This document provides the process for Warehousing Control, Preservation, Identification and Traceability Product.
This document covers the process for define the practices that must be followed for handling and storage of finished goods in compliance of ISO 13485.
(Version at end of page)
Signed V15 RB 15.07.2024
The process covers all documents and process and products as defined in the Standard of Procedure.
Approval: Author of the document, Marelize Robertson
Changes: Author of the document, Rachel Belcher
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 regard 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
References
ISO 13485 Clauses 7.5.8, 7.5.9 and 7.5.11
Non-Conformance, Deviations and Concessions & Corrective Action SOP
Documents
Mock Recall SOP QMS Site
Non-Conformance SOP QMS Site
Production SOPs Share Point
Customer Service SOPs Share Point
Inventory SOPs Share Point
Technical SOPs Share Point
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 and dispatch
The receiving personnel must do spot checks on the vehicles delivering products and dispatching stock and inspect the vehicles for the following:
That the products were protected from light and rain, i.e. the delivery truck has a closed canopy;
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.
The delivery truck is lockable to secure the products delivered;
The products are not mixed with other materials that will compromise the integrity of the products delivered.
Should the transport fail an inspection, a non-conformance must be raised according to the Non-Conformance SOP
All packaging for stored, receipt 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.
Temperatures should be controlled and monitored using calibrated monitoring devices.
Monitoring is conducted at points representing the extremes of the temperature range (hot spots or cold spots) based on temperature mapping.
Recorded temperature monitoring data should be available for review.
The equipment used for monitoring should be checked at suitable intervals and the results of such checks should be recorded.
Monitoring equipment should be calibrated once a year and a reminder should be set on Trello.
All monitoring records should be kept for at least the shelf-life of the stored pharmaceutical products plus one year.
The organisation followed the procedure for preserving the conformity of product to requirements during processing, storage, handling, and distribution.
Preservation applies to the constituent parts of a medical device.
The organisation 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
Products and their component parts are protected and preserved at all stages from receipt to delivery in order to maintain conformity to requirements.
The products are stored in designated areas.
Inward receipts and outward releases are controlled.
Products in storage are assessed periodically to detect deterioration
All packaging is designed and quality checked to preserve and ensure product quality
Protection of the product during delivery to the customer is confirmed with vehicle
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
The product identification is by labeling provided by the principal or by the organisation (for products manufactured by the organisation) and this serves as identification throughout product realisation.
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
The product status with respect to monitoring and measurement requirements throughout product realisation 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
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 authorised concession is dispatched, used or installed.
If required by applicable regulatory requirements, the organisation shall document a system to assign unique device identification to the medical device.
Any medical devices returned to the organisation are identified and distinguished from conforming product by location in a secure location until disposition is decided
For all products manufactured by the organisation, the following SOP must be followed when labelling product:
1. For each unique product code, a label template must be prepared by the production team. The template must satisfy the following conditions:
Name of the medical device
Product code
GS1 Barcode
Description of the device
Name and address of Envision Africa
Lot number
Sterilisation expiry date
Date of manufacture
Storage conditions
Sterilisation marker (chemical process indicator)
Document number of the instructions for use, for reference purposes
An indication of the acceptable usage
Compatibility, if applicable
2. The head of production must approve the label template and a signed sample must be uploaded to the drive and named with the template description, revision number and date
3. Before any changes can be made to the product label a change control needs to be submitted
4. The Head of Production an / or system administrator must review and sign a copy of each print run for successive batches, as the lot number and expiry date will change. The lot number must be compared to the batch sheet and the expiry date assessed for suitability (the earliest expiry date of the critical components must be taken). The signed copy must then be filed and retained for two years refer to the Production SOP00060P - Production procedure pack label printing.
5. Any unsterile sample that is manufactured for viewing purposes only should be clearly marked with the unsterile sticker as per the Production SOP 0055P - Assembly of an unsterile procedure pack.
This procedure describes the process for identifying materials and product throughout production, service and delivery
The raw materials used throughout different departments determines the traceability requirements. Where traceability is required, the unique identification of the product is recorded and controlled via different processes e.g. Picking slip, Sales invoices on software etc. The identification of the product status is maintained throughout production, storage, installation and servicing of the product to ensure that only product that has passed the required inspections and tests is dispatched or installed
Production
Traceability requirements are documented in work instructions for the eye packs manufactured.
Traceability requirements are documented in work instructions for the products requiring it. Refer to the Production SOP 0034P - Allocating lot info to works order.
