SOP (Standard Operating Procedure) Numbering

[Anonymous16-2]

Hello and Happy Friday!

I just started in a new company... the person before me "created" some SOPs and assigned the document numbers AA-XX-XX-XXX-XX (where AA are the initials of the company and the X's are numbers), they really make no sense even thought there is an SOP on Writing SOPs. The format the person used is difficult to follow and if I need to create new SOPs or forms it's really not as easy. We'll need to re-write all the SOPs anyway, and while going through this exercise, I wonder if it's too late to reassign SOP numbers. I need to fix the QMS and get us to a point where we can get audited and certified, but I never experienced anything like this....

Your help is greatly appreciated!

 

[Edward Reesor]

If they need to be re-written/revised anyway, I would implement the system that you plan to use (with an introductory executive summary that explains the rationale for the new numbering system) and do it all at the same time. I imagine that this challenge is not all that unique in companies that are purchased or merged. V1 of the new document would state something along the lines of, "replaces xx-xxx V15". Make sure you do a CPAR action for the project with rationale, validation and verification activities included.

 

[Anonymous16-2]

Thank you @Edward Reesor!

What do you mean by introductory executive summary? is this to be added to the Change Control document? My rationale is basically to make it easier to create new SOPs and be able to create forms... would that be a good rationale?

 

[Jim Wynne]

Make sure you do a CPAR action for the project with rationale, validation and verification activities included.

What is a CPAR action?

 

[Edward Reesor]

Basically, but if you ask yourself the standard "why" five times, you should get to the root of the summary. Stating that something is easier doesn't necessarily make it safer (and making something safer is what you need to address in a quality system).

I used the term CPAR to refer to a Corrective and Preventative Action Report/Form/Plan/Action/etc. as that's the term we use in-house. Others might call it CAPA. Its the rationale behind why something is changed, and what was done. I was nailed for not creating a CPAR after an audit revealed that I didn't have some kind of form or report. I just created the form, but the following audit asked for the CPAR that went along with it.

 

[Sebastian]

First, thread is not related to quality manual, but document control, so it should be moved to subforum Document Control Systems, Procedures, Forms and Templates.
Second, there is related thread QMS Overhaul - Reorganizing and Renaming Documents - Internal References
I put there my numbering template, which is very simple and supporting process approach.

 

[Baljit Kaur]

Hello and Happy Friday!

I just started in a new company... the person before me "created" some SOPs and assigned the document numbers AA-XX-XX-XXX-XX (where AA are the initials of the company and the X's are numbers), they really make no sense even thought there is an SOP on Writing SOPs. The format the person used is difficult to follow and if I need to create new SOPs or forms it's really not as easy. We'll need to re-write all the SOPs anyway, and while going through this exercise, I wonder if it's too late to reassign SOP numbers. I need to fix the QMS and get us to a point where we can get audited and certified, but I never experienced anything like this....

Your help is greatly appreciated!

1) Sop number should be unique and traceable for every SOP. This is the only guidelines requirement, So define first 2 to 3 digits or alphabets for department code and other 2 to 3 digits should represents the serial number of that
particular SOP. Serial number should be open to enter more SOPs in that particular department in future if there is requirement of more SOP. And if it is necessary for you to add the company code in SOP numbering system you can add 2 to 3 alphabets to represents company name, otherwise the all SOP should be printed on Company logo standard paper.

2) SOP on writing SOP is quality system guidelines requirement to harmonization the format and procedure of writing SOP on so many other activities in the company.

3) Strong QMS can be established in company by developing SOP on all QMS factors; I.e. Deviation handling system, OOS handling, OOT handling, Change control system and Market complaint handling system.

 

[Marc]

First, thread is not related to quality manual, but document control

Moved to the appropriate forum.

So define first 2 to 3 digits or alphabets for department code and other 2 to 3 digits should represents the serial number of that

Just to be clear, "numbering" (document identification) can be done in what ever a company wants. Some companies, for example, do not use numbering systems.

@Anonymous16-2 would do well to read through the existing discussions about document numbering here. For example, see: Search results for query: document numbering

I wonder if it's too late to reassign SOP numbers. I

You can re-number your documents at any time. Point to remember is where in one document another document is referenced, the referenced has to realigned. So depending on how many documents you have this can be a significant chore.