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Result Recording and Sample calculation

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

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1 Answer

  • Best Answer
    Posted on Aug 19, 2011 at 02:39 PM

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

    FF

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