Latest activity
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Jjohncharles replied to the thread Environmental Monitoring - Incubation of Plates.If you would like to do dual incubation I would have an APC count at day 3 (at which point you would stop counting bacteria) and a Y&M...
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Bev D reacted to Randy's post in the thread Corrective Action for Supplier that Quality is not up to expectation. What is the best course of action? with
Like.
Probably 99% of what you need you can get free off the internet by going to www.osha.gov and just looking. Right now, based on your... -
GGolfman25 replied to the thread IATF 16949 QMS in OEM.My opinion. Your doing it backwards? First, not 100% sure what you classify as OEM, but it doesn't sound automotive -- so why are...
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Miner replied to the thread IATF 8.5.2.1 Traceability.Does your traceability work in both directions? For example, if a customer has an issue with the product can you: Trace it all the way... -
Randy replied to the thread Corrective Action for Supplier that Quality is not up to expectation. What is the best course of action?.Probably 99% of what you need you can get free off the internet by going to www.osha.gov and just looking. Right now, based on your... -
Sidney Vianna replied to the thread ISO 9001 News Tirelessly Improving the Brand Integrity of ISO 9001 - Working Group under ISO TC 176.I have no idea if ISO is financially supporting the work of the ISO 9001 Brand Integrity group, but, how much longer until they pull the... -
GGolfman25 replied to the thread Corrective Action for Supplier that Quality is not up to expectation. What is the best course of action?.So it sounds like the are a health and safety training/supply company? And for whatever reason they have missed some appointments, etc...
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BBig Jim replied to the thread Calibration Out of tolerance Condition report.Hopefully it is a rare event if you are managing calibration well. What I frequently see is that in such a rare event that the as...
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Zzumayin1 reacted to Mikey324's post in the thread New AIAG FMEA Process - How to complete the new format with Like.
Like I said before, i foresee people having to spend more time "making it look right" than adding meaningful content.
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Zzumayin1 reacted to Stevebod's post in the thread New AIAG FMEA Process - How to complete the new format with Like.
Ok so the new "process" has been published and I have (tried and tried again) to read it and understand it. So far 5+ reads later and I...
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Bev D replied to the thread Corrective Action for Supplier that Quality is not up to expectation. What is the best course of action?.If only you had said this in the first post. It doesn’t change the answer but teh earlier posts just wasted our time and yours...
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LLittlemiss replied to the thread IATF 8.5.2.1 Traceability.Thanks John!
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EI'm embarking on this thread as I've recently assumed the role of developing and implementing a Quality Management System (QMS) at an...
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Semoi replied to the thread Ppk study, using pooled standard deviation or not?.If you want to study the critical input parameters, multi vari charts are great. Nevertheless, before I plunge into a variational... -
TTidge replied to the thread Risk Analysis : 2 devices used in combination (hazard in device A, but harm using device B).I would recalibrate the thinking relating to Hazards. Hazards are sources of Harm. The Hazard is something elemental that must be...
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TTidge replied to the thread Service Tool application for Medical Device.If this tool is only going to be used by service personnel (who are presumably NOT the end users) I believe that the tool's software...
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TTidge reacted to yodon's post in the thread IEC 62304, Multiple software systems in one medical device with Like.
They're separate software items with separate risk profiles.
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TTidge replied to the thread Executed ISO 13485 Internal Audit template.As @yodon wrote: Another company's tracing to their internal documents won't help very much. If no formal tracing already exists and...
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TThat's rather (company) private information. Somebody may share, but I wouldn't expect it. The standard is pretty clear on what the...
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JJackie82 replied to the thread Corrective Action for Supplier that Quality is not up to expectation. What is the best course of action?.I need train my employees in Safety and Health. I hired this company to do so. They never show up or therefore lack of. No phone calls...