Professional Documents
Culture Documents
Omnex is headquartered
and operates from the
United States through
offices in Michigan.
Chad Kymal is the CTO and founder of Omnex Inc., an international consulting and training organization
headquartered in the United States. After graduating from the General Motors Institute, Chad spent a
number of years working at General Motors and KPMG before founding Omnex Inc. in 1986. Over the
course of Chads successful career, he has served on the Malcolm Baldrige Board of Examiners and has
received numerous quality achievement awards, including the Quality Professional of the Year award by
the American Society for Quality (ASQ) Automotive Division in 2005. In addition to his bachelors degree
from GMI, Chad holds both a masters degree in industrial and operations engineering from the
University of Michigan and an MBA Cum Laude from the University of Michigan. He is a member of Tau
Beta Pi.
Chad both developed and teaches auditor training for ISO 9001, ISO 14001, and OHSAS 18001 / ISO
45001, as well as an Integrated Management Systems Lead Auditor training course where all three
standards are combined in a single audit. Chad is the founder of AQSR, a global registrar that routinely
provided integrated audits in QMS, EMS, and OHSMS. Chad is also on the ISO/TC 176, ISO/TC 207,
PC283 committees for ISO 9001:2015 (Quality Management), ISO 14001:2015 (Environmental
Management) and ISO 45001 (Health and Safety Management Systems.
Omnex has been working in the Automotive industry for 30 years and Omnex principals been active in
writing different automotive standards including QS 9000, ISO/TS 16949, Semiconductor
Supplement, APQP, FMEA and Core Tools. Chad conducted the first world-wide witness
audit for QS 9000 a predecessor to IATF 16949. He is the author of seven books and
more than 100 papers including several on integrated management systems.
Chad is currently working on books for ISO 14001 and IATF 16949.
IATF 16949
Automotive
System Automotive Specific Requirements
Requirements
ISO 9001:2015
Generic Quality Management System
Requirements
Automotive
Certification
IATF 16949 Audit Process, Rules for
Scheme Certification
Customer
Specific
Customer Specific Requirements of
Requirements Customers Subscribing to IATF 16949
11
Transition complete.
Sept. 14, 2018 All ISO/TS 16949 and ISO 9001:2008 certificates
are no longer valid.
6.2.1
7.5.1 GENERAL
8.1.2 CONFIDENTIALITY
8.3.2 DESIGN AND DEVELOPMENT
8.4.1.1 GENERAL - SUPPLEMENTAL
8.5.6 CONTROL OF CHANGES
10.2.5 WARRANTY MANAGEMENT SYSTEMS
0.0
20.0
40.0
60.0
80.0
100.0
120.0
0
10
20
30
40
50
60
8.5.1.5 Total productive
40%
8.5.1.1 Control plan
6.1.2.3 Contingency plans
8.5.1 CONTROL OF
7.2.3 Internal auditor
8.3.5.2 Manufacturing
8.5.1.2 Standardised work -
20%
8.5.1.3 Verification of job set-
8.5.1.6 Management of
7.1.5.1.1 Measurement
9.3.2.1 Management review
8.4.2.4 Supplier monitoring
9.1.1.1 Monitoring and
4.3.2 Customer-specific
6.1.2.1 Risk analysis
7.2.1 Competence -
Vital Few: Total NC vs Clauses
9.2.2.3 Manufacturing
8.5.6.1 Control of changes -
9.2.2.2 Quality management
7.2 COMPETENCE
7.5.3.2 Control of
8.3.2.1 Design and
8.5.4.1 Preservation -
10.2.1 Nonconformity and
10.2.4 Error-proofing
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
Distribution of Top 60% by Clause Number
Clause-wise Top Total NC
350
313
300
250
200
150
114
100
73
51
50
33
14
0
0
Clause 8.0 Clause 7.0 Clause 9.0 Clause 6.0 Clause 10.0 Clause 4.0 Clause 5.0
3rd Party Top 60% Total NC
Number of Clauses in Top 60%
16
14
12
10
0
8.0 7.0 9.0 10.0 6.0 4.0 5.0
Clause No. and Name 3rd Party NC 3rd Party Total NC % Cumulative %
8.5.1.5 Total productive maintenance 48 4.92% 4.92%
8.5.1.1 Control plan 38 3.90% 8.82%
6.1.2.3 Contingency plans 37 3.79% 12.62%
8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION 26 2.67% 15.28%
