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AQL Sampling Plan SOP / WI - Medical Device Industry
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AQL Sampling Plan SOP / WI - Medical Device Industry
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Some Related Topic Tags
ansi z1.4 - inspection by attributes, aql (acceptable quality level), medical device company or industry, sampling plans for attribute data, sop (standard operating procedure)
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  Post Number #1  
Old 7th September 2017, 04:18 PM
amanm

 
 
Total Posts: 3
Thank You! AQL Sampling Plan SOP / WI - Medical Device Industry

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.

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  Post Number #2  
Old 7th September 2017, 04:32 PM
Eredhel

 
 
Total Posts: 273
re: AQL Sampling Plan SOP / WI - Medical Device Industry

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?
  Post Number #3  
Old 7th September 2017, 04:37 PM
amanm

 
 
Total Posts: 3
re: AQL Sampling Plan SOP / WI - Medical Device Industry

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.
  Post Number #4  
Old 7th September 2017, 04:43 PM
Statistical Steven's Avatar
Statistical Steven

 
 
Total Posts: 1,128
re: AQL Sampling Plan SOP / WI - Medical Device Industry

Quote:
In Reply to Parent Post by amanm View Post

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.
Thanks to Statistical Steven for your informative Post and/or Attachment!
  Post Number #5  
Old 3rd November 2017, 09:45 AM
Romvill2002

 
 
Total Posts: 34
Re: AQL Sampling Plan SOP / WI - Medical Device Industry

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?
  Post Number #6  
Old 3rd November 2017, 10:12 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,214
Re: AQL Sampling Plan SOP / WI - Medical Device Industry

Quote:
In Reply to Parent Post by Statistical Steven View Post

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!
  Post Number #7  
Old 3rd November 2017, 10:22 AM
amanm

 
 
Total Posts: 3
Re: AQL Sampling Plan SOP / WI - Medical Device Industry

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.
  Post Number #8  
Old 3rd November 2017, 12:15 PM
Proud Liberal's Avatar
Proud Liberal

 
 
Total Posts: 158
Re: AQL Sampling Plan SOP / WI - Medical Device Industry

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).

Last edited by Proud Liberal; 3rd November 2017 at 04:53 PM. Reason: uploaded reference to attachment from different post
Thanks to Proud Liberal for your informative Post and/or Attachment!
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