Teams building software as a medical device (SaMD) tend to think of ISO 14971 as the hardware team’s problem. Risk management files, FMEA tables, severity scores: all quality and regulatory territory, while the engineers close Jira tickets.

Ask anyone in manufacturing or in a project-driven company who has the most difficult job, and without hesitation they will say: the scheduler/planner.

A food company spends months and significant budget on consumer research before launching a new product. The survey scores are strong, so the store managers stock it. Six months later, the product is quietly pulled from the shelves.

Think fast: What’s the No. 1 rule of troubleshooting?

Focusing on metrics is key to achieving your desired business results—but it can be difficult to determine which metrics actually matter.

The most charming AI model may be the one most likely to mislead you. That’s the uncomfortable reality behind the latest fight over Claude, ChatGPT, and Grok.

Hospitals continue to face increasing financial uncertainty as healthcare reimbursement rates shift and margins tighten. 

A lot of computerized maintenance management system (CMMS) rollouts fail quietly. It’s a common scenario: The software is installed, technicians are logging hours, and the digital work orders are flowing.

Rapid changes in the global business environment require developing and adapting management systems so they remain relevant and effective.

For more than 30 years I’ve audited management systems in manufacturing, automotive, laboratory, service, and nuclear environments. During that time I’ve watched internal auditing change shape several times. Paper checklists gave way to process-based auditing.