Result Recording and Sample calculation

[Former Member]

Dear Experts,

I have a concern regarding the sampling designed

According to the sampling plan in local SOP the samples to be taken for all ZAPI and ZRAW as per below points.

Withdraw sample from each container for Identification test. Here the sample size will very form material to material.

Make a pool of sample according to No. of containers /5 for Other tests, like Assay,LOD,Potency,Microbiological tests etc...

And there is Retention Sample.

To meet this requirement, I have designed the sample management like this......

There will be two partial Samples for Sample drawing procedure

Partial Sample 010 has formula for Primary Samples :- P2.

Partial Sample 010 has no Pooled Sample

Partial Sample 010 has Reserved Sample; Fixed No 1; along with Sample Size.

Partial Sample 020 has Primary Sample IF P2>=5 THEN P2/5 ELSE P2 to meet the pooling of containers for other test than Identification.

Partial Sample 020 has Pooled sample 1

Partial Sample 020 has no Reserved Sample.

No at the other end In inspection plan we have two operations;

Operation 0010 ; Identification where all the MICs will be linked with Partial Sample 010 and Sample size for Identification test will be assigned along with Sampling procedure.

Operation 0020; QC Laboratory where all the MICs will be linked with Partial Sample 020 and Sample size for Chemical and Micro Analysis tests will be assigned along with Sampling procedure.

For an example for Material X:-

Sample Size = 2gm, for Identification (ID) is maintained at respective MICs in Inspection plan

Sample Size = 50gm, for Chemical and Micro Analysis tests maintained at respective MICs in Inspection plan

Sample Size = 150gm maintained at SDP for Reserved.

If we receive a consignment 10 Containers for Material X. Then system will create sample as below.

10 Primary samples from Partial Sample 010 of SDP each have sample size 2 and result needs to be recorded for each sample. This is very lengthy hence not acceptable to business.

02 Primary samples from Partial Sample 020 of SDP each have sample size 25 and result not required to be recorded for it.

01 Pooled samples from Partial Sample 020 of SDP each have sample size 50 and result needs to be recorded for it.

01 Reserved Sample (There is no issue with this so not elaborating more)

Total Sample size is 220 (20+50_150)

{10*2=20 Primary Samples for ID

2*25=50 Pooled Samples for Chem and Micro

150 Retain Sample}

Now the requirement is We don't want to record result for all 10 Primary sample from Partial Sample 010 but want to calculate the sample size as per above quantity.

Kindly give me some guidance!!!!!!!

Regards,

Shyamal

[former_member42743 · Accepted solution]

What happens if you create a pooled sample for 010 and use summarized result recroding for it?

FF

[Former Member · Accepted solution]

Hi Craig,

When I try to use pool sample for 010 is not calculating the sample size as 2*10 = 20 (2g for Each Primary Sample X 10 = 20g in Total)

But is calculating as 2/10 = 0.2 for each Primary sample.

Regards,

Shyamal

[former_member42743 · Accepted solution]

I think what you'll need to do is create a sampling procedure for each container type you expect to receive. So if you get BUOM KG's in 55 gal drums, you'll need a sampling procedure for drums. If you get it in a 2000lb super sac, you'll need a sampling procedure for that. And of course separate inspection plans for the drum material and one for the super sac material since the same characteristic will specify different sampling procedures.

The sampling procedure will specify a sampling scheme for that container. I.e. for the super sacs with normal inspection you would specify 0-2000 = 2 g sample. 2001-4000 - 4 g sample. 4001-6000 = 6 g. etc. etc..

When the sample size for the ID characteristic is figured out, it will be 10g or 20 g. Whatever. It is based on the total lot size.

The sample drawing procedure will take the sample size of 20 g now, and apply that to the pooled sample. That will be divided by the primary samples, (P2 = 10) for a set of 10 primary samples of 2 g each.

