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410 Int. J. Productivity and Quality Management, Vol. 7, No. 4, 2011
Copyright © 2011 Inderscience Enterprises Ltd.
Overview on the application of ISO/TS 16949:2009, ina worldwide leader company in the production of
stainless steel tubes for automotive exhaust systems
M. Bevilacqua
Dipartimento di Energetica,
Università Politecnica delle Marche,
Via Brecce Bianche 12,
Ancona 60131, Italy
E-mail: [email protected]
Filippo Emanuele Ciarapica
Facoltà di Scienze e Tecnologia,
Libera Università di Bolzano,
Piazza Università, 5,
Bolzano 39100, Italy
E-mail: [email protected]
Giancarlo Giacchetta
Dipartimento di Energetica,
Università Politecnica delle Marche,
Via Brecce Bianche 12,
Ancona 60131, Italy
E-mail: [email protected]
Barbara Marchetti*
Facoltà di Ingegneria,
Università degli Studi eCampus,
Via Isimbardi 10,
Novedrate (CO) 22060, Italy
E-mail: [email protected]
*Corresponding author
Abstract: This paper presents an overview on the quality approach of acompany that is at the leading edge in the sector of stainless steel-based
products and represents an example of best practice in pursuing a continualimprovement and the customer satisfaction. In this study, the attention has beenfocused on the application of the technical specification ISO 16949:2009 inaccordance with the ISO 9000:2008, for the quality control of stainless steeltubes produced for automotive applications in one of the company plantdevoted to the realisation of welded tubes for mufflers and exhaust pipes. Thecase study examined demonstrates how the effective adoption of the standardscan help in reaching the highest level of performances in the production
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Overview on the application of ISO/TS 16949:2009 411
process, giving high-quality products and consolidating the company positionon the market.
Keywords: QMS; quality management system; technical specification;
automotive; APQP; advanced product quality planning; PPAP; production partapproval process; FMEA; failure modes and effect analysis; exhaust systems;MSA; measurement system analysis; GR&R; gauge repeatability andreproducibility.
Reference to this paper should be made as follows: Bevilacqua, M.,Ciarapica, F.E., Giacchetta, G. and Marchetti, B. (2011) ‘Overview on theapplication 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.410–439.
Biographical notes: M. Bevilacqua is a Full Professor in Industrial Plants atUniversità Politecnica delle Marche, since 2007. His research activity mainlydeals with multiphase flow transport and separation analysis, environmentalanalysis 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 Università diBolzano. His research topics mainly focus on industrial plant design, facilitymanagement in the healthcare sector, fuzzy mathematics and QFD methods,
business process reengineering (BPR) methods in operation sector, applicationof energy management methods to healthcare sector, development of business
plan for industrial plants, soft computing techniques in reliability analysis andmaintenance activities planning, project management techniques applied tosmall–medium firms, life cycle assessment (LCA) and logistics. He is theauthor 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 Mechanicaland Industrial Plants at Università Politecnica delle Marche, since 1999. He is aPermanent Member of the Scientific Committee for ‘Multiphase Fluid-dynamics in Industrial Plants’. His research activities are related to themanagement and optimisation, from a technical and economic point of view, of
processes in different industrial realities. He is the author of several papers thathave been published in several national and international journals andconference proceedings.
Barbara Marchetti graduated in Mechanical Engineering at UniversitàPolitecnica delle Marche, she received her PhD in Mechanical Measurementsfor Engineering at University of Padova in 2004. Her research activities arerelated to development and application of measurements systems fordiagnostic, optimisation and control of production processes. She also studiesquality management systems and environmental performances evaluations bythe 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 theUniversità Telematica eCampus of Novedrate (CO).
The authors would like to state that they give an equal contribution in writingthis paper.
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412 . Bevilacqua et al.
1 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 firm’s management, because it allows the identification ofa 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 non-
compliant 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
today’s 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
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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 ofvehicle 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.
