How successful are manufacturers in achieving compliance with the Machinery Directive and who is policing it.
Introduction.
There is little doubt that most manufacturers produce excellent products, which are for the most part safe, but few manufacturers put in sufficient effort to demonstrate this and can easily be challenged. The fact that most products are safe is excellent news for manufacturers, because it means that European regulatory authorities have no obvious reason to challenge them. This appears to be born out by the absence of public examples of where a regulatory body has challenged a European or foreign manufacturer, but actually this hides an underlying truth.
Examples of how European directives are policed.
There is a common misconception that manufacturers are not being challenged, when in fact they are frequently being challenged by their competitors who use CE marking as a marketing tool. They do this simply by educating users about CE marking so that they can identify the virtues of their own products and make users aware of potential flaws in their competitor's products. Users are also becoming more discriminating as they learn more about CE marking and their own obligations under the Provision and Use of Work Equipment Regulations.
It is true that regulatory bodies seldom challenge manufacturer without provocation, but frequently do act on information received from others, who have done little more than point out an obvious flaw in the safety of a product. Regulatory bodies then seek technical advice from notified bodies and in most cases instruct manufacturers to rectify their product. Instances such as these have seldom been made public, but the consequences for manufacturers, both commercially and financially, have in some cases been devastating. There are even cases where one manufacturer has entered into litigation against a competitor only to find that their product fails to comply with European requirements just as much as their competitor's. In cases such as these neither party can win.
The European Commission is aware of this situation and has two schools of thought. One faction believes that far more regulation is required, while the other believes that since there have been no serious accidents in service, the form of self-regulation described above is sufficiently effective. It is our belief that there is a very fine balance between these two camps and the balance could tip in favour of increased regulation at the slightest provocation.
Standards of compliance with European directives.
Most manufacturers prepare some form of technical file or documented evidence of compliance with a European standard, before claiming compliance with a European Directive, but the evidence that they assemble to support their claim of compliance is frequently inadequate. A well-documented technical file or evidence of compliance with a European standard takes time to prepare and dependent on how much resource a manufacturer is prepared to invest in this task, it can take a few weeks to several months to prepare properly. Should a regulatory body challenge a manufacturer, most European member states will only allow them a few days in which to prepare and present their Technical File. If such a file does not already exist it is virtually impossible for a manufacture to prepare a file that will stand up to close examination in the time allowed. Manufacturers should therefore pay more attention to the preparation of these documents otherwise they could be vulnerable.
Technical Files, as their name implies, are highly technical documents and many manufacturers do not realize that the Essential Health and Safety Requirements of the Machinery Directive demand a high level of technical information to confirm compliance. Frequently manufacturers will type out each essential Health and Safety Requirement of the Machinery Directive but simply make the statement "Complies" next to each requirement, without providing any justification.
All too often when justification is provided it is not relevant to the clause that is being addressed and this is just as perplexing. In most of the cases that we have encountered, manufacturer can actually provide adequate justification but do not realize it. Frequently much of the information that is needed exists in their service, inspection and design department records and if properly identified, can be referred to with ease. Good Technical Files are the closest thing to a design guide and should be thought of in this way.
Manufacturers never want to advertise that a product is not in compliance with European Regulations and yet many quite unwittingly do. All too often we find Declarations of Conformity with the Machinery Directive that fail to confirm compliance with the EMC Directive, which nearly always applies. Many declarations imply full compliance with a large number of standards, many of which cannot be complied with in full and too many of which are simply not applicable. Some products are covered by a multiplicity of labels that advertise that there are hazards. The first requirement of the Machinery Directive is to reduce risk so that there is no need to identify hazards. If the hazards identified by a label can be remedied, this is a clear violation of the Machinery Directive and should be avoided.
Observations in Technical Files.
The first clause of the Machinery Directive identifies three definitions and is an invitation to manufacturers to identify danger zones around their machine, operators and anyone who might be exposed to hazards on a machine. Without this information it is very difficult to complete a hazard and risk assessment which is the first step in considering compliance with the Machinery Directive.
Invariably manufacturers do not identify danger zones, operators and others people who might be at risk and frequently do not conduct an adequate hazard and risk assessment. All to often when a hazard and risk assessment is conducted only technical staff are involved and others who should be consulted are not. If a good hazard and risk assessment is not conducted it is also too easy to over or underestimate risks associated with different hazards and in some cases this has proved very costly.
