Product testing, qualification and regulatory compliance – every design engineer encounters these during their career. An effective compliance program is not solely a matter of efficiency; rather, efficiency should be an inherent component of an effective program, and it results from the organization’s experience and understanding of various test programs and the ability to achieve its goals. In order to guide organizations to starting an effective compliance test program, there are a few crucial mechanisms that need to be in place. Though examples provided in this article refer primarily to electromagnetic compatibility (EMC) compliance, these ideals of preparation and planning are widely applicable otherwise.
(Source: Laird Connectivity)
Stay Ahead of the Game from the Start
There are several things you can do in order to build a successful compliance program from the start. One of the first things is gaining management’s support for the compliance process. Ensuring that company leaders recognize this importance is crucial. Appreciating that “designing for compliance” will save significant time and cost during conformity testing is a key component of an effective test program.
Preparing and planning an effective compliance program also requires design parameters that encompass applicable regulatory and quality standards. Every engineer should understand that the primary goal of design is to product requirements, but designing products to meet regulatory requirements is equally important. It is useless to design a product that cannot meet applicable regulatory standards regardless of how good it is, as the product simply cannot be sold. A good rule of thumb is to recognize that components incorporated into designs for compliance purposes can always be removed later if proven unnecessary. However, the opposite — incorporating components after a design is complete — is exponentially more difficult.
Pre-compliance testing, or pre-scanning, can also be helpful to give approximations of performance. The best way to avoid any unnecessary delays or rejections in compliance testing is to pre-scan early and often. On-the-go testing allows you to ensure that your product will pass regulatory testing contingent on any design changes you’ve made along the way.
Think of it this way: if you were making soup, you’d taste it along the way to ensure it’s seasoned properly. Pre-scanning is no different: it allows you to check your “flavors” (i.e.: test results) before your product is done proverbially cooking so you don’t end up with something that falls short of expectations.
Find the Market, Know the Standards
Another key step is to identify the countries where the product will be available in order to understand its legal requirements, directives, and standards which will need to be considered in the design.
A product offered only in the U.S. is subject to different legal requirements than the same product offered internationally. Products which are intended for international markets may require additional testing, which increases the cost and time of compliance testing. Mutual recognition agreements (MRAs) exist between countries, allowing the demonstrated compliance of one country to transfer to another one; however, additional declarations, documentation, and filing fees may still be required.
Documentation, Information and Operation
Preparing and planning an effective compliance program ultimately requires that you ensure all documentation and information relevant to the product is available before requesting a quotation for test services from a compliance partner.
Compliance test facilities will often provide guides that assist in gathering relevant information required during the test program as well as in the development of an effective test plan, but it’s still a good idea to discuss the project with the compliance partner to avoid any unwanted surprises.
First and foremost, ensure proper operation of each test sample that will be supplied to the testing facility. The largest contributor to delays in the testing schedule (product noncompliance notwithstanding) is anomalous operation of devices provided for testing.
Second, coordinate with the test facility the operational modes that will be required during the compliance program. This might include developing special test software/firmware exercising the device’s functionality, monitoring the essential functions of the device while under test, or configuring the product into its multiple modes of operation.
Third, provide as much documentation regarding the product as possible. This may include but is not limited to schematics, block diagrams, theories of operation, application descriptions and any applicable peripherals.
Finally, to supplement this documentation, create an operating procedure for the product that describes the essential functions and performance criterion. Additionally, outline expectations in the event of an observed conformity issue. Proper attention to detail will ensure a higher probability of success during final compliance.
The cost of ensuring compliance is real and is subject to rapid increases when not properly planned. Preparing and planning an effective compliance program will include all of the above, but most of all some patience and discipline: it can be rewarding to learn your product has passed regulatory testing, but without a solid partner with the knowledge and expertise it can be just as equally frustrating.
|Colin Halladay is the strategic business development manager of test services at Laird Connectivity’s Testing Services Business Unit, which provides a full range of services and expertise to champion product certification needs around the globe. This experienced team of testing and compliance experts work closely with customers who require a reliable and experienced partner to oversee compliance testing needs. To contact Colin directly, please email Colin.Halladay@lairdconnect.com.|