I have choosen to use the word "compliance folder" (CF) for the file where we
are keeping this kind of data. 2 reasons :
- the word is used in some laws (Australia)
- I include results from tests that are not regulatory. Examples :
* climatic tests : not regulatory at all but part of the product
compliance
* tests against harmonized standards when the DOW is not reached :
strictly speaking it is not regulatory testing. It will become regulatory
testing after DOW only.
Our CF are organized in 10 parts :
1) Contents ... lists the reference of all the documents included in the CF
2) EC declaration of conformity
3) Product safety features : including description of the product, safety
components, certificates,...
4) Safety declaration of conformity plus tests reports (against international
standards not only EU)
5) EMC product features
6) EMC declaration
7) Environmental tests reports
8) Follow up of product modifications
9) Telecom interfaces features
10) EC certificate (when TTE-SES applicable). Will be replaced by EC
declaration of conformity against R&TTE if applicable.
The safety and EMC declarations contains all compliances achieved by the
product. These declarations are not written for the CE marking scheme but for
commercial purposes. A restricted declaration is written according to LVD and
EMC directives (or soon R&TTE).
And of course, even if we are based in France, our CFs are all written in ...
English !
Hope that helps.
Corinne SALINGRE
CS TELECOM Approvals Manager
John Allen wrote:
> A comment to Ron in particular:
>
> I think the answer to your question is "reality" and "practicality".
>
> I came to more or less the same conclusion at least 5 years ago as we have
> so much legislation to deal with nowadays, and many of the problems and
> solutions are common.
>
> That means we need to identify, solve and record much of the same (or
> virtually the same) information for a variety of purposes - therefore why
> not use a single document structure to list and store it all.
>
> Therefore, in conjunction with Engineers here, I created a thing we call
> the "Product Regulatory Archive File" ("PRAF") - the name of which is
> quite deliberately different from TCF, TF etc.
>
> Sounds odd, but each word has a fairly obvious meaning:
> - Product = For a specific Product or system
> - Regulatory = Holds Regulatory information
> - Archive = Long term storage and updating
> - File = File (or file structure in reality).
>
> It encompasses all the requirements for all the regulations and each
> section has a very common structure.
>
> The attached document gives the structure of Sections 1 to 3 of our PRAF -
> and the remaining sections are generally clones of the LVD section but with
> somewhat different requirements and routes to compliance:
>
> This WORD 97 file is only 32kB and is intended to be printed on A4
> Landscape paper - but the full one for the PRAF structure is much bigger
> and is in Tabular form!
>
> Nevertheless have fun and I would appreciate comments from anyone.
>
> Other versions of a similar concept would be appreciated by me (and
> probably a few other people!).
>
> John Allen
> Product & System Safety Manager
> Communications Division
> Racal Defence Electronics Ltd
> Bracknell
> UK
>
> ----------
> From: WELLMAN,RON (A-PaloAlto,ex1)[SMTP:[email protected]]
> Sent: 01 March 2000 18:12
> To: '[email protected]'; [email protected]
> Subject: RE: Technical Files
>
> Hello Brian,
>
> Could you please provide more information as to who is driving this?
>
> Regards,
> +=================================================================+
> |Ronald R. Wellman |Voice : 408-345-8229 |
> |Agilent Technologies |FAX : 408-345-8630 |
> |5301 Stevens Creek Blvd., |E-Mail: [email protected]|
> |Mailstop 51L-SQ |WWW : http://www.agilent.com |
> |Santa Clara, California 95052 USA| |
> +=================================================================+
> | "Common sense is the collection of prejudices acquired by age |
> | eighteen." - Albert Einstein |
> +=================================================================+
>
> -----Original Message-----
> From: [email protected] [mailto:[email protected]]
> Sent: Wednesday, March 01, 2000 4:07 AM
> To: [email protected]
> Subject: Technical Files
>
> Just to throw an English two pennorth into this discussion
>
> There appears to be a move in the UK towards creating a single
> technical file in which you keep the records , test results drawings
> calculations etc for every directive that your product has to comply
> with. i.e Low voltage, emc, pressure equipment etc.
>
> The object being that should the worst happen you have a nice tidy
> document to show that you have shown "due diligence" which seems
> to be what the courts will be looking for.
>
> As other correspondents have stated this does not apply if you have
> chosen the TCF route for emc compliance
>
> Regards
>
> Brian Harlowe
>
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