Yeah,  I'm already working on the critical component flag for SAP, but that's 
another thread,  SAP does all our revision control, the doc archives are slaved 
off of that.

I'm working with an outsource manufacturer (US based) on a product they are 
supplying us for integration.  They are also supposed to supply the TF reports 
and content but they don't seem to understand what a critical components list 
is.  I've given them examples and not gotten very far so I was looking for 
something more official like  from the standards.
-Dave

-----Original Message-----
From: Brian Oconnell [mailto:oconne...@tamuracorp.com] 
Sent: Thursday, March 13, 2014 4:36 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Critical Components definitions

Do not know, but in principle should be ok. The 'flagged' components in the 
company's document control system is typically a superset of the C/C table in 
safety report.

The TF should probably reflect reality(red/blue pill inclusive); that is, 
tabulate the flagged stuff in the BoM, in addition to including the C/C tables 
found in the safety and EMC reports.

Brian


From: Charlie Blackham [mailto:char...@sulisconsultants.com]
Sent: Wednesday, March 12, 2014 1:07 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Critical Components definitions

Dave

Directive are “higher level” documents that won’t prescribe how you must do 
things.
Tables of “critical components” are typically listed in safety test reports, 
such as tables for EN 60950 clause 1.5.1.

As Rich says, “Critical components lists” are things that help manufacturers in 
that they allow you to clearly identify components that are “safeguards” .

Once you have such a list, flag all included items on your PDM system to (try 
and) stop second sourcing alternative parts without appropriate checks and 
sign-off being done first.

Don’t just list them in your Technical File, add a flag to your PDM system – 
that way you have a fighting chance of controlling what happens in reality ☺

Regards
Charlie

-----Original Message-----
From: Nyffenegger, Dave [mailto:dave.nyffeneg...@bhemail.com]
Sent: 11 March 2014 22:30
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Critical Components definitions

Related to my original question, we normally keep the critical components list 
in the technical file.   Looking at the 2006/42/EC New Machinery Directive 
Annex VII requirements for the technical file I don't see anything see anything 
that specifically refers to a critical components list.  So I'm wonder where 
the interpretation of that requirement comes from and the details normally 
provided in the list.  

There is a reference " calculation notes, test results, certificates, etc., 
required to check the conformity of the machinery with the essential health and 
safety requirements" and " any technical report giving the results of the tests 
carried out either by the manufacturer or by a body chosen by the manufacturer 
or his authorised representative,".

Are the critical components lists including the manufacturer, their part 
number, applicable standards and NRTL markings that we normally include in the 
file for each component being used to fulfill the requirements for the above 
for purchased critical components?  Or is it just customary to include this 
information in a critical components list and include the list in the technical 
file?

thanks
-Dave

-----Original Message-----
From: Brian Oconnell [mailto:oconne...@tamuracorp.com]
Sent: Monday, February 24, 2014 1:38 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Critical Components definitions

Concur with Mr. Nute. Was once asked to provide a "clear definition of a 
safety-critical component". To comprise a definition, provided a parametric and 
descriptive listing of 27 items. The last line was:

27. Any component or material or process that I deem critical to safety and/or 
critical to a regulatory requirement.

Brian

-----Original Message-----
From: Richard Nute [mailto:ri...@ieee.org]
Sent: Saturday, February 22, 2014 12:13 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Critical Components definitions

Hi Dave:

There are no "standard" definitions for critical components.  However, do a 
Google search for "critical components list" and you will find a number of 
examples and opinions as to a definition of critical components.  For example,

http://www.tracglobal.com/sites/tracglobal.com/files/pdfs/componentacceptabilityforceproductsafety.pdf

I prefer to think of a "critical component" as a "safeguard."  A safeguard is a 
component, part, or assembly that provides protection against one or more 
hazardous energy sources.  Basic insulation, supplementary insulation, and 
reinforced insulation are safeguards against electric shock.

Failure of a safeguard can lead to an injury, or calls into play a 
supplementary safeguard such as supplementary insulation or grounding.

The enclosure may be a supplementary safeguard against electric shock or 
against spread of fire or against both.

The point is, you must know the safety function of the component, part, or 
assembly before you can identify it as a "safeguard" or "critical component."

In practice, however, a critical component is any component the certification 
engineer says is a critical component.


Best regards,
Rich

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