SAMPLING OF PACKING MATERIALS

SAMPLING OF PACKING MATERIALS

1.0  OBJECTIVE : To lay down a procedure for sampling of packaging materials.

2.0  SCOPE : To describe the procedure for sampling of Primary packing materials i.e. Aluminium Foil, Blister Aluminium Foil, PVC Film etc. and secondary packing materials i.e. Cartons, labels, Leaflet shipper etc.

3.0  RESPONSIBILITY :Quality Control Executive/Officer

4.0 ACCOUNTABILITY : Quality Assurance Manager

5.0  PROCEDURE

5.1  On receipt of the Goods Receipt Note {GRN} from the Stores check the detail given on GRN and note the details of GRN in Packaging Material Sample Inward Register kept  in Packing Material Testing Lab. Note  down  the SAP Lot  number as Analytical Reference number(A R  No.) and the supplier’s  Lot No. (if any) shall  be  considered  as  Batch number.

5.2 Based on the number of containers listed in GRN select the number of packages to be sampled as per the sampling plan given in Table -1a

5.3 Enter the details of sampling containers in SAP and print out “SAMPLED” label.

5.4  Go to the appropriate “UNDER TEST” packaging material storage area and identify the material to be sampled from the label on the pack.

5.5 Ensure that the warehouse pastes the “UNDER TEST” labels correctly.

5.6 Verify the number of packages as mentioned in GRN.

5.7 Check the packing condition of the material and the details mentioned on the labels.

5.8 In case of any discrepancy in step no. 5.5, 5.6 and 5.7 inform the Quality Assurance Manager and the Warehouse In-charge for corrective action.

Sampling of Primary & Secondary packing materials: 

5.9 Open the packages carefully and observe the material for any abnormality. In case the packing material is found in damaged condition, the same shall be informed  to Manager QA.

After decision of Manger QA the material shall be further segregated or rejected.

In case of segregation the packs found in good condition shall be sampled, the remaining quantity shall be rejected. Prepare the rejection note for damaged containers / roll / packs and paste “REJECTED” label and ensure that such containers/packs/rolls are transferred to rejected area.

5.12  Withdraw the samples randomly from different containers equal to sample size as per Table -1b.

5.13 Close the containers to be sampled with the help of BOPP Tape/ties.

5.14  Protect the samples from external contaminants like dust, water, and direct sunlight during sampling and testing operations.

5.15  Paste the ” SAMPLED”  label on  the containers  from which  the  sample  is  collected.

5.16 Carry out testing of the packaging material  as per the  laid down specifications of the   respective material.

5.17  Record the  dimensions observed  for the  required  number of samples  as specified in individual Physical Inspection Report.

5.18 Inspect the total number of samples of packaging materials based on Critical, Major or Minor visual defects. These defects are detailed on the format of individual Physical inspection reports.

5.19   Note down the total number of defects, which are categorized under the headings critical, major and minor.

5.20 Compare with the accept and reject numbers against the quantity of number of samples collected from Table 1 b.

5.21  If the defects in any category is equal to or more than reject number, inform the  Quality Assurance Manager for rejection of the consignment.

5.22  All excess packaging materials after completion of testing and reporting shall be destroyed. 

Table 1-a

No. of Cases, Rolls or Boxes or Bags in a lot Cases, Rolls or Boxes or bags to be

 sampled

1-8 2
9-15 3
16-90 5
91-150 8
151-280 13
281-500 20
501-1200 32

Table 1-b 

MIL – STD – 105 D SINGLE SAMPLING PLAN, GENERAL INSPECTION LEVEL – I

(NORMAL INSPECTION)

Batch or Lot Size (Nos.) Sample Size (Nos.) AQL=0.25 % AQL=0.40 % AQL=1.0% AQL=2.5% AQL=4.0%
A R A R A R A R A R
2-8 2 0 1 0 1 0 1 0 1 0 1
9-15 2 0 1 0 1 0 1 0 1 0 1
16-25 3 0 1 0 1 0 1 0 1 0 1
26-50 5 0 1 0 1 0 1 0 1 0 1
51-90 5 0 1 0 1 0 1 0 1 0 1
91-150 8 0 1 0 1 0 1 0 1 1 2
151-280 13 0 1 0 1 0 1 1 2 1 2
281-500 20 0 1 0 1 0 1 1 2 2 3
501-1200 32 0 1 0 1 1 2 2 3 3 4
1201-3200 50 0 1 1 2 1 2 3 4 5 6
3201-10000 80 0 1 1 2 2 3 5 6 7 8
10,001-35000 125 1 2 1 2 3 4 7 8 10 11
35001-150000 200 1 2 2 3 5 6 10 11 14 15
150001-500000 315 2 3 3 4 7 8 14 15 21 22
Over 500000 500 3 4 5 6 10 11 21 22 21 22

NOTE :

  • In case of Aluminium Foil, Blister Aluminium Foil, Box Strapping Roll, PVC Film & Shrink Film, take out one meter of sample from each box sampled as per Table I -a.
  • In case of Aluminium foil use only three samples for Gram mage testing.
  • In case of BOPP tape & Polybag (for dispensing purpose) take out one sample from each box sampled as per Table I -a.
  • This sampling plan will not be applicable for packaging materials like corrugated boxes, corrugated trays, partition plates etc. For these items three number of samples will be drawn.
  • – From Military Standard, sampling procedures and tables for inspection by attributes, US Dept. of Defence, MIL-STD-105 D, 1963. 

Specimen of  “UNDER TEST” and  “SAMPLED” Labels

MFR of Sildenafil Citrate Tablets

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