During the course of our work we see many SOPs and often come across procedures that are difficult to read and do not clearly describe the procedure.
A long SOP does not necessarily make it a good one! When writing an SOP it is worth thinking about what its purpose is and who is the target audience?
Once a quality system becomes too large or complex, it is difficult to maintain and keep updated. Keep SOPs and the in-depth Work Instructions separated.
SOPs give instructions on how an organisation performs key activities in order to ensure compliance standards are met.
Some simple rules for writing SOPs
- Decide your format: All quality system documents should include (minimum) the following:
- Title
- Purpose
- Document Reference
- Version Number
- Issue Date
- Pagination
- Author
- Approval Signatures (where appropriate)
- Map the procedure (a simple flowchart can be helpful): Who, how, what, when.
- Involve the people who actually carry out the activity
- Keep the language simple – avoid using terminology that may be specific to your organisation or overly using ‘quality speak’.
- Break up large sections of text with diagrams/pictures.
- Avoid ‘bulking’ up the SOP with unnecessary words or over explanation. The SOP should be short and clear.
- Test the procedure – perhaps using someone who has a limited knowledge of the procedure.
Remember: Your Quality System is a ‘live’ system. It should be accessible to all relevant staff and reviewed regularly for accuracy, changes in regulations that may affect the procedure or to make improvements.