410

Int. J. Productivity and Quality Management, Vol. 7, No. 4, 2011

Overview on the application of ISO/TS 16949:2009, in

a worldwide leader company in the production of
stainless steel tubes for automotive exhaust systems
M. Bevilacqua
Dipartimento di Energetica,
Universit Politecnica delle Marche,
Via Brecce Bianche 12,
Ancona 60131, Italy
E-mail: m.bevilacqua@univpm.it

Filippo Emanuele Ciarapica

Facolt di Scienze e Tecnologia,
Libera Universit di Bolzano,
Piazza Universit, 5,
Bolzano 39100, Italy
E-mail: f.ciarapica@univpm.it

Giancarlo Giacchetta
Dipartimento di Energetica,
Universit Politecnica delle Marche,
Via Brecce Bianche 12,
Ancona 60131, Italy
E-mail: g.giacchetta@univpm.it

Barbara Marchetti*
Facolt di Ingegneria,
Universit degli Studi eCampus,
Via Isimbardi 10,
Novedrate (CO) 22060, Italy
E-mail: barbara.marchetti@uniecampus.it
*Corresponding author
Abstract: This paper presents an overview on the quality approach of a
company that is at the leading edge in the sector of stainless steel-based
products and represents an example of best practice in pursuing a continual
improvement and the customer satisfaction. In this study, the attention has been
focused on the application of the technical specification ISO 16949:2009 in
accordance with the ISO 9000:2008, for the quality control of stainless steel
tubes produced for automotive applications in one of the company plant
devoted to the realisation of welded tubes for mufflers and exhaust pipes. The
case study examined demonstrates how the effective adoption of the standards
can help in reaching the highest level of performances in the production
Copyright 2011 Inderscience Enterprises Ltd.

Overview on the application of ISO/TS 16949:2009

process, giving high-quality products and consolidating the company position
on the market.
Keywords: QMS; quality management system; technical specification;
automotive; APQP; advanced product quality planning; PPAP; production part
approval process; FMEA; failure modes and effect analysis; exhaust systems;
MSA; measurement system analysis; GR&R; gauge repeatability and
reproducibility.
Reference to this paper should be made as follows: Bevilacqua, M.,
Ciarapica, F.E., Giacchetta, G. and Marchetti, B. (2011) Overview on the
application of ISO/TS 16949:2009, in a worldwide leader company in the
production of stainless steel tubes for automotive exhaust systems, Int. J.
Productivity and Quality Management, Vol. 7, No. 4, pp.410439.
Biographical notes: M. Bevilacqua is a Full Professor in Industrial Plants at
Universit Politecnica delle Marche, since 2007. His research activity mainly
deals with multiphase flow transport and separation analysis, environmental
analysis of process plants and maintenance management. He is the author of
several papers that have been published in several national and international
journals.
Filippo Emanuele Ciarapica is an Associate Professor at Libera Universit di
Bolzano. His research topics mainly focus on industrial plant design, facility
management in the healthcare sector, fuzzy mathematics and QFD methods,
business process reengineering (BPR) methods in operation sector, application
of energy management methods to healthcare sector, development of business
plan for industrial plants, soft computing techniques in reliability analysis and
maintenance activities planning, project management techniques applied to
smallmedium firms, life cycle assessment (LCA) and logistics. He is the
author of several papers that have been published on national and international
proceedings and journals.
Giancarlo Giacchetta is a Full Professor in the Scientific Sector of Mechanical
and Industrial Plants at Universit Politecnica delle Marche, since 1999. He is a
Permanent Member of the Scientific Committee for Multiphase Fluiddynamics in Industrial Plants. His research activities are related to the
management and optimisation, from a technical and economic point of view, of
processes in different industrial realities. He is the author of several papers that
have been published in several national and international journals and
conference proceedings.
Barbara Marchetti graduated in Mechanical Engineering at Universit
Politecnica delle Marche, she received her PhD in Mechanical Measurements
for Engineering at University of Padova in 2004. Her research activities are
related to development and application of measurements systems for
diagnostic, optimisation and control of production processes. She also studies
quality management systems and environmental performances evaluations by
the application of LCA methodology. She is the author of several papers
published in national and international journals and conference proceedings. At
present, she works as a Researcher in the field of Mechanical Plants for the
Universit Telematica eCampus of Novedrate (CO).
The authors would like to state that they give an equal contribution in writing
this paper.

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Introduction

According to Montgomery (2005), quality is one of the most important decisive factors in
the selection of products and services. Therefore, quality leads to successful business,
growth, and increases competitiveness, as well as improves the work environment and
involves the employees in achieving the corporate goals and brings a substantial return of
investment.
Nevertheless, even if total quality management (TQM) is a philosophy that delivers
long-term benefits in terms of profitability, customer satisfaction and quality of products,
according to Raj and Attri (2010), it is generally experienced that TQM implementation
is a hard and very painful process.
Different organisations work for TQM implementation and utilise their resources to
achieve the anticipated benefits. However, there are certain barriers that inhibit the
successful implementation of TQM. In their work, they proposed an index of barriers in
the TQM implementation, evaluating their inhibiting power.
Savino et al. (2008) described how quality management systems (QMSs) can be a
strategic tool for improving a firms management, because it allows the identification of
a set of quality pointers able to monitor every process. In their work, they developed a
QMS methodology able to define a set of finalised pointers to objectively measure
production improvements, or to define the lacks of a certain production process.
The improvements obtained have been mainly related to a decrease in non-conformities
(NCs) in production and, with the new QMS, the production processes have given the
same performance with the introduction of new products.
Thanks to their effort in the application of an effective QMS in compliance with
the standards, the company in which this case study was carried on, already leader in the
stainless steel production was able to reach a primary position also in the difficult
automotive market. In this business area, the quality requirements are indeed particularly
high. Since a car is the result of the assembling of about 10,000 parts, for avoiding noncompliant output, it is necessary to have a percentage of defects of each component in the
order of part per million. Moreover, the majority of the organisation in the sector follow a
just-in-time approach; therefore, to obtain the constant availability of compliant material
to feed the production lines, it is necessary to reduce to the lowest value the number of
defected supplies. Moreover, the increasing global competition over the past decade has
forced the original equipment manufacturers companies to improve quality and efficiency
facing their suppliers with multiple, mandated requirements that put a continuing
pressures to reduce price, improve quality, while producing an environmental friendly
product, using lean manufacturing practices (Johnson et al., 2007).
Batson (2008) presented a survey and a synthesis of best practices in supplier
development in the US automotive industry. The supplier development literature up
through the early 1990s consisted mostly of case studies. Since then, enough has been
determined through industry surveys and academic research to enable the identification
of success factors (the prerequisites) and best practices process and methods used in
todays automotive supplier development efforts.
Considering that to effectively manage the supply chain represents one of the most
critical aspects to achieve success in the automotive industry, since the production of a
vehicle involves as many as 30,000 suppliers and service companies (Dyer and Ouchi,
1993), the need of developing a specific standard for the sector was perceived by the
main automotive industries. In their paper, Sroufe and Curkovic (2008) explained as, in

