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
(Version at end of page)
Signed V25 ML - 29.10.2024
The process covers all documents and process and products as defined in the SOP
Approval: Author of the document, Monica Lucas
Changes: Logistics Manager
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
SHEQ - Safety, Health, Environment and Quality
NCCA – Non Conformance Corrective Action
ISO13485 Clause 7.5.8, 7.5.9 and 7.5.11
Non-Conformance, Deviations and Concessions & Corrective Action SOP
Facility (Cleanliness & Personal Hygiene, Waste & Pest Control) Health & Safety
Sales, Customer Related Processes & Returns
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. Refer Stock Management 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 refer QUARANTINE area in SOP INFRASTRUCTURE
refer SOP Infrastructure & Environment as not applicable as not required for the products
The organization follows 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
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. refer INFRASTRUCTURE
Inward receipts refer EXTERNAL PROVIDERS and outward releases are controlled refer SOP SALES, CUSTOMER RELATED PROCESSES & RETURNS.
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
NOT Stored on the floor and on pallets or racks in bin locations
Protected within the storage facility
The product identification is by labeling provided by the principal and identifies the product by suitable means throughout product realization.
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 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
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.
If required by applicable regulatory requirements, the organization shall document a system to assign unique device identification to the medical device.
Any medical devices returned to the organization refer SOP Sales, Customer Related Processes & Returns are identified and distinguished from conforming product by location in a secure location until disposition is decided refer point 7
Any damaged goods, returns and rejects are located in the QUARANTINE area refer SOP INFRASTRUCTURE
The organization provides for traceability of products through the LOT numbers, which are provided by the manufacturer
A recording is transacted in the financial system for INCOMING goods and DESPATCH goods
Traceability is in accordance with applicable regulatory requirements
Records of Traceability are kept digitally on the financial system through the item code.
Vehicle Inspection
Any vehicle that is delivering goods (except containers, which are sealed for preservation of products) and those used to transport or deliver goods is 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.
Delivery
Trauma: Time Tree (app) is used to make note of which drivers deliver specific cases and who collects; vehicles are signed out by drivers
Other products: mainly delivered by courier as per SOP External providers.
Returns follow procedure in SOP Sales, Customer Related Processes & Returns
Products should not be returned without the necessary and relevant documentation and should not be returned in non-protective and original packaging
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.
All returned and rejected products must be clearly labelled, sealed and stored separately in a secure manner in a clearly marked designated area.
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
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
The Risk Assessment to is found in SOP PREVENTIVE 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 25; 29.10.2024 - ML - Checked and Confirmed. Digitally signed by ML.
Revision 24; 26.11.2023 - ML - Checked and Confirmed. Digitally signed by ML.
Revision 23; 25.10.2023 - SCR - removal of PALIN, 8.2 removal of temperature control essential requirements as not applicable
Revision 22; 17.10.2022 - ML - Checked and Confirmed. Digitally signed by ML
Revision 21; 16.05.2022 - ML - Inclusion of Stock Management SOP reference under 8.1 Digitally signed by ML
Revision 20; 07.10.2021 - ML - 8.2 Temp control corrected 8.3 approved for product not stored on the floor, and process verified. Digitally signed by ML
Revision 1; 10.05.2021 - ML - Digitally signed new Site by ML
Revision 18, 07.01.2021 New format with Approval / Scope / Responsibilities, Risk based approach and Records and revision history added and new googlesite format. Amending of links and addition of items 8.2 Temperature Controlled Areas and 8.7 Returns
Revision 17, Digitally signed on 08.11.2020 by ML
Revision 1-16, unknown due to googlesite change to new googlesite
Name Retained by/ in Retention period Hard copies Destroyed by
Traceability by Financial documents Bookkeeper 5 years Bookkeeper