Compliance is mandatory
Strategies and Considerations for Product Compliance Engineering
About a month ago, I went to the IEEE Symposium on Product Compliance Engineering. From their mission statement:
The Mission of the ISPCE it to provide a forum for product safety engineers and design engineers to discuss and disseminate technical information related to product safety, to enhance personal product safety engineering skills, and to provide product safety engineering outreach to engineers, students and others with an interest in this field as well as the related fields of product safety regulatory compliance.
It’s a niche field, to be sure. And the group of people at this conference wasn’t huge, but it was an incredibly knowledgeable crowd.
The timing of this conference was ideal for me. A large part of my summer will be spent on a production ramp and getting a new product ready for market. I’ll hopefully be able to speak about that directly at a later date, but let’s look at the general knowledge I gained from this experience.
Depth of compliance knowledge
This symposium reminded me just how deep this rabbit hole can go. I’ve spent a notable chunk on my career working with lithium-ion batteries. So I have had plenty of exposure to that particular regulatory environment. As an electrical engineer, EMC (Electromagnetic Compatibility) is another huge aspect of compliance engineering. But these were just a few of the available discussions about regulations. Each was presented as a track at this 3-day event in San Jose. At the end of it, I had broadened my understanding of the world of product compliance.
Sessions
The track on EMC was one of the primary drivers of this conference —and also a driver of my decision to attend. There was a track on 60601 updates for everyone in the medical devices world. My favorite was the track on lithium batteries, including the latest on UN38.3 rules that went into effect this year. These two fields are directly applicable to the product I’m currently working on. But it was the depth of new fields that was really a focus for me: hazardous locations, international requirements, and a whole host of other topics in product safety and compliance.
Networking
At least as valuable as the sessions was the networking. My main focus in that realm was to get every test lab rep’s business card. I now have a deep list of test lab reps that I can reach out to for quotes on short notice. This is a valuable tool in any product engineer’s bag of tricks. It was especially interesting to see which labs were specializing in which sorts of work. Some focused on complex testing, tests that would have multiple stages and acceptance criteria. Others were targeted towards helping you get your compliance certification paperwork wrangled through the bureaucracy of regulatory agencies. Some specialized in the compliance requirements of parts of the world that most of us don’t consider, such as Latin America.
Product Compliance Takeaways
Through all of this, I was reminded of a few key lessons when it comes to product compliance:
Research
It’s important to understand which requirements apply to your product. It’s often more than just FCC.
Does your product include lithium batteries? There’s a whole slew of standards to be aware of. What about lasers? There’s another book you’ll need to have open on your desk to make sure you are allowed to ship your product.
There can be any number of applicable standards for your product. Having good relationships with test labs and compliance experts is key.
And you should track these requirements as you would any other product requirement. Right after “the product exterior will be blue” goes “the product will conform to IEC 62509.” Again, without strict adherence, it’s likely your product will be delayed or not allowed to ship at all.
Schedule early
Test lab time can be hard to come by on short notice, especially for more involved tests. It’s important to get that lab time booked as soon as you know your schedule. Try your best to sync your test sample delivery with your test date so that the testing doesn’t delay your launch.
Don’t forget the paper process, either. Even after testing is complete, there’s often the time required to navigate the bureaucracy. Each regulatory body and their official approvals is the key to product. This is even more complicated when you’re launching product in multiple countries. Often times, you’ll need to hire an expert from your target market to help you navigate the process.
And then there’s your own process. Getting quotes, negotiating pricing, selecting test vendors, and cutting POs is going to be much the same as for any other supplier. These things take time and should be tracked in your schedule.
Compliance starts during design
The best way to ensure compliance is to consult with experts at the start of the process. You can raise your hand during designs to ensure the compliance testing is baked into the full schedule. Each test item also assumes you will pass the first time.
Ensure the designers understand the requirements and the consequences of ignoring them: Failing a test will blow your schedule out of the water.
We all know the iterating on a design is much cheaper if you do it early in the schedule rather than later on. Consult with experts who have taken products through these tests before. Run your own tests and book lab time to pre-test your designs if necessary. It’s worth all of that cost if it means passing your compliance testing the first time.
Through this work, you can ensure that when you hit mass production and product launch, your products will be certified for the market access they need.
