IATF

16949:2016
 Webinar Objectives

This webinar is designed to:

✓ Provide a simple high level overview of the IATF 16949:2016 standard

✓ Briefly explain the foundation for an IATF Quality Management System

✓ Provide tips for implementing & improving the effectiveness of an IATF QMS
IATF Simplified
A ten minute tour through the standard
International Automotive Task Force

SOURCE:
http://www.iatfglobaloversight.org/about-iatf/
International Standardization Organization

SOURCE:
https://www.iso.org/about-us.html
Philosophy of the IATF 16949 Standard

SOURCE:
ISO 9001:2015 Standard
 Philosophy of an IATF Quality Management
anization identifies Issues, Interested Parties, and creates Processes
System
rformance Indicators with goals are established for each process
yees are trained to execute the processes and generate records
al Audits gather evidence that is used to determine QMS effectiveness
anagement makes decisions based upon data at Management Reviews
 Philosophy of an IATF Quality Management
anization identifies Issues, Interested Parties, and creates Processes
System
rformance Indicators with goals are established for each process
yees are trained to execute the processes and generate records
al Audits gather evidence that is used to determine QMS effectiveness
anagement makes decisions based upon data at Management Reviews
 Philosophy of an IATF Quality Management
anization identifies Issues, Interested Parties, and creates Processes
System
rformance Indicators with goals are established for each process
yees are trained to execute the processes and generate records
al Audits gather evidence that is used to determine QMS effectiveness
anagement makes decisions based upon data at Management Reviews
 Philosophy of an IATF Quality Management
anization identifies Issues, Interested Parties, and creates Processes
System
rformance Indicators with goals are established for each process
yees are trained to execute the processes and generate records
al Audits gather evidence that is used to determine QMS effectiveness
anagement makes decisions based upon data at Management Reviews
 Philosophy of an IATF Quality Management
anization identifies Issues, Interested Parties, and creates Processes
System
rformance Indicators with goals are established for each process
yees are trained to execute the processes and generate records
al Audits gather evidence that is used to determine QMS effectiveness
anagement makes decisions based upon data at Management Reviews
 IATF Simplified

Overall Content IATF 16949:2016 includes:

• 10 Sections
Documents Required
• 160 Auditable Elements
• 351 Specific Requirements
Records Required • 42 Required Documents
• 43 Required Records
KPI’s Required
 IATF Simplified

Some examples of documents required by IATF:

Overall Content
• Quality Manual (including the Scope of the QMS)
• Processes & Procedures
Documents Required • Work Instructions
• Anti-Bribery / Employee Code of Conduct / Ethics Escalation
Policies
Records Required • Organizational Roles, Responsibilities, and Authorities
• Quality Policy and Quality Objectives
• Contingency Plans
KPI’s Required • Internal and/or External Laboratory Scope(s)
• Competence Process & Listing of Trained Internal Auditors
• Record Retention Policy
• Supplier Selection and Evaluation Criteria
• Total Productive Maintenance System
• Control Plans / PFMEA’s / DFMEA’s
 IATF Simplified

Some examples of records required by IATF:

Overall Content
• Results of Risk Management Activities
• Calibration Results
Documents Required • Employee Competence and Training
• Completed PPAP’s
• Changes to Production Processes
• Manufacturing Feasibility Analysis Reviews
Records Required • Design & Development Activities
• Internal Audit and Supplier Audit Results
• First off / Last Off Product Approvals
KPI’s Required • Product Serialization Traceability
• Product Release Documentation
• Disposition of Nonconforming Product
• Re-worked and/or Repaired Product Dispositions
• Key Performance Indicator Data
• Management Review Results
• Implemented Corrective Actions
 IATF Simplified

Some examples of KPI’s required by IATF:

Overall Content
• Product / Service Conformity
• Customer Satisfaction
Documents Required • Measurement System Analysis (variation in inspection/testing
equipment)
• QMS Process Effectiveness Goals
• Quality Objectives Performance
Records Required • Manufacturing Feasibility (production capacity)
• Productivity Targets
• Supplier Performance (product/service quality / OTD / premium
KPI’s Required freight)
• Total Productive Maintenance Objectives (OEE / MTBF / MTTR)
• Manufacturing Process Studies
• Customer Disruptions / Field Returns / Warranty Claims / Recalls
• Premium Freight Frequency
• Effectiveness of Risk Management Activities
Foundation of a QMS
Quality Manual / Quality Policy & Objectives / Processes & Procedures
Creating an Effective Quality Management
System
Quality Manual An effective Quality Manual includes:
• Context of the Organization (IATF Section 4)
Quality Policy • Corporate Responsibility (IATF 5.1.1.1)
• Quality Policy (IATF 5.2)
• Quality Objectives Table (IATF 6.2)
Quality Objectives • Roles & Responsibilities Table (IATF 5.3)
• QMS to IATF Bridge Table (IATF 7.5.1.1)
Processes • Communication Table (7.4)
• Analysis & Evaluation Table (IATF 9.1.1)
Procedures
Creating an Effective Quality Management
System
Quality Manual An effective Quality Policy is:
• The driving force of an organization’s future
Quality Policy • A filter when making critical decisions
• A rallying point for employee engagement
• An “elevator pitch” for new business development
Quality Objectives • A picture of the organization’s culture

