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K V Kumar
April 21, 2015 3 minute read
Hi All,
Physical Samples management is the functionality normally used in Process industries like
Pharma/Food/Chemical etc.
Primary samples are taken directly from the population or inspection lot.
Reserve samples are primary samples that are reserved as specimen samples.
Number of samples to be taken for above three types samples is calculated by sample drawing Procedure.
Scenario : Lets say I received a material from a vendor 100 L material supplied in two containers each 50
L.Now I have to check this material . so I need to take samples from each container lets say I take 1 L from
each container. so my primary samples will become two (each 1 L) as I take sample from each container.
Primary samples are the ones directly taken from inspection lot qty. Now the above two primary samples are
mixed to make a pooled sample. In my example it will become 1+1 = 2 L. Pooled samples are created by
mixing primary samples. these pooled sample is used for analysis. Reserve samples are taken from lot
directly and not used for immediate analysis. they are stored for future reference as per regulatory norms.
Normally they are destroyed once the expiry of the material is reached. in our case let say 0.25 L taken
separately and stored.
Process Flow :
De ne primary samples, pooled samples and Reserve samples as shown below in the three di erent tab…
Finally save the sample drawing Procedure.
Assign the inspection points (200) & Sample Drawing Procedure in the Inspection Plan header – QP02
During creation of Inspection plan assign the inspection points (200) & Sample Drawing Procedure in the
header as shown below
Complete the creation of inspection plan.
During saving of the inspection lot physical samples will get created as per the Sample drawing procedure
assigned in the inspection plan. Check for the same in QA02/QA03.
During result recording system will ask the physical sample number for identi cation as shown below. to
distinguish for which physical sample RR is done ..
Once RR done complete Usage decision as per the regular process
Thanks
Kumar
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5 Comments
Nitin Jinagal
Regards,
Nitin
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Former Member
Hi Kumar,
Could you please update the example with the inspection plan used? it would be useful to see the mic’s with
their partial sample type and their qties. Didn’t get why in your screenshot the container eld is empty but
the sample size is calculated on the assumption you have 2 containers.
Thanks,
Andy
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Sourabh Maheshwari
the sample size here is not calculated based on the number of containers
if you see the screenshots for physical sample, he has provided a xed number of 2
you need to use the formula in case you need to calculate based on the number of containers
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Arijit Banerjee
Hi Kumar,
This is indeed a very useful document which helps many of us to clarify our doubts and try this setup.
Thanks for creating this nice document.
Please can you can add a few more critical touch-base points to improve the depth of contents in this
document –
a) What Sampling Procedure was used for MIC for the insp plan used in your example.
b) In case Sampling Procedure was used, what is the Sampling type used against it? [Ex; 100 – Fixed
Sample, or 200 – 100% inspection, or 300 – Use Sampling Scheme, or 400 – Percentage Sample]
c) You draw xed number of samples through Sample drawing procedure. Whereas, there is a chance that
sampling procedure linked to MIC can also have xed sample/% sample, etc. So, in those cases, which
would take a precedence and how are things are being calculated for your example?
d) You have not mentioned for your 89 inspection type, why physical samples with number range 8xxxxxxxx
is picked? Where is the linkage? Probably, you can add the con g related nodes below in your document for
better clarity –
A) SPRO —> Quality Management => Quality Inspection => Sample Management => a) De ne Physical-
Sample Types – This links to the number range picked.
b) De ne Number Range –
Thanks for your checking and update the document accordingly if you feel it to be correct
Thanks,
Arijit
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Narendra Reddy
Dear Kumar,
Thanks for such wonderful document. We, have a scenario for time based in process sampling inspection
based on every hour depending on sampling point. Samples from Tank A – one hour based; Samples from
Tank B – two hour based likewise.
I have maintained a seperate option in master receipe t.code C201 & C202 like below
Operation 20 – Tank A – and in Quality Data Tab selected Time-related; TFac 1.00 HR
Operation 30 – Tank B – and in Quality Data Tab Selected Time-related; TFac 2.00 HR
I think, somewhere i am missing further details to mention like to inform the system that the particular order
planned to run for 12 hours or 18 hours. I tried this to maintain in the process order schedule dates and time
start and time end. But it does not work ?
I read on the thread, to maintain the time frame on task-list – i could not get this anywhere to de ne; also i
feel this is not a right place to inform the system how long the production is planned.
Finally, when i go to QE51N for result recording, i could just nd only one inspection sample data to enter…
and their is a button for Next Inspection (shortest interval). I think it is not creating enough inspection
samples data for results recording (assuming 8 hours operation, need 8 samples data to enter) similar to
Quantity based.
Please help.
Narendra
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