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Marcelo Antunes
20th May 2013 02:09 PM

Revision of Brazilian GMP Regulation - RDC 16/13 (RDC 59 and Portaria 686)
It applies to all medical devices, including IVDs. The translation you have is wrong, "medical and diagnostic products for in vitro use" should be "medical devices and IVD medical devices". ... (702 views, 6 replies)

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Marcelo Antunes
20th May 2013 02:05 PM

IEC 62304 - 5.2.9 Verify Software Requirement
This is realted to a requirements engineering process, if you use a formal one, you probably is already doing everything the standards is requiring. If not (which seems to be your case), you need... (89 views, 3 replies)

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Boingo-boingo
20th May 2013 01:30 PM

Is there any "rate the auditor" done on Elsmar or anywhere else?
As AndyN mentioned, it depends on the number of audit days. While I agree with Jim Wynne's comment about not doing something not welcomed by your top management, I still believe that you could... (427 views, 17 replies)

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Sandy S
20th May 2013 01:14 PM

PFMEA (Process FMEA) Recommended Actions help
I have a question for anyone.... I ave recentley started a new company. When reviewing the FMEA it is terrible. We have things like wrong material with a 1 ranking.... as if it means nothing.. would... (202 views, 2 replies)

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Jim Wynne
20th May 2013 11:29 AM

Gage R&R (Repeatability and Reproducibility) for Dummies
You're welcome. Our own MSA guru Miner has posted comprehensive MSA information in a series of blog posts here at the Cove. It's a treatment of the subject you're not likely to find anywhere else. (23,430 views, 48 replies)

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Marc
20th May 2013 11:15 AM

New Folks - Please Take a Minute & Introduce Yourself/Say Hello! (8/2010 to TBD)
Welcome to Elsmar, Helen! (145,295 views, 793 replies)

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Hemanta Bhatt
20th May 2013 11:09 AM

From Quality to Business Excellence: A Systems Approach to Management
From Quality to Business Excellence: A Systems Approach to Management by Charles G. Cobb Good reading to understand how the various improvement models and management systems can be integrated to... (89 views, 0 replies)

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Sidney Vianna
20th May 2013 11:00 AM

Done... OHSAS 18001 registration
Congrats, Claes. For organizations such as yours, the upcoming universal adoption of the High Level Structure for the future versions of ISO Management System Standards, adding the likely... (93 views, 5 replies)

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Hemanta Bhatt
20th May 2013 10:49 AM

What is the role of the Six Sigma Black Belt?
Six sigma black belts play an important role in leading and nurturing six sigma program in an organization more at the operational level unlike the MBBs (master black belts) who generally play more... (586 views, 5 replies)

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Ninja
20th May 2013 10:23 AM

How do you introduce new hires to ISO 9001?
Both. "We use a QMS to make our business successful." Your best tool IMO is examples of not following the system and the negative consequences. It isn't about the audit, and it isn't even... (154 views, 6 replies)

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danielschaefer
20th May 2013 09:38 AM

Method Comparison Design Onput Sample Range Requirement
Well, I wrote this nice hypothetical that gave better insight to my question but it deleted when I accidently hit the mouse pad and then "backspace" sending my browser back a page. :( Lesson learned.... (124 views, 3 replies)

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gbcqc
20th May 2013 08:47 AM

Has anyone purchased their powerball tickets? 17 May 2013
I did not know there was such a thing as a trustworthy (any type) Lawyer.:lol::lol::lo l: (194 views, 8 replies)

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db
20th May 2013 08:45 AM

Delivering an effective and all inclusive EHS program in a Food company
EHS programs can be integrated into Hazard Analysis and Critical Control Points (HACCP) Prerequisite Programs (PRPs) and Good Manufacturing Programs (GMPs). Care must be given to ensure the integrity... (162 views, 2 replies)

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Sandy S
20th May 2013 08:42 AM

Draft of Elements of System FMEA
I have a question for anyone.... I ave recentley started a new company. When reviewing the FMEA it is terrible. We have things like wrong material with a 1 ranking.... as if it means nothing.. would... (428 views, 8 replies)

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Jim Wynne
20th May 2013 08:28 AM

Root Cause of Documentation Errors
These things boil down to human error of some sort, and the subject has been discussed a lot here. Here are a few of many threads: Nonconformity Caused by Human Error - How to make a Corrective... (548 views, 11 replies)

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Steve Prevette
20th May 2013 06:59 AM

How to measure Loosening and Tightening Torque (VDA 5 - MSA)
Torques can be verified, did it all the time on submarines. You torque the item (in this case a valve, in your case a screws) closed/snug direction. That value is read off of the torque wrench. ... (381 views, 4 replies)

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nurhakim
20th May 2013 03:17 AM

Is Air Burst test for oven treated condoms still required under ISO 4074?
Hi, I would like to know whether lot testing for air burst test for oven treated condom is applicable/required under ISO 4074. One of our customer mentioned that it is no longer required, however... (75 views, 0 replies)

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Jamie Ward
20th May 2013 03:15 AM

Medical Device Registration Requirements in Kuwait
Hi Shirley, i cam accross this document while researching. Acceptance by the MOH usually takes 2-4 weeks after application. Hope info helps you! (1,111 views, 4 replies)

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sreenu927
20th May 2013 02:11 AM

Current MRI Labeling requirement for European Union
Hi - Well, I am not expert at MRI things. However, I found afew for you as attached and as below links. http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM283578.pdf... (187 views, 2 replies)

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Stijloor
20th May 2013 01:34 AM

Recommended Sealing for Granite Top in a Clean Room
A Quick Bump! Can someone help? Thank you very much!! (135 views, 1 replies)