ISO 10377 Provides Guidance to Create Safe Products

Status

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 control. To a regulator, it’s compliance. To a lawyer, it’s liability. To the working group that created ISO 10377, it was orchestrating all views into one practical methodology that will turn out a safe, reliable consumer product every time. This has been the endeavor of the ISO Project Committee 243 (“PC 243”) on consumer product safety, and its accomplishment has been the First Draft Form of ISO 10377, Consumer Product Safety: Practical Guidance for Suppliers.

Since 2008, this working group has held responsibility for writing this new industry standard. 20 countries have participated directly in the standard’s development.ⁱ 8 countries have held observer status.ⁱⁱ ISO 10377 has been led and chaired by Dr. Elizabeth Nielsen, a former Canadian regulator and current CSA representative. Standards Council of Canada served as Secretariat, and Cathy Frederickson, CSA, worked as the committee’s Secretary. In 2010-2011, PC 243 met in Geneva, Switzerland; Vancouver, Canada; Santiago, Chile; Sydney, Australia; and San Francisco, California to write the current draft of the standard.

The standard has now entered ISO Enquiry Stage 40.20 during which voting by all ISO member bodies will occur through May 15, 2012.ⁱⁱⁱ If approved in its First Draft Form, the standard will be published later this year.^iv Below is a preview of the new standard.

Purpose

The purpose of ISO 10377 is “provide practical guidance to suppliers on decisions to be made about the safety of consumer products[.]”^v However, guidance about safety to one supply chain does not communicate effective guidance to those in another supply chain, or to those creating different products. Moreover, safety’s intrinsic quality is that many professions that have a say in its process. The ISO Project Committee 243 understood this and developed a standard that would speak to more than one type of entity and to more than one type of professional.^vi Also, it was likely that Small and Medium Enterprises (SMEs) would benefit the most from the standard.^vii Thus, it would need to be easily applied.

Safety in the Supply Chain

ISO 10377 has three principal sections that mirror the creation, production, and distribution functions of supply chain entities. These three sections are Safety in Product Design, Safety in Production, and Safety in the Marketplace.

Safety in Design covers those tasks that evaluate safety during the original product design.^ix These tasks include the preparation of documents and materials that comprise the product’s technical specifications, the designation of a product’s life cycle, and the method to arrive at a tolerable risk through hazard identification, by an analysis of the population, and an assessment of risk that determines how consumers are exposed to hazards.^x Here, the standard is proactive. It requires product suppliers to take action to designate a product’s use and misuse, reduce or eliminate hazards from a product’s design, and communicate hazards to the product’s user through warnings and instructions. It shows suppliers how to accomplish these tasks.^xi

Safety in Production covers the manifestation of design principles and hazard analysis into the actual creation of the product.^xii It tackles the practical steps necessary to move basic safety principles along the supply chain from design to manufacturing. This occurs by integrating safety into production practices and into the production facility so that safety is examined and deliberately embedded into each task that could come about during Production, such as best manufacturing practices, design validation, product prototypes, material procurement, tooling, controlling product specifications and component assemblies, testing samples, and auditing production runs.^xiii

Safety in the Marketplace covers those tasks to be executed by the usual importer, distributor, or retailer to confirm that the product ordered meets safety requirements, usually through a pre-purchase assessment.^xiv The more important task, however, is the ongoing collection of data once the product reaches its users. This data identifies trends in product safety, including product defects, repairs, incidents, claims, and warranty returns, all of which may spot a product hazard missed through earlier assessments, will verify conformance of a product to its foreseeable use, and will determine the need for continuous improvement .^xv

Safety in the Organization

More than any other principle, ISO 10377 advocates the implementation of a safety culture within an organization, as well as up and down that organization’s supply chain.^xvi Here also, the standard does more than simply acknowledge a good idea. Instead, ISO 10377 describes in detail the operation of a continuous improvement process, illustrates the risk reductions actions necessary to achieve a tolerable risk, and provides a checklist to create a product safety management plan. These items manifest an operational presence of a product safety culture within the organization.

