Rough Transition to IATF 16949

3rd Party Audit Findings,

Conclusions, and
Recommendations
Chad Kymal, CTO Omnex, Inc.
August 22, 2017

DRIVING WORLDWIDE BUSINESS EXCELLENCE

Copyright 2017 Omnex, Inc. All Rights Reserved.

Omnex Introduction 4

International consulting, training and software development organization founded

in 1985.
Specialties:
Integrated management system solutions.
Elevating the performance of client organizations.
Consulting and training services in:
Quality Management Systems, e.g. ISO 9001, IATF 16949, AS9100, QOS
Environmental Management Systems, e.g. ISO 14001
Health and Safety Management Systems, e.g. OHSAS 18001
Leader in Lean, Six Sigma and other breakthrough systems and performance
enhancement.
Provider of Lean Six Sigma services to Automotive Industry via AIAG alliance.

Copyright 2017 Omnex, Inc. All Rights Reserved.

About Omnex 5

Headquartered in Ann Arbor, Michigan with offices in major global markets.

In 1995-97 provided global roll out supplier training and development for Ford
Motor Company.
Trained more than 100,000 individuals in over 30 countries.
Workforce of over 500 professionals, speaking over a dozen languages.
Former Delegation Leader of the International Automotive Task Force (IATF)
responsible for ISO/TS16949.
Served on committees that wrote QOS, ISO 9001, ISO 14001, ISO 45001, ISO 13485
QS-9000 and its Semiconductor Supplement, ISO IWA 1 (ISO 9000 for healthcare).
Member of AIAG manual writing committees for FMEA, SPC, MSA, Sub-tier Supplier
Development, Error Proofing, and Effective Problem Solving (EPS).

Copyright 2017 Omnex, Inc. All Rights Reserved.

Omnex Key Global Offices 6

Omnex is headquartered
and operates from the
United States through
offices in Michigan.

The company maintains

international operations in
the many countries to
provide comprehensive
services to clients
throughout Western
Europe, Latin America
and the Pacific Rim
Omnex Global Head Quarters (Michigan, USA) Middle East (Dubai)

Asia Pacific HQ (Chennai, Pune, Delhi, Bangalore) Thailand (Bangkok)

www.omnex.com
info@omnex.com China (Shanghai, Guangzhou, Wuhan) Eastern Europe (Czech Republic)

Europe (Berlin, Germany)

Singapore

Copyright 2017 Omnex, Inc. All Rights Reserved.

Chad Kymal 7

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.

Copyright 2017 Omnex, Inc. All Rights Reserved.

 Rough Transition to IATF 16949 8
3rd Party Audit Findings, Conclusions, and Recommendations
Globally, there are over 68,000 organizations certified to ISO/TS 16949:2009 that
will need to undergo a transition audit to IATF 16949:2016. As of April 2017, 181
of these audits have been completed this year, resulting in an average of 5.3
nonconformities and nearly one major nonconformity (0.73) per audit. There is a
lot we can analyze and learn from these audits. What areas are receiving
nonconformities? What surprises lie in these nonconformities? What are 3rd
party auditors finding/not finding? For example, who thought Total Productive
Maintenance was going to be one of the top nonconformities? The list of
nonconformities can be used as a preventive measure to ensure key registrar
nonconformities are addressed before your transition audit.
Omnex has performed a large number of gap analysis audits for our customers
and will compare our findings to the list of registrar nonconformities. What were
Omnexs top findings? How many of them still remain? Why are companies still
receiving major nonconformities for Auditor Competencies and CSRs when
that was one of the top findings in Omnexs gap analyses? These are just some of
the questions we will explore.

Copyright 2017 Omnex, Inc. All Rights Reserved.

Agenda 9

IATF 16949:2016 Background

Analysis of Total Minors and Majors
Analysis by Clauses 4.0 to 10.0
Minor Non-conformances
Major Non-conformances
Summary

Copyright 2017 Omnex, Inc. All Rights Reserved.

Rough Transition to IATF 16949
Initial Results from the Initial
181 3rd Party Audits
The IATF 16949 Family of Documents

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

Copyright 2017 Omnex, Inc. All Rights Reserved.

