Doctoring the DoC
Author : Ron Sinclair MBE, SGS Baseefa
12 April 2013
It is now nearly 10 years since UK ATEX Directive Notified Bodies were asked by the then Department of Trade and Industry (DTI, now BIS, the Department for Business, Innovation and Skills) to add a level of monitoring to Declarations of Conformity (DoCs) during regular surveillance visits to manufacturers.
Until that time, we had been told that, since the DoC is a legal document produced by the manufacturer and it was not mentioned in EN 13980, we should not investigate or pass comment: it was none of our business. Then a new incumbent at the DTI became aware that many DoCs were, to put it very politely, inaccurate, although a correct term might have been “utter rubbish”.
In the intervening period, we have worked with manufacturers to try to help them to understand the requirements in Annex X of the directive (or, in extreme cases, even to make them aware of its existence).
So why raise the subject now? Put very simply, the publication and transition to EN 80079-34 from EN 13980 as the standard for QA Systems in the Ex manufacturing sector fully legitimises the activity and we should now (hopefully) also see some degree of monitoring elsewhere in Europe.
But how? It still does not mention DoCs directly, but a new clause 4.2.3( j) contains the sentence: ‘The manufacturer shall have a documented process to annually check the validity of all Ex-related certificates, standards, regulations and other external specifications.’
A simple way to check the effectiveness of such a process? Look at the DoCs. If they are wrong, the process is definitely not working. There is obviously more to it than that, but it does provide a very good starting place for auditing that clause.
We have been having an internal discussion at Baseefa as to whether the annual check required by the standard is sufficient, or whether it should be more frequent. In the end, we agreed with the wording in the standard. A typical standard becomes harmonised between two and six months after publication. The superseded standard usually loses harmonisation status three years after the publication of its successor. Thus an annual review should not exceed half of the transition period between standards, still leaving the manufacturer with about 18 months to get his house in order.
What does the manufacturer have to do? The answers are all given on the European Commission web site, but from my experience of dealing with some manufacturers (and from an occasional look at some LinkedIn forums), I have concluded that most people prefer to “phone a friend” rather than take the trouble to read the documents.
What must be remembered is that it is not a condition of the ATEX Directive that you should meet any particular standard. A standard is an easy route to the end, but not the only one. You can use harmonised standards (the easiest and most obvious option, if available), non-harmonised standards (though you have to justify their use), or no standards at all (provided you can demonstrate all the original research that proves your chosen solution is as adequate as using a harmonised standard).
As I indicated earlier, there is usually about 30 months overlap when both the new and the older standard enjoy harmonised status, so for a product under continuous development, to keep the applicable standards up-to-date need not be an issue.
If you do not wish to “update” the equipment, there are still options. The easiest is to be able to demonstrate that none of the significant differences between the two editions of the standard affect your particular equipment. Information is now available in each harmonised standard (in Annex ZY) clearly indicating which changes in the standard may be regarded as substantial.
For older editions, the European Notified Bodies Group has placed a compendium list on the EU Commission web site giving the identical information, right back to the EN 50014 series of standards.
Also, there is a separate document which amplifies the information given in 10.3 of the ATEX Guidelines (See ExNB/10/388/CS and ExNB/10/397/CS). These documents can be a little difficult to find, so I recommend using the links given at www.baseefa.com.
This will sort out how to separate harmonised from other standards (as required by the directive), and will leave, for most companies, just one remaining problem. Does the authorised signatory still work for the company? Many retired people might still find themselves in line for prosecution if their old company breaks the ATEX Rules.