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CE certification and requirement for risk assessment
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Posted By Caithriona Duggan
Is there a regulatory requirement for a manufacturer of equipment/machinery to provide a risk assessment in conjunction with CE certificate issue ?
Cheers,
Caithriona.
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Posted By The toecap
Yes. I believe it is called The supply of machinery regs... 1996 (i think). I need help on this date and exact title.
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Posted By The toecap
I also see i sent a wrong answer. No but you do need to do it due to the Puwer regs and MHSW regs etc. Even the HASWA 74
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Posted By Peter Still
Toecap,
You were (nearly) right the first time! The Supply of Machinery (Safety) Regulations 1998 apply to manufacturers of machinery. PUWER and the MHSW apply to the use of machinery/equipment.
However these relate to a duty to perform a risk assessment, not necessarily to provide one. The SoM regs require you (the manufacturer) to provide adequate information for safe use, not necessarily to provide the results of your RA. However I'm aware of some clients who believe they have a right or even a duty to demand the manufacturer's RA, either so they can better understand the safety measure provided by the manufacturer or in the mistaken belief that it discharges their duty to perform an RA themselves.
Hopw this helps.
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Posted By Mitch
When we supply machinery into the EU (unfortunately not that often!) we CE mark, we do not carry out a risk assessment, this is down to the purchaser/end user. We do, as has been pointed out, supply information in the safe use, operation and maintenance of the machinery.
Mitch
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Posted By Peter Still
Mitch and Caithriona,
The following is an extract from the HSE guidance "Supplying new machinery":
"12 How does the manufacturer make sure that machinery can be used safely?
There are several procedures which they must follow, but in particular they should:
identify the health and safety hazards (trapping, crushing, electrical shock, dust or fumes, noise, vibration, etc) that are likely to be present when the machinery is used;
assess the likely risks;
eliminate the risks, or if that is not possible:
provide safeguards (eg guarding dangerous parts of the machinery, providing noise enclosures) or, if that is not possible:
provide information about any residual risks and place signs on the machinery to warn of risks that cannot be reduced in other ways (eg 'noisy machine' signs).
Manufacturers may wish to refer to standards or other specifications when designing machinery"
The regulations themselves make several references such as "Guards or protection devices used to protect against the risks related to moving parts must be selected on the basis of the type of risk". How are you going to demonstrate compliance with that, if you haven't performed an RA?
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Posted By Mitch
Peter,
All the machine "types" have been RA'd this allows us to guard and warn against residual risks etc as you have pointed out, we do not give customers copies of the RA's you would not believe how involved this can get, in ignorance, I do not mean that disrespectfully but you just open a can of worms!
Mitch
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Posted By Mitch
Caithriona,
Getting back to your original question why are you asking are you being asked for one or are you asking for one?
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Posted By Peter Still
Mitch,
Oh yes I would believe the cans of worms that can open!
As I said in an earlier post, the duty is to perform a RA, not provide an RA.
I've come across cases where the machine user has simply copied the manufacturer's RA and assumed that constituted the "suitable and sufficient" RA required under e.g. PUWER. I agree with you that giving a copy of the manufacturer's RA to the user has no benefit in terms of safety.
My concern was that your post gave the impression that you didn't perform a risk assessment during design and build of the machine, and I'm happy to hear that impression is false.
BTW I apologise to anyone who was misled by my mistake in the date of the regulations; 1992 SI no. 3073, amended 1994 SI no. 2063.
BERR are considering the results of their consultation on the UK implementation of the new Machinery Directive 2006/42/EC.
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Posted By Mitch
Peter,
Unfortunately I am aware of only 1 customer, in the UK, who has carried out a RA when we have supplied a machine, we do not actually install that many, it is usually the customer!
Mitch
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Posted By Pete Longworth
The basic requirement is to supply machinery that has been built taking into account certain "Essential Health and Safety Requirements". These requirements are detailed within the Supply of Machinery Regs. In order to meet these requirements, the designer, manufacturer etc would take into account the various type A, B or C standards. At the design stage a risk assessment would be undertaken to decide which standards and which essential health and safety requirements needed to be met. When affixing the CE mark the manufacturer would be, in effect declaring that these standards and requirements had been met. All of this information, together with information on specific hazards such as noise and vibration data, any test results etc would be compiled in a technical file and supplied to the end user.
