Definition of the term (“What is an SOP?”)
SOP (Standard Operating Procedure) is the English term for the German term “Standardarbeitsanweisung”. This is to be understood as a typical procedure or a standardized sequence of actions describing processes with respect to validating the results and documenting them, especially in critical sectors with potential effects on the environment, health and safety.
Which sectors/industries need it?
They are a requirement for the official authorization, especially in the pharmaceutical industry. This especially affects the certification of products and services. Since this is a regulatory approval, the authority also checks the content. It is investigated whether there are violations of corresponding procedures. If this is the case, this can result in various consequences down to the prohibition of selling product or services.
Which advantages does it have?
Due to the possible authoritative sanctions, standard operating procedures are stronger than ordinary work instructions describing the procedures within an organization etc. Additional advantages of electronically documented SOPs (enabled by the module Document Control) are:
- Verification and release processes controllable with workflows
- Comprehensive document management incl. versioning
- Compliance with all requirements/regulations
- Electronic management of your specifications (e.g. work /process instructions, test specifications, hygiene plans, operating instructions), form sheets, contracts and other document types
- Reduction of process runtimes for creation, revision, release and distribution of specifications
- Easy distribution of documents and use of the signature circulation
- Reduction of unnecessary printouts and paper
What are the steps from the creation of an ASOP to it implementation?
- Documentation (or process description),
- Verification by a second person with signature and applied verification criteria
- Notification and training of affected persons as well as
- Change management with optimized documentation and possibly information on the training
An SOP is documented in a handbook. It contains a distinct ID, a version number, a date or period of validity and the names and signatures of the creator, approver and releaser. This information ensured a comprehensive traceability of a document. Moreover, it must be recorded that the employees of the organization were informed of the content of an SOP and must be notified in case of a change to an SOP.