EXTERNAL PROVIDERS (Purchasing & Supplier Management)
1. Purpose
This document provides the process for all purchases of goods and services (excludes consumables that do not affect medical devices) which are authorized and purchased from Approved Suppliers and to provide for the evaluation of suppliers
This document covers the process for Purchasing / Control of External Providers and provide the basis for selection, evaluation, re-evaluation of suppliers and the procedure and documentation for purchasing and product verification in compliance of ISO13485
2. Approval
(Version at end of page)
Signed V27, HJM 22.02.2024
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
External Provider - Supplier or subcontractors that provide materials or services
PRINCIPAL - Legal and Labelled manufacturer of the product
6. Abbreviations
SOP – Standard Operating Procedure
COA - Certificate of Analysis
COC - Certificate of Conformance
7. References
ISO13485 Clause 7.4
Provider Supplier Contracts Quality Agreements
8. Procedure
8.1 Purchasing Procedure (7.4.1)
a. Overseas & Local Suppliers click PROCEDURE
b. Internal computerized process and activities follows:
Process:
a) Supplier Evaluation,
b) Supplier Selection,
c) Purchasing Information (and acquisition),
d) Incoming Goods verification,
e) Supplier monitoring and
f) Supplier re-evaluation if required
The process covers acquisition of materials and / or products which require specifications and verification activities that affect product Quality, safety and performance of the medical device
Outsourced activities e.g. Pest Control, Safety equipment, Auditing via a consultant are through contracts or appointment, as relevant
The procedure does not cover Consumables, capital items and auxiliary items, which do not require specifications and verification activities and do not affect product Quality, safety and performance
8.2 Supplier Management
Once a critical supplier is approved by management, their details are recorded, as are non-critical suppliers where appropriate
Critical suppliers are the suppliers of critical components, products or components that affect quality, safety and / or performance or are the only supplier - refer RISK
The evaluation is as per the SUPPLIER EVALUATION FORM and re-evaluation may be based on quality, price and delivery and as per SUPPLIER EVALUATION FORM
Records are maintained as reports and / or copies of the ISO certification retained.
The supplier evaluations / re-evaluations are followed in Monthly Quality Objectives Measurement as an input to SOP Management Review to analyse supplier performance
Auditing of the supplier may be decided and follows the Internal Audit SOP
Any Non-conforming findings follow the same route as for the Non Conformance SOP
SUPPLIER MONITORING is done on incoming inspection and the Non Conformance SOP
8.3 Supplier Selection
Before a supplier is listed, the management member will take the following into consideration where relevant:
On site assessment and / or evaluation report of the supplier's capability and/or quality systems
Evaluation of product samples
Past history with similar supplies
Inspection / Test results of similar supplies
Published experience of other users
Service suppliers – skills evaluation
On time delivery
Price
8.4 Provider Risk Assessment
Suppliers of manufactured products where the supplier is set and monitored as per an exclusive contract agreement, the Level 0 is assigned where no selection, evaluation and re-evaluation; including a QA agreement, is followed.
Risk is classified as Level 1 (Significant/Critical), Level 2 (Medium) and Level 3 (Low) where the criteria is:
* Top Management reserved the right to conduct on-site audits but with communication to the supplier
8.5 Purchasing Documentation (7.4.2)
Purchasing documents contain information to describe the product to be purchased, including where appropriate;
requirements for approval of product, procedures, processes and equipment,
requirements for qualification of personnel, and
quality management system requirements
The above 3 items are covered in the by the sub-contractor agreements and part of financial practices e.g. Purchase Order, Delivery Notes.
The purchasing records must be sufficient to provide for traceability; which may include Sterilization certificates/ COA/ COC.
8.5.1 QA Agreements
Purchasing information includes, as applicable, a written agreement that the supplier notify the organization of changes in the purchased product prior to implementation of any changes that affect the ability of the purchased product to meet specified purchase requirements.
