Basics of CE Marking

I've recently had the task of preparing documentation for CE marking products to be installed into a European facility. Mostly machinery such as hydraulic packages, also some mechanical type equipment. When providing machinery such as this, certificates must accompany the machine declaring it meets the requirements of applicable safety standards. Researching what needed to be done was quite a task. Explanations on the net range from confusing to so specialized its difficult to determine just what applies to your equipment. I'm writing this so as to augment what's already out there, and clarify some of the issues that had at least me stumbling for quite a while until I managed to sort it out.

There are two types of certificates: Declaration of Incorporation and Declaration of Conformance. Declaration of Conformance is required if the machine is complete, ready to go other than providing services such as electricity, air, cooling water, etc. Declaration of Incorporation on the other hand are for equipment that even if provided with services, it still requires additional equipment provided by someone else to turn it into a complete functioning machine.

The path for either declaration is basically the same, differentiating only in some of the final steps. The end result, the declaration, is the final step of a process documented in the technical construction file (TCF). Compiling the TCF is really not that difficult. Some steps are fairly straightforward. The most challenging part are the risk analysis and the Essential Health and Safety Requirements (EHSRs). I will go into more detail on those later. But first lets list what's in the TCF, along with some explanations:

1. General description of the machinery - Customer's statement of work, design criteria, your firm's proposal to the customer, purchase order to your firm.
2. Information necessary to understand the operation of the machinery - Design and production drawings.
3. Detailed drawings, calculations, test results, certificates - These items would be used to check the conformity of the machinery with respect to the essential health and safety requirements
4. Documentation on risk assessment - List of EHSRs which apply to the machinery, hazard identification, and the description of the protective measures implemented to eliminate identified hazards or to reduce risks, statement of the residual risks.
5. The standards and other technical specifications used , indicating the EHSRs covered by these standards.
6. Technical reports giving the results of the tests carried out by the manufacturer or by a body chosen by the manufacturer or his authorized representative - If there are no docs specifically related to CE you can use internal QC reports, inspection reports, results of acceptance tests, vendor material reports, etc.
7. A copy of the instructions of the machinery - The product manual.
8. Any declarations of conformity or incorporation for other products included in the machinery.
9. A copy of the EC declaration of conformity or incorporation.

Items 4 (Hazard Analysis and Risk Assessment) and 5 (EHSRs) are the ones that require the most work

More to come.

Hazard Analysis and Risk Assessment

Hazard Analysis

Hazard analysis is basically a what-if type of analysis. Imagine the equipment installed and functioning, and then think of what could go wrong or something a person might do with (no matter how dumb). For example a hydraulic hose under pressure may leak. Potential result someone gets sprayed in the eye with hydraulic fluid. Or a maintenance person may be working on a coupling between a motor and a pump, and someone turns on the motor. Result broken fingers. You get the idea. The documents that will guide you through this are parts one and two of Safety of Machinery: EN ISO 14121-1 and EN ISO 14121-2. There you will find a detailed list of the types of hazards that can occur.

Risk Assessment

Risk assessment  is performed for each identified hazard. Risk is the product of a hazard's potential severity (ranging from near neglible to loss of life), it's likelihood of occurrence (ranging from almost impossible to almost certain), and potential number of persons affected. For example walking on a board 1 foot off the ground or 30 feet up in the air both have the same likelihood of mistepping and falling off. However the severity of potential injury is small in the first case but large in the second. Hence the second scenario has a much higher risk.

Risk Reduction

Risk reduction are the steps taken to eliminate the risk, reduce the risk to a lower level, or provide sufficient warnings and training if the risk can not be reduced.

More to come

Essential Health and Safety Requirements (EHSRs)

This is were the rubber hits the road. EHSRs can be either very specific for particular categories of equipment, or generic as described in one of the Directives, such as the Machinery Directive. However just because they are generic does not mean they are not detailed. They often are also mutually exclusive. This is best explained with an example. Take a small machine with some moving parts, hydraulic lines, and a few electrical devices. Now potentially several directives may apply, such as the Machinery Directive, the Low Voltage Directive, and the Pressure Directive. Often the determinants are the dominating features of the equipment.

EHSRs typically follow the hazard analysis, applicable EHSRs being determined by the findings of the hazard analysis. Now to be honest I in fact found that reviewing the EHSRs first made it easier to determine the types of hazards I should be concerned with. It's sort of doing things in reverse. Looking at the answers first and then formulating the questions. But then this isn't a school test. You can do things in any order you want, as long as the end results are in order.

More to come