Overview on the application of ISO/TS 16949:2009

413

1995, a joint venture between Ford, General Motors and Chrysler published QS 9000,
which was derived from the 1994 version of ISO 9000. In 2000, ISO 9000 was rewritten
and became the foundation for ISO/TS 16949, which is replacing QS 9000. The
International Automotive Task Force (IATF), which consists of an international group of
vehicle manufacturers and trade associations, developed TS 16949 in conjunction with
ISO 9000:2000. GM and Ford insisted that all suppliers should make the transition from
QS 9000 to ISO/TS 16949 by the end of 2006. Daimler Chrysler called for the transition
in 2004. In 2008, over 6,000 Tier 1 and Tier 2 suppliers worldwide had already achieved
ISO/TS 16949 registration. US firms lead the way, followed by firms in Germany,
France, Spain, Italy, China, Brazil and India.
The application of the ISO/TS 16949, in conjunction with ISO 9001:2008, defines the
requirements that the company QMS has to satisfy in order to design, produce and, when
necessary, provide installation and service of automotive-related products.
This paper will present in Section 2, a brief description of the company in which
the study was carried on; in Section 3 some related research work. Section 4 explains the
basic concept of the ISO/TS 169449 and describes the five pillars and how they are
applied by the company. Section 5 presents some conclusions.

The company

The industrial group in which the study has been carried out (that is not named for
privacy reasons), is divided in different business areas, such as steel, building, home
products, engineering, energy, tourism and services. The steel coil processing is the core
activity with a yearly output of 5.3 million tons. The group has operations worldwide
with 6,500 employees, 51 sales offices, 210 representations and 50 manufacturing plants,
covering 6 million m2, where 5,500 km of carbon and stainless steel products are
manufactured every day, serving more than 12,000 customers with 365,000 trucks, 3,650
trains and 360 vessels every year. In recent years, the group entered in the automotive
market as supplier of stainless steel tubes for exhaust systems and, following its qualityoriented policy, has adopted from the beginning of the new business area, the ISO/TS
16949 standard.
The company stands among the steel markets top independent players in the world.
On one hand, freedom on the raw material market translates into great flexibility in stock
management and price policy; and on the other hand, pioneering strategic partnership
agreements on a world scale ensure quality steel supply on a regular basis. After first
transformation within its controlled value chain, the company develops the world widest
range of tubes, open profiles and cold-drawn bars. A unique range both in terms of
materials, carbon and stainless steel grades which complies to the requirements of several
industry sector, and in terms of shape and thicknesses, from standard products to the most
sophisticated value-added, highly customised solutions. Its manufacturing units include
Europes largest cold-drawn tube plant and the biggest facility for stainless steel tubing
production and the advanced-technology-welded tube plant.
In Figure 1, the general diagram of the processes related to the overall stainless steel
division is presented.

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M. Bevilacqua et al.

Figure 1

General process diagram

Literature review

Shahin (2008) in his paper outlines how the actual economic climate, characterised by
increasing competition and structural turbulence, require a higher combined level of
productivity and quality. He demonstrated the inter-linkages among quality and
productivity, and review similarities of the two important concepts. He introduces major
quality factors, which are the possible sources for poor/high productivity, and presents
the development of some advanced models to address the direct and indirect relationships
between quality and productivity. This study has also highlighted the fact that improving
quality plays a fundamental role in increasing operations productivity in organisations.
Souraj et al. (2010) demonstrate in their paper that for organisations to be successful,
the use of well-structured management systems (MSs), quality management (QM)
approach and methodologies for continuous improvement (CI) are all essential. TQM has
been a dominant management concept for CI utilising Demings concepts of plan-docheck-act (PDCA). Lean Six Sigma is a widely accepted methodology for CI considered
among most modern in the 2000s. Recently, different MSs have gained more attention, as
they form critical infrastructure for improving and controlling different operating areas of
any organisation.
This is even more evident in the highly competitive automotive market. The quality
approach of the automotive industries and their suppliers has been studied by many
researchers from different points of view, but few works present real-life problems and
case studies.

