Standard Operating Procedure for Handling and Storage of Machine Parts
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/113/2025 |
| Supersedes | SOP/CRM/113/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 21/01/2026 |
| Effective Date | 26/01/2026 |
| Review Date | 21/01/2027 |
1. Purpose
The purpose of this SOP is to define the procedures for the proper handling and storage of machine parts used in the cream manufacturing process. Proper handling and storage prevent damage, contamination, and ensure parts are readily available when needed for maintenance or replacement.
2. Scope
This SOP applies to all machine parts used in the Creams Department. It covers the procedures for receiving, handling, inspecting, and storing machine parts, ensuring that they are kept in a safe and organized manner.
3. Responsibilities
- Production Team: Responsible for ensuring that machine parts are handled correctly during production and that any damaged parts are reported immediately.
- Maintenance Team: Responsible for receiving, inspecting, storing, and maintaining machine parts. Ensures that parts are available when required and in good condition for use.
- Quality Control (QC): Ensures that machine parts meet the required specifications and are free from defects before use in production.
4. Accountability
The Maintenance Supervisor is accountable for ensuring that all machine parts are handled and stored according to this SOP. The Production Supervisor is responsible for reporting damaged parts or any issues with the parts during production.
5. Procedure
5.1 Receiving Machine Parts
- Upon receipt of machine parts, verify the parts against the purchase order and delivery note to ensure that the correct items have been delivered.
- Inspect each part for visible damage or defects. Any damaged parts should be immediately reported to the Procurement and Maintenance Team for further action.
- Ensure that all parts are accompanied by appropriate documentation, such as the Certificate of Conformance (CoC) and any other relevant quality documentation.
- Record the received parts in the Inventory Log (Annexure-1), including part numbers, quantities, supplier information, and inspection results.
5.2 Handling Machine Parts
- Handle machine parts with care to prevent damage. Always wear appropriate Personal Protective Equipment (PPE) when handling parts to ensure safety and hygiene.
- Use correct lifting techniques or equipment (e.g., trolleys, hoists) when handling heavy or bulky parts to prevent injury or damage to the parts.
- Ensure that the parts are not exposed to any hazardous conditions during handling, such as moisture, dirt, or extreme temperatures that may affect their quality or functionality.
- Label all parts clearly with relevant information such as part number, description, and date received to ensure proper identification and traceability.
5.3 Storing Machine Parts
- Store machine parts in a designated storage area that is clean, dry, and secure. The storage area should be free from any contaminants, moisture, or extreme temperatures that could damage the parts.
- Ensure that parts are organized according to categories (e.g., valves, seals, bearings) to facilitate easy access and identification when needed.
- Store machine parts in their original packaging or in suitable containers to protect them from dust, moisture, and physical damage.
- Ensure that all parts are stored with proper labeling and identification to make retrieval and inventory management easier.
5.4 Inspection and Inventory Management
- Perform regular inspections of stored machine parts to ensure that they remain in good condition and are not damaged or deteriorated.
- Conduct periodic inventory checks to verify that parts are available in the correct quantities and that they are properly labeled and stored.
- Record all inspections and inventory checks in the Inventory Log (Annexure-1), including part numbers, quantities, condition, and any discrepancies found during the inspection.
- Ensure that all defective or expired parts are promptly removed from storage and returned to the supplier or disposed of according to the disposal SOP for machine parts.
5.5 Requisitioning and Issuing Machine Parts
- When a machine part is required for maintenance or repair, submit a requisition to the Maintenance Team, ensuring that the part number, description, and quantity needed are accurately listed.
- The Maintenance Team will retrieve the requested part from storage, ensuring that the part is in good condition and ready for use.
- Record all issued parts in the Inventory Log (Annexure-1), including the part number, date issued, and recipient’s name.
5.6 Storing Defective or Unused Parts
- If a part is found to be defective during maintenance or installation, it should be returned to the supplier or stored in a designated “Defective Parts” area for further investigation and resolution.
- Ensure that unused parts are returned to the storage area and properly labeled for future use. Verify that they are stored in the correct location and are easy to access when needed.
5.7 Documentation and Record-Keeping
- Maintain accurate records of all machine parts received, stored, issued, and inspected. Ensure that all documentation is readily accessible for future reference and audits.
- Keep the Inventory Log (Annexure-1) up to date, and ensure that all activities, including part handling, inspections, and stock movements, are documented in the log.
- Ensure that records are reviewed periodically by the Quality Assurance (QA) team to ensure compliance with GMP and internal quality standards.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Inventory Log
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- Machine Manufacturer’s Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Inventory Log
| Part Number | Part Description | Quantity Received | Quantity Issued | Quantity Available | Condition | Supplier |
|---|---|---|---|---|---|---|
| PM-1234 | Sealing Valve | 50 | 10 | 40 | Good | ABC Suppliers |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/03/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/03/2025 | 2.0 | Format Revision and Updates | Standardization of Document | QA Head |