SOP on SOP

1.0 OBJECTIVE

To lay down a procedure for the preparation, approval, control and revision of Standard Operating Procedures.

2.0 SCOPE

This procedure is applicable to all the standard operating Procedures used at <COMPANY NAME> and address.

3.0 RESPONSIBILITY

3.1 Preparation & Execution: Executive-Quality Assurance

3.2 Review: Executive-Quality Assurance

3.3 Approval: Head-Quality Assurance

4.0 PROCEDURE

4.1 Prepare the SOP on the approved format on A-4 size paper.

4.2 Prepare the SOPs to describe the operating procedures and steps.

4.3 Write all the SOPs in clear, unambiguous language and easy to understand.

4.4 Write the SOPs under the following sub-headings:

1.0 OBJECTIVE

2.0 SCOPE

3.0 RESPONSIBILITY

4.0 PROCEDURE

5.0 ABBREVIATIONS

6.0 ANNEXURE

7.0 CHANGE HISTORY

4.4.1CHANGE HISTORY

4.4.1.1 The Change history consists of Superseded Number, Change control Number and Reasons for revision in a table format.

1.0 OBJECTIVE

To lay down a procedure for the preparation, approval, control and revision of Standard Operating Procedures.

2.0 SCOPE

This procedure is applicable to all the standard operating Procedures used at <COMPANY NAME> and address.

3.0 RESPONSIBILITY

3.1 Preparation & Execution: Executive-Quality Assurance

3.2 Review: Executive-Quality Assurance

3.3 Approval: Head-Quality Assurance

4.0 PROCEDURE

4.1 Prepare the SOP on the approved format on A-4 size paper.

4.2 Prepare the SOPs to describe the operating procedures and steps.

4.3 Write all the SOPs in clear, unambiguous language and easy to understand.

4.4 Write the SOPs under the following sub-headings:

1.0 OBJECTIVE

2.0 SCOPE

3.0 RESPONSIBILITY

4.0 PROCEDURE

5.0 ABBREVIATIONS

6.0 ANNEXURE

7.0 CHANGE HISTORY

4.4.1CHANGE HISTORY

4.4.1.1 The Change history consists of Superseded Number, Change control Number and Reasons for revision in a table format.

4.4.2 OBJECTIVE

Write here the reason for preparing the SOP in one sentence or maximum two sentences starting with a letter ‘To’.

4.4.3 SCOPE

This Section defines the applicability of the SOP and also specifies department, areas or sections to which this SOP shall be applicable.

4.4.4 RESPONSIBILITY

Write here the designation of the person / persons who are directly responsible for the operations mentioned in the ‘Objective’ of the SOP.

4.4.5 PROCEDURE

4.4.5.1 Write the procedure/method in short sentences. Do not write the instructions in long paragraphs.

4.4.5.2 Mention all the checks to be carried out, records to be maintained, frequency of various operations, checks and special precautions, if any.

4.4.5.3 Enclose all the Annexure with SOP, if applicable.

4.4.6 ABBREVIATIONS

4.4.6.1 Mention a list of all abbreviations & their full forms/descriptions used in the SOP. If there is no Abbreviation in the SOP, mention ‘Not Applicable’ under this subheading.

4.4.7 ANNEXURE

4.4.7.1 Mention a list of all Annexure enclosed in the SOP. If there is no Annexure in the SOP, mention ‘Not Applicable’ under this subheading.

4.5 Format Requirements

4.5.1 Prepare all the SOPs as per specimen format given as Annexure-1. The type of font for the contents in SOPs shall be ‘Times New Roman’ .The font size to be used for contents of SOPs shall be as follows:

4.5.2 Fonts

Write here the reason for preparing the SOP in one sentence or maximum two sentences starting with a letter ‘To’.

4.4.3 SCOPE

This Section defines the applicability of the SOP and also specifies department, areas or sections to which this SOP shall be applicable.

4.4.4 RESPONSIBILITY

Write here the designation of the person / persons who are directly responsible for the operations mentioned in the ‘Objective’ of the SOP.

4.4.5 PROCEDURE

4.4.5.1 Write the procedure/method in short sentences. Do not write the instructions in long paragraphs.

4.4.5.2 Mention all the checks to be carried out, records to be maintained, frequency of various operations, checks and special precautions, if any.

4.4.5.3 Enclose all the Annexure with SOP, if applicable.

4.4.6 ABBREVIATIONS

4.4.6.1 Mention a list of all abbreviations & their full forms/descriptions used in the SOP. If there is no Abbreviation in the SOP, mention ‘Not Applicable’ under this subheading.

