Standard Operating Procedure
Standard Operating Procedure ( SOP for short , also called Standard Operation Procedure ), in German for example standard procedure or standardized procedure (both are rarely used), is a binding textual description of the processes involved, including the examination of the results and their documentation, especially in areas of critical processes with potential environmental, health and safety effects.
SOPs are used for the official approval of products and services and are found in particular in the pharmaceutical industry, the aviation industry and also the military. Therefore, the content of these is checked by the authorities themselves; Violations of the processes described can have serious consequences, including the prohibition of the marketing of products and services. Thus, standard operating procedures differ from the work instruction that within an organization, for example the procedure. A business working process , describes and is not associated with an administrative sanction threat.
Structure of an SOP
(Elements that are required in an SOP)
Aim and purpose
What should be achieved and why?
application
Workspace
Description of the process
How and with what is the activity carried out?
Competence, qualification
Who is responsible, who is allowed to perform?
documentation
What, where, how, by whom?
Creation, introduction and further development
The following steps are connected from the creation to the introduction of an SOP:
- Documentation of the processes (e.g. description of a procedure), the more critical the success, the more detailed
- Examination of the SOP using the 6-eyes principle. (Create, check, release)
- Information and training for those affected
- Change management with optimization of documentation and, if necessary, information and training
The SOP is written down in a manual (also called a guide). An SOP usually contains a unique identifier, a validity date or period, a version number and the name of the creator, the approver within the organization, possibly the official auditor and the approver with the respective signatures. It should therefore be clearly recognizable who specified what and when in order to ensure traceability at all times . It must also be noted that the employees are informed about the content of the SOPs and have been trained accordingly in the event of changes to the SOPs.
Pharmaceutical industry and clinic
SOPs are mandatory for pharmaceutical companies in the areas of clinical development and production, since in both cases chemical substances are tested or manufactured for use on humans. The aim of the SOPs is to describe the procedure for developing a drug in order to comply with ethical and official standards, and to guarantee their purity and effectiveness in the production of drugs. The guidelines for these SOPs are set and checked by national authorities (e.g. the FDA in the USA, EMA in Europe), while the manufacturers each have to set up their own SOPs.
Another application is triage , in which the limited available resources are determined according to a ranking and limited to the medically urgently required and practically possible treatments.
aviation
SOPs have also been used as checklists in aviation for many decades . They are used by the pilots and flight attendants.
Individual evidence
- ↑ McMurdo Station Medical Standard Operating Procedures as of 2006 ( Memento of the original from June 11, 2014 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
