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Friday, December 5, 2008

SAMPLING OF PACKING MATERIALS

1.0 OBJECTIVE
To lay down a procedure for sampling of packaging materials so as to get the representative sample of the whole lot.
2.0 SCOPE
This SOP Covers the procedure for sampling of packing material and this is applicable to Quality Control Department
3.0 RESPONSIBILITY
Quality Control Chemist/ Executive.
4.0 ACCOUNTABILITY
Department Head.
5.0 PROCEDURE
5.1 GRN (Goods Received Note) Receipt procedure:
5.1.1 Switch on the computer and double click on SAP(ERP) log on. And double click on server name on the Desktop.
5.1.2 SAP initial screen will appear. Type user name and password and press enter.
5.1.3 Main menu screen will appear. To proceed further, follow the transaction:
Via Menus
User menu for F12QCPM – Quality - Customized Reports - UNDER TEST STATEMENT LIST
Via Transaction Code
Y_DRD_18000045
Date
Date at which lot created
Click the field, click [down arrow] key & select the ‘date’ and click on ‘choose’ button. Similarly go to the other field repeat the same.
Origin
Describes what causes the lot to be created
Click the field, click [down arrow] select the required origin (01) and double click.. Similarly go to the other field repeat the same, in case you want to select more than one ‘lot origin’ type of material.
Material Type
Defines the group of materials
Click the field, click [down arrow] select the required origin (01) and double click.. Similarly go to the other field repeat the same, in case you want to select more than one ‘material type’
Radio buttons,
materials are displayed as per the status of material [Under test / Approved / Rejected..]
Select one of the desired options
Click the “Execute” icon to advance to the next screen named “Under test Statement List”, from this screen , materials of selected type, which are “under-test” Inspection lots can be seen.
5.1.5 Note down GRN date, Material name, AR NO.(Inspection lot) , In-house batch No., quantity and Vendor and Vendor Batch No.,in the register.
5.1.6 Click on the AR No. The system displays the “Display inspection lot” Screen and note down the manufacturer’s name & manufacturing batch no. from this screen.
5.1.7 Check whether the material falls under either approved supplier or not. The list of approved suppliers for the material is available in the QC Lab
5.1.8 If the supply of the item is from an approved vendor sampling of the material shall be done as per sampling plan given in Annexure
5.2 Prepare Sampled Labels , Pooled Sample label as per laid down procedure. [Refer Annexure for specimen label ]
5.3 Go to the appropriate under test packaging material storage area and identify the material to be sampled from the label on the pack.
5.4 Ensure that all the rolls of labels and foils are affixed with “UNDER TEST” labels. For all other packaging materials at least two “UNDER TEST” labels shall be affixed on materials of each pallet (refer Annexure for specimen label).
5.5 Check that the number of packages as mentioned against in GRN.
5.6 Check the packing condition of the material and details mentioned on the labels.
5.7 In case of any discrepancies in Step No. 5.3, 5.4 and 5.5 inform Warehouse In charge for corrective action.
5.8 Open the packages carefully and observe the material for any abnormalities and record it on the Sampler’s Remark Sheet
5.9 Withdraw the samples for testing.
5.10 Replace immediately the sampled quantity of material withdrawn from different packages with the material from one package and mark the sample same as loose pack. Close all the packages.
5.11 Label the sampled packages with the “SAMPLED” labels [refer for specimen] duly signed. Mark the sampled packages as N/1/n, N/2/n,.... N/S/n.Where ‘N’ is the total number of containers, ‘n’ is the number of containers sampled and ‘S’ is the serial number of the sampled container.
5.12 Protect the samples from external contaminants like dust, water, and direct sun light during sampling and testing operations.
5.13 Carryout testing of the packaging material as per the laid down specifications of
respective material.
5.14 After finishing the analysis, enter the testing results in SAP(ERP) inspection sheet.After given Usage decision take print out of certificate of analysis & GRn from sap. Attach one sample of packing material ( Like Cartons, Foil, Label…) with document.
5.15 All excess packaging materials after completion of testing and reporting shall be destroyed as per the laid down procedures.

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