Processes

Procedures
Creating an Effective Quality Management
System
Quality Manual Effective Quality Objectives are:
• Company-wide (not department specific)
Quality Policy • Business related (not process related)
• Customer centered
• Time stamped (reviewed for revision annually)
Quality Objectives • Measurable with specific goals

Processes

Procedures
Creating an Effective Quality Management
System
Quality Manual Effective Processes:
• Describe “what” the company does
Quality Policy • Transform planned inputs into expected outputs
• Have KPI’s with goals to determine effectiveness
• Adequately address all applicable IATF elements
Quality Objectives • Adequately address all of the company’s activities
• Are documented on Turtle Diagrams
Processes • Point to the Procedures that support them

Procedures
Creating an Effective Quality Management
System
Quality Manual Some examples of suggested IATF Processes:
• Management Commitment, Planning, & Change Control
Quality Policy • Design, Development, and Special Characteristics
• Competence, Awareness, and Motivation
• Resource Management and Calibration
Quality Objectives • Product Realization and Error Proofing
• Continual Improvement and Problem Solving
• Supplier Development and Outsource Control
Processes • Controlling Nonconforming Product, Re-Work, & Repair
• Internal Auditing

Procedures
Creating an Effective Quality Management
System
Creating an Effective Quality Management
System
Quality Manual Effective Procedures:
• Describe “who” does what and “when” it is done
Quality Policy • Identify a series of actions taken by different people
• Support the operation of a specific process
• Highlight different actions based upon decisions
Quality Objectives • Are documented using a flow chart

Processes

Procedures
Creating an Effective Quality Management
System
Quality Manual Some examples of suggested IATF Procedures:
• Actions to Address Risks and Opportunities
• Advanced Product Quality Planning
Quality Policy • Employee Training
• Dispositioning Nonconforming Product
• Corrective and Preventive Action
Quality Objectives • Customer Complaint and Satisfaction
• Document and Record Control
• Management Review
Processes • Product Design
• Purchasing
• Receiving Verification
Procedures • Supplier Selection and Approval
• Supplier Monitoring and Evaluation
• Total Productive Maintenance
Creating an Effective Quality Management
System
Implementing & Improving a
QMS
Employee Engagement / Internal Audit / Management Review
Implementing & Improving a Quality Management
System
Employee Engagement Ideas to create a culture of engagement:
• Employee input in determining Issues & Interested Parties
• Centering the culture around the Quality Policy
Internal Audits • Incentives to reach annual Quality Objectives
• Employee Training Program (Quarterly QMS Days)
• Management Mentoring Program
Management Reviews • Professional Development Program
• Public Performance Dashboards (updated monthly)
• Quarterly QMS performance meetings
• Semi-annual QMS staff meetings
• Annual QMS awards luncheon
Implementing & Improving a Quality Management
System
Employee Engagement Implementing an effective Internal Audit Program:

• Comprehensive internal auditor training program

Internal Audits • Audit plan discussed & approved at Management Reviews
• Identifying Audit Objectives / Scopes / Criteria
• Progressively scheduled QMS process audits (annually)
Management Reviews • Full QMS audit (every three years)
• Customer specific requirement audits
• Product audits
• Manufacturing process audits (every three years all shifts)
Implementing & Improving a Quality Management
System
Employee Engagement Conducting an effective Management Review:

Internal Audits • One annual Management Review

• Presentation – Discussion – Decisions
• Evaluating trends not “snapshots”
Management Reviews • 23 specific topics are required to be included
• 3 categories are required to generate actions from
Support / Resources
How Nimonik and the McDae Group can help
Implementing & Improving a Quality Management
System
Nimonik
• Mobile Auditing Software
• Customizable Auditing Templates
McDae Group • Ability to gather photographic objective evidence
• Comprehensive Internal Audit Reports
• Manage, Close, and Document Corrective Actions
Implementing & Improving a Quality Management
System
Nimonik
• Customizable Templates
• Full IATF Implementation Consulting
McDae Group • Employee Awareness Training
• Internal Auditor Training
• Internal Audits
• Supplier Development and Improvement Support
• Supplier Audits
• Management Review Training & Facilitation
Questions & Answers
www.nimonik.com www.mcdae.com