Just commentary ­ no authoritative information. This sounds like the
customer company¹s lawyers looking to divert blame in the event of a lawsuit
by showing due diligence on their part, and maybe, just maybe, redirecting
the blame vector towards your company if someone can make the case your
company didn¹t adequately assess your product's risk.

Ken Javor
Phone: (256) 650-5261




From: "Kunde, Brian" <[email protected]>
Reply-To: "Kunde, Brian" <[email protected]>
Date: Thu, 17 May 2018 18:43:38 +0000
To: <[email protected]>
Conversation: Customer Requests for Risk Assessments
Subject: [PSES] Customer Requests for Risk Assessments

Our company makes Laboratory Equipment (test and measurement analyzers).
  
Our company performs a Risk Assessment early in the development stage of all
new products as so suggested by such documents. We generally use the EN ISO
12100. Creating this document highlights the possible sources of risks and
allows our engineers to design products with an inherent design which
minimizes the risks as much as possible.   Our Risk Assessment becomes a
document with a lot of detailed information including calculations, test
results, detailed data, and other design specifications.  Such information
is considered highly confidential by our company.
 
On occasion, and in increasing frequency, our company is asked by potential
customers to provide them with a Risk Assessment Report for our products.
Sometimes they threaten us such as they will not or cannot consider our
products unless we provide such documentation.
 
1.      Why are customers asking for a Risk Assessment?  Where did that
requirement become from?


2.      Other than the potential loss of a sale, are we obligated to provide
our customer with a Risk Assessment?  I do not see such a requirement in the
Directives or Standards we use.


3.      Any of you been receiving similar requests? If so, do you provide a
Risk Assessment? If so, are you not worried about providing such
information?  Couldn¹t this information be used against you in court? Is
there a fear of providing useful information to your competitors?

 
Part 2:
I have requested a sample of the Risk Assessment our customers are expecting
our company to provide. The examples documents are for the most part
meaningless with little real detail about anything.  But, if that is all
they want to make them happy, we are considering generating such a document
just to satisfy these requests.  Any comments?
 
When I ask our customers what information they are looking to gain from the
Risk Assessment, they tell me they want to know the level of residual risks
our products might have.  I reply that all residual risks are well
documented and warned about in the provided User Manual.  However, this
doesn¹t seem to satisfy them. They still want a Risk Assessment Report.
 
So are other companies having to generate a stripped down Risk Assessment
with no real detail to satisfy these customer requests?  Or is it just us?
 
Thanks for your input, comments, and suggestions.
 
The Other Brian

LECO Corporation Notice: This communication may contain confidential
information intended for the named recipient(s) only. If you received this
by mistake, please destroy it and notify us of the error. Thank you.
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