sop on sop
1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for preparation, approval, issuance, retrieval and destruction of standard operating procedure.
2.0 SCOPE
2.1 This SOP is applicable for preparation of standard operating procedure
3.0 RESPONSIBILITY
3.1 It is the responsibility of QA department to lay down the procedure for this SOP and other SOPs that are dependent on this SOP. Concerning Department Personnel as well as Head of each area are responsible for complying with the principles established in this SOP.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance
5.0 PROCEDURE
5.1 Preparation and Approval of SOP
5.2 SOP shall be prepared by experienced personnel of concerned department in approved format as given in Annexure – IV with below mentioned points.
5.3 The SOP’s are prepared in Microsoft word and is printed on specified A4 size white paper with logo and company name & address printed at top left corner.
5.3.1 The Left margin is about 1”.
5.3.2 The Right margin is about 1”.
5.3.3 The Top margin is about 1”.
5.3.4 The Bottom margin is about 1”.
5.4 The SOP must have following fonts:
5.4.1 All characters are in “Times New Roman” font with font size of 10.
5.5 The header consists of following:
5.5.1 Header shall be divided in four columns. First and second column divided in three rows and third and fourth column divided in five rows respectively.
5.5.2 The header consists of all the characters in capitals and made bold in all the four columns.
5.5.3 The first row of first column is “SUBJECT”.
5.5.4 The second row of first column is “DEPARTMENT”.
5.5.5 The third row of first column is “TITLE”.
5.5.6 The first row of second column is “STANDARD OPERATING PROCEDURE”.
5.5.7 The second row of second column is name of the concerned department.
5.5.8 The third row of second column is the title of SOP.
5.5.9 The first row of the third column is “SOP NUMBER”.
5.5.10 The second row of third column has two rows, first row is “EFFECTIVE DATE” (effective date is the implementation date of SOP and it will be written by hand of SOP after training) and the second row is “REVISION NUMBER” (revision number will be 00 for new SOP and then after it will be in series as 01, 02, 03…etc. as per revision of SOP).
5.5.11 Any changes in the format or SOP shall be handled through Change Control Procedure as per current version of SOP No During the implementation of changes in format, if there is no impact on the text of the SOP to which the format pertains, only format shall be revised without revision of the SOP. Otherwise the SOP shall be revised along with the format.
5.5.12 The third row of the third column has two rows first row is “REVIEW DATE” (review date for all SOPs will be 2 years from the effective date, if any SOP is having effective date “15/05/19”, its review date will be “14/05/20”.) and second row is “PAGE NUMBER” (page number shall be in x of y format).
5.5.13 All the values of third column shall be filled in fourth column.
5.6 The footer of first page consists of the following:
5.6.1 Footer consists of all characters in capitals & made bold in the table.
5.6.2 The footer has two rows and each row has four columns.
5.6.3 The width of first row is 6mm and second row is about 10mm.
5.6.4 The first row and first column is “ISSUED BY”.
5.6.5 The first row and second column is “SIGNATURE”.
5.6.6 The first row and third column is “ISSUE DATE”.
5.6.7 The first row and fourth column is “COPY NUMBER”.
5.6.8 The second row of the first column is “QUALITY ASSURANCE
5.6.9 The after footer has CONFIDENTIAL.
Note: QA personnel shall fill the format with sign, date and copy number in front page at the time of issuance of SOP.
5.7 The footer of second page onwards consists of the following.
5.7.1 Footer consists of two rows, all characters of first row & first column of second row are capitals & bold in the table.
5.7.2 The footer has two rows and each row has four columns.
5.7.3 The first row and first column is “Blank”.
5.7.4 The first row and second column is “Prepared By”.
5.7.5 The first row and third column is “Reviewed By”.
5.7.6 The first row and fourth column is “Approved By”.
5.7.7 The second row of the first column is “Sign/Date”.
5.8 The first page of each SOP must have a table of below the header. Table consists of following”.
5.8.1 A table of five columns and five rows.
5.8.2 The width of each row is “15.5cm”.
5.8.3 The first row has no column.
5.8.4 The width of second, third , forth and fifth column is about 31.0 mm
5.8.5 The first row is “APPROVAL LIST”
5.8.6 The second row of the first column is blank.
5.8.7 The second row of the second column is “DESIGNATION”.
5.8.8 The second row of the third column is “NAME”.
5.8.9 The second row of the forth column is “SIGNATURE”.
5.8.10 The second row of the fifth column is “DATE”.
5.8.11 The third row of the first column is “PREPARED BY”.
5.8.12 The forth row of the first column is “REVIEWED BY”.
5.8.13 The fifth row of the first column is “APPROVED BY”.
5.9 On the first page of each SOP have the table “CIRCULATION LIST” which consists of:
5.9.1 A table with rows and four columns.
5.9.2 The first row is “CIRCULATION LIST”.
5.9.3 The width of first and forth column is about 55 mm.
5.9.4 The width of second and third column is about 25 mm.
5.9.5 The second row of the first column is “Department”.
5.9.6 The second row of the second column is “Copy No.”.
5.9.7 The second row of the third column is “No. of Copies Issued”.
5.9.8 The second row of the fourth column is “Details of copies”
5.9.9 The remaining rows of the table are used for filling the data.
5.10 All SOP’s have a unique numbers as described below.
5.10.1 The SOP number contains nine characters, first three characters represents the company name, next three characters represents department code and last three numeral characters indicates the serial number of SOP.
