For many product engineers, the huge gap between design and delivery limits their product vision. Far too many issues can bring a varying degree of friction – that well-known result of inefficiency – to the process.
One of the most challenging aspects of manufacturing is international certifications. This is a problem especially for custom products which incorporate multiple manufacturing techniques. Some examples:
- formed and machined metal
- cable and harness interconnects
- molded plastics and printed circuit board assemblies (PCBA)
A number of international organizations such as CE, CPSIA, FCC, FDA, and UL govern and regulate those product categories and many others. These organizations, in turn, often base their governance by adherence to hundreds of other related certification authorities such as the International Standards Organization (ISO). In some cases, more than just the product must comply with certain standards and requirements. The factories and their upstream suppliers must each have their certification, too.
Miserable Miasma
The complexity of this certification microcosm is immensely challenging. How can one product engineering team handle it? How can one team make sure the final product meets the performance, safety and use standards?
Now add annual certification(s) audits to the process. Auditing the handful of related entities and the dozen parts of a new medical innovation can be overwhelming to even the most experienced and resourceful product engineer and team.
The whole process is just about impossible to supervise, much less control, at arm’s length, halfway around the world.
The solution is to have a large team of engineers and procurement specialists on site who have broad experience in multiple manufacturing domains. It’s hard to bring that solution when the team is limited to only a handful of designers or engineers. Most of our customers simply don’t have the workforce, or the expertise, to chase down all the loose ends common to international certification.
How EastBridge delivers difficult international certifications to your easy button
EastBridge solves the international certifications problems most OEMs encounter. Our people can be on site in days, and often are already there. And they think in terms of best practices because they work with so many different types of applications at so many different factories.
We manage the entire process by correctly identifying the requirements and approved the vendors early in the design process. Then we put boots on the ground to inspect the products during manufacturing to make sure all the requirements are being met. And we can troubleshoot the problems and fix them to our clients’ satisfaction
Over the past 15 years, we’ve developed a rock-solid process for getting product certification. We manage (and greatly simplify) the process for our customers in specific ways and means. Here are the major pieces:
- Develop an understanding of their products and applications to provide meaningful advice or recommendations about relevant certifications and testing protocols.
- Identify vendors (and supporting supply chain) that hold the necessary credentials to fulfill international certifications.
- Carry out on-site manufacturing, quality system and financial due diligence audits to confirm the capabilities of candidate vendors.
- Publish either a 22-point (must system) or 100-point (must system) vendor scorecards. These may include our recommendations regarding documentation, reporting manufacturing techniques, etc.
- Periodically re-audit the facilities to confirm they continue to hold to our customers’ and international standards.
- For those customers request our assistance with issues on the manufacturing site, we will go to the facility, diagnose manufacturing and quality problems, conduct shop floor trials, develop robust manufacturing methods and inspection techniques, and implement a recovery plan.
- Perform WIP (work in process) inspections, final inspections, laboratory analysis (in-house and with internationally certified third-party labs) and provide COCs (Certifications of Compliance), test data, laboratory results and other documentation.
Product designs trigger a variety of considerations in any certification process. In our experience, applying this system streamlines product certification.
No matter the manufacturing process challenge, EastBridge has the right people with the right experience at the right place ready to put your design on the dock.
Let us help you overcome your international certificate challenge.
Thanks for reading.
–Jack
