ANSI Z1.9 AQL 0.4 - What are the starting equipment expectations?

R

RJW80501

#1
Hello all--

I'm a newbie here!...and, not all that conversed in the world of ANSI, but the pharmaceutical manufacturing company I work for does use the "Z1.9 AQL 0.4" standard for their sampling plans...

Having said all that, there is a process at our company whereby we fill a single “trace number” of powder API into vials, using a gravity-fed, vibrating trough method. The vials are fed into position on under a "nozzle" and onto a checkweigher and then subsequently filled. The checkweigher will tell the nozzle equipment when to stop filling and then the vial is sorted through the associated automation (reject/accept) and moved down the process stream accordingly.

We typically have lot sizes from 6000 to 13000 vials that are run in this particular process. Regardless of lot sizes mentioned previously, we weigh sample a total of 400 vials per lot—much more than what is asked for by Z1.9 AQL .04.

Here’s where I have a problem with our sampling rate and quantity. A single lot of API, filled as described above, is actually done using either 2 or 4 completely independent filling nozzles. Our filling equipment for this process actually consists of two “fillers”, each of which has two nozzles. We can either use one or both fillers (and subsequently, 2 or 4 nozzles) to complete a vial-filling process. However, all four nozzles run completely independent of each other (e.g. each has its own hopper, vibrating trough and checkweigher). In theory, we could run 2 or 4 completely different API’s simultaneously—and that’s where I think we are not following the intent of the ANSI standard.

If I understand correctly, the in-process sampling is supposed to be representative of each process and the associated equipment used to perform that process. For our process, what occurs on nozzle “A” has no bearing on what occurs on the other nozzles, and vise-versa.

This, I believe, is where the sampling rate (for the process in question) of 400 per lot came from. They took the ANSI requirement of 100 samples (for a lot size of 10k-35k) and repeated it across all four nozzles. In reality, each nozlle will fill anywhere from 1500 to 6500 vials.

In my mind, we are actually over-sampling and just causing ourselves more work. If (as I believe) each filler assembly were treated as its own lot. Each nozzle inreality, olny fill anywhere from 1500 to 6500 vials -- the equivelent of 50 or 75 samples per nozzle, per Z1.9 (depending on lot size and # of nozzles involved). Again, it is just one API across all nozzles.

In a nutshell, what is the expectation of the ANSI standard in relationship to the equipment involved? Is the sampling supposed to be representative of each physical process, or of the whole lot e.g. of the one API that is run across 2 or 4 independent nozzles? Finally, where does ANSI spell out its expectations in regard to what the standard is applicable to (equipment and or processes)?
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#3
The answer is: both are basically correct.

A manufacturing lot would be defined as the parts that come from one filler assembly (nozzle/hopper...). You can utilize and AQL sample for each of these lots based on their sample size.

An inspection lot can be defined as the combination of the manufacturing lots. The sample size would be based on the combined lot size and the sample would have to be randomly selected among the mfg lots. If there were a failure the mfg lots would be treated as a single lot...

as to the question of oversampling: how did you arrive at a sample size of 100? and is your AQL .4%? Are you using an accept number of c=0 or c>0?

ANSI will define lot formation in the text of the standard. I don't ahve it in front of me so I can't point to the section right now. but it's basically what I've outlined above...
 
S

Sturmkind

#4
I agree with Bev D. The exact text from the standard on page 3 is:

"5.1 LOT OR BATCH. The term lot or batch shall mea 'inspection lot' or 'inspetion batch', i.e., a collection of units of product from which a sample is to be drawn and inspected to determine conformance with the acceptability criteria, and may differ from a collection of units designated as a lot or batch for other purposes (e.g., production, shipment, etc).

5.2 FORMATION OF LOTS OR BATCHES. The product shall be assembled into identifiable lots, sublots, batches, or in such other manner as may be prescribed (see 5.4). Each lot or batch shall, as far as is practicable, consist of units of product type, grade, class, size, and composition, manufactured under essentially the same conditions, and at essentially the same time."

Two alternatives for reducing your inspection effort could be considered:
1) Zero Acceptance Number C=0 Sampling Plans by N. Squeglia (index table attached herein for discussion purposes only).
2) Sampling by variables using either graphic statistics or ANSI Z1.9 (a.k.a. MIL-414).
 
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