7.2.3 Internal auditor competency 23 2.36% 17.64%
8.3.5.2 Manufacturing process design output 23 2.36% 20.00%
8.5.1.2 Standardised work - operator instructions and visual standards 23 2.36% 22.36%
8.5.1.3 Verification of job set-ups 23 2.36% 24.72%
8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment 20 2.05% 26.77%
7.1.5.1.1 Measurement systems analysis 19 1.95% 28.72%
9.3.2.1 Management review inputs - supplemental 19 1.95% 30.67%
8.4.2.4 Supplier monitoring 18 1.85% 32.51%
9.1.1.1 Monitoring and measurement of manufacturing processes 18 1.85% 34.36%
4.3.2 Customer-specific requirements 14 1.44% 35.79%
6.1.2.1 Risk analysis 14 1.44% 37.23%
7.2.1 Competence - supplemental 14 1.44% 38.67%
8.4.2.3 Supplier quality management system development 14 1.44% 40.10%
7.1.5.2.1 Calibration/verification records 13 1.33% 41.44%
7.1.5.3.1 Internal laboratory 13 1.33% 42.77%
8.7.1.4 Control of reworked product 13 1.33% 44.10%
9.1.2.1 Customer satisfaction - supplemental 13 1.33% 45.44%
10.2.3 Problem solving 13 1.33% 46.77%
7.5.1.1 Quality management system documentation 12 1.23% 48.00%
8.3.3.3 Special characteristics 12 1.23% 49.23%
8.4.1.2 Supplier selection process 12 1.23% 50.46%
8.4.2.4.1 Second-party audits 12 1.23% 51.69%
9.2.2.3 Manufacturing process audit 12 1.23% 52.92%
8.5.6.1 Control of changes - supplemental 11 1.13% 54.05%
9.2.2.2 Quality management system audit 11 1.13% 55.18%
7.2 COMPETENCE 10 1.03% 56.21%
7.5.3.2 Control of Documented Information (Contd.) 10 1.03% 57.23%
8.3.2.1 Design and development planning - supplemental 10 1.03% 58.26%
8.5.4.1 Preservation - supplemental 10 1.03% 59.28%
10.2.1 Nonconformity and Corrective Action 10 1.03% 60.31%
10.2.4 Error-proofing 10 1.03% 61.33%
Number of Cumulative
Non Percentage of
Conformance Percentage of Total Total Non
Clause No. And Name s Non conformance Conformance
8.5.1.5 Total productive maintenance 48 4.9 4.9
8.5.1.1 Control plan 38 3.9 8.8
6.1.2.3 Contingency plans 37 3.8 12.6
8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION 26 2.7 15.3
7.2.3 Internal auditor competency 23 2.4 17.6
8.3.5.2 Manufacturing process design output 23 2.4 20.0
8.5.1.2 Standardized work - operator instructions and visual
standards 23 2.4 22.4
8.5.1.3 Verification of job set-ups 23 2.4 24.7
8.5.1.6 Management of production tooling and manufacturing, test,
inspection tooling and equipment 20 2.1 26.8
7.1.5.1.1 Measurement systems analysis 19 1.9 28.7
0
10
20
30
40
50
60
8.5.1.5 TOTAL PRODUCTIVE MAINTENANCE
3rd Party NC
7.1.5.2.1 CALIBRATION/VERIFICATION RECORDS
Omnex NCs
Note: Any clauses underlined in red were not present during Omnex Gap Analysis
10.2.3 PROBLEM SOLVING
7.2 COMPETENCE
10.2.4 ERROR-PROOFING
0.6 0.6 0.4 0.4 0.2 0.8 0.8 0.4 0.6 0.6 0.2 0.6 0.4 0.6 0.4 0.4 0.2 0.8 0.8
Major Non-conformances
7.0
100.0
6.0
80.0
5.0
4.0 60.0
3.0
40.0
2.0
20.0
1.0
0.0 0.0
0.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
1.0
4.3.2 CUSTOMER-SPECIFIC
7.2.3 INTERNAL AUDITOR
5%
9.2.2.2 QUALITY MANAGEMENT
8.5.1.5 TOTAL PRODUCTIVE
9.3.2.1 MANAGEMENT REVIEW
8.5.1.1 CONTROL PLAN
9.3.1.1 MANAGEMENT REVIEW -
4.4.1 QMS AND IT'S PROCESSES
4.4.1.2 PRODUCT SAFETY
4.2 UNDERSTANDING THE
6.1.2.1 RISK ANALYSIS
6.1.2.3 CONTINGENCY PLANS
2%
8.3.2.3 DEVELOPMENT OF
8.5.1.2 STANDARDISED WORK -
5.3 ORGANIZATIONAL ROLES,
7.1.5.1.1 MEASUREMENT
7.1.5.2.1
7.2 COMPETENCE
7.5.1.1 QUALITY MANAGEMENT
8.3.5.1 DESIGN AND
8.3.5.2 MANUFACTURING
8.5.1 CONTROL OF PRODUCTION
8.5.1.7 PRODUCTION
9.1.1.1 MONITORING AND
9.2.2 INTERNAL AUDIT
conformances
Vital Few: Major NCs vs. Clauses
0
7.0 8.0 9.0 4.0 6.0 5.0 10.0
Clause-wise Top Major NC
30
26
25
25
20
20
18
15
10
10
5 4 4
0
Clause 9.0 Clause 8.0 Clause 4.0 Clause 7.0 Clause 6.0 Clause 5.0 Clause 10.0
3rd Party Top 80% Major NC
Vital Few Major Non-conformances
3RD PARTY CUMMULATIVE PRESENT IN TOP 60% OF
CLAUSE NO. AND NAME MAJOR NC % TOTAL 3RD PARTY NC?