Continuous improvement captures both the organization improving itself to create safer products and the organization improving the product based on data collected from product users.^xvii The latter ensures that informed decisions are made so that the next design and production cycle advances the safety attributes of the product. For example, product data may be obtained from focus groups who anticipate product use before its design is completed. Feedback may come from production staff who test prototypes or audit sample production units. Also, traditional buyers in the supply chain may comment on product use seen in the field or obtained directly from consumers. Regardless of its origin, a continuous improvement plan marshals this product data through a careful analysis, an action plan, and a decision whether changes are required in the product.

A safety culture is also manifested through a reliable risk assessment of the product’s hazards.^xix This assessment occurs principally during design but also may occur during continuous improvement and when evaluating a corrective action. Its sole function is to arrive at tolerable risk. Its elasticity as a model and its capacity to act as a threshold will fully realize a safe product every time it is applied, but only if its deliberate risk reduction steps are adequately engaged. It can be perfunctory if unused or even create liability if it is misused. When employed as a benchmark, it removes hazards that are unacceptable during product use, creates consistency across products, and establishes internal reliability across company functions. It is likely the single most indispensable unit of measure in the standard.^xx

Finally, the standard also shows how to build a product safety culture through a Product Safety Management Plan.^xxii This plan reiterates safety-related tasks to perform during design, production, and marketplace in the supply chain through a simple checklist, which also incorporates quality assurance objectives. For example, five (5) detailed steps would begin a Product Safety Management Plan in an SME. These five steps are: (1) commitment from management; (2) a Product Safety Policy that expresses risk tolerance; (3) appointing a Product Safety Officer; (4) integrating safety-related tasks during design, production, and marketplace functions of the organization; and (5) setting up a communication protocol across the organization.^xxiii

A Safer Product

Despite the processes and orchestrations within and among organizations, the simplicity of ISO 10377 is that it touches every supplier regardless its position in the supply chain and touches every product regardless its origin. Products are safer when suppliers are accountable for their contributions to the product, whether those contributions arise from raw materials, components, subassembly preparation, design, manufacturing, or labeling.

Products that are identified when are created and are traced as they travel through the supply chain create this accountability.^xxv Traceable products, including their components and subassemblies, should carry a unique identifier that is labeled, marked, or tagged at the source. Suppliers should request identified products from vendors who can provide it. Suppliers should be able to trace products back to their direct source and identify the next direct recipient of product in the supply chain.^xxvi ISO 10377 suggests 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 necessary.

Further, products are safer when documentation is prepared about the product, its design, its production, and its management in the marketplace.^xxvii A document retention program might say how long to keep a document but it should say what product documents to keep. Here also, suppliers should be able to know a product’s development through its documents and, literally, trace design, risk assessment, hazard analysis, and testing decisions back to the product’s conception.^xxviii

Finally, safer products reduce liability. Although the standard speaks solely to product safety, it is no accident that the standard also guards the individual supplier’s exposure to liability for safe products as well. In its most vibrant form, a supplier can accomplish both safety and certain liability prevention in a single step. For example, a safer product design that is improved by a hazard analysis and risk assessment creates a product with less exposure to liability for latent defects that later may harm the product user. The creation of a production prototype and verification of production readiness reduces the prospect for manufacturing defects to arise during a production run. Likewise, a hazard analysis directs a supplier to remaining hazards that require warnings and instructions to the product user, both of which reduce defective warning claims in the U.S.
 

Mark A. Kinzie is a member delegate of the ANSI Technical Advisory Group to PC 243 that drafted ISO 10377 during its meetings. He is a principal at AVERTURE, a law firm with its core services in regulatory compliance, product recall, and process solutions. Reach him at mark.kinzie@averture.net or via telephone at 314.862.7878.
 

