Content by Stephanie Ojeda
Improve Complaint Management for Life Sciences With an Automated QMSWays to stay compliant while reducing risks to patients
Thu, 06/29/2023 - 12:03
Effective complaint handling is fundamental to life-sciences quality management, with implications for operations, product design, risk management, and more. It’s also critical to ISO 9001, FDA Quality System Regulation (QSR), and EU Medical Device…
Why Manufacturers Are Integrating EHS and QualityWhat’s driving the shift, and what are the potential benefits?
Tue, 05/02/2023 - 12:03
Quality management and environmental health and safety (EHS) have traditionally existed as siloed processes and roles in most organizations. It’s easy to see why, given the forces that have shaped quality and safety during their history. Modern…
Eight CAPA KPIs You Should Be Measuring NowCompanies should track a range of CAPA metrics
Thu, 12/08/2022 - 12:02
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. Like any quality process, tracking CAPA key performance indicators (KPIs) is crucial…
Mastering the 8D Problem-Solving MethodologyA guide to root cause analysis in manufacturing
Wed, 05/07/2025 - 14:26
Every day, quality leaders face a variety of production and process issues. While some problems are easy to fix, others require deeper investigation—such as using a 5 Whys analysis or Fishbone diagram. But then there are the stubborn, recurring…