Standard operating procedure shall be prepared as per following procedure.........
Note: Font size & pattern should be as per firm requirements.
1.0 OBJECTIVE
To lay down a procedure for preparation, approval, revision, distribution and control of Standard Operating Procedures (SOP’s)
2.0 SCOPEThis SOP shall be applicable to all Standard Operating Procedures of--------------------.
3.0 RESPONSIBILITY
Officer /Executive: Preparation of SOP.
Department Head: Review/check of SOP.
Head, Quality Assurance: Approval, compliance and accountable to procedure.
4.0 DEFINITION (S)
SOP is defined as an authorized written procedure giving instructions for performing operations.
5.0 PROCEDURE
5.1 Preparation, approval and revision procedure
5.1.2 All new SOP’s shall be prepared after initiation of change control, as per format in Annexure-1.
5.1.3 Use A4 size (Width: 8.64” and Height: 11.85” approximately) white paper. However, the page size may be changed to accommodate annexure and attachments to SOP’s. e.g. (Width: 11.85” and Height: 8.64” approximately).
5.1.4 Format SOP’s with the following page margins:
Top: 1.0”, Bottom: 1.0”, Left: 0.7”, Right: 0.7”, Header: 0.7” and Footer: 0.7” approximately.
5.1.5 The main SOP body text shall be in black color “Calibri” type font in size “12” and text matter shall be bordered i.e. 21/4pt. However, if required in special cases e.g. in formats, font size may be changed.
5.1.6 Prepare SOP’s in an unambiguous, easy to understand language. Prepare SOP in draft form as required & print with ‘’DRAFT’’ only .The draft copy shall be circulated for checking and shall be retained up to approval.
5.1.7 All SOP’s shall follow sub heading in the sequence described below. All sub-headings shall be Bold and CAPITAL letters.
1.0 OBJECTIVE
2.0 SCOPE
3.0 RESPONSIBILITY
4.0 DEFINITION (S)
5.0 PROCEDURE
6.0 ABBREVIATION (S)
7.0 REFERENCE (S)
8.0 FLOW CHART
9.0 ANNEXURE (S)
10.0 DISTRIBUTION
11.0 REVISION CARD (Separate annex)
5.1.8 All sub-headings and subsequent sub-headings shall be uniquely numbered e.g.
5.0 Main heading
5.1 Sub Heading of 5.0
5.1.1 Sub Heading of 5.1
5.1.9 The following details shall be given under each of the headings (Step No.: 5.1.7).
Sr. No.
Heading
Description
1.Objective
State the reason for writing the SOP. Objective should be concisely written in one or two statement, starting with the word “To”.
2.Scope
State the scope / applicability of the SOP e.g. processes / equipments / policies / particular section/site.
The scope should clearly define the applicability w.r.t. machine/ area/departments to the entire site .
3.Responsibility
State the designation of the persons responsible for performing the job as described in SOP. Care must be taken to ensure that preferably one to two persons are responsible for compliance of SOP.
4.Definition
State the definition of important terms incorporated in SOP. If there is no definition then type NA (i.e. Not Applicable).
5.Procedure
Give in short, unambiguous sentences : the operating procedure, all checks to be done, records to be maintained, frequency of various operations, special precautions, if any, etc. SOP must not have long paragraphs but preferably in paragraphs with few short sentences. Special instructions may be given as ‘Note’, etc.
6. Abbreviation(s)
State the abbreviation(s) used in SOP if any, otherwise type NA.
7.Reference(s)
State the reference(s) used in SOP if any, otherwise type NA.
8. Flowchart
A flow chart detailing the steps involved with the procedure shall be mentioned here if any, otherwise type NA.
9.Annexure(s)
Mention annexure(s) used in SOP if any, otherwise type NA. Page numbering of each annexure shall be running format and shall be independent of other annexure(s), if any; SOP and revision card.
10.Distribution
State the name of the departments to which controlled copies of the SOP’s are to be distributed.
