QCS-003 In-Process Quality
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PURPOSE
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To define a procedure for inspection of all manufacturing processes on which material is being manufactured.
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SCOPE
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This SOP applies to all manufacturing processes on which the product is being manufactured.
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REFERENCE(S) & ATTACHMENTS
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References
- In-house
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Attachments
- Attachment- I : In-Process Quality Formats (see List of Formats - QC, Annexure)
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RESPONSIBILITY
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QC Department Head: To prepare the SOP and its scope.
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QA Head: To approve the SOP and to ensure implementation.
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DISTRIBUTION
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Quality Assurance
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Quality Control
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DEFINITION(S) & ABBREVIATION(S)
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Definitions
- Nil
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Abbreviations
- Nil
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PROCEDURE
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Process Monitoring:
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Quality shall identify and define controls to monitor the production process.
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Quality inspectors shall ensure that the material to be used for manufacture carries an "Approved" status label.
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Quality inspectors shall ensure that the parameters set are as per the 'Standard Process Parameters'.
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Quality inspectors shall ensure that all monitoring instruments, including electronic equipment, are operative and calibrated.
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Quality inspectors shall give line clearance before commencing any manufacturing operation and shall maintain the record as evidence.
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In-Process Inspection:
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Quality inspectors shall understand the sequence of the process, as well as the variation of a parameter and its effect on the semi-finished or finished products.
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Quality inspectors shall identify and define in-process checks to ensure compliance with the planned output.
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A sampling plan, including sample size, shall be defined. Test reports of raw and packing materials shall be prepared.
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If a deviation is observed in parameters — set versus actual values through monitoring instruments — the batch, or part of the batch (if traceable), produced shall be tested for possible deviation. The sample size and sample location shall be reconsidered to locate and measure the possible deviation. Any deviation observed shall be recorded in the Deviation Report.
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If a deviation is observed in the semi-finished product at any stage of production, the Quality Control Head shall decide the further appropriate action. The action could be rework of the material, possible correction in further stages of production, or rejection of the batch in process. Records of the deviation shall be maintained.
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The Corrective and Preventive Action procedure shall be followed for any deviation observed.
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The specifications of finished products shall be defined and shall be consistent with customer requirements for their intended use.
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The acceptance criteria for all tests shall be defined.
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Records of testing for all batches shall be maintained and shall be traceable, to allow decisions to be taken objectively for release of the finished product.
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REVISION HISTORY
+----------------+----------------+----------------+----------------+----------------+----------------+ | Revision No. | 00 | Effective | | CC No. | | | | | Date | | | | +----------------+----------------+----------------+----------------+----------------+----------------+ | Details of revision: New SOP | +-----------------------------------------------------------------------------------------------------+
Attachment- I : List of Formats - QC
Sr. Format No. Format Description Type Size No. (mm)
1 SIPL/QCS/003/F01/00 In-Process Quality Single x 100 A4 Inspection - Printing Pages
2 SIPL/QCS/003/F02/00 In-Process - First Off Single x 100 A4 Printing Pages