This is a huge topic and I would never claim to understand all details and aspects, however I would like to highlight one specific angle that we have discussed over the years.
In Europe, the placing of Personal Protective Equipment (PPE) of class three on the market is regulated by directive 89/686/EEC, the PPE directive. This is a very comprehensive piece of legislation that defines parameters for the manufacturing, quality control and certification, but also basic ergonomic and health and safety requirements that manufactures have to consider when designing and producing equipment. The compliance with this directive is indicated by the CE mark on the product and the declaration of conformity in the technical manual. Further central elements of the directive are traceability during the manufacturing process and third party testing, whereby the manufacturer has a notified body verify type certification, quality assurance – and ultimately compliance with the directive. The notified body is indicated on the technical label by the four digit number behind the CE sign.
One of the reasons for this post is to share a drawing I made last year for a presentation Chris and I made last year at the Climbers’ Forum at the Tree Care days in Augsburg. This asked the question whether certification ensures that a product is fit to perform the foreseen purpose. The image depicts the two routes that can be followed to achieve conformity:
Often as not, manufacturers will certify according to existing EN standards. These define the scope, the pre-conditioning of samples, test parameters and set up of testing. This is all very well for a product that fits one of these boxes, such as a pulley, a sling or a karabiner. This first route is indicated by the top path in the drawing: pre-defined EN standard hurdles that a device must successfully pass to achieve conformity with the directive.
However, for a piece of equipment that doesn’t fit one of the standards, that is innovative, new, or just plain different, things may be a bit less straightforward One route a manufacturer then may choose to follow is simply to look for a standard which they know their device will pass and to certify according to this. This is true to the letter of the PPE directive, but in my eyes not to the spirit.
For cases like this there is a different route a manufacturer can choose to take by writing a manufacturer standard. In this case, you define your own criteria for testing. This is indicated in the drawing by the lower route, the adventure obstacle course. The obstacles are set by the manufacturer, but critically, both routes lead to conformity to the PPE directive. In my eyes this is the more honest route to take: by doing so the foreseen use can be more clearly indicated to the end user and the testing corresponds more accurately with the purpose the device was designed for, rather than just ticking boxes of a standard that has very little to do with the actual use of the piece of equipment.
If the manufacturer decides to take the lower route and to create a manufacturer standard the conformity will be indicated on the device and in the technical manual, however there will be no EN standards indicated, for obvious reasons. The manufacturer does however need to supply the end user with information in regards to how the testing was done, so that the end user can in turn decide, based on his or her risk assessment whether the testing corresponds with the intended use.
So ultimately the prime target is to achieve conformity with the PPE directive. To do so there are two routes: the EN standard route or the manufacturer standard route, both are equally valid. In a sense the EN standards are nothing other than a form of shorthand, interchangeable modules used to express requirements.
The final point that the drawing makes is that certification is in itself not guarantee that a device is fit for purpose. The fit for purpose party tent may be just behind the conformity finishing line, in which case things are fairly straight forward. However, there may be a bit of a walk between the finishing line and the tent. In this case the end user needs to identify this and to take extra measures to ensure that the device is not only certified but is also fit for the intended purpose.
In my opinion the whole certification process should be viewed like a dialogue between the designer and manufacturer of a piece of PPE and the end user. The designer/ manufacturer uses this process to ensure they have done their due diligence and to explain the rationale behind the device. The end user aims to understand this thought process and to use the device in the way intended. In this respect the declaration of conformity is a legal agreement between the manufacturer and the end user, whereby both parties agree to obligations and responsibilities.
This may all sound a little dry and theoretical, but it does have very real implications for a person working a height. In this respect I would encourage you to meet up with manufacturers whose equipment you use, to discuss issues with them and to get a feeling of what the ideas and concepts behind the devices are. One great occasion to do so is at the Tree Care Days in Augsburg, beginning of May, as there are many brands and manufacturers represented there at the trade show…