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Event	By	Thread/Post	Forum
New Post	ssz102 16th May 2012 09:47 PM	Determining Sample Size and Frequency for Features on Control Plans according with my experience, the size of sampling depends the type of product your production or how does the product are manufacturing? generally speaking, sampling 3---5pcs for cosmetic, and... (3,703 views, 7 replies)	FMEA and Control Plans
New Post	samsa 16th May 2012 07:43 PM	IEC 62366 vs. IEC 60601-1-6 - Has IEC 62366 now replaced IEC 60601-1-6? I went to the CENELEC web site and saw a Project: EN 62366:2008 with a date of withdrawal of 2010-12-01 and no replacement indcated. Then under Project: EN 60601-1-6 the 2010 edition was shown to be... (7,489 views, 18 replies)	IEC 62366 - Medical Device Usability Engineering
New Post	GEETA_DE 16th May 2012 07:36 PM	Excel Uncertainty Calculator wanted Does any one can help me with excelsheet to calculate the meteorological measurments uncertainty, also the model seperatly? Thanks (7,671 views, 9 replies)	Calibration and Metrology Software and Hardware
New Post	Miner 16th May 2012 06:52 PM	SPC Newbie looking for Excel Spreadsheet formula for a sample size of 40 components Is there a particular reason why you would want to create a rational subgroup that large? While subgroup sizes this large are possible, rational subgroups of this size are very rare. SPC... (81 views, 3 replies)	Capability, Accuracy and Stability - Process, Machine, etc.
New Post	DannyK 16th May 2012 06:15 PM	AS9101 Process Effectiveness Assessment Report/Nonconformance Record Review Modules I took the module training and found it clarifies the expectation for how the PEAR and Nonconformities should be filled out. It was a worthwhile training. (153 views, 1 replies)	AS9100, Nadcap and related Aerospace Standards and Requirements
New Post	Sidney Vianna 16th May 2012 05:45 PM	Traceability Requirements for Computer Hardware Equipment under ISO 13485 Have you had a chance to ask that very question to your TUV inspector? S/he HAS to identify the requirement for you. This sounds something that would apply to ISO 27001, rather than ISO 13485. (103 views, 1 replies)	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
New Post	v9991 16th May 2012 03:35 PM	What does your Internal Audit Reveal? current tally is as follows. overview percent NC to current procedures (28%) improvements (22%) insufficient/inadequate (17%) Repeat obs ... (439 views, 5 replies)	Internal Auditing
New Post	Hershal 16th May 2012 03:25 PM	ISO 17025 Compliance within an ISO 9001 Organization One or two other thoughts. Jennifer is correct that you need to watch specific requirements in both Sections 4 and 5. The specific revision list she mentioned is one, but there are many more. ... (1,119 views, 12 replies)	ISO 17025 and related Metrology Topics - Measurement Devices, Calibration and Test Laboratories
New Post	allan-M 16th May 2012 02:48 PM	How to Show "Date/time" Data Graphically in Minitab Please? one way is to create a column with say "1" in each row where you have a time. The scatter plot will show your irregular row of dots. You may have already got to this point. Then edit symbols to add... (88 views, 1 replies)	Using Minitab Software
New Post	v9991 16th May 2012 02:11 PM	Which improvement tool/approach do you adopt for driving Continuous Improvement? here are few quick references implied through 'etc...' TQM - Six Sigma... http://asq.org/learn-about-quality/continuous-improvement/overview/overview.html SPC - pareto - bar charts - 5W - fishbone... (206 views, 3 replies)	Quality Tools, Improvement and Analysis
New Post	v9991 16th May 2012 01:51 PM	Common Root Cause for Failures in Scaleup & Commercial (Validation) Batches current tally is as follows... inadequate/inaccurate design (25%) stability studies (25%) input controls (13%) inprocess controls-spec (13%) fp spec (13%) dynamic customer/market requirements ... (219 views, 2 replies)	US Medical Devices (21 CFR part 820)
New Post	Wes Bucey 16th May 2012 01:48 PM	I was assigned as Kaizen Leader for our MRB Area - Your advice appreciated I'm a big champion of "Lean" dating from even before I was a charter member of the "Advanced Manufacturing Interest Group" which was the precursor to the Lean Division of ASQ. In this case,... (257 views, 5 replies)	Quality Tools, Improvement and Analysis
New Post	v9991 16th May 2012 01:28 PM	The Most Cited Topics and Areas of FDA Audits Current tally is as follows. area percent CAPA (38%) Records - Documentation - Change Control (19%) Production & Process controls (13%) Medical Device Reporting (13%) Management (13%)... (216 views, 3 replies)	US Medical Devices (21 CFR part 820)
New Thread	England 16th May 2012 01:27 PM	Animal Tissue (Pericardium) Engineering Process Control Hi, Can someone describe a general description of the process control (what to control and how) of the engineering of animal tissue, that is from tissue (pericardium) from porcine there is a... (58 views, 0 replies)	US Medical Devices (21 CFR part 820)
New Post	MIREGMGR 16th May 2012 01:27 PM	Distribution of OBL Product - Does this constitute manufacturing? That's a common approach, especially in consumer products that use common AAA, AA, C or D type batteries under a removable plastic door, where the remove-strip can be fed out through that door. ... (257 views, 14 replies)	US Medical Devices (21 CFR part 820)
New Post	Jim Wynne 16th May 2012 01:23 PM	ISO/TS 16949 Cl 7.5.1 a) - Characteristics of the Product - Need Clarification The requirement applies to any stage of product realization where information about the product is needed in order to carry out the work. (134 views, 4 replies)	ISO/TS 16949 - International Automotive Quality Systems Standard
New Post	Bev D 16th May 2012 12:50 PM	Sample Size based on Process Capability Indices (Pp/Ppk)? Barbara - this one sounds like an urban myth. no direct knowledge of something is usually a sign that we are talking about the Yeti. I supppose one could come up with a 'safe' table for this... (146 views, 3 replies)	Capability, Accuracy and Stability - Process, Machine, etc.
New Post	iamtroll 16th May 2012 10:39 AM	Determining the "Detection" Number Component of the FMEA RPN I think that you have to use common sense and look at all of the components of detection. Then using whatever system of detection levels evaluation you use apply a number. Remember, this is not... (146 views, 3 replies)	FMEA and Control Plans
New Post	MIREGMGR 16th May 2012 10:25 AM	Sterilisation ISO 11135 EtO-in-a-Bag (Novel Non-Traditional EtO Sterilization) It's funny how timing works sometimes in the regulatory world. This morning, FDA's weekly Warning Letter report includes... (217 views, 6 replies)	Other Medical Device Related Standards
New Post	Marc 16th May 2012 10:18 AM	Do You HULU 2? new thread (or updated) You can get them but they are expensive, and these days most streams are encrypted. Expect to spend about US$6K for a 10 foot dish, accessories and installation. It's more of a hobby thing than... (274 views, 13 replies)	Cable TV, Internet Access and Telephone

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	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