To lay down an approved procedure for the Preparation, Distribution, Review, Retrival and Archival of Standard Operating Procedure
This procedure is applicable to the preparation, distribution, review, retrival and archival of Standard Operating Procedure used in Quality Assurance, Quality Control, Production and Stores Departments.
5.1 Standard Operating Procedure: Standard Operating Procedure is a logical sequence of events in instructional form for performing the activities.
5.2 Master Copy: The first copy of Standard Operating Procedures that bears original signatures are stamped ‘MASTER COPY’ in red ink, at the top left corner.
5.3 Controlled Copy: A photocopy of the Master Copy along shall be stamped as ‘CONTROLLED COPY’ in Green ink with Sign and Date at the bottom left corner that shall be used with in the organization and is distributed to a limited number of authorized document holders.
5.4 Display Copy: A photocopy of the Master Copy stamped as ‘DISPLAY COPY’ at the Top Right corner in Red ink.
5.5 Uncontrolled Copy: A photocopy of the Master Copy for the use of customers / external agencies shall be stamped as ‘UNCONTROLLED COPY’ in Red ink across the centre of each page.
5.6 Training Copy: A photocopy of the Master Copy shall be stamped as ‘TRAINING COPY’ in Red ink in the bottom right corner of each page. The training shall be conducted to all users in the department.
5.7 Obsolete copy: The superseded Master copy of any document or a copy of any discontinued document that is taken out of use is stamped as ‘OBSOLETE COPY’ in red ink in the bottom right corner of each page.
6.0 PROCEDURE :
6.1 Design of standard operating procedure:
6.1.1 The standard operating procedure shall be created in specific format (refer)
6.1.2 SOP shall be prepared by using Microsoft word on A4 size paper. The text shall be in ‘Normal’ style with ‘Times new roman’ ‘Regular’ font size of 12. Single line spacing shall be assigned between lines and paragraphs.
6.1.3 The header shall contain company logo, name and location, title, page number, sop number, revision number, date of issue and effective date.
6.1.4 Footer shall have the provision for the signature, date and designation of the prepared by, checked by and approved by.
6.1.5 Each page of standard operating procedure shall be consecutively numbered indicating page the number and the total number of pages in the sop. E.g. page 1 of 2and 2 of 2.
6.1.6 The sections shall be serially numbered using Arabic numeral starting for 1.0and the subsections of each section shall also be serially numbered as 1.1, 1.2, and so on. Its subsections shall further be numbered as 1.1.1, 1.1.2 and so on.
6.1.7 After the completion of the sop shall be signed and dated along with the designation of the signatories.
6.2 Identification of Standard Operating Procedure:
The standard operating procedures shall be written in nine sections. Refer format QAGP:001:F01:00.
6.2.1 Purpose: objective of writing the particular sop. It should start with the phrase ‘to lay down an approved procedure…………..’
6.2.2 Scope: the area / equipment/ instrument/ facility/ system/ department/ personnel to which the procedure applies.
6.2.3 Responsibility: the designation of the person(s) who are directly responsible for carrying out the activity mentioned in the purposed of the sop.
6.2.4 Accountability: The designation of the person(s) who are accountable for complying the sop.
6.2.5 Definitions: Meaning of the unique terms used in the sop.
6.2.6 Procedure: Detailed stepwise activities to be performed and shall be written in a simple language with simple sentence structure step by step.
6.2.7 Reference: Other documents referred for the preparation of the sop.
6.2.8 Enclosures: Formats required for recording the information such as formats, lists, tables, checklists and labels shall be attached with the sop.
6.2.9 Abbreviations: Full form of the abbreviations shall be used in first afterwards short forms shall be used. All abbreviations used in the sop shall be mentioned in this section.
6.3 Numbering of Standard Operating Procedure:
6.3.1 SOP shall be identified by an alphanumeric numbering system.
6.3.2 SOP shall be numbered with 4 alphabets; first 2 alphabets specify department and other 2 alphabets specify the functional subgroup and Arabic numerical serial number in 3 digits starting from 001.
6.3.3 Department code for Quality Assurance Department shall be ‘QA’ and it should be the first two letters of all the SOPs indicating that the particular SOP belongs to Quality Assurance Department.
6.3.4 Functional subgroup code (2 alphabets) shall be assigned as per functional area where the sop is applicable.
6.3.5 The following functional subgroup codes that shall be used in SOP:
GP: General Procedures
EO: Equipment Operating Procedure
IO: Instrument Operating Procedure
EC: Equipment Cleaning Procedure
CL: Calibrating Procedure
6.3.6 The department code along with functional subgroup code shall be the first part, which will then be followed by a colon further followed by serial number.
E.g. PREO:001, where PR- Department Code ( i.e. Production Department)
EO- Functional Subgroup Code (Equipment Operation)
001-Arabic numeral serial number (Specifies a particular SOP)
6.3.7 Design and Numbering of formats:
18.104.22.168 The format shall have header with company logo, name of the organization, title of the format, page number and effective date. The format number along with the revision number shall be mentioned in the bottom right corner of each page (Refer Format No. QAGP:001:F02:00)
22.214.171.124 Format shall have identification SOP number based on the procedures under which they are prepared. Format prepared under a procedure shall be serially numbered. Final copy of the format shall bear the signature of the authorized person along with date, specifying the copy as Master Copy.
