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AQL Sampling Plan SOP / WI - Medical Device Industry
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AQL Sampling Plan SOP / WI - Medical Device Industry
AQL Sampling Plan SOP / WI - Medical Device Industry
AQL Sampling Plan SOP / WI - Medical Device Industry
AQL Sampling Plan SOP / WI - Medical Device Industry
AQL Sampling Plan SOP / WI - Medical Device Industry
AQL Sampling Plan SOP / WI - Medical Device Industry
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 #9  
Old 6th November 2017, 01:54 AM
kuyakut

 
 
Total Posts: 113
Re: AQL Sampling Plan SOP / WI - Medical Device Industry

What is the acceptance criteria stated in your protocol?

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  Post Number #10  
Old 6th November 2017, 01:56 AM
kuyakut

 
 
Total Posts: 113
Re: AQL Sampling Plan SOP / WI - Medical Device Industry

Quote:
In Reply to Parent Post by Romvill2002 View Post

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.
  Post Number #11  
Old 6th November 2017, 06:57 AM
locutus

 
 
Total Posts: 43
Re: AQL Sampling Plan SOP / WI - Medical Device Industry

ISO 2859 series should probably be looked at instead of ANSI Z1.4. While the AQL tables are contained in ISO 2859-1 there is much more proper statistical sampling methods that should be used. ANSI Z1.4 is fairly antiquated now after just being re-copied from MIL STD 105 which was already long in the tooth. The way manufacturing is done today especially with automation, small lots, and bespoke materials, Steven was probably eluding to that.
Thanks to locutus for your informative Post and/or Attachment!
  Post Number #12  
Old 6th November 2017, 02:19 PM
Statistical Steven's Avatar
Statistical Steven

 
 
Total Posts: 1,107
Re: AQL Sampling Plan SOP / WI - Medical Device Industry

Quote:
In Reply to Parent Post by Ajit Basrur View Post

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

Thanks!
The ANSI Z1,4 is incorrect for use in validation for the Medical device industry for the following reasons

1. ANSI Z1.4 requires switching rules which are not implemented during validation.

2. ANSI Z1.4 is tabled for AQL, when the regulatory framework should be on patient risk or Type II (LQ) risks.

3. ANSI Z1.4 allows for failures in your sample and still pass the sample. All failures during validation would need to be investigated.

Hope that helps.
Thank You to Statistical Steven for your informative Post and/or Attachment!
  Post Number #13  
Old 6th November 2017, 02:22 PM
Statistical Steven's Avatar
Statistical Steven

 
 
Total Posts: 1,107
Re: AQL Sampling Plan SOP / WI - Medical Device Industry

Quote:
In Reply to Parent Post by locutus View Post

ISO 2859 series should probably be looked at instead of ANSI Z1.4. While the AQL tables are contained in ISO 2859-1 there is much more proper statistical sampling methods that should be used. ANSI Z1.4 is fairly antiquated now after just being re-copied from MIL STD 105 which was already long in the tooth. The way manufacturing is done today especially with automation, small lots, and bespoke materials, Steven was probably eluding to that.
Locutus, Z1.4 is just the National Standard of ISO 2859. They are for all purposes identical (see 2013 version)
Thank You to Statistical Steven for your informative Post and/or Attachment!
  Post Number #14  
Old 13th November 2017, 06:18 PM
Romvill2002

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

Thats the problem, the acceptance criteria was based on the successfully completing 10 samples instead of basing the results on 95% CI.
  Post Number #15  
Old 14th November 2017, 12:46 PM
Statistical Steven's Avatar
Statistical Steven

 
 
Total Posts: 1,107
Re: AQL Sampling Plan SOP / WI - Medical Device Industry

Quote:
In Reply to Parent Post by Romvill2002 View Post

Thats the problem, the acceptance criteria was based on the successfully completing 10 samples instead of basing the results on 95% CI.
At 95% confidence, a sample of 10 where all were accepted gives you 95% confidence with 74% reliability. In other words, LQ is 26%
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