Purpose:
To describe the procedure for the preparation, implementation and control of Standard Operating Procedures
Responsibility : Manager - QA, All Head of the Departments.
Procedure
A. General
A Standard Operating Procedure (SOP) is a written approved procedure which describes how to perform a operation in a plant. It is not necessarily specific to a given material or product but is of a general nature.
Standard Operating Procedure (SOPs) should be created in every department of the factory and should cover the various phases of a manufacturing operation and its control. They must list by steps what must be done and how it is to be done.
B. Writing of SOP
1. Department Head will write the SOP and will submit to Manager - QA for approval.
2. The title should be clear and should indicate the nature and purpose of the document.
3. Where the procedure bears instructions it should be in the imperative and in the form of the steps.
4. The contents should be clear, precise and unambiguous, the language should be such that the user can easily understand them.
5. The size and shape of the document and the quality and colour of the paper used should be such that typing or printing, reproduction and filing become easy and simple.
C. Approval of SOP
1. SOP becomes operational only if it is signed and approved.
2. The signatories should include the person who writes the document, i.e. the representatives of Engineering, Production, Quality Control, Quality Assurance, Management review department and the person who approve the use of the procedure. All SOPs will have signature in black ink.
3. Manager - Quality Assurance will approve all the procedures which will have impact on the quality of the Company’s products.
4. In case of non-availability of Manager - Q.A., works manager can sign.
5. Master copy of SOPs of all departments will be kept with Q.A. Department. These copies will be stamped “MASTER COPY” in blue ink on top right corner.
6. All department copies of SOPs will have a stamp “DISTRIBUTION COPY” in blue ink on top right corner.
D. Implementation of SOP
1. Once SOP is approved, which needs to be circulated to any Department. Records of the circulation will be maintained by QA Department
2. An approved SOP should not be altered until any required or desired change is accepted by the individual concerned for the implementation of the SOP.
3. If a procedure is to be changed it must be re-written and again approved before the change is implemented.
1. The revised SOP should be given a new number and it should indicate which number SOP it supersedes, date effective, next revision date and page numbers.
2. An outdated or superseded SOP should be removed from active use. Master copy of superseded SOP should be kept in a archive file with “OBSOLETE” stamp in red ink across the page for reference at any time and all controlled copies will be destroyed.
E. Distribution of SOP
Master copy of Approved SOPs will be kept with QA Department. The list of SOPs distributed to various departments and number of copies distributed will be prepared and kept with QA Manager. If any additional copies are required in the later date a copy of master copy will be issued by QA Manager / Manager - QA with a signature on each page at the bottom after stamping “ISSUED BY” in blue ink.
F. Review of SOP
All SOPs will be reviewed and if required, they will be revised by the respective Department Heads as and when it is necessary and all SOPs must be reviewed after two years within the 2 months period. The revised SOPs will be approved by the Manager - Quality Assurance
Any SOP when reviewed after the due date which does not require any change or revision, will be kept as it is but will have following stamping at bottom on all pages :
Reviewed on : Reviewed by :
Valid upto : Approved by :
The above stamping will be in blue ink and signed and dated by authorised persons.
Each sheet of the SOP shall show in the header as under:
1. Name of Department
2. SOP No
3. Next review date
4. Title
5. Effective Date
6. Prepared by
7. No of pages
8. Superseds SOP No
9. Approved by
10. Authorised by
Between two horizontal lines, the applicable title of SOP shall be described.
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