How can you tell if a document is a SOP, Procedure, or Work Instruction? Also, what are the connections between each of these documents? Is one more important than the other? Do you need to write an SOP before the Work Instruction… or should it be the other way round?
In this tutorial, we look at:
- How to document SOPs, Work Instructions and Procedures
- How to structure the documents in the correct sequence
Difference between Work Instructions and Procedures
Work Instructions – tell you how to do something. They are very specific instructions, for example, how to complete a form.
Procedures – tell you who does what when. In other words, it identifies who completes the form and when this should occur.
In simple terms:
- Procedures tell you Who, What and When
- Work Instructions tell you How
SOP, Work Instruction, & Procedures: How to structure
If you look at the documents like a pyramid, then
- Standard Operating Procedures are the top layer. These are often shared with customer and rarely hold confidential data.
- Procedures (second tier) describe the process. They are more detailed and often contain both a narrative (i.e. text description of the steps) and visuals, usually in the form of use cases and workflow diagrams. These documents will be examined during audits.
- Work instructions (third tier) describe the work to be performed. These provide the lowest possible level of detail. As the name implies they are instructions to perform a specific piece of work. Some are less than one page. Just a list of bullet points.
ISO: Documenting SOPs, Work Instructions, & Procedures
If you’re documenting ISO processes, then you can approach them based on levels. Again, this is similar to the idea of a pyramid or tiered structure.
- Level 1 = Quality Assurance Manual – these are mandatory documents for ISO and must be maintained as the project evolves. This is the starting point for document-related goals, objectives and accountability.
- Level 2 = Procedures – Document interection between departments/business units in terms of input/outputs.
- Level 3 = Work Instructions – Any document that defines how work objectives are achieved.
- Level 4 = Records – evidence of conformance.
To be clear: Level 3 documents are sometimes referred to as SOPs, Process Instructions, or Procedures.
Does it make a difference?
Yes, in that if you chop and change terminology, you’ll confuse the readers (and possibly the writers) and also raise concerns with the auditors.
No, if you use a consistent document convention and apply the same guidelines across all documents.
In other words, if ISO did not exist, would you still use the same document naming conventions?
To recap:
- Work Instructions are 3rd level documents
- Procedures are 2nd level documents and
- Quality Manual is the 1st level document
In the next tutorial, we’ll look at how to write more effective work instructions.