/> – Inventory Control Team: Maintains accurate inventory records and oversees stock levels, ensuring FIFO/FEFO protocols are followed.
– Production Team: Utilizes only approved materials in production processes and reports any quality concerns to QC.

4) Procedure

4.1 Material Receipt
4.1.1 Verification of Documentation:
– Upon receipt of materials, check for the accompanying documents, including the purchase order (PO), material safety data sheet (MSDS), and certificate of compliance (CoC).
– Ensure that the details on the documents match the ordered quantity, description, and specifications.

4.1.2 Initial Physical Inspection:
– Inspect the delivery vehicle for cleanliness and ensure no visible contamination or damage to the materials occurred during transport.
– Check packaging for integrity, labeling accuracy, and any signs of tampering.

4.1.3 Unloading Materials:
– Use appropriate material-handling equipment, such as forklifts or pallet jacks, to unload materials without causing damage.
– Ensure proper ergonomics and safety protocols are followed during the unloading process.

4.1.4 Quarantine Procedure:
– Transfer the received materials to the quarantine area and label them with “Quarantine” tags.
– Ensure that quarantined materials are segregated from approved or rejected materials.

4.2 Inspection and Testing
4.2.1 Sampling Protocol:
– Collect representative samples of each batch following the predefined sampling plan (e.g., ANSI/ASQ Z1.4 or similar standards).
– Ensure that sampling tools are sterilized to avoid contamination.

4.2.2 Material Testing:
– Conduct physical tests to assess dimensions, weight, color, and texture.
– Perform chemical testing, such as spectroscopy or chromatography, to confirm material composition.
– Functional tests may include mechanical strength, flexibility, or thermal stability assessments, depending on material requirements.

4.2.3 Approval or Rejection:
– Approve materials that meet all specified quality parameters and assign them an “Approved” tag.
– Reject non-compliant materials, label them as “Rejected,” and move them to the designated rejection area.
– Record test results, non-conformances, and corrective actions in the material inspection log.

4.3 Storage of Approved Materials
4.3.1 Storage Area Requirements:
– Maintain storage conditions specified in the material’s technical documentation, such as temperature, humidity, and light exposure limits.
– Ensure clean, dry, and pest-free storage environments.

4.3.2 Organized Storage:
– Store materials by lot numbers, expiration dates, or production priority.
– Separate materials by type to prevent cross-contamination.

4.3.3 Environmental Monitoring:
– Use temperature and humidity sensors to monitor storage conditions continuously.
– Log environmental readings at regular intervals and take corrective actions if deviations occur.

4.3.4 Material Labeling:
– Label all approved materials with information such as lot number, date of receipt, expiration date, and storage conditions.
– Ensure that labels are legible and securely attached to containers or pallets.

4.4 Inventory Management
4.4.1 Traceability System:
– Maintain a detailed log of material movement from receipt to production.
– Use inventory management software to track material usage and stock levels in real-time.

4.4.2 Stock Rotation Protocols:
– Implement First-In, First-Out (FIFO) for non-perishable materials and First-Expired, First-Out (FEFO) for perishable materials.

4.4.3 Inventory Audits:
– Conduct monthly physical inventory counts and reconcile discrepancies with electronic records.
– Generate audit reports and address any inventory inconsistencies promptly.

4.5 Handling Non-Conforming Materials
4.5.1 Segregation of Rejected Materials:
– Store rejected materials in a designated rejection area, clearly labeled to prevent accidental use.
– Update inventory records to reflect rejected status.

4.5.2 Disposition Procedures:
– Notify suppliers of non-conforming materials and initiate return or replacement requests.
– If disposal is required, follow approved waste management protocols and document the process.

4.6 Emergency Procedures
4.6.1 Contamination Events:
– Immediately isolate contaminated materials and notify the QC department.
– Investigate the source of contamination and implement corrective actions.

4.6.2 Storage Condition Deviations:
– If storage conditions exceed allowable limits, evaluate the impact on material quality.
– Perform reinspection and testing to determine usability.

4.7 Documentation Requirements
– Maintain records for all stages of material handling, including receipts, inspection logs, storage conditions, and inventory transactions.
– Ensure that documentation is archived for at least the minimum retention period required by regulatory bodies.

5) Abbreviations

– CoC: Certificate of Compliance
– MSDS: Material Safety Data Sheet
– FIFO: First-In, First-Out
– FEFO: First-Expired, First-Out

6) Documents

– Purchase Orders
– Material Safety Data Sheets (MSDS)
– Certificates of Compliance (CoC)
– Material Inspection Reports
– Storage Condition Logs
– Inventory Records

7) Reference

– ISO 13485: Medical devices – Quality management systems
– FDA CFR Title 21, Part 820: Quality System Regulation
– ANSI/ASQ Z1.4: Sampling Procedures and Tables for Inspection
– ISO 14644: Cleanroom Standards

8) SOP Version

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

Annexure

Annexure 1: Material Inspection Checklist

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

Annexure 2: Storage Condition Log

Date	Time	Temperature	Humidity	Remarks
DD/MM/YYYY	HH:MM	Temperature in °C	Humidity in %	Comments