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Event	By	Thread/Post	Forum
New Post	Stijloor 20th November 2009 08:15 PM	Eliminating Cosmetic Issues and Customer Complaints What's acceptable and/or repairable is decided by your customer. There may be a standard available that includes criteria for defects and their acceptance, but unless you and your customer have... (462 views, 12 replies)	Problem Solving, Root Cause and Failure Analysis
New Post	True Position 20th November 2009 08:08 PM	Who has dropped their AARP membership because of its stand on healthcare? Why are you spending all this time attacking Michael Moore? I do not see people using his movies as a justification for their beliefs. (872 views, 61 replies)	<b>Controversial</b> Discussion Topics
New Post	John Martinez 20th November 2009 08:02 PM	What should be changed in the ISO 9001:2014 Standard? Been there done that. ANSI SPPE - worked off a quality manual. Each company that came in wanted OUR manual to state what THEY wanted to say. Problem is when two different clients wanted two... (6,662 views, 118 replies)	ISO 9001 - Quality Management Systems Standard
New Post	John Martinez 20th November 2009 07:56 PM	Validation - The process or product? ISO 9001 Clause 7.3.6 Nope. Boat. I use that light hearted example to explain the two to newbies. A concrete life preserver is what you get from a low cost registrar. :topic: (446 views, 12 replies)	ISO 9001 - Quality Management Systems Standard
New Post	Stijloor 20th November 2009 07:44 PM	Lean Simulation Game Jack, Thanks for your thoughtful response. :agree: I have a colleague who provides "Lean" training and consulting and may be able to identify a good source. Stijloor. (73 views, 5 replies)	Lean - Lean in Manufacturing and Services
New Post	John Martinez 20th November 2009 07:35 PM	ISO 9001:2008 Permissible Exclusions I'd run this one past your registrar's technical department. If I were your auditor, that's who I would contact for a decision. I'd hate to make this call and have another auditor come behind me... (882 views, 36 replies)	ISO 9001 - Quality Management Systems Standard
New Post	John Martinez 20th November 2009 07:25 PM	What is the appropriate number of NC (Nonconformances) for this case? This is another "can of worms". I disagree in total that any organization put KPI's on number of non-conformances. It is counter productive. ALL FINDINGS should be viewed as an opportunity to... (461 views, 22 replies)	Nonconformance and Corrective Action
New Post	Stijloor 20th November 2009 06:54 PM	"Gated Conditions" - Separation of automotive and non-automotive product There may be a translation issue here. What is the Dutch term for "Gated Conditions?" I have never heard about this requirement. Stijloor. (171 views, 4 replies)	ISO/TS 16949 - International Automotive Quality Systems Standard
New Post	Stijloor 20th November 2009 06:35 PM	What are the main reasons to update data in MDS? I do not know about the IMDS, but when you transfer production lines, you must re-PPAP. Stijloor. (58 views, 1 replies)	RoHS, REACH, ELV, IMDS and Restricted Substances Related Regulations
New Thread	mmantunes 20th November 2009 06:27 PM	Interesting article - Analysis of Risk: Are Current Methods Theoretically Sound? There´s an interesting article in the October edition of MDDI - Analysis of Risk: Are Current Methods Theoretically Sound?. I´ve read it once but will need a second read to fully have an... (37 views, 0 replies)	ISO 14971 - Medical Device Risk and Hazard Control
New Thread	Juan Dude 20th November 2009 06:24 PM	Google Offers Peek at Operating System, a Potential Challenge to Windows MOUNTAIN VIEW, Calif. — Google began lifting the veil on its planned Chrome operating system on Thursday, but it said that computers powered by the software would not be available for a year. The... (35 views, 0 replies)	Computer, Cell Phone and Internet News
New Post	Bev D 20th November 2009 06:23 PM	Plotting Cpk as Function of Measurement Event no.... what are you trying to learn or accomplish or demosntrate? my suggestion would be for you to go to 'first principles' and understand what process control and process capability are all... (101 views, 8 replies)	Capability, Accuracy and Stability - Process, Machine, etc.
New Post	Micked 20th November 2009 06:22 PM	Seeking thoughts on using BOTH FTA (Fault Tree Analysis) and FMEA I was just a humble engineer at the time, using common sense. We brought in Dev Raheja as a risk management guru (he's of Indian descent :D). I guess he is retired now. His book Assurance... (299 views, 17 replies)	ISO 14971 - Medical Device Risk and Hazard Control
New Post	Micked 20th November 2009 06:10 PM	Risk Analysis of Software - ISO 14971:2007 Getting back to the original post... IMHO validation can never be a Risk Control Measure, you have to design some protective measure in there up front. As a last resort you can always use labeling... (1,129 views, 18 replies)	ISO 14971 - Medical Device Risk and Hazard Control
New Post	Marc 20th November 2009 06:08 PM	ISO 9001 Audit Checklist Excel .xls Template The differences are so small that I don't see a problem using a check list for the 2008 version. Just remember there are different types of internal audits. Compliance to the Standard is just one... (8,143 views, 10 replies)	Excel .xls Spreadsheet Templates and Tools
New Post	Marc 20th November 2009 06:04 PM	Internal Audit Check List that Parallels the Standard? The purpose of the internal audit plays a part in this. Sometimes in an internal audit they may want to do a Compliance to the Standard type of audit. What is used to audit in any audit is... (7,090 views, 28 replies)	Internal Auditing
New Post	Jennifer Kirley 20th November 2009 05:49 PM	Bad news/good news day Dr. Kirley sez (I'm not a doctor but I still say it) to have chicken soup. I heard a news story once about how a team of doctors and scientists studied the effects of chicken soup. They couldn't... (71 views, 3 replies)	Coffee Break and Water Cooler Discussions
New Post	mmantunes 20th November 2009 05:16 PM	Medical Device Registration Process in Brazil - Anvisa No, as i said before, devices under RDC 24 (cadastre) are exept from the need to send the certificate in the registration petition. This applies (RDC 25) to class II and IV devices, IVD devices of... (3,348 views, 32 replies)	ISO 13485 - Medical Devices - Quality Management Systems
New Post	bobdoering 20th November 2009 04:56 PM	Anyone seen Metrology Improvements (P/T, GR&R) as Six Sigma Projects? It is hard to really assign a value of replacing bad data with meaningful data - and a solid analysis of the MSA for a situation may be doing just that. You might create data that shows you are... (47 views, 2 replies)	Six Sigma
New Post	Marc 20th November 2009 04:02 PM	VDA 6.3 Audit Evaluation Sheet Are you looking for a VDA 6.3 compliance audit example? (78 views, 3 replies)	VDA Standards - Germany's Automotive Standards

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The Juran Trilogy	The Deming PDCA Cycle	QMS Implementation	FMEA Information	APQP Information
Auditing Information	8-D Problem Solving	Statistics	Error Proofing (Poka Yoke)	Brainstorming
Identifying Waste	Pull Systems	Lead Time Reduction	Planned Maintenance	Quick Setup
Discovering Change	Process Capability - Cp vs. Cpk	Histogram Animation	Process Loop Animation	Taguchi Loss Function
		Fishbone / Cause and Effects Animation