4.4.7 ANNEXURE

4.4.7.1 Mention a list of all Annexure enclosed in the SOP. If there is no Annexure in the SOP, mention ‘Not Applicable’ under this subheading.

1.0 OBJECTIVE

To lay down a procedure for the preparation, approval, control and revision of Standard Operating Procedures.

2.0 SCOPE

This procedure is applicable to all the standard operating Procedures used at <COMPANY NAME> and address.

3.0 RESPONSIBILITY

3.1 Preparation & Execution: Executive-Quality Assurance

3.2 Review: Executive-Quality Assurance

3.3 Approval: Head-Quality Assurance

4.0 PROCEDURE

4.1 Prepare the SOP on the approved format on A-4 size paper.

4.2 Prepare the SOPs to describe the operating procedures and steps.

4.3 Write all the SOPs in clear, unambiguous language and easy to understand.

4.4 Write the SOPs under the following sub-headings:

1.0 OBJECTIVE

2.0 SCOPE

3.0 RESPONSIBILITY

4.0 PROCEDURE

5.0 ABBREVIATIONS

6.0 ANNEXURE

7.0 CHANGE HISTORY

4.4.1CHANGE HISTORY

4.4.1.1 The Change history consists of Superseded Number, Change control Number and Reasons for revision in a table format.

4.4.2 OBJECTIVE

Write here the reason for preparing the SOP in one sentence or maximum two sentences starting with a letter ‘To’.

4.4.3 SCOPE

This Section defines the applicability of the SOP and also specifies department, areas or sections to which this SOP shall be applicable.

4.4.4 RESPONSIBILITY

Write here the designation of the person / persons who are directly responsible for the operations mentioned in the ‘Objective’ of the SOP.

4.4.5 PROCEDURE

4.4.5.1 Write the procedure/method in short sentences. Do not write the instructions in long paragraphs.

4.4.5.2 Mention all the checks to be carried out, records to be maintained, frequency of various operations, checks and special precautions, if any.

4.4.5.3 Enclose all the Annexure with SOP, if applicable.

4.4.6 ABBREVIATIONS

4.4.6.1 Mention a list of all abbreviations & their full forms/descriptions used in the SOP. If there is no Abbreviation in the SOP, mention ‘Not Applicable’ under this subheading.

4.4.7 ANNEXURE

4.4.7.1 Mention a list of all Annexure enclosed in the SOP. If there is no Annexure in the SOP, mention ‘Not Applicable’ under this subheading.

4.5 Format Requirements

4.5.2 Fonts

4.8 Contents of Header

4.8.1 Logo: Logo of COMPANY

4.8.2 Address: The name of address of the plant for which SOP is applicable.

4.8.3 Procedure Name: Standard Operating Procedure

4.8.4 SOP No: A unique Number as per procedure

4.8.5 Dept: The name of the Department for which SOP is applicable.

4.8.6 Supersede No: Consists of two numerical characters which start from ‘00’ with increment in one digit after each revision. ‘00’ indicates the first issuance of that particular SOP.

4.8.7 Area: The area / sub-section of the Department shall be mentioned wherever applicable.

4.8.8 Subject: Detailed heading of the SOP.

4.8.9 Effective Date: The effective date shall be hand written by QA. after final approval before circulating the SOPs.

4.8.10 Review Date: The review date shall be hand written by QA. after final approval before circulating the SOPs. The normal review period shall be 2 years from the effective date of the SOP. For example if any SOP is having effective date “17/04/2013”, its review date will be “16/04/2015”.

4.8.11 Page No: The page number shall be mentioned in ‘xx’ of yy’ format.

4.8.12 Make: Manufactured by is present in only Quality Control Instrumentation Standard operating procedure.

4.9 Contents of Footer

4.9.1 Prepared by: Designated person, who has initiated the SOP shall sign with date in blue ink in the column “Prepared By”.

4.9.2 Checked by: Designated person, who has reviewed the SOP, shall sign with date in blue ink in the column “Checked By”. For all the Departments it is Head of the respective Department and for QA it shall be Executive or above of the department.

4.9.3 Approved by: The person finally approving the SOP, shall sign with date in blue ink. Approval shall be done by Head Quality Assurance for all SOPs.

4.9.4 Format No.: This is a unique number assigned to the format used for preparation of all SOPs. The details of Format numbering system given in SOP.

