Documented procedure (SOP) vs Documented protocol
As we all know that in our laboratories, we are required to have some SOPs as per ISO 15189. Some of them are mandatory and some are not mandatory to have.
Is there a need to have Specific protocols apart from the available documented procedures?
e.g. If you have the SOP for method verification that covers both qualitative and quantitative tests, do you need a protocol that is specific for HIV rapid test verification? if YES, when do we need to have both SOP and protocol?
Comments
I think its yes. There could be a generalized SOP but a protocol document that it specific to a process or procedure as far as it is referenced or has its roots from your policies. Remember the hierarchy of documents. There should not be any orphan document. An example in my lab, we have an SOP for Emergency preparedness and contingency plan, and then again we have a protocol for Emergency Evacuation which is referenced in the SOP. So I think the protocol can exist alongside a generalized SOP where the protocol gives specific directions for a procedure.
But again, it is important to put in mind that there should not be a lot of documents which addresses the same procedure. This could be cumbersome for users as they need to look or access a lot of documents for a procedure that could have been addressed by just one document.
I agree with @Ebenezer Benefo. Both procedures and protocols may be required especially if its a research based institution.