SOP OF SOPS (SOP on Standard Operating Procedure) are documented processes that a company has in place to ensure that services and/or products are consistently delivered every time while meeting minimum quality standards. In practice, most SOPs are written as a step-by-step series of operating instructions that can show employees what they need to do to accomplish a task. SOPs are designed to ensure efficient, quality production on a consistent basis, regardless of who follows them.
Purpose:
To describe the SOP OF SOPS (SOP on Standard Operating Procedure) for Preparation, Review and Approval of Standard Operating Procedures.
Scope:
This procedure is applicable to all SOPs at The Searle Company Ltd Lahore.
Responsibility:
Executive/Officer QA/Designee: Preparation And Revision / Periodic Review Of Sops.
QC Manager / Production Manager/Store Manager: Review and Training of SOP.
QA Manager / Production Manager: Approval of SOP
- Procedure SOP OF SOPS (SOP on Standard Operating Procedure)
- The shelf life of SOP will be one year. All SOPs shall be as per the SOP format, attached as Annexure 1
- Each page including Annexure shall bear company logo.
- All the SOPs shall consist of Header, Content.
- The Header part of each SOP shall remain common for all pages excluding format & Annexure pages. The Header part of the SOP shall consist of the following:
STANDARD OPERATING PROCEDURE:
Standard Operating Procedure shall be printed in Arial letters. Font Size: 14, Style: Bold.
Title:
The title of SOP shall be in Arial letters. Font Size: 12, Style: Normal, Bold Sentences Case. It should be self descriptive.
Block for Stamping Purpose:
This Space shall be used for putting stamp for controlled documents on the photocopies.
Department:
The name of the department preparing the SOP shall be in Arial letters. Font Size: 12, Style: Bold, Regular.
Page No:
The page number shall appear on the right hand corner of the header. This specifies the page number, with respect to the total number of pages of the SOP, excluding the Annexure.
SOP No.:
Numbering of SOP:
SOP number shall consist of 15 characters.
- First three characters, ‘SOP’ denotes “Standard operating Procedure”.
- (Refer Annexure 2)
- Fourth, Eighth and eleventh character denotes slash (/).
- Fifth to seven character is Department or Section code. e.g. QCD for Quality Control Department, 6 for Production, 5 for Warehouse. (Refer Annexure 2 )
- Ninth and tenth characters denotes for technical terms e.g GN for General, RM for Raw material
- Twelfth, Thirteen and fourteen characters denotes serial number of SOP, starting from “001″onwards.
- e.g. First new SOP of Quality control, finished product at Searle Pakistan Ltd shall have SOP number as SOP/QCD/FP/ 001.
Revision:
In case of a new SOP, Revision No. will be ‘’00’’. If Revision of SOP is done than the previous SOP No. will be written against Supersede.
Effective Date:
The effective date is the Date from which the SOP shall be effective. Training shall be given to all concerned personnel before effective date of the SOP.
Review Date:
- This is the Date, before which the SOP shall be reviewed. SOP will be revised as required in case of any changes seen internationally, or after a period of two years.
- SOP shall be reviewed, before the defined review period through a change control procedure.
- QA shall assign a review date, two years from the effective date.
Prepared by:
Person preparing the SOP from the initiating department shall sign with the date, in black ink. Designation shall be printed with Department, mentioned in Annexure-2
Reviewed by:
Head of the initiating Department/Designee shall review the SOP and sign with date, in black ink. Designation shall be printed with Department, mentioned in Annexure-2
Approved by:
Department Head or Head of Quality assurance/Plant Head shall approve all SOPs of Production, Quality Assurance and Quality Control department. They will sign with date in black ink.
Content Part:
All SOPs shall contain the following sections:
- Purpose
- Scope
- Responsibility
- Procedure
- Training
The details of the five sections shall be as follows:
Purpose:
This section shall describe the justification for the preparation of the SOP and what is expected from it.
Scope:
This section shall indicate the applicability of the SOP for its intended use.
Responsibility:
This section shall indicate responsibilities of the personnel for the intended activity.
Procedure:
This section shall cover stepwise activities performed and conditions / precautions required for implementing the SOP.
SOP text shall be written in simple and clear language in Font Style, “Arial”, with a Font size of ‘11’ and space between the lines shall be 1.5 lines. A4 size white paper shall be used for printing.
Bold letters shall be used for Heading and / or Subheadings.
All the signatures and date shall be in black ink except signature of approval.
All SOP shall be written in English language.
Frequency:
The frequency of operations shall be mentioned in the procedure if applicable.
References:
References shall be mentioned in the procedure if applicable.
Revision Log:
Revision Log shall have following details:
Revision No. Effective Date Reason
Abbreviations:
The Abbreviations used in the SOP shall be described in this section.
Relevant Records
All relevant records linked with this SOP shell be mentioned here.
TRAININGS
PERIODICAL TRAINING:
The staff responsible for performance of this operating instruction has to be demonstrated periodically about the content of this SOP.
TRAINING FOR NEW EMPLOYEES:
Before starting with the job, the employee has to be demonstrated about the content of this SOP.
ANNEXURES:
- Annexure shall be formats, used for recording the data, related to the activity.
- Annexure shall have a unique format number linked to the relevant SOP