Edition #22 - Supply Chain Risk: What You Don’t Know Can Hurt Your Product

Many product businesses assume compliance is something you simply “design into” a product.

The truth is your product can be compliant today and non-compliant tomorrow without you changing a thing. A supplier might swap a material, change a coating, or alter a process. Often these changes are made with the best of intentions, as suppliers may be dealing with obsolescence, availability issues, cost pressures, or process improvements.

However, even well-intentioned changes can create unexpected product risk, especially when they affect regulatory requirements. Supply chains are complex and often stretch across regions, countries, and cultures. Changes are not always communicated, particularly when suppliers do not fully understand where your product is sold or what regulations apply.
There are two key actions you can take to mitigate this risk:

1. Control changes
All modifications that impact the product or its production should follow a documented change management process. Suppliers should formally propose and document any changes before implementation. Internally, changes should be reviewed, assessed, and approved before rollout. A strong change control system keeps specifications, product performance, and risk management aligned. Ensure this process is clearly documented in your supply agreements.

2. Set clear expectations around compliance
Even with disciplined change management, you need a framework to ensure every material, component, and process meets regulatory requirements. This includes:

• making suppliers aware of all markets where the product will be sold
• specifying regulatory requirements in agreements
• requiring Declarations of Conformity that are updated at least every two years
• requiring these are backed with test certification from accredited laboratories
• performing your own risk-based verification testing
  

When these two actions work together, the supply chain remains stable and predictable, reducing the likelihood of costly disruptions, recalls, or compliance breaches.
A compliant product requires more than compliant design. It requires a supply chain that understands your markets, communicates changes effectively, and can demonstrate compliance when needed.

The next newsletter will continue exploring supply chain-related risks, with a focus on transparency in the supply chain.