Standing operating procedure

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The terms standard operating procedure and standing operating procedure, both abbreviated by the initialism, SOP, occur in a variety of different contexts, such as healthcare, education, industry, the military, etc.

General use

A standard operating procedure consists of a set of instructions having the force of a directive, and covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness. Standard Operating Policies and Procedures can act as effective catalysts to drive performance-improvement and improve organizational results.^[1] Every good^{[citation needed]} quality system is based on its standard operating procedures (SOPs).

Military use

In military terminology SOPs describe a procedure or set of procedures to perform a given operation or evolution or in reaction to a given event. There is a popular misconception that SOPs are standardized. However, the very nature of an SOP is that it is not standardized across a large military element (such as a corps or division) but rather describes the unique operating procedure of a smaller unit (such as a battalion or company) within that larger element. "Standing" operating procedures take effect until further notice, at which time the issuing authority amend or dissolve them. Therefore, the military more correctly uses the term "standing operating procedure" in lieu of "standard operating procedure."

Unit members typically promulgate SOPs, based on unit experience and local conditions. They are normally approved by the unit's Officer Commanding or Commanding Officer.

SOPs differ from tactics and strategy in that they are unit-orientated and -formulated and are not the product of the unit's parent service's doctrinal agencies. Tactics and strategy are generally formulated by official agencies (often service branches, corps or arms) who are tasked for the purpose by the parent service and published in the service's official service manuals, for example, the United States Field Manuals (FMs), the Australian Manual of Land Warfare (MLW), and others. In cases where the unit's SOPs cover the same topical area as doctrine generated by the unit's parent service, the SOP may be considered to be the unit's interpretation of the official doctrine.

SOPs often offer guidance where official doctrine does not cover a situation, or treats a situation only in extremely broad terms. SOPs are often used to provide practical detail to the some times high level guidance of official doctrine.

Where official doctrine exists, SOPs will usually, at least in general terms, adhere to the official doctrine. However SOPs may on occasion ignore official doctrine, especially when a service/corps generally regards official doctrine as out-of-date, inadequate or incorrect.

SOPs also differ from standing orders in that personnel may legally disregard or interpret them, as required by the situation; however, acting contrary to a posted command-signed SOP is generally considered the same as violating a published order and punished accordingly.

Clinical research

In clinical research, the International Conference on Harmonisation (ICH) defines SOPs as "detailed, written instructions to achieve uniformity of the performance of a specific function". Organizations involved in clinical research—whether pharmaceutical companies, sponsors, contract research organizations, investigator sites, ethics committees or any other parties—require SOPs to achieve maximum safety and efficiency of the performed clinical research operations. All people and sites involved in clinical studies (both at the sponsor and at the investigative sites) must have appropriate SOPs in place in order to conduct clinical research in compliance with current regulations.

In the United States of America, the ICH GCP (good clinical practice) Step 5 Guideline (Section 3.2.2) also suggests that an Institutional Review Board (IRB) have its own SOPs or written standard procedures.^{[citation needed]} This itself proves^{[citation needed]} that the presence of SOPs form an integral part of clinical trials at all levels.

Inspections target these quality documents since the most frequent reported deficiencies during inspections are the lack of written SOPs and/or the failure to adhere to them. The risk of GCP non-compliance is high at organizations with a poor availability of clinical-research-specific SOPs. The risk of GCP non-compliance is also high where SOPs exist but the staff or the people for whom they were written lack awareness of them or of the need for them.

The training of staff using SOPs therefore becomes very important, so that staff actually become aware of why and how SOPs can play an important role in fulfilling the ICH and other regulatory requirements.

Good manufacturing practice

An SOP is a written document or instruction detailing all steps and activities of a process or procedure. These should be carried out^{[by whom?]} without any deviation or modification to guarantee the expected outcome. Any modification or deviation from a given SOP should be thoroughly investigated^{[by whom?]} and outcomes of the investigation documented^{[by whom?]} according the internal deviation procedure.

All quality impacting processes and procedures should be laid out^{[by whom?]} in Standard Operating Procedures (SOPs). These SOPs should form the basis for the routine training program of each employee. SOPs should be regularly updated to assure compliance to the regulatory requirements and the working practice. A minimum review schedule of 3 years is recommended^{[by whom?]}. Changes of SOPs are in general triggered by process or procedural changes / adjustments. The internal site change-control procedure should manage these changes.

Part of the activity list of such changes should be to update the related SOP. SOPs should be in place for all quality systems plus the specific operational activities on site. The structure of an SOP System and the total amount of individual SOPs should be carefully taken into consideration^{[by whom?]}. Too many SOPs could lead to a collapse of the SOP System. System SOPs should not be mixed up to keep systems and interaction between quality systems easy.^[2]

ISO 9000 is essentially requires the documention of all procedures used in any manufacturing process that could affect the quality of the product.^[3]

Information-technology industry use

The information technology industry uses the terms "Standard Operating Procedure" and "SOP" interchangeably to describe a best-practice approach to executing tasks related to the production and maintenance of hardware and software, as well as to incident and change management. A number of packages may aid in the automation of the execution of information-technology SOPs for large enterprises, note for example Creekpath, iConclude and Stratavia's Data Palette.

See also

• Quality control
• GxP
• Run Book Automation
• Operational research
• Bureaucracy

References

1. ^ Guide to Writing Policies and Procedures, Work.com
2. ^ Good Manufacturing Practice on GMP Quality
3. ^ ISO 9000

External links

• ICH Guidance E6: Good Clinical Practice: Consolidated guideline^{[dead link]}
• European Medicines Agency Guideline for Good Clinical Practice
• SOP Writing for Clinical Trials: Staff Training Aspects by Akanksha Saxena, International Biopharmaceutical Association Publication, 2005.
• Standard Operating Procedures in the NHS