Medical Devices - How to justify the Sampling Plan used?

R

reenu

#1
I work for a medical company and have been asked to statistically justify the sampling plan we have in place. How to go about this? If we choose the c=0 plan it has certain implications (about acceptance of the lots). That part is not the issues...the issue is how to produce a business justification. As in --> why is the c=0 plan adequate.

Any suggestions or advice greatly appreciated.
 
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J

joshua_sx1

#2
Re: How to justify the plan used?

...I’m not familiar with sampling plan that has c=0... but in general (and in most logical way), to justify any plan is to see its result & effect against your established target or objective... since your concerned is more on business justification for having that sampling plan, you can do the reverse approach which is, your initial plan must be evaluated first - its effectiveness against your target... and accordingly, if the result does not fall within your target (or does not giving you an accurate yield that makes your process reliable), you need to change your plan... and if it does, then you can conclude that your plan is justifiable & adequate...
 

yodon

Staff member
Super Moderator
#3
Not exactly my area either, but your justification should be risk based. What's the probability of harm to a patient given the sampling plan? If it's in line with your risk management controls, you're ok.

I'll try to dig a little more with some of our clients to see how they approached justification but I expect that, in the end, they have to tie it to risk.
 
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