July 11, 2013    Volume 20, No. 9

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New ISO Product Safety Standard Will Impact Every Global Manufacturing Company; Retailers, OEMs And Governments Will Be Able To Trace A Flaw Directly Back To Its Source


By Richard A. McCormack
editor@manufacturingnews.com

A new product safety standard from the International Standards Organization (ISO) is going to have a big impact on all global manufacturers and companies that buy from them.

The "Consumer Product Safety -- Guidelines for Suppliers" standard (ISO 10377) allows retailers and OEMs to trace every part and component of a product through the supply chain to determine exactly where a defect or a counterfeit has occurred.

The standard "will affect all suppliers irrespective of their role in the supply chain and all types of products whatever the origin," says ISO. The standard requires that every item in a product be "traceable and carry a unique identifier that is labeled, marked or tagged at the source," says the standards group. "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."

The standard applies to all consumer products except foodstuffs, drugs and cars. It was spurred in part by the recall of unsafe toys containing toxic lead paint made in China and sold to millions of Americans. The standard addresses unsafe and counterfeit cosmetics, electrical appliances, sporting goods, furniture and many other products that have caused fires, choking, lacerations, falls, electrocution, strangulation, entrapment, explosions, suffocation, collapse, poisoning, amputations and drowning.

ISO 10377 intends to build safety and accountability into a product from the design stage by providing guidance "for the identification of hazards, reliable risk assessment and steps to reduce potential product risks," says ISO. "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 is aimed at small and medium-sized enterprises "as well as larger firms and offers risk assessment and management techniques for safer consumer products," says ISO. "Safer products reduce liability."

The new standard has four "pillars." The first is in promoting a product-safety culture across organizations by requiring record management and document control, creating product monitoring and traceability processes and promoting corporate cultures that embrace continuous improvement. The second involves improving the design of products by requiring that manufacturers provide end users with any warnings and instructions concerning any risks. The third involves safety in the production of a product by promoting basic safety principles across supply chains through design validation of prototypes, materials and tooling, and controlling product specifications and component assemblies, testing samples and auditing production runs. And, finally, the standard "specifies the responsibilities incumbent on the importer, distributor and retailer to ensure that the product ordered continues to meet all the safety requirements," says ISO. "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."

The standard allows suppliers to "insist" that their vendors provide them the ability to track products back to their direct source, as well as clearly identify "the next direct recipient of the product in the supply chain," says ISO. "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."

Companies will be required to keep all of a product's documentation, including those related to its design, production and management in the market. "A document retention program might specify how long users need to hold on to a document, but it should also state what product documents to keep," says ISO. "Suppliers should be able to recognize a product's development through its documentation and trace its design, risk assessment, hazard analysis and testing decision back to its conception."

The new standard intends to align product recall practices worldwide by providing "one global language for product recall communication," says ISO. The standard includes what companies must do when there is a recall, such as providing refunds, retrofits, repairs, replacements and disposal of products that are defective, along with requirements on how to notify the public when there is a recall.

"From the beginning, the primary motivating factor was global consumer protection," says ISO. "We were well aware of the expansion of local businesses into the global marketplace, and the significant competitive advantage that compliance with international standards can offer entrepreneurs. We need international guidelines that every type of business in every country can implement and follow."

The new standard means that OEMs will have more involvement in their product's development -- "be it at the raw materials, components, sub-assembly preparation, design, manufacturing or distribution stage," says ISO. "Creating a prototype and checking its production readiness reduces 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."

China leads the world with the number of unsafe products that have been recalled, with 2,124 recalls. The United States has had 685 major product recalls, followed by Taiwan at 299, Mexico at 106 and Hong Kong at 91, according to the Consumer Product Safety Commission.

The new standard does not address the use of unsafe chemicals in products, but ISO says that it will be working with the International Conference on Chemicals Management (ICCM) on a program to identify "actions to improve access to information on chemicals contained in products," says ISO.

The ICCM "has mandated the United Nations Environmental Program to lead a project aimed at facilitating and guiding the provision, availability and access to relevant chemicals-in-product information throughout the product life cycle," says ISO. A proposal with regard to the labeling and tracking of chemicals will be presented in 2015. Pilot projects will commence in product sectors such as toys, building materials, textiles and electronics, says ISO.


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