WAREHOUSING, PRESERVATION, IDENTIFICATI0N & TRACEABILITY

1. Purpose 

This document provides the process for Warehousing control, preservation, identification and traceability product.

This document covers the process to define the practices that must be followed for handling and storage of finished goods in compliance of ISO13485

2. Approval

(Version at end of page)

Signed V2 NG 02.04.2025

3. Scope

The process covers all documents and process and products as defined in the SOP

4. Responsibilities

 Approval: Bruce Manuel

Changes: Nicholas Gilbert 

5. Definitions

Warehouse- a large building where raw materials or manufactured goods may be stored prior to their distribution for sale

Primary packaging - packaging that is in direct contact with the product (labels, packets, carton)

Secondary Packaging – packaging for shipping / dispatch but maybe a carton if the product has primary packaging

Preservation of Product - adequate measures are taken to protect/preserve product during internal processing and delivery to the intended destination

Identification - the action or process of identifying a material or product

Rework - the action of redoing a production procedure for an item / batch in order to correct a defective / faulty aspect/s (eg: packaging /  labelling / out of specification) mainly in regards to disposable products

Confomity Assessment Body  - (CAB) an organization that performs conformity assessment activities. These activities involve demonstrating that specified requirements are met for a product, process, system, person, or body. Essentially, a CAB verifies whether something complies with established standards or regulations. Examples of CABs include testing laboratories, inspection bodies, and certification bodies. 

6. Abbreviations

SHEQ - Safety, Health, Environment and Quality

NCCA – Non Conformance Corrective Action

CAB - Confomity Assessment Body (CAB)

7. References

ISO13485 Clause 7.5.8, 7.5.9 and 7.5.11

Non-Conformance, Deviations and Concessions & Corrective Action SOP 

External Providers SOP

Sales Customer Related Processes & Returns

Cleanliness Health & Safety

8. Procedure

DISTRIBUTION Process

8.1  Warehousing

1. Premises used are as per OUTSOURCED ACTIVITIES refer Manufacture SOP and the following is to be verified by PMB though ISO certification activities of the Conformity Assessment Body (CAB)

2. Premises should provide protection for the goods from contamination and deterioration, including protection from excessive local heating or undue exposure to direct sunlight. The goods received or dispatched at receiving or dispatch bays, docks, platforms or areas should be protected from dust, dirt and rain. Premises should be kept free of rodents, vermin, birds, pets and pests. refer Cleanliness SOP

3. Premises should have dedicated and demarcated areas available for the receipt of stock, general storage area, goods in quarantine, goods rejected, cold-chain storage, goods returned, dispatch

4. The receiving personnel must do spot checks on the vehicles delivering products and dispatching stock and inspect the vehicles for the following:

a) That the products were protected from light and rain, i.e. the delivery truck has a closed canopy;

b) The delivery truck does not have evidence of spillage inside that could lead to possible contamination or have been exposed to anything that can cause contamination to the products, e.g. any hazardous substances etc

c) The delivery truck is lockable to secure the products delivered;

d) The products are not mixed with other materials that will compromise the integrity of the products delivered.

All packaging for stored, receipt or dispatch of stock should be carefully inspected for tampering, contamination and damage and if necessary the suspected container of the entire delivery should be quarantined or set aside for further investigation.

8.2 Temperature Controlled Areas

Temperature management is for the Outsources Subcontract Manufacturer refer External Providers SOP

8.3 Preservation of Product (7.5.11)

The organization ptovides for preserving the conformity of product to requirements during processing, storage, handling, and distribution. 

1. refer OUTSOURCED ACTIVITIES refer Manufacture SOP

2. Products are; 

• Identified by code and description, printed on the boxes by the manufacturers

• Handled by staff to ensure no damages

• Packaged into delivery boxes and labelled to ensure that the integrity of the products are not compromised during transportation

• Stored in bin locations and on racks

• Protected within the storage facility

8.4 Identification (7.5.8)

1. The product identification is by means of labelling provided by the organization to  identify product by suitable means throughout product realization.  

2. All labels and containers should not be altered, tampered or changed.  The legislation relating to labels and containers should be adhered to at all times

3. Identification of product status is therefore maintained throughout acquisition, storage, installation and servicing of product to ensure that only product that has passed the required inspections and tests or released under an authorized concession is dispatched, used or installed.  refer OUTSOURCED ACTIVITIES refer Manufacture SOP

4. If required by applicable regulatory requirements, the organization shall document a system to assign unique device identification to the medical device.

5. Any medical devices returned to the organization are identified and distinguished from conforming product by location in a secure location until disposition is decided

8.5 Traceability (7.5.9)

1.     The organization provides for traceability of products

2.     The extent of traceability is followed in the sales documentation SOP Sales, Customer Related Processes & Returns

3.     Traceability is in accordance with applicable regulatory requirements

4.     Records of traceability are kept digitally.

5.   PMB Health and Safety Services (CC) will maintain the traceability of its products.

8.7 Returns

• 1. Returns follow procedure in SOP Sales, Distribution, Customer and Feedback

  2. Products should not be returned without the necessary and relevant documentation and should not be returned in non-protective and original packaging 

  3. Goods returned / due to be rejected are handled in a procedurally correct manner with reasons for returns determined and any further actions followed through and recorded.

  4. All returned and rejected products must be clearly labelled, sealed and stored separately in a secure manner in a clearly marked designated area.

  5. The final decision, after evaluation, to return the goods to stock or destroy any rejected goods and in the event of non-conformance then the procedure Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed

9.  Risk Based Approach

In the event of non compliance follow SOP  NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT   refer Document]

9.1 Trend Analysis and Continual Improvement

The analytical reviews of internal audits, and any other quality related matters, are reported to management and as part of the input from Data Analysis to management review

The Trend Analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.

10. Revision History

Revision 2 NG 04.02.2025 changed ownership

Revision 1 New, HJM 9.09.2024

 11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

Traceability by Financial documents       Bookkeeper 5 years Bookkeeper