Hazard- and risk-based approaches to product design and manufacturing may be required by some standards, but they are also simply good practice. These approaches require a more holistic view of the product, intended use, skillset of users, materials, environment, and end-of-life. They allow for flexibility in future enhancements in technology, and they can help manufacturers create products that go beyond mere compliance to a safety standard but rather meet the needs of consumers. Such considerations for today and the future can help ensure success.

Technology often changes more quickly than standards. Consumer trends also adapt and evolve more quickly than the industry can keep up. It’s beneficial to take a more holistic look at the scenarios that could result in hazards or other risks a manufacturer wants to avoid. Some product standards such as IEC 60601-1 and 61010 recognize this and include requirements for risk assessment and management. Others such as IEC 62368, take a hazard-based approach. In either case it is a good idea for manufacturers and designers to take these approaches upon themselves because the result is simply a better product.

Risk-Based Approach

A risk-based approach starts with the premise that any product can pose a wide range of risks. It considers composition, intended use, materials, actual use, environmental issues and ultimate discarding. It can be complex, requiring knowledgeable teams and schedules that include for risk analysis throughout the design process, including time to make modifications.

Risk-based strategies should include:

• Foreseeable Use Assessment – In addition to intended use, consider how a product might be used in real-world conditions. Identify as many potential uses associated with the product as possible and evaluate them against data such as injury and fatality statistics, human factor assessments and critical parts research to predict a wider range of risks, which can be addressed.
• Design Hazard Analysis – This analysis can identify potential risks related to product design, such as sharp edges or corners, material selection, electrical components, etc. Potential risks should be addressed with design modifications early when they are less costly, easier to implement and will have less of an impact on production schedules.
• Physical Hazard Assessment – Could a product inadvertently result in suffocation, strangulations, unintended impact or burns? A physical hazard assessment will identify whether such issues are factors in a product’s design.
• Product Testing and Certification – Compliance testing to international product safety standards can be done with ISO 17025 and ISO 17065 accredited organizations to illustrate that a product meets safety standards and requirements. In the U.S., it is recommended to work with an OSHA-recognized Nationally Recognized Testing Laboratory (NRTL).
• Risk Assessment Screening – A comprehensive screening can identify and evaluate risks in both new and existing products. This weeds out potentially unsafe products and illustrates due diligence in ensuring the safety of all products.

The most recent international safety standards for electrical medical devices and laboratory equipment, IEC 60601-1 and IEC 61010 respectively, include requirements for risk management and analysis, documented in a risk management file (RMF). However, even if it isn’t a requirement, an RMF can be a useful tool for documenting and tracking risks, as well as steps taken for mitigation. There are four major concepts to consider when it comes to the risk management process and the RMF:

First, it must define an applicable standard or guideline to which the product is complying.  This ensures that a standard operating procedure, work instruction and/or method that complies with the applicable standard or guideline is in place. The RMF will be reviewed against the requirements and all procedures laid out within the standard.

Second, the RMF should clearly illustrate the process used to identify risks and verify that the final document meets both the manufacturer’s needs and the minimum requirements established in the first step. The risk procedure outlines all of the necessary steps for creating an RMF. This might include requirements for a risk plan, hazard analysis, verification and validation procedures, or information collection during and after production. Where the procedure indicates that a step should be taken or a document generated, the manufacturer should illustrate that those steps were indeed followed and the risk file has been generated.

Third, any information related to risk management must be included in the file. This could be as easy as making a statement about expected service life, or as complicated as a structural mechanical analysis of a support system. Regardless, an RMF should well document the information that addresses risk mitigation.

Finally, specific hazards must be evaluated through analysis and risk management procedure. Certain hazards may have been specifically identified by the IEC or manufacturer.  It is important to illustrate that the hazard/risk has been evaluated using the risk management process. This includes identifying the hazard, determining the acceptability of it to create harm, assigning risk controls for unacceptable hazards and verification/validation of risk controls.

RMFs should indicate the intended environment for a device, as well as the required testing, levels and specific, detailed immunity pass/fail criteria. This information should be used to determine how the product will be monitored to demonstrate compliance with the criteria, specification of acceptable degradations that don’t lead to unacceptable risk and justification for any special increased or reduced test levels. The RMF should also determine the modes, settings and configurations for testing likely to result in unacceptable risk and identify product risk frequencies.

Additional considerations for an RMF may include: emissions testing and immunity testing; notes about product configuration for testing, consistent with intended use; and product configuration information for all cables, tubing, containers, circuits and special hardware or software needed when the product is used as intended. It is important to be aware that determinations made in the RMF regarding the applicability of testing, product essential performance, intended environment and restrictions, and any potential loss of function that the user might experience due to degradations of operation that occur during testing must eventually be documented in the information to the user, and can have a real impact on marketing of the product.

These RMF guidelines illustrate many of the considerations that need to be taken when conducting risk assessments, including intended environment, potential hazards, mitigation, testing and acceptable parameters.

Hazard-Based Approaches

A hazard-based approach essentially seeks to identify and classify hazards apparent in a product under normal and abnormal operating conditions as well as fault conditions. It requires verifying suitability of the safeguards that are required to be applied to protect against the hazards. Some manufacturers may mistakenly take the term “hazard-based” to mean “risk analysis,” however, they are not the same. A hazard-based approach does not involve risk analysis on an individual product basis, but essentially seeks to identify and classify hazards apparent in the product under regular and abnormal operating conditions, as well as safeguards applied to protect against them. It means evaluating a product against potential hazards and implementing a hierarchy of safeguards.

Theoretically this approach allows for new unanticipated technologies to be assessed against the standard requirements, without the need for technical committee approval. It also allows for changes to technology, which inevitably will evolve more quickly than the standards. In short, the hazard-based approach allows for a standard to theoretically not become obsolete as the industry evolves. Hazard-based approaches and hazard-based safety engineering (HBSE) have proven to be popular enough that they are now integrated into product safety standards, including IEC 62368 for IT and A/V equipment.

Taking a risk- and/or hazard-based approach can be good practice beyond fulfilling requirements set forth by standards. They help manufacturers make products that fit consumer expectations and demands. They also ensure that products are prepared for an ever-evolving industry. As technology evolves, these approaches allow for products that continue to offer safety and performance. Going beyond standard requirements, these design strategies can help to ensure the success of products today and well into the future. Q