SOP QA001: SOP for writing SOP

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1	Purpose:
	To lay down the procedure for preparation of Standard operating Procedures.
2	Scope:
	This SOP is applicable for preparation of Standard Operating Procedures for all the employees/departments of  xxxxx (insert the name of the organization and location).
3	Responsibility:
	Department		Responsibility
	User Department		It is the responsibility of each user Department Head to initiate preparation, authorization, training (to concerned personnel) and implementation of the SOP. It is also the responsibility of the user department to ensure the presence of the current version of the SOP in the Department.
	Quality Assurance Department		QA department is responsible for review and authorization of the SOP. Archiving of master copy and issuance of control copy as per the request.
4	Abbreviations:
4.1	SOP		Standard Operating Procedure
4.2	QA		Quality Assurance
4.3	RF		Record Form
5	Definitions:
5.1	Attachment:		An approved designed layout attached to an SOP for better understanding of the procedure (flowchart, drawings, P&IDs etc) or having space for data entry (recording the activity).
5.2	Controlled Copy:		A copy of original document (Master Copy) which is controlled as per document control procedure. A controlled copy stamp is used to differentiate such copy from other copies and traceability. These copies are subject to retrieval as per document control procedure.
5.3	Master Copy:		When a document is authorized and signed in blue ink is called master copy. In SOP a master copy stamp is used to control all the master copies and differentiate them from other documents.
5.4	Standard Operating Procedure:		Standard operating procedures (SOPs) are the detailed written instructions that specify how a test or administrative procedure is to be performed, or how a piece of equipment is operated, maintained and calibrated. SOPs describe the "standard" approved procedures that are routinely carried out in a GMP facility.
5.5	Uncontrolled copy:		A copy of original document (Master copy) which is not subject to document control procedure. An Uncontrolled copy stamp is used to differentiate such documents from other documents.
6	Procedure:
6.1	SOP shall be prepared for all the operations, activities to be performed and instructions followed in xxxxx (insert the name of the organization and location).
6.1.1	Creation of SOP:
6.1.1.1	For all the new projects the SOPs shall be created as per the Project Quality Plan.
6.1.1.2	For existing project any new SOP shall be created following a change control procedure justifying the need of new SOP. The change control number shall be mentioned in the History column of the SOP.
6.1.1.3	New SOP shall be drafted as per the instructions given below and printed with a watermark stating DRAFT # on every page of the SOP across the text matter.
6.1.2	Review, Approval and Authorization of SOP:
6.1.2.1	Draft copy shall be circulated for review and comments to concerned departments.
6.1.2.2	The reviewer shall review and mark corrections/suggestions, if any on the SOP and send it to user department for incorporation.
6.1.2.3	The user department shall incorporate the comments or suggestions in the SOP in consultation with Head of the Department.
6.1.2.4	The Final copy of the SOP shall be printed in the appropriate sized paper mentioned below by the user. The copy shall be signed in the ‘prepared by’ columns of approval page.
6.1.2.5	This copy shall then be reviewed and approved by the Head of the Department or his designee in ‘approved by’ column of the approval page.
6.1.2.6	This copy shall then be forwarded to head of Quality Department for review and authorization.
6.1.2.7	Head Quality Department shall review and authorize the SOP by signing in the ‘authorized by’ column of the approval page.
6.1.2.8	The Quality Department shall stamp the copy as ‘MASTER COPY’ on top right corner of the SOP.
6.1.3	Training of SOP:
6.1.3.1	After approval from Quality Head, the Quality department shall make a photocopy of the SOP and stamp it as ‘TRAINING COPY’ in green ink at lower right corner of the SOP and send it to user department for training.
6.1.3.2	The person who has prepared or approved the SOP shall impart the training to the staff. A person designated by Head of Department or Head Quality shall also impart the training, if needed. The person who have already undergone the training and has approved training record s can also impart training, if needed.
6.1.3.3	During the training the trainer shall ensure that all the sections of the SOP are explained and understood by the trainees.
