Andrew Gordon, the Compliance manager at CESystems, outlines the risks associated with using office-orientated software for compiling and managing Technical Files for CE marking machinery, then he explains the benefits of using a system based on dedicated software.
Under the Machinery Directive 2006/42/EC and the corresponding national Regulations, machine builders are legally obliged to prepare a Technical File if they are intending to place machinery on the market in the European Economic Area. There is a similar obligation if CE marking equipment to the Low Voltage Directive (LVD), EMC Directive and others.
Depending on the circumstances, the Technical File will typically be prepared by an engineer or someone from the Quality Assurance department. Although the Machinery Directive does not require a Technical File to be prepared and stored as a physical entity, it must be possible to produce the necessary documentation when requested to do so by the relevant authorities; in Great Britain this will most probably be the Health and Safety Executive (HSE).
For a relatively simple one-off machine, the task of preparing the Technical File may be straightforward. However, for more complex machines, assemblies of machinery, or series-manufactured machines, the task can become considerably more involved. In addition, standards can change or certifications become out of date, so a Technical File that is valid for one machine may not be for another machine manufactured months or years later. As well as being able to create a Technical File, therefore, it is important to be able to maintain it and manage it for the duration of production and beyond (as required by the Machinery Directive). Also, if the machine is subsequently modified such that the Technical File's contents need to be reassessed, the Technical File needs to be user-friendly and future-proof.
Machine builders often create systems in-house for compiling and managing Technical Files, typically with office-orientated software packages such as spreadsheets (eg Microsoft Excel) or databases(eg Microsoft Access). For managing a Technical File that must, by definition, have a long life, and which may have to be produced as evidence in a court of law, such approaches are fraught with risks. For example, data in spreadsheets can very easily be hidden, or data altered or deleted inadvertently. Entire files can be deleted or overwritten, and multiple copies of files can be created on different computers or in different directories, with conflicting data and no certainty about which is the correct and up-to-date version. Multi-user capability is very limited, and password protection can be circumvented. There is no audit trail, and Excel spreadsheets can contain auto-start macros that launch when the spreadsheet is opened and before an auditor can check the contents. Macros written in one version of Excel may not work in future versions.
Having established the problems and risks associated with this approach to Technical File management, what are the alternatives? Large organisations may have the resources to create a custom system based on a Microsoft SQL database or similar, but in-house software is notoriously difficult and costly to maintain. There are some machinery safety specialists that offer Technical File management services, but these can also be expensive to subscribe to, depending on the pricing model. Another alternative is CETech, a software package developed by CESystems and proven in a number of companies that CE mark products to various European Directives. The CEMach module within CETech has been developed specifically for use when CE marking to the Machinery Directive 2006/42/EC.
CETech guides users through the steps involved in generating a Technical File. Documents and other files can be imported into the database for centralised storage and access. Licensed users can upload files and edit them, they can grant access rights to suppliers so that they can also upload files, and a built-in audit trail ensures that all database changes are tracked. Reports can be generated at any time, and a built-in diary alerts users if certifications are about to expire. In particular, a Product Control Document can be generated with a single mouse click to provide an overview of a machine's compliance status. The database is preloaded with lists of standards harmonised to various Directives, and these lists can be updated. If a standard is updated or superseded, CETech can be searched to identify all products that have been designed in accordance with that standard so that any necessary action can be taken. CETech can either be operated as a standalone system on a desktop PC or it can be hosted on the cloud and accessed from anywhere by anyone with the appropriate access rights.
Engineers who are wholly or partly responsible for compiling a Technical File will find that they can save considerable amounts of time, whether the machine concerned is a one-off or destined for series production. With all the information available in one place, less time is spent searching for information and checking to see what documents have or have not been added to the Technical File. If suppliers are granted access to the database so that they can upload documents, even more time is saved because the engineer simply has to check the documentation. When machines are being updated, upgraded or otherwise modified such that the CE marking may need to be reviewed, having a single point of access to the Technical File makes the process quicker and simpler, especially if changes are subsequently required.
If responsibility for compiling or maintaining Technical Files lies with quality assurance personnel they can benefit from the time savings and also the way in which CETech issues alerts prior to, for example, supplier certifications going out of date. By making use of the built-in RSS reader and the feeds from the European Commission's website, it is also easy to ensure that the database of Harmonised standards is kept up to date. Moreover, if a standard is updated, amended or superseded, the database can be searched so that all products built to that standard can be identified in order that appropriate reviews can be undertaken and documentation and/or designs changed. CETech is particularly beneficial for series machines that are in production for a number of years, as it helps to avoid machines becoming non-compliant without the manufacturer's knowledge.
Often it is a senior manager or director whose signature appears on the DoC (Declaration of Conformity) or DoI (Declaration of Incorporation) and who, therefore, take personal responsibility for compliance. By using a dedicated software tool for technical file management - and especially one such as CETech that has been written by compliance engineers - there is a much reduced risk that machines will become non-compliant and the individual placed in a situation where they could be prosecuted. This risk reduction is, of course, in addition to improvements in the utilisation of the engineers and quality assurance personnel who can spend less 'unproductive' time compiling and managing technical files. CESystems believes that the reduction in engineering and QA time will easily pay for CETech. In the event of a request for documentation being made by the regulatory authorities, CETech also makes it considerably easier to respond in a timely manner.
Machines often have a long lifetime and it is almost inevitable that they will be modified at some point. If the modifications are undertaken in-house and require changes to the Technical File, it is highly beneficial if the Technical File is managed in such a way that it can be easily modified. Furthermore, if a machine buyer insists on a rigorous approach to Technical File management, it is more likely that all standards and certifications will be up to date, with no errors or omissions. This not only gives peace of mind, but helps to ensure that the machine is, in fact, safe.
Managing Technical Files using office-orientated software is fraught with risks, whereas CETech offers a number of benefits to machine builders, line builders and system integrators. Small companies are likely to appreciate the control it gives them, while large companies will like the way CETech helps to demonstrate due diligence. The savings in engineering time and QA time should easily pay for the system, which is priced to be affordable for all users. Considering the long lifetimes expected of machines, the future-proof aspects of CETech are highly beneficial. Individuals whose signatures appear on Declarations of Incorporation and Conformity will welcome CETech's ability to reduce the risks associated with personal liability.