WHS010 Incoming Foil Stock SOP

1.0 PURPOSE

1.1 To define the step-by-step procedure for verifying, inspecting, and approving or rejecting incoming raw materials.

2.0 SCOPE

2.1 This SOP applies to all received raw materials, packaging components, and outsourced parts.

3.0 REFERENCE(S) & ATTACHMENTS

3.1 References

3.1.1 ISO 15378:2017

3.2 Attachments

3.2.1 Nil

4.0 RESPONSIBILITY

4.1 Warehouse Department Person:

4.1.1 To prepare the SOP.

4.1.2 To prepare a list of the SOP in Warehouse Department.

4.2 Production Head:

4.2.1 To ensure the training of the SOP to all concerned department personnel involved in implementation of the SOP.

4.2.2 To ensure the implementation of the SOP after training.

4.3 Quality Assurance Person:

4.3.1 To check the SOP.

4.3.2 To maintain the original copy of the SOP.

4.3.3 To issue controlled copy of the SOP.

4.3.4 To maintain issuance record of SOP.

4.3.5 To retrieve the controlled copy of the SOP when it is superseded/obsolete and maintain its record.

4.4 QA Head:

4.4.1 To approve new or revised SOP.

4.4.2 To ensure the implementation of the defined system.

4.5 Plant Head:

4.5.1 To approve new or revised SOP.

4.5.2 To ensure the implementation of the defined system.

5.0 DISTRIBUTION

5.1 Quality Control

5.2 Production

5.3 Quality Assurance

5.4 Warehouse

6.0 DEFINITION(S) & ABBREVIATION(S)

6.1 Definitions

6.1.1 Nil

6.2 Abbreviations

6.2.1 Nil

7.0 PROCEDURE

7.1 Material Receipt and Unloading:

7.1.1 Vehicle Check: Inspect the delivery vehicle for cleanliness, signs of pest infestation, and damage prior to unloading.

7.1.2 Verification: Cross-verify the Purchase Order (PO), Delivery Challan, and Supplier Invoice to ensure the delivery is meant for the facility.

7.1.3 Quarantine: Place all incoming materials in the designated "Quarantine" or "Under Inspection" area. Do not move them into general inventory yet.

7.2 Document Verification:

7.2.1 Collect the Certificate of Analysis (CoA), Certificate of Conformance (CoC), and any required regulatory compliance documents.

7.2.2 Verify that the Batch Number, manufacturing/expiry dates, and material grades match the specifications outlined in the PO.

7.3 Physical and Quality Inspection:

7.3.1 Visual Inspection: Check for external damage, leakages, pest activity, or tampering on containers. Ensure labels are legible and intact.

7.3.2 Sampling: Pull representative samples from the shipment according to the specific Acceptance Quality Limit (AQL) plan or standard sampling protocols.

7.3.3 Testing: Conduct testing based on the raw material specification sheet.

7.4 Disposition (Accept, Reject, or Hold):

7.4.1 Accepted: If the material meets all parameters, affix a Green "Accepted" label, record the results in the system, and release the material to the warehouse.

7.4.2 Rejected: If the material fails inspection, affix a Red "Rejected" label, log a Non-Conformance Report (NCR), and move the material to a segregated, locked quarantine area to await return to the supplier.

7.4.3 Hold: If documents are missing or results are inconclusive, affix a Yellow "Hold" label pending further investigation.

7.5 Key Documentation:

7.5.1 Goods Receipt Note (GRN)

7.5.2 Incoming Inspection Checklist

7.5.3 Certificate of Analysis (CoA)

7.5.4 Non-Conformance Report (NCR) (for rejected lots)

7.6 Roles and Responsibilities:

7.6.1 Stores/Warehouse Team: Unloads goods, verifies basic delivery notes, and quarantines material in the staging area.

7.6.2 Quality Control (QC) / Incoming Quality Control (IQC): Reviews quality documents, performs physical/chemical testing, and assigns status tags.

7.6.3 Procurement/Purchasing: Communicates with the supplier regarding discrepancies and returns.

8.0 REVISION HISTORY

+----------------+----------------+----------------+----------------+----------------+----------------+ | Revision No. | 00 | Effective | | CC No. | | | | | Date | | | | +----------------+----------------+----------------+----------------+----------------+----------------+ | Details of revision: New SOP | +-----------------------------------------------------------------------------------------------------+