Standard Operating Procedure (SOP)

Standard Operating Procedure SOP, the word itself has its meaning. Any work, activity, or process has a standard procedure in its system in every organization. To understand and follow the same procedure for particular activity by every user/worker/employee, SOP is prepared and is elaborated in an easy way. The step-by-step procedure of operation of equipment/ instrument or instructions to carry out any activity is called standard operating procedure. SOP minimizes the variation in process or procedure because of consistent implementation of the same procedure. 

Preparation of SOP:

There shall be a Standard operating procedure to prepare standard operating procedure. A draft copy of the SOP shall be prepared first and reviewed by stakeholders. Then final SOP is prepared with correction of stakeholder's comments (if any). After that final approval shall be taken. There shall be the minimum frequency of revision of SOP. Version number shall be changed in a new revised version of SOP. SOP is revised when it is due for revision or if any change is needed to do in the SOP as per guideline. 

There are some points to be considered while preparing SOP are as follows.

• SOP shall be easy to read and understood. 
• It shall be an elaborate step-by-step procedure of activity. 
• SOP shall cover all related regulatory guidelines. 
• Information provided in SOP shall be unambiguous and shall not be complicated. 
• The vernacular language shall be used wherever required. 
• Process flow charts, diagrams, or images shall be used wherever required for easy understanding. 
• A checklist shall be included wherever step-by-step procedure is there, to avoid missing any checkpoint. 
• SOP shall have a specific format and some minimum contains such as given as follow. 
  
  
  

Contents of Standard Operating Procedure:

Details of company/Organization: In the header of the document, details of the company or organization are mentioned: the name of the company/ organization, Logo (sometimes address in short). 

Document Details: Document title, document number, version number, and page number in the format of page X of Y. 

Approvals: On the first page signatures of all members/ stakeholders involved in SOP and final approval of the Quality assurance head and Plant head shall be taken. 

Table of contents: All contained points shall be listed in this table with the page number. 

Aim: In this point, the Aim of the standard operating procedure shall be mentioned. 

Scope: In this point scope of SOP is mentioned including wherever it is applicable and implemented with the address.

Definition: Some definitions of critical concepts which are included in the SOP shall be defined here. New terms shall be defined in detail. 

Abbreviations: Some abbreviations which are used in the SOP shall be elaborated here on this point.  

Responsibilities: The responsibility of all stakeholders shall be elaborated on this point. 

Procedure: Step-by-step procedure of activity or operation of equipment or any process shall be elaborated in easy language. This point is most important for any User/employee of the organization. Any precaution to be taken shall be mentioned. This procedure is for reference. 

Annexures: Any attachments, forms, or any format required shall be attached with proper format and numbering system. 

Details of distribution: SOP shall be distributed to different departments. The list shall be mentioned here for distribution copies. 

References: References used shall be listed down. Cross references shall be noted for reference of the user

Change history: Tracking of changes done in the SOP shall be recorded here for future reference of the user. 

SOP is the most important document. SOP shall be followed by every employee of the organization. Any deviation from the SOP shall be recorded. This SOP is a regulatory requirement hence it is followed by every organization. SOP is the first document for every new employee of the organization. Training of all SOP shall be done before the implementation of the SOP. All users shall be trained before using any equipment/instrument or before performing any activity.