An in-depth discussion on the new automotive Quality Mangement System Standard 16949: 2016 and the challenges in moving to this new version from the old ISO/TS 16949. From processes to procedures, work instructions to risks, Michael Wolfe and Jonathan Brun discuss the best practices to stay in complete compliance with the standard.

1. IATF
16949:2016

2. 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

3. IATF Simplified
A ten minute tour through the standard

4. International Automotive Task Force
SOURCE:
http://www.iatfglobaloversight.org/about-iatf/

5. International Standardization Organization
SOURCE:
https://www.iso.org/about-us.html

6. Philosophy of the IATF 16949 Standard
SOURCE:
ISO 9001:2015 Standard

7. Philosophy of an IATF Quality Management
Systemanization identifies Issues, Interested Parties, and creates Processes
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

8. Philosophy of an IATF Quality Management
Systemanization identifies Issues, Interested Parties, and creates Processes
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

9. Philosophy of an IATF Quality Management
Systemanization identifies Issues, Interested Parties, and creates Processes
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

10. Philosophy of an IATF Quality Management
Systemanization identifies Issues, Interested Parties, and creates Processes
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

11. Philosophy of an IATF Quality Management
Systemanization identifies Issues, Interested Parties, and creates Processes
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

12. IATF Simplified
Overall Content
Documents Required
Records Required
KPI’s Required
IATF 16949:2016 includes:
• 10 Sections
• 160 Auditable Elements
• 351 Specific Requirements
• 42 Required Documents
• 43 Required Records

13. IATF Simplified
Overall Content
Documents Required
Records Required
KPI’s Required
Some examples of documents required by IATF:
• Quality Manual (including the Scope of the QMS)
• Processes & Procedures
• Work Instructions
• Anti-Bribery / Employee Code of Conduct / Ethics Escalation
Policies
• Organizational Roles, Responsibilities, and Authorities
• Quality Policy and Quality Objectives
• Contingency Plans
• 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

14. IATF Simplified
Overall Content
Documents Required
Records Required
KPI’s Required
Some examples of records required by IATF:
• Results of Risk Management Activities
• Calibration Results
• Employee Competence and Training
• Completed PPAP’s
• Changes to Production Processes
• Manufacturing Feasibility Analysis Reviews
• Design & Development Activities
• Internal Audit and Supplier Audit Results
• First off / Last Off Product Approvals
• 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

15. IATF Simplified
Overall Content
Documents Required
Records Required
KPI’s Required
Some examples of KPI’s required by IATF:
• Product / Service Conformity
• Customer Satisfaction
• Measurement System Analysis (variation in inspection/testing
equipment)
• QMS Process Effectiveness Goals
• Quality Objectives Performance
• Manufacturing Feasibility (production capacity)
• Productivity Targets
• Supplier Performance (product/service quality / OTD / premium
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

16. Foundation of a QMS
Quality Manual / Quality Policy & Objectives / Processes & Procedures

17. Creating an Effective Quality Management
System
Quality Manual
Quality Policy
Quality Objectives
Processes
An effective Quality Manual includes:
• Context of the Organization (IATF Section 4)
• Corporate Responsibility (IATF 5.1.1.1)
• Quality Policy (IATF 5.2)
• Quality Objectives Table (IATF 6.2)
• Roles & Responsibilities Table (IATF 5.3)
• QMS to IATF Bridge Table (IATF 7.5.1.1)
• Communication Table (7.4)
• Analysis & Evaluation Table (IATF 9.1.1)
Procedures

18. Quality Manual
Quality Policy
Quality Objectives
Processes
An effective Quality Policy is:
• The driving force of an organization’s future
• A filter when making critical decisions
• A rallying point for employee engagement
• An “elevator pitch” for new business development
• A picture of the organization’s culture
Creating an Effective Quality Management
System
Procedures

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

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

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

22. Creating an Effective Quality Management
System

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

24. Quality Manual
Quality Policy
Quality Objectives
Procedures
Some examples of suggested IATF Procedures:
• Actions to Address Risks and Opportunities
• Advanced Product Quality Planning
• Employee Training
• Dispositioning Nonconforming Product
• Corrective and Preventive Action
• Customer Complaint and Satisfaction
• Document and Record Control
• Management Review
• Product Design
• Purchasing
• Receiving Verification
• Supplier Selection and Approval
• Supplier Monitoring and Evaluation
• Total Productive Maintenance
Creating an Effective Quality Management
System
Processes

25. Creating an Effective Quality Management
System

26. Implementing & Improving a
QMS
Employee Engagement / Internal Audit / Management Review

27. Implementing & Improving a Quality Management
System
Employee Engagement
Internal Audits
Management Reviews
Ideas to create a culture of engagement:
• Employee input in determining Issues & Interested Parties
• Centering the culture around the Quality Policy
• Incentives to reach annual Quality Objectives
• Employee Training Program (Quarterly QMS Days)
• Management Mentoring Program
• Professional Development Program
• Public Performance Dashboards (updated monthly)
• Quarterly QMS performance meetings
• Semi-annual QMS staff meetings
• Annual QMS awards luncheon

28. Employee Engagement
Internal Audits
Management Reviews
Implementing an effective Internal Audit Program:
• Comprehensive internal auditor training program
• Audit plan discussed & approved at Management Reviews
• Identifying Audit Objectives / Scopes / Criteria
• Progressively scheduled QMS process audits (annually)
• 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

29. Employee Engagement
Internal Audits
Management Reviews
Conducting an effective Management Review:
• One annual Management Review
• Presentation – Discussion – Decisions
• Evaluating trends not “snapshots”
• 23 specific topics are required to be included
• 3 categories are required to generate actions from
Implementing & Improving a Quality Management
System

30. Support / Resources
How Nimonik and the McDae Group can help

31. Implementing & Improving a Quality Management
System
Nimonik
McDae Group
• Mobile Auditing Software
• Customizable Auditing Templates
• Ability to gather photographic objective evidence
• Comprehensive Internal Audit Reports
• Manage, Close, and Document Corrective Actions

32. Nimonik
McDae Group
• Customizable Templates
• Full IATF Implementation Consulting
• Employee Awareness Training
• Internal Auditor Training
• Internal Audits
• Supplier Development and Improvement Support
• Supplier Audits
• Management Review Training & Facilitation
Implementing & Improving a Quality Management
System

33. Questions & Answers
www.nimonik.com www.mcdae.com