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Peng Yuan 12770
 According to IATF 16949:2016 7.1.5.1.1 Measurement systems analysis
Statistical studies shall be conducted ...
Yosi Shiloni 15642
Hi there,
I would like to know if there any guideline on what to do in case there is a chance that we sent defective ...
It will depend on the industry you're in, the related product risks, and any applicable regulations.
Tom Hudson 15618
I work in medical device so 21 CFR Part 820 and ISO13485 are some of my governing regulations and I am curious how you ...
That depends on how you track your changes, releases, and deployments in the Design History File and the Device ...
Ben Osburn 14981
Hey guys,

I work in a factory where our products are measured on many different machines. Do we need to make work ...
Not necessarily. If the instructions are something that can be trained effectively, or are intuitive, then you ...
Ben Osburn 14981
Hey Guys,

Does anyone have recommendations about how often product audits should be done? I'm thinking it should ...
Ben Osburn May '20
Duke Okes 1670 Duke Okes May '20
Product return is certainly one consideration, since it let's you know (with some uncertainty) how often ...
Duke makes great points.  But if you want this to truly be an audit, it can be treated as such.   You can create a ...
Ben Osburn 14981 Ben Osburn May '20
Thanks guys. We really only do product audits when there are returns now, but the problem is we get multiple returns ...
Duke Okes 1670 Duke Okes May '20
So you may want to consider doing some pre-shipment audits, and/or some process audits that focus on the controls ...
My default answer is that all supplier monitoring, including product audits, should be performed at a frequency ...
Vicki Ong 14896
Hi Everyone,

I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of ...
Vicki Ong May '20
David Zubrow 3279
Hi, I just want everyone to be aware that the Software Division is a voting member of the US Technical Advisory Group ...
David Zubrow May '20
Susan Young 857
Is there a way that this can be accomplished without signatures for proof of approval.?
Susan Young May '20
If this is like things in the past, the registration and you logging in will flag the 1.2 credits.
Hi Susan - Review and Approval can be accomplished several ways.  It would begin with deciding who that approval ...
Brian Frye 14044
What documents do I need to be aware of before I start translating our standards?
Brian Frye May '20
Brian Frye 14044
Our organization is looking to translate a couple of our standards.  What governing documents or guides should I ...
Brian Frye May '20

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