SALES, CUSTOMER RELATED PROCESSES & RETURNS
1. Purpose
This document covers the process for sales and returns including Exports
2. Approval
(Version at end of page)
Signed 20 AA 15.08.2023
3. Scope
The process covers all documents and process and products as defined in the SOP
4. Responsibilities
Approval: Author of the document, Alexi Arhondonis
Changes: Author of the document, Alexi Arhondonis
5. Definitions
Distribution- The movement of goods and services from the source through a distribution channel, right up to the final customer, consumer, or user, and the movement of payment in the opposite direction, right up to the original producer or supplier
Sale- Contract involving transfer of the possession and ownership (title) of goods or property, or the entitlement to a service, in exchange for money
Expired Stock - any Specified Inventory that has a “Use By”, “Expiry Date” or other similar date on the labelling rendered the product obsolete and is unsellable.
6. Abbreviations
SHEQ - Safety, Health, Environment and Quality
SOP - Standard Operating Procedure
NCCA – Non Conformance Corrective Action Record
7. References
ISO13485 clauses 7.1, 7.2
Warehousing, Preservation, Identification and Traceability SOP
Non-Conformance, Deviations and Concessions & Corrective Action SOP
8. Procedure
8.1 Essential Principles
The company establishes the customer requirements related to product by determining the:
a) requirements specified by the customer, including the requirements for delivery and post-delivery are determined at the time of the purchase request
b) requirements not stated by the customer but necessary for specified or intended use, as known are evaluated at sale confirmation;
c) applicable regulatory requirements related to the product as established, as necessary;
d) any user training needed to ensure specified performance and safe use of the medical device follow Control of Promotional & Training Material SOP;
e) any additional requirements determined by the organization are determined.
The organization reviews the requirements related to product, which is conducted prior to the organization’s commitment to supply product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and ensures that:
a) product requirements are defined and documented;
b) contract or order requirements differing from those previously expressed are resolved;
c) applicable regulatory requirements are met;
d) any user training identified is available or planned to be available;
e) the organization has the ability to meet the defined requirements.
When the customer provides no documented statement of requirement, the customer requirements are confirmed by the organization before acceptance.
When product requirements are changed, the organization ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements refer Change Control.
Medicines Returns , quarantined and reject goods must be segregated
All returned and rejected health products, including medicines and medical devices, must be clearly labelled, sealed and stored separately in a secure manner in a clearly marked designated area.
Rejected Product means batches of Product or Pipeline Product which are either
(i) not in compliance with the applicable Specifications, (GMPs, the Legal Requirements) as a result of the Manufacturing or Warehousing failure or deficiency, or
(ii) determined by final decision management not to be suitable for final release or release to market.
“return” means sending back to the manufacturer, wholesaler or distributor a pharmaceutical product, which may or may not present a quality defect;
“quarantine” means the status of starting or packaging materials, intermediate, bulk or finished products isolated physically or by other effective means whilst awaiting a decision on their release or refusal;
8.2 Customer Related Processes
Customer requirements are established, confirmed and any changes are addressed and agreed through the Sales process. which follows the standard order, receipt, pick and pack, dispatch and invoice financial process. refer SALES for process and Flow Diagram
8.3 Export
In the event of Exports there are 2 possible activities;
a) DIRECT delivery from the overseas manufacturer, orders are place on the SUPPLIER following SOP External Provides , then the stock is shipped from supplier to customer without arriving at SAHealth
b) For STOCK items, Follow this SALES procedure after purchasing of goods are per SOP External Provides and stock is managed as per SOP Warehousing for Stock Management
Free Sale Certificates required to follow the SAPHRA website guideline
8.4 Returns
Should stock be returned and deemed as non-conforming and rejected (via the non conformance process) the client is credited and stock is returned to the supplier for credit refer; Warehousing, Preservation, Identification and Traceability SOP to be followed - refer Flow Diagram
8.5 Expired Stock
In the event of expired stock in the warehouse or when returned as expired stock, Warehousing, Preservation, Identification and Traceability SOP to be followed - refer Flow Diagram
8.6 New Products
In the event of a new product the Regulatory processes for product registration and safety & performance processes are followed
8.7 Non Conformances
In the event of non-conformances 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 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 20, 15.08.2022 - AA - inclusion of a new bullet 8.2 Export
Revision 19, 25.01.2022 - AA - deletion of line under Purpose
Revision 18, 26.11.2021 - AA - addition of 8.4 Expired stock
Revision 17, 19.08.2021 - AA - Updated Information
Revision 16, 01.07.2021 - TNA - updating responsibilities
Revision 15, 03.05.2021 - AA Approved
Revision 14, 28.04.2021 - TNA - New format with Approval / Scope / Responsibilities, Risk based approach and Records and revision history added and new google site format. Amending of Links and forms
Revision 13, Digitally signed on 05.12.2019 by AA
Revision 1-12, unknown due to google site change to new google site
11. Records
Name Retained by/ in Retention period Hard copies Destroyed by
Sales Financial records per FICA 5 years Manager
Customer Feedback Sales staff transferred verbally or in reports 5 years Manager
stored on the Google Drive