Overview on the application of ISO/TS 16949:2009

415

According to Singh (2010), the adoption of industry-specific QMS standards, such as

ISO 16949, has been hardly analysed at firm-level. In his paper, he describes how this
industry/sector-specific standard has been developed beyond the ISO 9000 for the
automotive sectors, where the quality issues are critical. These standards seem to play a
quality signalling function. The study explores the inter-firm variations in holding the
automotive industry-specific harmonised QMS standard ISO/TS 16949 accredit for 466
auto component producers in India. Alternatively, it examines the holding of ISO/TS
16949 and/or (earlier widely accepted) QS 9000 accredit(s) in terms of the firm-specific
variables. The logistic regressions indicate considerably higher probabilities for bigger
and pure-technical collaboration enterprises. For holding the ISO/TS 16949 accredit, also
the foreign financial collaboration has a favourable influence on SMEs; however, overall
the foreign ownership, even the majority foreign equity, has negligible impact on large
firms. He suggested preparatory cum financial assistance for the ISO/TS 16949
certification.
Willem (2004) defines some guidelines which help in making the transition from QS
9000 to ISO/TS 16949. Kartha (2004) in his paper examines the relationship between
ISO 9000 quality standards, QS 9000, ISO/TS 16949 and the Baldrige criteria for
performance excellence revised in the year 2002. A comparison is made between
Baldrige criteria and the various elements of ISO 9000, QS 9000 and ISO/TS 16949
standards and their similarities and differences are examined and the implementation of
ISO 9000 requirements as an initial step for TQM implementation is discussed. Johnson
and Khan (2003) describe a study made into the application of process failure mode and
effect analysis (PFMEA) in a sample of suppliers to an automotive manufacturing
company in the UK. The objectives of the research were to study the concerns and
inhibitors that PFMEA users have, establish how the effectiveness could be determined,
evaluate PFMEA use as a problem prevention technique and to recommend best practice.
The research methodology included the use of interviews, workshops and questionnaires
involving 150 quality approved suppliers among manufacturers of brakes, electrical
equipments, glass, mechanisms, paints, plastics, pressings, raw materials and seats
through to hardware, both in the UK and in mainland Europe. Conclusions were drawn to
show that the PFMEA technique has its limitations, caused by a number of issues and
recommendations for overcoming these limitations of the PFMEA process were
presented.
To explore the strategic implications of ISO 9000:2000 adoption with the aim of
building theory, Sroufe and Curkovic (2008) chose qualitative data collection methods
(primarily field-based data collection), focusing their examination on industries that had
multiple firms involved with ISO quality standards. For this reason, they targeted
automotive industry companies and limited their efforts to plants having experience with
ISO 9000:2000. An initial list of ten automotive suppliers was generated based on
geographic proximity, a web-based search of ISO-registered plants, contacting managers
at registered plants and obtaining recommendations from those same managers. The
sample included automobile original equipment manufacturers (OEMs) and Tier 1
suppliers.
Robinson and Malhotra (2005) presented a case study of a firm that is a first-tier
supplier in an offshoot of automotive supply chain to better illustrate the supply chain
QM themes and their treatment in industrial practice.
One of the ISO 16949 pillar, i.e. widely applied by the company in particular with the
use of the control charts, consists in the statistic process control (SPC). According to

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Mahaney et al. (2007), SPC is an integral component of almost every industrial process,
and proper outlier (i.e. out of control) detection is crucial if processes are to remain in
statistical control.
Prajapati and Mahapatra (2009) in their paper provide a survey and brief summary of
the work on the control charts for variables to monitor the process mean and dispersion
from the first general model of control charts proposed by Shewhart in 1931 to the new
and various approaches that have been developed in this area since then.
Jarrett and Pan (2009) suggest multivariate methods for the construction of quality
control charts for the control and improvement of output of manufacturing processes.
They demonstrate the usefulness of multivariate process control in comparison with
univariate or Shewhart style control charts.

ISO TS 16949

The company policy is very attentive to the quality issues and continuously supports the
production chain investing in research, technology and staff training. It has adopted a
QMS, based on the ISO 9000:2008 and employs a team of quality assurance specialists
that, together with the highly skilled staff of technician, have earned the most important
certifications for products and processes.
The ISO/TS 16949 is a technical specification that defines the requirements of the
QMS for automotive-related products. It represents the rationalisation of the different
specifications adopted from the automotive industries all around the world (AVSQ94 in
Italy, EAQF94 in France, VDA 6.1 in Germany and QS 9000 in USA) in a single
technical specification through the creation of the IATF group.
This synthesis comes as an answer to a sector that went through a heavy globalisation
phenomenon and that needed homogeneity of the related standards.
According to Hoyle (2005), the purpose of ISO/TS 16949 is to assist organisations
supplying products or services into the automotive sector, to operate systems that not
only ensure whether these products and services meet customer requirements, but also
provide continual improvement, emphasise defect prevention and reduce variation and
waste in the supply chain.
The standard provides also a vehicle for consolidating and communicating concepts
in the field of QM that have been approved by an international committee of
representatives from the automotive industry as well as from national standards bodies.
The five pillars of the ISO/TS 16949 are:
1

advanced product quality planning (APQP)

production part approval process (PPAP)

failure modes and effect analysis (FMEA)

statistical process control

measurement system analysis (MSA).

This study concentrates in the QM approach in one of the company sectors: the
production of stainless steel tubes for automotive applications and on the application of
the ISO/TS 16949 in the relative processes.

Overview on the application of ISO/TS 16949:2009

417

4.1 Advanced product quality planning

The process of developing new components, standardised by the Automotive Industry
Action Group (AIAG) is defined as APQP. This method, originally part of the ISO 9000,
then adopted also by the ISO/TS 16949, is now an instrument to define, plan and monitor
all the development phases of the product or process necessities to satisfy the customer.
Bobrek and Sokovic (2005) describe in their paper the structure of APQP process.
It consists of four phases with five major activities along with ongoing feedback
assessment and corrective actions, as showed in Figure 2.
The outputs of the APQP method, as schematised in the previous diagram, consist in
a series of actions to undertake in order to obtain the complete planning of the production
process as detailed in Table 1.

4.1.1 APQP: planning phase

This phase has the aim of understand the needs and the expectations of the customers in
order to plan and define the quality programme. The inputs needed, the available
instruments and the outputs expected are showed in Figure 3.
In the company analysed, the areas involved in the APQP first phase are the
marketing, quality and production departments as illustrated in Table 2, in which an
extract from the 7.1.1.1 PSGQ procedure for the product advanced quality planning,
applied in the plant object of this study, is shown.
Figure 2

Structure of APQP

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M. Bevilacqua et al.

