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Establishment of Effective Measurement Criteria for a Mock Recall

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Posted 08 November 2010 - 08:28 AM

Hi ! I am new in this forum, Recently my company had a surveillance audit and the auditor Issued us 1 minor CAR and a few obs.What i would like to ask is about the mock recall.The auditor ask us to considered the establishment for effective measurement criteria of mock recall .Can somebody help me?Please..TQ for your help.


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Posted 12 November 2010 - 04:11 PM

Obviously it will depend upon what you have written in your Recall Procedure, but a couple of simple measurable criteria are

The time to complete the different stages of the procedure, eg how long to assemble the recall team, how long to complete the traceability of materials and products. Give some targets such as 2 hours or 4 hours and then you can compare your performance.

How accurately you can reconcile raw materials to finished products in a forwards trace eg 98 - 102%

There are probably others as well

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