STOCK MANAGEMENT

1.Purpose 

This link provides access to the Stock Management for all products 

2. Approval

 (Version at end of page)

Signed V27- CR - 28.07.2025

3. SCOPE

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

4. RESPONSIBILITIES

Approval: Author of the document, Monica Lucas

Changes: Logistics Manager

5. Definitions

Trauma - products used for acute injuries normal through surgical procedure.

SOP - a defined process for the activities related to the scope.

6. Abbreviations

FIFO - First In first Out (Stock that will expire first, gets used first)

NCR – Non Conformance Record

SOP - Standard Operating Procedure

SMS - Stock Management System

POD - Proof of Delivery

7. References

ISO13485 clauses 7.5

8. Procedure

8.1 Preservation of product (7.5.5)

1. This preservation includes identification, handling, packaging, storage, and protection and also applies to the basic parts of a product.

2. The procedure also covers the control of product with a limited shelf-life (expiry date)  or requiring labeling instructions – Werkomed’s products do not have special storage requirements

3. Werkomed therefore defines the medical device shelf life applicable under specified storage conditions, which are recorded where applicable by the Warehouse Manager

4. The product identification and acceptance status is maintained throughout production, through subcontract agreements, and preparation for distribution to ensure that product released for distribution has passed all inspections and required testing

8.2 Forecasts and Supplier Orders

MEDICAL DEVICE CONSUMMABLES ORDERS

1. Forecasts are put together by the responsible staff member. The order volume and level is confirmed with the Director.

2. Orders are sent directly to the supplier for manufacture.

3. Freight forwarders then handle the logistics of importing the stock on Werkomed's behalf.

TRAUMA DIVISION

1. For the Trauma division, the stock is managed using a rolling annual stock forecast. 

2. Stock at the branches are kept at a level of 1 month based on their usages. This is updated quarterly to manage changing trends. 

3. The stock at the Head Office level in Johannesburg is kept at a level of 8-10 weeks, as the manufacturer takes 6-10 weeks to manufacture stock. 

4. The Warehouse and Logistics Manager proposes an order forecast, and the National Sales Manager approves the levels. 

5. The Purchase Order is then created by the Logistics Manager. The Director then approves the order.

6. The supplier sends an email to acknowledge the order.

7. Once the order is ready for dispatch by the supplier, the list is approved by the Warehouse and Logistics Manager.  

8.3 Incoming goods

1. Other products - MEDICAL DEVICE CONSUMMABLES

• • • All stock items are received from suppliers via courier and or container at First Freight Medical Warehouse; and delivery notes of the goods is checked/ inspected for the correct identity, quantity and signs of any possible damage, by receipts personnel. The product is then received into stock-holding on the accounting system by the Bookkeeper. 

    • The list of goods is checked against the Suppliers Invoice (or written up on a sheet) and the Lot Number and Expiry Date is listed. 

    • The Warehouse & Logistics Manager then checks the sheet against Purchase Order, Suppliers Invoice and Packing List. 

    • The stock is stored in demarcated area on shelves or pallets, by the warehouse controller / assistant and casual staff.

    • All received goods are then documented per batch number and expiry dates

    • In the event of non-conformance the items are placed in a designated Quarantine area and labelled to ensure identification, the extent of non-conformance is noted and subject to review by nominated personnel

    • All products are labelled by the suppliers and are easily recognized by packaging and labeling 

    • Storage in warehouse is in a logical, per product range designated area.

      2. Orthopedic products – TRAUMA DIVISION

• • • All stock items are received from suppliers via courier and delivery notes of the goods are identified and verified in accordance with the requirements of the delivery note and the purchase order by the relevant staff member who inspects the stock for the correct identity, quantity and signs of any possible damage

    • The product is then received into stock-holding on the accounting system by the Team Leader or Logistics Manager. 

    • The stock is stored in a separate warehouse store in a demarcated area. Orthopaedic stock components are kept in Bins, Racking or movable shelves.

8.4 Outgoing orders for MEDICAL DEVICE CONSUMMABLES

1. An order is sent to the relevant staff member via email, who then checks stock availability. Should stock be available with an acceptable expiry date, then a pick note is generated. 