4.10 Generation of New SOPs

4.10.1 User dept. shall prepare the draft SOP as per the procedure described above. Draft copy shall be identified by stamping “DRAFT COPY” in Black colour ink.

4.10.2 Draft copy shall be circulated to the responsible persons for its review. The responsible persons may recommend for any changes in the text.

4.10.3 Draft copy shall be prepared as per SOP format in Annexure-1 and attach Annexure-4 to capture review comments.

4.10.4 Based on the recommendation, user dept. shall correct the draft SOP and take final print out for Checking and Approval by the respective departments.

4.10.5 After Checking and Approval, user dept. shall submit the Original Copy(Master Copy) of SOP to QA for control and issuance and shall destroy the draft SOP.

4.11 Training to New SOP

4.11.1 Once the SOP is approved by Quality Assurance department, the training for new SOP shall be given. The Respective department Head shall schedule for training.

4.11.2 The photocopy of the training records of the new SOPs or Revised SOPs shall be attached to the Master SOP.

4.11.3 The effective date for implementation of new SOP or revised SOP shall be decided based on the training schedule.

4.12 Stamping the SOP

4.12.1 After approval of the standard operating procedure by Head, Quality Assurance, stamp it with “MASTER COPY” in red colour ink, “CONTROLLED COPY” in green colour ink, “DISPLAY COPY” in “blue colour”, “OBSOLETE COPY” in black colour ink, “DRAFT COPY” in Black colour and “UNCONTROLLED COPY” in blue colour ink.

4.12.2 Put the “MASTER COPY” stamp on top left hand side of the SOP, “CONTROLLED COPY” on bottom left side of the SOP, “DISPLAY COPY” on bottom right side of the SOP and “OBSOLETE COPY” on centre of the standard operating procedure.

4.12.3 Put the “UNCONTROLLED COPY” on Top Right hand side of the SOP and “DRAFT COPY” on Back side of the SOP.

4.12.4 Specimen seals of MASTER COPY, CONTROLLED COPY, DISPLAY COPY, OBSOLETE COPY, UNCONTROLLED COPY and DRAFT COPY are given in Annexure -2.

4.13 Distribution of Standard Operating Procedures

4.13.1 After the approval of the standard operating procedure Head- Quality Assurance shall identify the departments for distribution of SOPs

4.13.2 Photocopy the “MASTER COPY” and stamp “CONTROLLED COPY” as mention above.

4.13.3 Issue the “CONTROLLED COPY” of standard operating procedure for author department and other related departments.

4.13.4 Issue the required “DISPLAY COPY “of standard operating procedure for author department only. (for instruments, equipment and systems)

4.13.5 Issue the “UNCONTROLLED COPY” where there no control is required.

4.13.6 Record the distribution particulars in standard operating procedure distribution format in Annexure-3

4.14 Retrieval of Standard Operating Procedures

4.14.1 Request concerned department for retrieval of standard operating procedure during the standard operating procedure review date and ask them to submit the “CONTROLLED COPY” and “DISPLAY COPY” [if any] to Quality assurance department.

4.14.2 Enter the particulars of retrieval in the standard operating procedure distribution format in Annexure-3.

4.14.3 Retrieval section of the standard operating procedure include date of return, returned by [concerned department] and received by [quality assurance] with signatures.

4.15 Review and Revision of Standard Operating Procedures

4.15.1 Review the standard operating procedures whenever necessary or during the standard operating procedure review.

4.15.2 Follow the change control procedure to review and revise the standard operating procedure.

4.15.3 Use SOP review form to review the SOP as Annexure-4.

4.15.4 Change the superseded number from old to new [Eg: ‘00’ to ‘01’]

4.16 Storage of Standard Operating Procedures

4.16.1 Put the “OBSOLETE COPY” stamp on “MASTER COPY” of standard operating procedure and store the standard operating procedures in the designated area.

4.16.2 Store all “MASTER COPY” SOPs at QA Department.

4.17 Destruction of Standard Operating Procedures

4.17.1 Destroy the standard operating procedure copies retrieved from the respective departments [Display and controlled copies] by quality assurance personnel as per SOP. Record the destruction in Annexure-3.

5.0 ABBREVIATIONS

5.1 SOP :Standard operating procedure

5.2 QA- Quality Assurance

6.0 ANNEXURE

6.1 Annexure -1: SOP Format

6.2 Annexure-2: Specimen Seals

6.3 Annexure -3: SOP Issuance, Retrieval and Destruction Record

6.4 Annexure-4: SOP Review Form

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Quality Assurance SOP's

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Change Control