AQL Sampling Plan SOP / WI - Medical Device Industry

[amanm]

Hello everyone,

I work in the Medical Device Industry and we use the ANSI/ASQ Z1.4 Standards Inspection Sampling. We usually make components and also assemblies in batches / lot ranging from 200-50000 parts. I was creating a SOP document to help our QC personnel understand what is AQL Inspection and how many parts are needed to be tested and at what accept/reject ratio. If anyone of you could help me with a template for SOP Sampling Plan, I would highly appreciate.

Thank you. Have a wonderful day.

 

[Eredhel]

Do you use job travelers/routers? Could you just put an inspection OP with the required number to check? Not sure if you need your inspectors to understand all the nuances of it or just know how many to grab.

Edit: Do you already have all the AQL charts?

 

[amanm]

Yes we do use job travelers. I do not want it for the inspectors. So because some of us already knew how to use the AQL table and figure out the Sample Size, Ac/Rj ratio, we never created a SOP / WI. But now, we are planning on a FDA Inspection soon, so I would like that document to be written and controlled.

 

[Statistical Steven]

I work in the Medical Device Industry and we use the ANSI/ASQ Z1.4 Standards Inspection Sampling. We usually make components and also assemblies in batches / lot ranging from 200-50000 parts. I was creating a SOP document to help our QC personnel understand what is AQL Inspection and how many parts are needed to be tested and at what accept/reject ratio.

If you work in the Medical Device industry then Z1.4 is the incorrect methodology for sampling. Look into LQ based sampling strategies.

 

[Romvill2002]

Hello All, I need your help. I was working on validating a new component - pressure switch for a medical device that runs fluidic sampling of cells. Anyway, my sample size was 10 with ten repetitions. 9 out of 10 passed the test. Should i fail the entire validation protocol?

 

[Ajit Basrur]

If you work in the Medical Device industry then Z1.4 is the incorrect methodology for sampling. Look into LQ based sampling strategies.

Steven, just curious why would you say it as "incorrect". The ANSI / ASQ Z1.4 is one of the Recognized Consensus Standards.

Thanks!

 

[amanm]

Even I wanted to know the same. But I was more interested to get an answer to my question rather starting a whole new discussion.

 

[Proud Liberal]

I don't have any experience with the Medical Device Industry, so I don't know if this even applies to your situation. Here is a re-print of something I had posted here under a different thread.

NOTE: see attachment "OC Curves (Grant & Leavenworth, Statistical Quality Control, 5th edition).pdf" in my original post "How to Mathemetically Derive the AQL Tables given Lot Sizes".

I've always avoided using lot sizes based on the section in Grant & Leavenworth's Statistical Quality Control "Fixed Sample Size Tends Toward Constant Quality Protection" (see figures 12-1 and 12-2 in attached excerpt). This greatly simplifies incoming inspection and eliminates "games" being played with lot sizes to effect sample sizes.

Instead, I generate a AOQL plot of the sampling plan (in automotive, it is mandated that c=0) and use the maximum value to determine the worst case condition that my customer should expect (ie: n=35, c=0 yields approx 1% max value).​

 

[kuyakut]

What is the acceptance criteria stated in your protocol?

 

[kuyakut]

Hello All, I need your help. I was working on validating a new component - pressure switch for a medical device that runs fluidic sampling of cells. Anyway, my sample size was 10 with ten repetitions. 9 out of 10 passed the test. Should i fail the entire validation protocol?

I think you should follow the acceptance criteria stated in your protocol.