I am the QA at a small manufacturer of dips and other ready to eat meals. I have only been here a week and my previous QA role was in pharma. We have our first SQF audit in May and I am a bit concerned because I feel that we have a lot of gaps in our QMS but am not sure if this is just my pharma brain talking. We have a consultant who I have been talking to this week and the reason for my concern is that he seems to think I am being too rigorous in what I want to do and that I shouldn't worry so much. I will give an example...
In my previous role we have Policies which say basically what the company does for a certain issue and references the relevant lower level procedures. Then we have the procedures which is a detailed who, what, where , when, how to do the process and then there are SOPs/WIs which is more of a how to for specific tasks such as cleaning a piece of equipment and then there are records.
At the moment we have heaps of records but none of them have overarching procedures which tell you to fill our the records! An example is that we have batch records for when we make a product but there is no procedure that tells you to make the product and the details around that. The consultant seems to think this is fine for SQF but I am not so sure....in GMP for Medical Products you definitely need a Production Procedure as well as the batch record that goes with it. Is this necessary or am I being too pedantic? Thanks in advance