audit. Thousands of companies have depended on us for advice and support in achieving and maximizing the value of their registration efforts. It was to be expected that we would do well and we did. Lapses in compliance could not be blamed on ignorance of the requirements or not understanding what the auditor’s expectations would be. This was a particularly challenging year for IBS as a company. Siemens completed their acquisition of IBS and began the exciting but demanding process of integrating us into the “Digital Factory” Group. This integration resulted in new systems and processes to learn and master. The impact rippled through documentation updates, training requirements, Assessment criteria and almost every facet of our Quality Management System and business processes. We have been registered for over 15 years and we have enough Lead Assessors on staff to populate our own Registrar. It is easy to fall into a compliance rut, same process, same training, etc. This year under the leadership of a new CEO, who understood the value as well as the challenge of organizational change, we were encouraged to form teams to rethink processes and people. Everyone in the organization moved out of their comfort zone to accept new responsibilities and to update and redefine almost every business and quality process. Utilizing the Management Review process we defined a framework of measureable quality objectives that mapped to our business plan goals for the year.

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Topics: 9001 Software

Emergency Drills for Environmental Health & Safety

Posted by Mary McAtee on Dec 04, 2014 @ 10:00 AM

It was a blessedly slow news cycle over the Thanksgiving holidays. Buried in the stories about the awful travel weather, the Turkey pardons and Black Friday craziness was a story that caught my interest here in New York. In New Jersey, land of chemical companies and refineries, a large producer of a highly flammable chemical, found themselves at the center of an unsettling news story. The company failed to provide local Emergency Services with information concerning the types of chemicals and the volumes produced at their facility, as mandated under New Jersey law. To make matters worse, they were also found to have failed to develop threat assessment and Risk Analysis records with supporting contingency plans. The plant in the story was located less than two miles from an Elementary school in a primarily residential area. They were ultimately fined four thousand dollars, the maximum penalty provided for under New Jersey law. Sadly, a spokesman for the state indicated that recent audits of New Jersey refineries and chemical producers uncovered many plants that were not meeting minimum requirements in these areas. In particular, the spokesman was concerned that the failure to notify local Emergency Services such as Fire and Police could lead to greater risk for first responders and less effective action in the case of an emergency event. Although not specifically mandated by law, the official pointed out that notifying regional Emergency Services, in addition to the closest local Fire and Police responders is a proven best practice. Regional Emergency Services will almost certainly be called upon for support in the event of an incident or emergency. Not understanding the chemicals produced, the likely resulting health and environmental threats to both the first responders and surrounding community puts everyone involved at greater and needless risk.

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Topics: EH&S

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


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

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