SOP For SOP

1. OBJECTIVE
To provide a procedure for preparing of Standard operating procedure

2. SCOPE
It is applicable to Quality Assurance Department

3. RESPONSIBILITY
• Quality Assurance Manager
• Assistant Manager

4. SAFETY INSTRUCTIONS
• Restricted SOP information, do not release or divulge outside without authorization

5. PROCEDURE
5.1 Prepare the SOP on the approved format on A-4 size paper.
5.2 Prepare the SOPs to describe the operating procedures and steps.
5.3 Write all the SOPs in clear, unambiguous language, easy to understand and easy to follow.
5.4 Write the SOPs under the following sub-headings:
• OBJECTIVE
• SCOPE
• RESPONSIBILITY
• SAFETY INSTRUCTION
• PROCEDURE
• RELATED DOCUMENTS
• DISTRIBUTION INDEX
• ABBREVIATIONS
• REFERENCES
• REVISION HISTORY

5.4.1 OBJECTIVE
Write here the reason for preparing the SOP in one sentence or maximum two sentences starting with a letter ‘To’.
5.4.2 SCOPE
This Section defines the applicability of the SOP and also specifies departments, areas or sections to which this SOP shall be applicable.
5.4.3 RESPONSIBILITY
Write here the designation of the person / persons who are directly responsible for the operations mentioned in the ‘Objective’ of the SOP.
5.4.4 SAFETY INSTRUCTION
Write the safety instruction that have to be taken while following this SOP
5.4.5 PROCEDURE
Write the procedure/method in short sentences. Do not write the instructions in long paragraphs.
Mention all the checks to be carried out, records to be maintained, frequency of various operations, checks and special precautions, if any.
5.4.6 RELATED DOCUMENTS
Mention a list of all Annexure enclosed in the SOP. If there is no Annexure in the SOP, mention ‘Not Applicable’ under this subheading.
5.4.7 DISTRIBUTION INDEX
Mention the name of department where copy of SOP is applicable and has to send
5.4.8 ABBREVIATION
Mention a list of all abbreviations & their full forms/descriptions used in the SOP. If there is no Abbreviation in the SOP, mention ‘Not Applicable’ under this subheading.
5.4.9 REFERENCES
You can also give the references from which data is collected or the reference of guideline that you follow to writing SOP
5.4.10 REVISION HISTORY
Give all the revision history of SOP
5.5 FORMAT REQUIREMENTS
The type of font for the contents in SOPs shall be ‘Times New Roman’. The font size to be used for contents of SOPs shall be 12 with headings in bold and upper case.
5.6 NUMBERING SYSTEM OF SOP
5.6.1 Each SOP shall have a unique numbering system. Once number is allocated to any SOP, the same number shall not be repeated to other SOP.
5.6.2 Each SOP No. consists of alphanumeric characters. For example first SOP prepared in the QA department shall be numbered as XY/QA/SOP/001.
5.6.3 1st &2nd alpha character indicates the plant name
5.6.4 3rd, 6th and 10th characters are slash “/” for separator
5.6.5 4th and 5th letters are for department for which SOP is applicable
5.6.6 7th, 8th and 9th for standard operating procedure..
5.6.7 Next to 10th, numerical characters indicate serial number of that particular department code. ‘001’ indicates first SOP prepared under particular department code.
5.6.8 Department wise Code for SOP Numbering system for Manufacturing and Quality Control:
5.7 CONTENTS OF HEADER
5.7.1 Title: Detailed heading of the SOP.
5.7.2 SOP No.: Unique SOP No. as per procedures described in the point no. 5.7 shall be mentioned here.
5.7.3 Revision No. : Revision No. consists of two numerical characters which start from ‘00’ with increment in one digit after each revision. ‘00’ indicates the first issuance of that particular SOP.
5.7.4 Issue Date: The issue date shall be stamped by Q.A. after final authorization before circulating the SOPs.
5.7.5 Effective Date: The effective date shall be stamped by Q.A. after final authorization before circulating the SOPs.
5.7.6 Supersedes Revision No: The revision history of previous SOP will be mentioned
5.7.7 Review Date: The normal review period will be 1 to 2 years from the effective date of the SOP. For example if any SOP is having effective date “01-12-2020”, its review date will be “01-12-2022”.
5.7.8 SOPs shall be revised on need basis with proper justification. All SOPs shall be mandatory reviewed and revised once in two years.
5.7.9 Upon first revision of an SOP, the details of revision shall be recorded on the revision page of the respective SOP.
5.7.10 Page: The page number shall be mentioned in ‘xx of yy’ format.
5.7.11 Signatures: The Header comprises of three columns i.e. Prepared By, Checked By and Approved By, Each of the three columns consist of 3 rows i.e. Name of the person who signs the SOP in full signature and the date on which the person signs the SOP.
5.8 CONTENTS OF FOOTER
Following statement will be mention in Footer “Restricted SOP information, do not release or divulge outside without authorization”
5.9 GENERATION OF NEW SOPs
5.10 User dept. shall prepare the draft SOP as per the procedure described in the point no. 5.4 to 5.9. Draft copy shall be identified by stamping or watermark on each page.
5.11 Draft copy shall be circulated to the responsible persons for its review. The responsible persons may recommend for any changes in the text.
5.12 Based on the recommendation, user dept. shall correct the draft SOP and take final print out for approval and authorization along with Change History Log.
5.13 After approval and authorization, user dept. shall submit the Original Copy (Master Copy) of SOP along with ‘Change History Log’ to QA for control and issuance and shall destroy the draft SOP.

6. RELATED DOCUMENTS
SOP Format – Annex-I

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

8. ABBREVIATIONS
QA Quality Assurance Department
SOP Standard Operating Procedure

9. REVISION HISTORY