Regulatory compliance lies in the critical path of every product launch. The only way to avoid shipment delays is to include key milestones for compliance throughout the overall project plan. Each of the milestones will have a work breakdown structure (task list) that needs to be completed to reach the milestone. We provide engineering and management consulting services to develop a solid plan that includes regulatory compliance, and can work closely with your engineers and managers to execute the plan.
Design Reviews (electrical and mechanical)
When it comes to the design of any product for compliance with electromagnetic compatibility (EMC), product safety, and other regulatory requirements, that the electrical and mechanical requirements are considered. Good designers catch the majority of problems, but those not identified can produce a single point failure that can be devastating to the product ship date or the costs associated with any redesign of the project. Therefore it is imperative to solve as many problems up front and fix them, or at the very least, provide the appropriate "hooks" to allow mitigation later.
Electrically, there are many design techniques available for mitigating EMC problems pertaining to both emissions and immunity requirements. A review of schematics and interconnects, can identify a multitude of design problems before they are committed into etch. The filtering of any interconnects, including the slow-speed ones, is frequently required in order to prevent the cables attached to them from becoming "radiators" that cause EMC failures. Clock routing and termination, whether on the surface of the printed circuit board (PCB) or on an inner layer, must be designed for emissions, timing, and signal integrity. PCB layer stackup of ground and power planes, signal layers, and component placement are an absolutely critical part of the design.
Additionally, component selection of critical components MUST be identified for any product safety concerns such as operating within the thermal specifications, voltage and current ratings, and the necessity for any component regulatory requirements. The critical component list needs to be provided to the safety agency certifying the product as part of that process. If you wait for the agency to create that list, always at the very end of the design cycle and the beginning of the product release cycle, any design changes needed could be quite costly.
Therefore, a preliminary design review at critical milestones should be performed to eliminate these issues during the early stages of any design project. By doing so, the risks to the project delivery date are substantially lowered.
EMC Mitigation & Pre-compliance Testing
There are many reasons that some designs still have EMC issues even after careful design, such as using an existing PCB or sub-assembly to reduce design time. Since the first EMC tests are performed well into the development cycle, any possible design changes must be kept to a minimum and this is where the "hooks" put in place during the design review earn their value! By the time prototypes are produced, your company wants to sell the product. In order to legitimately to do so, the product must be made compliant. The closer to the product ship date, the more expensive any "fixes" can be, but they must be implemented, and quickly. It's highly likely that many of the parts and sub-assemblies have already been ordered and "fixes" to any of them will have to be re-worked. A working knowledge of the different techniques and pre-compliance testing as early in the prototyping process as possible are what it takes to reduce the risks.
Determination of Product Approval Requirements
Knowing the regulatory requirements during the conceptual design stage so that the technical issues can be addressed up front is vital to the designers. Power supplies, power cords, language requirements, and labeling are often the things that cripple a product's release. By identifying this earlier in the development process, these issues can be addressed earlier and, hence, reduce the bottleneck as the product is released. Sales and marketing must also be made aware of some of these restraints so they too can plan a global release.
The North American and European markets are fairly well understood technically, but the administrative process to actually obtain the necessary approvals, or "marks", can take much more time than many companies allot and needs to be a part of the overall project planning to reduce risks. When other markets in Asia, South and Central America, and Africa are being slated by marketing, the administrative process of obtaining approvals can become quite difficult to navigate. These markets require extensive consideration and planning and should be considered on a separate release cycle so that sales and marketing don't commit to customers without being able to deliver. The ability to gain approvals for different model numbers (no matter how similar the products), re-branding of the same product, or delivering a family of products is a complex process highly dependent on the destination country. Although North America and Europe are harmonized for many types of products, some are not harmonized very well, if at all. The remainder of the world may have technical requirements that are similar to these two major markets, but the administration process can be drastically different.
And of course, the requirements may change mid-stream without any notice. All of these difficulties must be dealt with during the product release cycle. Embracing this challenge is not for the faint of heart and everyone should have an expectation that sovereign nations will do what they perceive as best for them.
ISO/IEC 17025 Quality Systems
Most laboratories are accredited to ISO/IEC 17025, the quality standard applicable specifically for laboratories. As an auditor for the National Voluntary Laboratory Accreditation Program (NVLAP), and as the creator of the quality system demo website found at our sister site, OpenTestLab, consulting services related to quality systems are provided with lots of experience behind it.