A second alternative would be to create the inspection plan in the alternative UOM. Say super sacs. You receive in 10. You could create a large sampling scheme for this where a lot size of 1 = 2 g. 2 = 4 g, 3 = 6 g, etc... While it would be a large sampling scheme, you'd only need one sampling procedure and one sampling scheme. The inspection plan will see a BUOM of 20,000Kg but convert that to 10 super sacs. The sampling procedure would see an inspection lot qty of 10 super sacs. The sampling scheme calcualtes a sample size of 20 for a lot size of 10. The sample size is applied to the pooled sample and then distributed to the 10 primary samples.

This should work for all container types. If the plan was in drums, 20,000 kgs might calcuate out to 30 drums. The sampling procedure looks up 30 to find that is 60 and returns a sample size of 60g. That is applied to the pooled sample and divided amoung the primary samples, (P2 = 30), for 2 g per primary sample.

FF

[Former Member · Accepted solution]

Hi Craig,

I think the first option is brilliant. But to implement that I have to collect so much data,

normally how much material is used to received in each container, and based on that I can design my sampling schema.

will collect the data, implement the same and revert..

Thanks again!!!!!!!!

Regards,

Shyamal

[former_member42743 · Accepted solution]

Yes.. the first alternative is a lot of data.

The second is less data but only works if the amount per container you pull for sampling is the same regardless of container. i.e. if you pull 2 grams per drum, you also pull 2 grams per super sac. If not then you need separate procedure/schemes/plans for each.

You might be able to get with two types however. A small sampling plan and a large sampleing plan.

So for all containers under say 1000 lbs (drums and smaller), you use sampling plan A/scheme A and plan A.

For containers over 1000 lbs you use sampling plan B/scheme B and plan B.

That might reduce the amount of data you need by a lot.

Let me know how you make out.

FF

[Former Member · Accepted solution]

Hi FF,

I am very much close to get the solution, but some thing is wrong pls guide me where and what needs to be be corrected.

I have material with Base UOM KG and I need to sample in G only.

I have created as Sampling Schema:- where

Valuation Parameter is u201CWithout Valuation Parametersu201D

Sampling tables is u201CInsp. Severitiesu201D

Inspection severity is 004-Normal Insp.

And I have pasted the table as below (Here, it is concluded that for this material always the quantity / container will be 50Kg only)

Lot Size =========> Sample Size

50==============> 2

100=============> 4

150=============> 6

... =============>...

... =============> ...

10000000000=====>100

(it is the maximum lot size by default system selects)

I have created a Sampling procedure where I attached this schema. And this sampling procedure is assigned to all those characteristic on the Operation where the partial sample is 010.

When I calculate sample for the the inspection lot Where the lot size is 100Kg and received number of containers are 2 EA.

it is calculating 300g as total sample size

where It is picking

100g for two primary samples for partial sample 010, creating two primary samples of 50g each and a pooled sample of 100g

(This is not correct, since the lot size is 100, I am expecting it should pick 4 as a sample size but it is always picking 100 from the maximum lot size only, and this is happening for any no of containers )

Here I need you guidance, why it calculating like this, the rest of sample calculation is okay.

Your inputs will be highly helpful to me since I am almost close to this, only this last section is out of my understanding.

Regards,

Shyamal

[former_member42743 · Accepted solution]

I assume your inspection plan UOM is "g" (grams).

If you received 100kg when it is assigned to the plan the lot size is 100,000 G now and therefore it picks 100 as your lot size from your sampling scheme.

From your posting you say your lot size is 100Kg of 2 containers of 50kg each.

Thus your container size is 50,000 g

You sampling scheme should be

50,000 ===> 2

100,000 ===> 4

150,000 ===>6

200,000 ===8

etc...

FF

[Former Member · Accepted solution]

Hi FF,

Thanks a ton, a billion Ton!!!!!!

Now it is working exactly as per requirement.

The only thing I would like to share is, it has nothing to do with the UOM in Inspection plan at Header level, it is considering UOM at MIC level only.

Thanks Again!!!!!!!!

Regards,

Shyamal

[former_member42743 · Accepted solution]

Thanks for the important tidbit about the UOM at the MIC level being used. I've never tried having a different MIC UOM from the header UOM.

That will come in handy.

FF