Technical File Retention

2011-08-14 18:28:00


Technical File Retention
The Technical File
The ATEX Directive 94/9/EC uses two terms; The Dossier and The Technical Documentation but common usage is the term The Technical File.
(The term Technical File is not used within the IECEx Certification Scheme, but its role is fulfilled by the ExTR issued by the IECEx Certification Body.)
Whether the technical file is in support of EC-Type Examination in accordance with Annex III, Internal Control of Production in accordance with Annex VIII, or Unit Verification in accordance with Annex IX, the technical requirements are the same. The difference lies in who is responsible for acceptance of the validity of the file.
Historically, manufacturers of electrical equipment have been used to certification bodies, such as Baseefa, preparing the technical file for them. The file would consist of the certificate, plus the report on examinations and tests, plus the manufacturers drawings, which had usually been modified after discussion to show the relevant detail to demonstrate compliance with the standard. In contrast, the ATEX Directive presumes that the manufacturer will prepare the technical file which, for certain conformity modules, will then be validated by the Notified Body.
A technical file is made up of all the documentation necessary to back up a manufacturers Declaration of Conformity with specified criteria in accordance with the ATEX Directive. This includes both a full description of the equipment and the results of the appropriate conformity assessment process.
The best words to describe the purpose of a Technical File are given in Annex IX of the directive:
The aim of the technical documentation is to enable conformity with the requirements of the Directive to be assessed and the design, manufacture and operation of the equipment or protective system to be understood.
To this end, all three Annexes (III for Type Examination, VIII for Internal Control of Production and IX for Unit Verification) list six aspects to be included in the Technical File.
A General Description
This would include type identification and performance information, as well as an outline description. This should provide sufficient overview such that the particular equipment could be recognised, and any specific interface details that might be necessary are made clear.
Design and manufacturing drawings, layouts, schedules, etc.
For a Technical File to have a life beyond just one single manufactured item of equipment, there is an art in preparing the necessary drawings, to ensure that they do not contain surplus information that might lead to unnecessary modifications to the Technical File throughout the life of the product. On the other hand, the drawings do need to contain everything that is relevant to demonstrate compliance with the directive or the harmonised standards.
Descriptions and explanations necessary to understand the drawings and the operation of the product
Our experience at Baseefa is that this information is usually split between the general description, the drawings (often with copious notes) and the installation, maintenance and operation instruction document, rather than identified separately. Where the symbol X is used with the certificate number or technical file number (as required by EN 13463-1) there will be a need to explain the purpose of the particular Special Conditions for Safe Use that it refers to.
Lists of standards or other solutions to meet the EHSRs of the directive
The wording used in Annex III is - a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied.
This clearly allows the use of solutions not in the harmonised standards, but does require a full description of each solution (and, by implication, the rationale for it achieving equivalent safety). The description of the solutions will often be incorporated with the result of the examinations. Note that the justification of equivalent safety can sometimes be very arduous, but use of a non-harmonised standard may sometimes be appropriate.
Calculations and Examinations
This is the argued case for compliance with the EHSRs, either via harmonised standards or other solutions. For example, drawings might show tolerances but there is a need to demonstrate how the build up of tolerances and concentricities can affect rotational clearances if they are relevant to the protection. Many of the requirements in the standards can be fulfilled without a test and there needs to be a record of that fulfilment. A dimensional measurement on a sample is usually regarded as an examination, rather than a test.
Test Results
Although calculation and examination will provide most evidence of compliance, there are some requirements which can only be demonstrably met by conducting tests on sample equipment; for example, temperature rise, or deformation after impact.
Technical Files for Non-Electrical Equipment
There is an inherent difference in the way that the harmonised standards for electrical and non-electrical equipment approach protection. For electrical equipment, it is presumed that the electricity is a potential source of ignition. For non-electrical equipment the same presumption regarding mechanical ignition sources cannot be made and it is first necessary to determine if a potential ignition source exists and then under what circumstances it may become active.
The Ignition Hazard Assessment required by EN 13463-1 is an organised method of identifying where and how protection is required. As Baseefa, we were responsible for drafting the simple example of the mechanical parts of a solenoid valve that appears in Annex B to the first edition of the standard. We were concerned that the other example (that of a complicated conveyor belt installation) might overface those who had comparatively simple equipment. Most equipment will fit between the two extremes. The examples in the second edition of the standard have been changed to show different aspects related to a slightly different way of expressing the ignition risk assessment.
