| Mar 20 | Nadcap - AC7102 - Heat Treament - TUS question We are HT certified (just info for the background). Point on AC7102 rev E 10.8.5.4 Are temperatures indicated by all furnace thermocouples recorded and included as part of the TUS record? (U11 & U13) We are in compliance with this requirement. Howev.. |
| Mar 20 | Sustainability audit per EICC supplier code of conduct I would like to ask people here about experience and learnings from a Sustainability audit based on the lines of EICC - Supplier code of conduct. We are up to taking one in the near future. |
| Mar 20 | Determining AQL and Sample Plan - Batch size is from 1-500 I recently been assign a project on finding a correct sample plan. My company does a 5% inspection once we get the part from our vendor from there we put it on the shelf. The problem I have is that we do not have much data at all besides the inspect.. |
| Mar 20 | SPC for Precision Machining Presentation- ASQ Central Kentucky Section SPC for Precision Machining - ASQ Presentation - Elizabethtown, KY March 25, 2010 The next ASQ Central Kentucky section meeting will be held on March 25, 2010,at the Stone Hearth restaurant in Elizabethtown, KY. The meeting begins at 6:00. The cost .. |
| Mar 19 | Calibration - Buying New Tools - How do you determine the next calibra.. Hi everyone, I am having a hard time finding anyone agree on how to handle calibration in general, so I thought I\'d turn to you. I\'m in precision machining, so we have all the standard stuff: calipers, thread/pin/height gages, micrometers, etc. Ques.. |
| Mar 19 | Wes Bucey Presents! April 15 ASQ1212 meeting On Thursday, April 15, 2010, I\'ll be substituting for the original main speaker with a new presentation. The location is in Buffalo Grove, Illinois, a suburb about 35 miles northwest of Chicago\'s Loop. If you are an ASQ member or interested in becom.. |
| Mar 19 | Measurement Systems Analysis - Miner\'s Blog Series Measurement Systems Analysis - Miner\'s Blog Series I wanted to bring attention to Miner\'s series of blog entries on MSA starting with Intro to Measurement System Analysis (MSA) of Continuous Data – Part 1: What and Why? Miner has been around h.. |
| Mar 19 | Permanent Part Identification - Parts produced during system over-ride First, my apologies if this thread started in the wrong area. I trust that our moderators will move it to the correct forum and chastise me in private. Now, on to the problem. In one of our processes, we do a laser welding operation of automotive co.. |
| Mar 19 | Job Lead: Chicago Based QA Manager with medical device experience We have a client who is looking for a Quality Manager with medical device experience (ISO 13485). |
| Mar 19 | Supplier PPAP Requirements - Level 3 or Level 4 When requesting a PPAP subission of a supplier, it is common that not all elements will apply. For example, if the supplier is not design responsible I would not expact a DFMEA submission from them. Even though the DFMEA will not be a part of the PP.. |
| Mar 19 | OnTime for Management in small Medical Software company? Thanks for a great forum, it´s a pleasure to read the threads and get inspiration for future improvements and implementations :). I\'m working in a small medical software company and implemented our quality management system last year without any pre.. |
| Mar 19 | Conformity Assessment - Informative FREE book by ISO & UNIDO A very informative and FREE book on conformity assessment is available from the ISO website. Be aware, it is almost 9MB in size. >>DOWNLOAD http://www.iso.org/iso/pressrelease.htm?refid=Ref1305 Quote: The fruitful partnership between ISO (Internatio.. |
| Mar 19 | MSA (Measurement System Analysis) on Multi-Phase Measurement System We run a test that has two steps. First, the sample is exposed to a controlled damaging influence for 16 hours. Second, a numeric (distance) measurement is made of how much damage the sample sustained. There are 2 of these distance measuring devices.. |
| Mar 19 | ISO 13485 in Hospital Central Sterilization and Clinical Engineering S.. Anyone have experience in implementing ISO 13485 in the central sterilization and clinical engineering services located in a Hospital? Regards Xavier Canals-Riera |
| Mar 19 | Knowledge of CAR/PAR Procedures - Should the entire organization know/.. Quick question for the Cove: Should the entire organization know/understand the 6 required procedures? CAR, PAR, Control of Doc/Rec, Internal Audit and MGMT Review? Our guys can find the procedure without issues but I am less than confident they und.. |
| Mar 19 | Small Variation in Thickness Measurements in Gage R&R Study When we are doing our GR&R studies, it ususally involves taking measurements on the thickness of the parts. The problem is that there is very little if any variation in the thickness. For example, .032 +/-.001 on the thickness, we might get from .03.. |
| Mar 19 | MDD 93/42 as amended by dir 2007/47 in force next week (21 mars) Dear all as you know on March 21, 2010 comes into force the amendment of Directive 93/42/EEC by the directive 2007/47/EC We are compiling a list of national rules in force, you can help us with those of your countries? SPAIN Directive MD 93/42/EEC a.. |
| Mar 19 | Setting Departmental Objectives - Product and Process design & develop.. Dear All, We are an ISO/TS 16949 company manufacturing Automotive Accessories and supplying to various OE, Export Market and After Market. We have to set departmental objectives inline with Business objectives of our organization. As a part of our o.. |
| Mar 19 | ISO 13485 Internal Audits Must Cover All Elements of QMS? Quick question relating to Internal Audits - does the audit schedule have to cover every element of our QMS? We have a small team looking to revamp our Internal Audit process as we feel our current process is barely fit for purpose. There are three .. |
| Mar 19 | RFID on a Medical Disposable Kit - Active Medical Device? Hello All, Attaching a passive RFID tag on a medical disposable kit, the group (disposable+RFID tag) becames an active medical device? What is your opinion? Thank you |