2. This pick note with the delivery note is then e-mailed to the administrator at First Freight Medical, who then pulls and packs the stock.

3. The administrator replies to the e mail with a signed picking slip to confirm the order being actioned.

4. Delivery notes are uploaded on the First Freight Online Portal as POD

8.5 Bookings for Trauma Department:

1. Stock Movements are managed on an in-house Stock Management System and financially by the Accounting package.

2. Stock is billed and booked out to hospitals. For more detail on this, please refer to the Logistics Process Flow document.

3. Stock is billed according to usages recorded at a hospital level. Various checks are in place to confirm correctness. 

4. Delivery notes, charge sheets and quotes are handed to, and signed for by the designated accounts personnel. 

Invoices and Statements

1. The Accounts staff member, then checks that all is correct, and processes the order on Pastel once an order number has been received from the hospital. They also file all the documents related to the billings.

2. A statement is checked by the Accounts staff member, and is sent out monthly to all Accounts Receivable Companies.

8.6 Stock Management

1. Stock is accounted for by monthly or quarterly stock takes. 

2. Stock count is the responsibility of the The Team Leaders and the National Operations Manager. 

3. The physical stock is verified against the accounting system, and any deviations or variances are investigated by the relevant party and adjusted where necessary.

8.7 Expired or Damaged Stock

1. Stock which has reached its expiry date, has been quarantined, damaged, rejected, recalled or returned should be transferred to the appropriate warehouse in Pastel, and the stock moved to the appropriate location. Gloves in good condition, are donated to charities, and the goods maybe disassembled and destroyed as necessary. Orthopedic goods are stored in designated quarantine /cabinet/shelf/bins in the Logistics Warehouse.

2. The Logistics Manager prepares an appropriate report to the General Manager stating what the goods are, the reason for them being moved, and an appropriate recommendation of action that should be taken.

3. The General Manager will then either approve the recommendation for action, or request further analysis. 

8.8 Storage Areas

1. Storage areas are of sufficient capacity to allow orderly storage of the various categories of materials and products: starting and packaging materials, intermediate, bulk and finished products, products in quarantine, released, rejected, returned or recalled.

2. Stock of components and trays for sets to be made up are kept in clean non-sterile areas.  

3. Storage areas are designed or adapted to ensure good, safe and dry storage conditions.  In particular, they are clean and dry and maintained within acceptable temperature limits.  

4. Receiving and dispatch bays protect materials and products from the weather.  Receptions areas are designed and equipped to allow containers of incoming materials to be cleaned where necessary before storage.

5. Where quarantine status is ensured by storage in separate areas, these areas are clearly marked bins and shelving.

6. Physical quarantine storage provides security of storage.

7. A Segregated area is provided for the storage of rejected, recalled or returned materials or products.

8.9 Process

9. Risk Based Approach

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

Risk Based approach Report

The 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 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 27: 28.07.2025-CR- link update for Logistic process flow under point 8.5 

Revision 26:  29.10.2024 - ML - Checked and Confirmed. Digitally signed by ML

Revision 25:  05.10.2024 - CR - Outgoing orders for MEDICAL DEVICE CONSUMMABLES added a link to the SOP

Revision 24;  26.11.2023 - ML -  Checked and Confirmed. Digitally signed by ML

Revision 23; 26/11/2023 - CR - 8.1, 8.3, 8.4, 8.6, 8.7 & 8.9

Revision 22;  25.10.2023 - SCR -  PALIN , FOLEY etc removed replaced with CONSUMMABLES

Revision 21;  17.10.2022 - ML -  Checked and Confirmed. Digitally signed by ML

Revision 20;  07.10.2021 - ML -  Updated process. Digitally signed by ML

Revision 19;  10.05.2021 - ML -  Digitally signed by ML

Revision 18, 05.05.2021 - TNA - Updating the SOP to the new format.   Approval / Scope / Responsibilities / Risk Based , approach / Records and Revision History. Amending links and forms

Revision 17, Digitally signed on 02.11.2020 by ML

Revision 1-16, unknown due to googlesite change to new googlesite

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by