IATF 16949 Customer Specific US OEMs Core Tools

APQP: Advance Product Quality Planning

Guidelines for a product quality plan for the development of a product
or service that satisfies the customer.
FMEA: Failure Modes and Effect Analysis
Methodology used to ensure potential problems have been considered
and addressed throughout the product and process development
process (i.e., APQP).
SPC: Statistical Process Control
Basic statistical methods associated with statistical process
control and process capability analysis used for continual improvement
efforts.
MSA: Measurement Systems Analysis
Guidelines for assessing the quality of a measurement system where
readings can be replicated on each part.
PPAP: Production Part Approval Process
Ensures product consistently meets customer engineering specification
requirements during production run at the quoted production rate.

Copyright 2017 Omnex, Inc. All Rights Reserved.

12
Current Transition Timeline (IATF 16949) 13

Oct. 3, 2016 IATF 16949 released

Oct. 2, 2017 No more audits for ISO/TS 16949:2009.

All audits must be to the IATF 16949.

Transition complete.
Sept. 14, 2018 All ISO/TS 16949 and ISO 9001:2008 certificates
are no longer valid.

Organizations need to transition according to their surveillance and

recertification anniversary after Oct. 2, 2017.
You can opt for earlier, but you cannot go past that date.

Copyright 2017 Omnex, Inc. All Rights Reserved.

 0
10
20
30
40
50
60
8.5.1.5 TOTAL PRODUCTIVE MAINTENANCE
8.5.1 CONTROL OF PRODUCTION AND
8.5.1.2 STANDARDISED WORK - OPERATOR
7.1.5.1.1 MEASUREMENT SYSTEMS
9.1.1.1 MONITORING AND MEASUREMENT
7.2.1 COMPETENCE - SUPPLEMENTAL
7.1.5.3.1 INTERNAL LABORATORY
10.2.3 PROBLEM SOLVING
8.4.1.2 SUPPLIER SELECTION PROCESS
8.5.6.1 CONTROL OF CHANGES -
7.5.3.2
10.2.1
7.2.2 COMPETENCE - ON-THE-JOB TRAINING
7.5.3.2.1 RECORD RETENTION
8.6.1 RELEASE OF PRODUCTS AND
4.2 UNDERSTANDING THE NEEDS AND
7.1.5.2 MEASUREMENT TRACEABILITY
8.3.3.2 MANUFACTURING PROCESS DESIGN
8.5.1.7 PRODUCTION SCHEDULING
8.7.1
7.1.5.1 GENERAL
8.3.4.4 PRODUCT APPROVAL PROCESS
9.3.1.1 MANAGEMENT REVIEW -
7.3.1 AWARENESS - SUPPLEMENTAL
8.3.2.3 DEVELOPMENT OF PRODUCTS
8.7.1.1 CUSTOMER AUTHORIZATION FOR
9.2.2.4 PRODUCT AUDIT
6.2.2
7.1.4.1 ENVIRONMENT FOR THE
8.2.3.1.3 ORGANIZATION
8.7.1.7 NONCONFORMING PRODUCT
9.1.1.3 APPLICATION OF STATISTICAL
5.1.1.3 PROCESS OWNERS
5.3.2 RESPONSIBILITY AND AUTHORITY
7.1.3.1 PLANT, FACILITY, AND EQUIPMENT
8.3.1 GENERAL
8.4.1 GENERAL
8.5.3 PROPERTY BELONGING TO
8.6.6 ACCEPTANCE CRITERIA
9.1.3 ANALYSIS AND EVALUATION
Total NC vs Clauses for the First 181 IATF Audits Performed

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

8.4.2.3 Supplier quality

7.1.5.2.1
7.1.5.3.1 Internal laboratory
of the total Nonconformities

8.7.1.4 Control of reworked

9.1.2.1 Customer satisfaction
10.2.3 Problem solving
There are 35 NCs in this list of 60%

7.5.1.1 Quality management

8.3.3.3 Special characteristics
8.4.1.2 Supplier selection
8.4.2.4.1 Second-party audits
10%

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%

ISO 9001:2015 Clause

ISO 9001:2015 & Clause has not changed
Clauses have not changed
Top 10 Total Non Conforming Clauses

