Performing Risk Assessments under the new Gas Appliance Regulation
BSI has just completed a series of seminars and webinars in the UK to educate the industry about the new Gas Appliances Regulation (GAR) which came into force in April 2018 across the whole of the EU. Much of the change from the old Gas Appliances Directive to the new Regulation is administrative, but there is one new technical requirement that is clearly causing anxiety amongst manufacturers – the requirement to perform a risk assessment on all gas appliances and fittings in essential requirement 1.2:
This has to be used in conjunction with the new risk reduction requirement in 1.3:
Looking at the context of where these requirements came from, and considering events within the industry over the last few years, it seems to me that this is in response to a standards-making process that has often not been challenging the industry to continually improve the safety of gas appliances... there has been complacency in my personal opinion.
- Users of a cooker died because they closed the grill door (contrary to the product instructions)
- Camping stoves exploded because users cooked on a bigger pan than permitted by the instructions
- The pace of new technology, which introduces new risks faster than standards can respond
Placing the obligation onto the manufacturer to assess the risks from their own products would seem to be the best solution to these problems - it's also clear that this assessment must apply in addition to compliance with any of the standards.
The most common question I have been asked is about the mechanics of how the risk assessment should be made and whether it must be documented. Dealing with the second part first, the answer is a resounding "yes", as it is simply not possible to evidence the fact that you have shown due diligence unless the risk assessment has been documented. As a GAR Notified Body, BSI will expect to see these risk assessments as part of our conformity assessment to ensure they are reasonable.
Turning to the mechanics of the assessment, the regulation does not specify a method, so the manufacturer is free to use any methodology or tools they are comfortable with. There are many models available, but my favourite is the simple "9-box grid" which rates every risk identified by probability and impact (severity), allowing visibility of the most serious risks classified as "High" or "Medium".
Risks identified as High or Medium then need to be considered in the context of the risk reduction strategy laid out in essential requirement 1.3, often referred to as "terminate, treat, or tolerate", where risks are addressed through design solutions, with warnings and instructions used to deal with residual or low risks to try and minimise further.
As a classic example - consider some live electrical wires; it would be necessary to first consider insulating or enclosing them to prevent people touching them. If that was not technically feasible, (think gas cooker spark electrodes), then other solutions would be needed to make the situation safe, (current limiting in this case). Finally, a warning sign might be useful to address the residual risk facing service personnel who may need to gain access in order to make commissioning adjustments to the appliance.
Types of Risk to Consider
This is probably the trickiest part of the exercise and where most people were maybe looking for guidance, and I have broken it down into four main categories where I think that consideration of risks needs to be given:
1) Manufacturing Defects
Many people I have spoken to have not been considering this as one of the risks to be analysed, but I can see no reason why it should be excluded. Within the last few years, I have been involved with three horribly expensive product recalls, each of which arose because of production defects: two related to wrong versions of software being used; the other related to the wrong overheat thermostat being fitted to a product.
The critical parts of the design should be identified and a quality plan drawn up that includes inspections or tests to identify the fault if present. I'm sure many companies do this as a matter of course as part of their Quality Management System, but does it link to a product-specific risk assessment?
2) Installation Errors
This is a tricky part of the law. Article 3 of the Gas Appliances Regulation requires that appliances be safe and comply with the GAR when "normally used" - a term that is defined and means that appliances are "correctly installed and regularly serviced in accordance with the manufacturer's instructions". So this could mean that installation errors are not required to be considered, as there is simply no requirement for appliances or fittings to be safe when not installed correctly?
Personally, I think that would be a mistake, and manufacturers would be well-advised to consider the risks that could arise from errors made by the competent installer for the following reasons:
- Installer competence varies from country to country - in some countries, (UK and Germany for example), there is a well-regulated system of qualification and monitoring of gas installers while in other countries, installation is carried out by people that are basically plumbers. Installers will carry a responsibility in all markets, but the manufacturer should consider the target markets and the complexity of the installation to ensure these are compatible.
- In any market, installers may make reasonable mistakes, and appliance designs should be tolerant of these as far as practicable. If you specify a CO2 value of 9.35% in the flue as a commissioning level, then you should be sure that the appliance will be safe when it's set to a level that implies a reasonable level of accuracy on the part of the installer (say ± 0.5% in this case).
- Gas appliance safety standards take little account of reasonable installer error - I think there is an underlying, unwritten assumption in most standards that appliances are properly installed before starting any testing.
And then we have the products that are installed by the end-user and there is no "competent installer" involved. Things like barbecues, camping stoves and the like. Standards are still weak for these products and still contain the unwritten assumption that installation will be performed correctly.
These products need to be designed to be a little more fool-proof so that incorrect assembly becomes impossible or very difficult. The quality of instructions provided may also need improving. It might be ok to state that installation must be in accordance with "the rules in force" when dealing with professional installers who would reasonably be expected to know what the rules are, but do you really think a householder is going to go out and buy the installation standard to find out what is needed? Will the person buying a cooker for their camping trip understand what "adequate ventilation" is, or should that be explained more clearly?
3) Component Failures
Failure of key safety components like control thermostats is something that standards generally do address, so this part should not be too taxing to undertake. Despite the tests mandated by standards, it's always worth documenting an FMEA (Failure Modes Effects Analysis) to ensure the impact of component failure is understood. My favourite example of getting this wrong was the commercial boiler that used a separate control and overheat thermostat (as mandated by the standard), but mounted them using a single fixing, which was the component that failed in service, rendering both thermostats inoperative at the same time.
The other great example here relates to new technology - standards tend to be less useful here, as they are written around products that already exist. New technology often introduces new risks that were not considered in the past, so if you are planning to make your gas appliance operate via an app, or remotely via some "Internet of Things" gateway, you need to be sure that the risks associated with this model of operation have been identified and addressed. I can still recall the debates surrounding the first remote controlled gas fires, and the product recall that followed the discovery that one model could be unexpectedly switched on by a child's toy!
4) User or Operator Error
This is the biggest category of risk. Going back to the requirements, the GAR requires appliances and fittings to be safe when "normally used", which means "used in accordance with its intended purpose or in a way which can be reasonably foreseen". Intended purpose is what gets written in the user manual and the associated sales and marketing literature - so if I buy a product like a portable stove, one of the intended purposes is going to be cooking on a beach, and there is no point trying to weasel out of it later by warning me to "use on a firm level surface only" in small print within the instructions... the manufacturer needs to be sure that associated risks (of pan stability or air inlets being blocked by soft sand, for example) have been addressed by design.
"Reasonably foreseen" use becomes a much trickier concept, and manufacturers need to consider the reality of how people use their products in real life, and take these uses into account when designing them. Simply warning that such use is not permitted will not work, unless the other risk reduction techniques are not technically or economically feasible.
I had a look around my home today for some examples of things that may fall into the category of "reasonably foreseen" use:
- My lawnmower requires that I do not use it when it's raining. Well, newsflash, if I am cutting the grass and it starts raining, I usually don't stop.
- Our gas hob instructions state that I must not use a pan greater than 250mm diameter - has anyone bought a frying pan recently? I just went and measured ours and it's 290mm.
Techniques that manufacturers can use to identify reasonably foreseen use might include things like product user focus groups, or the collating of complaints and feedback from the field. It's a fast-moving subject though, and how long before manufacturers of toasters are required to take into account this little gem?
On 07 November 2017, we are running a practical and interactive workshop, focusing on completing Risk Assessments to the requirements of the GAR.
Author: Graham McKay
Global Head of Gas & Electrical Products