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Could someone please chime in and share their approach for conducting hazard analysis for off-the-shelf / commercial-off-the-shelf software? What level of detail do we need to include? Our current hazard analysis matrix contains the following fields (columns): Hazard number, Hazard (actual hazard), Hazard Origin (e.g., clinical, device component, tool, etc.), Severity, Occurrence, Risk Index, Control Measure Type, Risk Control/Mitigation, Software Hazard? (Hazard that can result from software malfunction or can be mitigated by the device built-in software), New Hazard? (New hazard introduced by mitigation  (Yes / No)), Mitigation Occurrence, Mitigation Risk ...
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I am currently attempting to schedule an Audit for one of our critical suppliers per our QMS procedures. This particular supplier is indicating they will charge us an "On Site Audit Service Fee". $6800 minimum ($6000/auditor + $800 admin fee). I have conducted suppler audits for years and never came across a fee-to-audit program. Have others come across this? And, how have you handled this scenario. Thanks in advance for any insight and feedback.
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Faith on Our Society

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​ My wife and I were among the victims of Hurricane Harvey after our house was flooded. In the suffering, we have seen so many people stretched out their hands to help. A group of volunteers from the SUNRISE club came to our house, to cut off the lower part of the sheetrock walls on the first floor. People from all places brought food and other necessities to every damaged house. My neighbors opened up their doors to take us in. My colleagues offered help to clean up the mess. Businesses demonstrated their good wills as well. Air Canada rescheduled our flight twice without charge when we stuck in Canada, and the rental car company did not charge a higher ...
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hello ASQ community, I found an ambiguity in the question and answer from CSSGB Study Guide In Part III: Measure Phase (Section E: Measurement and analysis (MSA)), Question no. 78 - Which of the following is a measurement system analysis (MSA) term for variation in measurement when measured by two or more appraisers multiple times? a. Calibration b. Stability c. Repeatability d. Reproducibility Correct Answer is d but answer given on page 63 is c Kindly confirm if such mistakes are not made when checking our exams. Best Regards, Mustafa Pasha
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Mentor Program

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I have found mentor programs to be great at not only reducing negative turnover, but also creating a "safe-haven" for associates to discuss quality issues and corrective actions. I am looking to design my own and was wondering if anyone has an example they could share?
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In supply chain management, there are many people involved like supplier, manufacturer, distributer, retailer and customer, which become a very big network. Is it possible to implement the lean sigma tools in supply chain management
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Hello, I have read in an article that ISO 9001 standards will be revised for every five years and were last revised in 2015. There may be lots of new changes to the standards which all the organizations need to meet in order to get ISO certified. So how do all the companies get updated with the new changes and how long does it usually take to migrate their quality management system to the new edition of the standard ? Giri Sai Jagadish Mahamkali Graduate Student, University of Central Missouri, USA
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Announcing an ASQ Canada quality conference in Ottawa, ON, Canada from Sept. 25-26, 2017 Featuring speakers/seminars from the pharmaceutical, biomedical and healthcare sectors. Please check out the website: www.conference2017.asqottawa.ca Thank you, Cathy Campanaro
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Looking for Product Warranty Software- with strong Quality Data Features My company currently uses a warranty database designed for customer service only. It is good for tracking returns but doesn't have a very good reporting structure for quality improvement. We collect all returns and also keep a separate database on a excel spread sheet to create quality reports. This is very tedious and time consuming. I am looking for a new database that can combine and produce real time charts by customer, products, defect categories etc... a more quality focused vs. customer service focused database.
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Hello, I will be very thankful for your information about; As a quality manager, Is it a good option to reduce the quality of a packaging material to reduce the cost of a food product? Thanks!!! Monalisa Biswas Graduate Student, USA.
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Hello, I will be very thankful for your information about: T ools аnd techniques does the process of Quаlity Plаnning include? Thanks!!! Monalisa Biswas Graduate Student, USA.
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Finding your company way