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

8.5.1.1 CONTROL PLAN

6.1.2.3 CONTINGENCY PLANS

0.8 0.6 0.6

0
8.5.1 CONTROL OF PRODUCTION AND SERVICE

7.2.3 INTERNAL AUDITOR COMPETENCY

8.3.5.2 MANUFACTURING PROCESS DESIGN

8.5.1.2 STANDARDISED WORK - OPERATOR

8.5.1.3 VERIFICATION OF JOB SET-UPS

8.5.1.6 MANAGEMENT OF PRODUCTION

7.1.5.1.1 MEASUREMENT SYSTEMS ANALYSIS

0.6 0.4 0.2 0.4 0.4 0.4

1
9.3.2.1 MANAGEMENT REVIEW INPUTS -

8.4.2.4 SUPPLIER MONITORING

9.1.1.1 MONITORING AND MEASUREMENT OF

4.3.2 CUSTOMER-SPECIFIC REQUIREMENTS

6.1.2.1 RISK ANALYSIS

0.8 0.4 0.8 0.8

1
7.2.1 COMPETENCE - SUPPLEMENTAL

8.4.2.3 SUPPLIER QUALITY MANAGEMENT

3rd Party NC
7.1.5.2.1 CALIBRATION/VERIFICATION RECORDS

7.1.5.3.1 INTERNAL LABORATORY

8.7.1.4 CONTROL OF REWORKED PRODUCT

9.1.2.1 CUSTOMER SATISFACTION -

Omnex NCs

Note: Any clauses underlined in red were not present during Omnex Gap Analysis
10.2.3 PROBLEM SOLVING

7.5.1.1 QUALITY MANAGEMENT SYSTEM

8.3.3.3 SPECIAL CHARACTERISTICS

8.4.1.2 SUPPLIER SELECTION PROCESS

8.4.2.4.1 SECOND-PARTY AUDITS

9.2.2.3 MANUFACTURING PROCESS AUDIT

8.5.6.1 CONTROL OF CHANGES - SUPPLEMENTAL

9.2.2.2 QUALITY MANAGEMENT SYSTEM AUDIT

7.2 COMPETENCE

7.5.3.2 CONTROL OF DOCUMENTED

Top Total 3rd Party and corresponding Omnex NC's with Audit Coverage

8.3.2.1 DESIGN AND DEVELOPMENT PLANNING

8.5.4.1 PRESERVATION - SUPPLEMENTAL

10.2.1 NONCONFORMITY AND CORRECTIVE

The numbers are related to Omnex Gap Analysis. % assessments that have found the same non-conformance. 1 =100% and .2 = 20%

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

Copyright 2017 Omnex, Inc. All Rights Reserved.

21
 Major NC vs. Clauses
8.0 120.0

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

9.2.2.1 INTERNAL AUDIT

9.3.2 MANAGEMENT REVIEW
10.2.1 NONCONFORMITY AND
29 Total Major Non-

10.2.3 PROBLEM SOLVING

4.1 UNDERSTANDING THE
4.3 DETERMINING THE SCOPE
5.3.1 ORGANIZATIONAL ROLES,
5.3.2 RESPONSIBILITY AND
6.1.1 ACTIONS TO ADDRESS
6.1.2 ACTIONS TO ADDRESS
6.1.2.2 PREVENTIVE ACTION
6.3 PLANNING OF CHANGES
7.1.3 INFRASTRUCTURE
7.1.5.1 GENERAL
7.1.5.2 MEASUREMENT
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
Distribution of Top 60% by Clause Number

