STOCK MANAGEMENT

1. PURPOSE

This document provides the process for Stock Management and it defines the practices / processes that must be followed in compliance with ISO 13485.

2. Approval

(Version at end of page)

Signed V14  SZ 09.09.2024   

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, Managing Director

Changes: Author of the document, Simangele Zungu , HR Officer

5. Definitions

Arthroplasty is a surgical procedure to restore the function of a joint. A joint can be restored by resurfacing the bones. An artificial joint (called a prosthesis) may also be used. Various types of arthritis may affect the joints. The surgical reconstruction or replacement of a joint. The ageing of the world's population has been the primary driver for hip replacement, or arthroplasty"

Orthopedics (or orthopaedics) is the line of surgery and treatment involving the musculoskeletal system, and can entail degenerative conditions, trauma, sports injury, tumors, and congenital issues. You may have noticed the spelling variations of orthopedics/orthopaedics.

Orthopedics is the field of medicine concerned with the study and treatment of the musculosketetal system, particularly the spine, joints, and muscles. Orthopedics mainly deals with correction of disorders and deformities related to the musculosketal system; hence, orthopedics is central to the treatment of back pain.

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

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

Replenishment - is the process of re-ordering in-demand inventory that is low or out-of-stock. The purpose of replenishment is to ensure that a retailer has the right quantity of product, at the right location, at the right time to maximize sales and minimize costs. 

Consignment - is the process by which a person gives over something to the care of another party, retaining full ownership until the property is sold.

Consignee - acts as a sort of middleman, which is the individual that buys or retains the goods and passes them along to a third party or the final buyer. 

Consignor - may also be referred to as the shipper, obtaining shipping or transfer documents for the goods they are selling to the consignee.  

Our loan set service offers you the option to order implants and instruments for scheduled surgeries which we deliver and collect according to an agreed timeline. 

Stock Re-ordering Level is the process of re-ordering in-demand inventory that is low or out-of-stock. The purpose of replenishment is to ensure that a retailer has the right quantity of product, at the right location, at the right time to maximize sales and minimize costs. 

LOT / SN (serial number) - batch number for products for production

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 Preservation of product 7.5.5

8. Procedure

8.1 Preservation of product 

1. Preservation refer Warehousing, Preservation, Identification and Traceability SOP 

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

3. IMPLANTCAST controls the medical device shelf life applicable under specified storage conditions, which are recorded where applicable by the Stock Controller.

8.2 Forecasts and Supplier Orders

ORTHOPAEDICS - ARTHROPLASTY DIVISION

1. Forecasts are put together by the responsible staff member. The order volume and level is confirmed with the Managing Director. 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 2 weeks, as the manufacturer takes 1 week to deliver stock. 

4. Orders are sent directly to the supplier for delivery.

5. Freight forwarders (SUPPLIERS) are then handled by the Logistics of importing the stock on IMPLANTCAST's behalf.

6. The Logistics and Operations Manager, Business Administrator and Regional Sales Manager Designate proposes the order forecast, and the Managing Director approves the levels. 

7. The Purchase Order is then created by the Logistics and Operations Manager and Business Administrator incorporating the stock required by other branches. The Managing Director then approves the order, and the Business Administration sends the order to the supplier via email. 

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

9. Once the order is ready for dispatch by the supplier, the list is checked by the Managing Director and Business Administrator.  

8.3 Stock Management

1. Stock also follows work instructions for loan sets which is group of implants and instruments in a set package, which is borrowed  to hospitals when an implant is done;

a) Loan set Implants and Instruments , which is where non regular products borrowed from Germany for specific procedures where LOT and usage reports are generated

2. Any loan set, with packed from stock or borrowed as per 4 above, follow;

a) Time tree for tracing cases and products with interaction between Sales and logistics

b) SMS jobs where logistics follow bookings from a) above and use LOT , product reference number and product details to record cases

c) are processed through Decontamination before returned to stock or to Germany

3. Stock is accounted for on a Quarterly basis by method of a full Stock Counts, stock count is the responsibility of the Logistics Supervisor, the physical stock is verified against the accounting systems, and any deviations or variances are investigated by the relevant staff member and adjusted where necessary and no same staff member involved in physical stock count may be involved in accounting system capturing.

8.4 Incoming goods

A.    Other products (Local stock) – Palacos, Palamix, Synibowl (cement bowl), Sterile Hoods, Isolation Drapes, Femoral Headslides

B.    Orthopaedic products – ARTHROPLASTY & ORTHOPAEDICS DIVISION

C.    Orders for Consignment In - Stock (Germany)

D.    Orders for LoanSets (Germany and Local Suppliers) 

1. All stock items are received from suppliers via courier and /or container; and delivery notes or Proforma - Consignment Invoice or loan sets Invoice  for of the goods is checked/ inspected for the correct identity, quantity and signs of any possible damage, by receipts personnel. 