Table 1

Specific actions of APQP output

Plan and define

programme

Product design and

Process design and
development verification development verification

Design goals

Reliability and
quality goals x

Preliminary
bill of
materials

x
x

Preliminary
process flow

Design for
manufacturing and
assembly (DFMA)

Design verification

Design reviews

Prototype build

Preliminary
x
list of special
products and
processes
x
characteristics
Product
x
assurance plan

Figure 3

Design FMEA
(DFMEA)

Engineering
drawings
Engineering
specifications
Material
specifications

Drawing and
specifications
changes

New equipment,
tooling and facility
requests

Special product and

process
characteristics

Prototype control
plan

Gages/testing
equipment
requirements

Product and process

validation

Packaging standards x

Production trial run

Product/process
quality system
review

Measurement
system evaluation

Process flow chart

Preliminary process
capability study

Floor plan layout

Characteristics
matrix

Production part
approval

Production
validation testing

PFMEA

Pre-launch control
plan

Packaging
evaluation

Process instructions

MSA

Production control
plan

Preliminary process
capability study plan

Quality planning
sign-off

Packaging
specifications

Scheme of the APQP planning phase

Overview on the application of ISO/TS 16949:2009

Table 2
Dept. in
charge

419

Planning phase, extract from 7.1.1.1 PSGQ procedure, advanced products quality
planning, of the examined productive plant
Dept. in
collaboration

Document and/or
data in input

Activity

Document and/or
data in output

Marketing Quality

Reexamination of
requirements related
to the automotive
products

Definition and
Customer
acquisition of
specifications
requirements and of
technical specifications

Marketing Quality

Reexamination of
requirements related
to the automotive
products

Evaluation of customer Meeting reports

implicit requests from correspondence
market researches and
previous experiences

Quality

Production

Customer
specifications

Identification of
Mod. A: list
specific requirements feasibility analysis
of product and process Mod. B: feasibility
and risk analysis

Quality

Production

Customer
specifications

Verification of product Mod. A: list

feasibility
feasibility analysis
Mod. B: feasibility
and risk analysis

Quality

Feasibility and risk

analysis

Emission of product
specification

Mod. C: product
specification

Quality

Product
specification

Emission of process
flow diagram

Process flow
diagram

FMEA emission

Mod. D: FMEA of
process

Quality

Multidisciplinary x
group

Product
specification

Process flow
diagram

The Mod. C defines the product specification by taking into account the requirements
of the specific customer. In this case, however, those are included, for the majority of
customers, in the standard product specification for stainless steel tubes for automotive
applications.
The defined requirements are related both to the raw material and to the superficial
finishing, as in the extract presented in Figure 4 from standard product specification.
Supplementary requirement with respect to the UNI EN 10296-2 is the
recommendation about the grain structure that has to be homogeneous in form and size,
with a maximum number of non-metallic inclusions defined by the standard ASTM E45.
Those characteristics guarantee a good workability of the material.
The dimensional tolerances respect the UNI EN ISO 1127 that represent the standard
for the market of stainless steel tubes.

4.1.2 APQP: process development phase

The aim of the second phase of the APQP is to ensure a global and critical review of the
project requirements and of the technical information correlated. The instruments and
the outputs are showed in Figure 5.

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The process development phase is characterised by a multidisciplinary approach that

involves also the Technical Service and the Logistic Department to put together all the
documentation necessary for the preproduction series and the consequent assessment of
the compliance to the customer requirements. The feasibility analysis is necessary to
evaluate if it is possible to reach the volumes of production required in coherence with
the established time, costs, quality and reliability level. In this phase, it is also possible to
identify if there could be problems related to the industrialisation.
Table 3 lists the department involved, the activities carried on and the outputs
produced in the process development.
Figure 4

Extract from standard product specification

Figure 5

Scheme of the APQP process development phase

Overview on the application of ISO/TS 16949:2009

421

From the FMEA of process, derives the editing of the matrix of characteristics, the
control plan and finally the production specification used by the production departments.

4.1.3 APQP: product and process validation phase

Once known the product characteristics (dimensions, superficial finishing, tolerances,
etc.) and the production technologies, it is possible to define the sequence of the
activities. The instruments and the outputs of the process validation phase are described
in Figure 6.
In the plant analysed, quality controls are carried out on materials, production
processes (in-line and offline) and products.
The TX031 production line performs two types of controls: on the sheared strip and
on the final product.
The first is performed when the strip is inserted in the production line and consist of a
thickness measurement. The tolerance falls within the B class (r0.02) of the nominal
diameter.
Table 3

Process development phase, extract from 7.1.1.1 PSGQ procedure, advanced products
quality planning, of the examined productive plant

Dept. in
charge

Dept. in
collaboration

Document and/or
data in input

Quality

Technical
service

Product
specification

Quality

Quality

FMEA of process

Production

FMEA of
process

Matrix of
characteristics

Activity

Document and/or
data in output

Mod. D: quality
Evaluation of
workrooms and plants plan
disposition with
relation to the presence
of appropriate control
points, suitable
collocation of control
charts, repair stations
and defects collection

Evaluation of the
suitability of the
production site in
relation to the new
product characteristics

Editing of the characteristics Mod. E: matrix of

matrix, for each production characteristics
phase, with parameters that
influence the larger number
of product characteristics
Editing of the control plan
for the preseries

Mod. F: control
Plan

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M. Bevilacqua et al.

Table 3

Process development phase, extract from 7.1.1.1 PSGQ procedure, advanced products
quality planning, of the examined productive plant (continued)

Dept. in
charge

Dept. in
Document and/or
collaboration data in input

Quality

Production

Quality

PFMEA
Control plan
Process flow
diagram
x
Product
specification
Analysis of
measurement
instruments,
revision
applicable
x
x
x

Activity

Document and/or
data in output

Editing and distributing to

the personnel involved in
the production and control
of the correct operative
instructions

Mod. G:
production
specifications

Verification of reliability of
measurement in relation to
their linearity, accuracy,
repeatability

Quality record
applicable

Production Logistic

Product
preservation,
revision
applicable

Definition of packaging
characteristics in order to
preserve the product and his
functional and dimensional
properties

Mod. G:
production
specifications

Quality

Quality record

Reports about the activities

and the results of working
groups to the plant direction

Report on the
activity of the
working group

Figure 6

Scheme of the APQP product and process validation phase

The product control phases instead are the following:

x

Non-destructive control by Eddy current technique on the 100% of the welded strip
to detect the presence of anomalies and discontinuities.