126.96.36.199 Formats shall be issued as electronic copies with the QA issued, sign and date stamping on the formats. QA personnel shall sign and date during issue.
188.8.131.52 The photocopy of the master format shall be taken and stamped as ‘CONTROLLED COPY’ in Green ink along with sign and date.
184.108.40.206 The photocopies of the controlled copy format shall be stamped with QA issued with sign and date and distributed to the departments.
220.127.116.11 The department code along with functional subgroup code which is 4
alphabets shall be the first part, which will then be followed by colon further
followed by a serial number and a colon, and then format number in alpha numeric followed by a colon, and the revision number. E.g. the first format of an SOP designed shall have the format number as, QAGP:001:F01:00.
18.104.22.168 The labeling formats shall be same as the order of the format.
22.214.171.124 If the format undergoes a change, the revision number shall be changed to the next number.
6.4 Preparation and Distribution of Standard Operating Procedure:
6.4.1 The person responsible for the preparation of SOP shall prepare a Draft Copy and stamp it as DRAFT COPY in Red ink, in the left column provided in the footer of each page and circulate for suggestions or corrections if any.
6.4.2 Necessary corrections shall be made based on the feedback and a final print out to be taken and the Draft Copy to be destroyed.
6.4.3 The final copy of the SOP shall be signed in original shall be termed as master copy. This shall be indicated by stamping ‘MASTER COPY’.
6.4.4 Once the SOP is authorized and stamped as ‘MASTER COPY’, no manual corrections shall be allowed in the SOP.
6.4.5. Master list of SOPs shall be prepared as an index as per the format QAGP:001:F03:00. The master list shall be prepared for each department and functional subgroups and shall be coded as first three letters MLS indicating Master List of SOP followed by a colon and the department and functional subgroup and a colon followed by three digit numerical revision number starting from 001. If the Master List undergoes revision the serial it shall be changed into the next revision number. E.g. The Master List of SOPs for the Quality Assurance General Procedure Department shall be written as MLS:QAGP:001.
6.4.6 The required number of copies required to be distributed to be made by photocopying the Master Copy and enter the details in the ‘SOP Issue and Withdrawal Control Sheet’(refer Format QAGP:001:F04:00) and attached with each Master copy of the SOP.
6.4.7. If a copy of a particular SOP is required by outside agency then the copy shall be stamped as ‘UNCONTROLLED COPY’ with the consent and in consultation with QA Manager.
6.4.8 No SOP shall be copied by anyone other than the concerned person for any purpose. If such copies are made they will be treated as unauthorized / unofficial.
6.4.9 All the previous versions ‘CONTROLLED Copies’ and ‘Display Copies’ shall be retrieved and destroyed while issuing the new amended versions. The old version Master copies shall be stamped as ‘OBSOLETE COPY’ and retained with the department for future reference only.
6.5 Review of Standard Operating Procedure:
6.5.1 SOP shall be periodically reviewed before 15 days of completion of two years or as and when there is any relevant intermittent change in the SOP required.
6.5.2 The concerned head of the department shall review the ‘SOP Review Sheet’ Refer format QAGP:001:F05:00.
6.5.3 If any change is required it shall be noted in the change control form as per the change control procedure. Any change in the SOP/format, the SOP shall be revised to the next revision number.
6.5.4 If the SOP undergoes review, the revision shall be mentioned in the revision number column as 01 for first version, 02 for second version and so on for new SOP revision number will be 00. if any SOP number is required to specify in some other document for reference, only the SOP number shall be specified without the revision number.
6.6 Changes to the SOP:
6.6.1 Any change to the SOP shall be made as per instructions given in Change Control SOP
6.6.2 Whenever any SOP/format undergoes a change the revision number shall change to the next number. A brief description of the change recorded in the SOP Review Sheet.
6.6.3 The amended documents shall be distributed as per the instruction in section 6.4 onwards.
6.6.4 All the controlled copies and Display copies of the superceded SOP shall be withdrawn and destroyed before issuing the amended SOP.
6.6.5 The Master Copy of the superceded SOP shall be stamped as Obsolete Copy and shall be held in the department for future reference. A record of destruction shall be made in column provided in the SOP Control Sheet and attached to the obsolete copy.
6.6.6 Master List of SOP shall be revised and maintained separately.
6.7 Retrieval of Standard Operating Procedure:
6.7.1 All the previous versions Controlled Copies and Display copies shall be retrieved and destroyed before issuing the new amended versions. The Master Copies shall be stamped as ‘OBSOLETE COPY’ and retained in the department for future reference.
6.8 Storage of Standard Operating Procedures:
6.8.1 All master copies of the SOP to be stored under lock and key. It shall be easily retrievable but access to be limited only to the authorized persons.
6.8.2 Obsolete copies shall be filed and stored separately from that of the current versions of the master copies.
6.9 Control of data in computer:
6.9.1 Any instruction/information/data stored in computer hard disc/electronic copies shall not be considered as official for regulatory purposes. The approved copies that are signed shall be considered as official documents.
6.10 Archival of Standard Operating Procedures:
6.10.1 Obsolete SOP shall be stored for 5 years from the superceded date.
6.10.2 After the storage period the obsolete SOP shall be torn into pieces and put to fire for