PLM & Engineering Rules

Document or file management means different things to different people. For example, if you work in human resources you would likely want a single location for all of your files.  Those files could be company policies, resumes, offer letters, etc.  You would need strict access controls so that the information doesn’t get into the wrong…

Thoughts on FDA Compliance

ISO13485 – This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. Any discussion about FDA compliance and quality management is ultimately about risk management.…

Risk Management

ISO14971 is a risk management standard for medical devices. Its purpose is to help manufacturers to establish a medical device risk management process that they can use to identify hazards, to estimate and evaluate risks, and to develop, implement, and monitor the effectiveness of risk control measures. A large part of FDA compliance is risk management. I can’t imagine any company that doesn’t assess their risks. I am sure that there are…

A PLM Story…

Way back in the Sherpa days, our president used to always tell us that our software was designed to get the right information to the right person at the right time. At the time, I wasn’t excited about this being the best way to describe what our software did.  However, this description has held up…

Business Process or Customer Journey

Wikipedia describes a business process as a collection of related, structured activities or tasks that produce a specific service or product. It can often be visualized with a flowchart as a sequence of activities with interleaving decision points with relevance rules based on data in the process. For years, the focus of business process management was to manage a collection…

New Product Introductions & PLM

I just saw a report on a study that showed that more than half of new product introductions [NPI] fail. There are many components of introducing a new product and in most cases there is not a formal process in place. In the beginning… Someone will come up with an idea for a new product…

Process Improvement Process

The benefits of business process management There are many benefits to managing your business processes.  The benefits may differ from company to company, but they are very real. The University of San Francisco posted a blog that identifies some important benefits: – Increased accountability – Improved reliability – Simplify regulatory compliance – Avoid waste -…