Dimensional non-destructive controls of the external diameter and of the seam weld
thickness.

Destructive control of the welding on sample taken on the production line: one
sample for every 20 bars. The test realised are:

buckling test

Overview on the application of ISO/TS 16949:2009

widening test

radial expansion test.

423

More destructive tests are performed in the company metallurgic laboratory and concern
mechanical characterisation (tensile test), chemical and metallographic analysis and
corrosive atmosphere simulation.
Table 4 shows the product and process validation phase, extract from 7.1.1.1 PSGQ
procedure, advanced products quality planning, of the examined productive plant.

4.1.4 APQP: production phase

In this phase, the multidisciplinary APQP group has to assess that (Figure 7):
x

the production is compliant with the control plan and the process flow

the product satisfies the specifications.

Any added requirement or activity has to be indentified for evaluation and the resolution
before starting the mass production.
Table 5 presents the production phase, extract from 7.1.1.1 PSGQ procedure,
advanced products quality planning, of the examined productive plant.

4.2 Production part approval process

Within the APQP process, the AIAG has developed a PPAP standard. The PPAP
identifies the methodology requested from ISO/TS 16949 for approving products and
processes and has the objective of guarantee that (Figure 8):
x

the component suppliers understand clearly the customers requirements minimising

the risk of failure

the product is compliant with such requirements

the production process (including sub-suppliers) is capable of consistently producing

conforming products

the QMS will prevent that non-conforming components could reach the market or
compromise the safety and reliability of finished products.

The PPAP produces a series of documents (PPAP package) formalised in a form called
part submission warrant (PSW) that has to be approved by the suppliers and customers.
The PPAP is applied to the products realised in a defined productive plant, with reference
to the materials, machineries, instruments and methods of production. It may be required
for all components and materials of the finished product, also if processed by external
sub-contractors. It is required in case of:
1

new component or part

design or process modification

materials or suppliers variation

machines or tools variation.

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Table 4

M. Bevilacqua et al.
Product and process validation phase, extract from 7.1.1.1 PSGQ procedure, advanced
products quality planning, of the examined productive plant

Dept. in Dept. in
charge collaboration

Document and/or data

in input

Activity

Document and/or
data in output

Matrix of characteristics Preproduction

Quality Production

PFMEA

Control plan

Process flow
diagram

Product specification

Editing and distributing Mod. G: production

to the personnel
specifications
involved in the
production and control
of the correct operative
instructions

Quality

Analysis of measurement Verification of

Quality record
instruments, revision
reliability of
applicable
applicable
measurement in relation
to their linearity,
accuracy and
repeatability

Producti Logistic
on

Product preservation,
revision applicable

Definition of packaging Mod. G: production

characteristics in order specifications
to preserve the product
and his functional and
dimensional properties

Quality

Quality record

Reports about the

Report on the
activities and the results working group
of working groups to
activities
the plant direction

Figure 7

Scheme of the APQP production phase

Overview on the application of ISO/TS 16949:2009

Table 5

Production phase, extract from 7.1.1.1 PSGQ procedure, advanced products quality
planning, of the examined productive plant

Dept. in
charge

Dept. in
Document and/or
collaboration data in input

Quality

Quality

Marketing

Figure 8

425

Quality

SPC

Production
specification

Continual
improvement

Activity
Reduction of the
productive process
variability with the
assistance of the:
x

control charts

data processing
and analysis

Document and/or data

in output
Quality record
applicable

Customer satisfaction Indicators for

assessment
automotive tubes
production processes

Example of PPAP process flow

As stated from AIAG, there are currently 18 elements that represent the PPAP
requirements,
1

Design records
a

for proprietary components/details

for all other components/details.

Authorised engineering change documents (written authorisation from customer for

incorporating product or process change in any component).

Customer engineering approval.

426

M. Bevilacqua et al.

DFMEA (developed for parts or materials for which the supplier is responsible of the
design that has to be reviewed and signed by supplier and customer).

Process flow diagram (a copy of the process flow, indicating all the production
process steps in sequence, including incoming components).

PFMEA (all the process flow steps are followed and any possible source of problems
during the fabrication and assembly of each component is assessed. The document
has to be reviewed and signed-off by supplier and customer).

Control plan.

MSA studies (document that contains studies on Gauge R&R, bias, linearity,
stability for all the measurement and test equipment used).

Dimensional results (produce the evidence that dimensional verifications required by

the design record and control plan has been performed and the relative results are
compliant with the specified requirements).

10 Record of material/performance tests results (contains a summary of every test

performed on the components and parts).
11 Initial process studies (determination of initial process capability or performances, it
shows all SPC charts affecting the most critical characteristics).
12 Qualified laboratory documentation (copy of all laboratory certifications).
13 Appearance approval report (submission is required if the product/part has
appearance requirements on design record).
14 Sample production parts.
15 Master sample (a sample that is approved by customer and supplier, and can be used
for operators training on inspections).
16 Checking aids (if there are special tools for checking parts, this section shows a
picture of the tool and calibration records, including dimensional report of the tool).
17 Customer specific requirements (specific requirements expressed by customer that
have to be included on the PPAP package).
18 PSW (this form summarises the entire PPAP package).
An example of material test results, comprehending chemical analysis, mechanical and
destructive tests according to the control plan on testing samples is reported in Figure 9.
The document refers to a certificate (Test certificate 10508057346), elaborated for the
batch test following the UNI EN 10204 metallic product control documents. The
certification is of the 3.1 type that provide a specific control before the expedition to
ensure the compliance with order specifications.
The dimensional tests, executed on a range of samples following the customer
specifications, are recorded in the form presented in Figure 10.
After the PPAP approval request presentation, the responsible of approval from the
customer side, evaluates the PAPA package that includes all the documents produced in

Overview on the application of ISO/TS 16949:2009

427

all the APQP phases, and gives notification to the supplier. The result of the evaluation
can be:
x

Full approval: the organisation is authorised to provide the product.

