Musings of an ATEX Auditor - By Roger Stillman, arcSIL Consulting

Meeting the requirements of the ATEX Directive 94/9/EC is mandatory for anyone placing on the market in Europe a product intended for use in potentially explosive atmospheres. The means for achieving this can vary, depending on the type of device and the level of risk in its intended use, from self-declaration to full-blown product certification by a Notified Body which includes periodic manufacturing audits to ensure on-going conformity of the products to their certified safety concepts. Failure in this respect can have dire consequences - remember Buncefield 2005?

As an independent consultant, I conduct such audits for two of the major Notified Bodies, Sira and Baseefa, against the requirements of the European standard EN 13980 which, itself, is an extension of ISO 9001 intended to meet the specific QA requirements of the Directive.

Over the years I have come across a number of problems which seem to be common to many manufacturers, some of which may strike a chord with readers of this article. They tend to fall into two main categories: interpretation of the Directive; application of EN 13980.

Aren’t these the same? Well... not entirely! The writers of EN 13980 took the view that some aspects of the Directive were the responsibility of the manufacturer, since they are legal requirements rather than technical, and hence are glossed over or not covered at all.

Interpreting the Directive

lMany manufacturers have not read it (not surprising as one tends to fall asleep by page two) nor even have a copy for reference: "the Law says I must have my product certified in order to sell it in Europe, which I’ve done, so what more do I need to know?"

lBoth the EU and the UK Government have published Guidelines on applying the Directive (or UK Regulations) but few people know that these exist nor how to find them.

lThose manufacturers who have made the attempt often miss some of the details buried deep within it but which, nevertheless, are legal requirements. Some examples:

n EC Declarations of Conformity (D of Cs): must be drawn up by manufacturers for all certified equipment (components have an ‘Attestation of Conformity’) and should accompany each item (or batch) sold. The wording on this varies, depending on the equipment category, but should give confidence that the product conforms to the latest state of the art.

n Technical ‘State of the Art’: manufacturers are required to take into account the latest technical knowledge regarding the safety of their product(s) and to apply it "immediately". This generally means applying the latest ‘harmonized’ protection concept standards, even when the products were originally certified to older standards appropriate at the time. In this case, the manufacturer should compare the old standard with the new and decide if the product still conforms. If not, he must submit it for further assessment and, possibly, re-certification, by a Notified Body.

n Harmonized Standards: standards which provide a presumption of meeting the essential health and safety requirements of the Directive throughout Europe. These standards are only considered ‘harmonized’ once they are published in the Official Journal of the EU - which is not the same as being released by the standards-writing bodies (there can be a considerable time-delay in publication in the OJ).

n Record-keeping: how often do I see a policy or procedure which just refers to ‘records relating to certified products’ (or some such wording) and which are to be kept for an ‘indefinite’ period. No! The Directive is quite specific about what records are to be kept for "a period ending at least 10 years after the last equipment was manufactured". These include the technical documentation which defines how the product meets its certified requirements and the certificates themselves, plus any additions, modifications etc. In addition, records must also be kept which demonstrate that the manufacturing processes met the QA requirements throughout the lifetime of production: description of the quality management system plus the decisions, reports and certificates from any external certifier as well as those from the Notified Body responsible for the issue of the Quality Assurance Notifications.

Application of EN 13980

Well, now, this should be easy as it is only ISO 9001:2000, plus some technical bits which are both good engineering practice and common sense. Isn’t it? Essentially, yes, but the Devil is in the details (and ‘common sense’ seems to be the least common of all the senses!):

l The first problem is that, as stated earlier, this standard deals with the QMS requirements for production to ensure consistent product conformity. It does not address details of any of the requirements of the Directive listed above, for example: Control of Records. All of the above aspects of record-keeping are ‘covered’ by the single need to retain: "those [records] arising from regulatory requirements" - which few people seem to have read.

l The second problem is that, although structured as ISO 9001:2000, it harks back more to earlier versions of ISO 9000 in requiring large amounts of documented procedures; this at a time when many enlightened manufacturers are moving away from this practice to electronic operational and engineering process systems with minimal reliance on detailed documentation. As a result I often find that certain aspects of EN 13980 get overlooked or are dealt with poorly. Examples include:

n Purchasing safety-critical components - inadequate verification that received items conform in every respect to certified requirements; over-reliance on ‘certificates of conformity’ from suppliers (often not worth the paper they are written on and rarely checked); no checks that the certification of pre-certified ATEX items is still valid; insufficient control over sub-contracted sub-assembly work especially when carried out overseas etc.

