Applying AQL when 0 defects are acceptable

M

MEDQA

#1
Hello - I'm looking to justify / validate a chosen inspection qty due to a Corrective Action. I'm not sure AQL is the appropriate method as we can't accept any qty of defects. Will try to explain the situation below, keep in mind I'm new to this wonderful stuff.

A sales rep received 4 defective parts, so we 100% inspected current inventory, 17 of 135 parts (13%) were found to be defective.

Testing and sorting methods were developed along w/ Root Cause and Corrective Action. Along with new sorting / inspection measures, parts were 100% inspected before sterilization, we want to do a final inspection on a sampleling of parts when they return, if all goes well alleviate the need to 100% inpect again.

My initial thought was that if we inspect 13% of the 466 pcs and get 0 defects we are okay. If any defects are found we should 100% the balance?

Note - as per AQL, defect seems to be Critical / Major with no harm to person, the part will simply not function.

Any direction would be greatly appreciated.
 
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#2
Welcome

Did you see the list of associated threads below?

Check into a C=0 sampling plan discussion thread for some ideas.

No sampling plan will guarantee zero defects, for true zero defects you will need strong poka yoke (search the Cove.

In fact 100%, 200% or 500% inspection will not guarantee zero defects....

And just for completeness SPC will not guarantee zero defects, not even the 6 Sigma folk would go that far

If you really need zero, bring on the poka yokes....

Was this any help?
 
M

MEDQA

#3
Hello - I'm also not sure how to decide on the Acceptance Quality Limit, I read that most medical devices would use .040, .065 or 1.0 related to a major defect. I reviewed a 0 acceptance Number Sample Plan which shows that we would need to pull 315 pcs @.040 or 100%.

The subject will be up for discussion at a meeting, & will most likely be decided by upper management. I just wanted to offer any input possible for what qty would be appropriate as per ISO 13485 etc.

Reason for not wanted to 100% after sterilization is that the inspection process at this point subjects the parts to acquiring another problem.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#4
Hello - I'm looking to justify / validate a chosen inspection qty due to a Corrective Action. I'm not sure AQL is the appropriate method as we can't accept any qty of defects. Will try to explain the situation below, keep in mind I'm new to this wonderful stuff.

A sales rep received 4 defective parts, so we 100% inspected current inventory, 17 of 135 parts (13%) were found to be defective.

Testing and sorting methods were developed along w/ Root Cause and Corrective Action. Along with new sorting / inspection measures, parts were 100% inspected before sterilization, we want to do a final inspection on a sampleling of parts when they return, if all goes well alleviate the need to 100% inpect again.

My initial thought was that if we inspect 13% of the 466 pcs and get 0 defects we are okay. If any defects are found we should 100% the balance?

Note - as per AQL, defect seems to be Critical / Major with no harm to person, the part will simply not function.

Any direction would be greatly appreciated.
If your parts were good before sterilization, what in the process caused the defects? Fix the process, don't inspect after sterilization.
 
M

MEDQA

#5
The Non conformance shares the root cause of a process problem which we believe to be fixed and supplier recall which has been sorted. Checking parts after sterilization will be part of our validation.

The parts found to be defective in the initial sort and received by the sales rep, were also 100% inspected before sterilization....
 
Q

qualitytrec

#7
Welcome to the cove. To try to answer your question I would need more info. What is your lot/batch size. Sampling plans are based on lot size or total number of pieces. I am with the others who suggested putting error prevention in place. Poka-yoke is important for zero defects because the issue needs to be taken care of in the process.
Quality 101 is if you make defectives you will ship defectives.

Mark
 
M

MEDQA

#8
Lot size is 466 pcs.

Just to clarify, there were 2 potential root causes, supplier recall or a process issue. Defects could be the result of 1 or both.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#9
Lot size is 466 pcs.

Just to clarify, there were 2 potential root causes, supplier recall or a process issue. Defects could be the result of 1 or both.
What do you mean by one of the potential root causes being a supplier recall?
 
M

MEDQA

#10
Hello -

The supplier issued a recall months ago for non conforming material which was not communicated internally by the responsible party (who is no longer with us). We learned of the recall when we started the internal investigation to determine the root cause of the non functioning part the sales rep received. In the investigation we found a step in the process that had the potential to cause a similar defect as the supplier's non conforming material.
 
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