6.1.3.4	The user department shall complete the training in 10 days from the date of approval and send the records along with training copy to Quality Department.
6.1.3.5	The persons mentioned in training list are considered to be trained in that SOP. Quality Department then destroys the ‘TRAINING COPY’.
	Note: In case of retraining or training of new personnel, controlled copy can be used for training purpose.
6.1.4	Distribution and Filing:
6.1.4.1	Once the training is imparted the SOP shall be dated with effective date and next revision date on approval page with blue ink and issued to departments as per distribution list.
6.1.4.2	A photocopy of the master copy shall me stamped as ‘CONTROLLED COPY’ with date and signature of the issuer. The record of issuance shall be maintained as per SOP (Control of Documents).
6.1.4.3	Master copy shall be archived by Quality Department in master file at secured location.
6.1.5	Changing SOP:
	Any change in the SOP (non typographical errors, changes, additions) shall follow change control procedure as per the current version of the change control SOP (Ref. no). However, typographical changes or additions do not require a change control. The change shall be mentioned in revision history column.
6.1.6	Revision of SOP:
	SOP shall be revised after every two years such that the month of Next Review shall be exactly two years from effective date. Tolerance of ± 1 month is allowed.
	SOPs are living documents and shall be updated as necessary as the procedure change or reference document change or regulatory requirements change.
6.2	Layout:
	All the SOPs prepared under ………….. shall have a harmonized format and layout. SOP shall be prepared as per the following scheme:
6.2.1	Formatting:
6.2.1.1	All the SOPs shall be prepared in A4 paper and printed on single side. SOPs shall be appropriately stamped to differentiate between Master, Control and Uncontrolled copies.
6.2.1.2	Page Setup shall be as follows:
	Margins: Top: 0.8”, Bottom: 0.8”, Left: 1.0”, Right: 0.8”, Gutter: 0”, Gutter Position: Left Orientation: Preferably Portrait
	Font: Times New Roman, Font Style: Regular, Font Size: 12,  Font color: Automatic
	Header: Header of all the pages shall be same and shall have the following structure with formatting: Header from top: 0.5”
	Content			Formatting
	Company Name/ Logo			Top of the document, Center Aligned
	Document Category /Type			1st row of the Header, Times New Roman 12, All Caps, Bold, Center Aligned
	Department:			2nd Row, Times New Roman 12, Capitalize Each Word, Regular, Center Aligned
	Title:			3rd Row, Times New Roman 12, Sentence Case, Regular, Alignment Justified
	SOP No.:			4th Row, Times New Roman 12, Capitalized Each Word, Regular, Left Aligned
	Revision Number:			4th Row, Times New Roman 12, Capitalized Each Word, Regular, Left Aligned
	Supersedes:			5th Row, Times New Roman 12, Capitalized Each Word, Regular, Left Aligned
	Page number:			5th Row, Times New Roman 12, Capitalized Each Word, Regular, Left Aligned, in the format of page X of Y, where X is page number and Y is number of pages.
	Footer: The footer of the SOP shall contain the Form Number which is the number of the prescribed format in which the SOP shall be prepared. Footer from Bottom: 0.5”
6.2.2	Numbering: All the SOPs shall be assigned a unique number. The number shall be assigned as follows:
	QA/001
	Where, QA stands for department code i.e, Quality Assurance             001 stands for the number of SOP
	Wherever reference to revision number is required the SOP number shall be identified with revision number as: QA/001, Rev.00 Rev.00 means the reference SOP QA/001 is of Revision 00.
	Other Schemes for coding can also be used, en example is provided in next post.