Interim approval: the organisation is authorised to provide the product for a limited
period of time or for a limited number of pieces. The NC causes have to be clearly
identified and the PPAP has to be represented to obtain the full approval

Rejected: the organisation is not authorised to provide the product to the customer.

If the criteria of acceptance are not satisfied by the scheduled date for the approval is
necessary to submit a plan of corrective actions and a modified control plan.
The PPAP documentation has to be kept for one year more than the period of time in
which the product is considered as active (part number).

4.3 FMEA
FMEA has been effectively promoted in the automotive sector by industries and groups
as AIAG (2002, 2008a,b), the Society of Automotive Engineers (SAE, 2009) or the
American Society for Quality (ASQ).
The Quality Associates International defines the failure mode and effects analysis
(FMEA) as a systematic team driven approach that identifies potential failure modes in a
system, product, manufacturing and assembly operation caused by either design,
manufacturing or assembly process deficiencies. Although there is one person in charge
for coordinating the FMEA process, all FMEAs are team based.
Figure 9

Material test results of PPAP

428

M. Bevilacqua et al.

Figure 10 Dimensional results of PPAP

It also identifies critical or significant design or process characteristics that require

special controls to prevent or detect failure modes. FMEA is a tool used to prevent
problems from occurring.
In the proposed case study, since the product is defined by the customer technical
specifications, the company implements only the PFMEA in which all the criticalities of
a new productive process or a modification of an existing one, or his adaptation for
similar products, are evaluated.
Product FMEAs can be conducted at different phases of a product life cycle
(preliminary or final design, prototype) or on the ongoing production.
The development of PFMEA consists in the identification of:
x

the major functions or operations of the process

all credible failure modes for each process function

the failure effects, failure causes and current controls for each potential failure mode

Overview on the application of ISO/TS 16949:2009

429

the occurrence, severity and detection for each failure cause (these ratings produce
the risk priority number (RPN))

corrective/preventive actions to improve the process/test.

The relative risk of a failure and its effects is determined by three factors:
x

Severity: the consequence of the failure if it occurs.

Occurrence: the probability or frequency of the failure.

Detection: the probability of the failure being detected before the impact of the effect
is realised.

The RPN is used to rank the need for corrective actions to eliminate or reduce the
potential failure modes and is calculated as:

RPN

(Severity u Occurrence u Detection)

Failure causes with the highest RPN should be analysed first:

x

high occurrence number indicates the causes should be eliminated or controlled

high detection number indicates a need for additional controls

high severity number indicates product or process redesign may be needed.

The process functions can be divided in basic (specific functions for which the process is
designed) and secondary (subordinate functions). In the car exhaust system, the basic
function is represented by the ejection of exhaust gases from the engine in accordance
with the regulatory standards and the secondary functions by low noise level, long
duration, aesthetical requirements, etc. In this case, a possible failure mode for the basic
function could be the deficiency in the gas ejection (no ejection or ejection non-compliant
with standards). Instead for the secondary ones the failure could be represented by a high
noise level (pipes breaking, catalyst malfunctioning), low duration of base material (crack
from fatigue or corrosion), non-compliant finishing, etc.
After having identified the failure modes, it is necessary to assess their effects and the
correspondent gravity as showed in Table 6.
The following steps in the risk analysis are the assessment of the occurrence
probability and of the detection. The respective scales used from the leader company and
included in the FMEA procedures are represented in Tables 7 and 8.
Table 6

Severity rating scale 7.1.1.1 PSGQ procedure, FMEA

Description severity (S)

Criteria

Rating

Hazardous without
warning

Very high severity ranking when a potential failure mode affects safe
vehicle operation and/or involves non-compliance with government
regulation without warning

10

Hazardous with warning

Very high severity ranking when a potential failure mode affects safe
vehicle operation and/or involves non-compliance with government
regulation with warning

Very high

Fundamental damage to the production line. The 100% of the product could
be discarded. The vehicle/product is inoperable with loss of primary
functions

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M. Bevilacqua et al.

Table 6

Severity rating scale 7.1.1.1 PSGQ procedure, FMEA (continued)

Description severity (S)

Criteria

High

Damage to the production line. A fraction of the production (less than

100%) is discarded. Vehicle/product is operable but at reduced level of
performance. Customer very dissatisfied

Moderate

Damage to the production line. A lower fraction of the production is

discarded. Vehicle/product is operable but comfort/convenience item
inoperable. Customer dissatisfied

Low

Low damage in production line. The totality of the product can be

reworked. Vehicle/product is operable but comfort/convenience item
inoperable. Customer is somewhat dissatisfied

Very low

Fit and finish/squeak and rattle item do not conform. Defect noticed by
most customers (greater than 75%).

Minor

Fit and finish/squeak and rattle item do not conform. Defect noticed by 50%
of customers

Very minor

Fit and finish/squeak and rattle item do not conform. Defect noticed by
discriminating customers (less than 25%)

None

No discernible effects

Table 7

Rating

Occurrence rating scale 7.1.1.1 PSGQ procedure, FMEA

Description occurrence (O)

Definition

CPK

Rating

Very high: persistent failures

More than three occurrences in 10 events

< 0.33

10

Very high: persistent failures

Three occurrences in 10 events

0.33

High: frequent failures

Five occurrences in 100 events

0.67

High: frequent failures

One occurrence in 100 events

0.83

Moderate: occasional failures

Three occurrences in 1,000 events

Moderate: occasional failures

One occurrence in 10,000 events

1.17

Moderate: occasional failures

Six occurrences in 10,000 events

1.33

Low: relatively few failures

Six occurrences in 10 million events

1.67

Very low: few failures

Two occurrences in 1 billion events

2.00

Less than two occurrences in one billion

2.00

Remote: failure is unlikely

events

Table 8

Detection rating scale 7.1.1.1 PSGQ procedure, FMEA

Description detection (D)

