Sampling Plan and Procedure wanted - Chemical Trading Company

raghu_1968

Involved In Discussions
#11
OK. Thank you. Now in the case of square root(N) +1 which equals the number of containers to sample, what method do I use to determine how many samples from each container?
The container which i mean is "a drum". The statement which is provided previously has to be read as:

1. If the number of drums from the lot/batch is less than 5, then all the drums have to be sampled.

2. If the number of drums from the lot/batch are more than 5, then Square root(N) + 1 has to be followed.
 
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chimie

#12
Yes, I understood that part, but I wanted to know how to determine how many samples from each drum? Thank you.
 

v9991

Trusted Information Resource
#13
Yes, I understood that part, but I wanted to know how to determine how many samples from each drum? Thank you.
quantity of sample from each drum should be determined by :-
amount required to perform the single identification test +
total sample required for complete-analysis

above logic sounds well with fewer no. of containers;
where there are more no. of containers, we simply draw representative samples from each drum, collect samples for individual-representative samples and pool/blend(bag) rest of quantity for pooled analysis; (replace the remaining quantity into a identified containers)


however, i would like to reiterate the point that...square root(n) + 1 is old practice...you might be forced to upgrade through some audit observation...
(the point is, through square root procedure, you are not inspecting individual container...hence not ensuring the quality of material....)
 
C

chimie

#15
Got one more question, please. Can we do a complete analysis testing on at least 3 different lots of material that come in and then reduce the testing to just critical tests after having confidence that we have a reliable supplier? Thanks!
 

v9991

Trusted Information Resource
#16
it depends on regulations pertaining to respective geographies/countries. where you operete and also where you supply...
for US ...YES,
in India, ...NO
for EU...not sure...

but I am not really sure if 3 batches are adequate...
whatever be the number...it ought to be supported by
1) suitable systematic assessment (viz., audits, trend of OOS / complaints at partners end...
2) criticality of materials to your product performance
3) !!! etc !!! need to back it up with your own procedures & its assessment of effectiveness of such reduced testing program.
4) you will also need to account for technical/logistic feasibility of particular analytical technique!!! (though this would not provide any marks in the quality/technical reviews...)
if you look at it,,, each one of points above needs to have specific-assessment criteria outlined in your procedures, and then have suitable review mechanisms built into your system to take care of roll-back as and when required...

hope this helps.
 
Last edited:

raghu_1968

Involved In Discussions
#17
however, i would like to reiterate the point that...square root(n) + 1 is old practice...you might be forced to upgrade through some audit observation...
(the point is, through square root procedure, you are not inspecting individual container...hence not ensuring the quality of material....)
Can you elaborate this little bit. Interested to know about the alternate to square root(n) + 1.
 

v9991

Trusted Information Resource
#18
Can you elaborate this little bit. Interested to know about the alternate to square root(n) + 1.
1) alternate is already mentioned in my earlier post...sample each container and run physical observation & identification/critical test on that...+ pool the sample and perform complete analysis on same. (
particular to raw materials... the uniformity/homogeneity have impact on output/quality of product...hence, its our responsibility to ensure that identity, purity of materials...leads to above recommended approach)

2) another alternative is discussed which is similar to that of next one.. here in WHO document...
ref. pg 18 of http://apps.who.int/prequal/info_general/documents/TRS929/WHO_TRS_929-Annex4.pdf

3) another alternative usually followed in packaging materials is the sampling plans providing stringent/tighetened-normal-reduced criteria (derived from mil standard of acceptance sampling) ...again depending upon the level of confidence required for specific material - process and partner's performance etc.,
just in case if you have not already seen this...
ref. tables secion V...MIL-STD-105D...http://www.woodencrates.org/standards/MIL-STD-105.pdf

hope this helps...
 
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