Scott Replying to your comments to my comments a) to d) !!
a) I don't know about you, but a lot of us have considerable difficulty in enforcing "unwritten" requirements as we have to "prove" them first - and as I said, I have yet to see anything (apart from the current discussion) to substantiate that this requirement is in either the letter or the spirit of the Directives b) Conversely, you don't - or at least all of the many (at least 10-15!) companies for which I have worked - update all the other company documentation every time someone senior leaves. I accept the comment about cheques etc., but such items are a date-related response to a date-related requirement - and the banks do not accept company cheques from non-employees for obvious legal financial reasons, and as part of the commercial agreements for the establishment of company bank accounts. c) Sorry (and partially in response to what someone else said), but a lot of companies (including us) do make a wide range products for a comparatively long period of time - sometimes 5-10 years - and have no technical need to update them hardware wise but simply make software or cosmetic changes which do not affect safety/EMC/etc compliance. If we have no need to update them technically, why should we - given the wording and implementation of the current directives and the clear statements of the dates when the "presumptions of conformity" ends in either the standards (EN60950 etc) and/or the lists in the OJ and on the EU website (http://europa.eu.int/comm/dg03/directs/dg3b/newapproa/eurstd/harmstds/r eflist/lvd.html) - continuously do detailed reviews (and they have to be detailed!) against the standards as each amendment comes out. Our approach is that we will comply with the legal requirements - and those requirements clearly state the position as I have put it. d) I think your approach of "proforma" DoC's is actually a very "dangerous" and unneccessary one for several reasons. (i) You are combining a "type-certification" DoC with a Certificate of Conformity (CoC) to the individual order placed by the customer. As far as I know and read from the Directives, such a requirement is definitely neither stated or intended - the only requirement is that the DoC shall be signed and shall be available if requested. (ii) If a company is unable - or feels it unnecessary for the same reasons that I have already stated - to update the certification on to cover the latest amendments to the standard in question because the product has not changed, then the combined DoC is technically incorrect. In fact I have recently rejected a DoC from a sub-contract supplier which was dated 1999, but stated compliance with the 1992 version of EN60950 (which is now at Amendments A4 & A11 issue level!).!!!! However, I would have been happy if it had stated that the DoC had showed product also complied with Amds 1 & 2, and had been dated before 01-10-1997 to show that the product had been certified before 01-01-1997, as permitted in the current version of the Foreword to that standard. Finally, to take up one or two of the points made in the introduction to your reply I would be appalled if the production and test processes applied to a product depended entirely on the whim of the personnel performing those actions! The LVD and other New Approach Directives clearly state that the production/test controls on the continued compliance of a product must be stated in the Technical File (or TCF etc.) and I take this to clearly imply that you should include copies of the relevant production control documentation - together with any approved change requests etc., - in such files. That documentation must contain all the required controls and test - and, where, neccessary, the rationales for them (or clear cross-reference to the company documentation which states those rationales). Thus there should be absolutely no reason why a critical hipot test should be omitted in any of the circumstances you describe! For someone to abritrarily decide that a test or control is unnecessary and to delete it is a clear breach of company procedures!!!!! The very least that should occur is that a formal "change request" must be submitted, justified and approved - and this process must be codified in company operating procedures. However, if you don't have such company operating procedures (or you do but you don't enforce them!) then you are definitely in BIG trouble! You will never be able to control design and manufacture of ANY product to comply with the requirements of the Directives or any other legislation or standards (and certainly won't get/keep ISO 29000 etc. certification !). EN29000 (etc) and the majority of third-party certification schemesrequire the appropriate procedures and training to ensure compliance with them. The above processes for the continued design and manufacturing control will - if correctly defined and implemented - always ensure that the product remains in compliance - regardless of whether the DOC signatory leaves the company. They will flag up when a product is in the process of change and should - if correctly written and applied - ensure that any relevant regulatory issues are fully considered and addressed, and that recertification to the current/new/updated standards occurs as appropriate. Finally, I would argue strongly that even if the DOC signatory stays in the company for the whole life of the product - and many years thereafter! - that this does not then guarantee the continued compliance of the product! "Think about it" if you don't have the control procedures - or even if you do but don't enforce them properly!! Regards John Allen Racal ---------- From: Scott Douglas[SMTP:s_doug...@ecrm.com] Sent: 11 November 1999 21:36 To: john.al...@rdel.co.uk; emc-p...@ieee.org Subject: RE: D of C - Who Signs? John, Good that you disagree, wouldn't want everybody just following along. I said the DofC should be re-signed for the following reasons: If the original signatory is no longer employed by the manufacturer, then fine. All of the product shipped prior to the departure of the signatory is okay and nothing needs done for that. As for product shipped after the departure of the signatory, I think those DofC's are no longer valid unless re-signed by a new signatory. Consider what is the purpose of the signature except to advertise a name for the enforcement folks to go after. If the name was not important, then why have it signed at all, why not just use the company name instead? The signature says that a responsible person certifies that the product complied when it was first designed and tested. But it also says that nothing has changed since then and what is made today is as compliant today as what was made back when the form was first signed. Or think of it this way. You work for my company and you sign the DofC. We make, test and ship hundreds of the product. All our procedures are compliant, etc. Then you leave my company and we keep shipping product with a DofC with your signature. One day, the person running the hipot tester at the end