Device tracking sampling plan for device tracking audits - Medical device industry

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Rios oxnard qe

Does anyone know of a standard sampling plan such as ANSI/ASQC Z1.4 that has been used to determine the sample size for a device tracking audit or any other type of audit. I am in the medical device industry and we need to come up with a sampling plan for our device tracking audits. I was told I could use Z1.4 but have only used it for incoming inspection. I hope you can help. Thank you.
 

Al Rosen

Leader
Super Moderator
Rios oxnard qe said:
Does anyone know of a standard sampling plan such as ANSI/ASQC Z1.4 that has been used to determine the sample size for a device tracking audit or any other type of audit. I am in the medical device industry and we need to come up with a sampling plan for our device tracking audits. I was told I could use Z1.4 but have only used it for incoming inspection. I hope you can help. Thank you.
The FDA Guidance document reference MIL-STD-105E, which is equivalent to ANSI/ASQC Z1.4. I've attached the guidance and the mil standard in case you aren't familiar with them.
 

Attachments

  • Medical Device tracking guidance.pdf
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  • 105E.pdf
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Jim Wynne

Leader
Admin
Al Rosen said:
The FDA Guidance document reference MIL-STD-105E, which is equivalent to ANSI/ASQC Z1.4. I've attached the guidance and the mil standard in case you aren't familiar with them.

Thanks for the attachments, Al.:agree1: I was having a discussion about 105E with a coworker yesterday and couldn't find my old copy.
 

Al Rosen

Leader
Super Moderator
Jim Wynne said:
Thanks for the attachments, Al.:agree1: I was having a discussion about 105E with a coworker yesterday and couldn't find my old copy.
I have the handbook too. It's too large to post, but I can split zip it and e-mail if you pm your address to me.
 
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Rios oxnard qe

Since the MIL-STD-105E was first cancelled in February 1995, and pointed to ANSI/ASQC Z1.4 as a possible replacement, we decided to try ANSI/ASQC Z1.4. The DoD cancelled MIL-STD-105E again in March of 2001 but this time without replacement. However, my understanding is that even though it was cancelled a company can still use it. All it means is that the US Government is abdicating responsibility for it.

One of my reference books states that there is only 3 major difference between the two sampling systems:

1. non-conforming is substituted for defects in ANSI/ASQC Z1.4
2. optional procedure for switching from normal to reduced inspection
3. scheme aspect of sampling is emphasized in ANSI/ASQC Z1.4

I would like a copy to review and help me decide which to use, thank you.
 

Jim Wynne

Leader
Admin
Rios oxnard qe said:
Since the MIL-STD-105E was first cancelled in February 1995, and pointed to ANSI/ASQC Z1.4 as a possible replacement, we decided to try ANSI/ASQC Z1.4. The DoD cancelled MIL-STD-105E again in March of 2001 but this time without replacement. However, my understanding is that even though it was cancelled a company can still use it. All it means is that the US Government is abdicating responsibility for it.

One of my reference books states that there is only 3 major difference between the two sampling systems:

1. non-conforming is substituted for defects in ANSI/ASQC Z1.4
2. optional procedure for switching from normal to reduced inspection
3. scheme aspect of sampling is emphasized in ANSI/ASQC Z1.4

I would like a copy to review and help me decide which to use, thank you.

I'll be happy to forward copy (thanks to Al Rosen doing the same for me). The file is 4.8mb zipped; let me know if you have a broadband connection or if you need it broken up further.
 
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