Another important aspect which often overlaps with Regulatory: Good Manufacturing Practices (GMP’s)

What are GMP’s? Many of you can google things and bring back links, I’m sure, but in practical terms, in real life, they mean several things.

1) Traceability – you need to be able to trace everything you sell back to its source as far as you can. That means all products, parts of products, packaging pieces, etc. need to have part numbers and quality checks. Speaking of which….

2) Quality System – you need to have one. There must be a set policy on Quality that is followed. The policy must lay out who is responsible for what in the company as far as doing Quality Assurance and Quality Control. It must also lay out a system for creating SOP’s and other documents needed to ensure traceability.

3) Security – There must be some way to ensure that your parts, components, etc. are not adulterated somehow. Incoming materials must have a system for quarantine and checking them against their specifications before admitting them into the production area. People must also be signed in, tracked, and/or screened when they visit.

4) Regulatory – Here’s the overlap. In order to be considered GMP, all proper ISO, FDA, and other applicable guidelines must be followed for the product and the facility. For example, a facility that sells medical devices in the US must be registered with the FDA.

It’s very easy to google some documents on this and spit them out, and if I’ve forgotten anything major, feel free to add. However, my question is how would these things influence a project in the Initiation, Planning, Execution, Closing, and Monitoring/Controlling phases, each?