of the production line quits and, as a cost savings measure, the manufacturing manager decides to not replace the person. No more hipot testing and nobody told me about that. But the product still gets through customs in the EU because of your signature on the DofC. Somebody gets electrocuted by a defective product. When the lawyers go looking for the person that signed the DofC, I will tell them where to find you. After all, you signed the form and said the product was compliant, right? No offense intended, sir. Now to answer your points directly: a) Not a good reason. Look to the spirit and intent of the requirement, not just to whether or not it is being enforced. b.) Again not a good reason. You get a new CFO, treasurer, whatever. Do they leave the old guy's signature on your paycheck? Things change and people move on. Keeping up is part of the process. c.) This too is part of the process. Your signatory is not replaced on a monthly basis. People usually stay in a job a little longer than that. And reviewing and updating your DofC should be happening anyway to update standards tested to or whatever. We are not re-issuing DofC's for product already shipped, just what will be shipping tomorrow. Updated versions can be implemented by effectivity dates and should be an ongoing process. d.) Maybe so or maybe not. Let me tell you how I do it. Our DofC is a blank form with all the compliance stuff preprinted. The signature is a real signature, but is preprinted on the blank form, just like on your paycheck. Then, at shipping time, the packer fills in the blanks for product model and serial number and for the date. The DofC is then folded up and stuck in one of those plastic envelopes on the side of the shipping box. Key point here is that the signature is preprinted but the model, serial # and date are not. Keep in mind that which standard and which version/date of that standard this particular DofC are claiming compliance to are listed, preprinted. There is no reviewing the products because you are declaring compliance to whatever standard you originally tested them to and are declaring you are still building/testing them the same way. As for the part where the standards have been updated since the original signature, that is true. But here again, we make conscious decisions to build a product a certain way. That may be to old standards, current standards or future standards. And, when new requirements come along, like when the CE mark became mandatory, we all adapt and adjust. Your point e.) is valid, no argument there. I just don't see why, when a new signature is placed on the form, it changes anything. If nothing has changed from the original design, then the new signatory is saying the same as the old, the product is compliant to a certain version of a particular standard. No need to update products for that. Conversely, if the standard has been updated and the optional period has gone by, then you have to update both the product and the DofC regardless of who the signatory is. As for not being envisioned by the creators of the directives and standards, that is not unusual nor unacceptable. There are oft many cases where unintended consequences occur because someone made something become a rule we all have to follow. That is why standards get updated and directives replaced. Or why companies choose to stop sending certain products to certain places. All that said, am I so far off in the outfield as to be playing in a different game? I think our process not unreasonable and follows the spirit and intent. But, I am willing to listen and, if I really am out there, somebody please tell me. I'd like to find an easier way. Regards, Scott s_doug...@ecrm.com ECRM Incorporated Tewksbury, MA USA -----Original Message----- From: john.al...@rdel.co.uk [mailto:john.al...@rdel.co.uk] Sent: Thursday, November 11, 1999 11:55 AM To: emc-p...@ieee.org Subject: RE: D of C - Who Signs? Importance: Low Hi Folks I disagree strongly with Scott's assessment that the DoC has to be resigned for several very important and pragmatic reasons: a) To-date I have yet to see any official EU or other substantive document to support his viewpoint. b) People are always "coming and going" - it is a fact of business life, and new personnel inherit the legal responsibilities of the old. (That said, the "old" personnel could still be prosecuted for knowingly breaking the law if they had falsely signed a DoC). c) If Scott's viewpoint were widely held we would all be continuously updating and reissuing our DoC's. In fact we would have little time for anything else - like developing new products! d) The date of the signature then becomes critical - and could force a complete review of the product against the latest versions of the appropriate referenced standard(s). The problem comes if those standards have themselves been updated since the date of the first signature - in which case a product might have to be modified merely because the person signing the original DoC had left the company! The latter proposition is plainly ludicrous and not envisaged in the Directives or in the harmonised standards, which allow you to continue manufacturing an unaltered compliant product for some considerable number of years after the last date you are allowed to certify to a particular issue level of a standard. e) The only realistic and supportable reasons for updating the DoC are thus that : (i) The product itself changes; (ii) The standard(s) change, and you are going to continue manufacturing beyond last date at which it is permissable to to manufacture and certify to the particular issue level of the standard(s); (iii) The company and/or model names/number change. The above opinion is my own, but I can see no reason why we - or any other company - should take any different view. Regards John Allen Product & System Safety Manager Racal Defence Electronics Ltd Bracknell UK ---------- From: Scott Douglas[SMTP:s_doug...@ecrm.com] Sent: 11 November 1999 13:39 To: reyno...@pb.com; emc-p...@ieee.org Subject: RE: D of C - Who Signs? The DoC must be re-signed. Scott s_doug...@ecrm.com ECRM Incorporated Tewksbury, MA USA -----Original Message----- From: reyno...@pb.com [mailto:reyno...@pb.com] Sent: Thursday, November 11, 1999 10:16 AM To: emc-p...@ieee.org Subject: D of C - Who Signs? Importance: Low Hello! Forgive me for asking a possibly dumb question but here goes: If the EU Declaration of Conformity is signed by a responsible/technically competent person who has been nominated on behalf of the company's Directors and then that person leaves the company, does his/her replacement who assumes the same level of responsibility need to go back and re-issue all of the old D of C's with their signature on the document. In other words is it acceptable to issue D of C's to suppliers/customers which have been signed by someone who has left the company. Thankyou in advance. Tony Reynolds Pitney Bowes (UK) Ltd Tel +44 (0) 1279 449479 Fax +44 (0) 1279 449118 e-mail: reyno...@pb.com --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
