What is Standard Operating Procedure (SOP)?

What is meant by SOP?

SOP stands for standard operating procedure.

• A standard operating procedure (SOP) is a collection of written instructions that detail a routine or repeated task that an employee in an organization is expected to carry out. 
• It gives information that may be used to accomplish work correctly and consistently so that predetermined standards can be met and a quality final result can be achieved.

Need of SOP

• Standard operating procedures provide information regarding the routine work process. 
• It provides documentation on the manner in which the activities are to be carried out. 
• It details the fundamental actions that are taken by the program as well as the technical actions that are taken, such as the analytical process and the process for maintaining, calibrating, and operating the equipment. 
• The standard operating procedure (SOP) needs to include detailed instructions that employees can refer to while performing their jobs.

Benefits of SOP

• To supply individuals with all of the knowledge regarding safety, health, the environment, and operations that is required for a job to be done correctly.
•  To guarantee that manufacturing procedures are carried out in a consistent manner in order to keep quality control of the process and the product. 
• To ensure that procedures continue without interruption and are finished according to the timetable that has been established. 
• To guarantee that there will not be any malfunctions in the production or any other processes that could endanger anyone in the neighborhood.
• You are responsible for making sure that the approved procedures are carried out in a manner that complies with both corporate and government standards. 
• To act as a training document that users can refer to in order to learn more about the procedure for which the SOP was prepared. 
• To act as a guide or checklist for coworkers who are responsible for monitoring job performance in order to encourage appropriate performance. 
• To act as a check list for accountants and auditors. 
• So that it can be used as a chronicle of history 
• To provide an explanation of the various steps involved in a process 

SOP Writing Style

• It is written in a format that is easy to read and understand, is sufficient, and contains step-by-step instructions. 
• The information that is supplied should not be confusing and should not be ambiguous. 
• It is important to make use of the active voice and the present tense of the verb. 
• Should be straightforward and concise. 
• It is recommended that a flow chart be utilized in order to illustrate the process that is being presented. 

The Form and Content of the SOP

• Company ‘s name & pagination 
• Title 
• Identification & control 
• Review & approval 
• Purpose 
• Scope 
• Responsibility 
• Procedure 
• Checklist 

SOP Preparation 

• SOP’s should be written by an individual who is familiar with both the operations and the internal structure of the organization. If you want better outcomes, working as a team might be the way to go. In a perfect world, standard operating procedures should be drafted by a group that comprises some or all of the following individuals:
  • Those responsible for carrying out the tasks. 
  • Those who will be responsible for performing maintenance on the equipment that is part of a SOP. 
  • Engineers and other professionals who create machinery and procedures. 
  • Technical engineers 
  • Safety personnel 
  • Environmental personnel 
  • Equipment manufacturers

Precautions for preparing SOP

• It is important that the instructions and procedures be written in language that is easy to understand. 
• During the manufacturing process, records are created in such a way that they will prove that all of the actions necessary by the stated procedures and instructions have in fact been taken, and that the product’s quality and quantity are as expected. 
• Any deviations that are deemed substantial are thoroughly recorded and investigated. 

Procedure for preparing a SOP

• It is important that the instructions and procedures be written in language that is easy to understand. During the manufacturing process, records are created in such a way that they will prove that all of the actions necessary by the stated procedures and instructions have in fact been taken, and that the product’s quality and quantity are as expected, by which process run smoothly. Any deviations that are deemed substantial are thoroughly recorded and investigated. 

Persons having Authorization

• Nominee recommended by the local personnel; this person should be an expert in their field and be familiar with GMP.
• General manager in charge of production duties 
• General manager (QC) 
• General manager (QA) 
• Candidate recommended by management (may also be the technical director) 

