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SOP consist of following parts,
Header
• It includes the company name.
• It is present on all Pages of Standard Operating Procedure or SOP.
• It is written in Bold capital letters usually font size of 16.
Type of Document
• It contains document type like,
STANDARD OPERATING PROCEDURE
• Write it in capital bold letters.
• Usually, 14 font size is used.
Tittle
• It contains the name of activity for which SOP is written e.g
COMPRESSION MACHINE
• Write it in bold and capital letters.
• Usually, font size is 12.
SOP Number
• SOP is given a unique number depending on an in-house coding system like SOP-DC-ABC-Z.
• DC is departmental code like PRD for production, STR for store etc.
• ABC is a sequence number starting from 001.
• Z is the revision number.
Effective Date
• It is the date from which SOP is going to be implemented. Mean it is the date from which SOP will be effective for that specific activity, after approval from all concerned persons.
• Before the effectiveness of SOP training of concerned personnel is conducted.
• It is written as dd.mm.yyyy. (day, month and year)
Review Date
• It is the date at which SOP should be reviewed.
Supersedes
• It includes the previous Revision number.
• If SOP is new it will be Nil.
Page No
• It includes a total number of pages.
Signature Box It includes,
• Prepared By
• Reviewed By
• Approved By
Prepared By
• It includes the name and designation of a person who writes the SOP.
• The person is from SOP initiating department e.g production, QA, QC etc.
• It is written as the name and designation of a person followed by signature and date.
Reviewed By
• It includes the name and designation of a person who reviews the SOP.
• Usually, the head of the department of the initiating department reviews the SOP.
• It is written as the name and designation of a person followed by signature and date.
Approved By
• It includes the name and designation of a person who approves the SOP.
• Usually, the head of the department of QA or Management representative/MR approves the SOP.
• It is written as the name and designation followed by signature and date.
Purpose
• Purpose section clearly describes the need of that SOP, why it is generated.
• For example in the case of SOP for Fluid Bed dryer, it is written as,
This SOP is generated to define a standard operating procedure for the operation of the fluid bed dryer.
Scope
• It includes the areas which are covered by a specific SOP.
• In the case of SOP for Fluid Bed dryer, Scope is written as,
This SOP is for the fluid bed dryer.
Responsibility
This Section highlights the responsibilities of personnel for that SOP.
Procedure
• This section includes a step by step description of how a task is to be performed.
• It should be written after a complete study of that specific task or operation for which SOP is to be established.
• The procedure should be in such a way that it can easily be understood by the end-user.
• It is written on A4 size white paper.
• Usually, the font size used is 12.
• Do not write long paragraphs.
• Write in steps.
• Headings and subheading should be written in bold capital letters.
Precautions
• Safety measures should be listed in this section.
Revision History
• It includes the data which represent the revision history of SOP.
• Reason for revision is mentioned in this section along with the date.
Annexure
• Annexures are specific formats which are used along with SOP for recording specific data.
• Annexures are attached with SOP, e.g
Annexure 1
Any checklist.
Annexure 2
Data recording form.
Footer of SOP
• Footer is on every page of SOP.
• It is usually written in 10 font size. It includes,
• SOP Number.
• Revision Number.
• Page Number.
• The page number is written as x of y.
• x is an individual page number.
• y is the total number of pages.
• Example, if the total number of pages are 4 then for 1st-page x of y means 1 of 4.
