Incoming Inspection Sampling Plan ISO 2859-1/ ISO 2859-2

Hi,

We are in a process to create our incoming raw material inspection procedure. We are planning to use ISO 2859 sampling by attributes scheme.
I am not sure whether to use ISO 2859-1 or ISO 2859-2.

Also, I have found that when number of lots are less than 10, ISO 2859-2 should be used. If any one from medical manufacturing guide me on determining sampling plan, I will appreciate it.

Regards,
Hitesh

hitesh said:

Hi,

We are in a process to create our incoming raw material inspection procedure. We are planning to use ISO 2859 sampling by attributes scheme.
I am not sure whether to use ISO 2859-1 or ISO 2859-2.

Also, I have found that when number of lots are less than 10, ISO 2859-2 should be used. If any one from medical manufacturing guide me on determining sampling plan, I will appreciate it.

Regards,
Hitesh

Click to expand...

2859-1. This gives you the sampling scheme by AQL for lot inspection. Sec 5 of the 2859-1 gives you the details.

Hi Somashekar,

I have read ISO 2859-1 and ISO 2859-2. Based on my understanding of these standards, ISO2859-1 is for continuous lots which means it is good for continuous production lots. For isolated lots, ISO 2859-2 is reffered. However, I am not sure how you determine what is continuous lots and what is isolated for incoming inspection.

Thanks for your feedback.

Regards,
Hitesh

hitesh said:

Hi Somashekar,

I have read ISO 2859-1 and ISO 2859-2. Based on my understanding of these standards, ISO2859-1 is for continuous lots which means it is good for continuous production lots. For isolated lots, ISO 2859-2 is reffered. However, I am not sure how you determine what is continuous lots and what is isolated for incoming inspection.

Thanks for your feedback.

Regards,
Hitesh

Click to expand...

Lots coming out from a controlled process. Controls on the process can be various and several lots could be coming out of such a process at various time intervals, each such identified lot is given the consideration.
Get some idea now Hitesh ...

If, I go to inspect a lot, but just for one time in the year, this is a isolated lot?

Although the process, during all the year have the same behaviour, but without any inspect with iso 2859

Hello guys,

I've been a member of this site since last year but this is the first time I'm going to ask a question. Since the MIL STD 105E was obsolete and has been replaced by a number of standards. I would like to ask what standard(s) should be appropriate for Glass Plastic Reinforced (GRP) product where the product characteristic involved, hardness, dimension and appearance. I was employed in a semiconductor company before and we are employing MIL STD 105 because the parts were small ang the lot is continuous. Unlike here in GRP manufacturing, products are big and usually delivered by batches. I would appreciate any advise from you guys. Thanks

Sampling plans such as Z1.4 and ISO 2859 are AQL based plans for attribute characteristics. The value of these standards are the switching rules, not the sample size selection. The FDA wants you to show your sampling plans with regard to the Type II error. More importantly, though the standard allows defects in a sample, in most FDA regulated industries, you must use zero defect acceptance plans or justify and document how nonconformity in the sample is handled.

ISO 2859-2 is for the isolated lots. If you are manufacturing products in batches, using this standard might be a good idea.