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.

One of the valuable services that the Safety/Compliance group can provide the 
company is an independent assessment of a risk, hazard, situation, etc. 

My previous company had Safety/Compliance located with Quality. There are many 
overlapping and similar functions between the groups such as auditing 
compliance, training teams, influencing business processes, managing change 
control, responding to customers...

-Mark Werlwas

  ----- Original Message ----- 
  From: Alan E Hutley 
  To: emc-pstc discussion group 
  Sent: Thursday, November 22, 2001 12:40 AM
  Subject: Quality Assurance and Product Approvals


  Hi All

  I have been following with great interest the detailed and in-depth responses 
to this topic.  I have noted that particularly in Europe as the list of New 
Approach Directives and other regulations grow, plus Safety and Quality issues, 
that companies are divesting more importance to this whole area.  

  Two questions, does the group see a time when we have a VP Compliance on 
level terms with VP Finance, VP Marketing etc, or is this already happening in 
the US.

  Second Question. Does the group think a formal qualification in Compliance 
Management & CE Marking would be a good idea.

  It seems amazing that considering the importance and complexity of this area 
there is not as yet one qualification that can prove a persons competence. At 
least in Europe I am not sure about the US and rest of the world.

  Any comments please.

  Alan E Hutley
  Editorial & Publishing Director
  EMC Compliance journal
  www.compliance-club.com

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