Used to outline process flows, key control points, and operational steps for positions, ensuring consistency with new employee training and system audit sampling.
Can be cross-referenced with turtle diagrams, FMEA, and control plans.
Start with a high-level flowchart and then break down sub-processes; clearly specify tools, parameters, record names, and safety tips in the SOP.
Update the version, training sign-off, and effective date simultaneously when changes occur.
Avoid disconnects between flowcharts and actual on-site processes; if the SOP is too long, split it into 'main procedure + job instruction'.
Pay attention to watermarks on electronic distributions and the retrieval of obsolete documents.