FEATURE TEST & MEASUREMENT
REDUCING RISK IN PRODUCT DESIGN AND DEVELOPMENT
Traditionally test standards have developed at a much slower rate than the pace of technology innovation. Chris Guy, UK Divisional
Director, TÜV SÜD Product Service, says incorporating the concept and application of risk management in the design and production stage of a product reduces risk at all stages of product development, helping to make a genuine contribution to the development process
A
ll European product directives now incorporate a requirement for risk
management, and the conformity assessment process requires a manufacturer to undertake a risk analysis and assessment. Many manufacturers are struggling to become fully cognisant of these changes, as there is no explicit description of the risk assessment process within the standards, it is instead referenced in the European Union’s (EU) New Legislative Framework (NFL). The EC’s Blue Guide on the implementation of EU product rules is a useful reference to understand all of the directives, regulations and decisions that are combined within the NFL. The risk assessment can be presented
in any format, but it is important to remember to keep it simple, so that the focus remains on showing how the equipment is compliant. However, there is a minimum amount of information that should be included for a risk assessment to be considered adequate. The risk assessment should primarily consider the intended use of the product, as outlined in its instructions, and the reasonably foreseeable use. Foreseeable use is quite subjective, so a reasonable consideration should be made according to the product type, environment and end-users. The risk management process must be used throughout the design process and product realisation to determine whether a particular requirement is applicable or not, whether an alternative requirement can be substituted, and whether it can be satisfied with alternative test criteria or testing procedures. It is essential that for any new product risk is first assessed and tested to meet the standard. An adequate risk analysis and assessment should cover product definition - identifying functions and features, together with labelling information and instructions for use,
14 MAY 2018 | ELECTRICAL ENGINEERING
including associated accessories or components. Risk identification should also be covered – identifying the hazards and subjects at risk, how the hazard may harm the subjects at risk, the potential harm, and the likely severity of harm. The foreseeable level of harm to the subject and probability must be assessed to determine the level of risk. Lastly, the analysis should cover risk reduction/mitigation to demonstrate how the risks are controlled. Controlled risk evaluation should be carried out once risks have been reduced in order to re-evaluate the risk level.
ASSESSING RISK Risk is a combination of the probability of occurrence of harm and the severity of that harm. A commonly used approach is to issue a number as a weighting for each probable risk and then multiply by the possible severity to reveal the risk level. It is important to remember that this combination does not necessarily mean ‘multiplication’, as multiplying the numbers is not always reliable and a certain amount of common sense should also be used. It is therefore important not to just accept the final risk level, but review how likely this is to occur as part of the risk management process and mitigate for it if necessary. For existing products, use historical user data as part of the risk management process, such as failures and accident rates. Also, look at customer complaints and warranty returns. If it is a new product with similar ones already on the market it is also possible to benchmark against those and use their data. The risk analysis and assessment should include the identification of applicable essential requirements, and the selection of appropriate harmonised standards, or other specifications as risk reduction measures. The assessment
should also include a conclusive statement that confirms the product’s overall compliance as a result of the risk assessment.
The risk management process must be used throughout the design process and product realisation
CONTINUAL PROCESS Risk assessment should be instigated at the start of the conformity assessment process, and not at the end, as many manufacturers may previously have done. Compliance risk management must be a continual process, and the manufacturer must re-assess the risks with every product modification. Where compliance is shown to be affected, the subsequent risk controls should be established and documented in the technical file before updating the declaration of conformity and/or EU-type examination certification as appropriate. While individual standards do not contain explicit descriptions of the appropriate risk assessment process, two useful reference documents exist to guide you. ‘ISO 31000:2009 – Risk Management Principles & Guideline’ details best practice, while ‘EN 31010:2010 – Risk Assessment Techniques’ delivers a detailed overview of what methods can be applied in a risks assessment scenario. While risk assessment is a vital part
It is essential that for any new product risk is first assessed and tested to meet the standard
of product development, every risk and associated risk reduction measure is not always adequately documented. Aside from complying with CE marking requirements under the NFL, effective risk assessment enables manufacturers to quickly foresee any potential problems early on in the product development process. Implementing such risk reduction measures is a key part of ensuring that products are both reliable and safe to use.
TÜV SÜD
www.tuv-sud.co.uk
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