WAREHOUSING, PRESERVATION, IDENTIFICATI0N & TRACEABILITY

1. Purpose 

This document provides the process for Warehousing control, preservation, identification and trace-ability product.

This document covers the process for defining 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 V13 BN 04.06.2024

3. Scope

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

This Policy must be read-with and comply with the Protection of Personal Information Act 04 of 2013, ("POPI"), the Company POPI Policy, PAIA Manual and processing of personal information envisaged under this Policy must be done in accordance with the aforementioned.

4. Responsibilities

 Approval: Author of the document, Henry Manyike

Changes: Author of the document, Bonang Ntuli

5. Definitions

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

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

Repair - is to restore (something damaged, faulty, or worn) to the original safety and performance condition to put the item back into acceptable working order again

Maintenance - this is required for preserving the condition of an item (infrastructure, machinery, products) 

Refurbishment - the process used to return medical devices to a condition of safety and effectiveness comparable to when new and without significantly changing the equipment's performance, safety specification and/or intended use as in its original registration (eg: sharpening scissors)

6. Abbreviations

SHEQ - Safety, Health, Environment and Quality

NCCA – Non Conformance Corrective Action

SOP - Standard Operating Procedure

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

Cleanliness (Facility & Personal Hygiene, Waste & Pest Control), Health & Safety 

Sales, Customer Related Processes & Returns 

INFRASTRUCTURE & ENVIRONMENT 

8. Procedure

8.1  Warehousing

• 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

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

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, receipted or dispatch 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 refer QUARANTINE area in SOP INFRASTUCTURE & Stock Management SOP.

8.2 Temperature Controlled Areas

There are no designated temperature controlled areas. A Fridge is used to keep a product cool and air-conditioners are used to keep areas cool.

8.3 Preservation of Product (7.5.11)

The organization followed the procedure for preserving the conformity of product to requirements during processing, storage, handling, and distribution, where preservation also applies to the constituent parts of a medical device.

The organization protects product from alteration, contamination or damage when exposed to expected conditions and hazards during processing, storage, handling, and distribution by:

• • designing and constructing suitable packaging and shipping containers;

  • documenting requirements for special conditions needed if packaging alone cannot provide preservation.

If special conditions are required, they are controlled and recorded 

1. Products and their component parts are protected and preserved at all stages from receipt to delivery in order to maintain conformity to requirements.

2. The products are stored in designated areas. refer to INFRASTUCTURE 

3. Inward receipts refer EXTERNAL PROVIDERS and outward releases are controlled. refer SOP SALES, CUSTOMER RELATED PROCESSES & RETURNS.

4. Products in storage are assessed periodically to detect deterioration 

5. All packaging is designed and quality checked to preserve and ensure product quality

6. Protection of the product during delivery to the customer is confirmed with vehicle

Products are; 

1. Identified by code and description, printed on the boxes by the manufacturers

2. Handled by staff to ensure no damages

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

4. Stored in bin locations and on racks

5. Protected within the storage facility

Dispatch

Delivery is managed by SOP Vehicle Management to assure product preservation.

8.4 Identification (7.5.8)

1. The product identification is by labeling provided by the principal and identifies the product 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. The product status with respect to monitoring and measurement requirements throughout product realization is not identified as all product stored and processed are released by the principal and verified on receipt as per Purchasing SOP for External providers

4. 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.

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

6. 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 through the LOT numbers, which are provided by the manufacturer.

2. A recording is transacted in the financial system for INCOMING goods and DISPATCH goods.

3. The extent of traceability is limited in Orthopaedic & Arthroplasty Division. 

4. Traceability is in accordance with applicable regulatory requirements

5. Records of traceability are kept digitally on the financial system through the item code.

8.6 Vehicles

• 1. Vehicles used to move, store or handle products should be suitable for their use to prevent exposure of products to conditions that could affect their stability and packaging integrity.

  2. Vehicles are loaded and packed correctly so to prevent movement and breakages and preferably on a First In, Last Out (FILO) basis.  

  3. The vehicles must:

     • Be clean and free from contamination of rats, vermin, birds, fungi etc;

     • Have solid sides;

     • Not transport non products which could result in contamination. 

     • Vehicles should be of sufficient capacity to allow orderly storage of the various categories of products during transportation.

     • Where special storage conditions (e.g. temperature and/or relative humidity) different from the expected environmental conditions are required during transit these are provided, checked and monitored and recorded. 

  4. Mechanisms should be available to allow for the segregation during transit of rejected, recalled and returned products as well as those suspected being counterfeits.  Such goods to be securely packaged, clearly labelled, and be accompanied by appropriate supporting documentation.

  5. Measures should be in place to prevent unauthorized persons from entering and/or tampering with vehicles, as well as to prevent the theft or misappropriation thereof or of the products.

  6. Where third-party carriers are used, wholesalers/distributors should develop written agreements with carriers to ensure that appropriate measures are taken to safeguard products, including maintaining appropriate documentation and records

  7. In the event of non-conformance then the procedure Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed

Vehicle Inspection

1. Any vehicle that is delivering goods (except containers, which are sealed for preservation of products) and those used to transport or deliver goods is to be inspected for good working order i.e. clean, no damages that could affect the packaging protection of the product or facilitate deterioration or damage and for pests in event of possible contamination; no food is to be transported with product, also refer to SOP Vehicle Management.

2. Delivery 

   1. Orthopaedic & Arthroplasty : Time Tree (app) is used to make note of which drivers deliver specific cases and who collects; vehicles are assigned to one driver.

   2. Other Products: mainly delivered by courier - sometimes utilizing Aircraft transport as per SOP External providers

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 13, 04.06.2024- BN - approval by HM

Revision 12, 11.04.2023 - NT - 8.2 corrected as no temperature controlled areas required

Revision 11, 18.05.2022 - NT - approval by HM

Revision 10, 07.12.2021 - NT - adding links and information

Revision 9, 17.11.2021  - NT - signed off from TNA

Revision 8, 27.08.2021 - TNA - updating responsibilities / addition of 4 new definitions

Revision 7, 04.02.2021 - TNA - New format with Responsibilities, Approval, Risk based approach and Records and revision history added and new google site format.  Addition of scope / amending links and forms

Revision 6,  Digitally signed on 21.10.2020 by TNA

Revision 1-5, unknown due to google site change to new google site

 11. Records

Name                               Retained by/ in                     Retention period Hard copies Destroyed by

Traceability by Financial Documents Accounts & Finance Department      15 years             Accounts & Finance Department