What is Standard Operating Procedure :
It is an authorized written document which describes the step by step instructions requirements for Quality system, performing operations, non specific to any product, process or material. It provides detailed procedure about systems applicable to various operation e.g. Equipment’s / Instrument’s / System’s Operation / Cleaning / Maintenance.
Everybody working in organization has to follow the instruction which are written in SOP and perform their activities accordingly.
Importance of SOP :
It is important for all industry as it explains about the Practices & procedures which are to be followed by each department before doing any activity. It plays a major role in every business of a organization & it is the backbone of all industries and integral part of Quality Assurance
Parameters of SOP :
Paper Size, ( A4 size) Paper Colour required, (White) Header, (with company logo & site name with Font Size 11 Arial Bold) SOP text (Arial with Font Size of 11) & Footer (Arial with Font Size of 11 & Footer format number Arial 10) which may vary organization to Organization.
Each SOP will have a header (in bold letters) with the following details :
Title: Mention the title of SOP for which being prepared, starting with word “Procedure for”.
Department: Mention respective department for which SOP is being written.
SOP No. : Mention a unique number to each SOP.
Supersedes: Mention previous version of SOP number with revision number. Write “Nil”, in case of the new SOP is written
Page No. : Mention the current page number followed by the total page numbers
Effective Date: Mention the date, month and year (DD/MM/YYYY) or (DD/MM/YY)
Review Before: Mention the “Review Before” date, Two years from the Effective Date.
Each SOP will have a Footer (in bold letters) with the following details :
Prepared By: Signature, date, name of person and designation shall be put who has written the procedure.
Reviewed By: Signature, date, name of person and designation shall be put who has reviewed the procedure.
Approved By: Signature, date, name of person and designation shall be put who has approved the procedure.
Format No. : All pages will have unique format number on the bottom right hand side corner outside the border.
Each SOP will have a middle portion (body) with the following subheadings :
Objective: State the aim for writing the SOP & restrict the purpose to one sentence or maximum two sentences statement, starting with the word “To”. This elaborates the usefulness of the SOP (elaborates on “What / Why”).
Scope: State the scope for which the SOP will be applicable. The scope may be applicable for processes / equipment / policies.
Responsibility: State the designation of the person(s) who is / are responsible for activity (competent enough / operating personnel / executing personnel).
Definition(s): Write the definition of the key / important words used in the SOP
Procedure: Write the procedure stepwise, short, unambiguous instructive sentences of the operating procedure, all checks to be done, record to be maintained, frequency of various operations, etc. Give special precautions (Operation / Cleaning / Calibration / Safety related), if any.
Distribution: Mention the Department name in which SOP is to be distributed.
Annex(es): Mention the title(s) of Annex(es) with Annex No. related to SOP
Reference(s): Mention the Reference(s) of SOPs which are linked with written SOP (existing).
Abbreviations: Mention the full form or full word or phrase for short forms used in the SOP
SOP Revision History Record: Mention the SOP Revision Number, Details for Revision(s) with Change Control No. and Effective Date (Sign./ Date).
Approval and Distribution of SOP :
All the SOP used in the organization shall be Approved by Quality Assurance & Approved copy shall be given to the concerned department for the training purpose.
Department Head / Designee shall give training to concerned personnel and SOP made effective within 30 calender days from from date of Approval.
Quality Assurance shall put Master stamp in the SOP & take the photocopy & issue the same to the concerned department by putting controlled or Display copy stamp.
All the approved SOPs master copy shall be kept in QA custody.
Revision of SOP :
Revision of SOP shall be done at any time within the two years of the issue date but must necessary be reviewed at the end of two years.
Modification/change/ revision shall be done in SOP’s with the help of change control system.
Old SOP copy shall made obsolete & new SOP shall be issued to respective department.
Cancellation or withdrawal of SOP :
In case SOP / Annex are no longer required, the concerned department will raise the change control for cancellation / withdrawal.
On completion of assessment SOP / Annex, shall be cancelled / withdrawn by QA Department.
The SOP No. allocated to the Cancelled / Withdrawn SOP shall not be allocated to any other new SOP.
Destruction of SOP :
Retrieved copies of SOP shall be destroyed by QA Department by any one of the following methods.
- Manual Tearing 2. Paper Shredding (through machine)
Destruction details shall be maintained by QA Department with proper documentation.
- SOP Training is important for all the employee working in the organization irrespective of freshers and experience personnel so every employee shall taken SOP training according to the Training scheduled.
- Current SOP copy shall be available in the respective department or workplace.
- SOP shall be displayed near to the instrument, equipment’s or in the particular area or work place where activity is going on.
- During cleaning activities in manufacturing area the concern personnel shall ensure that it should not come in contact with water.
- Everybody shall follow the SOP and do what is written in the SOP.
- Give appropriate training and evaluate prior to make effective to any SOP.
- It serves as a training document for teaching users about the process for which it was written.
- It provides guideline for accurate and timely data collection.
- To provide people with all safety, Health, environmental and operational information necessary to perform the job properly.
Pl find below the Template of SOP (Annex 1) .
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