Product Safety Standards have historically been based on fairly well-defined design, marking, labeling, & test requirements. The intent being a “repeatable and reliable” set of requirements that, at least theoretically, leads different parties to reach the same results and conclusions when using the same standard. This process of course limits the ability to use manufacturers’ input and “other considerations” in determining product compliance with the standards.
However, there is another established method of product safety that involves using a Risk Assessment to verify that a product incorporates suitable hazard mitigation methods to achieve a reasonable level of safety. Manufacturers of a few unique product types including medical products and industrial machinery have commonly used Risk Assessments in determining the safety of their products. However, most other product manufacturers have never prepared a formal Risk Assessment for their products. In fact, many product manufacturers do not know what a Risk Assessment is or how to prepare a Risk Assessment. Of course most manufacturers consider safety concerns, design in safety features, and obtain safety certifications for their products. Even so, for several reasons, product manufacturers that do not currently prepare written Risk Assessments for their products may want to reconsider.
The Standards are Changing:
There is a growing trend of incorporating Risk Assessment options into Product Safety standards. Several very well-known safety standards and compliance systems are being updated to include RA based requirements. If the standards that apply to your product are changing, you certainly may need a Risk Assessment. This includes:
- The upcoming transition to new hazard based standards IEC62368, EN62368, UL62368, & CSA62368 replacing the ITE standards IEC60950, EN60950, UL60950, CSA60950 and the Audio/Video standards IEC60065, EN60065, UL60065, CSA60065.
- The Laboratory, Test, Measurement, & Control standards IEC61010, EN61010, UL61010, & CSA61010, which added Risk Assessment based requirements beginning with the 3rd edition.
- The CE Machinery Directive which requires a Risk Assessment. Many manufacturers that meet UL & CSA standards in the US/CAN that are not RA based, fall under the CE-Machinery Directive and are having to prepare a Risk Assessment for the first time.
What is a Risk Assessment?
A Risk Assessment is a method to identify all hazards and quantify their level of risk within a product. This typically involves a written summary of the potential hazards associated with a product, with a numerical assessment of the likelihood of occurrence and severity of injury presented from each hazard. The RA also documents the hazard mitigation methods that provide protection from each hazard and how that reduces the hazard risk to an acceptable level.
The key to understanding the Risk Assessment process is that the manufacturer is to consider “all” potential risks, not just the 5 or 6 hazards defined in most product safety standards (electrical shock, electrical energy, fire, injury, chemicals, radiation). This is where the difficulty can begin for most 1st time preparers of a Risk Assessment – what hazards to consider? Many users are looking for a list to consider. Lists can help get the thought process started but it is important to think of the possible hazards and misuses based on your specific product, intended uses for the product, environment in which it is used, and the targeted users.
Reasonably Foreseeable Misuse:
Another key consideration is that all “reasonably foreseeable misuse” of the product must be considered. IEC61010-1 provides a definition for the term, stating that reasonably foreseeable misuse is “use of a product in a way not intended by the supplier, but which may result from readily predictable human behavior”. For the purpose of a risk assessment, that would be limited to reasonably foreseeable misuse that presents hazard risk.
This process begins by defining the intended use of the product including limits of operation, followed by a list of things a reasonable user might do with the product that it was not intended for = someone in a hurry, someone who didn’t read the manual, someone who is under pressure to increase output, someone who isn’t paying attention, someone who is tired, someone who is careless, someone who loses control of the product, etc. This could also include actions by users who don’t fit the average user profile (children, teens, small, large, short, tall, disabled).
Defining Tolerable Risk:
The manufacturer must also define their Tolerable Risk level using a Risk Table. This is an important piece of the Risk Assessment process. The manufacturer’s Tolerable Risk Table is used with the Risk Assessment to determine when additional mitigation methods must be employed until all hazards are mitigated to a tolerable level.
Standards for Risk Assessment:
Industries with a history of preparing Risk Assessment have several good standards that include lists of potential hazards and foreseeable misuse for a specific product type = medical (ISO14971), machinery (EN/ISO12100), and semiconductor products (SEMI S10). If you make another type of product, the machinery standard EN12100 is very educational in the process of developing a Risk Assessment including examples of many different types of hazards to consider. This standard would be helpful to anyone developing a Risk Assessment for the first time. Annex J of IEC61010-1 also provides a good, simple guide to creating an RA. There are also a few related standards for insuring the safety of software (medical software IEC62304) as well as functional safety (SIL ratings per IEC61508). These standards are often used as a means to mitigate potential hazards to a tolerable level.
Facts of a Risk Assessment:
- The basic elements of an RA must be included as described above. However, there is no required format – most of the requirements involving a Risk Assessment do not specify what format must be used = any format is acceptable including established FMEA (failure mode engineering analysis) and DFMEA (design failure mode engineering analysis) methods.
- It is a subjective process quantifying the likelihood and severity for each potential hazard – so no two Risk Assessments are alike.
- The outcome can vary based on a manufacturer’s tolerance for risk – different manufacturers prepare different risk tables.
- The outcome can change over time based on user experiences = the Risk Assessment can be updated, and additional mitigation methods can be added, if it is found that you underestimated the likelihood of an event occurring or the severity of the outcome.
Users not following an instruction or marking? It is common for manufacturers to overestimate the benefits of markings and instructions, especially for products that require no user training.
- The manufacturer prepares and maintains the Risk Assessment. The Certification agency may provide feedback on the Risk Assessment asking that it address specific potential hazards or questioning the level of mitigation afforded by specific safety features.
Should Every Product Have A Risk Assessment?
Even if your product safety standard has not added Risk Assessment based requirements, it is a very good idea for manufacturers to prepare a Risk Assessment. Why? Because manufacturers have ultimate liability = regardless of the number of safety certifications your product has, if someone is hurt by your product, you can be sued and found liable. If you simply meet the requirements in the safety standard without considering if other hazards are present in your product, you open yourself up to the potential for significant liability should your user encounter the hazard you overlooked.
Conclusions: For a few product categories, Risk Assessments are a common part of the product development and certification process. For others, new editions of several standards are introducing requirements that either specify the use or offer an alternative approach using a Risk Assessment. And yet, even if you are not required to have a Risk Assessment, the benefits that can be provided by the Risk Assessment process suggests that all product manufacturers should consider preparing a Risk Assessment as part of their product design system.
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