Glossary · Operator documentation
Standard operating procedure (SOP)
Also known as: SOP, Operator SOP
German: Standardarbeitsanweisung
In quality management and operations, a standard operating procedure (SOP) is a documented, controlled procedure that describes how a recurring operation — such as operating a machine, plant or process, cleaning, sampling or testing — is performed correctly, safely and consistently, by whom and with which records.
- Technical documentation
- Compliance
In one sentence
A standard operating procedure (SOP) is a controlled document that describes how a recurring operation is done correctly, safely and consistently.
Example
A pharmaceutical plant's SOP for line clearance names the responsible roles, the checks between two batches, the acceptance criteria and the record to sign, and refers to the filler's operating manual for the machine settings.
How it applies
- GxP: The EU GMP Guide counts procedures, "otherwise known as Standard Operating Procedures, or SOPs", among the required documents and asks that SOPs, work instructions and methods be written in an imperative, mandatory style. Under the FDA's good laboratory practice rules, 21 CFR 58.81 requires written standard operating procedures for nonclinical laboratory studies. See good manufacturing practice.
- Operator SOPs: Outside GxP, operators write SOPs for running machines and plants. They are derived from the manufacturer's operating manual and the site's own analysis and must not contradict the manual. The occupational safety variant is the safe operating procedure.
- Quality documentation: An SOP is a controlled document with an owner, a version, approval and a review date, and it is part of the quality documentation.
- Writing: One operation per SOP, steps in the order they are done, warnings before the step they concern; structures such as the DITA task keep steps, prerequisites and results apart.
SOP vs. work instruction vs. Betriebsanweisung
An SOP describes an operation and its roles; a work instruction details the steps of one activity at one workplace and is usually more granular. The Betriebsanweisung is a legal instrument of German occupational safety law with prescribed content; an operator SOP is often called a Betriebsanweisung in companies, but it only counts as one if it covers what the ordinance requires.