Audit Plan

Audit Date(s) : 17-18 Jan 2018

Site audited : ASTEELFLASH
104 Avenue de l’UMA,
La Soukra
TUNISIE

Product : WireX4G, Darwin

Audit Scope :
Qualification supplier audit (RFQ finalisation phase) :
• to qualify the supplier against the ISO 13485:2016 quality management system
• to qualify the supplier ability to secure eDevice’s business model through a pristine
execution and respect of its constraints and requirements
• to validate ability to set up a long term parntership demonstrating the right quality
and continuous improvement in all areas of the supplier’s business management
processes

eDevice Auditor Sullivan FERRARI: SF (lead) Quality Manager

team Frédéric JACQUOT: FJ Supply Chain and Production Manager
Gilbert NENY: GN Tests and Methods Manager
 Audit Plan

Day 1 : 11 Apr 2018

Time Activities Requirement

14:30-15:00 Opening meeting & Introductions Introductions and Opening
meeting.
Introduction of participants
Introduction and review of Agenda and audit scope Review Scope and Schedule of
Audit
General site presentation

15:00-15:45 Quality Management

Policy Management
Management Review - P01 – Management
Review Quality Plan - P05 – Qualité
Resources - P06 – Formation &
Training documentation and Job Description Recrutement
Risk Management
Communication
15h45-18h00 Document Controls
Control of Records - P05 – Qualité
Documented Instructions and SOP’s - P07 – Logistique
Planning of product realization

18h00-18h30 Wrap-Up

Day 2 : 12 Apr 2018

Time Activities Process

9:00-9:15 Day 1 Review and Review of Audit Schedule
9:15-10:30 Product Realization : New Product Introduction Process
Team and process organization - P08 – Engineering
Purchasing Controls - P09 – Achats
Receiving acceptance activities - P04 – Production
Design and development of manufacturing process - P07 – Logistique

10:30-12:30 Plant tour

12:30-13:30 Lunch
13:30-15:00 Calibration and Preventive Maintenance
In-process acceptance activities (control plan) - P03 – Maintenance et
Final acceptance activities Infrastructure
Identification & Traceability - P05 – Qualité

15h00-17h30 Measurement, Analyze and improvement

Deviation/Control of Non-conforming product - Améliorer Excellence
Change control (process, products, suppliers) Opérationnelle
Complaints process - P01 – Management
CAPA Process - P05 – Qualité
Metrics Management & Reporting to customer
Customer feedback handling
17:30-18:00 Audit Review Time
18:00-18:30 Audit Closing Meeting

Please note that in view of the limited time, auditors may review & discuss activities and documentation separately.