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Basic Risk based thinking questions


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Can someone help me understand the following question we received on a questionnaire from one of our customers? Please note we are new to formal risk based thinking processes, and still learning.... We're a relatively small high mix low volume company the designs and manufactures electronics if that helps. This questionnaire has a lot of six sigma type questions which I am very much unfamiliar with...

Does a risk analysis and mitigation plan exist to guarantee product quality and on-time delivery linked to Industrialization, Machine, Manufacturing Process, and Product?

In regards to industrialization I'm really not sure what they are referring to.

In regards to Machine & Manufacturing Processes, we don't use automated equipment or large machinery. We use PCs, and custom test fixtures which we keep duplicates or as well as a golden test fixture which is kept in a secure location. I think my response addresses this, but they want to know if have formally documented this in our risk based thinking processes/records. Is a simple yes sufficient to answer this question?

In regards to Product, I think the risks would be in regards to our suppliers / vendors. We do have a risk documented in that we always try to ensure we have duplicate sources for parts as well as vendors that offer services. In the case where we do not(a couple instances) we document how we mitigate these risks in our risk based thinking processes/records. Is a simple yes sufficient to answer this questions?

Any help to a new quality manager would be greatly appreciated.
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That's funny. I really like this forum because it seems to be mostly people that use common sense in approaching quality. I've come across a lot of quality professional elsewhere where what they propose makes no business sense.


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I'm in total agreement with Andy on this one. I've been on working groups for OEMs where all we did was meet quarterly and create/revise supplier quality documents that were flowed down by all applicable BUs.

These documents were written with SMEs in the room who, in general, knew more than most of the business unit level personnel that would be requiring their supply chain to complete.
I agree with Andy -- I'll bet they don't know what the question means either. I would answer yes and forget about it. :) If they ask for details, you can inquire further.

John Broomfield

Staff member
Super Moderator
My best guess is that your customer is seeking assurance that your design processes result in products that will fulfill their requirements.

Given that your management system does that you can truthfully answer “yes” after you’ve clarified exactly what they mean by “guarantee”.

After all, there are no guarantees in life.
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