FMDs For Regulatory Compliance: The Secret Weapon Against Disruptions

by Source Intelligence

on September 7, 2021

Manufacturers, procurement professionals, and essentially anyone involved with the supply chain knows how devastating it can be when a product is found to be non-compliant. The smorgasbord of global regulations and directives combined with sprawling multi-tier value chains can be overwhelming for companies to manage.

And, if not properly managed, an oversight or lack of transparency can result in a multitude of supply chain disruptions such as:

  • Products being pulled from certain markets
  • Products being held at the border
  • Steep fines and penalties
  • Legal liability and lawsuits
  • Brand reputation damage


This is where Full Materials Disclosures (FMDs) can come in to save the day. An FMD is a complete description right down to the raw materials of the parts, components, and/or substances that make up a product.



Benefits of FMDs For Regulatory Compliance



Let’s take a look at the many benefits of collecting FMDs and how you can effectively use them to mitigate the risks of not meeting regulatory requirements. 



Know Where Your Product Is At Risk



Essentially, FMDs allow supply chain professionals to be proactive with risk mitigation instead of reactive. You can’t prepare against threats you don’t know about, so FMDs arm you with the knowledge needed to make informed business decisions.  - Click To Tweet



FMDs provide a complete list of all of the raw materials that went into the making of a product and remain in the final product. Raw materials can include commonly known materials such as tin, cotton, gold as well as lesser-known substances like cadmium sulfide or ammonium sulfate.


Since regulations such as REACH, RoHS, SCIP, and Conflict Minerals require you to know and report on the materials in your products, FMDs are one of the best sources of information to mitigate non-compliance risks.



Limit Supplier Fatigue



Everyone is busy and no one wants to add extra work on their plate, especially if they don’t see any value in it. The same applies to your suppliers.


Asking for a lot of technical information, documentation, and back and forth communication can be taxing for manufacturers whose primary job is to make parts for your product. Furthermore, they may not even know the information you are requesting due to raw materials coming from further down the supply chain. Many suppliers may not understand the importance of the information you are requesting and may not be educated on the regulations for which you need to comply.


Gathering FMDs streamlines this process. An FMD rolls up everything you need to know about your product from your suppliers in one document. Suppliers can update the FMD once a year or as needed and you won’t have to go back to them for more information if there are regulatory changes like a new SVHC being added to REACH.



Increase Client Satisfaction And Confidence



If you are supplying enterprises with products, collecting FMD information will greatly benefit your client relationships. FMDs provide complete transparency and useful information for your clients to make informed decisions.


Many clients will ask for FMDs, and if you’ve already done the work of collecting them they will greatly appreciate the fast turnaround time. Not only are you liable for making sure your products are compliant, but your clients may be too. That means customers may request information such as a list of substances or information to fulfill FDA or RSL regulatory compliance requirements.



Decrease Unnecessary Time And Resources Expenditure



Just when you thought FMDs do it all, there’s even more benefit they can add. Collecting FMDs for regulatory compliance also clears up your workload.


By collecting a single document with all the information you need, there is:

  • Less back and forth communication with suppliers
  • Significantly fewer documents you’ll need to spend time reviewing
  • Fewer resources and time spent on hunting for information for regulations or for customer requests




How To Use FMDs For Product Compliance



Once you have your product FMDs, how do you use them for compliance?


FMDs contain the substance level data you need in order to validate against and comply with restricted substances regulations, including REACH, RoHS, California Prop 65, SCIP Database, and EU MDR.


You will have the information needed to determine the presence and concentrations of substances contained in your products and compare them to the applicable regulations. For example, RoHS needs calculations based on the homogenous material level, REACH requires it on the article level, and the FDA requires the product or assembly level.


FMDs align with industry reporting requirements (IPC 1752, IPC 1754, SCIP, IMDS, and IEC 62474) so you can avoid extra legwork.



How To Collect And Create FMDs



Now that you know the benefits of FMDs and how to use them, the next question is how do you go about collecting them from your supply chain? Or, if you’re a supplier and need to provide an FMD, how do you go about creating one?


At Source Intelligence, we make it easy to create and collect FMDs. Our FMD creator tool is web-based, allowing you or your suppliers to quickly and easily fill out the information needed for a complete document.


Our AI-powered platform makes it easy for suppliers to fill FMD requests with:

  • An easy-to-use interface
  • AI tools that can gather certain information to fill in gaps as needed
  •  A 24/7 multilingual supplier help team provides the support and any education needed for suppliers to successfully complete an FMD
  • Gather documentation and data needed from your supply chain to complete the FMD


To learn more about how we can help you add FMDs to your arsenal against supply chain disruptions, schedule a demo with one of our regulatory experts.


Request a Demo

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