Items Tagged with 'risk management'

The question for every executive is whether your quality infrastructure is designed for it or for a more forgiving era that no longer exists.

No matter the industry, every manufactured product carries critical information: specifications, safety warnings, regulatory markings and even serialized identifiers that are linked to traceability and quality control. 

Have you ever heard the expression “that is not the way we do things here!” Paradigm paralysis is one of the most prevalent—and least recognized—barriers to innovation in modern industry.

With regulatory requirements changing regularly, staying up to date and maintaining audit readiness is critical. Effective quality management protects an organization’s reputation and guarantees ongoing compliance.

Any conversation about automation and quality has to start with an acknowledgment that robots inherently improve quality. Robots produce more consistent work than humans. 

“Quality built the industrial world. Trust will build the intelligent one.”

When people think of medical devices, they often picture pacemakers, insulin pumps, or MRI scanners. Increasingly, however, medical innovation no longer comes in metal or plastic—it comes in code. Software as a Medical Device (SaMD) refers to software intended to perform a medical function without being part of a physical device.

Jenna Schoettker is a senior accreditation specialist at A2LA and has been in the industry for a long time. She's been working with Quality on a few different projects.

QP is the forward-looking mechanism for building a solid foundation established at the outset of product or service development cycles. This stance is necessary because development projects, despite beginning with clear objectives, typically encounter recurring difficulties as they progress.

Risk management has taken center stage in quality management, particularly with recent ISO updates. Organizations must recognize that risk encompasses both negative impacts and potential opportunities. By utilizing diverse analytical tools and effective brainstorming, businesses can navigate risks, minimizing downsides while capitalizing on growth opportunities.