AQL .65 Level III - Take a particular component off 100% Inspection

S

shiptowns

#1
Hello,

I work for a medical device company and I am just learning about AQL's. So I was told by my boss to rationalize why we should be able to take a particular component off 100% inspection and instead use AQL 0.65 level III?

This component has an FPY of 3 failures out of 5114. This component has a high cost.

How does one determine the best AQL level and why this is the best?

How does I rationalize AQL 0.65 level III and why is it right here?

Thank you,
 
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B

brahmaiah

#2
Hello,

I work for a medical device company and I am just learning about AQL's. So I was told by my boss to rationalize why we should be able to take a particular component off 100% inspection and instead use AQL 0.65 level III?

This component has an FPY of 3 failures out of 5114. This component has a high cost.

How does one determine the best AQL level and why this is the best?

How does I rationalize AQL 0.65 level III and why is it right here?

Thank you,
AQL sampling is not recommended for safety related,critical and high cost parts and assemblies.An external advice for such issuies is not advisable.Your boss is the only competent person to advise you on this.
Although boss is not always right,a subordinate has to work under decipline.
V.J.Brahmaiah
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#3
well now it all depends. but in order to give you good advice,we need to understand more about your situation.
(I am in the medical device industry and we don't do 100% inspection at incoming or at final release testing on everything - even critical products or components - and our quality and reliabilty are very high. so it can be done.

is this an incoming inspection test? or is it a final acceptance inspection prior to you shipping the component?

Assuming that it's incoming:
what is the component?
how critical is it to the performance of your product?
Will you catch a defective component in-house, even if thru final test of the product it goes into? Or is there a potential for an escape?
what are the consequences of an escape?
what is the cost in terms of $ and time delay if caught in house?
what defect level can you tolerate in house?

if this is a product you are shipping
what is your label claim concerning performance?
 
S

shiptowns

#4
1. The component is a CCD of value of 1.5k.
2. Very critical.
3. It is inspected incoming, and final QC so if defective it will get caught. However, component caught only in incoming QC can be sent back to vendor.
4. No time delay, sincewe get them in batches of 50-200. and so far only 3 out of 5114 have failed in incoming QC.
5. Defect level. We can live with 1-2 failures per month. We recieve 500-600 per month.
6. 1 year warranty.

So how would you rationalize AQL 0.65?

Thanks
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#5
well I wouldn't. remember that a AQL of .65 will allow a defect rate of .65% (or roughly 3-4 defective units per month) to be accepted 95% of the time IF they are present in the lot.

Now your vendor seems to be shipping them at a lower rate than that
(.059%) so a .65 AQL may be safe until your vendor's process gets worse.

*I* would work with the vendor to understand the cause of the defect(s) and require corrective action and/or SPC if the cause(s) are forma factor that could be measured with contiuous data. The I would have the vendor send me the control charts with each batch. The control chart would have ALL lots for the last 6-12 months...

You may suggest a tighter AQL.

why can't you return the part to the vendor is it's caught at final inspection? that seems odd.
 
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