The Technical Construction File (TCF), is required by the Machinery Directive, and its contents are listed in ANNEX VII of the Machinery Directive. The purpose of the technical file is to provide a means for the manufacturer to demonstrate the conformity of his product as well as to support market surveillance and enforcement activities.
The objective of the TCF is to demonstrate that the machinery complies with the requirements of this Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for the conformity assessment. As a manufacturer, it is your opportunity to demonstrate that the product is safe during all phases of its life including appropriately detailed documentation, calculations and drawings, how your product complies with all relevant Directives.
The Declaration of Conformity or Incorporation must give the name and address of the person authorised to compile the TCF, who must be established in the Community.
The technical file need only be 'compiled' as required. The term 'compiled' gives a purely administrational meaning to this role i.e. the person compiling the technical file is not responsible for its content. Even so, it is a legal duty on the person who takes on this role so proper arrangements should be made to ensure that this person is capable of compiling the file.
The authorities may request the TCF at any time up to 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.
It must be capable of being assembled and made available, by the responsible person within a period of time commensurate with its complexity. This time is generally considered to be between 24 hours up to a few days.
As explained previously, a list of the contents of the TCF can be found in Annex VII of the Machinery Directive. However, it only gives a general list of contents and this is not very informative.
Spiers Engineering Safety have researched this area in some detail and compiled a far more comprehensive guide with examples of inclusions for each section. This list can never be exhaustive as each machine must be assessed on its characteristics, however it is a very good start for those of you looking for additional guidance.
The information below must be representative of the assembly of machines as a whole. (I.e. the limits of the assembly defined in the conformity plan including all the major units identified as a minimum).
All inherent safe by design measures and other safeguards, protective devices will be detailed within the DRAs. The instruction handbook will include information to reflect all the control measures using the 3rd step of the 3 step method for risk reduction. Where residual risks remain (see the 3 step method), these will be highlighted within the DRAs and the instruction handbook.
Where information is required for immediate action by the operator this information, warning or marking will be replicated in a simple form at a suitable position in the task zone. This is normally done using adhesive stickers or markings on the machine. The incorporation of the assembly of machines will not remove, obscure, invalidate or otherwise reduce the effectiveness of such measures taken by the manufacturer of the constituent parts where possible.
Where this is not possible, such cases will be recorded within the DRAs for the assembly and suitable alternatives given.
To find out more about CE Marking and how Spiers Engineering Safety can help you compile the TCF, fill in an enquiry form and one of our designated engineers will be happy to help.Fill in an enquiry form