SOP for Line Clearance

OBJECTIVE

To provide a procedure for Line Clearance at all stages of mask Production and to ensure that appropriate controls are put in place to avoid cross-contamination or mix-up during all stages of Production.

SCOPE

This procedure applies to all staff during all stages of mask Production.

RESPONSIBILITY

• It is the responsibility of the operators to follow this procedure fully.
• It is the joint responsibility of the QC Executive and Production Supervisor to open and close Production lines at all stages by ensuring that controls are put in place for the attainment of a quality product.

PROCEDURE

General Considerations:

• Line clearances must be given after all checks have complied with specifications.
• To be done prior to commencement of a new batch.
• Effectiveness of line clearance to be checked after restart of operation and after the break.
• After trials, maintenance work and other activities which could affect product quality a fresh line clearance should be given.
• After obtaining line clearance status label of the activity in progress should be displayed.

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• Before any operation commences check whether the work area and equipment are clean and free from any starting materials, product residues, labels or documents not required for the current operation or of the previous batch.
• Check for the completeness of the document such that all the stages are signed for.
• Ensure that all the fabrics from the storage area are identified by labels, weights indicated and signed for.
• Ensure that the weighing scales are working properly and are calibrated.
• Before the packing operation begin, make sure that the work area, packing lines, printing machines and other equipment are clean
• The name and batch number of the product being handled should be displayed at each packing station or line
• Verify whether the correct batch number, manufacturing date and expiry date have been coded by checking each letter and number.
• Ensure the correctness of the printed packaging materials against the batch record.
• Sign the endorsed label, leaflet, and dispenser and attach to the document.

ABBREVIATION

QA: Quality Assurance

QC: Quality Control

IPQC: In-process Quality Control

REVISION HISTORY

Nil

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