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Fisher900116  
#1 Posted : 24 September 2018 21:54:20(UTC)
Rank: Forum user
Fisher900116

Under the Machinary Directive the manufacture of a machine can carry out there own internal checks ('self certification') according to Annex VIII. The manufacturers (or the manufacturer's authorised representative) do not need to use the services of a third party organisation (a notified body) while undertaking conformity assessment of their product. At the end of the process, they should carry out their own independent declaration on the Declaration of Conformity that the product satisfies the relevant provisions of the Directive. We currently have an engineering fabrication manufacture who has designed and manufacture a single chain and flight conveyor, I'm not aware of this having a CE mark. They have provided a user manual but no Declartion of Conformity/Incorporation. They have said they have a technical file. But how to we check that it meets all of the essential health and safety requirements without requesting a copy of there technical file and checking it meets all of the EHSR and harmonised standards. I know we should be carrying out our own PUWER risk assessment but surely they should demonstrating this through CE marking the product before placing on the market? Also what qualifications should the "Responsible Person" have in carrying out this assessment the only other way is to get them to use a notified body. Your thoughts on this please......

Edited by user 24 September 2018 22:50:09(UTC)  | Reason: Spelling mistakes

paul.skyrme  
#2 Posted : 25 September 2018 07:14:59(UTC)
Rank: Super forum user
paul.skyrme

Just a few quick responses before I go out today, sorry for the brevity.

The lack of DoI is in itself a breach of the MD/SMSR.

It is doubtful that the equipment warrants a DoC.

If the equipment does not carry a DoC, then it is not required to bear the CE mark, however, it must still meet the EHSR's and be accompanied by "integration instructions" to ensure that the assembly also meets the EHSR's.

Under PUWER Reg 10, it is the end users responsibility to verify that the equipment is compliant.

Neither they or you need to use a Notified Body unless the equipment falls under Annex iv.

A simple conveyor does not, and it is covered by a C-Type standard.

Roundtuit  
#3 Posted : 25 September 2018 07:26:57(UTC)
Rank: Super forum user
Roundtuit

There are no "qualifications" for the responsible person - dependent upon the business and the nature of the machine it could be the MD, CEO, Technical Director, Design Manager - all that matters is that they have the legal authority to sign on behalf of the business the companies declaration to market.

Roundtuit  
#4 Posted : 25 September 2018 07:26:57(UTC)
Rank: Super forum user
Roundtuit

There are no "qualifications" for the responsible person - dependent upon the business and the nature of the machine it could be the MD, CEO, Technical Director, Design Manager - all that matters is that they have the legal authority to sign on behalf of the business the companies declaration to market.

Fisher900116  
#5 Posted : 26 September 2018 00:29:49(UTC)
Rank: Forum user
Fisher900116

Thanks both for taking the time to respond, I have questioned the DoI today and stated that this is a beach in the MD/SMSR like you have advised. I've requested there technical file so I can review how they have applied the EHSR to this machine and am still awaiting a response. I had started the PUWER risk assessment process however hit the above stubbling block. I will look up the C-Type standard thank you. I still find it odd that the 'Respondible Person' doesn't have to have any formal qualification to be able to declaration to the market!!! I have however requested what knowledge and experience this Engineer has in applying machinary safety/EHSR, CE marking process, conformity assessments, complying the technical file and machinary standards especially when this is the first time of doing this and any previous conveyors we have purchased have been CE marked in the past.
paul.skyrme  
#6 Posted : 26 September 2018 06:12:55(UTC)
Rank: Super forum user
paul.skyrme

I know what my answer would be to you if you asked for a technical file, and it would be no, you cannot have a copy.

A correctly completed technical file would enable you to copy the equipment, it contains intellectual property of the equipment manufacturer, unless it is written into your procurement contract then I don't see why you are entitled to it.  The only organisation that can demand access to a full technical file is the HSE.

Your best bet is simply to assess the equipment against the EHSR's & / or the standards, depending on what is stated on the DoI, you'll probably need more than the c-type for conveyors to assess it though.

As far as the signatory goes, this person is a person with a "controlling mind" in the organisation with the authority to sign, and the ability to have the technical file constructed (it does not have to exist in physical form in full prior to equipment supply) and provided to the relevant authorities, i.e. HSE.

They have no need to be technical, the engineering is taken care of by the engineers, who should be competent to undertake their work, else there is a bigger issue.

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