There are No Good Manufacturing Practices

A Cartier Watch

Have you ever heard of Goodhart’s Law? Developed by British economist Charles Goodhart, the simple version is: “When a measure becomes a target, it ceases to be a good measure.” On its own, it’s a beneficial concept for Quality Management. For example, if you record the time it takes good, well-trained inspectors to measure a … Read more

Verifying Purchased Product According to ISO 13485 7.4.3

Verification of purchased product for ISO 13485

You’ve qualified your suppliers and purchased their products, but what should a company do once the products arrive? ISO 13485 section 7.4.3 is all about the verification of purchased products to ensure they meet the company’s and supplier’s specifications. What are the requirements for verification of purchased product? The variety in purchased product verification can … Read more

Retraining Is Not The Solution

It’s the third day of an audit. While you’ve been enjoying the provided lunches and getting away from checking email, you’re no longer entertained by the auditors’ elaborate stories and anxiety that a haywire Teams message will appear on the screen you’re sharing. For the last hour, he’s been locked in on one form that … Read more

Effective Supplier Management for Medical Devices (ISO 13485 7.4.1)

How to create an effective medical device supplier management process to meet ISO 13485 7.4.1

All medical devices start from somewhere, and that somewhere is usually supplied by an outside organization. Supplier management is critical for medical device companies as the quality and safety of their devices is determined by the products and services coming in their door. Many medical device companies have difficulty with supplier management, and for good … Read more

Customer-Related Processes for ISO 13485 (7.2 Explained)

While medical device companies can get caught up with processes and regulations, they are still businesses. And since they are businesses, they will have customers who purchase their products or services. In fact, ISO 13485 has an entire clause (7.2) dedicated to customer-related processes to ensure this aspect is incorporated into a company’s QMS. Like … Read more

Understanding Medical Device Change Control (ISO 13485)

Change is essential and necessary for any organization, especially medical device manufacturers. Organizations need to be constantly aware of changes to materials, suppliers, processes, specifications, and other items related to their products. Not only are medical device companies required to be mindful of changes, but they must implement change control to maintain the function of … Read more

Passing the ASQ CSSGB Exam: Tips and Tricks

I recently became an ASQ Certified Six Sigma Green Belt (CSSGB) and wanted to go over my experience with studying and passing the exam. This article will cover the process for applying, studying, and taking the exam, and will provide all the study material I used to pass the exam on the first try. As … Read more