2. The Lot Number, Serial number and Expiry Date is listed on the documents above. 

3. The Stock Controller/Logistics Operator then checks the STOCK ORDERING sheet against Purchase Order, Suppliers Invoice and/ or Packing List. 

4. The products are then received into stock-holding on the accounting systems by the Stock Controller/Logistics Operator. (Pastel - Inventory & SMS - Barcoding)

5. The stock is stored in demarcated area on shelves, by the Stock Controller/Logistics Operator/Warehouse Assistant. 

6. All received goods are stored on shelving by product code and the FIFO sequence for issue is to check for first expiry which is allocated to the next outgoing sales order refer 8.4

7. 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.  refer Nonconformance SOP 

8. All products are labelled by the suppliers and are easily recognized by packaging and labelling.

for C.    Orders for Consignment In - Stock (Germany) 

• Once the consignment stock is used in various facilities, the supplier needs to replenish the stock as soon as possible.

•  is the process of re-ordering in-demand inventory that is low or out-of-stock. The purpose of replenishment is to ensure that a retailer has the right quantity of product, at the right location, at the right time to maximize sales and minimize costs. 

for D.    Orders for LoanSets (Germany and Local Suppliers) 

• Once the LoanSet stock is used in various facilities, we report to the supplier immediately for billing purposes.

• LoanSet service offers us the option to order implants and instruments for scheduled surgeries which the supplier delivers and collects according to an agreed timeline. 

8.5 Outgoing goods

       Orders for Consignment Out - Stock

• • The order originates from the Consignment consumer (Hospital/Clinic/Pharmacy) which is received by 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. 

  • This pick note is then given to the Stock Controller/Logistics Operator, who pulls and packs the stock.

  • The Logistics and Operations Manager approves the mode of transport – whether it can be delivered in-house, via courier, or with a special convoy should there be a bulk delivery. 

  • Signed Delivery notes are returned as POD, and filed by the Stock Controller and Accounts Administrator.

  • Once the stock is used by consumer, we as the consignor,  will replenish the consignment stock.

8.6 Bookings for Arthroplasty & Orthopaedics Department

1. Stock Movements are managed physically on an in-house Stock Management System and financially by the Accounting package. For a more detailed report, please refer to the training manual, outlining this process which you will find in the Google Drive Folder.

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 captured at a hospital level. Various checks are in place to confirm correctness. 

4. Delivery notes, charge sheets and quotes are handed to, and signed off by the designated Accounts personnel and Logistics Supervisor. 

8.7 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.

2. A statement is checked by the Accounts staff member and Bookkeeper. This is then sent out monthly to all relevant Accounts Holders.

8.8 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 on Pastel, and the stock moved to the appropriate location. Orthopedic goods are stored in designated quarantine bins in the Logistics Manager's office.

2. The Nonconformance SOP is followed to manage Expired or Damaged Stock

3. The Logistics Supervisor prepares an appropriate report to the Managing Director stating what goods are, the reason for them being moved, and an appropriate recommendation of action that should be taken.

4. The Managing Director will then either sign off the recommendation for action, or request further analysis.

8.9 Storage Areas

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

2. Stock of components and trays for sets to be made up are kept in clean non-sterile metal cabinets, Bins / Cupboards.

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

6. Physical quarantine storage should provide security of storage.

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

8.10 Process

8.11 Nonconforming Product

follow  SOP Control of non conformances

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 supplier performance, and any other quality related matters, are reported to management and as part of the input to management review refer Data Analysis

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 15,  21.07.2025 - BN - 8.3 stock management updated from monthly to quarterly.

Revision 14, 09.09.2024 - SZ - approved by HM

Revision 13, 11.04.2023 - NT -  8.3 stock management (moved from 8.7 to 8.3) includes link to WI Loan set Implants & Instruments (borrows Germany), Time tree & SMS Jobs 

Revision 12, 20.09.2022 - NT - 8.1 preservation linked to Warehouse SOP and 8.3 removal of repetitive instructions as all type of devices follow instructions points 1-9

Revision 11, 18.05.2022 - NT - approved by HM

Revision 10, 03.02.2022 - NT - adding information on Orders for LoanSets

Revision 9, 26.11.2021 - NT - updating information on this SOP and adding the Logistics Process Flow document link.

Revision 8, 17.11.2021 - NT - signed off from TNA

Revision 7, 04.02.2021 (TNA) New format with Responsibilities, Scope, Risk based approach, Approval and Records and revision history added and new googlesite format. Amending links and forms

Revision 6,  Digitally signed on 20.10.2020 by TNA

Revision 1-5, unknown due to googlesite change to new googlesite

11. Records

Name                 Retained by/ in Retention period Hard copies Destroyed by

Delivery Note / Invoice etc Finance dept File 50 years     Business Administrator

and Stock Ordering sheets