Standard Operating Procedure – How to Create an Effective SOPs
A standard operating procedure (SOP) provides clear-cut directions and detailed instructions needed to perform a specific task or operation consistently and efficiently. SOPs should be followed the exact same way every time to guarantee that the organization remains consistent and in compliance with industry regulations and business standards. Before writing the SOP, the author(s) should perform a risk assessment of all the steps in the procedure to determine any obstacles that may arise during the process and any risks associated with those obstacles.
Key questions that should be answered in the standard operating procedure include:
- Who performs what role?
- What does each role do?
- What is the goal or outcome of each person’s role?
- Has what needs to happen been explained clearly?
Standard Operating Procedure (SOPs)?
Standard Operating Procedure (SOP) is a set of written instructions that document a routine activity within your company/division/work group. A documents which describes the operations of a certain work or job in order to ensure it’s quality. A set of compulsory instructions, systems, procedures or steps which is written so that other individuals can follow to complete the job safely.
Who is responsible and Accountable for follow The SOPs?
All the concern personnel who will perform a particular activity shat be responsible to follow the SOPs that are:
- Worker /Operator
- Safety officers
- Department Head
- Company representatives
- Anybody performing the work.
Where and When require to use SOP’s?
- Every Day for routine activity for Guiding all staff in daily processes
- In preparation for an audit/ Document & process review, Monitor’s review
- During an audit/review
- Training and Orienting new staff
- Refresher & Annual employ training
- Regulatory body’s review
What is the Objective of SOP’s?
- Describe how to perform and execute routine activities
- Provide a training of personnel
- Guide & standardise Standard working procedures
- Ensure quality & integrity of data generated/information captured
- Reconstruction/repeatability of activity with Consistency
- Provide the Written procedure for proper documentation
- Provide the procedure and Documentation of employee training
Based on the departmental activity, respective department representative describe the work processes from the beginning of work, what to do first, then what to do and what to do, First write the corresponding main process, and then make the corresponding sub-processes are detailed in step by step.
Write the key factors of job description considering all the steps in each sub-process (process, safety, quality, equipment, environmental protection, etc.)
SOP’s standard format for writing is divided into 12 parts:
- Cross reference Documents & references Documents
- Definition & Abbreviations
- Details Procedure of activity step by step
- Distribution Details
- Flow chart
- History Of SOP
Effective writing for SOP:
Keep language simple
Use a direct instruction
Refer to other SOPs rather than re-write instructions
Include flow charts, diagrams and/or photos if these describe something better than words
Avoid making it too long
What is Content of SOP Header ?
Description of header content is as follows:
Title: Subject of the SOP. It shall be prepared by with bold letters. The word “Title” shall be prepared by with capital letters.
Page No.: Mention page No. in this column. It shall be mentioned in “Page X of Y” format, X stands for page no. of the particular page and Y stands for total no. of pages of that SOP. Example: Second page of SOP with total 10 pages shall be numbered as “Page No. 2 of 10”.
SOP No.: SOP No. shall be allocates according the procedure mentioned.
Change Control Number (CC No.): In case of new SOP or revision of SOP, mention CC no. allocated by QA department in Header column of change control No.
Supersedes: In case of new SOP, mention “Nil” in this column. In case of revision mention SOP No. of the superseded SOP along with previous version number.
Effective Date: ‘Effective Date’ is the date when the content of SOP becomes operational for the user department(s). It shall be stamped by QA department after completion of training on the approved SOP, in DD MMM YYYY format.
Next Review Date: Mention the next review date on which the SOP shall be reviewed. On first page of header in bold letter. It shall be mentioned in DD MMM YYYY format with blue ink stamp. All the SOP’s shall be reviewed every two year. Example: If effective date is 01 JAN 2023 then next review date shall be mentioned as “31 DEC 2024”.
What is Content of SOP Body?
Contents of body
The content of body of Standard Operating Procedure shall contain the following headings (all headings shall be prepared by with capital bold letters).
Purpose as first point; an overview of the intention of preparation of Standard Operating Procedure shall be briefly mentioned under this heading.
Scope as second point; describes the site(s) / location(s) / plant(s) and/ or departments to which the Standard Operating Procedure is applicable.
Reference(s) & Attachment(s)
References as Third point; includes details of any references used in order to design the system. The references can be an official publication, any published literature, guidelines, instruction manuals etc.
Cross reference documents:
This Section contain cross reference SOPs or inter-linked departmental SOPs . Some SOPs are intimately linked to others. When information contained in more than one document is necessary to complete a task, it is useful to include a cross-reference section in each document.
Attachments/ Formats/ Annexure
Attachments as third sub-point; it shall enlist all specimen formats, specimen labels, flow charts or any other attachment with the SOP.
Definition & Abbreviation
Definition: Write down in this column wherever require the definitions of critical/ technical term related or used in SOP.
Abbreviations as fourth sub point; describes the meaning or explanation of term(s) which is (are) not common or having any specific meaning and expansion of abbreviation(s) used in the Standard Operating Procedure.
Responsibility as fifth point; specifies designation of the personnel and name of department that shall be responsible for implementation and compliance of the Standard Operating Procedure.
Procedure: This section shall divide into sub-section.
- describe the Safety/Precaution or EHS measure shall be prepared by as per requirement of SOP and
- describes the detailed procedure to be followed in simple and clear sentences. It may include the details of all operations, operational conditions and precautions to be taken, if any, etc.
If any coloured photograph is required for SOP then it can be incorporated in SOP
- History of revision as seventh point; history shall contain a chronological record of significant changes/ modifications in an SOP,
What is Content of SOP Footer?
Contents of Footer
Prepared By: Signature with date of a concern department person who prepared SOP. Prepared by signature and date shall appear on each page of the SOP.
Checked By: Signature with date of a concern department person who checked SOP. Checked by signature with date and date shall appear on each page of the SOP.
Reviewed By: Signature with date of a QA person who reviewed SOP. Reviewed by signature and date shall appear on each page of the SOP.
Approved By: Signature with date of QA Head and Plant Head who has approved the SOP signature and date shall appear on each page of the SOP.