4.3.2 CUSTOMER-SPECIFIC REQUIREMENTS 7 5% NO
7.2.3 INTERNAL AUDITOR COMPETENCY 7 11% NO
9.2.2.2 QUALITY MANAGEMENT SYSTEM AUDIT 7 16% YES
8.5.1.5 TOTAL PRODUCTIVE MAINTENANCE 6 20% YES
9.3.2.1 MANAGEMENT REVIEW INPUTS - SUPPLEMENTAL 6 25% YES
8.5.1.1 CONTROL PLAN 5 29% YES
9.3.1.1 MANAGEMENT REVIEW - SUPPLEMENTAL 5 32% NO
4.4.1 QUALITY MANAGEMENT SYSTEM 4 35% NO
4.4.1.2 PRODUCT SAFETY 4 38% NO
4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES 3 41% NO
6.1.2.1 RISK ANALYSIS 3 43% YES
6.1.2.3 CONTINGENCY PLANS 3 45% YES
8.3.2.3 DEVELOPMENT OF PRODUCTS WITH EMBEDDED SOFTWARE 3 47% NO
8.5.1.2 STANDARDISED WORK - OPERATOR INSTRUCTIONS AND VISUAL STANDARDS 3 50% YES
5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES 2 51% NO
7.1.5.1.1 MEASUREMENT SYSTEMS ANALYSIS 2 53% NO
7.1.5.2.1 CALIBRATION/VERIFICATION RECORDS 2 54% NO
7.2 COMPETENCE 2 56% NO
7.5.1.1 QUALITY MANAGEMENT SYSTEM DOCUMENTATION 2 57% YES
4.2 Understanding the needs and expectations of interested parties 3.0 2.3 40.6
0
5
10
15
20
25
30
4.3.2 CUSTOMER-SPECIFIC
7.2.3 INTERNAL AUDITOR
9.2.2.2 QUALITY MANAGEMENT
8.5.1.5 TOTAL PRODUCTIVE
9.3.2.1 MANAGEMENT REVIEW
8.5.1.1 CONTROL PLAN
3rd Party NC
8.3.5.1 DESIGN AND
8.3.5.2 MANUFACTURING PROCESS
1 0.2 1 0.8 0.6 0.2 0.2 0.6 0.4 0.6 0.6 0.8 0.2 0.4 0
8.5.1 CONTROL OF PRODUCTION
8.5.1.7 PRODUCTION SCHEDULING
9.1.1.1 MONITORING AND
Omnex NCs
Note: Any clauses underlined in red were not present during Omnex Gap Analysis
9.2.2 INTERNAL AUDIT (CONTD.)
9.2.2.1 INTERNAL AUDIT
9.3.2 MANAGEMENT REVIEW INPUTS
10.2.1 NONCONFORMITY AND
10.2.3 PROBLEM SOLVING
4.1 UNDERSTANDING THE
4.3 DETERMINING THE SCOPE OF
5.3.1 ORGANIZATIONAL ROLES,
5.3.2 RESPONSIBILITY AND
6.1.1 ACTIONS TO ADDRESS RISK
6.1.2 ACTIONS TO ADDRESS RISK
6.1.2.2 PREVENTIVE ACTION
Top Major 3rd Party and corresponding Omnex NC's with Audit Coverage
The 3rd Party audit results have been presented to us at a very good time. Many
organizations are getting ready for their 3rd Party audits in October, our suggestions
are as follows
Conduct a very thorough document review of your level I and II (Quality Manual and Process
documentation). Doing this will show you the deficiencies at the shall level.
Use the list of 56 NCs (Majors and Minors) in your checklist with the Changed Requirements highlighted.
This checklist is available to anyone who have taken Omnexs auditor training. We will be doing a second
webinar on how to prepare for the IATF 16949, watch for our e-mail soon to register for this webinar.
3rd Party Audits reveal that the changes in Leadership (5.0), Planning, and Risk Based
thinking (6.1) are not getting the non-conformances that were expected or Automotive
Organizations are doing a good job putting in systems in place for these changes.
Also, there is confusion between Automotive Supply Base and Auditors regarding
Second Party Audits. There will be a sanctioned interpretation soon that we hope will
clear up this confusion.
Overall, the Automotive Scheme is working well. 3rd Party auditors appear to be doing
a good job. It is a wake call for organizations to take the IATF 16949 transition seriously.
IATF 16949 and ISO 9001 represent a major change for many organizations. This is the biggest change
in Automotive Standards since QS 9000. Quality Organizations need to use this opportunity to rethink
their management systems and prepare for the next 20 years.
Copyright 2017 Omnex, Inc. All Rights Reserved.
Books 31
Upcoming Books on
ISO 14001 and IATF 16949
New Training Coming Soon: FCA and GM CQIs and CSRs for OEMs
Functional Safety Management (ISO 26262) Overview for Managers & Executives
Understanding Automotive SPICE and Integration with ISO 26262 and IATF 16949
Auditing Automotive SPICE and Integration with ISO 26262 and IATF 16949
Questions?
Thank You!
webinars@omnex.com
734.761.4940