This aspect also applies to OUTSOURCED activities (ISO 13485 4.1.5)
The template QA Agreement can be applied
Note that the contract must specify roles and responsibilities;, although not actually record the title 'Contract Giver' and 'Contract Acceptor' the;
Contract Giver - as SA Health Protection Services (Pty) Ltd
Contract Acceptor - the external providers name
The contract maybe in the format of the External Provider as the contract giver to SA Health Protection Services (Pty) Ltd as the contract acceptor in term of financial obligations however SA Health Protection Services (Pty) Ltd will ensure any aspects related to safety and performance/ efficacy of the health product is covered.
8.6 Verification of Purchased Product (7.4.3)
Refer to WAREHOUSING SOP under the WAREHOUSING header for verification of goods and vehicles through a VERIFICATION FORM
The inspection of received goods by the Warehouse personnel, is by checking against invoices and delivery notes, and where applicable, conformity certificates, to ensure the products (and other items where required) meets specified purchase requirements and recorded on VERIFICATION FORM
Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information; however this is unlikely to occur
Certificates are to be filed by the finance department with the financial documents
Verifying adherence of Critical Suppliers, such as distribution supplier(s), verifying compliance and effectiveness of action taken is through a date stamp / pen in on document and signature by the receiving party.
8.7 Essential Requirements
The organization provides this procedure to ensure that purchased products and materials specified purchase requirements generally in the format of agreed specifications.
The type and extent of control applied to the supplier and the purchased product depends on the effect of the purchased product on subsequent product realization or the final product
For subcontract manufactured products and sterilization activities this is covered by the sub-contract agreements, where ISO13485 is a pre-requisite
The organization or sub-contractor evaluates and selects suppliers based on their ability to supply product with the organization's requirements. Criteria for selection, evaluation and re-evaluation are defined and the results of evaluations and any necessary actions arising from the evaluation are reported
for medicines SAHPRA GWP : 4.02 SA Guide to GWP v2 Oct2011 for comment.doc ; Recommended Service Level Agreements (SLA’s) should include as a minimum and when applicable:
a) Rodent and pest control;
b) Cleaning services;
c) Couriers and freight forwarding (including any third party services);
d) Calibration services;
e) Fire extinguishers;
f) Waste disposal;
g) Preventive maintenance of critical equipment;
h) Security; and
i) IT.
6.6 The SLAs must ensure that the service provider is compliant with Good Warehousing and Distribution Practices and will be held responsible for any deviation from the agreement.
6.7 The contract should permit the contract giver to visit the facilities of the contract acceptor for a vendor approval inspection.
6.8 In accordance with Good Wholesaling and Distribution Practices, the contract giver is obliged to perform an annual vendor inspection at the premises of the contract acceptor.
6.9 All contract acceptors must comply with the relevant requirements stated in these guidelines.
6.10 Subcontracting of services by the contract acceptor may be permissible under certain conditions subject to a written approval by the contract giver.
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 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 27, 22.02.2024 - HJM - Added hyperlink to 8.1.3 & 8.5.1
Revision 26, 07.12.2023 - SC - Approved
Revision 25, 19.08.2021 - AA - Approved
Revision 24, 01.07.2021 - TNA - updating responsibilities
Revision 23, 03.05.2021 - AA Approved
Revision 22, 30.04.2021 - SCR - Outsourced activities and QA Agreements included 8.5.1
Revision 21, 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 20, Digitally signed on 13.07.2020 by AA
Revision 1-19, unknown due to google site change to new google site
11. Records
Name Retained by/ in Retention period Hard copies Destroyed by
Suppliers Orders, Delivery notes, Certificates Finance 5 years n/a
SUPPLIER EVALUATION FORM Google Site indefinite n/a
SUPPLIER EVALUATION sheet (RECORD) Google Site indefinite n/a
SUPPLIER QUESTIONNAIRE Google Site indefinite n/a
SUPPLIER RECORD Google Site indefinite n/a