ⁱ Participating Countries in PC 243 are Algeria, Argentina, Armenia, Australia, Barbados, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Italy, Japan, Jordan, Republic of Korea, Malaysia, Nigeria, Romania, and the United States.
ⁱⁱ Observing Countries in TC 243 are Finland, Hong Kong China, Malta, Russian Federation, Spain, Sri Lanka, Switzerland, and the United Kingdom.
ⁱⁱⁱ During the Enquiry Stage, the draft International Standard (DIS) is circulated to all ISO member bodies by the ISO Central Secretariat for voting and comments within five months. It is approved for submission as a final draft International Standard (FDIS) if a two-thirds majority of the Participating Members of the PC are in favor and not more than one-quarter of the total number of votes cast are negative. If the approved criteria are not met, the text is returned to the originating PC for further study and revision.
^iv Because this is a guidance standard, it offers no means for certification. ^v Clause 1, ISO/PC 243 NO88, DIS.1, 10377: (2012). Also, product recall is not addressed in ISO 10377. Instead, it is the subject of a separate ISO Project Committee, PC 240, which has prepared the draft standard ISO 10393, Guidance Standard on Consumer Product Recall and Corrective Action: Code of Good Practice. ISO 10393 has also reached its First Draft Form to be decided this year.
^vi Id. at Introduction.
^vii Id. at Appendix B, Informative Information and Guidance for Small Businesses.
^viii Id. at Clause 5, General Requirements, draft Figure 3: The Supply Chain.
^ix Id.at Clause 6, Safety in Design.
^x Id. at Clause 6, see e.g., Safety Considerations in Design (§6.2), Risk Evaluation (§6.3.4), Hazard Identification (§6.3.4.1); see also Annex D: Informative List of Common Hazards and Annex E: Informative Sources of Information.
^xi Id. at Clause 6; see e.g., Design Specifications (§6.2), Foreseeable Use & Foreseeable Misuse (§6.3), Risk Assessment (§6.3.4.7), Risk Reduction (§6.3.7), and Risk Communication (§6.3.8).
^xii Id. at Clause 7, Safety in Production.
^xiii Id. at Clause 7; see e.g., Production Planning (§7.2), Design Validation (§7.2.1), Production Readiness (§7.2.2), Tooling (§7.2.2.2), Production Runs (§7.3), Raw Materials, Components, Subassemblies (§7.3.1), Production Scheduling (§7.4), and Audits (§7.5.1).
^xiv Id. at Clause 8, Safety in the Marketplace.
^xv Id. at Clause 8; see e.g., Proactive Data Collection and Analysis (§8.3) and Ongoing Assessment of Product Conformance (§8.4).
^xvi Id. at Clause 4, Basic Principles for Addressing Consumer Product Safety, Promoting a Product Safety Culture within the Organization (§4.1.1) and Promoting a Product Safety Culture outside the Organization (§4.1.2).
^xvii Id. at Clause 5, General Requirements, Continuous Improvement (§5.3).
^xviii Id.
^xix Id. at Clause 6, Risk Assessment (§6.3.4.7); see also draft Figure 5: Diagram Illustrating the Flow of Risk Assessment.
^xx Other hazard analysis models are referenced in the standard. See e.g., Hazard and Risk Evaluation at Annex B.3, Informative Information and Guidance for Small Business, and Risk Assessment Methodologies at Annex E.5, Informative Sources of Information.
^xxi Id. at Clause 6, Risk Reduction, draft Figure 6: Example of Risk Reduction Process of an Organization.
^xxii Id. at Annex C: Product Safety Management Plans.
^xxiii Id.
^xxiv Id. at Annex C.1, Product Safety Management Plan Based on a Quality Assurance Manual.
^xxv Id. at Clause 5, General Requirements; Product Identification and Traceability (§5.5).
^xxvi Id. at Clause 5, General Requirements; Traceability across the Supply Chain (§5.5.1).
^xxvii Id. at Clause 5, General Requirements, Records Management and Document Control (§5.2.3); see also Documenting the Design Specification Process (§6.4), Documentation [in Production] (§7.5.4), and Pre-Purchase Assessment (§8.2) (auditing documentation from vendors).
^xxviii Id. at Clause 5, General Requirements, Records Management and Document Control (§5.2.3).