Standard Operating Procedure (SOP):
Meaning: Formalizes tasks, linking them to responsible people and resources; identifies "who," "what," and "when" of operations.
General: Summarizes the specifications of a process.
Focus On: Policy compliance, general quality assurance.
Functional Units: Interaction between departments or business units.
Document Level: QMS Document Level 2.
Application: Used for standardizing processes to make them systematic for management.
Work Instructions (WI):
Meaning: Detailed steps of activities, linked to SOPs; describes "how" tasks are performed.
General: Elaborates individual tasks outlined in SOPs.
Focus On: Specific job completion in a regimented manner.
Functional Units: Individual tasks.
Document Level: QMS Document Level 3.
Application: Used for defining precise steps and supporting daily operations.
Summary:
SOPs provide a high-level overview of processes, focusing on compliance and coordination across departments, making operations standardized and systematic. WIs are detailed instructions linked to SOPs, focusing on executing specific tasks consistently and effectively, supporting day-to-day business operations.