6.2.3	Department Code: All the departments under xxxxx (insert the name of the organization) are assigned department code as follows:
	Engineering                                                     : EN Human Resource and Administration               : HA Bulk Production                                              : BP Filling, Labeling and Packaging                        : FP Purchase Department                                      : PD Quality Assurance                                           : QA Quality Control                                               : QC Warehouse and Dispatch                                : WD
6.2.4	Approval Page:
	The approval page of the SOP shall have the name, signatures and date of the following people with their department and designation/ role in the department. Prepared by: The person who writes the SOP shall have relevant experience in that activity or field and shall have knowledge of the organizational structure. Reviewed/Approved by: The person who technically reviews the SOP for completeness shall have a relevant experience in the activity or the field and shall have knowledge of the organizational structure. Authorized by: The SOP after the review cycle shall be reviewed by QA Department keeping in mind the regulatory requirement and Quality Management System.
	Effective Date and Next Revision Date: The effective date and Next review date shall be assigned by quality assurance department and shall be filled by hand in blue ball pen ink. These dates shall be assigned only after the training has been imparted to the concerned personnel and training record evaluated. The date shall be filled in DD.MM.YYYY format (D-Day. M-Month. Y-Year).
6.2.5	Revision: SOP shall be revised after every two years such that the month of Next Review shall be exactly two years from effective date. Tolerance of ± 1 month is allowed.
6.2.6	Text Pages: The pages subsequent to Approval Page shall have uniform contents as described below. Footer from bottom shall be 0.5”.
6.2.7	Contents:
6.2.7.1	The contents of the SOP shall be divided into 10 major headings. The contents of the technical and administrative SOP are same, however and specific description required by a technical SOP, such as preparation of solutions, reagents and other preparatory activity before the described procedure shall be included under procedure.
6.2.7.2	The headings shall be consistent in all the SOPs prepared under xxxx (insert the name of the organization) QMS. All the headings shall be in Bold followed by colon and should have a fixed sequence. Text description in the heading shall be written below the heading and all the text shall be aligned as justified. If any of the heading is not relevant to a particular SOP, ‘Not Applicable’ shall be written below the heading. Important text which needs special emphasis shall be put as ‘Note’. The text of the note shall be bold italicized and shall start after the colon following the heading ‘Note’, e.g., Note: Note signifies important instruction which require special emphasis.
6.2.8	Following is the indication of the text to be written under each individual heading:
6.2.8.1	Purpose: This heading represents the question ‘why’ -          why this procedure is written -          why it is being performed
6.2.8.2	Scope: This heading represents the question ‘when’ and ‘where’ -          when this procedure needs to be performed -          where these procedure applies -          sometimes it is prudent to mention what is not within the scope of the SOP for making the SOP more specific
6.2.8.3	Responsibility: This heading represents the question ‘who’ -          who performs the procedure and who sees it is performed correctly
6.2.8.4	Abbreviations: Under this heading all the relevant abbreviations pertaining to the SOP in question are explained for better understanding and representation of the procedure.
6.2.8.5	Procedure: The heading represents the question ‘how’ -          how to perform the procedure -          the procedures can be of two types, administrative and technical. The technical procedure shall have following subheadings 5.1 Precautions and Safety 5.2 Equipments 5.3 Materials and Reagents 5.4 Preparation of Solutions 5.5 Procedural Steps
	·          Procedure should be written in a concise, step-by-step, easy-to-read format. ·          The numbering shall be done using a multilevel list for different headings and subheadings and for each step to make them distinct. Where ever appropriate simple list and bullet points can also be used. ·          Subheadings may be used to divide procedure in logical steps and text of such subheadings may be kept bold. ·          The information presented should be unambiguous and not overly complicated. ·          The active voice and present verb tense should be used. The term "you" should not be used, but implied. ·          The document should not be wordy, redundant, or overly lengthy. ·          Use diagrams and flow charts wherever appropriate. ·          It is recommended to give 6 point space between different paragraphs.
6.2.8.6	Reporting: This section guides the person performing the activity for reporting pre-activity, activity and post activity operations. The section provide reference of the documents to be filled such as log books, record sheets, BPR etc.
6.2.8.7	Attachments:
	SOP can contain the following attachment which has specific function as follows::
6.2.8.7.1	Annexure are explanatory text/documents given at the end of the procedure for better understanding of the procedure. Annexure includes flow charts, diagrams, tables, formats or any other data which is necessary for better implementation of the procedure.
