Rel-ion will provide a Certification of Irradiation following the processing of all products to its customers. A copy will be maintained by Rel-ion for 5 years. During processing, several documents are generated and will be retained in Rel-ion file, together with the copy of the Certification of Irradiation.
The Incoming
Material Control Sheet records the count and surface
inspection for each incoming shipment. |
The Work Order
provides all instructions to the shift supervisors for
processing and handling the individual run. |
The Run Data
Sheet lists all Dosimetry readings and calculations.
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The Material Handling Control Sheet contains accountability for count and conditions of products when:
unloaded from
totes
loaded for
shipment to customer.
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The Pallet Configuration Sheet describes how the customer’s product is be re-palletised.
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The Dosage Distribution Map and Density Data Work Sheet are developed from dose distribution reports performed at the time of product validation.
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The Notice of Deviation is used in the event of any circumstances deviating from customer specification.
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A Radiation Services Agreement insures conformance with subsections 201.150 and 801.150 of Title 21 (US-FDA), if applicable.
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Quality Assurance
All activities of the facility and all the above records are continuously reviewed by the Quality Assurance Department. Once a year the facility will be audited by the Corporate Quality Assurance Department to insure consistency with the Quality Assurance Manual.
The Quality Assurance Department consists of: |
Product Quality
Assurance. |
Technical Quality Assurance. |
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The Product Quality Assurance person is responsible for proper processing of the products, while the Technical Quality Assurance person is responsible for the equipment and all machinery used during processing. |