11.Revision Card
The revision card (refer Annexure-II) shall contain history of revision of the SOP. It shall always be the last and separate page of the SOP and shall have the following information in the order
- Serial no.
- Version No. (Starting from 00, 01…) Under ‘Version No.’ current version number of the SOP shall be mentioned.
- Change Control No.: Mention the change control number based on which the revision/ initiation of the document has been approved
- Details of revision: mention in brief, points added or revised to a procedure or change / addition / deletion of annexure (in case of new SOP mention ‘new SOP’).
- Effective Date: Effective date of SOP shall be mentioned in DD/MM/YY format; for supercedes version effective date shall be typed and for current version effective date and review date shall be handwritten by QA person at the time of creation of copies for circulation.
5.1.10 SOP Header
5.1.10.1 Each SOP incorporates header as per Figure 1 with details as described in the table-1.
5.1.10.2 The header information shall be common for all pages of the SOP.
5.1.10.3 All text in the header shall be Calibri type font, size ’12’. All headings described under column ‘Description’ shall be in bold.
Figure 1: Contents of SOP Header
< Item 1> Restricted Circulation
Name of company <Item 2>
Address <Item 3>
<Item 4>
(Logo)
DOCUMENT TYPE <Item 5>
Title<Item 6>
Department<Item 7>
SOP No <Item 8>
Supersedes.<Item 9>
Page No. <Item 10>
Effective Date
<Item 11>
Review Date
<Item 12>
Table 1- Contents of Header
Item no.
Description
Explanation
1Restricted Circulation
Restricted Circulation printed on the top right hand of page
2 Company name
‘---------------’printed on top center of the page in capital case.
3 Address
at beneath of Company name.
4 Logo
Print on top (Logo) of age right hand corner.
5 Document name
Print ‘STANDARD OPERATING PROCEDURE’ in capital case in center of each page.
6 Title
Print title of SOP in bold, title case. In case the space is insufficient, the font size may be reduced. The title should be self-explanatory and short.
7 Department
Mention department name. (Refer to table-2.)
8 SOP No.
Mention SOP no. in the format XX/NNN-ZZ where :
XX : is two digit alphabetical department code (for department code, refer table 2)
‘/’ : Forward slash
NNN: Serial no. of SOP in a department like 001, 002, etc.
‘-’ : ‘dash’
ZZ: Version no. of SOP. The first version of SOP is 00. Subsequent revisions will be 01, 02…
e.g. The tenth SOP of Quality Assurance is QA/010-00
9 Supersedes.
Mention previous revision number. Write “Nil”, if the SOP is new.
10 Page No.
Mention the page number in running format (current page of total number of pages) in normal font size e.g. page no. 4 of 5, 5 of 5.
11Effective Date
Write date when the SOP is scheduled to be implemented with blue ink pen in DD (date)/MM (month)/YY (year). e.g. 15/04/17
12 Review Date
It shall normally be 2 years from the effective date. Review shall be completed ± 1 month from the effective date. However any change in SOP can be brought on need basis though Change Control Procedure, Mention review date in DD (date)/MM (month)/YY (year) e.g. if the effective date is 15/04/17, then the review date will be 14/04/19.
Table 2: Department Codes
Department Name
Code
Quality Assurance (QA)
Quality Control(QC)
Production(PR)
Warehouse(WH)
Engineering(EN)
Human resource(HR)
Information Technology(IT)
Accounts (AC)
5.1.11 SOP Footer
5.1.11.1 Each SOP incorporates footer as in Figure-2 with details as described in the table 3.
5.1.11.2 The header information will be common for all pages of the SOP.
5.1.11.3 All text in the footer shall be Calibri type font size 12. All heading described under column ‘Description’ shall be in bold.
Figure 2: SOP Footer format
Prepared By
<Item 1>
Checked By
<Item 2>
Approved By <Item 3>
Designation
<Item 4>
Head, QA
Sign and Date
<Item 5>
Name
<Item 6>
Format No.: <Item 7>
Table 3 : Content of Footer
Item no.
