SOP on SOP

Purpose

To define a procedure for preparation, review, approval, issuance & retrieval of Standard Operating Procedure.

Scope

This SOP applies to all the functions in order to prepare, review and approve all standard operating procedures (SOPs). This SOP applies to all the activities performed by any department at Shakambhari Ispat & Power Ltd.

Reference(S) & Attachments

References

Iso 15378:2017 & Iso 9001:2015, 5.7.3

Attachments Attachment–I: Format of SOP Attachment–II : Distribution and retrieval record. Attachment–III : Flow chart of new SOP preparation Attachment–IV : Flow chart of SOP revision Attachment–V : Format for SOP index Attachment–VI : Flow chart for discontinuation of SOP Attachment–VII: Logbook Issuance register RESPONSIBILITY:

• User Department Person: To initiate the preparation of SOP. To prepare the SOP. To prepare a list of the SOP. User Department Head: To confirm the content, correctness and detailing of SOP. To ensure the training of the SOP to all concerned department personnel involved in implementation of the SOP. To ensure user the implementation of the SOP after training.
• Quality Assurance Person: To check the SOP. To maintain the original copy of the SOP. To issue controlled copy of the SOP. To maintain issuance record of SOP.
  • To retrieve the controlled copy of the SOP when it is superseded/obsolete & maintain its record. QA Head/Plant Head - To approve new or revised SOP. To ensure the implementation of the defined system.

Distribution

I.Quality Assurance II. Quality Control III.Production IV. Ware house. V. Engineering VI. Human resource and Administration.

DEFINITION & ABBREVIATION(S)

• Definitions
  • Standard Operating Procedure (SOP) - A written authorized procedure, which gives instructions for performing operations/activities.
• Abbreviations
  • QA: Quality Assurance
  • QC: Quality Control
  • SOPs: Standard Operating Procedures

Procedure

Preparation of new SOP- The concern department person or head shall identify the need for creating of new SOP. Department person/user shall inform to the department head or his deputy for new SOP requirement. Department head shall evaluate the requirement of creating new SOP. If department head thinks that SOP need is justified to address the activity or perform the task, he will assign task of new SOP creation to the concern department person or expert. QA Head or designee shall verify the SOP requirement & evaluate the rationale/ justification for creation of new SOP. If it is justified the change control shall issue to the concern department. In case any SOP exists in the system to address the activity same shall be issued to the department & new SOP request shall be rejected. General Guidelines: Use positive sentences, simple & directive language in SOP writing. All the SOP’s shall be written in MS-Word and shall be printed on one side of the page. SOP shall be typewritten in single spacing using MS-Word or equivalent. A4 size (Width: 8.27” and Height: 11.69” approximately) white paper shall be used. However, the page size can be changed to accommodate attachments to SOP only Format of SOP shall be with the following page margins: Top: 1.0”, Bottom:0.5”, Left:1.0”, Right:0.7”, Header:0.7” and Footer:0.7”. The main SOP body text shall be in black color “Arial” type font in size “11”& “10” for address in footer. However, if required in special cases e.g. in formats, font size can be changed. The SOP shall be translated to local language as per requirement on respective format as per attachment-I, where necessary. The list of SOPs for local language if prepared shall also be prepared as per attachment -VI. If any English SOP changes, the same revision of local language SOP shall be changed simultaneously. In case of any confusion or clarity required the English revision shall be considered final. Format of SOP (as per attachment –I): Title: Mention title of the SOP, which is expressive of the subject of the SOP. It shall describe the aspects covered by the procedure exactly and include as many key words as possible for easy retrieval. SOP No. (SOP numbering system) The numbering system for allocation to any SOP shall be department/Section specific to the unit i.e. SIPL for SHAKAMBHARI ISPAT & POWER LTD. QA shall allocate the number of SOP. The numbering system has a sequential number in three digits with Prefix code prefixed as below in table-1: Table-1 Sr. No. Department Dept. Code Section/Category Prefix Code

