A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The term “SOP” may not always be appropriate and terms such as protocols, instructions, worksheets, and laboratory operating procedures may also be used.
The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result. SOPs are usually specific to the organization or facility
The purpose of SOP’s
1. SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization.
2. They document the way activities are to be performed to maintain consistency with technical operations and to support data quality.
3. They describe the analytical processes, and processes for maintaining, calibrating, and using equipment.
4. S.O.P’s maintain quality control and quality assurance processes and ensure compliance with governmental regulations.
Format and Contents of SOP
1. Company Name and Pagination
The company name and pagination must appear on every page.
2. Title The title should be descriptive.
The title should use directive language to declare what is being done to what. A SOP titled “Compression Machine” is not descriptive of the procedure’s content. A more appropriate title would be “OPERATION OF COMPRESSION MACHINE”.
3. Identification and control
Procedures must be easily identified by giving unique number and version number. This identification number of the SOP supports accountability of the document throughout the facility and over time as it changes.
4. Review and approval
All Sops shall have space for signature of initiator (the person who has written the SOP) Reviewer (The persons who has reviewed the SOP) and approver (Quality Assurance Head of the organization).
The purpose or objective of the procedure should restate and expand well written title. Expand or qualify the directive language used in the title (e.g. to describe the operation procedure of compression machine)
The scope should provide limits to the use of procedure. The scope shall be written in such a way that it answers following questions.
• Are there certain samples that are appropriate to test by this method?
• Do these operations apply only to certain equipment or certain departments?
• Is there a limit to the capacity, volume, or throughput of the procedure?
• State to what areas this procedure does apply and does not apply?
Who is responsible for performing the work described? Who is responsible for implementing the procedure?
Describe the procedure in a step by step, chronological manner. Use active verbs and direct statements (e.g. check the cleanliness of machine and tools)
Many activities use checklists to ensure that steps are followed in order. Checklists are also used to document completed actions. Any checklists or forms included as part of an activity should be referenced at the points in the procedure where they are to be used and then attached to the SOP.
In some cases, detailed checklists are prepared specifically for a given activity. In those cases, the SOP should describe, at least generally, how the checklist is to be prepared, or on what it is to be based. Copies of specific checklists should be then maintained in the file with the activity results and/or with the SOP. Remember that the checklist is not the SOP, but a part of the SOP.
1. To provide people with all the safety, health, environmental and operational information necessary to perform a job properly. Placing value only on production while ignoring safety, health and environment is costly in the long run. It is better to train employees in all aspects of doing a job than to face accidents, fines and litigation later.
2. To ensure that production operations are performed consistently to maintain quality control of processes and products. Consumers, from individuals to companies, want products of consistent quality and specifications. SOPs specify job steps that help standardize products and therefore quality.
3. To ensure that processes continue uninterrupted and are completed on a prescribed schedule. By following SOPs, you help ensure against process shut-downs caused by equipment failure or other facility damage.
4. To ensure that no failures occur in manufacturing and other processes that would harm anyone in the surrounding community. Following health and environmental steps in SOPs ensures against spills and emissions that threaten plant neighbors and create community outrage.
5. To ensure that approved procedures are followed in compliance with company and government regulations. Well-written SOPs help ensure that government regulations are satisfied. They also demonstrate a company’s good-faith intention to operate properly. Failure to write and use good SOPs only signals government regulators that your company is not serious about compliance.
6. To serve as a training document for teaching users about the process for which the SOP was written. Thorough SOPs can be used as the basis for providing standardized training for employees who are new to a particular job and for those who need re-training.
7. To serve as a checklist for co-workers who observe job performance to reinforce proper performance. The process of actively caring about fellow workers involves one worker coaching another in all aspects of proper job performance. When the proper procedures are outlined in a good SOP, any co-worker can coach another to help improve work skills.
8. To serve as a checklist for auditors. Auditing job performance is a process similar to observation mentioned in the previous item only it usually involves record keeping. SOPs should serve as a strong basis when detailed audit checklists are developed.
9. To serve as an historical record of the how, why and when of steps in an existing process so there is a factual basis for revising those steps when a process or equipment are changed. As people move from job to job within and between companies, unwritten knowledge and skills disappear from the workplace. Properly maintained written SOPs can chronicle the best knowledge that can serve new workers when older ones move on.
10. To serve as an explanation of steps in a process so they can be reviewed in accident investigations. Although accidents are unfortunate, view them as opportunities to learn how to improve conditions. A good SOP gives you a basis from which to being investigating accidents.
11. Standardization of activity. SOPs identify planned and agreed upon roles and actions. This information helps standardize activities and promote co-ordination and communication among personnel. SOPs thus help to assure the quality and consistency of a service.