An SOP documents required steps, controls, responsibilities, and records for performing a process consistently and safely.
Definition
A Standard Operating Procedure (SOP) is a controlled document that defines how a process or task must be performed. It typically includes purpose, scope, responsibilities, materials, safety requirements, steps, checks, records, and revision control.
An SOP is broader and more formal than standard work in many organizations, especially where compliance, quality systems, or auditability matter.
History
SOPs developed in regulated, technical, military, laboratory, manufacturing, and service environments where consistent execution and record control were necessary. Quality systems use SOPs to define processes and demonstrate control.
When to Use
Use an SOP when a process must be performed consistently across people, shifts, locations, or time, especially when safety, quality, compliance, training, or customer outcomes depend on the method.
Step-by-Step
- Define purpose, scope, process owner, and users.
- Observe the actual process and gather requirements.
- Write clear steps, decisions, controls, safety points, and records.
- Include visuals or references where they reduce ambiguity.
- Review with operators, quality, safety, and process owners.
- Train users and verify competence.
- Control revision, access, and obsolete copies.
- Audit use and update after changes or lessons learned.
Examples
- Laboratory: SOP defines sample preparation, equipment checks, and result recording.
- Manufacturing: SOP defines setup, inspection, and reaction plan requirements.
- Service: SOP defines customer escalation and documentation requirements.
Common Pitfalls
- Writing the ideal process instead of the real controlled method.
- Too much text and not enough usable instruction.
- No owner for updates.
- Training not verified.
- SOP conflicts with local standard work or forms.
- Uncontrolled copies on the floor or shared drives.