In the second of our in-depth articles from Vic Clements of RFI Global, we examine the hot topic of compliance with the RoHS Directive, particularly what levels and types of evidence are required
We should have always been suspicious about how easy it would be to comply with the RoHS legislation because of the small number of pages in the directive. How very easy to find its requirements, but what a challenge to figure out what compliance means and how to demonstrate it.
One of the biggest failings of the directive is the lack of definition of any conformity assessment procedure. Those of us familiar with the CE regime will know that such procedures are always included in New Approach directives defining the processes and documentary evidence needed to demonstrate compliance. The omission of such a procedure from RoHS is somewhat of a surprise. While it is not a CE marking directive, it has been brought in under Article 95 of the EU Treaty which means that it has, as its basis, the preservation and facilitation of the Single Market.
It could be argued that giving the Member States each the opportunity to have their own and differing compliance procedures is not the best way to support the Single Market and we can only hope that the UK’s efforts to establish a common approach to compliance throughout the EU will bear fruit. It remains to be seen whether Member States adopt a common procedure or choice of procedures in their national transpositions.
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Vic Clements
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Without any definition of what compliance evidence is required, we must go back to basics. The first problem is determining exactly what compliance means. The law requires that products containing more than the maximum concentration values of the restricted substances are not sold after 1st July 2006. Any producer continuing to supply non-conforming products will be committing an offence and be open to prosecution. The problem arises because of the way the concentration values are defined as percentages by weight in homogeneous materials.
This is not universally understood and is sometimes misinterpreted leading to situations where producers believe their products are compliant where in reality they may not be.
As an example I have seen letters from manufacturers to their suppliers requesting them to confirm that the components they supply have less than 1000ppm of lead, mercury etc. This of course is a meaningless question in the context of RoHS as it is the concentrations in the homogeneous materials in the components that need to be determined not the concentrations in the components themselves.
A wire-wound resistor for example could contain six or seven separate homogeneous materials so knowing or asking about the concentration in the component is a waste of time and effort and will tell the producer nothing about the compliance status of his product. It is important that the correct questions are asked in order to get meaningful answers.
It is not only suppliers who sometimes misinterpret the meaning of compliance. I have seen a test report from a reputable laboratory that clearly showed measurements of concentrations as a percentage of the weight of the product tested. These, as to be expected, were well within the limits allowed and the manufacturer believed in all innocence that his product was compliant. Worse than this he had been assured by the laboratory in question that this was the case and had been given a compliance “approval certificate”.
Clearly establishing RoHS compliance of a finished product by testing is neither practical nor cost effective in all but the simplest products. In order to do this properly and accurately the product would need to be disassembled then broken down, separated and ground up into all its constituent homogeneous materials which could number in the thousands. Each one of these would then need to be analysed to determine the concentration values of the restricted substances. Any single homogeneous material exceeding the limits would result in a non-compliant product.
Compliance is not really measurable at the finished product level and I would be cautious with any laboratory claiming to be able to do this particularly if they offer a third party “approval”. Check that they understand what they should be measuring and that they have costed it correctly and remember that a test report is not legally required as evidence of compliance.
So what evidence will be required by the enforcing authorities? UK Statutory Instrument 2005 No.2748 implementing RoHS into UK law has now been published but as expected, it contains little that is instructive on the subject of compliance evidence. Regulation 8 requires that technical documentation is prepared and submitted if required to the Secretary of State (in actuality the enforcing authority) showing that the equipment in question complies. It does not give any further indication as to the nature and extent of this evidence. However Regulation 16 provides for a defence of due diligence in the event of prosecution and it is this that can give greater insight into what the compliance evidence needs to be.
Under the regulation it shall be a defence to show that a person had taken all reasonable steps and exercised all due diligence to avoid committing the offence but of course it does not and cannot define what “reasonable” steps are or what “diligence“ is, as this is for the court to decide. It is not always possible to predict what a court may find to be “reasonable” under the circumstances and this concept is very much a tenet of English Law and does not necessarily automatically translate into the continental Napoleonic Legal Code so don’t assume that it will be the basis of other Member State provisions.
Further help here comes from the National Weights and Measures Laboratory (NWML) which has been appointed as the RoHS enforcing agency in the UK. The website www.rohs.gov.uk contains useful information and a description of due diligence and what it might mean and I do not intend to reproduce that here. Suffice it to say that it will be expected that producers set up management systems to control the content of their products through the supply chain and that they must beable to demonstrate that these systems are worked correctly.
It emphasises that the extent of the measures and level of evidence must be balanced against the risk of non-compliance. The evidence must reflect the activities undertaken to firstly determine and then maintain compliance. This is a classical quality system type approach involving the implementation of a documented system verified by audit.
RoHS compliance can only be achieved by addressing firstly internal processes to ensure that the offending substances are not added to the product during stages of in–house manufacture and secondly, and most critically, the compliance of components and materials down the supply chain. Two basic strategies are available for determining and assuring supply chain compliance with RoHS, these are supplier declarations and material/substance level data.
The first of these is simply the collecting of declarations from your immediate first tier suppliers that confirm the products they supply you comply. This is the simplest and lowest cost approach but how much can you rely on the veracity of the declaration? The supplier could be lying. The supplier could be honest, but in error due to misunderstanding or inaccurate information from his suppliers, and of course you must ask the right questions.
It is essential that the supplier declares that levels in homogeneous materials are not exceeded, not the concentrations in components. Employing supplier questionnaires consisting of declarations plus supplementary questions give a little more confidence as they force the supplier to think more about the answers and so give you more insight into reliability of response, however the answers could still be inaccurate due to lack of understanding or false information further down supply chain. It may be appropriate to carry out supplier audits or have analysis done in cases where the risk of non-compliance or lack of veracity of information is considered high.
The second approach requires suppliers to provide details of what their products contain at the homogeneous material level, in the form of material/substance level declarations. By definition this approach gives added confidence as in order to provide you with the data your first tier suppliers must dig deeper into their supply chains but this will add significant cost and effort in terms of collecting and handling the data. Consideration must be given to the most effective way of handling the increased logistics.
Substance level data has to be collected, collated and transmitted in an accurate fashion up the supply chain. This can be done manually with spreadsheets or electronically with software.
Clearly these two approaches differ in terms of the level of confidence versus risk that they afford and complexity in their implementation. Risk of non-compliance increases with the likelihood of inaccurate or incorrect data or information and the longer and more complex your supply chains are, the less confident you can be that this is the case.
In any given approach there are confidence-building measures that can be employed in the form of supplier audits and chemical analysis. As in all things, the more confidence you require, the more you will have to pay in terms of time effort and money. The main difference between the two approaches is that collecting substance level data provides a higher level of confidence and lower risk at the expense of a significant increase in effort and complexity.
In order to decide which approach is appropriate you must consider the of risk of non-compliance of the product, the risk of having inadequate evidence associated with each, and the degree to which you wish to employ confidence building activities to reduce this risk. Bear in mind that the more confident you want to be that your products are indeed compliant and that you can satisfactorily demonstrate this, the more complex your activities will be and the more you will have to pay.
There are unfortunately no hard and fast rules here. It seem to be that if you are happy that your products are compliant, then go ahead and declare that and hope in the event of challenge the enforcing authority agrees with you. It may well be that the NWML will give further guidance when enforcement starts and we can only hope that the Member States will all institute the same or similar approaches. We may well have to wait for test cases to establish precedent.
Vic Clements is a specialist in RoHS and WEEE legislation at UK test house RFI Global Services
The first article in this series looked at the forthcoming European environmental legislation, and asked who is responsible under the legislation
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