Items Tagged with 'CAPA'

The FDA’s new Quality Management System Regulation (QMSR) represents the most significant shift in FDA quality system compliance in over 25 years.

If you didn’t know any better, you might think Sainyam Arora has been in the quality field for decades. 

For decades, quality has been treated as something that sits alongside production rather than as an integral part of it. Most organizations invest in quality primarily to avoid failure: recalls, regulatory findings, customer complaints, and brand damage. 

In the early 1980s, my Quality career emphasized variation and corrective action. Although I’ve attended various solution-branded workshops, many organizations still struggle with understanding variation and effectively implementing corrective actions.

During a career in which I devoted a large portion to developing and implementing improvement programs, one thing became crystal clear. Improvement programs with a focus on sustained improvement were more valuable than speed of implementation.

As expressed in the blog 3 Functional Ways Risk is Critical to Quality Management by LNS Research, an organization’s approach to enterprise quality management should never remain stagnant. 

For medical device manufacturers, having a product that functions as designed is critical, as a person’s health—or even their life—could be at risk. It’s one thing if my Alexa won’t respond to a voice command to remind me of a task, but it may be life threatening if my asthma inhaler won’t give me the medication I need when I’m struggling to breathe.

In today's increasingly competitive manufacturing environment, the need to investigate and track quality related events is a crucial factor in the day-to-day manufacturing operations.