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CAPA, FMEA, and the Process Approach

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Corrective action and preventive action (CAPA) is probably the most important process in any quality management system because so much else depends on it.

Incorporate Cyber Resilience in Your Business

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Photo by Petter Lagson on Unsplash
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Few of us today are unaware of the significance of cybersecurity and the threat of cyberattacks on our computers, smartphones, and other devices.

FTX: The Harmful Consequence of No Oversight and Poor Risk Management

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What’s your decision-making philosophy? Do you toss a coin, or do you consider all the risks of your decisions? As a quality professional, you've probably developed a well-thought-out approach to decision making and risk management.

Hanging by a Thread: The Life of a Bridge Inspector

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Yup, that’s me in the photo. You’re probably wondering how I ended up hanging under a bridge over the Mississippi River. I’m a certified bridge safety inspector.

European Commission Proposes Extending MDR Deadlines

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Updated 12/12/22

Eight CAPA KPIs You Should Be Measuring Now

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Corrective and preventive action (CAPA) is a core function in any quality management system (QMS), and a critical piece in the plan-do-check-act process approach.

How to Conduct Level of Repair Analysis (LORA)

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Every day, manufacturers rely on a large number of tools, machinery, and infrastructure to produce their goods.

How to Prioritize Cybersecurity Risks in Medical Devices

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Unpatched vulnerabilities

Why Did Adidas Wait So Long to Drop Kanye West?

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Why do companies bury their heads in the sand instead of facing dangerous facts, whether about quality problems or other issues? It happens more often than you might think—most recently with Adidas.

Equipment Calibration: The What’s, Why’s, and How’s

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An important part of production is to carefully monitor and control temperature, speed, volume, weight, or mass. To ensure these measurements are always accurate, manufacturers need to calibrate their equipment and instruments regularly.

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