It would be up to the end user to conduct a risk assessment into how the machine will be used.
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Posted By Peter Still
Mitch,
Without knowing your company or the kind of customers you have, I'd say that's fairly typical! Usually when I ask end-users for sight of their RA, I either get a blank look or a stupid response like "it's category 3".
However the original question was about the responsibilities of manufacturers, not the ability of users to comply with MHSW and PUWER. Caithriona can I repeat Mitch's question - why are you asking?
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Posted By Peter Still
Pete,
There is no statutory requirement for machinery to meet any standards. Of course the Essential Health & Safety Requirements (EHSRs) of the regulations have to be met, and compliance with standards is very helpful in demonstrating that they have been met. However only those standards that have been harmonised under a Directive can be give a Presumption of Conformity to the national regulations that implement the Directive. These are usually only the C standards. Where there is no C standard for the particular machine type, A & B standards can be used, but they are often too general to give any Presumption of Conformity.
The manufacturer must be able to provide a technical file on demand from the regulatory authorities. However no such file need exist in one place or be supplied to the customer.
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Posted By Pete Longworth
I never said there was. What I said was that in attempting to meet the essential health and safety requirements machinery designers and manufacturers would take into account any relevant standards. OK the technical file would be supplied IF REQUESTED so maybe you got me on that one or maybe its just semantics.
The main thrust of my post was to illustrate that the designer / manufacturer would conduct a risk assessment to establish which essential health and safety requirements would need to be met and which standards , if any, would assist in doing this. The CE mark would be affixed partly to indicate that this had been done.
The risk assessment to control the operation of the machinery at the point of use would be the responsibility of the end user. In other words I was trying to answer the original question.
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Posted By Ian Mitchell
I would equate all this to substances. Think of the Supply of Machinery Regs commitment as the MSDS, and the recipient's PUWER duties as COSHH.
You can expect your supplier to provide you with the hazards and general control measures, but you must do your job-specific assessment!!
It is no different whether it is paint or a pressure washer! :-)
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Posted By Marcus74
The original post asks if there is a regulatory requirement for the manufacturer to "provide" a RA in conjunction with the CE certification.
Am I correct to conclude that the answer to the specific question is "No" ?
The manufacturer has to compile a Technical File that comprises of (but not limited to)
1,Drawings, Calculations, Test Results etc
2,Description of the methods used to eliminate hazards.
3,Standards and other Technical Specifications used.
etc etc.
In order to compile this information especially the methods used to eliminate hazards one can only assume that some form of RA has to be carried out during design etc, but I thought that the manufacturer was only obliged to make the Technical File available to an enforcing authority upon request ?
I have however seen a situation where a new piece of machinery was being installed and an engineer from the customer assumed that the E-Stop system was Cat3 only to find it was Cat2. He contacted the Manufacturer and asked for a copy of their RA justifying the use of Cat2 and was supplied a copy with no problems.
Forgive me if im wrong but as I see it, Yes Risk Assessments would have to be carried out, but there is no requirement for any to be provided with the CE Certification.
That doesn't mean you cant ask to see one though if your unsure of anything.
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Posted By Peter Still
Marcus,
That seems to me to be a pretty good summary. The answer to the original question is definitely 'no'.
The manufacturer (or his authorised representative in the EEA) doesn't actually have to compile a technical file, but must be able to if demanded by an enforcing authority. Of course his customer can ask for a copy, and the manufacturer can then either agree or not, but that is a contractual issue rather than a legal requirement.
In some circumstances such as your example concerning e-stops, it makes a lot of sense for the manufacturer and user to liaise on the risks that are foreseen during use. For example the user presumably knows the skill levels of machine operators, and others who might need to operate an e-stop, better than the machine manufacturer does. However the question was is there a regulatory requirement, and the answer is 'no'.
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CE certification and requirement for risk assessment
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