Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.

This course is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization's performance specifically related to equipment, processes and documentation.

Why You Should Attend:

• Supplier and Vendor Auditing
• Types of Supplier and Vendor Audits
• Proper Auditor Conduct
• Skills for Conducting Regulatory Compliance Audits
• Preparing and Planning for a Supplier and Vendor Audit
• Performing the Audit
• Observation Classification
• Writing an Audit Report
• Conducting a Follow-up Audit
• Lead Auditor Certification Programs

Areas Covered in the Session :

• What a supplier and vendor audit is
• Background and basics of supplier and vendor auditing

Proper Auditor conduct:

• Communication
• Dress
• Punctuality
• Difficult situations

Necessary skills for conducting audits
How to prepare and plan for a supplier and vendor audit

Know how to properly perform an audit:

• Opening meeting
• Touring the facility
• Questions
• Observations
• Close out meeting

Proper questioning techniques
Proper audit observation classification
Write an audit report
Conducting a follow up audit

How to become Lead Auditor certified:

• ASQ Certification
• ISO Certification

Who Should Attend:

• Senior quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Production supervisors
• Validation engineers
• Manufacturing engineers
• Production engineers
• Design engineers
• Process owners
• Quality engineers
• Quality auditors
• Document control specialists