Stage 8 – Signing-off the Procedure

sop-signoff-procedures

We’ve now completed seven stages in the Procedure writing process. From gathering the requirements, interviewing the Subject Matter Experts, drafting the procedures and getting them reviewed. This takes us up the stage where the documents must be signed off by the Project Stakeholders. While this seems straightforward, there are a few hazards  that need to be avoided.

Getting the Procedure Approved

Now that you have finished writing the procedure, you need to get it approved and sent out to those who will use it.

  • The procedure should have been reviewed by the SME and others assigned to reviewing the SOP.
  • Changes have been incorporated.
  • The Version History has been updated to reflect the changes to each draft.

How to get it approved:

  • Send the final document to the person assigned to approve the document (usually your manager) with the correct naming structure, for example, ACME-Pharma-D-SOP-05052009. The ‘D’ means the document is still in Draft and is not a Final document.
  • The approver examines the documents. Their role is not to check the integrity or accuracy of the material (the SMEs should have done this) but rather to ensure that it has been through the correct review process.
  • The Approver enters the name, date, and any comments to finalize the document. Most SOP templates have a section for the Document History at the start.
  • The Approver saves the document and change the D to F, so that this is now a Final document.
  • Tip: Most companies save their official procedures as PDFs. We use CutePDF (www.cutepdf.com) to convert our Word documents into PDF. It’s free and very easy to use. Install it and then click File, Print and choose CutePDF Writer to generate the PDF file.
  • The Approver returns the document to the Document Owner (possibly you or your team lead) who changes the status from D to F. The document is now Final.
  • Circulate the procedure to the main contributors, so they have a copy for their reference. I’d suggest you include a nice ‘thank you’ to those who’ve helped with this piece of work. It doesn’t take much time and shows you’ve appreciated their time and effort. And, of course, builds up some goodwill that you may need when you start the next round of procedures.
  • Encourage feedback and acknowledge users to contact you if they find something that needs to be addressed.

Finally, to make sure those who need to use the procedure can find it, add it to your Document Management System and, if applicable, to your Intranet.

Procedures must be reviewed on a scheduled basis and also when IT systems are upgraded or changed.

Factor this into your project schedule and highlight whatever resources you may need in advance. Procedures are living documents and must be treated as such. When any step changes, the procedures must be updated to reflect these changes.

What do you look for when approving documents? How do you know you’ve got it right?

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