6.2.8.7.2	Formats are special annexure which provided template for preparation of a specific document such as SOP, Specification, MFR, BPR etc.
6.2.8.7.3	Record Forms are used to record pre-operation, operation and post-operation activity as well as provides documented evidence with linkage and traceability for proper functioning of a quality system. These filled records are necessary for proper functioning of Quality System.
6.2.8.7.4	Annexure containing reference text required for proper understanding and implementation of the SOP shall be placed first serially followed by the formats and record forms. Annexure are not included in page numbering system of the SOP.
6.2.8.7.5	Identification of Annexure and Record Form:
	All the Annexure and Formats/Record Form shall bear a unique number for uniformity, identification and traceability. The number shall be printed in footer of the attachment and aligned left. Font should be Times New Roman and font size 10. Record form number shall be assigned as follows: QA/001/00-AT001 Where, QA/001           stands for SOP number 00                                        stands for revision number of document AT                   stands for Attachment             001                  stands for subsequent number of record forms
	To differentiate Formats and Record Forms from all other attachments, code AT is suffixed with RF followed by subsequent number in the series such as: QA/001/00-ATRF004
6.2.8.7.6	Format of all the annexure and record forms shall follow the pattern given below.
i.	Header: Header of all the pages shall be same and shall contain company logo and name. Below the company logo and name annexure number shall be given. When record forms and annexure are issued for recording any information the annexure number shall be deleted. the following with formatting:
	Contents				Formatting
	Company Logo and Name:				Top of the document, Center Aligned

ii.	Contents:
	·         Format of all the documents such as SOP, Specification, Report, Protocol etc are defined in the respective reference procedures. The formats shall be annexed to the SOP.
	·         The contents of the Annexure and Record Forms shall be designed on need bases and shall contain page numbers. ·         The flow of activity shall be captured in the record form along with dates, times, done by, supervision, review authorization as needed. The font of the typed text shall be Times New Roman and rest of the formatting shall be decided as per requirement. Sufficient space shall be provided for filling of data.
	·         Wherever the activity step is performed the record shall end into date and time of the activity performed along with the signatures of the person who performed the activity and the person who supervised the activity.
iii.	Footer:
	Footer of every page of attachment shall have an attachment number as per the above described format along with at box space for approval of the annexure (Approved By) as given below:
	Footer of the Attachment:
	(Attachment number xxxx)						Approved By (Signature):____________
6.2.8.8	References: This heading enlists all other SOPs, manuals, guidelines and other documents which provide more information on performing the procedure or consulted for preparing the procedure. Note: If the SOP is prepared for operation of equipment/instrument, user guide for the equipment/instrument shall be listed in the reference section and ensure that the user has been trained for operating the equipment prior to performing the procedure.
6.2.8.9	Distribution: This heading enlists the distribution record of the SOP. Distribution list  directs the SOP to person/department which will perform the activity.
6.2.8.10	Revision History: This heading addresses the change. What changes were made in the SOP since last revision and traceability of change? Histories of Recent three revisions shall be given in this column.
6.2.9	SOP Master list/Index:
6.2.9.1	SOP master list/index of all the departments shall be maintained at QA department and shall be regularly updated.
6.2.9.2	When new sop is introduced the detail of the same shall be hand written in the master index till it is reprinted.
7	Reporting
	NA
8	Annexure:
	S.No.	Title						Pages
	1	Format for Standard Operating Procedure						2
9	References:
9.1	WHO/VSQ/97.01: WHO guide to good manufacturing practices (GMP) requirements. Part 1: Standard operating procedures and master formulae.
9.2	EPA QA/G-6: Guidance for preparing standard operating procedures.
10	Distribution:
	Master Copy			Archived in Quality Assurance Department
	Controlled Copy 1			Quality Assurance Department
	Subsequent Controlled Copy			Department making request
11	History:
	Revision Number			Change Summary
	00			None