Description
Explanation
1Prepared By
This shall be the officers/executive of initiator of the SOP.
2 Checked By
This shall be the head of department or the designee. In case of QA, the designee of Head QA shall sign. If in any specific case, the SOP is required to be checked by other department viz. QC, Utility etc., then Head of that department shall sign in the checked by column of the SOP.
3 Approved By
There shall be two signatories to approve a SOP for implementation.
- All SOP’s shall be finally approved by Head, Quality or his/her designee.
- Plant Head or his/her designee shall approve, as second signatory, for all SOP’s except QC and microbiology SOP’s. QC shall be approved by Head, QC respectively in these cases.
4 Designation
Print designation of personnel signing for prepared by, checked by and Approved by.
5 Sign and Date
Sign with date in blue permanent ink. Date shall be in DD/MM/YY format.
6 Name
Name of the personnel signing for Prepared By, Checked By and Approved By shall be hand written in blue permanent ink.
7 Format no.
Mention QA/001/F01-01 in normal type font.
5.1.12 Revision Card
5.1.12.1 Contents and format of header of revision card shall be similar to the SOP header except <Item 5>. Document name shall be mentioned as “REVISION CARD (STANDARD OPERATING PROCEDURE)” in capital case in center of the page. The Format No. for the revision card shall be mentioned as QA/001/F02-00
5.1.12.2 The revision card shall have stand-alone page numbering independent of number of pages in the SOP and annexure.
5.1.12.3 Footer of the revision card shall be as per point 5.1.11.1.
5.1.12.4 Format numbering shall be in the format SOP No./FN-XX, where –
SOP No.: This shall be the SOP no. of SOP in which the format has been initially explained.
/ : This shall be forward slash
F : This shall represent the format no.
N : This shall be the format serial no. 01,02,03….12, 100, etc.
- : This shall be dash
XX : Version no. of format. First version of a format shall be 00 and subsequent versions shall be 01, 02, etc. e.g. First version of tenth annexure of SOP No. QA/008 shall be QA/008/F10-00
5.1.12.5 Formats and appendix which will form a part of the SOP shall be prepared along with SOP and attached to the SOP.
5.1.12.6 The header of formats shall be contain SOP header items (1,2, 3,4 & 6) as per point no. 5.1.10.3.
5.1.13 In case the same format has to be referred in another SOP, then format number shall be same as the parent SOP.
5.1.14 All handwritten information including signature and date shall be in permanent blue ink ballpoint pen.
5.2 Distribution and Control Procedure
5.2.1 To make an SOP effective, ensure all the relevant documents like formats,
Logbooks/registers, infrastructure requirement are available and training of personnel on the procedure is completed.
5.2.2 Quality Assurance shall put the effective date and review date at the time of issuance.
5.2.3 All original SOP’s shall be stamped as ‘“MASTER COPY” in Green color ink on the top right hand side corner on all the pages (Refer Annexure-VI).
5.2.4 For preparation of distribution copies, QA shall take photocopy of the “MASTER COPY” and stamp it as “CONTROLLED COPY” in red ink on the at right bottom corner of all the pages. QA personnel issuing the two copies shall sign with date in DD/MM/YY along with the department code & copy no. to which the copy(s) is to be provided, copy no. 1 for office and copy no.2 for display purpose. Revision card shall not be distributed and shall be kept along with the “MASTER COPY”.
5.2.5 Quality Assurance department controls distribution of all SOP’s by entering details of distribution in “Distribution and Retrieval Record” (Annexure – IV).
5.2.6 Any photocopy of SOP’s required by external agencies other than regulatory / statutory / legal authorities if issued, Quality Assurance shall issue a photocopy of “MASTER COPY’’ stamped as “UNCONTROLLED COPY” in black ink at the bottom right hand side corner on all the pages.
5.2.7 Following revision of any SOP, the superseded “MASTER COPY” shall be stamped “OBSOLETE” in red ink on the centre of the each page diagonally and archived.