Traceability is maintained by the documentation of lot numbers of the raw materials used in works orders and the lot numbers are checked during Picking SOP0026P - Picking, verified during production as per SOP0027P - Preparation and SOP00349P - Allocating Lot info to works order
Configuration management is a means by which identification and traceability is maintained.
Records of traceability are kept
Production identification of measuring and monitoring status
The product status with respect to monitoring an measurement requirements are identified. During assembly the product status can be tracked on the software used.
Patient stickers are available on the product label, should a non-conformance occur it can be reported and the products can be traced and performance measured. Non-conforming product will be logged by following the non-conformance procedure.
During production the procedure pack should pass certain quality checks:
SOP001P - Use Rotary Sealer & SOP002P Use of PP Heat Sealer : Visual inspection of seal integrity
SOP0035P -Dye Penetration testing
SOP0051P -Calibrated Weight
Quality checks to pass before the product is released for dispatch:
SOP0060P - Production procedure pack label printing - Sampling expiry dates, Calibrated weight
Check sterilisation indicator colour
Coc received for sterilisation indicating that the batch passed the sterilisation cycle
Implantable devices
Not applicable
Finished Goods - Distribution to Customers
The Customer Service Department will receive an order an process the sales order by allocating a lot number and checking the quantity available on the Inventory Stock Sheet. The Lot number is recorded on the Sales Order / Tax Invoice. SOP0003_CS - Customer Order
The sales order with the selected lot number will be handed over to inventory, where the Material Handler shall pick the correct stock and lot indicated.
After confirming the stock availability by the Material Handler the sales order will move back to the customer service department to generate a "Copy Tax Invoice".
The documentation and stock will move to the dispatch area where the box and it's contents will be verified against the documentation by the Inventory stock Controller.
The box gets approved by the Inventory Stock Controller for dispatch and the copy tax & tax delivery note shall be signed off
Once the stock is delivered the delivery note shall be attached to the "Copy tax & Tax Delivery note" to maintain traceability
a Waybill is also available
Records of traceability are kept - SOP0005_CS - Customer Stock Queries
Finished Goods received from Supplier
Records of the name and address of the shipping package consignee are maintained
Records of stock may include the delivery note, GRN document, shipping documents etc.
Finished Goods received from Supplier identification of measuring and monitoring status
For non-conforming products received from the supplier follow the non-conforming product SOP
Technical
"Rent to own" machines: Finance links the serial number to the product description
Machine purchase to own: Directly invoice the machine and the serial number is selected from the system that will reflect on the invoice
Records of traceability are kept
Technical identification of measuring and monitoring status
Servicing reports / Installation reports available
Released PDI and device release form - serial number recorded on the document, created on Synchroteam and google device list used for checks and balances to ensure all machines are on one list to view where their are installed. This Device list also indicates the next service date.
Upon installation a installation report is generated - and the serial number recorded ensuring traceability of the checks done
Services and installations are solely completed by competent Technicians from Envision Africa.
Other
Mock recalls are performed annually to ensure that each department can trace the device in question
Suppliers are required to maintain records of the distribution of medical devices to allow traceability and make sure records are available for inspection, recalls etc.
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.
Vehicles are loaded and packed correctly so to prevent movement and breakages and preferably on a First In, Last Out (FILO) basis.
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.
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.
Measures should be in place to prevent unauthorised persons from entering and/or tampering with vehicles, as well as to prevent the theft or misappropriation thereof or of the products.
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
In the event of non-conformance then the procedure Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed
Returns follow procedure in SOP Sales, Customer Related Processes and Returns
No person shall sell any medicine, medical device unless it complies with the standards and specifications. Any medical device that has been recalled is under investigation with regards to its quality status or awaiting the outcome of quality control. The above-mentioned medical devices may not be sold and must be isolated and placed in ''Quarantine'' until the Authorised Representative makes the final decision regarding the outcome of the quarantined products. All medical devices should be clearly marked / moved to their designated quarantine zones within the different departments.
The quarantine area must be a designated area and all the stock therein should be clearly marked or sectioned off.
Products and devices under investigation should remain in quarantine until indicated otherwise by the Person Responsible these products could be:
2.1. Products that are under suspicion of being counterfeit products, possible contaminated stock
2.2. Products that have been recalled / withdrawn from the market ( refer to the Recall SOP)
2.3. Products that have been returned from the market due to complaints
The Responsible person will investigate products quarantined and make the final decision regarding the release or discarding of the product. Each department will be notified of the final outcome
A complete list of the products affected is kept electronically on the QMS Google Drive and the information recorded for each product on the document will include the product code, lot number, store holdings and quantity.
