Product development risk reduction

However, 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), which was created to improve market surveillance and the quality of conformity assessments within the European Union. 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.

Two useful reference documents can be used as a guide to using an appropriate risk assessment process. ISO 31000:2009 – Risk Management Principles & Guideline – is the ‘bible’ of risk assessment as it 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.

Not only does the risk assessment process ensure that products meet regulatory requirements, it reduces the risk of costly non-compliance, which would require product re-designs and re-testing, and cause significant time-to-market delays for new and upgraded products. Risk assessments can also improve product performance and reliability by reducing the chances of failures, helping to strengthen a brand’s market reputation. 

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 then any tests to meet the standard completed.

An adequate risk analysis and assessment should cover:

• Product Definition - identify functions and features, together with labelling information and instructions for use. Associated accessories or components should also be identified
• Risk Identification – identify the hazards and subjects at risk
• How the hazard may harm the subjects at risk
• The potential harm
• The likely severity of harm - the foreseeable level of harm to the subject and probability must be assessed to determine the level of risk
• Risk reduction/mitigation –
demonstrate how the individual risks are controlled
• Controlled Risk Evaluation - once risks have been reduced, re-evaluate the risk level

Risk assessment

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 assessment should also include a conclusive statement which confirms the product’s overall compliance as a result of the risk assessment.

It is vital that the risk assessment is conducted at the start of the conformity assessment process, and
not at the end, and it must be a continual process that is reviewed 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.

Aside from complying with CE marking requirements under the NFL, implementing and fully documenting risk reduction measures is a core element to help ensure that products are both reliable and safe to use, having a positive impact on the end-user experience and ultimately their brand loyalty. It is such a risk assessment process that will enable designers to more effectively predict any problems in the early stages of design and development, to mitigate risk, minimise cost and optimise time to market.