Guides/Production and operations

Operations1:35

Production and operations

The shop floor in the QMS: work orders, batch records, product release, equipment qualification, calibration and maintenance.

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The shop floor in the QMS: work orders, batch records, product release, equipment qualification, calibration and maintenance. Work orders, batches, releases, equipment, calibration and maintenance.

What you'll see

1
Production and operations: from the work order to the shipped product.
2
Work Orders plan what is built, and when.
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Batch and lot records give full traceability.
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A batch record links materials, production steps and the release decision.
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Product Releases document the final approval before shipping.
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Equipment Qualifications record installation, operation and performance checks.
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Calibrations show which instruments are due, and which are overdue.
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Maintenance keeps a history for every piece of equipment.
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Receiving Inspections check incoming goods before use.
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Distribution Records show where each batch went.
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Returns are handled as RMAs, with an investigation where needed.

The screens show sample data for a fictional company, Nordic MedTech Oy. Captions are on screen and available as a CC track.

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