The process is not difficult but it does require the ability to ask questions and state the obvious. For example, a bearing is clearly not an ignition source in normal operation. However, bearings do reach end-of-life conditions which could be ignition capable, particularly if bearing collapse were to result in high speed rubbing between inappropriate materials.
The Ignition Hazard Assessment, whilst being probably the single most important part of the process, does not have an obvious position within the defined contents of the technical file. For this reason, most technical files are not broken into sections in the way envisaged by the writers of the directive.
There is a curious difference in the marking requirements between the directive and the two basic standards. The directive does not require a certificate number or any other like number to be marked. EN 60079-0 requires that electrical equipment shall be marked with a certificate number. The first edition of EN 13463-1 requires either a certificate number or a technical file number.
Storage of Technical Files
The ATEX Directive places requirements on the storage of manufacturers technical files.
Unlike other directives where there may be considered to be an allowance to assemble the technical file after the event, ATEX clearly requires the technical file to be a fixed and identifiable document, available at the time of despatch of the equipment.
In the case of both the modules Type Examination and Internal Control of Production, the ATEX Directive specifies that the manufacturer shall keep the technical files for a period of not less than 10 years after the last item was manufactured. The same would apply to the notified body.
For Category 2 non-electrical equipment, the manufacturer has to deposit the file with a Notified Body, in effect giving the file the same traceability as a certification package. The directive, itself, does not give a reason, but there are probably two aspects: The European Commission want to ensure that there is a safe copy stored away from the manufacturer for security purposes and for access if the manufacturer goes out of business; it puts pressure on the manufacturer to actually create the report at the right time and prevents him from altering the report in the light of subsequent events, should there have been an incident involving the equipment.
The European Group of Notified Bodies for the ATEX Directive have agreed that it is necessary to have a charging regime for file storage which encourages the manufacturer to advise the body when production of a particular item has ceased, and thus limit the time commitment for storage.
Baseefa charges are based on the following:-
Files created as part of Type Examination - free for 10 years.
Files transferred from EECS or other Notified Bodies - free for 10 years
Files where Baseefa is responsible for the production phase - free for 10 years after the issue of the last QA Notification of Verification certificate.
After the initial free storage period for each of the above, we reserve the right to charge for continuing storage in line with the charges for deposited files.
Deposited files for Category 2 or M2 non-electrical equipment (i.e. Files where Baseefa had no part in the preparation of the file, and no part in the production phase) - an initial fee valid for storage for a period up to 13 years but subject to roll forward by renewal every three years. (i.e. after three years the manufacturer is asked if the equipment is still in production and, if so, the renewal fee covers storage for the following thirteen years, thus ensuring that the file is stored for at least ten years after the last date of production.)
Current fees can be checked with Baseefa.
Receipt of Internal Control of Production Files
It is a mandatory requirement in the ATEX Directive that Technical Files created as part of the Internal Control Production module for Category 2 and Category M2 non-electrical equipment are deposited with a Notified Body and that the Notified Body should acknowledge receipt of the file. We provide a formal receipt which confirms that the file has been deposited but that we have not looked at it.
You may send us supplementary information to add to the file but you may not remove it from our premises, since to allow you to do so would defeat the object of the independent retention. It will be treated confidentially and only copied to those who have a statutory right of access, such as the European Commission.
Should you misplace your copy of the file, we can arrange to supply photocopies at an appropriate charge.
Technical File Review
When requested, we will review the content of any technical file deposited with us on a purely optional and voluntary basis. We will confirm, by the issue of a formal Review Receipt that, in our opinion, the file, as passed to us, contains appropriate data to substantiate a Declaration of Conformity to the Directive. In doing so, we will not take responsibility for the veracity of the information in the file, but confirm that the way the information is presented allows a conclusion that the equipment is compliant. The fee for this service includes the initial thirteen year storage and, as it depends on the complexity of the equipment, will be quoted on receipt of the file.
Manufacturers of non-electrical equipment compiling their first technical file have found this service invaluable in giving them confidence that they have prepared a valid technical case for compliance.
Voluntary Certification
Should you prefer (or your customer require), we can, of course, proceed with full Type Examination on a voluntary basis. This is particularly popular with some types of Category 3 electrical equipment (e.g. motors and luminaires) where, historically, certification in some form has been regarded as the norm.
In this case, we issue a Type Examination Certificate as an accredited certification body, rather than as a Notified Body, as the ATEX Directive does not mandate Notified Body involvement for Category 3 Equipment. This service is also available for Category 2 and Category M2 Non-electrical Equipment should it be required.

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