Risk Management in Safety Product Design and Development

When talking about products, a wide range of technologies and applications are involved. Some can be very simple and come with low risk to users, while some other ones can be complex and “dangerous” to users.

Safety standard developers are dedicated to developing safety requirements. However, manufacturers, who know their product best, are the key drivers in identifying and minimizing risks from safety products. This has prompted the need to use a “Risk Management process”.

By definition, Risk Management is a tool to identify, control and monitor all aspects of a product that can affect its’ safety and effectiveness throughout the lifecycle. For the sake of users, manufacturers should bear the responsibilities of risk minimization and ensure their products are safe for use.

Common misconceptions about Risk Management have led to misuses of the tool. Risk management should not be used:

	To legitimize completed design.
	To collate risk already identified and attribute arbitrary estimations.
	Only in the design phase of a product lifecycle.
	Only for new-design products only.
	Or that Risk Evaluation is to be carried out by standard developers.

Risk Management should be intended for the following:

	To guide a design and make decisions early about methods of controlling design.
	Risk Management information develops and evolves with the design.
	Risk Evaluation is the job of the manufacturer with input from users and other stakeholders, specific to any product, but particularly products that have a safety intent.
	Risk Management is a full lifecycle process in which gathering information in the production and post-production phases are the most crucial to an effective risk management process.
	Risk Management should be carefully applied to completed designs, focusing on gathering post production information to develop information.

Advanced Applications

The Risk Management process generates a wealth of information and data. However this data should not be left in its raw form. Derivations can be made from this raw data to provide safety concepts focusing on safety and performance of the device. Some of these concepts are:

To enhance safety, it is crucial for manufacturers to understand and meet user’s expectation when designing and re-designing of safety products. They need to ensure solutions to safety problems, essential performance, expected service life and risk control means are aligned with expectations of risk and benefit.

As safety or perceived safety is not absolute, it will change with time because of trial and error. Therefore it is important to gather feedback from real users on expectations and tribulations of the products, its uses, risks and benefits. Moreover, manufacturers need to know clearly about their perceived safety of a product and its actual performance when in use. Below are some guiding questions that may help manufacturers understand state-of-the-art expectations of their products.

Post Design Information — Feedback from actual users

When a product is in the hands of actual users, risks are no longer theoretical. Potential risks and harm can become real. As such, Risk Management cannot end when a product leaves the factory. Instead, that is when it starts. Manufacturers should institute a pro-active system to gather feedback on the product from various stakeholders such as Users / Operators, Production Personnel, Installation Personnel and Service Personnel.

The feedback system is designed to gather product specific and pertinent information on new unidentified risks, effectiveness of risk controls, misuse of product and risk acceptability. The gathered information shall be reviewed and inputted back into Risk Management System for further analysis and continuous improvement.

Moreover, manufacturers should be aware of the latest trend and technology of similar products in similar use, as well as the latest update on new product safety standards and regulations. Using this kind of full lifecycle approach to product design and development can yield a better safety of products.

The above content is extracted from a presentation delivered by Steve McRoberts, Principal Engineer of Underwriters Laboratories, at the World Congress on Safety and Health at Work, Seoul, Korea 2008.