The communication channel
5.1. A notification will be sent by the Person Responsible via email to the different departments once the Person Responsible identifies products that needs to be quarantined. The following emails are listed:
Customer Service: monique@envisionafrica.co.za, saaleha@envisionafrica.co.za, charlay@envisionafrica.co.za
Inventory: catherine@envisionafrica.co.za; lynn@envisionafrica.co.za; warehouse@envisionafrica.co.za
Production: anashya@envisonafrica.co.za; dean@envisionafrica.co.za
Top Management: james@envisionafrica.co.za; william@envisionafrica.co.za
5.2. It remains the departments line managers responsibility to ensure that employees are competent and knows the action required when they receive such notification (refer to Training SOP). The departments shall inform their superiors of the notification received. The person responsible received the following email addresses to notify:
5.2.1. Customer Service
Person Responsible: Customer Service Manager , Email: monique@envisionafrica.co.za ; Contact number: 072 235 0031
Alternative contact details: Senior Customer Service Administrator, saaleha@envisionafrica.co.za; Contact number: 010 007 2431
5.2.2. Supply Chain
Person Responsible: Supply Chain Manager, Email: catherine@envisionafrica.co.za; Contact number: 010 007 2431
Alternative contact details: Inventory Controller, lynn@envisionafrica.co.za; Contact number: 010 007 2431
5.2.3. Production and Quality
Person Responsible: Production Manager, anashya@envisionafrica.co.za, Contact number: 010 007 2431
Alternative contact details: Product Manager, dean@envisionafrica.co.za, Contact number: 010 007 2431
Person Responsible: QA and RA Officer, rachel@envisionafrica.co.za, Contact number: 010 007 2431
Alternative contact details (Quality): Chief Operating Officer, william@envisionafrica.co.za, Contact number: 010 007 2431
The QA and AR Officer will continue that all the departments recived the notification wihtin 10 minutes of sending the notification email.
Communication sent out regarding the products that needs to be quarantined is only for internal use. Should the outcome be to recall the products (refer to the recall SOP) and or should the products be discarded / returned for credit.
The records must be kept for at least 5years after the last date of entry
In the event of non-compliance follow SOP Non-Conformance Corrective Action.
The Risk Assessment to is found in SOP Preventative Action Risk Assessment refer Document.
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.
Revision 15; 15.07.2024 - RB - Change over to SharePoint Site
Revision 14; 2023.01.23 - MR - 23.01.2023 - DK - Removed IVD under 8.8.
Revision 13; 20.12.2022 - MR - 20.12.2022 - DK - Changed nr. 7 References and Documents;, added SOP and linked; Updated 8.5. Traceability typed procedure, replaced standard wording, 11. Added documents under records and linked
Revision 12; 21.09.2022 - MR - DK 21.09.2022 - 8.7. Returns - Removed point 2-5. , 8.4. Identification to reference non-sterile samples added nr. 5,
Revision 11; 18.07.2022 - MR - 8.8. '' moved to their designated quarantine zones within the different departments.'' Updated''. - DK 18.07.2022
Revision 10; 16.05.2022 - MR - Added 8.8. Handling of quarantine products
Revision 9; 15.02.2022 - MR - Temperature Mapping, Monitoring Data & Calibrated Certificates Linked
Revision 8; 14.10.2021 - MR - Updated responsibilities
Revision 7; 30.08.2021 - TNA - addition of 4 new definitions
Revision 6; 05.08.2021 - MR - Reviewed
Revision 5, 24.06.2021 - TNA - New format with Approval, Scope, Responsibilities, Risk based Approach and Records and revision history added and new google site format. amending links
Revision 4, Digitally signed on 06.01.2020 by WJW
Revision 1-3, unknown due to google site change to new google site
Name Retained in Retention period Hard copies Destroyed by
Calibration certificates Envision Africa N/A
Temperature mapping Envision Africa N/A
Production Works Orders Production Office (Hard copies) 1 year
Production Works Orders Off-site storage (Hard copies) 5years
Sale Invoices & DElivery Notes ?CS ?
Inventory stock movement sheet
Eye pack Stock Movement sheet Google Drive N/A
Production Raw Material Movement sheet Google Drive N/A
Mock Recall Records Google Drive N/A
Invoice File (CS) Machine Serial Numbers ?CS ?
Technical Records Share Point N/A