E
Later Post:
So, I like the idea of the form (that way I don't need all the approval signatures that an SOP/WI require). Or, another idea was to make it a "reference" document.
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Eohara:
You have indicated that you are going to use the "nice format" anyway, so why is it necessary to abandon the SOP? I am a bit concerned if the main reason for not keeping this SOP active is to avoid the approval signatures that an SOP/WI require. SOP/WI should have approval signatures at appropriate levels and this would not be considered a critical SOP so the approval process should be simple.
If you had to write an SOP to cover this, I would say it is not critical to have but think of the value to a new employee who may need to write an SOP and needs to understand what is required for the sake of the company - not auditors. It is standard practice for companies who operate under GMP to have a standard format for their SOPs and it certainly makes life easier for inspectors.
So, I like the idea of the form (that way I don't need all the approval signatures that an SOP/WI require). Or, another idea was to make it a "reference" document.
============================
Eohara:
You have indicated that you are going to use the "nice format" anyway, so why is it necessary to abandon the SOP? I am a bit concerned if the main reason for not keeping this SOP active is to avoid the approval signatures that an SOP/WI require. SOP/WI should have approval signatures at appropriate levels and this would not be considered a critical SOP so the approval process should be simple.
If you had to write an SOP to cover this, I would say it is not critical to have but think of the value to a new employee who may need to write an SOP and needs to understand what is required for the sake of the company - not auditors. It is standard practice for companies who operate under GMP to have a standard format for their SOPs and it certainly makes life easier for inspectors.
Thanks Logic and everyone. You're bringing up all the things I've thought of (and more), and I see why I hadn't made my decision. There's good reasons for both sides.
Logic - no worries on my SOP maintenance. I inheirited a bunch of VERY detailed and thorough GMP procedures that my company was not following. I archived all procedures that didn't strictly deal with our QMS, and revised SOPs like "Corrective Action" and "Control of Non-Conforming Product" to fit with our company and fulfill ISO.
I have also thought about the new person that would benefit from documentation. I think I will keep this open, and work on my non-compliant clauses in ISO before I tackle this.
I appreciate everyone's comments!
