Re: Regulatory General Discussion : ouput of Compliance group
I read in !emc-pstc that Andre, Pierre-Marie pierre- marie.an...@intel.com wrote (in 9985493A802AD5118C4E0090274627535EC2EE @swsmsx34.isw.intel.com) about 'Regulatory General Discussion : ouput of Compliance group', on Mon, 17 Dec 2001: The good argument is really in the FULL implication of the Compliance group in the design process right ? with full power to sign off the design changes IMHO, the European EMC and Low Voltage Directives effectively require this to be the case. -- Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk After swimming across the Hellespont, I felt like a Hero. --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: No longer online until our new server is brought online and the old messages are imported into the new server.
RE: Regulatory General Discussion : ouput of Compliance group
Doug, thanks you for your inputs. The good argument is really in the FULL implication of the Compliance group in the design process right ? with full power to sign off the design changes best regards to all compliance engineers Pierre-Marie Andre Senior Approval Engineer -Original Message- From: Doug McKean [mailto:dmck...@auspex.com] Sent: samedi 15 décembre 2001 01:26 To: EMC-PSTC Discussion Group Subject: Re: Regulatory General Discussion : ouput of Compliance group Andre, Pierre-Marie wrote: So has anybody some thoughts or argument on the measurement or evaluation of an Compliance Group ? Well, I'd hate to let the dirty little secret out of the bag for those of us who would fall under such and evaluation. Important in such an evaluation would be that the company has allowed the compliance engineer to have significant input to the design/mfring processes. I've been in companies where evaluations from the compliance engineer amounted to nothing more than a suggestion. Very frustrating. Other places had the compliance engineer greatly involved as a signatory in product release and with ECR/ECOs. Start with an ideal world where the compliance engineer has complete planning, budgeting, signatory/approval powers with the complete product cycle from prototype-to-product release-to product obsolescence. Consider that as the complete model. Then, as the person has less and less involvement/approval power in those areas, they are thus less responsible for them and thus, they are not to be evaluated in those areas. You'll probably find the typical compliance engineer ends up in reality scheduling tests w/no approval powers, has input to ECR/ECOs but no signatory powers, inputs into product design by way of memos, sometimes are the last to know about significant design changes, and might answer to someone who knows little about compliance engineering. IMO, evaluation would be difficult. Regards, Doug McKean --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: No longer online until our new server is brought online and the old messages are imported into the new server. --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: No longer online until our new server is brought online and the old messages are imported into the new server.
Re: Regulatory General Discussion : ouput of Compliance group
Doug, You've described the poles-apart situations of regulatory compliance very well. I've worked in both types of situations, and can say that my contribution and worth to the company in the first example far exceeds anything that can be achieved in a company of your last example. I've felt underused and undervalued, and made haste to find another job. Educating management just did not work when they have their minds set otherwise. taniagr...@msn.com - Original Message - From: Doug McKean Sent: Friday, December 14, 2001 4:59 PM To: EMC-PSTC Discussion Group Subject: Re: Regulatory General Discussion : ouput of Compliance group Andre, Pierre-Marie wrote: So has anybody some thoughts or argument on the measurement or evaluation of an Compliance Group ? Well, I'd hate to let the dirty little secret out of the bag for those of us who would fall under such and evaluation. Important in such an evaluation would be that the company has allowed the compliance engineer to have significant input to the design/mfring processes. I've been in companies where evaluations from the compliance engineer amounted to nothing more than a suggestion. Very frustrating. Other places had the compliance engineer greatly involved as a signatory in product release and with ECR/ECOs. Start with an ideal world where the compliance engineer has complete planning, budgeting, signatory/approval powers with the complete product cycle from prototype-to-product release-to product obsolescence. Consider that as the complete model. Then, as the person has less and less involvement/approval power in those areas, they are thus less responsible for them and thus, they are not to be evaluated in those areas. You'll probably find the typical compliance engineer ends up in reality scheduling tests w/no approval powers, has input to ECR/ECOs but no signatory powers, inputs into product design by way of memos, sometimes are the last to know about significant design changes, and might answer to someone who knows little about compliance engineering. IMO, evaluation would be difficult. Regards, Doug McKean --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: No longer online until our new server is brought online and the old messages are imported into the new server.