Quality Assurance

Qad

System related

Qas

Equipment, Machine and instruments

Qai

Quality Control

Qcd

System related

Qcs

Equipment, Machine and instruments

Qci

Production

Prd

System related

Pds

Equipment, Machine and instruments

Pdi

Warehouse

Whd

System related

Whs

Equipment, Machine and instruments

Whi

Engineering

End

System related

Ens

Equipment, Machine and instruments

Eni

Human Resources

Hrd

--

Hrs

Sales

Sad

--

Sas

Purchase

Pud

--

Pus

Note: *Additional department codes in production can be created depends on the activity at plant locations this should be defined in SOP on SOP. - Mention SOP no. in the format LC/YYY/NNN & Version ZZ where: LC : for location code that is SIPL ‘/’ : Forward slash YYY:Section code of location as mentioned in above table. ‘/’ : Forward slash NNN: Serial no. of SOP in a department like 001, 002, etc. ZZ: Revision no. of SOP. The first Revision of SOP is 00. Subsequent revisions will be 01, 02 and so on for carrying any modification/change in documents/SOP/WI/Formats. For example, the first SOP written for warehouse equipment shall be numbered as SIPL/WHI/001 and Version as 00. Sequential number shall be assigned to the SOP. The sequential number after the last SOP number shall be assigned to the new SOP. This number shall not be re-assigned to any other SOP even after deletion of that documents/SOP/WI/Formats. Example: If the last SOP prepared in QA department is for system SIPL/QAS/020, Version 00, then newly inducted SOP shall be numbered as SIPL/QAS/021 and Version 00. Any revision to the existing SOP shall be numbered with the same SOP number suffixing the revision code viz. 00,01,02,03 etc. For example, the second revision of SOP No. SIPL/QAS/001 and Version as 01 shall be numbered as SOP No. SIPL/QAS/001 and Version shall be 02. User department shall prepare a list of all assigned numbers of the issued SOP for their departments as per Attachment- VI. Change Control Number (CC No.): In case of new SOP, mention CC no allocated by QA department. in this column mention the CC No. Means had any change in this SOP. Effective Date: Mention the effective date from which the SOP shall be implemented. It shall be mentioned in DD.MM.YYYY format with blue ink pen. While deciding effective date consider training time required to provide training to all concerned. Five days is recommended after the approval & before implementation of SOP. Next Review Date: Mention the next review date on which the SOP shall be reviewed. It shall be mentioned in DD.MM.YYYY format with blue ink pen. All the SOP’s shall be reviewed every two years. Example: If effective date is 01.07.2026 then next review date shall be mentioned as “30.06.2028”. Page No.: Mention page No. in this column. It shall be mentioned in “Page X of Y” format, X page no. of the page and Y stands for total no. of pages of that SOP. Example: Second page of SOP with total 10 pages shall be numbered as “Page No. 2 of 10”. Prepared By/Date: Signature of a person with blue ink pen, who has written the SOP and date, shall appear in this column. Written by signature and date shall appear on each page of the SOP. Checked By/Date: Signature of QA person and user department head or designee with blue ink pen, who has checked the SOP, and date shall appear in this column. QA person shall sign each page of the SOP. Approved By/Date: Signature & date of Plant Head and QA Head with blue ink pen, who has approved the SOP, and date shall appear in this column. Content of the SOP: Purpose: Mention the intended use of the SOP in this column. It is a statement, which justifies the need of the SOP. Scope: Mention the application of the SOP in this section. It shall describe the extent of are covered by the SOP. References and Attachments: References: Mention the details of any references used in order to design the SOP. The references can be an official publication, guidelines, instruction manuals, other SOP’s and in-house procedure /system to accomplish an activity. Attachments: Mention Attachment(s) used in SOP if any, otherwise type NA. Page numbering of each attachment shall be running format of SOP. Format Number shall be footer in left hand of each page. Format numbering shall be in the format LC/SOP No./FNN/XX, where LC : Location code that is SIPL / : This shall be forward slash SOP No.: This shall be the SOP no. of SOP in which the format has been initially explained in point number 7.2.2.2 / : This shall be forward dash F : This shall represent the format. NN : This stands for the format serial no. of that SOP and shall be 01,02,03…10,11 and so on. / :This shall be forward slash XX : revision no. of format. First revision of a format shall be“00” and subsequent revision shall be 01, 02, etc. e.g ; Thirteenth format of SOP No. SIPL/QAS/002 Revision no as 00 shall be SIPL/QAS/002/F13/00 for QA department. In case of revision of attachment (s) the SOP shall be revised & assigned next revision number to SOP as well as attachment. But in case of SOP revision & no change in attachment format, the attachment format remains unaffected (i.e. revision number shall remain same of attachment). In case revision of attachment format, the SOP is also revised to accommodate the change & assign next revision to SOP also along with format. Annexure shall be revised independently without impact the SOP & shall be attached separately from the SOP (Not a part of SOP text), other provision shall remain applicable as defined for attachment. But in case of revision of annexure format the same procedure applicable as for attachment. Responsibility: Mention the responsibilities of individuals/departments along with the clear ownership in this column. Distribution: This section provides a guideline for distribution of the controlled copy of the SOP to the concerned departments. Additional copies shall be issued for specific purpose & distribution record shall be maintained if it is controlled copy. In case of no change in SOP & further extension of validity the distribution record of initial & as well as after validity extension shall be maintained along with original SOP. Definitions of terms: Write down definitions of terms in this column where require. Procedure: This section shall start with new page. Outline of the logical steps to be carried out to complete the purpose of the SOP. When require, give example or attachment for more clarification. Each step of the activities / operations shall be explained. Frequency pertaining to monitoring, calibration, validation, checking, cleaning and sampling shall be mentioned, whenever it is applicable. The instructions for any in-process controls with their limits shall be mentioned in the SOP. Where necessary, the requirements for storage conditions of materials / products shall be mentioned in the SOP. Where require information about format, Label, Equipment, Instrument and Area identification shall be mentioned in the SOP. If require, specific work environment shall be mentioned in which the operation has to be performed. Any safety precaution required to be taken while performing activity shall be mentioned in the SOP. Flow chart shall be used for better explanation and clarity of the process where necessary. Abbreviation shall be mentioned in the SOP by giving full form of the abbreviation f first time. e.g. Standard Operation Procedure (SOP) History: A brief history of changes made in the SOP shall be written in this section. Checking and Approval procedure- A draft copy of the SOP shall be circulated for checking. All comments raised during the checking procedure shall be discussed among the users & evaluated by the originator. The approver shall approve the inclusions/exclusions in the final form of SOP. QA personnel and user Department Head or designee shall check the SOP for verification of its content and sign. The QA Head and Plant Head or their designee shall approve the SOP. After approval of SOP concern Department Head or designee shall ensure that all the concerned persons get training before implementation of the SOP. Issuance and Implementation of SOP: After approval of SOP concern Department Head or designee shall ensure that all the concerned persons get training before implementation of the SOP. The user Department Head or designee shall submit the final soft copy of the SOP after approval to QA department. QA Department Head must prepare a “MASTER COPY” of all SOPs’ and kept it with themselves. QA shall put the “MASTER COPY” stamp in green ink on the top of the left side of each page of the SOP.