Internal auditing - concentrating on checking that procedures are being followed rather than exploring how effective the production processes are in ensuring the conformity of products to their certified criteria. For example: it is rare to find evidence of ‘vertical product’ audits which, by following the ‘paper trail’ from a finished product back through all the production records can check that all has been done competently, that the customer is going to receive what he asked for and which, by appropriate examination can show that it conforms to the certified design. The reason often given for not doing this is that "that is what we have inspectors for". Yes, but they usually look at only their section of work, not the whole picture, and what better way is there for ensuring that they do their job effectively?

n Management Reviews - again it is rare to find evidence to demonstrate that reviews examine the effectiveness of the management system with respect to certified products. Often, certified products make up only a very small proportion of the output and so consideration of them tends to get ‘lost in the noise’. The problem here is that, although small, it is this proportion that can land the company in a court of enquiry if something involving their product goes bang. Management need assurance that they can demonstrate ‘due diligence’ in meeting the requirements of the Directive. Even without this putative threat, there are financial implications to complying with certification, especially in respect of keeping up with harmonized standards etc, which may need tough commercial decisions to be taken.

n Product recall - the objective of the Directive is to ensure that products not meeting its Essential Health and Safety Requirements (EHSRs) are not placed on the market - confidence in this fact being demonstrated by relevant CE marking supported by appropriate certification where necessary. Hence manufacturers have an obligation to recover any non-conforming products they have sold which they believe to be dangerous. In such a circumstance, they are required to inform the relevant Notified Body, as well as affected customer(s) and keep written records of all corrective measures for at least 10 years. Since such events are usually (thankfully) rare, most manufacturers I visit have not considered it necessary to enshrine this requirement in their policies and procedures. They must do so.

Question: how much of this is applicable to a simple mechanical device such as a valve? Answer: very little to the valve itself since, generally, it can be considered a device which is incapable of causing an explosion through its own potential source of ignition (there
are exceptions however, see Peter Churm’s article on page 25).

However, it becomes a different story once actuators and monitoring devices are attached, especially those powered by electrical means. This now becomes
an assembly within the meaning of the Directive, of which the valve is a component, and this assembly falls into one or another category requiring CE marking under the Directive.

The IECEx Scheme (a footnote)

The ATEX Directive only exists for products sold for use in potentially explosive atmospheres within the member states of the EU. Outside Europe it has no legal meaning, although certification to it is sometimes demanded by organisations in other countries as a means of demonstrating a benchmark for safety.

Organisations in other countries, notably the mining community in Australia, decided that this benchmark was too low for their purposes as it only gives presumption of meeting the ATEX EHSRs for marketing. An approach was made to the International Electro-technical Commission (IEC), who set up a certification scheme for Ex products based on the applicable IEC standards.

The IECEx Scheme is similar to most product certification schemes in that, of itself, it has no mandatory legal requirements but is voluntary. Little known at first, the Scheme is gradually gaining more widespread recognition in terms of both rigour of application and international acceptance. Under the Scheme, unlike ATEX, all products undergo type-testing and certification, irrespective of their intended use, and all production facilities are subject to their quality management systems being subject to periodic audit by the Scheme’s approved certifiers. CE marking, along with the associated ATEX zone coding, is irrelevant (although the protection coding is not!) and there is no requirement for EU Declarations of Conformity.

It is interesting to note that, whereas ATEX certification can be awarded on the basis of IECEx certification plus a few additional assessments against the ATEX EHSRs, the reverse is not accepted. It is also interesting to note that the most recent EU harmonization process brings the European Norm standards in line with those of the IEC.

Roger Stillman regularly lectures at BVAA Training courses on the subject of Safety Integrity Levels (SILs), and can be contacted via e-mail:
rstill@tinyworld.co.uk

References

Links to sources of information on the ATEX Directive, its guidelines, harmonized standards, the IECEx Scheme can be found on the Sira and Baseefa websites:

www.baseefa.com (access ‘Links’ near the top right-hand corner)

www.siracertification.com (access ‘Downloads and Further Ex Information’ at the top of the page and follow ‘Useful Links’ on its drop-down menu)

www.iecex.com will take you directly to the Scheme’s homepage, but navigating to useful information can be quite tricky.

BVAA has produced its own ATEX guide for the valve industry.

Published: 25th September 2009