5.10.2 All groups of characters shall be separated by /.
5.10.3 The number of SOP is COM/XXX/NNN
Where
COM : Company name
XXX : Department Code
NNN : Serial number shall be in three digits (e.g. 001, 002….003 etc).
5.10.4 The department code shall be given as per following table:
| Department | Department Code |
| Quality Assurance | QAD |
| Production Department | PRD |
| Engineering | ENG |
| Quality Control | QCD |
| Ware House | WHD |
| Finish Goods Store | FGS |
| Human Resource & Administration Department | HRA |
| Information Technology Department | ITD |
| Purchase Department | PUR |
5.11 The contents of the second page onwards of the SOP must include the following:
5.11.1 OBJECTIVE – To define the purpose of procedure.
5.11.2 SCOPE – To define the area of application of procedure.
5.11.3 RESPONSIBILITY – To define the responsibilities of person directly associated with implementation of the SOP.
5.11.4 ACCONTABILITY – To define the accountability of persons directly associated with the output.
5.11.5 REFERENCE(S) –To define the reference.
5.11.6 ENVIRONMENT, HEALTH & SAFETY – To describe briefly and clearly Environmental, Health and Safety if required
5.11.7 PROCEDURE – To describe briefly and clearly the actual way of carrying out operations.
5.11.8 HISTORY – To describe briefly and clearly the history of the document, in a tabular format consisting of:
5.11.8.1 A table of three columns and two rows
5.11.8.2 The width of each row is at least “140mm”.
5.11.8.3 The width of first column is about 40 mm.
5.11.8.4 The width of second column is about 60 mm.
5.11.8.5 The width of third column is about 40 mm.
5.11.8.6 The first row of the first column is “SOP NUMBER”.
5.11.8.7 The first row of the second column is “REASON FOR CHANGE”.
5.11.8.8 The first row of the third column is “REVISION NUMBER”.
5.11.8.9 The first row of the fourth column is “CHANGE CONTROL NUMBER”
5.11.8.10 The first row of the third column is “EFFECTIVE DATE”.
5.11.8.11 If required, further rows can be added.
Note: SOP no. and reason for change shall be given in the history with current version details of SOP (New SOP shall be written in the reason for change for new SOP in the history).
5.11.9 ABBREVIATIONS: To describe all the abbreviations used in the SOP.
5.11.10 ANNEXURE: Annexure shall be the format of records/logbooks/registers.
5.11.10.1 Annexure details with Annexure No., Title of Annexure and Format No. of annexure shall be written in the table as shown in SOP template as per Annexure .
5.11.10.2 All master annexure shall be attached with the master SOP as Annexure-I, Annexure-II, Annexure-III etc as per the requirement.
5.11.10.3 The header shall be as follows with the Annexure no., company name, work address, department name and title of the format at the page’s top.
5.11.10.4 The footer of the annexure shall contain the following information
• Format No. left side on bottom of page.
• Page no. of the annexure shall be mention in right side on bottom (Page numbering system: Page No. X of Y).
5.11.10.5 Numbering System for Annexure / Format
Format No. : COM/XXX/NNN/FNN-ZZ
COM/XXX/NNN = SOP No.
/ = For Separation
(Between SOP No. and Format No.)
FNN = Format No. (e.g. F01, F02 etc.)
– = For Separation
(Between Format No. and Revision No.
ZZ = Revision No. of Format (e.g. 00, 01, 02 etc.)
5.11.10.6 After approval QA person affix red coloured “MASTER COPY” stamp with sign & date and issue the photocopies of master formats by affixing of green coloured “CONTROLLED COPY” stamp to concerned department with sign & date.
5.11.10.7 When any changes made in the format revision no. shall be changed and revision history shall be given in the “FORMAT REVISION HISTORY” of the format on the back side of last page of format.
5.11.10.8 Old Master format shall be obsolete and controlled copy shall be submitted to QA department.
5.12 Spacing between lines of the text 1.5.
5.13 The main subject point is typed in capital, bold face while rest of the text is typed in regular font.
5.14 Type references to any point or subject in the text of the SOP in capital letters are enclosed within inverted commas.
5.15 All points shall be with serial number.
5.16 The main point must be numbered sequentially in bold font. The sub points must be numbered by giving the main point number and the sub point number sequentially, separated by a period, in regular font. Sub points of the sub point follow a similar pattern e.g. the number of this very point is the 16th sub point of the main point 6. Hence it is numbered ‘6.16’. .