Re: Regulatory General Discussion : ouput of Compliance group
Andre, Pierre-Marie wrote: So has anybody some thoughts or argument on the measurement or evaluation of an Compliance Group ? Well, I'd hate to let the dirty little secret out of the bag for those of us who would fall under such and evaluation. Important in such an evaluation would be that the company has allowed the compliance engineer to have significant input to the design/mfring processes. I've been in companies where evaluations from the compliance engineer amounted to nothing more than a suggestion. Very frustrating. Other places had the compliance engineer greatly involved as a signatory in product release and with ECR/ECOs. Start with an ideal world where the compliance engineer has complete planning, budgeting, signatory/approval powers with the complete product cycle from prototype-to-product release-to product obsolescence. Consider that as the complete model. Then, as the person has less and less involvement/approval power in those areas, they are thus less responsible for them and thus, they are not to be evaluated in those areas. You'll probably find the typical compliance engineer ends up in reality scheduling tests w/no approval powers, has input to ECR/ECOs but no signatory powers, inputs into product design by way of memos, sometimes are the last to know about significant design changes, and might answer to someone who knows little about compliance engineering. IMO, evaluation would be difficult. Regards, Doug McKean --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: No longer online until our new server is brought online and the old messages are imported into the new server.
Regulatory General Discussion : ouput of Compliance group
Hi there, A few days ago there was some very interesting discussions about the Compliance groups among companies. A lot of ideas came out very clearly like do a company needs a centralized regulatory group,how to fund it,how to explain our regulatory tasks (quite complex !),how to structure it. Some extracts of the previous discussions : RE: Quality Assurance and product approvals Unless the role of the Compliance group is very narrow and involves only support of one function (which I doubt), I feel that an independent Compliance group is essential. It should be functionally independent to any other group and reporting to the MD, or, reporting to the QA Director/Manager. This will mean you can realistically argue for adequate resouces to do a professional job for all those groups requiring your services. You will have somebody independent at the right level in the organisation supporting the Compliance group - essential when $$$ are involved. Let's face it, no RD Manager is going to approve headcount for a 2nd Compliance Engineer whose primary function is to do audits of the production facility to ensure critical components are controlled as they should, and, to support Sales/Marketing to achieve product approvals worldwide. (To bring this back to procedures/process) There also needs to be a 'document' which highlights: 1. What services the Compliance group offer; 2. The inputs (from other groups) required, and the outputs to be expected from each service; 3. Turnaround time (this will never be 100% accurate) With a document such as this published it raises awareness among each of the functions that the Compliance group do have organisation-wide responsibilites and are not at the beck and call of just one group. It forces them to plan for compliance also. It gives the Compliance group more credibility and visibility I still have some question about the output of such a group.Since we are only producing a so called Type Approval it appears for some people that we are measured with the number of Type Approval granted. But this measurement is un realistics since some approval require 6 months effort whereas others require only a few days ! In others words the measurement must include the difficulty and complexity of the approval. So has anybody some thoughts or argument on the measurement or evaluation of an Compliance Group ? many thanks for your help Pierre-Marie Andre Senior Approval Engineer ---BeginMessage--- I think the point raised by Gary re: where the Compliance group fits into the organisation structure is more important than procedures/process, although I disagree with him about where that should be. Let me explain. Having a good working relationship with Engineering is indeed critical, however from my experience I believe it essential for the Compliance group to be organisationally independent of Engineering. If not, then there are always conflicts of interest when allocating the (usually limited) Compliance resources between: Engineering - there are 4 design reviews this week and preparation required for a safety pre-compliance test next week; Operations - the agency auditor is visiting next week and there is some prep needed; Sales/Marketing - the Russian approval is expiring in 2 weeks and you need to re-apply, prepare doc pack, etc. How do you prioritise without getting slack from at least one functional head ?? Obviously if the Compliance group is actually a group and not just 1 or 2 persons, then with a good understanding of the roles amongst the group members the above does not really pose a problem. However I do NOT believe this is the case, particularly in the current climate of lay-offs, with us Compliance folk are becoming less essential. Unless the role of the Compliance group is very narrow and involves only support of one function (which I doubt), I feel that an independent Compliance group is essential. It should be functionally independent to any other group and reporting to the MD, or, reporting to the QA Director/Manager. This will mean you can realistically argue for adequate resouces to do a professional job for all those groups requiring your services. You will have somebody independent at the right level in the organisation supporting the Compliance group - essential when $$$ are involved. Let's face it, no RD Manager is going to approve headcount for a 2nd Compliance Engineer whose primary function is to do audits of the production facility to ensure critical components are controlled as they should, and, to support Sales/Marketing to achieve product approvals worldwide. (To bring this back to procedures/process) There also needs to be a 'document' which highlights: 1. What services the Compliance group offer; 2. The inputs (from other groups) required, and the