5.2.8 All controlled copy shall be retrieved from the user department and recorded in the “Distribution and Retrieval Record”. (Annexure-IV). Retrieved copies of SOP shall be destroyed by shredding, QA shall supervise this activity.
5.2.9 In case a department requires additional copy, other than an uncontrolled copy, request for the same shall be raised on as per Annexure-IV, duly approved by the department Head. If the request is approved by Head QA, distribution shall be maintained as per “Distribution and Retrieval Record” (Annexure-IV).
5.3 Revision Procedure of SOP
5.3.1 All the SOP’s shall be revised as per change control procedure.
5.3.2 In case the SOP is due for revision and there is no change in the text of SOP, stamp ‘REVIEWED BY / DATE’ and ’NEXT REVIEW DATE’ in blue ink at the bottom center of first page of “MASTER COPY” (Refer Annexure-VI). All previously distributed controlled and reference copies shall be retrieved and destroyed as per point 5.2.8. Records shall be maintained in the “Distribution and Retrieval Record” (Annexure-IV). Re-issuance shall be as per previously point’s 5.2.3 to 5.2.6. Stamping with the stamp ‘REVIEWED BY / DATE’ and ’NEXT REVIEW DATE’ shall be followed only once. For the second revision schedule, even if no changes are required, the SOP shall be revised using the change control procedure.
5.3.3 In case there is no perceived change in the SOP procedure, still a change control shall be required to initiate stamping as defined in point 5.3.2.
5.3.4 In case of cancellation of any SOP, change control procedure shall be fallowed and all control copies shall be destroyed and Master copy shall be absolute as per point no. 5.2.7 .
5.4 Preparation and Control of Vernacular SOP
5.4.1 Vernacular SOP shall be prepared as per requirement i.e. the SOP’s which shall primarily being used by contract workers shall be translated into vernacular language like Hindi e.g. cleaning SOP.
5.4.2 The format of the SOP shall be as per Annexure-1
5.4.3 Vernacular SOP’s shall be prepared from approved version of English SOPs only.
5.4.4 Personnel with adequate knowledge of the vernacular language shall prepare SOP’s. QA department shall maintain a list of personnel identified for the purpose. (Annexure- VII).
5.4.5 Distribution and control of the vernacular SOP’s shall be as per English SOP’s (point 5.2). The SOP no. shall be as that for English SOP. Vernacular SOP’s shall be revised as and when the English SOP’s are revised.
5.5 The adequacy of translation shall be checked by back translation of the SOP into English.
5.6 A master list of SOP’s shall be maintained as per SOP index annexure-III. The SOP’s for which vernacular SOP’s are available shall be highlighted.
6.0 ABBREVIATION(S)
QA : Quality Assurance
SOP : Standard Operating Procedure
etc : et cetera
e. g. : for example
NA : Not applicable
7.0 REFERENCE(S)
Nil
8.0 FLOWCHART(s)
Available with SOP, as separate page.
9.0 ANNEXURE(S)
Annexure No.
Details/Title of Annexure
Format No.
(Current version)
Annexure-I
SOP Format
QA/001/F01-01
Annexure – II
Revision Card
QA/001/F02-00
Annexure – III
SOP requisition and distribution form
QA/001/F03-01
Annexure – IV
SOP issuance ,retrieval and destruction record
QA/001/F04-01
Annexure -V
Master SOP index
QA/001/F05-01
Annexure – VI
Stamp impressions
QA/001/F06-01
Annexure – VII
List of Personnel for Vernacular SOP preparation
QA/001/F07-00
10.0 DISTRIBUTION
10.1 Master copy: Quality Assurance
10.2 Controlled Copy (s) (No.1): Quality Assurance, Quality Control, Production, Stores, Engineering, Human resources, Information Technology, Production Planning
10.3 Controlled Copy No. 2: Nil
11.0 REVISION CARD
Revision history available with SOP, separate page
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