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

ISO 900:2015 & Clause has not changed

ISO 9001:2015 Clause

8.3.5.1 DESIGN AND DEVELOPMENT OUTPUTS - SUPPLEMENTAL 2 59% NO
8.3.5.2 MANUFACTURING PROCESS DESIGN OUTPUT 2 60% YES
8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION 2 62% NO
8.5.1.7 PRODUCTION SCHEDULING 2 63% NO
9.1.1.1 MONITORING AND MEASUREMENT OF MANUFACTURING PROCESSES 2 65% YES
9.2.2 INTERNAL AUDIT (CONTD.) 2 66% NO
9.2.2.1 INTERNAL AUDIT PROGRAMME 2 68% NO
9.3.2 MANAGEMENT REVIEW INPUTS 2 69% NO
10.2.1 NONCONFORMITY AND CORRECTIVE ACTION 2 71% NO
10.2.3 PROBLEM SOLVING 2 72% NO
4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT 1 73% NO
4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM 1 74% NO
5.3.1 ORGANIZATIONAL ROLES, RESPONSIBILITIES, AND AUTHORITIES - SUPPLEMENTAL 1 74% NO
5.3.2 RESPONSIBILITY AND AUTHORITY FOR PRODUCT REQUIREMENTS AND
CORRECTIVE ACTIONS 1 75% NO
6.1.1 ACTIONS TO ADDRESS RISK AND OPPORTUNITIES 1 76% NO
6.1.2 ACTIONS TO ADDRESS RISK AND OPPORTUNITIES (CONTD.) 1 77% NO
6.1.2.2 PREVENTIVE ACTION 1 77% NO
6.3 PLANNING OF CHANGES 1 78% NO
7.1.3 INFRASTRUCTURE 1 79% NO
7.1.5.1 GENERAL 1 80% YES
7.1.5.2 MEASUREMENT TRACEABILITY 1 80% YES
 Top Non Conformances Minors and Majors (w/Duplicates Identified)
PRESENT ONLY IN TOP 60% OF TOTAL NC PRESENT ONLY IN TOP 80% OF MAJOR NC
TOTAL # CLAUSE NO. AND NAME MAJOR # NC
4.3.2 CUSTOMER-SPECIFIC REQUIREMENTS 7
CLAUSE NO. AND NAME NC
7.2.3 INTERNAL AUDITOR COMPETENCY 7
8.5.1 CONTROL OF PRODUCTION AND SERVICE
9.3.1.1 MANAGEMENT REVIEW - SUPPLEMENTAL 5
PROVISION 26
4.4.1 QUALITY MANAGEMENT SYSTEM 4
7.2.3 INTERNAL AUDITOR COMPETENCY 23 4.4.1.2 PRODUCT SAFETY 4
8.5.1.3 VERIFICATION OF JOB SET-UPS 23 4.2NC
UNDERSTANDING
Present in Top 60% of Total and Top 80%THE NEEDS AND EXPECTATIONS OF INTERESTED
of Major
8.5.1.6 MANAGEMENT OF PRODUCTION TOOLING AND PARTIES 3
NC
MANUFACTURING, TEST, INSPECTION TOOLING AND 8.3.2.3 DEVELOPMENT OF PRODUCTS WITH EMBEDDED SOFTWARE 3
EQUIPMENT Clause No. and
20 Name Major # NC
5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES 2
8.4.2.4 SUPPLIER MONITORING 9.2.2.2 9.2.2.2 Quality
18 management system audit 7
7.1.5.1.1 MEASUREMENT SYSTEMS ANALYSIS 2
8.5.1.5
4.3.2 CUSTOMER-SPECIFIC REQUIREMENTS 8.5.1.5 Total14
productive maintenance 6
7.1.5.2.1 CALIBRATION/VERIFICATION RECORDS 2
7.2.1 COMPETENCE - SUPPLEMENTAL 9.3.2.1 14
9.3.2.1 Management review inputs - supplemental
7.2 COMPETENCE 6 2
8.4.2.3 SUPPLIER QUALITY MANAGEMENT
8.5.1.1SYSTEM
8.5.1.1 Control plan 8.3.5.1 DESIGN AND DEVELOPMENT OUTPUTS 5- SUPPLEMENTAL 2
DEVELOPMENT 6.1.2.1 14
6.1.2.1 Risk analysis 8.5.1 CONTROL OF PRODUCTION AND SERVICE3PROVISION 2
7.1.5.3.1 INTERNAL LABORATORY 13
6.1.2.3 6.1.2.3 Contingency plans 8.5.1.7 PRODUCTION SCHEDULING 3 2
8.7.1.4 CONTROL OF REWORKED PRODUCT 13
8.5.1.2 Standardised work9.2.2 INTERNAL
- operator AUDIT (CONTD.)
instructions and 2
9.1.2.1 CUSTOMER SATISFACTION - SUPPLEMENTAL 13 9.2.2.1 INTERNAL AUDIT PROGRAMME 2
8.5.1.2 visual standards 3
10.2.3 PROBLEM SOLVING 13 9.3.2 MANAGEMENT REVIEW INPUTS 2
8.3.3.3 SPECIAL CHARACTERISTICS 7.5.1.1 7.5.1.1 Quality
12 management system
10.2.1 documentation
NONCONFORMITY 2
AND CORRECTIVE ACTION 2
8.3.5.2
8.4.1.2 SUPPLIER SELECTION PROCESS 8.3.5.2 Manufacturing
12 process
10.2.3design
PROBLEM output
SOLVING 2 2
8.4.2.4.1 SECOND-PARTY AUDITS 9.1.1.1 Monitoring
12 and measurement
4.1 of manufacturing
UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT 1
9.1.1.1
9.2.2.3 MANUFACTURING PROCESS AUDIT processes 12 4.3 DETERMINING THE SCOPE OF THE QUALITY 2 MANAGEMENT
7.1.5.1 7.1.5.1 GENERAL SYSTEM 1 1
8.5.6.1 CONTROL OF CHANGES - SUPPLEMENTAL 11
5.3.1 ORGANIZATIONAL ROLES, RESPONSIBILITIES, AND AUTHORITIES
7.2 COMPETENCE 7.1.5.2 10
7.1.5.2 MEASUREMENT TRACEABILITY
- SUPPLEMENTAL 1 1
7.5.3.2 CONTROL OF DOCUMENTED INFORMATION 5.3.2 RESPONSIBILITY AND AUTHORITY FOR PRODUCT
(CONTD.) 10 REQUIREMENTS AND CORRECTIVE ACTIONS 1
8.3.2.1 DESIGN AND DEVELOPMENT PLANNING - 6.1.1 ACTIONS TO ADDRESS RISK AND OPPORTUNITIES 1
SUPPLEMENTAL 10 6.1.2 ACTIONS TO ADDRESS RISK AND OPPORTUNITIES (CONTD.) 1
8.5.4.1 PRESERVATION - SUPPLEMENTAL 10 6.1.2.2 PREVENTIVE ACTION 1
10.2.1 NONCONFORMITY AND CORRECTIVE ACTION 10 6.3 PLANNING OF CHANGES 1
10.2.4 ERROR-PROOFING 10 7.1.3 INFRASTRUCTURE 1

