ISO 10377 is aimed at small and mediumsized enterprises (SMEs) as well as larger firms and offers risk assessment and management techniques for safer consumer products. In fact, focus groups used a draft of the standard in meetings with SME suppliers to help identify key requirements and assess its usefulness. The standard is divided into four main sections outlining general principles, safe design, safe production and retail safety (see Box overleaf).
Safe and sound
To a consumer, product safety means family protection.
Products are safer when suppliers have a hand in their development, be it at the raw materials, components, sub-assembly preparation, design, manufacturing or distribution stage. Creating a prototype and checking its production readiness reduce the likelihood of defective products during a production run. Hazard analysis then points out any remaining hazards that might warrant a warning and instructions to the end user.
But safer products also reduce liability. Although ISO 10377 focuses chiefly on product safety, it unsurprisingly also limits the supplier’s responsibility. The upshot is greater safety and reduced liability in one fell swoop. The bottom line : a product with less chance of harbouring latent defects that might inadvertently harm the user.
Regardless of company structure and organization, ISO 10377 will affect all suppliers irrespective of their role in the supply chain and all types of products whatever the origin.
The importance of traceability
Products should be traceable and carry a unique identifier that is labelled, marked or tagged at the source. This also goes for raw materials, components and subassemblies. Suppliers should insist on properly identified products from vendors and be able to trace products back to their direct source and identify the next direct recipient of the product in the supply chain.
ISO 10377 asserts that traceability will meet business needs, such as regulatory compliance and product safety evaluations, and will improve the control, efficiency and cost of a product recall, if required.
Safer products reduce liability.
Products are safer when they carry documentation about the product, its design, its production and its management in the market. A document retention programme might specify how long users need to hold on to a document, but it should also state what product documents to keep. Suppliers should be able to recognize a product’s development through its documentation and trace its design, risk assessment, hazard analysis and testing decisions back to its conception.
A safety culture from beginning to end
ISO 10377 provides practical guidelines on risk assessment and management for safer consumer products.
ISO 10377 emphasizes the importance of building safety into the product at the design stage, providing guidance for the identification of hazards, reliable risk assessment and steps to reduce potential product risks. It serves as a benchmark for eliminating hazards that would be unacceptable during product use, delivering consistency across the board and establishing a culture of trust across all company functions.
The standard also stresses the need for an organizational safety culture that spans the entire supply chain. It explains how to build a product safety culture through structured product safety management, placing renewed emphasis on the safetyrelated tasks to be performed at the design, production and marketing stages according to a simple checklist and incorporating quality assurance objectives.
For example, for an SME, a five-step approach would be a good place to start their product safety management plan : (1) checking management’s commitment to product safety ; (2) developing a product safety policy in line with the company’s risk tolerance ; (3) appointing a product safety officer ; (4) integrating safety-related tasks at design, production and marketing stages ; and (5) setting up a communication protocol across the organization.
A four-pillar agenda
For the user’s convenience, ISO 10377 is divided into four main sections highlighting specific areas.
- General principles : sketches out the basics such as promoting a product safety culture across the organization, striving for continual improvement, better staff training, record management and document control, and establishing product monitoring and traceability processes.
- Safety aspects of design : addresses design technical specifications, tolerable risk through hazard identification, risk assessment and reduction/elimination, and warnings and instructions on any residual risks to the end user.
- Safety in production : gives practical steps for promoting basic safety principles across the supply chain, with a focus on such aspects as manufacturing practices, design validation, product prototypes, material procurement, tooling, controlling product specifications and component assemblies, testing samples and auditing production runs.
- Safety in the marketplace : specifies the responsibilities incumbent on the importer, distributor and retailer to ensure that the product ordered continues to meet all the safety requirements. This is done through pre-purchase assessments and ongoing data collection once the product reaches its users, to identify any product hazards that were missed during earlier assessments.
Safety equals protection
Mark Kinzie, an ANSI delegate to project committees ISO/PC 240, Product recall, and ISO/PC 243, Consumer product safety, recently stated : “ Safety, especially product safety, can mean different things to different people. To an engineer, it’s hazard analysis. To a risk manager, it’s loss of control. To a regulator, it’s compliance. And to a lawyer, it’s liability.” Of course to a consumer, product safety simply means family protection – a fact acknowledged by ISO/PC 243, the project committee in charge of creating this practical guidance document.