What if I find a defect after AQL (Inspection)? Pharmaceuticals

Jim Wynne

Leader
Admin
#11
Hello, Alan,
I am familiar with Trigger Alarm Systems, rather than AQL.
My question is: If my sampling lot size is 200, with acc as 7, rej as 8, found 8 defective units when I am at the 50 count, do I stop the inspection and reject the whole batch? And also if after taking a fresh sampling batch, another 200, should I use the same method?
Thank you,
More information is needed:
  • Is a static population being sampled?
  • Are you sampling a lot from a supplier, or material that will be further processed and/or sent to a customer?
  • What sort of criteria are being used in inspecting the samples?
  • How did you arrive at your sample size and acc/rej numbers?
  • Would you really accept 8 defectives?
 
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Zero_yield

"You can observe a lot by just watching."
#12
If I'm understanding the question correctly, I would generally recommend continuing to test the 200 even if you've had 8 failures in the first 50.

Once you've failed the lot, I'm assuming someone is going to conduct an investigation (either internally or at your supplier, if it's a purchased part). The person conducting the investigation is going to need to define the problem and assess the risk and impact. If you haven't finished your sampling, it could be hard to impossible to understand the extent of the issue. If you stop inspection, you might miss the quantity of defects or the range of defect types.

For example, compare two scenarios: You test the other 150 and have 0 additional failures, and you test the other 150 and have 24 additional failures (i.e., about 8 for every 50). If 15%+ of the batch is defective, it points to a much bigger failure that needs immediate correction than being a hair over AQL.

If you don't finish your sampling, you also might miss another issue with the product. For example, let's say these are a molded plastic component you purchased from a vendor, and the inspection is cosmetically inspecting 50 samples from the beginning of the run, 50 samples from the end of the run, and 100 samples pulled randomly in-between. Let's say you've only checked 50 samples from the beginning / middle of the run and found excess flashing around the edges. If you don't check the parts from the end of the run, you might miss that there was discoloration, malformed parts, or embedded particulate that didn't show up until the end of the run.

Of course, this depends somewhat on the time / effort / expense of testing each unit. The company I work for has a 100% inspection for certain characteristics. The general rule of thumb is that if the first ~20% of a batch all fails, stop inspection and escalate to a nonconformance. It's just not worth the equipment and operator time to keep inspecting something we're reasonably certain is going to fail anyway.
 

Zero_yield

"You can observe a lot by just watching."
#14
Thank you very much for your quick response. I would say the rule of thumb applies here.
Just for some more context around it: That started as a decision between Manufacturing, Quality, and Engineering. It's ultimately a business decision - the product is being scrapped either way, so there's no customer/consumer risk. It's all producer/business risk. We're consciously accepting the cost if any of those parts might have passed to reduce the cost of inspecting units we suspect will fail anyway. That is how we've assessed minimizes the financial impact to the business for our particular process and product.

Since you're inspecting to an AQL level, you're definitely failing the inspection either way, so I can see the logic in stopping the inspection and scrapping the batch. Depending on the situation, you may want to get the right people in the room to discuss the financial impact and make the right decision for your particular business, process, and product.
 
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