AQL Level Change for FDA Validated Unclassified Dental Product

E

ehrycko

#1
Hello All. I'm new to Elsmar and new to dealing with validated products so I hope someone can answer my question below.

Our co manufactures a 510K approved, validated, FDA listed dental guard which is listed as unclassified in the 510K. Currently our acceptance testing criteria for Visual defects on this product is broken up into multiple AQL levels. IE some defects are listed ANSI Z1.4 S/N .4, others at S/N .65, and the rest at S/N 2.5. Our company is making a system wide change to only have one AQL level for all visual defects using whatever the tightest current AQL level is which meets all of our commercial and other medical customers specs. so far. My question is whether or not changing the AQL level for all visual defects to Z1.4 S/N .4 will affect the validation of this particular product and require us to re-validate?

Thanks in advance for your answers.
 
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Statistical Steven

Statistician
Staff member
Super Moderator
#2
Hello All. I'm new to Elsmar and new to dealing with validated products so I hope someone can answer my question below.

Our co manufactures a 510K approved, validated, FDA listed dental guard which is listed as unclassified in the 510K. Currently our acceptance testing criteria for Visual defects on this product is broken up into multiple AQL levels. IE some defects are listed ANSI Z1.4 S/N .4, others at S/N .65, and the rest at S/N 2.5. Our company is making a system wide change to only have one AQL level for all visual defects using whatever the tightest current AQL level is which meets all of our commercial and other medical customers specs. so far. My question is whether or not changing the AQL level for all visual defects to Z1.4 S/N .4 will affect the validation of this particular product and require us to re-validate?

Thanks in advance for your answers.
Simply answer is No...you might not need to revalidate. At the time of your validation, you met easier acceptance criteria. If you can retrospectively show that your process can meet the more stringent requirements, you should not need to revalidate. Since you did not use Z1.4 for validation (well I hope you did not call it out specifically in your validation protocol), the retrospective process should be easy.

BTW, make sure you specify the LQ in addition to the AQL.
 
E

ehrycko

#3
Steven, thanks for your answer. Validation was done by an outside service but our protocols did specify ANSI/ASQ Z1.4 Inspection Level I, Single Normal, AQL ** and then the visual defects to look for were listed under there separate sections for .4, .65, & 2.5. I was under the impression that as a general rule we would be ok with the change since putting all defects at ANSI/ASQ Z1.4 Inspection Level I, Single Normal, AQL .4 is a tighter inspection level than .65 and 2.5, is this correct?
 

Statistical Steven

Statistician
Staff member
Super Moderator
#4
Steven, thanks for your answer. Validation was done by an outside service but our protocols did specify ANSI/ASQ Z1.4 Inspection Level I, Single Normal, AQL ** and then the visual defects to look for were listed under there separate sections for .4, .65, & 2.5. I was under the impression that as a general rule we would be ok with the change since putting all defects at ANSI/ASQ Z1.4 Inspection Level I, Single Normal, AQL .4 is a tighter inspection level than .65 and 2.5, is this correct?
In general you are correct. My concern is that reducing all defects to an AQL of 0.4 should cause you to reduce your catergories to a single accept reject number for all defects and not still have 3 categories. What is your accept reject number for AQL 0.4?
 
E

ehrycko

#5
with the qty per bin we use all three AQl levels end up being accept on 0 reject on 1. our sample size for .4 is 32, .65 is 20, & 2.5 is 5 pcs so with the change we would just inspect 32 pcs acc 0, rej 1
 

Statistical Steven

Statistician
Staff member
Super Moderator
#6
with the qty per bin we use all three AQl levels end up being accept on 0 reject on 1. our sample size for .4 is 32, .65 is 20, & 2.5 is 5 pcs so with the change we would just inspect 32 pcs acc 0, rej 1
Then no need to revalidate. I was worried you would have a situation like this

AQL n acc/rej
2.5 50 2/3
0.65 80 0/1
0.4 125 0/1

becomes

0.4 315 2/3

This could allow that lower AQL features could have defects.
 
N

NormanAQL

#8
AQL n acc/rej
2.5 50 2/3
0.65 80 0/1
0.4 125 0/1

becomes

0.4 315 2/3
With multiple inspections that have different sample sizes you don't add the various sample sizes. Z1.4 section 9.4 addresses this and allows for using (with approval) the code letter of the largest sample size. So that example becomes
AQL sample acc-rej
2.5 125 7-8
0.65 125 2-3
0.4 125 1-2
 

Statistical Steven

Statistician
Staff member
Super Moderator
#9
With multiple inspections that have different sample sizes you don't add the various sample sizes. Z1.4 section 9.4 addresses this and allows for using (with approval) the code letter of the largest sample size. So that example becomes
AQL sample acc-rej
2.5 125 7-8
0.65 125 2-3
0.4 125 1-2
Agreed..but he is using various sample sizes...

The real issue for me is if the defects are independent and if you can more than one defect per part with different classifications.
 
N

NormanAQL

#10
He is doing a three different inspections at different AQL levels on a single batch. Sometimes this will end up with different sample sizes for each inspection.

The Z1.4 standard, section 9.4 recognizes this and allows for adjusting the sampling plans so that all three have the same (largest) sampling size. So only a single sample has to be pulled for inspection.

The three inspections remain independent. Each class of defect is counted separately. Each defect count is compared to its corresponding accept-reject numbers. Should not be combining the accept-reject number or defect counts.

With the example the fully independent inspection pulls 3 sets totaling 315 pieces and does 315 total inspections. The combined inspection pulls a single set of 125 pieces and does 375 total inspections.

It comes down to the inspection details and how it interacts with production line. Is the inspection destructive to the part? Disruptive to the part or production line?
 
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