Master Copy

QA shall take required number of photocopies of the SOP from original copy for distribution to various departments. QA shall put the “CONTROLLED” stamp in green ink on the top of the right side of each page of the SOP. The stamp shall indicate the date of issuance, issued by sign and copy number. Controlled stamp

Controlled Copy

Only, If Stamp Is Green

Date.............Sign………. Copy No……………….. QA person shall make necessary entries in the distribution and retrieval record (Attachment-II) at the time of issuing the controlled copy. QA person shall retrieve all the controlled copies of the superseded revision and destroy the same. The “CONTROLLED” copies of the superseded SOP shall be retrieved in exchange of issuing a “CONTROLLED” copy of the new SOP. This shall be done on the effective date of the new SOP. QA person shall put the “SUPERSEDED” stamp in red color on the original copy of the superseded SOP. SUPERSEDED Superseded stamp

Superseded

The user department after receiving “CONTROLLED” copy of the new SOP shall implement the SOP. Photocopy of the controlled copy is not permitted. Any photocopy that is not having green stamp of “CONTROLLED” shall not be considered valid for use. In case SOP, if asked by customer or any outside agency or others for reference, it shall be issued as “UNCONTROLLED” by putting “Blue color” stamp on each page of SOP. Uncontrolled stamp UNCONTROLLEDShall not be kept updated

