SOPs come with high costs: document control, revision, review, training, increased documentation demonstrating compliance with the SOP, and high audit/inspection scrutiny for strict adherence. Consider the following before writing an SOP:
- Is it do-able? Is it practical? Can the SOP be consistently followed?
- How will you train on the SOP initially, as new staff are added, and as the SOP is revised?
- How will you document the SOP has been followed?
- How will you assess compliance? Will you need to perform periodic monitoring?
- What is the added regulatory burden and cost of compliance?
