sop sampling of packagin material.

OBJECTIVE:Objective of this SOP is to describe the procedure for sampling of Packaging Material.

SCOPE:This procedure is applicable for sampling of Packing Material Received.

REFERENCE:In House

RESPONSIBILITY

1. 1. QC Officers/Executive : To follow the procedure as per SOP.
2. QC Head : To ensure proper execution of SOP.
3. QA : To ensure SOP is properly being implemented.

ABBREVIATION:

SOP – Standard operating procedure,

QC – Quality Control,

QA – Quality assurance,

GRN – goods receiving note,

A.R. – Analytical Report.

EQUIPMENTS:

Sampling bag, Hand gloves & Nose mask.

PROCEDURE:

1. After receiving GRN from stores, check details, enter the details and assign AR Number for GRN in packaging Material entry register.
2. Issue ‘UNDER TEST’ label with details of consignment to store department.
3. Exit the QC laboratory through change room following proper exit procedure.
4. Enter in stores area according to given entry procedure.
5. Fill the consignment check list before sampling as per Annexure I given below.
6. Sampling plan shall be specific for Primary packing & Secondary packaging materials.
7. Do the sampling as per sampling plan.
8. Affix the “UNDER TEST” label.
9. After sampling fill Sampling sheet as per Annexure II.
10. Enter in Q.C laboratory through change room following exit procedure.
11. Packaging material is to be tested consignment wise; when one consignment is under analysis, sampling of second consignment is not to be done.
12. In the likely event of food grade certificate for primary packing materials like tubes and foils are not received then QC officer has to ensure that the certificate is received with followups.

SAMPLING PLAN:

A] Primary Packing Materials

1. HDPE tubes and caps
2. Aluminium foil – printed and plain etc.

B] Secondary Packing Materials

1] Labels 2] Cartons 3] Leaflets 4] Shrink sleeves.

C] Tertiary Packing Materials

Shippers etc

1. The sampling plan & procedure shall be carried out on random basis by using the following formula.
2. If there is ‘n’ number of containers in a lot then sampling shall be carried out as follows-

3. The other containers that have not been sampled shall be inspected on line for performance & any discrepancy therein shall be communicated to QA and production department.
4. Such discrepant containers should be immediately isolated from packaging area and shall be properly labelled and handed over to store personnel to keep it in rejection room.
5. This plan shall be applicable for each lot of the consignment & for each packing material.

FREQUENCY:

Every time new consignment is received.

ANNEXURE:

Annexure I: Consignment Check list.

Annexure II: Sampling Sheet.

Annexure – II

List for checking consignment Before Sampling for Packing Material

Checked By:                                                                                      Date:

Annexure – II

Sampling Sheet for Packaging Material