In most cases when we look at designing a new product we don't have the advantages (or some may say restrictions) of a clear set of regulations and a legacy of previous compliant products on which to base our new design.
In the automotive industry for example, legacy information and knowledge is an immense help in developing new cars. Design regulations such the ADR provide a strict and well understood framework for acceptable performance and safety.
Of course there are other products that are regulated by government (for a full listing of mandated standards, check out the ACCC's Product Safety Website), but the vast majority are not. In these cases, importers and manufacturers are obliged under consumer protection and trade practice regulations in Australia to ensure that their product is safe for use and is safely used. Importers and manufacturers retain a liability to any consumer that suffers an injury due to defects in their product and in their products that are used in other finished goods.
From a humanistic viewpoint, products should always be safe and no harm should come to the users / consumers. From a pragmatic viewpoint, importers and manufacturers need to be able to defend the safety of their products in a court of law.
How do you defend the safety of your product?
You need to be prepared to be able to convince a court of law that you have done everything in your power to design, manufacture and sell a safe product.
Safety requires you to take a holistic approach to your product as it is influenced by user expectations, regulations, its design, manufacturing, marketing, advertising, markings, warnings and instructions for use.
You need to employ a structured process across all these elements as the way to ensure that the solutions are designed to make the product as safe as possible.
In my opinion, organisations that are using a haphazard rather than a structured approach to addressing the hazards and risks associated with the use of their products has fallen behind an acceptable state of the art and will expose themselves to being unable to establish a defence on the basis that the state of scientific or technical knowledge at the time when they supplied the product was not such as to enable that defect to be discovered.
Design Frameworks – Structured Approaches
There are a number of different frameworks that you can employ to manage the safety of your products during all stages of the product lifecycle.
These processes and frameworks are based on the identification of hazards and the management of the activities undertaken to design out the risks, or where the risk cannot be removed, the actions put in place to ensure that then user and consumer has the information necessary to use the product safely.
HB 295 – Product Safety Framework
Standards Australia published HB 295, Product Safety Framework Set, in 2008. This series contains a Product Safety Framework (PSF) that is designed to enhance the safe supply, sale and use of products. It is a product risk management system that addresses the sources of risk associated with products and establishes a set of requirements and test methods to manage such risks with products. It is a checklist based system that helps you identify the hazards and manage the risks in your product.
An advantage of the Handbook is that it includes a wide range of Generic Requirement Modules that include excerpts from a wide range of standards to cover product performance and safety specifics.
Standards Australia intends to expand the handbook with the future inclusion of Specific Product Guidelines.
Failure Mode Effect Criticality Analysis (FMECA)
FMECA is a long and well established technique that is used throughout industry to manage the design of products and systems and is a process that we use at Bayly.
Our FMECA process is derived from the requirements of the International IEC 60812 standard and can adapt the FMECA process to conform to other relevant standards used in military, medical and automotive industries.
FMECA processes are adaptable to your specific requirements and can be applied across the whole product lifecycle. In their rigorous application, FMECA processes allow organisations to control risk levels across their product range and operations by mandating levels of acceptable criticality and by applying known failure rates and behaviour. In this manner, the FMECA process is able to become a repository for a wide range of safety data and parameters that can be applied consistently and can guide design and operational processes to ensure acceptable levels of performance and risk.
The Consumer – the often overlooked variable
Structured frameworks for managing the technical aspects of product safety can be readily applied in your business processes, but when we look for processes that help us understand the critical consumer interface we are struggle to find models and frameworks that we can apply in our business.
Many product safety defects arise when consumers and users do things with your products that are inconceivable and sometimes plain stupid. Of course, this is a defence when you can prove that the way your product has been used is unreasonable, but what expectations are reasonable?
Understanding your consumer
There is no substitute for understanding your consumer in this instance. When undertaking design research activities, it is critical to ensure that hazards that might be observed or identified are collected and included in the design analysis.
Other tools, such as “Voice of the Customer” (VOC), are used to formulate a customer’s needs and wants into technical specifications and requirements for the design of a product. These tools can be adapted to identify hazards from the customer’s expectations and managed in the design process.
Communicating with your consumer
Accurate advertising, proper labelling, and thorough instructions about product limitations will go far in tempering user expectations.
Safety information in advertising can create an "express warranty". Through labelling and warnings, you must warn about reasonably foreseeable misuse of your product. In addition, you should know the general background of the people who will read the labels and warnings.
You should, when designing warnings, follow a relevant standard such as ANSI Z535, ISO 7001 or other applicable standard. Pictograms are a preferred way to convey warnings as they work through language and reading barriers. Remember that after designing warnings, you should test them by using a human-factors expert to test both the warnings and their location.
In preparing product instructions, keep the end user foremost in mind. Make no assumptions about the user’s knowledge or background.
Bear in mind that anything conveying information is a record. Clear detailed records should be kept for the expected life of the product.
IF.... Product Safety is critical to your business and you need to do something about it
IF.... your current design partner is not talking to you about Product Safety, then talk with the team that does understand
When assessing the safety of a product, it is mandated by law that we consider;
- how the product has been marketed
- how the product is packaged
- how the product is marked
- how the product is provided with warnings and instructions for use
- how reasonable are the expectations of how the product should be safely used
- timing of when the product is supplied and when the defect causes injury
In defending the safety of your product you must establish
- the defect in the product did not exist at the supply time; or
- that the product had that defect only because there was compliance with a mandatory (regulated) standard for them; or
- the state of scientific or technical knowledge at the time when they were supplied by their actual manufacturer was not such as to enable that defect to be discovered; or
- if they were comprised in other goods (finished goods)—that defect is attributable only to:
- the design of the finished goods; or
- the markings on or accompanying the finished goods; or
- the instructions or warnings given by the manufacturer of the finished goods.
Part VA, Section 75 of the Trade Practices Act (1974) deals with the Liability of Manufacturers and importers for defective goods. Access the Act here.