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Hi All,

Physical Samples management is the functionality normally used in Process industries like Pharma/Food/Chemical etc.

Following three types of physical samples are available:

  Primary samples are taken directly from the population or inspection lot.

  Pooled samples are created by pooling primary samples.

  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 :

  1. Create Sample Drawing Procedure – QPV2
  2. Assign the Sample Drawing Procedure in the Inspection Plan – QP01
  3. Create Manual Inspection Lot – QA01
  4. Check for the Physical Samples created -QA02
  5. Results recording of the Inspection lot – QA32/QA02/
  6. Usage Decision – QA32

Create Sample Drawing Procedure – QPV2

click on new entries…

Click on sample-drawing item folder

Click on New entries button.

Define primary samples, pooled samples and Reserve samples  as shown below in the three different 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.

Creation of inspection lot

here inspection lot is created manually for 100 L qty

assign the inspection plan

calculate the sample size.

Now save the inspection lot.

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.

Check for the Physical Samples created -QA02


Go to Change mode QA02.

Now go to Sample tab

Now click on button. Now we will be able to see the three types of physical samples created and each sample identified with unique number.

Results recording of the Inspection lot – QA32/QA02

During result recording system will ask the physical sample number for identification 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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4 Comments

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  1. Andrei Jercan

    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 field is empty but the sample size is calculated on the assumption you have 2 containers.

    Thanks,

    Andy

    (0) 
    1. 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 fixed number of 2

      you need to use the formula in case you need to calculate based on the number of containers

      (0) 
  2. 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 fixed number of samples through Sample drawing procedure. Whereas, there is a chance that sampling procedure linked to MIC can also have fixed 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 config related nodes below in your document for better clarity –

    A) SPRO —> Quality Management => Quality Inspection => Sample Management => a) Define Physical-Sample Types – This links to the number range picked.

    b) Define Number Range –

         b.i) Number Ranges for Physical Samples

         b.ii) Number Ranges for Physical-Sample Drawing

    B) SPRO —> Quality Management => Quality Inspection => Inspection Lot Creation => Maintain Inspection Types – Link Physical-sample type here, which is created before.

    Thanks for your checking and update the document accordingly if you feel it to be correct 🙂

    Thanks,

    Arijit

    (0) 

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