SOP on Preparation, Approval and Control of Corporate manuals
Objective : To lay down a procedure for the preparation, approval and control of corporate manuals.
Scope : This Standard Operating Procedure is applicable for the preparation and implementation of all corporate manuals prepared at various sites.
Responsibility : Officer/Executive -Concerned department shall be responsible for preparing the corporate manual at there respective site as per the SOP.
Head- Concerned department of the respective site shall be responsible for review and checking the corporate manual.
Corporate Head-Concerned department shall be responsible for approving the manual for all sites
Head -Corporate QA shall be responsible for approving the corporate manual.
Head-Concerned department of respective site shall be responsible for implementation of the Corporate manual a there respective site.
Head-Site QA shall be responsible for the compliance of the corporate manual at there respective sites.
Officer/Executive shall be responsible for assigning the number to the manual.
Head-QA concerned site shall be responsible for compliance of the SOP.
Abbreviations and Definitions
SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
Corporate Manual : Manual that is applicable for all the sites including R&D and Plant.
Procedure :
Generation of New Corporate Manual
All corporate manuals shall be written in clear and easy to understand language.
All the manuals shall be generated on computer in the format. The text of the manual shall be typed preferably in font face ‘Times New Roman’ with font size ‘12’ or with other appropriate font size as per the requirement of the manual.
Corporate manual shall be printed in black colour on standard A-4 size sheet of good quality having company’s corporate logo on the top left hand side of the sheet.
All manuals shall be prepared using Microsoft Word application software
- Page setup and Page border settings.
- Top margin shall be 0.8 inch (0.8”)
- Bottom margin shall be 0.6 inch (0.6”)
- Left margins shall be 0.6 inch (0.6”)
- Right margin shall be 0.6 inch (0.6”)
- Page Layout from edge shall be header 0.5” and Footer 0.5”.
Form Number of the Manual (format) shall be put in the ‘footer’ and not surrounded by the page border.
Upper portion (non text part) of the manual (format) shall be put into the ‘Header’.
Description of the format for Corporate manual preparation.
First page of the manual shall be the cover page of the manual.
“Company Name” shall be written in the center of the Top portion, below the header. It shall be typed in Bold with font size 13.
“Document number” shall be written below the Company Name with font size 13.
“Title” of the manual shall be written in the center of the A-4 sheet and it shall be clear and self descriptive.
In middle lower part above footer, year of preparation of the manual shall be typed in bold with font size 13.
Second page shall be the approval sheet containing “Header” comprising of following information’s.
“Document Number” it is the unique number assigned to each particular manual.
Document number shall consists of nine characters
1st and 2nd character denotes “Company Name”.
3rd character shall be a dash.
4th and 5th characters shall represent the “Corporate manual”.
6th character shall again be a dash.
7th, 8th and 9th characters shall represent the serial number of the manual.
For 1st corporate manual, the numbering shall be PB-CM-001.
“Supersedes” it represent the previous version of the document.
“Document Title” it signifies the main topic of the document or it represent the document.
“Rev. No.” it generally shows the current operational version of the document and shall be denoted in two numeric characters. New SOP shall carry Revision No. ‘00’ and the subsequent revisions shall be denoted by 01, 02, 03 and so on. (to be typed in regular font with font size 11)
“Effective date” it represent the date on which the document or manual becomes operational and same shall be written in DD-MM-YY format. e.g. 5th April, 2025 shall be written as 05-04-25.
“Next review date” shall be the date on which the review of the same has to be taken and same shall be written in DD-MM-YY format. e.g. 5th April, 2027 shall be written as 05-04-27.
Header of the document continues to Annexure three of the manual or text part of the manual.
Approval sheet contains the following listed information.
Manual shall be prepared, checked by and approved from the concerned department personnel and shall be approved by Head-QA.
Initiator department personnel who has prepared the manual shall put his name, department, designation, signature and date alongwith in the respective columns.
Initiator department personnel who has checked the manual shall put his name, department, designation, signature and date along with in the respective columns.
Initiator department personnel who has approved the manual shall put his name, department, designation, signature and date along with in the respective columns.
Head-Corporate QA shall be responsible for final approval of manual.
Page numbering shall be done on the top right hand side with font size “10” as per annexure3 in header itself e.g. it there are ten pages in the document than page numbering shall start as 01 of 10 and ends as 10 of 10. Also the page numbering shall start with the text part of the manual and shall not displayed.
Consecutive pages shall contains the relevant information in detail as mentioned below:
Table of contents
This generally contains the details of the parameters that are to be included in the manual.
Objective
As first point; an overview of the intention of preparation of corporate manual shall be briefly mentioned under this heading. The ‘Objective’ shall always start with the word ‘To
Scope
As second point; describes the site(s) / location(s) / plant(s) and/ or departments to which the corporate manual shall be applicable.
Responsibilities
As third point; specifies designation of the personnel and name of department that shall be responsible for implementation and compliance of the corporate manual.
Abbreviations and Definitions
As fourth 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 Corporate manual.
Procedure
As fifth point; 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.
References
As sixth point, reference describes the guidelines/procedure from where the relevant information has been taken
Annexures
As seventh point; it shall enlist all specimen formats, specimen labels, flow charts or any other attachment within the manual.
Distribution
As eighth point; describes the distribution of the SOP to various concerned departments
History
As ninth point; history shall contain a chronological record of significant changes / modifications in the manual in brief.
Narrative text of each heading shall be aligned below the heading, not across the length of the heading.
Main headings of the manual shall be numbered 1.0, 2.0, 3.0,…….and so on. Each heading shall be typed in bold keeping first letter capital and rest in small for each word. The subsequent numbering for headings or steps shall be typed with outline numbering system through five levels. For instance, first level number for the heading at fifth position shall be ‘5.0’ and its second level shall be 5.1, 5.2……so on and the fifth level shall be ‘5.1.1.1.1’ against the first step of every subsequent level. After fifth level the sub-numbering can be marked as ‘a’, ‘b’ and so on or ‘i’, ‘ii’ and so on.
Note: Method or procedure adopted for typing the text for this manual can be used as reference for the typing of other manuals.
The initiator department shall forward the draft(s) of manual under preparation (putting “DRAFT’ word on every page of the manual as water mark of appropriate size) to QA department for comments and necessary input, if any.
Once the Draft manual is finalized, concerned department shall print the finalized manual and after putting their signatures in respective columns submit the hard copy along with the soft copy to documentation cell of QA.
Documentation Cell of QA shall review the final printed copy and approve the same.
After approval, Head, QA or his / her designee shall forward the manual to Incharge, Documentation Cell or his/ her designee for putting dates by hand in ‘Effective Date’ and ‘Next Review Date’ columns of the manual in DD-MM-YY format, once the training records are received at Documentation Cell of QA.
Distribution of the manual shall be done as per SOP “Documentation and Data control”.
Biennial review of a manual shall be undertaken as per SOP ‘Document and Data Control’ , however change in any the manual shall be undertaken through SOP titled ‘Change Control’.