Creation of Procedures Order

[mdenham]

Writing standard operating procedures (SOPs) involves a lot of interelated processes (and therefore cross-references to other SOPs and work instructions). However, when one is starting to create a new quality management system (QMS), no documents exist.
My question is therefore twofold:

1. In what order would you recommend creating the procedures for a new QMS (at least to address the mandatory sections of the ISO 9001).
2. For a procedure that might reference another distinct procedure (that hasn't yet been written), how do you approach things? Do you leave all cross-references out until such time that the QMS is up-and-running, before back-tracking an updating the procedures with cross-references now that they exist?

 

[geoffairey]

Writing standard operating procedures (SOPs) involves a lot of interelated processes (and therefore cross-references to other SOPs and work instructions). However, when one is starting to create a new quality management system (QMS), no documents exist.
My question is therefore twofold:

1. In what order would you recommend creating the procedures for a new QMS (at least to address the mandatory sections of the ISO 9001).
2. For a procedure that might reference another distinct procedure (that hasn't yet been written), how do you approach things? Do you leave all cross-references out until such time that the QMS is up-and-running, before back-tracking an updating the procedures with cross-references now that they exist?

A pragmatic approach has to be taken.

1) I would write the documents which are required the most. Yes, if you don’t have written procedures which are required to meet the standard, these will need creating to pass certification, but if you have high risk operational procedures which need writing where failure would harm the organisation, I would focus on those first.
2) You can’t reference what can’t be evidenced (i.e. with a doc reference) but if a procedure is in place and happening without being formally documented, you can mention the “name” of the procedure e.g. IT Helpdesk procedures or Transport procedure, updating the referencing document when you formalise those informal procedures.

Either way, your document control will need to be up to scratch, so I’d recommend that all controlled versions be stored in a single folder on a server / SharePoint site / web page / … to reduce the risk of uncontrolled versions being used. I’ve often wondered if a Wiki would be better in this sort of situation as it would allow easier updating and cross referencing.

 

[vtsyj]

I would recommend to start with a holistic view of your QMS, or draft out a high level process map. Once you have a clear idea of the processes within the organization, you may group the SOPs required and proceed to draft it. Personally, I will start with Systematic Procedures before proceeding to Operational Procedures, then Supporting Procedures.

Examples:
Systematic Procedure - control of documents, nonconformity / corrective action, internal audit, management review
Operational Procedure - order taking, order planning, design, purchasing, production, inspection, etc
Supporting Procedure - training, maintenance, calibration, etc

 

[Randy]

Do what works for you. Keep it minimal and keep it simple. Don't do like a previous poster with some "Rube Goldberg", multi-layered, potential nightmare.

 

[Ed Panek]

Your QMS serves you.