What is the Technical Construction File (TCF)?
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.
What is the objective of the TCF?
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.
Who is Responsible for the TCF and what does this entail?
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.
How long is this person responsible for the TCF?
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.
When do I have to produce the TCF?
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.
What should be included in the TCF?
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.
A guide to the contents of the TCF for an Assembly of Machines
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).
- The technical file will include design specifications. However, the final documentation, used to evidence conformity and at times to be used as information for use, must be ‘as built’. Therefore, design specifications are not suitable as information for use or evidence of ‘as built’ unless reviewed after final verification of the assembly ‘post commissioning’.
- A general description of the machinery. This is usually included in the instruction handbook and shall include:
- i) Limits of the machine used in the Design Risk Assessments Graphical representation (GR) of the machine along with a basic description of the intended use. See ‘Use Limits’ in EN 12100. The GR shall identify the major units in the machine and their general layout (diagram) in relation to each other.
- ii) for a fixed installation will also identify permanent features such as structures, machine frames, auxiliary equipment, platforms etc.
- iii) the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery. The GR will identify task zones for machine operation and the residual risks in that zone. See Design Risk Assessments (DRAs). The sequence of operation for all modes/tasks. Methods of working for all tasks including suitable graphical representations (e.g. simple for normal use and detailed for fault finding). Drawings for control circuits (all energies) in sufficient detail to enable foreseeable maintenance and modification of the machine during its lifecycle. Piping and Instrumentation Diagrams (P&ID) for related processes.
- iv) Full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements, Specific examples:
- i) Sistema Report (13849)
- ii) Calculations for protective devices positioning with respect to stopping distances (EN 13855)
- iii) Scanning fields for presence sensing devices or trip devices, electrical/pneumatic/hydraulic design calculations, electrical test results, structural calculations for load bearing parts for whom failure increases risk, load testing certificates
- iv) Safety PLC programmes (soft and hard copy with checksum. The hard copy will include all safety related parameters for safety I/O), detailed record of verification by test of safety functions against design intent, any other safety related parameters such as process control Sound level Testing Vibration testing Lighting levels
- v) The documentation on risk assessment demonstrating the procedure followed, including: The manufacturer is required to provide the design risk assessments for inclusion in the technical file and the policy/procedure followed in producing them. The detail required will vary with the type and level of risk concerned. For example, this may include detailed ergonomic risk assessments where there is a manual handling task with foreseeable consequences
- vi) A list of the essential health and safety requirements which apply to the machinery
- vii) The manufacturer of his authorised representative must complete an EHSR checklist for the machine or assembly. However, in the case of an assembly, any constituent parts which are not suitably declared (see Annex II 1a and 1b) then the manufacturer of the assembly is responsible to provide the suitable documentation for these constituent parts in full. See points below. Also see ‘standards and technical specifications’
- viii) The description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery
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 an enquiry form