sampling of packaging materials

1.0 Purpose
1.1 To describe a procedure for sampling of Packaging Materials.

2.0 Scope
2.1 To describe the procedure for sampling of Primary packing materials i.e. Aluminum Foil, Blister

Aluminum Foil, PVC Film and Bottles etc. and secondary packing materials i.e. Cartons, labels,

literatures, etc at A B C Pvt. Ltd., Roorkee (UK), India.

3.0 Responsibility
Officer QC/ Executive QC Preparation of SOP and follow the procedure of SOP for the sampling of raw material
Assistant Manager Reviewing and Training of SOP
Manager QC Implementation of SOP
4.0 Accountability
4.1 Manager Quality Control is accountable for implementation and compliance with SOP.

5.0 Procedure
5.1 Daily in the morning, Officer QC (Packaging) shall take the report of materials receipt from

warehouse and make the entry in Sample Inward Register kept in Packing Material Testing Lab.
5.2 Simultaneously QC department also receives the intimation about the receipt of material from

the Warehouse personnel on ‘Goods Received Note’ (GRN).
5.3 On receipt of the Goods Receipt Note (GRN) from the Stores, check the detail given on

GRN and compare the details with Inward Register.
5.4 Based on the number of containers listed in GRN / Sample Inward Register; select the

number of packages to be sampled as per the sampling plan given in Table -1a.
5.5 Verify the number of packages as mentioned in GRN.
5.6 Check the packing condition of the material and the details mentioned on the labels.
5.7 Ensure that the materials received in the Warehouse are sampled within 07 days from

the date of receipt. However, if the priority requirement differs, the same can be extended by another 05 days.
5.8 Sampling of Primary packing materials
5.8.1 Start the sampling laminar bench 15-20 minutes before starting the sampling.
5.8.2 Before starting sampling, ensure that the sampling booth is clean. Get the container of one material

and of one batch at a time, shifted under Reverse Laminar Air Flow in sampling booth.
5.8.3 Use hand gloves and nose mask for sampling.
5.8.4 Sample as per table-1

S. No.	Sample Name	Sample Quantity
1	PVC Film	√ N +1
2	Plain Aluminum Foil / Base foil	√ N +1
3	Printed Aluminum foil	100%
4	Bottle	Minimum 10 Box
5	Cap	√ N +1
6	Lami Tube	100%

5.9 Sampling of Secondary packing materials
5.9.1 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 – Quality Control / Manager – Quality Assurance.
5.9.2 After decision of Manager – QA the material shall be further segregated or rejected.
5.9.3 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.
5.9.4 Withdraw the samples randomly from different containers equal to sample size as per table -2.

S. No.	Sample Name	Sample Quantity
1	C-Box	Composite 10 Nos.
2	Ploy Shrink / Poly Bag	Composite 10 Nos.
3	Sticker Label	100%
4	Printed Carton	100%
5	Plain Carton	√ N +1
6	Dropper	√ N +1
7	Measuring Cup	√ N +1
8	BOPP Tape / Cello Tape	Composite 05 Nos.
9	Leaflet	Composite 10 Nos.

5.9.5 Close the containers to be sampled with the help of BOPP Tape / ties.
5.9.6 Protect the samples from external contaminants like dust, water, and direct sunlight during

sampling and testing operations.
5.9.7 Paste the “SAMPLED” label on the containers from which the sample is collected.
5.9.8 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.
5.9.9 Note down the total number of defects, which are categorized under the headings critical, major and minor.
5.9.10 If the defect in any category is equal to or more, inform the Manager- Q.C / Manager- Q. A. for rejection of the consignment.
5.9.11 If the material passes the Physical Inspection, carry out testing of the packaging material as per

the laid down specifications and STPs of the respective material and record the dimensions observed in the test protocol.
5.9.12 All excess packaging materials after completion of testing and reporting, shall be destroyed.

6.0 Reference
From Military Standard, sampling procedures and tables for inspection by attributes, US Department of Defense, MIL-STD-105 D, 1963

7.0 Attachments
Annexure-I: Sampling Report for Packaging Materials

8.0 Distribution
Distribution of the controlled copy to concerned departments.
Additional copies may be issued for specific purpose.

9.0 Abbreviations
PVC : Polyvinyl Chloride
BOPP : Bioaxially Oriented Poly Propylene

10.0 Revision History