The total number of NCs between Minors and Majors to focus on

are 56 Non-conformances
 Top 10 Major Non Conformance Clauses

Clause No. And Name Major Cumulative

Majors % Major %
4.3.2 Customer-specific requirements 7.0 5.3 5.3
7.2.3 Internal auditor competency 7.0 5.3 10.5
9.2.2.2 Quality management system audit 7.0 5.3 15.8
8.5.1.5 Total productive maintenance 6.0 4.5 20.3
9.3.2.1 Management review inputs - supplemental 6.0 4.5 24.8
8.5.1.1 Control plan 5.0 3.8 28.6
9.3.1.1 Management review - supplemental 5.0 3.8 32.3
4.4.1 QMS and its processes 4.0 3.0 35.3
4.4.1.2 Product safety 4.0 3.0 38.3

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

0.8 0.6 0.4 0.8 1 0.6 0

9.3.1.1 MANAGEMENT REVIEW -
4.4.1 QUALITY MANAGEMENT
4.4.1.2 PRODUCT SAFETY
4.2 UNDERSTANDING THE NEEDS
6.1.2.1 RISK ANALYSIS
6.1.2.3 CONTINGENCY PLANS
8.3.2.3 DEVELOPMENT OF
8.5.1.2 STANDARDISED WORK -
5.3 ORGANIZATIONAL ROLES,
7.1.5.1.1 MEASUREMENT SYSTEMS
7.1.5.2.1
7.2 COMPETENCE
7.5.1.1 QUALITY MANAGEMENT

