Quality Systems

 Basic Coverage to familiarize Internal Quality Auditors "what to look for" when auditing these Core Tools.

• Advanced Product Quality Planning(APQP)
• Production Part Approval Process (PPAP)
• Failure Mode Effects Analysis (FEMA)
• Statistical Process Control (SPC) 

• Measurement System Analysis (MSA)

• Cover Requirements of 18 Point Criteria
• Conduct Audits
• Auditor Etiquette
• Auditing Techniques

Basic Quality Engineering Course

}        The Quality System

◦         Quality Philosophies and Foundations

◦         Quality Management System

◦         Elements of the Quality System

–         Documentation of the Quality System

–         Quality Training

}        Management & Leadership

◦         Leadership Principles and Techniques

◦         Communication Skills

◦         Customer Relations

◦         Supplier Management

}        Product and Process Design

◦         Classification of Quality Characteristics

◦         Design Inputs and Review

◦         Technical Drawings and Specifications

◦         Design Verification

}        Product and Process Control

◦         Tools

◦         Material Control

◦         Measurement and Test

◦         Metrology

◦         Statistical Process Control

}        Continuous Improvement

◦         Quality Control Tools

◦         Continuous Improvement Techniques

◦         Corrective Action

◦         Preventative Action

}        Certificates

• To become familiar with and understand the new requirements. 
• Determine what audit evidence is required in order to demonstrate compliance to the requirement.

•    Set up the Schedule (The “5” minute rule)
•    Management Team Assignments
•    Develop Timeline
•    Develop Implementation Action Plan
•    Overview Training (Management and or Staff)
•    Develop Manual, Procedure, Work Instructions and Forms)
•    QMS Training (Staff and or Management)
•    Interview Registrars
•    Train Internal Auditors
•    Conduct Audit (Phase I & II)
•    Conduct Management Review
•    Submit documentation to Registrar
•    Prepare for Implementation Audit by Registrar

•    Set up the Schedule (The “5” minute rule)
•    Management Team Assignments
•    Develop Timeline
•    Develop Implementation Action Plan
•    Overview Training (Management and or Staff)
•    Develop Manual, Procedure, Work Instructions and Forms)
•    QMS Training (Staff and or Management)
•    Interview Registrars
•    Train Internal Auditors
•    Conduct Audit (Phase I & II)
•    Conduct Management Review
•    Submit documentation to Registrar
•    Prepare for Implementation Audit by Registrar

•    Set up the Schedule (The “5” minute rule)
•    Management Team Assignments
•    Develop Timeline
•    Develop Implementation Action Plan
•    Overview Training (Management and or Staff)
•    Develop Manual, Procedure, Work Instructions and Forms)
•    QMS Training (Staff and or Management)
•    Interview Registrars
•    Train Internal Auditors
•    Conduct Audit (Phase I & II):  Process, Product, Customer and Core Tools
•    Conduct Management Review
•    Submit documentation to Registrar
•    Prepare for Implementation Audit by Registrar

•    Set up the Schedule (The “5” minute rule)
•    Management Team Assignments
•    Develop Timeline
•    Develop Implementation Action Plan
•    Overview Training (Management and or Staff)
•    Develop Manual, Procedure, Work Instructions and Forms)
•    QMS Training (Staff and or Management)
•    Interview Registrars
•    Train Internal Auditors
•    Conduct Audit (Phase I & II)
•    Conduct Management Review
•    Submit documentation to Registrar
•    Prepare for Implementation Audit by Registrar

•    Detailed discussion concerning each process
•    What does the Standard require
•    What do you require
•    What does the Registration Auditor look for besides the requirements
 

•    What is required per the Standard
•    Proving Compliance
•    Manual and Procedure Templates