OBJECTIVE
- To outline areas, activities, and parameters that need to be checked during mask production and packing operations.
- Ensure correct and documented time intervals are followed during in-process checking.
- Ensure that any non-conformances are tackled promptly so that corrective and preventive action is taken immediately.
SCOPE
The procedure applies to all the in-process controls to be undertaken during mask production and packing.
RESPONSIBILITY
- It is the joint responsibility of the operators and the QC Executives to follow the procedure as per this SOP.
- The supervisor shall ensure that the procedure is being followed as per this SOP.
- The QA Manager and the Production manager should ensure that appropriate corrective actions are taken whenever a problem is encountered to attain a Quality product.
PROCEDURE
- Ensure line clearance is performed as per SOP SOP for Line Clearance.
- Ensure that all the fabrics for mask production are identified by labels, and weights indicated and signed for.
- Check for completeness of document such that all stages are signed for.
- Ensure machine settings are correct and proper.
- Perform the following checks on the mask:
- Appearance (Color of the outer and inner layer).
- Number of layers
- Folds on the mask
- Dimensions (length and width).
- Nose bridge insertion
- Ultrasonic welding of fabric
- Ear loop welding
- Machine speed
Packing Operations:
- Check the following during packing operations:
- The general appearance of the packages.
- Whether the quantities of the contents are as per pack size.
- Whether the correct packaging materials are being used.
- Whether coding of the dispenser.
- Use of security seal tape on dispensers
- The frequency of in-process checks shall be as stipulated in BPR.
ABBREVIATIONS
BMR: Batch Manufacturing Records
BPR: Batch Packaging Record
SOP: Standard Operating Procedure
IPQC: In-process Quality Control
QC: Quality Control
REVISION HISTORY
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