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

6.3 PLANNING OF CHANGES

7.1.3 INFRASTRUCTURE
7.1.5.1 GENERAL
7.1.5.2 MEASUREMENT
0 0.4 0.8 0.6 0.6 0.8 0.8 1 0.6 0.6 0.4 0.8 0.8 0.8 0.4 0.2 0.2 0.2
Summary 30

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

Implementing Integrated Management Systems

QMS, EMS and OHSMS Including Aerospace,
Automotive and Food Safety Management
Systems written by
Chad Kymal, Gregory Gruska and R. Dan Reid.
NOW AVAILABLE through ASQ Press!

Other Books Available by Chad Kymal:

AS9101D Auditing for Process Performance:
Combining Conformance and Effectiveness to Meet
Customer Satisfaction
The ISO/TS 16949:2002 Auditor Handbook
The ISO/TS 16949:2002 Implementation Guide:
Gaining Value From Your ISO/TS 16949
Implementation
How to Audit ISO 9001:2008 A Handbook for
Auditors

Copyright 2017 Omnex, Inc. All Rights Reserved.

Now Available! 32

Now Available from ASQ Press:

How to Audit ISO 9001:2015:

A Handbook for Auditors

Upcoming Books on
ISO 14001 and IATF 16949

Copyright 2017 Omnex, Inc. All Rights Reserved.

IATF 16949 Courses Available 33

Transition Training for IATF 16949:2016 and ISO 9001:2015

IATF 16949:2016 Internal Auditor Training
IATF 16949:2016 Lead Auditor Training
Understanding the Requirements of IATF 16949:2016
IATF 16949:2016 Second Party (Supplier Auditor) Training
IATF 16949:2016 Product Auditor Training
IATF 16949:2016 Manufacturing Process Auditor Training
Understanding Automotive SPICE and Integration with ISO 26262 and IATF 16949
IATF 16949 Executive Overview
Understanding, Documenting and Implementing IATF 16949:2016
Risk and Implementing Risk Strategies for ISO Management Systems
BOS: Aligning Objectives - Risk in Planning including Context and Interested Party
Expectations

New Training Coming Soon: FCA and GM CQIs and CSRs for OEMs

Copyright 2017 Omnex, Inc. All Rights Reserved.

ISO 26262 & Automotive SPICE Courses Available 34

Functional Safety Management (ISO 26262) Overview for Managers & Executives

Auditing to ISO 26262 Functional Safety Management Systems Standards

Understanding Automotive SPICE and Integration with ISO 26262 and IATF 16949

Auditing Automotive SPICE and Integration with ISO 26262 and IATF 16949

Copyright 2017 Omnex, Inc. All Rights Reserved.

Upcoming Public Training IATF 16949 35

Understanding and Documenting: 2 days

Internal Auditor Training: 4 days These classes can also be
Lead Auditor Training: 5 days delivered at your site.
Consulting and
Aug 28-Sep 01, 2017-Mississauga, ON
Implementation Assistance is
Aug 28-Sep 01, 2017-San Jose, CA also available.
Sep 11-15, 2017-Ann Arbor, MI
Sep 18-22, 2017-Greenville, SC
Sep 25-29, 2017-Mississauga, ON
Oct 02-06, 2017-Chicago, IL
Oct 16-20, 2017-Ann Arbor, MI

To see our full training schedule through 2017

www.omnex.com/training

Copyright 2017 Omnex, Inc. All Rights Reserved.

 Upcoming Public Training ISO 26262 36

Auditing to ISO 26262 Functional Safety

Management Standards: 5 Days
These classes can also be
Oct 9-13, 2017-Ann Arbor, MI delivered at your site.
Consulting and
Implementation Assistance is
also available.

To see our full training schedule through 2017

www.omnex.com/training

Copyright 2017 Omnex, Inc. All Rights Reserved.

 37

Questions?

Thank You!
webinars@omnex.com

734.761.4940

Copyright 2017 Omnex, Inc. All Rights Reserved.