My personal experience agrees with John.   I prefer to work with Engineering 
and reporting someplace in Engineering;--  it makes my job easier when 
compliance is "designed" right from the very beginning rather than be 
responsible later to get it past agencies.   At that point, it suddenly became 
my "problem" when it did not comply!   When I told management that they should 
fix things before we submitted the product formally, the response was "let's 
see what the agency will do...."   This left me frustrated and embarrassed my 
ego.

If you catch things in the very beginning, engineering is usually amenable to 
changing things.   Later, it is very difficult and, obviously, much more costly.

[email protected]
  
  
----- Original Message -----
From: John Woodgate
Sent: Wednesday, November 28, 2001 2:48 PM
To: [email protected]
Subject: Re: Quality Assurance and Product Approvals
  

I read in !emc-pstc that Mark Werlwas <[email protected]> wrote (in
<[email protected]>) about 'Quality
Assurance and Product Approvals', on Wed, 28 Nov 2001:
>    On the aspect of the "where to put Product Safety/Compliance in the
>    organization" discussion bears mentioning on the forum. In general I
>    advocate that the Product Safety/Compliance department be separate from
>    Engineering, Sales, and Operations. The Safety/Compliance group should 
> avoid
>    conflicts of interest (real or apparent) that may arise in the above
>    mentioned groups. Even the occasional appearance of a conflicting interest
>    can undermine the credibility of the Safety/Compliance team.

But this militates strongly against 'designing-in compliance', and is
very liable to create a 'them and us' conflict between Design
Engineering and Compliance. The *maintenance* of compliance in
manufacture is a Quality function.
--
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk
After swimming across the Hellespont, I felt like a Hero.

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