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 :
- Create Sample Drawing Procedure – QPV2
- Assign the Sample Drawing Procedure in the Inspection Plan – QP01
- Create Manual Inspection Lot – QA01
- Check for the Physical Samples created -QA02
- Results recording of the Inspection lot – QA32/QA02/
- 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 . 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.