Hi All,
There are various thoughts on how to lay out the Q1 (ninth edition) QM, that is, either an exact replica of the Q1 or in your own words.
What's wrong with using the Q1 template, is it frowned upon by the API auditors? I would think it makes things easier for them with regards to referencing etc. when they are carrying out an audit. As long as the manual then refers to the companies procedures which are in their own words.
I should mention that we are working from a blank canvas as we don't have a current "working" manual only a draft API Q1.
Any thoughts, or even better, first hand experience.
Thanks
I've only ever dealt with 1 API auditor. He was very impressed with what he had and called it "one of the best I've ever seen". My Quality Systems Manual pretty much mirrors the API Spec. This is what is required; this is WHAT we must do. It doesn't make sense to go fancy with that in my opinion. However, my Quality Procedures Manual and all associated forms and documents are HOW we carry out the WHAT. That is something that must be tailored to your operation.
What is required of you is the same thing required for all of us; the requirement or spec does not change from company to company. What is does change is how each company goes about fulfilling the specification, or executing it. Your procedures should accurately describe the practices with which you fulfill, meet, or exceed what is required.
Note-- be careful with some of the language you use. There is a difference in May vs Shall, or Required vs Recommended, or Annually vs Continuously or As Needed.
Don't paint yourself in a corner. If you say "this is what we do" in your procedure, you better do it, otherwise you might be meeting API specifications and requirements, but not your own, which will be a finding all the same.
If you say you evaluate all employees every month, now you have to have a papertrail for that proving it. I have on a few of my preventative maintenance forms "operators must perform pre-use inspections prior to every shift; document Once per week at a minimum" -- so instead of having to make sure I can prove they are performing this inspection every day as I require, I only have to show documentation of it once a week.
Simple but true phrase - Say what you do, & do what you say. Q1 is so vague and broad. Your procedures should narrow it down to the way you do it. But dont make it so narrow that you create a paper monster that will be impossible to maintain.