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Administrative Compliance: Your Achilles Heel?

This article outlines the administrative obligations contained in the European EMC Directive, 2004/108/EC, with particular reference to the Declaration of Conformity (DoC).  It considers the mounting evidence, including that resulting from European market surveillance campaigns, that insufficient attention is paid to ensuring that the supporting documentation is not only in place, but also up to date.

The requirements of the EMC Directive, like all New Approach directives, can be broadly split into two;

  • the technical requirements and
  • the administrative requirements

Compliance with the technical requirements is demonstrated (in most cases) by assessing a product against the relevant harmonised European standards and compliance with the administrative requirements is demonstrated by ensuring that the requisite documents and paperwork are available and up to date. In the case of the EMC Directive, the requisite paperwork is normally Technical Documentation and a valid DoC.

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Only by meeting both the technical and the administrative obligations should the CE Marking be affixed to a product and the product placed on the market.

ADMINISTRATIVE REQUIREMENTS

Whilst concerns regarding the number (or suspected number) of non-compliant products on the market is nothing new, historically many of these concerns have tended to relate to the technical aspects of compliance.

Deficiencies in administrative compliance have, with the exception of market surveillance activities, only tended to come to light when a DoC has been requested by a potential customer and the manufacturer has been unable to supply one in a reasonable time frame.

Under both 89/336/EEC and 2004/108/EC, there is a stated requirement to produce a valid DoC and the minimum requirements of what it should contain are clearly stated as follows:

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  • reference to the Directive
  • identification of the apparatus to which it refers
  • name and address of the manufacturer and, where applicable, the name and address of his authorized representative in the Community
  • dated reference to the specifications under which conformity is declared to ensure the conformity of the apparatus with the provisions of this Directive
  • date of the declaration
  • identity and signature of the person empowered to bind the manufacturer or his authorized representative

MARKET SURVEILLANCE ACTIVITIES

The EMC Administrative Co-operation Working Group (ADCO) carried out the 4th EMC Market Surveillance Campaign during 2011.

The primary purpose of the campaign was to assess the compliance of a range of LED lighting products with the administrative and technical requirements of the EMC Directive. Administrative compliance included checking of the DoC.

The results of the surveillance activities were published towards the end of 2011 [1]. The overall administrative compliance was found to be only 28.8% with the main deficiencies relating to the CE marking and the DoC.

Declarations of Conformity were available for only 74.4% of the assessed LED lighting equipment, meaning that 1 in 4 assessed products did not have a DoC available. It is possible that some of those products may have been technically compliant, however as they were not administratively compliant, they did not meet the requirements of the EMC Directive.

Almost half of DoCs presented had major deficiencies including:

  • missing reference to the Directive
  • incorrect Directive referenced
  • inadequate identification of the product
  • incorrect standards
  • not issued by the manufacturer and/or authorised representative

Overall, only 39.9% of the assessed products were presented with an acceptable Declaration of Conformity. In other words 61.1% of the assessed products were not presented with an acceptable Declaration of Conformity, either because one did not exist or because it had major deficiencies.

Previous EMC Market Surveillance Campaigns raised similar concerns about compliance levels generally and administrative compliance specifically.

FURTHER EVIDENCE

The ADCO market surveillance results of 2011 reflect the compliance position of the LED market; a fast growing and fast changing industry.

Are the deficiencies identified in DoCs for LED lighting products representative of those commonly found elsewhere?

At York EMC Services (YES) we see a significant number of DoCs each year, either via our DoC Checking Service or as part of our wider consultancy work and therefore an answer to the question above is readily available. And that answer is an emphatic “yes”; all the issues identified in the market surveillance activities for LED lighting are commonly observed by YES across a wide range of different industry sectors.

Probably less than 10% of DoCs that arrive at YES for assessment could be classed as being anywhere approaching correct with the other 90% containing a range of deficiencies, many of which would be considered as major.

Given the copious number of sources of information for what should be included on a DoC; specialist training providers, consultants, industry websites and even the EMC Directive itself this is a disappointing state of affairs.

As regards deficiencies, there are a number of recurring themes, of which the top 3 are:

  1. The standards are incorrectly applied, out of date or undated
  2. The reference to the Directive is incorrect
  3. Identification of the apparatus covered by the DoC is inadequate

Each of these will now be considered in turn including typical examples of where and how the requirements have not been met.


STANDARDS

The most common issues, by some distance, relate to the presentation of standards on a DoC. These issues break down into a number of subcategories which will be considered in more detail.

Perhaps to start off on a positive note, it is worth stating that it unusual to see a DoC where the manufacturer has selected completely incorrect product specific or generic standards. No doubt these do exist but, it seems, not in significant numbers.

Listing basic standards
It is relatively common to see a DoC which lists basic standards as opposed to product specific or generic standards. Figure 1 shows a typical example.


Figure 1: References to basic standards are commonplace

CE Marking is based on the correct application of harmonised European standards which includes product specific and generic standards. In lay terms, basic standards, which contain details of the test methods, are the support acts to product specific and generic standards. They are not “CE Marking” standards and are not listed in the OJ. A DoC should be made against product specific and/or generic standards as appropriate.

In relation to Figure 1, there are several questions that the DoC does not answer:

  • Against which standards is the product being declared for EMC? The answer to this question is that we simply don’t know. EN61000-4-X immunity standards are referenced by virtually every product specific and generic standard published in recent years. Conspicuous by its absence is reference to EN61000-4-3 for radiated immunity.
  • What about emissions? There are no emission standards listed at all.
  • Against which standards is the product being declared for electrical safety? The Low Voltage Directive is listed on the DoC but it contains no safety standards, so again the answer is that we simply don’t know.

