loss of effectiveness. Also called SOP. See FM 6-0 or FM [1]
[edit] Major Stages in the Preparation of an SOP Manual
The preparation of an SOP manual is an involved task and usually involves three major stages:
1. Business systems and process study by intensive interaction with process owners, managers, operatives, etc. to understand in detail the tasks that are performed.
2. Preparation of the draft manual
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3. Finalisation of the draft manual after discussion with users where any errors are corrected and process improvement recommendations are discussed and accepted or rejected.
[edit] Contents of a Standard Operating Procedure (SOP) Manual This section describes the possible contents of an SOP manual for an organization. Almost any type of organization – whether profit-making or otherwise - could use this template since the manual is concerned with business processes and operations.
1. Objectives of the SOP Manual
An SOP manual typically describes the standard operating procedures (SOPs) followed for various business processes within an organization Its main objectives are:
a. To systematically record all current business policies, processes and procedures currently followed
b. To clearly indicate the flow of actions performed from beginning to end of the process chain
c. To inculcate a culture of “CONTROL CONSCIOUSNESS” among process owners and operatives
d. To observe shortcomings in these policies, processes and
procedures and make suitable recommendations for improvements in the policies, process effectiveness, process efficiency, internal controls and compliance, as applicable, and
e. To serve as a basis for disseminating knowledge on the above among employees dealing with the relevant business functions, to enable adequate training to be imparted to concerned personnel with a view to making the business operations person-independent.
f. To act as a reference guide for Internal Audit, which assesses the extent to which the SOP is complied with.
2. Organization Structure
This is a macro organization chart showing the hierarchical or reporting relationships in the organization or business unit for which the manual is prepared.
3. Summaries of Business Processes
Each business process (such as procurement, sales and marketing, planning, quality assurance, production, maintenance, etc.) is summarized, and each summary could contain the following information:
a. Objectives of the business process
b. Micro organization (functional) structure chart
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c. Duties and responsibilities of each designated person involved in the process
d. List of tasks performed
e. Summary of Recommendations
The summary of recommended policies and procedures (e. above) lists, for each business process, the (“As-is”) practice, its
risks/shortcomings, and the recommended (“To-Be”) practice, with its expected benefits. Indicate along with each recommended practice the area of improvement envisaged (Efficiency / Effectiveness / Control / Compliance).
4. Detailed Chapters for Each Business Process
Each business process has a chapter containing the following sections:
a. Objectives of the business process
b. Summarized Block Diagram of process flow c. Detailed Process Flowchart
d. Outputs and inputs of each step in the process to clearly bring out the inter-dependencies between various functional units in the
organization and between the organization and its internal and external stakeholders (customers. suppliers, etc.)
e. Detailed textual description of process steps in strict logical
sequence. The steps would include both computer-based and manual procedures and are to be described precisely and in the correct
sequence. The text and the detailed process flowcharts should match.
f. The description in e. above should include descriptions of procedures to handle exceptions, i.e., exceptional but anticipated events.
g. Internal controls employed in the procedures to ensure that they are correctly and completely executed. Internal controls may be built into computerized business application systems such as ERP systems (like data entry, document preparation or report generation) or may be administrative controls exercised in the non-computer procedures of a business process.
h. Recommendations to improve the effectiveness, efficiency, control or statutory compliance of policies, processes and procedures which would replace the current policies, processes and procedures if accepted by users (if thought essential, desirable or practical, as applicable) after intensive discussions.
i. Exhibits of documents, reports, computer data entry screens, manual registers, etc. that are referred to as inputs to and outputs from
specific procedures
j. Accounting flow clearly showing which financial accounting general ledger accounts are operated wherever specific business transactions need to be recorded in the books of account.
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5. Appendices
One or more appendixes may be added at the end of the manual, but at least the following are recommended:
a. List of inputs b. List of outputs
c. Alphabetical glossary of terms [edit] 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 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.
[edit] 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
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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.
[edit] Good business and 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 to 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 22000 essentially requires the documention of all procedures used in any manufacturing process that could affect the quality of the product.[3][edit]
Information-technology industry useThe information technology industry uses the terms "Standard Operating Procedure" and "SOP"
interchangeably to describe a best-practice approach to executing
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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.