"Fresh off the presses" ;) according to the boss!!! How to incorporate the 4M processes into a existing system that doesn't check anything only changes stuff :confused:

I also have a question about how define responsibilities for corrective action processes we have a lot of overdue ones, and why do companies let the auditor tell them what to do instead of doing what works for their particular company!

4M'S 1. Man - change of operators 2. Machine - new, updating or improving facility 3.Method - changes in process i.e. operations, working conditions, 4. Material - raw material, parts change, packing change or auxiliaries. What are your processes? What is your current documentation like structure wise / what exists currently? Work Instructions? Setup instructions? How is document control currently handled?

An implementation project plan depends upon what currently exists vs. your goal / requirements. ...why do companies let the auditor tell them what to do instead of doing what works for their particular company... If that is happening, whoever the key person in your company who handles the QMS and interfaces with the auditors is needs some help IMO. And, if this is happening, the auditor is consulting not auditing. But again, more details - such as an example of what you're doing vs. what the auditor tells you to do - will help us to better answer your question.