Few ideas while Writing SOP

• The standard operating procedure (SOP) should include all of the safety, health, and environmental procedures, which ought to provide a comprehensive picture of all of the responsibilities for performing a work in the appropriate manner. 
• The SOP should live up to the expectations of the SOP specification. It should cover all of the steps that are necessary for a person to comprehend his profession in order for it to be useful. 
• People have a tendency to ignore lengthy SOPs, thus the standard operating procedure (SOP) should not comprise more than ten steps.
  • Break the lengthy SOPs into sub-job SOPs that make more sense.
  • The condensed standard operating procedures should simply include the steps, and not the comprehensive explanations. 
• Create standard operating procedures for persons who work in a variety of diverse interpersonal settings.
  • SOP should be written for people who work alone 
  • SOP should be written for groups of two or more people who operate together as a team 
  • SOP should be written for people who will oversee other people while they are doing a job 
• SOP should be written for persons who are not familiar with the rules
  • Think about the personnel who will be carrying out the steps of the SOPs in terms of their age, education, expertise, skills, experience, training, and the work culture they are accustomed to. 
  • Standard operating procedures (SOPs) ought to contain the processes that call for caution, precision, timing, help, and personal protection equipment. 
  • After a few weeks, evaluate how well the standard operating procedure is working, and make any necessary adjustments. 
  • When there has been a change in either the process or the equipment, review the SOP. 

SOP Review and Approval 

• Review of standard operating procedures (SOPs) ought to be performed by one or more individuals who have relevant knowledge and expertise.
• Standard Operating Procedures ought to undergo methodical revisions every 1-2 years. 
• Every standard operating procedure (SOP) that has been modified needs to have the date it was last reviewed added to it. 

SOP Format 

The three types of SOP format are

• Simple
• Hierarchical
• Flow Chart

Simple SOP format

• Ideal for standard operating procedures that are easy to understand and have a minimal degree of complexity 
• A straightforward structure presents the most important processes in an organized and straightforward summary. 
• When using a straightforward SOP style, you’ll want to limit the length of the document to three to five parts and include the following information: 
  • A proclamation of goals 
  • Values a brief synopsis followed by bulleted step-by-step instructions 
  • A table listing the names of those who are accountable for each step 

Hierarchical SOP format

• Structured in a hierarchical SOP format Ideal for vast, sophisticated, or specialized
• This is a more formal structure that contains a table of contents and headings to assist in organizing the material into bite-sized portions. 
• It is also sometimes referred to as a sophisticated SOP format. If you are going to use a hierarchical structure, you will need to add a table of contents and divide the procedure into numerous sections. 
• These sections should include the following items:
  • a proclamation of goals and values a summary 
  • as well as step-by-step instructions with information on how each task should be accomplished, 
  • as well as links to any standards to its relevant checklists or action plan(s), accountable teams or stakeholders for each stage
  • an overview of the entire process.

Flowchart Procedure 

• Ideal for standard operating procedures that can accommodate a wide range of tasks 
• Utilising a process flowchart the SOP format is a great tool for outlining both straightforward and intricate operations. 
• SOPs that include flowcharts may be of varying lengths. 
• They require a few essential components, which might be listed as follows:
  • a mission statement or introduction
  • an easy-to-follow flowchart or diagram showing what occurs in various scenarios
  • a list of personnel accountable for each step 

Advantages of Standard Operating Procedures

• Construct Consistency. 
• Enhance safety and quality assurance. 
• Spend less time and money. 
• Make employee management simpler. 
• Save your knowledge. Streamline audits. 
• Improve Autonomy. 
• Utilize Maintain to streamline SOP’s. 

Disadvantages of Standard Operating Procedures

• Excessive paperwork and a loss of workplace personality are two drawbacks of SOPs. 

What is the purpose and scope of SOP?

• An SOP’s goal is to ensure that employees carry out tasks consistently and correctly in order to provide high-quality results. SOPs should be drafted from the viewpoint of those who will actually use them, with a strict focus on practicality. 

What are the drawbacks of disregarding the SOP?

• Reduced Efficiency: In the absence of SOPs, work procedures may become ineffective, resulting in lost time and lower production. 
• Increased Risk: Lack of SOPs can result in compliance concerns and a higher risk of legal action in sectors like healthcare and finance.

Why SOP is rejected? 

• Untrue information. 
• False information promises are a criminal offence. 
• SOPs with inaccurate information are initially rejected. 
• The SOP evaluators are aware of how to identify wrong information.

Sample SOP Format