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According to IATF 16949:2016 7.1.5.1.1 Measurement systems analysis
Statistical studies shall be conducted ...
Statistical studies shall be conducted ...
Peng Yuan
5h
1
3
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 ...
I would like to know if there any guideline on what to do in case there is a chance that we sent defective ...
Yosi Shiloni
13h
Duke Okes
12h
It will depend on the industry you're in, the related product risks, and any applicable regulations.
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5
I work in medical device so 21 CFR Part 820 and ISO13485 are some of my governing regulations and I am curious how you ...
Tom Hudson
3d
That depends on how you track your changes, releases, and deployments in the Design History File and the Device ...
1
9
Hey guys,
I work in a factory where our products are measured on many different machines. Do we need to make work ...
I work in a factory where our products are measured on many different machines. Do we need to make work ...
Ben Osburn
6d
Not necessarily. If the instructions are something that can be trained effectively, or are intuitive, then you ...
5
40
Hey Guys,
Does anyone have recommendations about how often product audits should be done? I'm thinking it should ...
Does anyone have recommendations about how often product audits should be done? I'm thinking it should ...
Ben Osburn
May '20
Duke Okes
May '20
Product return is certainly one consideration, since it let's you know (with some uncertainty) how often ...
Denis Devos
May '20
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
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
May '20
So you may want to consider doing some pre-shipment audits, and/or some process audits that focus on the controls ...
Patrick Bryant
25d
My default answer is that all supplier monitoring, including product audits, should be performed at a frequency ...
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7
Hi Everyone,
I currently work for a small team in a Class 2 Medical Device company and we are currently in the mist of ...
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
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6
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
2
15
Is there a way that this can be accomplished without signatures for proof of approval.?
Susan Young
May '20
Ver-Non Wakefield
May '20
If this is like things in the past, the registration and you logging in will flag the 1.2 credits.
Denis Devos
May '20
Hi Susan - Review and Approval can be accomplished several ways. It would begin with deciding who that approval ...
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What documents do I need to be aware of before I start translating our standards?
Brian Frye
May '20
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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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