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I have been thinking about why many lean and six sigma programmes struggle to gain traction. We all know the methods work, you only have to look at people like Toyota and GE to see that. What do they have that others are missing. I have an idea of what causes many of the problems, I would be interested in your views. Most businesses chase cash investment to grow, sometimes they need cash investment just to survive. At the same time, they deem change to reduce, time, resources and cash used by existing processes too expensive, too difficult or unsustainable! This seems counter productive. If we now look at how many improvement projects immediately ...
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Being as how there is power in numbers and President Elect Trump is obviously a fan of social media, wouldnt it be great if the transition team is barraged with messages to promote the Baldrige Award in his Inauguration speech? If they got a few thousand of the same message, it might garner some attention It might also be worth showering the Dept of Commerce nominees with contacts to get them to add fuel to the fire, these are the nominees: Wilbur Ross as Secretary of the U.S. Department of Commerce and Todd Ricketts as Deputy Secretary of Commerce. I've already done this. The sight I used to submit my suggestion was here: https://apply.ptt.gov/yourstory/ ...
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"No I Won't Do That!"

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Noun 1. the telling of lies , or false statements; untruthfulness: From boyhood, he has never been good at lying. Synonyms: falsehood , falsity , mendacity , prevarication . Antonyms: truth , veracity . Adjective 2. telling or containing lies; deliberately untruthful; deceitful; false: a lying report. Synonyms: deceptive , misleading , mendacious , fallacious ; sham , counterfeit . Antonyms: true , candid , actual , correct , accurate , trustworthy ...
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So it has been a while since the last post but today starts a new day and a New direction. I will be working to setup the Workshops for developing and writing procedures based on Risk assessments. There is a major push to get your procedures written from a risk based thinking process, something I have been training personnel to do since 2009. 2017 will be a busy year for many companies. Many will be setting up shop again in the USA because the new President is pushing for lo wer corporate taxes and a small business friendly environment. There will be many small businesses looking to get Quality Management staff in place and ISO 9001:2015 certification ...
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Hello Everyone, I would be obliged on your information about: Influence of the Location & Nationality on Quality Management. Thank you for your valuable time, Shubham Mogal Master Student, German
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Three Simple Questions...

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A behaviour I suspect many lean six sigma mentors have seen with new belts is paralysis by analysis. Newly qualified, with access to powerful statistical analysis software and on their own for the first time, their first reaction is to conduct every statistical test they can think of, working on the principle that they are looking at the data from every perspective. What they are actually doing is in part showing off their new found skills and in part showing off their unconscious incompetence. That is not to say they are incapable, only that they lack experience. When mentoring new belts I always start them out with three simple questions. The reason for these ...
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Preparing for an upcoming ASQ Certification Exam? Concerned that your Statistics skills might be a bit rusty? The Mid-Hudson Chapter has a 2-day seminar just for you! Preparing for the Statistics Content on ASQ Exams November 8 & 9, 2016, 8:30 5:00 Dutchess Community College, Poughkeepsie, NY Are you preparing to take any of these exams? CQE, CQI, CQIA, CQPA, CQT, CRE, CSSBB, CSSGB, CSSYB, CMQ/OE If so, then you know that a significant portion of each of these exams is devoted to your mastery of many different areas of statistics. If its been too long since your last college stats course, or if you just dont feel ...
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A lecture by G. H. Watson

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An informative and wonderful lecture "The Future of Quality" been presented by Gregory H. Watson, previous ASQ Chairman, and one of most contributor of today quality management practices. Dr. Watson at the middle, Dr. Ayed, SQC Chairman on the left and myself on the righ
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A model: Culture of Quality Factor (CQF) (c) This is a TQM Services (c) developed concept for determining what level a company has achieved as a Culture of Quality. It is arguably a controversial model many quality management people will debate the merits of developing a formula to rate an organization's culture of quality. But since it is a requirement in all Quality Manuals as an objective, i.e. to establish a Culture of Quality an organization must be able to clearly state with evidence their Culture of Quality. So what makes a Culture of Quality? Is a culture of quality a mind set? Is it a Motto Do it right, the first time.? Is it ...
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