Are Supplier Control Issues causing Medical Device defects – Post Release?

The latest Medical Device Supplier Trend is contributing to more FDA Recalls.

It’s the Domino Effect of Outsourcing across every aspect of the Industry.

I recently spoke with a manager of quality at a large biotech company, and she told me about the issues they’re experiencing with their certified suppliers.

Here’s what’s occurring.

The biotech company spends an inordinate amount of time locating, vetting, certifying and then managing ongoing certification of  suppliers for everything from device components to offshore development shops – so it’s no easy feat to replace a supplier experiencing quality issues.

ISO 13485 states that Medical Device Suppliers shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained and consistency with how they provide their parts, to avoid negatively impacting the final biotech product. This includes the raw materials they use to build their components, sub-vendors they order the components from and where the components are assembled. Any change can generate problems for the biotech company during final assembly and test.

Put yourself in the shoes of the biotech company.

They design and build a medical device – they perform all the FDA mandated steps to get this product to final release, including stress testing performed on the component parts themselves before final assembly.

In other words, the biotech company has followed all the rules & regulations, every IV&V phase has passed and they ship the product. Then “bam!” there’s a problem in the field. CAPAs are submitted and root cause analysis is performed.

Eventually it’s determined that a supplier supplied component is the culprit. Investigation reveals the vendor changed their raw material supplier (because they’re trying to cut costs) and the so called harmless change caused an FDA Recall due to the peculiarity of the defect.

Now…multiply this by the number of supplier resources the Medical Device company is utilizing, as it outsources more & more aspects of the product design, development and manufacturing processes – and say each of those contract organizations ‘change’ their suppliers – can you see how difficult this has become?

How could this have been prevented?

By utilizing a proven order of attack for evaluating processes – to ensure you can verify everything in the chain is up to the task before, during and after product design, development, manufacture & shipment.

  1. Supplier Certification
  2. Feature Inspection Plans
  3. Receiving Inspections
  4. First Article Inspections
  5. Recall Prevention Testing
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