Uncontrolled

Shall not be kept updated For any Uncontrolled copy QA shall not be responsible to update the changes to copy holder. Review Procedure: All SOP’s shall be reviewed after every 2 years 1 month & should be implemented within 45 days of review date. The implementation date may be increased after discussing with QA Head if there is genuine or appropriate reason. However, SOP’s can be revised before the next review date. In case, changes are identified by user or any other reason (suggested during any audit, regulatory change, impact on system etc.) before periodic review date. Send a filled request as per attachment-III (Request for document /SOP review or new document/SOP preparation). After that QA shall issue the soft copy of the SOP. Revision required after review: After review, need of change is identified the user department shall raise a request for change control describing existing system & proposed system along with rationale & justification as per attachment-III. After review the rationale & justification QA shall issue change control. The user department shall initiate the revision of SOP and circulate draft SOP for checking. After correction based on comments, user department finalize the SOP after approval by QA head and location head. The detailed procedure is defined under point 7.5.1 to 7.5.5 The user Department Head or designee shall submit the original copy of the SOP after approval to QA department. QA shall take required number of photocopies of the SOP from original copy. QA shall put the “CONTROLLED” stamp in green ink on the top of the right side of each page of the SOP & SOP issuance as defined under point 7.6.4 to 7.6.6. QA shall retrieve the controlled copies of the SOP and destroy. The issuance & retrieval should be such that no superseded copy shall remain with the department after issuance of new copy. Revision not required after review: If Revision is not required after review of the SOP, re-certify SOP's for the validity of continuing usage. The QA Department Head or designee shall sign at the "Next review date" space with date and puts next review date based on the date of current review date in original copy of the SOP. QA shall retrieve the controlled copies of the SOP and destroy. QA shall issue the new controlled copy as per issuance procedure. If no change is observed even after four years of preparation of SOP, The SOP shall be reprinted and approval shall be taken. In the case of re-printing of SOP, the revision number of the SOP shall remain same & in supersedes column same number shall be displayed which is indicative that the SOP is re-printed & No revision is made since last four years from the date of preparation. Keep the attachment –III along with the original SOP if no revision is required. Discontinuation of SOP: The existing SOP may be discontinued with proper justification and approval of QA Head and Location Head. QA person shall retrieve all the issued controlled copies and destroy the same and update the distribution and retrieval record (Attachment II) and stamp with “OBSOLETE” in red ink in the center of all pages of original copy and archived the obsolete copy in SOP file. The SOP master list shall be up dated accordingly. (Refer Attachment-VI) Note: The number of discontinued SOP shall not be allocated to any other SOP. OBSOLETEObsolete stamp

Obsolete

Retention of superseded & obsolete SOP The superseded & obsolete copy shall retain for minimum 5 years after supersede or discontinuation. The copy shall destroy after the expiry of the retention period by shredded beyond use or destroy by incinerating. Issuance of Logbook: Issue of logbook shall be record in specified format with issue no. having sign & date of issuing authorities. For new logbook request after retrieval of old logbook, department head shall request to QA head for new logbook issuance. Department head shall responsible to check & sign daily logbook filling.

REVISION HISTORY

Revision No.

Effective Date CC No. Details of revision: New SOP Attachment: I Header For Restricted Circulation only Logo Company Name

Standard Operating Procedure

Title: Page No. SOP No. Version No. Effective Date Next review date

PURPOSE

SCOPE

REFERENCE (S) & ATTACHMENT (S)

RESPONSIBILITY

DISTRIBUTION

DEFINITION (S) & ABBREVIATION (S)

PROCEDURE

REVISION HISTORY

Footer Prepared By: Checked By: Approved By: SIPL/QAS/001/F01/00 Vill. & P.O.-Hoera, P.S.-Mogra, Dist.- Hoogly, West Bengal – 712147, India. Attachment: II Distribution And Retrieval Record: SIPL/QAS/001/F02/00 Attachment: III Flow Chart For Preparation Of New SOP New Sop Need identified Request for new SOP Approval for initiate of new SOP Get issued change control Initiation of new sop preparation (from user dept) Preparation of draft SOP and circulate for Checking Correction of draft SOP based on comments & finalization of SOP QA Allocate the number of SOP SOP Approval by QA Head and Plant Head Training of the SOP to concerned person Submit the original SOP to QA dept. for issuance Required number of photocopy Put controlled Stamp Entry in issuance Log Issue to the concern department

Sipl/Qas/001/F03/00

Attachment: IV Flow Chart For Revision Of SOP User shall request for SOP review QA shall issue soft Copy Review of SOP (from user department) Change require Extend Validity for 2 years NoYes Get issued change control form Preparation of draft SOP and circulate for Checking Correction of SOP based on comments and finalization of SOP SOP Approval by QA Head and Plant Head Training of the SOP to concerned person Submit the original SOP to QA dept. for issuance Required number of photocopy Put controlled Stamp Entry in issuance Log register Issue to the concern department Retrieve supersedes copies and destroy Superseded stamp on original copy

Sipl/Qas/001/F04/00

Attachment: V Format for Index of SOPs: SIPL/QAS/001/F05/00 Attachment: VI Flow Chart for Discontinuation of SOP

Sipl/Qas/001/F06/00

Attachment: VII Logbook Issuance Record: SIPL/QAS/001/F07/00