5.17 In the ending of the SOP “END OF SOP” shall be written on the last page.
5.18 All master annexure shall be attached with master SOP.
5.19 After preparation of SOP concerned departmental person shall take the printout and signature in specified location (In Prepared By) and forward it to Head of concerned department for reviewing.
5.20 After complete reviewing, the concerned department head sign in specified location (In Reviewed By) and send to QA department for approval.
Note: Executive QA or his/her designee shall review the QA SOPs.
5.21 Head-QA shall check the procedure and give the approval for this SOP.
5.22 All the QA and other dept. SOP shall be approved by Head-QA.
5.23 SOP’S DISTRIBUTION, RETRIEVAL AND DESTRUCTION
All the SOP’s shall be distributed & controlled by QA department for its safe, easy circulation, traceability & control. SOP’s will be prepared, distributed and controlled as per below mentioned instructions.
5.23.1 After approval of SOP concern department shall be submitted the signed hard copy of SOP along with the soft copy to QA department.
5.23.2 The duplicate soft copy of SOP will be deleted from concerned department computer.
5.23.3 All the soft copy of each department shall be remain in QA department for safety control.
5.23.4 The original copy with signatures will remain with the QA department in the master file of the same with red colour “MASTER COPY” seal at the right side top corner at front of each page of the document.
5.23.5 QA personnel put his signature and date on specified place.
5.23.6 Impression of “MASTER COPY” as specified given below:
5.23.7 Xerox copy of “MASTER COPY” will be distributed to the concerned departments with green colour “CONTROLLED COPY” seal at right side top corner near the master copy stamp at front of each page of the document to indicate authenticity of the same. QA authorized personnel put signature and date on specified place.
5.23.8 Impression of “CONTROLLED COPY” as specified given below:
5.23.9 For each department two numbers of SOP should be distributed, one copy for the file and another one for display as per requirement.
5.23.10 Xerox copy of “MASTER COPY” will be distributed to the concerned departments with blue colour “DISPLAY COPY” seal at right side top corner at front of each page of to indicate authenticity of the same. QA authorized personnel put signature and date on specified place Impression of “DISPLAY COPY” as specified given below:
5.23.11 QA personnel shall record the name of all document’s recipient with all information as required in register of “SOP Issuance, Retrieval and Destruction Register” as per Annexure-I.
5.23.12 For issuance of additional copies of SOP concerned department personnel fill the form “Additional SOP Requisition Form” as per Annexure-II.
5.23.13 The recipient of controlled SOP will put his signature in the specified column of issuance register of SOP; the recipient may be either a person or a department.
5.23.14 In case of revision due to any reason in SOP, procedure shall be followed as per point no. 7.1 to 7.23.
5.23.15 QA person shall affix the red coloured “OBSOLETE” stamp with sign and date in the centre of each page of the “MASTER COPY” of the previous version of SOP and enter the details in obsolete document register.
5.23.16 Impression of “OBSOLETE COPY” as specified given below:
5.23.17 QA person shall issue the photocopy of revised SOP to all concerned department as per above issuance procedure.
5.23.18 At the time of issuance all previously issued controlled copies and display copies of revised SOP shall be retrieved by QA department.
5.23.19 “OBSOLETE” stamped copy of SOP will be retained in QA up to 5 years from the review date.
5.23.20 All the retrieved controlled and display copies of previous SOP will be destroyed to avoid it’s accidental circulation and destruction details will be recorded in “SOP Issuance, Retrieval and Destruction Register” at specified column as per Annexure-I.
5.23.21 If no change required in existing SOP’s till then validity period (2 years) put the “REVIEWED” stamp with Blue Colour ink in center bottom at front of each page of controlled copy as well as Master copy. These SOP’s will be valid for next 2 years. After 2 years SOP’s should be re-print and follow the above mention procedure. Impression of “REVIEWED” stamp as specified given below:
5.23.22 In case of any controlled Document’s requested to be sent outside for reference purpose, QA department will take photocopy of respective controlled document’s “CONTROLLED COPY”.
5.23.23 QA person shall affix black coloured “UNCONTROLLED COPY” seal at the right side on bottom of each page of the said document with sign and date & distributed to the requester. Impression of “UNCONTROLLED COPY” as specified given below:
5.23.24 In case of any Master Document’s requested to be sent outside for reference purpose, QA department will take photocopy of respective document’s “MASTER COPY”.
5.23.25 QA person shall affix black coloured “REFERENCE COPY” seal at the right side on bottom of each page of the said document & distributed to the requester. Impression of “REFERENCE COPY” as specified given below:
5.23.26 QA personnel shall prepare the computerized Master Index of Standard Operating Procedure of Master SOP’s.
5.23.27 Format of the master index of SOP given as per Annexure-
5.23.28 After preparation of SOP Index Executive QA shall review and sign with date and send to Head QA for approval.
5.23.29 Master copy of SOP index shall be kept in QA department.
5.23.30 QA shall be issued controlled copy of master index to concerned department.
6.0 ABBREVIATIONS
SOP : Standard Operating Procedure
QA : Quality Assurance Department
EPA : Environmental Protection Agency