Definition

Absolute uncertainty

The product is not inspected or the defect caused by failure is not

detectable

Rating
10

Very remote

The possibility of detecting failure with usual controls is very remote

Remote

The possibility of detecting failure with usual controls is remote

Very low

Product is 100% manually inspected in the process

431

Overview on the application of ISO/TS 16949:2009

Table 8

Detection rating scale 7.1.1.1 PSGQ procedure, FMEA (continued)

Description detection (D) Definition

Low

Rating

Product is 100% manually inspected using go-no-go or other mistakeproofing gauges

Moderate

Some SPC is used in process, and product is final inspected offline

Moderately high

SPC is used and there is immediate reaction to out-of-control conditions

High

An effective SPC programme is in place with process capability (CPK)

greater than 1.33

Very high

All product is 100% automatically inspected

Almost certain

The defect is obvious or there is 100% automatic inspection with regular

calibration and preventive maintenance of the inspection equipment

An example of FMEA worksheet from the 7.1.1.1 PSGQ procedure is presented in

Table 9. From the sheet it is possible to prioritise the failure modes by ranking them in
order from the highest RPN to the smallest. The procedure establishes a cut-off RPN
linked to the value of the severity G. FMs with a RPN above that point of unacceptable
risk, with G in the highest range (910) are attended immediately.
Improvement and corrective actions must continue until the resulting RPN reaches an
acceptable level for all potential failure modes.
In order to realise the continual improvement objective, the FMEA has to be
considered as a living document:
x

has to be reviewed periodically and frequently

the S, O, D indicators have to be evaluated whenever the product or process change

any defect or potential cause of defect has to be added.

The FMEA is an effective tool adopted as standard from the automotive companies and
their suppliers, nevertheless it presents some limitations:
x

often the human errors and environmental conditions are neglected

since the possible failure is considered independent and evaluated separately, the
combined effect of the coexisting ones are not assessed

the real application can be very expensive and time consuming

the occurrence of failures can be very difficult to assess

the determination, interpretation and application of data emerging from the analysis
presents a level of uncertainty that is difficult to evaluate

if it is applied only to satisfy the customer requests is not effective.

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M. Bevilacqua et al.

Table 9

Example of FMEA worksheet from the 7.1.1.1 PSGQ procedure

Company name
Indication of plant

FMEA number TX 0.35 TX 0.36

FMEA

Revision 2

Date xx/xx/xx

Product
FMEA

Product

Product: Muffler Tube 30-76.1 Th. 0.8-4 (EN 1.4301-EN 1.4541-EN

1.4512-EN 1.4509-EN 1.4510)

FMEA type PFMEA

Process

Welded tube production line TX 35 TX 36

Evaluation
Occurrence

Severity

Detection

RPN

Evaluation Values

Evaluation

Values Evaluation Values

Resulting
Evaluation value

Corrective
actions

Remote

Slightly
perceivable

High

Low

150

None

Low

23

Little importance

23

Moderate

23

Medium

51100

Medium term

Moderate

46

Moderately
severe

46

Low

46

High

101200

Medium term

High

78

Severe

78

Very low

78

Very high

2011,000

Immediate

Very high

910

Extremely severe

910

Unlikely

910
Name of responsible of all involved
departments

1 18 Storage
1 7 1 7
check and
shorter stock
rotation

Chipped Visual
Noninspection
compliant blade
welding;
noncompliant
finishing

2 36 Increasing 1 7 2 14
control on
blades
quality

3 Strip Nonwith too compliant

much
welding
flash

Wrong Visual and

distance tactile
between inspection
blades

RPN

Control
measurements
scheduled

Detection

Incorrect Visual
or long inspection
storage

1 Drawing 1 Edges Nonof strip

oxidation compliant
from
welding
warehouse

2 Strip
with
chipped
edges

Failure
and/or
possible
defect
causes

Severity

Failure
and/or
possible
defect
effects

Occurrence

Component Subsystem
1 Insertion
of strip in
production
line

Failure
and/or
possible
defect

Improved
state

Responsibility
Date
Occurrence
Severity
Detection
RPN

Corrective
actions

Actual state

Improving measures

Working group

56 Control of 2 5 2 20
blades
distance

Overview on the application of ISO/TS 16949:2009

433

4.4 Statistical process control

Statistical tools allow measurement and evaluation of the performance in a process to
improve its quality. According to Montgomery (2005), statistical tools can be helpful in
developing activities previous to manufacturing, in measuring process variability,
in analysing this variability relative to product requirements or specifications and in
eliminating or greatly reducing variability in process.
These tools allow the interpretation of the process by detecting when the variables
change and experimentation by knowing how the variables can change by experimental
designs (Ott et al., 2005).
Statistical application in process control is very important to establish stability in the
manufacturing process and maintain a state of control over an extended period. It
provides the measurements of the central tendency: mean, median and mode; the
measurement of dispersion: standard deviation, variance and range; and the maximum
and the minimum to analyse and measure the variation in a process or product features or
characteristics (Mitra, 1998).
The application of SPC permits to improve the knowledge and the characterisation of
the process helps the designer to guarantee the correspondence between product and
process, allows to promptly identify process drift and to take real-time corrective actions
avoiding non-complying products. Finally, it is used to monitor processes in order to
reduce their variability and obtain a continuous quality improvement as defined in the
Deming cycle: PDCA.
The SPC is based on the seven basic statistical tools defined by Ishikawa: the
fishbone diagram along with the histogram, Pareto chart, check sheet, control chart,
flowchart and scatter diagram.
The company applies statistical tools for quality control in all the stainless steel
production line. A measurement campaign has been conducted recently by the same
authors, collecting and analysing, using different statistical tools, data on dimensional
non-destructive controls of the external diameter, of the TXM tubes produced on a
specific line TX 031 and results of destructive tests conducted on the same tubes.
Attributes (P) and variables (X  R) control charts and capacity index (Cp and Cpk)
were used to evaluate the process compliance and the product quality.
The study carried on showed that 64% of the processes are capable with a Cpk in the
range of 1.331.67 and that the buckling and radial expansion tests used to monitor the
welding quality, demonstrated that 75% of the analysed tubes are compliant.