When guarding is used to protect operators from hazards on a machine, this is normally designed quite adequately but all too often manufacturers believe that this is all that is required to comply with the Machinery Directive. While the Machinery Directive has large sections that are concerned with mechanical safety it has just as many that are concerned with the safety and integrity of electrical, mechanical and hydraulic control systems, and this tends to be overlooked. The section concerned with break up in normal operation addresses the mechanical strength of structures and components and the factors of safety that have been used, yet few Technical Files cover this in sufficient detail.
A very good measure of whether a manufacturer has complied adequately with the Machinery Directive is to examine the technical documentation that is supplied with a machine. The Machinery Directive has very specific requirements and if these are not satisfied, it is quite obvious. Notable examples are the absence of a proper description of what a machine has been designed to achieve and no reference to abnormal uses to which it should not be put. Other examples are failure to identify the location and purpose of controls, an absence of instruction on how to dismantle and reassemble a machine, no reference to the weight of heavy machine parts, filling or drainage points and little on how to inspect parts for wear. In some cases even circuit diagrams, particularly those relating to hydraulic and pneumatic control systems, are omitted.
User reaction.
Users need to know that the machines they purchase are safe because under the Provision and Use of Work Equipment Regulations, they take final responsibility for the safety of any machinery that they operate. The are also obliged to train their operators and rely on good information to achieve this. Users are getting better at identifying non-compliance with the Machinery Directive and once they have doubts can take quite positive action. Usually their first action is to invite a manufacturer to rectify a non-compliance on a machine and if this is achieved nothing more is said.
Users tend not to complain to regulatory bodies, because they are only interested in putting a machine into service and can do without other complications. If they are unsuccessful in getting a manufacturer to rectify non-compliance they will often implement their own solutions and deduct the cost of taking this action from the final bill. In more serious cases they have been known to withhold their final payment and have been very successful in justifying this action.
Conclusion.
Progressively the machinery industry is beginning to regulate itself and manufacturers are increasingly at risk if they fail to comply with the Machinery and other relevant European Directives. Many foreign manufacturers feel they are more at risk because they are facing competition from European manufacturers, but even European manufacturers are now coming under scrutiny.
There are a growing number of foreign manufacturers that have put substantial investment into making sure that their products are in full compliance with European Directives and their CE marking is beginning to gain more acceptance than that of their European competitors. These manufacturers are finding that they can use this to commercial advantage and many Japanese manufacturers have been successful in this.
Unless a manufacturer is able to work in strict accordance with a European standard that has specifically been written for their type of machine, it is necessary for to prepare a Technical File. This file is the only legal basis on which a manufacturer can justify making a claim of compliance with European directives for the purpose of applying the CE marking. Frequently Technical Files are not adequate and manufacturers could be vulnerable if a competitor or user challenges them.
Even when a manufacturer observes a European standard that has been specifically written for their type of machine, of which there are actually very few, they can only claim a presumption of compliance with the Machinery Directive. If they adopt this course of action they are still required to ensure that the standard fully satisfies all of the requirements of relevant European directives, because when they make their declaration of compliance with these directives they are claiming that they meet all of their requirements. Standards are only as good as the people that write them, and can lack the level of detail needed by all manufacturers to satisfy all requirements of the Machinery Directive. Since manufacturers have the final legal responsibility they should be very sure that any standards they use are adequate for their purpose. In addition manufacturers must prepare some form of file that explains why they comply with a standard.
Users are beginning to learn more about how to inspect machines to determine whether they comply with European Directives. As their knowledge improves they are becoming increasingly critical of manufacturers who do not properly comply with European Directives and can take positive steps to remedy this.
It is generally recognized that industry resents the imposition of European Directives and as a result is loath to invest in CE marking or access expert advice. Regrettably, this is not only a false economy, but also a failure to realize that machines that are in full compliance with European directives are highly saleable. There are credible organizations that can help manufacturers without imposing high charges and their involvement can actually reduce cost because they have ready access to the correct answers. CE marking need not be burdensome and can be turned to commercial advantage. It is one thing for machinery manufacturers to certify their own machines, but increasingly the credibility of their CE marking is going to be challenged and now is the time to prepare.
