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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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

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