4.5 Measurement system analysis

The MSA is defined in the ISO 9000:2008 and AIAG 2002 standards, as an experimental
and mathematical method of determining how much the variation within the
measurement process contributes to overall process variability.
Ensuring that an aspect of a product conforms to quality specifications is the goal of
measurement (Kimber et al., 1997). Incorrectly rejecting products that are compliant with
specifications or accepting products that are not compliant is both costly and has a
negative effect on a companys reputation. Therefore, the equipment used to make
measurements must be accurate to a level higher than the tolerance of the measurement.

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M. Bevilacqua et al.

The five parameters to investigate in an MSA are: bias, linearity, stability,

repeatability and reproducibility.
The basic parameters of the MSA are:
x

Stability: attitude of a measurement instrument to maintain constant the metrological

characteristics. It refers to processes which are normally free from special cause
variations. Analysing a system for stability typically involves the standard statistical
processes (SPC) and other standard deviation measurement tools. Determination of
stability standards in a system requires data sampled to cover a wide range of
possible variation factors, such as human resources, tools, parts, time, space and
location factors.

Accuracy: is the closeness of agreement between the average of a large number of

experimental measurements of a characteristic and the master value of that
characteristic. Accuracy is measured using the bias that is the difference between the
average value of all the measurements and the master value.

Linearity: represents the difference in the bias values through the expected operating
range of the gauge.

Precision is a measure of the degree of repeatability between measurements.

Repeatability is the variation in measurements performed under identical conditions.

Reproducibility is the variation due to different factors related to the measurement

system. Those include, but are not limited to, operators, different gauges,
temperature, humidity, etc.

According to Breyfogle (2003), the tool to address the operator consistency is a gauge
repeatability and reproducibility (GR&R) study, which consists in the evaluation of the
measurement instruments to determine its capability to yield a precise response. The
objective of a GR&R is to obtain the amount of variation in a measurement system, and
to allocate that variation to the two categories, repeatability and reproducibility (Benbow
and Kubiak, 2005).
In the examined company, the MSA study is performed during the productive process
in working conditions; measurements are taken by a certain number of operators on
several samples that represent the process variability.
To analyse the results the company uses the average and range method. Figure 11
shows the components of total variability measurements observations as defined in the
users Guide 2: data analysis and quality tools by MINITAB Statistical Software, where
the part-to-part variation (PV) represents the intrinsic variability of the measurable
characteristics between two subsequent samples of two different batches.
The value that gives the indication of the repeatability and reproducibility of the
measurement system is calculated as:

GRR

(EV) 2  (AV) 2

where EV is the equipment variation that expresses the variability induced in the
measurement by the instrument and AV is the appraiser variation that is a measure of the
reproducibility.

Overview on the application of ISO/TS 16949:2009

435

The total variation TV is calculated as:

TV

(GRR) 2  (PV) 2

In the AIAG MSA manual (third edition), the following criteria for the measurement
system acceptance are defined:
1

%GRR < 10%: acceptable

10% < %GRR < 30%: the system could be acceptable depending on factors, such as
the importance of application, cost of measurement device, cost of repair, etc.

unacceptable: it is necessary to improve the measurement system.

The final phase of the analysis consists in the evaluation of the distinct categories that can
be individuated from the measurement system that represent the capability of the
instrument of discriminating or resolution. According to AIAG, the number of categories
should be at least five.
The results are collected in the GR&R data sheet for the evaluation of the process
related to the measurement of the external diameter of the welded tube, using a digital
caliper. From the analysis, the resulting %GRR is 18.56, giving the indication that there
could be some issues related to the measurement performances even if the system is
acceptable. The relative GR&R form is presented in Figure 12.
Figure 11 Components of total variability measurements

436

M. Bevilacqua et al.

Figure 12 Example of GR&R report

Conclusions

A review of the technical specification ISO/TS 16949 and its application in a company
that represents an example of best practice in the adoption of a QMS have been
presented. It has been shown how the company addresses the different requirements of
the standard, and some examples of the documents produced and of the procedure
adopted have been proposed.
The different phases defined in the standard have been examined, and the five pillars
of the standard: APQP, PPAP, FMEA, SPC, MSA, have been explained.
It has been demonstrated that the APQP structure and specific actions, in particular
the following APQP phases have been described:
x

planning

process development

Overview on the application of ISO/TS 16949:2009

product and process validation

production.

437

The PPAP process flow and PPAP package formalised in a form called PSW, as
interpreted from the company has been reported.
The PFMEA implemented and the relative worksheet have been included in this
paper.
Results on a measurement campaign conducted by the same authors by using
statistical tools and SPC method have been presented.
Finally, the MSA results collected in the GR&R data sheet have been evaluated,
giving the indication that with a %GRR is 18.56, there could be some issues related to the
measurement performances even if the system is acceptable.
The overall study demonstrates that the main aims of the company, such as continual
improvement and customer satisfaction, have been effectively reached; thanks to its
quality-oriented policy and the capability to use the standard as a tool for addressing any
productive issues, and improving production process involving all the personnel and
suppliers.
The application of the standard also led to a number of corrective actions, such us
increasing controls on blade quality and relative position for avoiding non-compliant
welding and finishing of strips, or reducing the storage time of the strips in the warehouse
for solving the edge oxidation issue.
Future research activities will be related to the application of qualitative methods (e.g.
Delphy method) together with statistical tools, always in compliance with quality-related
standards.

Acknowledgements
The authors would like to acknowledge the reviewers for their constructive and helpful
comments and suggestions that helped in improving this paper value.

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