Friday, November 19, 2010

The Preparation And Maintenance Of Standard Operating Procedure (SOP)

1.0 Purpose : To provide instruction for the preparation and maintenance of Standard Operating
Procedure (SOP)

2.0 Objective : To provide documented procedure for preparation and maintenance of Standard
Operating Procedure. (SOP)

3.0 Scope : This SOP is applicable for the preparation and maintenance of Standard
Operating Procedure (SOP).

4.0 Responsibility :
• Preparation: Quality Assurance with all other departments.
• Overall responsibility: Quality Assurance In-charge.

5.0 Procedure:
• Page Set up for Standard Operating Procedure (SOP):
 Top Margin : 1”
 Bottom Margin : 1”
 Left Margin : 1.25”
 Right Margin : 1.25”
 Gutter : 0”
 Gutter Position : Left
 Header : 1.2
 Footer : 0.5”
 Line Spacing : 1.5 lines
 Font Size : 12 ( Minimum 10 for tables )
 Font Style : Times New Roman
 Paper Size : A4, 210 X 297 mm

• The Header of Standard Operating Procedure
Sr. No. Content Description
01 Name of Company Company name and document title shall be written in capital with font size 12 and font style Times New Roman at center of page.
02 Company’s logo Company logo shall be placed at the right side of the page.
03 SOP Title SOP title gives a short description about the purpose of the SOP.
04 Department This indicates on which department SOP will be used.
05 SOP. No. This indicates SOP Number.
06 Review Date Review Date shall be written as per this format “dd-mm–yyyy”. This indicates on which date user department will review SOP. All character of date shall be in numeric only and hand written.
07 Effective Date Effective Date shall be written as per this format “dd–mm–yyyy”. This indicates from which date SOP will be implemented. The gap between issuance and implementation will be utilized for Training on SOP. All character of date shall be in numeric only and hand written.
08 Revision No. This indicates Number of Revisions of SOP. Initially it is 00 and then revision start with .01, 02, 03….etc.
09 Supersedes This indicates previous version of SOP which has been superseded. Initially it will be NIL
10 Page Page number shall be written as per this format “page x of y. x indicates current page number and y indicates total number of pages.

• Numbering System for Standard Operating Procedure (SOP)
 SOP No. shall be in form of ANK / XX / YYY / ZZZ
 Where,
o ANK means Ankleshwar
o XX means Department Code
o YYY means SOP (Standard Operating Procedure)
o ZZZ means Serial number of SOP
• Department Code is as under:
 Production PR
 Quality Control QC
 Quality Assurance QA
 Maintenance MT
 Stores ST
 Personnel & Administration PA

• Explanation of Contents of Standard Operating Procedure (SOP)
 Purpose
o Indicates the purpose of SOP. It represents the title of SOP in detail.
 Objective
o Indicates the reason for preparing particular SOP in a department and how it going to help or facilitate a particular operation or activity.
 Scope
o It is limited to location, department, equipment, documents etc.
 Responsibility
o The functional responsibility for actual implementation and overall responsibility for supervision shall include under this heading..
 Procedure
o Under this header detail procedure shall be mentioned point wise. Each point shall be described in language that is easy to understand for user.
 Reference Document
o Means documents to be referred or filled prior, during or after completion of activity described in SOP. e.g. log books, formats, registers, worksheets, drawings, layouts, labels etc. shall be mentioned.

 Abbreviation
o In this header meaning and details description of certain key words used in the SOP.

 Copies to distribution sites and location
o In this header department name shall be mentioned, where controlled copy of SOP distributed by Quality Assurance Department
 Review History
o Following parameters shall be mentioned for review history

Sr. No. Previous
Revision No. New
Revision No. Review Date Reason For
Review Change Control No. Approved by



• Footer of Standard Operating Procedure (SOP)
 Blank Block
o Indicate space on each page of SOP for the displaying the status of SOP e.g. MASTER COPY. CONTROLLED COPY, UNCONTROLLED COPY, DRAF COPY, REFERENCE COPY, REVIEW DATE etc.
 Prepared By
o Mentioned user department who has prepared the SOP with designation, signature and date of preparation on every page.
 Checked By
o Mentioned user department who has checked the SOP with designation, signature and date of reviewed on every page.
 Approved By
o Mentioned who has approved the SOP with designation, signature and date of Approval on every page.
 Remarks:
o Signature of User Department in prepared by, checked by shall be done in Blue ink only, and Quality Assurance personnel will sign in Black ink.
• General notes for SOP drafting
 All SOPs should be made in Approved format only.
 There shall be written down procedure SOP for each activity.
 The need of SOP’s for various equipment / operation shall be consultation with Department Head along with actual user.
 SOPs for machine operation shall be prepared by in consultation with engineering department and user department.
 SOPs for validation, stability study and calibration shall be prepared in consultation with Quality Assurance.
 SOPs shall be prepared in language that is easy to understand.
 The writing of procedure in an SOP is based on the category of SOP.
o Specialized SOPs: Standard Operating Procedure of this category includes following points:
 General conditions or prerequisites
 Procedure
o All SOPs must provide complete information regarding
 Who will carry out the job
 Where will the job be done
 How the job will be done and when it be done in order to fulfill a successful work completion criteria.
• Control of Standard Operating Procedure
 Control of Soft Copy of SOP
o Soft copies of SOP control though Password Protection on Compact Disk with Corporate QA only. The access shall be restricted to QA Officer or Authorized personnel of QA.
o Soft copy will be stored in separate folder as :
 Main Folder as SOP
 Sub Folder as Department code e.g. PR, ST, PA, QC etc.
 Files as ANK/PRSOP/001,ANK/PR SOP/002, ….etc. for each department.

 Control of Master Copy of SOP
o Hard copy of SOPs shall be stored in QA department. The hard Master Copy will bear original signature and red stamped of “MASTER COPY” at bottom right side corner of the each page.
 Control of Controlled Copy of SOP
o Controlled copy is a photocopy of Master Copy and is under the control of QA for issue to user department which is stamped as “CONTROLLED COPY” at blue space at bottom side of each page in blue ink. Copying of this copy is strictly prohibited. The stamp shall be applied in blue ink on each page and shall bear the original signature and date issue of QA personnel with black ink.
 Issuance of SOP
o Controlled copy of SOP shall be issued to the user department, each SOPs issued and entry is recorded in SOP issue register.
 Recall of SOP
o SOP can be recalled in following condition:
 SOP is not displayable / distorted
 SOP is not legible
 For review
o Record of recall shall be maintained.
 Review of SOP
o SOP shall be reviewed after every 2 years from the date of preparation or when any change to be made in the procedure, format etc. through change control system. Only two reviews can be done and same will be re-printed, if there is no change in the content of SOP.


 Destruction of SOP
o Master copy of obsolete SOP shall be stamped as OBSOLETE in Red Ink and preserved for one year from the date of absolution. The destruction shall be carried out by QA personnel and recorded with date of destruction. Obsolete controlled copy will be recalled and destroyed by shredding.
• Training of Standard Operating Procedure
 Training on SOP shall be given to all related user respective to their job, prior to effective date. Training record shall be maintained.

6.0 Reference Document:
• SOP issuance logbook
• Standard SOP format.

7.0 Abbreviations:
• QA : Quality Assurance
• QC : Quality Control
• SOP : Standard Operating Procedure

8.0 Copies to Distribution Sites :
• Quality Assurance
• Quality Control
• Production
• Engineering
• Stores
• Personnel & Administration

9.0 Review History

Sr. No. Previous
Revision No. New
Rev. No. Review Date Reason For Review Change
Control
No. Approved
By

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