Standard Operating Procedures

I recently started a new position to attain QMS certifications. My old employer has a simple documentation structure: Quality Manual, Procedures, Instructions, Forms. Now, this new system is looking to implement Quality Manual, Standard Operating Procedures, Departmental Procedures, Work Instructions, and Forms.

What is this Standard Operating Procedures stuff? It seems to me that I am writing a blurb in the QM, then expanding for the SOP, Further expanding it for the DP, and then getting down to nitty gritty for the WI. Isn't this overkill on the documentation?

Any interpretations here are welcome. Thanks in advance!

SOP definition

So you also use 3 levels: Quality Manual, SOPs, and Reference Materials. Do you see any need for an interim level of procedures between the SOPs and the Reference Materials?

(By the way, the flow chart is upside down and backwards in the file.)

So you also use 3 levels: Quality Manual, SOPs, and Reference Materials. Do you see any need for an interim level of procedures between the SOPs and the Reference Materials?

Hi mitsu11,

actually I don't use SOP level. It was just a Web example of SOPs.

I used SOP in a pharma company, drug manufacturing.

SOPs are mandatory in pharma, as long as GMP and GLP, process validation and some other stuff.

You HAVE to comply and you must call them SOP. Personally I don't think the name you give to these documents is essential, I'm more interested in their purpose.

I've never heard of SOP in a food or food-related company, but it's only my best knowledge.

The documentation pyramid should be appropriate for the purpose, hence I believe no one better than you knows if the interim level fits or not.

Regards. Franco

After a long time I am here to participate on Post.
SOP what we generally refer to Standard Operating Procedure. I have my own doubt on it. Why do you need SOP? I think an operator who works on process or on machine day in day out understands better than any body How To Operate .Second if aim of SOP is for training to new entrant or joinee, SOP should be placed in Training Room or in offices or in session rooms and not on the machines. Yes, if SOP contain TROUBLE SHOOTING TIPS , It should be posted on or near the point of use. Please clarify

Actually, they want to use the SOP as a high level document, giving an overall explanation of the "Management Responsibility", or "Document and Data Control". I think the purpose is for the auditors, but it seems like more work than is really necessary.

The documents you mention would fall under work instructions in this system. Those I absolutely understand needing in certain areas, but not torturing the good workers with a needless document. I try to make them "own" the document, so that they can see the benefit in its existence.

What is this Standard Operating Procedures stuff ?
Any interpretations here are welcome.

An example from USDA USDA sanitation standard operating procedure

Rgds. Franco