Comprehensive Guide to Receiving and Storing Raw Materials in Medical Device Manufacturing

1) Purpose

This SOP establishes a standardized process for the receipt and storage of raw materials used in medical device manufacturing. The purpose is to ensure materials are handled, stored, and tracked in a manner that maintains their quality and compliance with regulatory standards.

2) Scope

This SOP applies to all raw materials received and stored for use in the manufacturing of medical devices. It covers processes from initial receipt, inspection, and storage to traceability and inventory management. This procedure is applicable to all warehouse and quality control personnel involved in material handling.

3) Responsibilities

– Warehouse Personnel: Responsible for receiving, inspecting, and storing raw materials in designated areas.
– Procurement Team: Ensures documentation such as purchase orders and certificates of compliance accompany deliveries.
– Quality Control (QC): Conducts inspections and tests to approve or reject materials.
– Inventory Control Team: Maintains accurate records of material stock levels and locations.

4) Procedure

4.1 Material Receipt
4.1.1 Documentation Verification:
– Verify delivery documents such as purchase orders (PO), packing lists, certificates of compliance (CoC), and invoices.
4.1.2 Visual Inspection:
– Inspect materials for visible damage, contamination, or packaging issues.
– Check that labels and markings match the PO details.
4.1.3 Material Quarantine:
– Place materials in a designated quarantine area pending quality inspection.
– Tag materials with a “Quarantine” label.

4.2 Inspection and Approval
4.2.1 Sampling:
– Collect samples according to the sampling plan (e.g., ANSI/ASQ Z1.4) for inspection and testing.
4.2.2 Testing:
– Perform physical, chemical, and functional tests to verify compliance with material specifications.
4.2.3 Approval or Rejection:
– Approve materials that meet quality standards and label them as “Approved.”
– Reject non-conforming materials, label them as “Rejected,” and move them to the designated rejection area.
4.2.4 Documentation:
– Record inspection results in the material inspection log.

4.3 Material Storage
4.3.1 Storage Area Preparation:
– Ensure the storage area meets environmental requirements such as temperature, humidity, and cleanliness.
4.3.2 Storage Location Assignment:
– Assign storage locations based on material type, lot number, and expiration date.
4.3.3 Handling Guidelines:
– Use appropriate equipment for material handling to prevent damage or contamination.
4.3.4 Labeling:
– Label all approved materials with lot numbers, expiration dates, and storage conditions.

4.4 Inventory Management
4.4.1 Material Traceability:
– Maintain records of material movement, including receipt, storage, and usage.
– Use inventory management software to track batch numbers and expiration dates.
4.4.2 Stock Rotation:
– Follow First-In, First-Out (FIFO) or First-Expired, First-Out (FEFO) methods to manage inventory.
4.4.3 Periodic Audits:
– Conduct regular inventory audits to reconcile physical stock with inventory records.

4.5 Handling Rejected Materials
4.5.1 Segregation:
– Store rejected materials in a separate, labeled area to prevent accidental use.
4.5.2 Disposition:
– Return rejected materials to the supplier, rework if possible, or dispose of them following waste management protocols.

4.6 Emergency Situations
4.6.1 Damaged Materials:
– In the event of material damage during storage, segregate the affected materials and notify QC immediately.
4.6.2 Environmental Deviations:
– If storage conditions deviate from specifications, assess the impact on material quality and take corrective action.

5) Abbreviations

– CoC: Certificate of Compliance
– QC: Quality Control
– FIFO: First-In, First-Out
– FEFO: First-Expired, First-Out

6) Documents

– Purchase Orders (PO)
– Certificates of Compliance (CoC)
– Material Inspection Log
– Inventory Records
– Rejection Reports

7) Reference

– ISO 13485: Medical devices – Quality management systems
– FDA CFR Title 21, Part 820: Quality System Regulation
– ISO 14644: Cleanroom Standards

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Material Inspection Log

Material Name	Batch Number	Inspection Date	Test Results	Status	Remarks
Material Name	Batch ID	DD/MM/YYYY	Pass/Fail	Approved/Rejected	Comments

Annexure 2: Inventory Audit Checklist

Audit Date	Auditor	Total Items Checked	Discrepancies Found	Remarks
DD/MM/YYYY	Auditor Name	Total Count	Details of Discrepancies	Comments