Ensuring that medical products are safe is one of the most important requirements during product development. Regulatory compliance is often required to prove safety, and successfully passing tests conducted in a compliance lab is one way to prove this compliance.
Agencies, like Intertek, give approval to companies to apply symbols such as ETL on product labels. This symbol signifies that the product complies with all appropriate standards and regulations, is safe, environmentally friendly, and performs as per labeling claims. At Philips, all Sleep and Respiratory Care products carry the ETL symbol.
In order to safeguard – and fast track – compliance, we’ve developed in-house capabilities in the form of a Compliance Lab. The Philips’ Compliance lab successfully combines compliance testing with reliability testing (normally performed in separate labs), which makes its dual capabilities a unique proposition for the organization.
The Sleep & Respiratory Care’s (SRC) Compliance Lab started as a small test lab 20 years ago. Today, it boasts a space of roughly 8,000 square feet and contains three types of test areas where employees can run tests to ensure that Philips develops and deploys safe, compliant and reliable products. It’s an Intertek-certified Satellite Level 3 lab. This means that the lab has permission to independently conduct tests and simply submit the reports to Intertek for a swift review of the data to gain final certification.
To maintain Satellite Level 3 certification, the lab undergoes an extensive annual audit by Intertek. Here, the Philips Quality System, the calibration records of all equipment, and the training records of all lab employees are extensively reviewed.
Most importantly, auditors evaluate the knowledge and testing capabilities of all personnel in the lab.
The Sleep & Respiratory Care’s (SRC) Compliance Lab started as a small test lab 20 years ago. Today, it boasts a space of roughly 8,000 square feet and contains three types of test areas where employees can run tests to ensure that Philips develops and deploys safe, compliant and reliable products. It’s an Intertek-certified Satellite Level 3 lab. This means that the lab has permission to independently conduct tests and simply submit the reports to Intertek for a swift review of the data to gain final certification.
To maintain Satellite Level 3 certification, the lab undergoes an extensive annual audit by Intertek. Here, the Philips Quality System, the calibration records of all equipment, and the training records of all lab employees are extensively reviewed.
Most importantly, auditors evaluate the knowledge and testing capabilities of all personnel in the lab.
After all, only highly qualified people can ensure that products comply with appropriate standards and achieve a high level of safety and quality.
But the team doesn’t stop here. They develop a potential Misuse model.
Much of the equipment in the Compliance lab is used to perform both compliance and reliability testing.
Take this example: a regulatory compliance standard may require a device to be dropped 12 times from a 1 meter height to guarantee it’s a safe device. In that same situation, the Reliability Misuse model may evaluate that the same device could be dropped 50 times from 1.5 meter height during its 5 years of life. Thus, in the first testing scenario, the freefall tester in the lab is used to perform the regulatory standard requirement of a 1 meter drop test.
However, the team goes beyond minimal standards to meet the Reliability Misuse model requirement, developed in-house by Philips’ testing engineers. When it comes to achieving quality products at Philips, we don’t stop at the bare minimum. We exhaust all options until we know that safety, reliability and high quality is ingrained in every product.
Having our own compliance lab means we can ensure that safety and quality is a priority right from the start of product development. Engineering testing and troubleshooting to guarantee robust product design can begin early during the design concept phase. This enables Quality and Regulatory (Q&R) personnel to detect defects early on instead of at the end of the product development cycle and directly deal with the problem with design engineers — so that consumers get the value and quality they expect from Philips.
"We have all the knowledge, the evidence, and the data required to perform in-depth root cause analysis right here in the lab. This is typically missing when you outsource the testing to an external lab. You will only get a pass/fail test report with minimal information that can help in failure investigation,” says Vaishali Hegde, Head of Quality Engineering.
If anyone stands up to raise a potential quality issue, SRC leaders will listen. And when you have management support, anything can be achieved.
The SRC leadership team believes that quality is a game-changer. Consequently, the reliability and compliance team is always sharing best practices across Philips — cementing a culture of quality. The reliability team has shared things such as innovative new processes in the Reliability Council and post-market failure data analysis techniques.
It’s in this sharing of knowledge and the desire for quality that we see the cross-pollination of practices. Quality has become the unifying element between all Philips professionals — it’s intuitive to all employees, and key to our future success.
December 07, 2020
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