Correct versions of standards
By far the most common issue relating to standards occurs when the product has been correctly assessed against a particular version of a standard, but that standard has subsequently been updated and either an amendment and/or a new version has been published. The transition period has then passed and as a result the DoC has become invalid.

Two examples of recently reviewed DoCs are shown In Figures 2 and 3. There is plenty of other potential discussion relating to the information contained in both Figures 2 and 3.


Figure 2: References to old generic standards are still commonplace


Figure 3: References to IEC801-X standards still exist but are fortunately not that commonplace

More specifically, and what can’t be seen from the snippet used in Figure 3, is that the DoC was signed in 2003. Therefore all of the standards listed were considerably out of date even at the time the DoC was signed!

Undated standards
All standards change on a regular basis either by amendment or publication of a new version. The newer standard may contain different tests or test limits/levels or other changes that affect how the product is assessed.

A standard listed on a DoC without an associated date means that is not possible to identify the precise version of the standard to which the product is being declared and by association the actual test requirements that have been met. Figure 4 shows an example of where undated standards have been included on the DoC.

In addition (and leaving aside the fact that most of the standards are undated) Figure 4 shows a DoC for a product meeting an impressively long list of EMC standards.

Figure 4: Keeping options open!

This must certainly be an interesting product; a cross between Information Technology Equipment (ITE) and a household appliance which is also Industrial, Scientific and Medical (ISM) Equipment and used in an industrial environment!

Upon further investigation, it transpired that the product covered by this DoC was in fact a piece of measurement equipment falling within the scope of EN61326-1; which isn’t actually listed!

REFERENCE TO THE DIRECTIVE

When doing presentations on the subject of DoCs I have often found myself anecdotally stating that I am as likely to review a DoC which references 89/336/EEC on as I am one which references 2004/108/EC. Several years since the passing of 89/336/EEC this still seems to be the case.

When researching for this paper, I picked 10 of the most recently assessed DoCs to check the frequency at which 89/336/EEC still appeared. Sure enough the 10 DoCs were split exactly 50/50; 5 referring to 89/336/EEC and 5 referring to 2004/108/EC.

Most of the examples used in this paper to illustrate other issues also make reference to 89/336/EEC.

DESCRIPTION OF THE APPARATUS

One of the key information requirements for a DoC is that the product(s) included should be able to be clearly identified. For manufacturers having a large number of products this can be a challenge but an important one to undertake. It should be possible to uniquely trace each product to a DoC; without ambiguity.

Figure 5 illustrates a common issue where the manufacturer is inadequately describing the scope of the DoC.

Figure 5: The statement “a range of” on a DoC is far too commonplace

The phrase “a range of” only defines the scope of the DoC in general terms. What products, types, models and/or variants are included in this range? The answer is that it is impossible to tell without additional information and furthermore it is highly likely that “the range” will change over time further reducing the traceability.

Figure 6 shows a good example of how to identify products within the scope of the DoC. In this example the actual product numbers can be identified clearly and unambiguously.

 

Figure 6: Robust identification of the products covered by a DoC

CONCLUSION

There is clear evidence that many products placed on the market are not compliant with the administrative requirements of the EMC Directive and therefore not compliant with the EMC Directive.

A recurring theme, when assessing DoCs, is that many were clearly valid when issued but have become invalid over time through not being maintained. This is demonstrated by the number of out of date standards that are often encountered.

What this reveals is that the issuing of a DoC is perceived by many manufacturers to be a one-off, isolated event rather than part of a compliance process.

In practice, issuing a DoC is simply one event in a whole series of events that when brought together form the compliance process for the product from concept to retirement from sale.

Ensuring on-going compliance (both technical and administrative) after the product is placed on the market is one phase of this process and the one that includes maintenance of the DoC.

A DoC should be a living document that is regularly reviewed to ensure that it accurately reflects the state of compliance of the product to which it refers. There should be a valid DoC for each day that the product is placed on the market.

Often an invalid DoC is just the tip of the iceberg and inevitably raises other questions about the technical compliance of the product.

  • Is it simply the case that the DoC hasn’t been updated or is there more to it?
  • Is it also the case that the changes to the standards have not been assessed for their technical significance to the product in question?
  • If the DoC is invalid, what is the likelihood that the Technical Documentation is also invalid?
  • If the DoC hasn’t been updated for several years, is it also the case that the product has changed in the meantime and that an EMC assessment carried out previously is no longer valid?

In other words could an invalid DoC be an indication that the product is actually neither administratively nor technically compliant….?

REFERENCE

  1. 4th EMC Market Surveillance Campaign, EMC Administrative Co-operation Working Group, 2011

 

Nick Wainwright
Nick has been involved with EMC all his working life, starting as an EMC test engineer in the telecommunications industry before moving into commercial testing.

He joined York Electronics Centre, the predecessor to York EMC Services, in 1990 as an EMC Test Engineer and worked his way up the organization until this year he was given the task of running the 40 strong company as Chief Operating Officer.

Nick takes a very hands-on approach to the roles he undertakes and has specified and designed EMC test facilities and implemented quality systems within laboratories to enable them to achieve accreditation to ISO17025.

Nick is a regular speaker at EMC conferences, courses and workshops on subjects ranging from CE Marking and standards to testing, ISO17025 and measurement uncertainty.

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