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Audit Plan: Audit Date(s) : Site Audited

The audit plan outlines a supplier qualification audit of ASTEELFLASH in Tunisia over two days in January 2018 by eDevice auditors. The audit will qualify ASTEELFLASH's quality management system against ISO 13485:2016 and evaluate their ability to meet eDevice's business model and requirements. Day 1 will involve reviewing quality management documentation and processes. Day 2 will include auditing the new product introduction process, plant tour, calibration, identification and traceability, measurement and improvement processes, and complaint handling. The auditors will hold opening and closing meetings to introduce the audit scope and discuss findings.

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Oussama Akkari
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87 views2 pages

Audit Plan: Audit Date(s) : Site Audited

The audit plan outlines a supplier qualification audit of ASTEELFLASH in Tunisia over two days in January 2018 by eDevice auditors. The audit will qualify ASTEELFLASH's quality management system against ISO 13485:2016 and evaluate their ability to meet eDevice's business model and requirements. Day 1 will involve reviewing quality management documentation and processes. Day 2 will include auditing the new product introduction process, plant tour, calibration, identification and traceability, measurement and improvement processes, and complaint handling. The auditors will hold opening and closing meetings to introduce the audit scope and discuss findings.

Uploaded by

Oussama Akkari
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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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.

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