Aren’t design controls and risk controls essentially the same thing?
Uh, no.
They are similar, but in the end, very different. Cousins more than siblings, if that helps.
Design controls describe what the product must do, while risk controls describe what it must not do.
You’ve seen me post design controls and the waterfall process of user needs, design inputs, design outputs, validation, verification, and design transfer to production.
It just so happens – and this is where the similarity thing comes in – that those are all key components of your risk management file.
It works like this:
Manufacturers must perform a risk analysis and assessment, then specify the risk control measures and production and post-production activities that will manage that risk.
And the risk identification process must take into consideration both foreseeable misuse and the known and foreseeable hazards associated with the device.
Potential hazards can be electrical, mechanical, biological, chemical and performance-related in nature, and the most effective way to minimize risk is to ensure that the device has an inherently safe design and manufacture – which brings us, quite amazingly, back to design controls.
Manufacturers can also control the potential for risk by implementing protective measures – either in the device itself or in the manufacturing process – or by providing users with safety information and training, if applicable.
Which circles right back to – say it with me this time – design controls.
Funny how that works.
Risk management and design controls are so interconnected that they really need to be at the same table, not managed by different departments on different floors that refuse to communicate with each other.
Design and risk controls are both part of your total product lifecycle management plan, and need to be reviewed, revised and maintained as any other quality system documentation.
And remember – risk analysis and mitigation is not just for your device or product. You should do a complete risk assessment on your training and hiring processes and materials, your operations, and your documentation protocols and processes as well.
Most regulatory challenges aren’t about missing information—they’re about applying the basics consistently.
If you want a refresher on those fundamentals:
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Video: Document Control Gone Wrong: Common Failures in QMS Systems
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Substack: QMSR Isn’t Just About Compliance Anymore
- And there are other controls to consider as well: Purchasing Controls: Why Your Supplier and Quality Agreement Actually Matter
And if you want to see how that translates into day-to-day work, Understanding and Implementing QMSR walks through it in a bit more detail.
Not exciting—but very effective.
