A standard operating procedure is a set of instructions having the force of a directive, covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness. Standard Operating Policies and Procedures can be effective catalysts to drive performance improvement and improving organizational results. Every good quality system is based on its standard operating procedures (SOPs).
In military terminology it is used to 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. That the operating procedure in question is said to be "standing" indicates that it is in effect until further notice, at which time it may be amended or dissolved.
SOPs are typically promulgated by unit member, and are 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 is lacking, or extremely broad. 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ignore official doctrine, especially when official doctrine is widely believed throughout the service/corps to be out of date, inadequate or incorrect.
SOPs also differ from standing orders in that they may be legally disregarded or interpreted, 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.
In clinical research, SOPs are defined by the International Conference on Harmonisation (ICH) as "detailed, written instructions to achieve uniformity of the performance of a specific function". SOPs are necessary for a clinical research organization—whether it concerns a pharmaceutical company, a sponsor, a contract research organization, an investigator site, an Ethics Committee or any other party involved in clinical research—to achieve maximum safety and efficiency of the performed clinical research operations. It is therefore a must that all people and sites involved in clinical studies (both at the sponsor and at the investigative sites) have appropriate SOPs in place in order to conduct clinical research and to ensure compliance with the current regulations.
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. This itself proves that presence of SOPs are an integral part of the clinical trial at all levels.
The presence of these quality documents is essential when inspections take place 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 and also if at all they are available the staff or the people for whom they were written are not either aware of them or their need.
It therefore becomes very important for the staff to train them on these SOPs so that they are actually aware of why and how SOPs can play important role in fulfilling the ICH and other regulatory requirements.
A SOP is a written document / instruction detailing all steps and activities of a process or procedure. These should be carried out without any deviation or modification to guarantee the expected outcome. Any modification or deviation from a given SOP should be thoroughly investigated and outcomes of the investigation documented according the internal deviation procedure.
All quality impacting processes and procedures should be laid out in Standard Operating Procedures (SOPs). These SOPs should be 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. Changes of SOPs are in general triggered by process or procedural changes / adjustments. These changes should be managed by the internal site change control procedure.
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. 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.
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