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medical device company or industry, receiving inspection, statistical quality control (sqc), acceptance plans
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  #1  
Old 17th March 2011, 01:26 PM
Ironcountry Ironcountry is offline
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Please Help! Medical Device Receiving Inspection AQL

The dilemma, determining a statistically valid sampling plan for receiving inspection of a wide range of class one and two medical devices from a wide range of suppliers. The sampling plan used is C = 0.

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Old 17th March 2011, 01:29 PM
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Re: Medical Device Receiving Inspection AQL

Could you please rephrase your question?

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Old 17th March 2011, 02:35 PM
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Re: Medical Device Receiving Inspection AQL

How to determine a statistically valid receiving inspection plan. My company purchases a wide variety of instruments and implants from many different suppliers.
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Old 17th March 2011, 02:45 PM
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Re: Medical Device Receiving Inspection AQL

The sampling plan needs to be based on the associated risks involved with the items you are inspecting. Somewhere you should provide the justification for your decisions.
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Old 18th March 2011, 10:43 AM
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Re: Medical Device Receiving Inspection AQL

Agree,

The risk management approach could be taken in consideration to define your sampling plans. Based the given risk you could create a table associating AQL's and attributes to inspect and then document such criteria into the QA procedure.

It is said that the customer is who sets the AQL's, but I have found that this is not always the case, thus the engineers find themselves in the need to set them, keeping always in mind that the customer deserves zero defects.

You could divide your product defect types by categories like critical, major and minor, and then set AQL's accordingly, just as an example: 0.65, 1.0 and 2.5 respectively. According to the FDA's QSR these sapling plans need to be reviewed from time to time to asses their adequacy and that they are sensitive to changes, so you could have that evaluation made in your quality group meetings, risk management process review meetings, or if feasible in a management review.

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