Focus on Success
Focus On Success PLANNING FOR PRODUCT COMPLIANCE As we look back from the vantage point of 2016, we look back on a series of changes to product compliance requirements in the United States that started intensively almost a decade ago. Events from discovery of leaded paint on toys in 2007, to finding, even with routine usage, lithium ion batteries (ever more widely used for their compact power source) could explode, have impacted product compliance expectations. These incidences, and many others, have lent product compliance a new level of sensitivity and opened the search for accountability on consumer issues that should not be overlooked. The easiest and best place to accommodate compliance in a product is in the early stages of the product development cycle. This becomes more challenging with many “off the shelf” products coming into the US market place without necessarily oversight from a full product engineering team in the US. New approaches to establishing compliance needs to take shape. And the legal accountability landscape changed as well. We no longer sit firmly in the seat of inventor, developer or manufacturer. For many of the products flooding our “want to have/need to have lists” we sit on the side of the purchaser. However, this is no longer a strictly “buyer beware” consumer environment. Often the original designer or developer can no longer be identified once the product is landed in the US and headed for the consumer shelves. So in the event that a consumer is disappointed, or worse has an experience with the product that could cause harm or injury, the place of purchase is the most likely place to go when seeking remedy. A chain reaction of seeking an accountable owner to support the “remedy” then starts. It may include the retailer of the product, the source they used to procure the goods, as well as any number of product brokers and vendors in between. The painful series of events when an affected party is seeking an owner, has some retailers setting more stringent requirements of “proof” of product compliance for a product before it is put on their shelf. This proof, at times, goes so far as to be tied to specific lots of products related to a specific purchase order. This seems to set up a cycle of hurdles that become impossible to overcome without repetitive and frequent retesting for compliance requirements. Indeed there can be some testing needed in today’s environment that was not a legal requirement a decade or more ago. In finding approaches to manage this, we can look to industries that have already faced tighten testing requirements, and had to meet increased “proof” requirements of lot for lot compliance criteria. At base, these approaches utilizes planning ahead and documented traceability as key steps to take a product to market and demonstrate the right level of testing and assessment. What is included in a product assessment has also taken on new dimensions. In product development stages, knowing the product is fit for use is essential. Fit for use in today’s environment includes assessing a product for “misuse” scenarios. This should take on as much significance as the assessment of appropriate usage. Reviewing the product potential misuses and assessing the design to check for prevention early in the product definition stages supports finding modifications that do not prevent desired effects but may help prevent unintended uses of a product. Building these into the design that
gets promoted to production, is far less costly than having to add them in later, or managing end user issues once the product is launch on its market. However this assessment even if done after the product is developed has value. Actions around clear, well presented instructions, and labeling to highlight actions to take, or NOT take, can often be identified before the product goes to the consumer. Traceability to the source of components or key elements and production processes becomes relevant when reviewing product compliance success. Ensuring traceability of the product and its components is of high value when assuring compliance. This requires a working knowledge of the source for manufacturing, and the supply chain providing the elements of the final product. This can play a significant role in helping reduce excessive testing and increases the likelihood that the end product will meet its compliance criteria when it is tested. A sometimes missed but impactful review should be conducted on the processes used to bring the product to life at the desired volume and in the expected condition. Everything that touches the product from chemicals used in production, tools/machinery used and the skill set of the workers in the process, play critical roles in producing a product that will pass compliance testing requirements. A perfect design can be destroyed in the production process. Conversely a poor design is rarely corrected in the production process, at least not without excess costs and intervention to redo elements of the design. And finally establishing a good partnership with a compliance lab that has the technical capability to assess what is needed for your specific product, for the chosen market, supports setting up the records of testing and compliance. Using the traceability to the key elements or components, if they were tested for relevant compliance requirements at the component level, can sometimes substitute for more costly finished goods testing. Being able to batch, or composite, similar materials can help defray testing costs as well. Using this method can introduce some risks, but being able to trace to the raw materials helps ensure that testing of composites of similar material is not taking on an unexpected risk. Taking all these steps, planning for compliance and executing that plan, need not be dependent on a firm’s internal resources or talent. There are many firms that specialize in offering the structured review of designs, processes, sources and labs for testing. This helps smaller organizations function at the same effectiveness and efficiencies that large self-sustaining organizations can enjoy. Using these as some of the key steps taken when planning for compliance, helps assure risks are reasonable and mitigated, which reduces bottom line risks as well. And the ability to use partners to help with these steps levels the playing field for players that cannot hire on full time support and allows planning for success to be an effective and efficient part of the design, development and production process on the path to market.
Look for other articles to help “Focus on Success” from the Managing Partner of FACS: Fry Advisory Consulting Services, Lyndall C Fry.
gets promoted to production, is far less costly than having to add them in later, or managing end user issues once the product is launch on its market. However this assessment even if done after the product is developed has value. Actions around clear, well presented instructions, and labeling to highlight actions to take, or NOT take, can often be identified before the product goes to the consumer. Traceability to the source of components or key elements and production processes becomes relevant when reviewing product compliance success. Ensuring traceability of the product and its components is of high value when assuring compliance. This requires a working knowledge of the source for manufacturing, and the supply chain providing the elements of the final product. This can play a significant role in helping reduce excessive testing and increases the likelihood that the end product will meet its compliance criteria when it is tested. A sometimes missed but impactful review should be conducted on the processes used to bring the product to life at the desired volume and in the expected condition. Everything that touches the product from chemicals used in production, tools/machinery used and the skill set of the workers in the process, play critical roles in producing a product that will pass compliance testing requirements. A perfect design can be destroyed in the production process. Conversely a poor design is rarely corrected in the production process, at least not without excess costs and intervention to redo elements of the design. And finally establishing a good partnership with a compliance lab that has the technical capability to assess what is needed for your specific product, for the chosen market, supports setting up the records of testing and compliance. Using the traceability to the key elements or components, if they were tested for relevant compliance requirements at the component level, can sometimes substitute for more costly finished goods testing. Being able to batch, or composite, similar materials can help defray testing costs as well. Using this method can introduce some risks, but being able to trace to the raw materials helps ensure that testing of composites of similar material is not taking on an unexpected risk. Taking all these steps, planning for compliance and executing that plan, need not be dependent on a firm’s internal resources or talent. There are many firms that specialize in offering the structured review of designs, processes, sources and labs for testing. This helps smaller organizations function at the same effectiveness and efficiencies that large self-sustaining organizations can enjoy. Using these as some of the key steps taken when planning for compliance, helps assure risks are reasonable and mitigated, which reduces bottom line risks as well. And the ability to use partners to help with these steps levels the playing field for players that cannot hire on full time support and allows planning for success to be an effective and efficient part of the design, development and production process on the path to market.
Look for other articles to help “Focus on Success” from the Managing Partner of FACS: Fry Advisory Consulting Services, Lyndall C Fry.