2 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 quality-oriented policy, has adopted from the beginning of the new business area, the ISO/TS
16949 standard.
The company stands among the steel market’s 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
Europe’s 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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414 . Bevilacqua et al.
Figure 1 General process diagram
3 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 Deming’s concepts of plan-do-
check-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.
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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 aquality 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 toshow 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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416 . Bevilacqua et al.
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 ofthe 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.
4 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 aQMS, 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 (AVSQ’94 in
Italy, EAQF’94 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)
2 production part approval process (PPAP)
3 failure modes and effect analysis (FMEA)
4 statistical process control
5 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.
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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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418 . Bevilacqua et al.
Table 1 Specific actions of APQP output
Plan and definerogramme
Product design anddevelopment verification
Process design anddevelopment verification
Product and processvalidation
Design goals
Reliability andquality goals
Preliminary bill ofmaterials
Preliminary process flow
Preliminarylist of special
products and processescharacteristics
Productassurance plan
Design FMEA(DFMEA)
Design formanufacturing andassembly (DFMA)
Design verification
Design reviews
Prototype build
Engineeringdrawings
Engineeringspecifications
Materialspecifications
Drawing andspecificationschanges
New equipment,tooling and facilityrequests
Special product and processcharacteristics
Prototype control plan
Gages/testingequipmentrequirements
Packaging standards
Product/processquality systemreview
Process flow chart
Floor plan layout
Characteristicsmatrix
PFMEA
Pre-launch control plan
Process instructions
MSA
Preliminary processcapability study plan
Packagingspecifications
Production trial run
Measurementsystem evaluation
Preliminary processcapability study
Production partapproval
Productionvalidation testing
Packagingevaluation
Production control
plan
Quality planningsign-off
Figure 3 Scheme of the APQP planning phase
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Overview on the application of ISO/TS 16949:2009 419
Table 2 Planning 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 ctivity
Document and/or
data in outputMarketing Quality Reexamination of
requirements relatedto the automotive
products
Definition andacquisition ofrequirements and oftechnical specifications
Customerspecifications
Marketing Quality Reexamination ofrequirements relatedto the automotive
products
Evaluation of customerimplicit requests frommarket researches and
previous experiences
Meeting reportscorrespondence
Quality Production Customerspecifications
Identification ofspecific requirementsof product and process
Mod. A: listfeasibility analysis
Mod. B: feasibilityand risk analysis
Quality Production Customerspecifications Verification of productfeasibility Mod. A: listfeasibility analysis
Mod. B: feasibilityand risk analysis
Quality Feasibility and riskanalysis
Emission of productspecification
Mod. C: productspecification
Quality Productspecification
Emission of processflow diagram
Process flowdiagram
Quality Multidisciplinarygroup
Productspecification
Process flowdiagram
FMEA emission Mod. D: FMEA of process
The Mod. C defines the product specification by taking into account the requirementsof 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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420 . Bevilacqua et al.
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 toevaluate 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
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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 phaseOnce 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 (0.02) of the nominal
diameter.
Table 3 Process development phase, extract from 7.1.1.1 PSGQ procedure, advanced productsquality planning, of the examined productive plant
Dept. incharge
Dept. incollaboration
Document and/ordata in input Activity
Document and/ordata in output
Quality Technicalservice
Productspecification
Evaluation ofworkrooms and plantsdisposition withrelation to the presenceof appropriate control
points, suitablecollocation of controlcharts, repair stationsand defects collection
Evaluation of thesuitability of the
production site inrelation to the new
product characteristics
Mod. D: quality plan
Quality FMEA of process Editing of the characteristicsmatrix, for each production
phase, with parameters thatinfluence the larger numberof product characteristics
Mod. E: matrix ofcharacteristics
Quality Production FMEA of process
Matrix ofcharacteristics
Editing of the control planfor the preseries
Mod. F: controlPlan
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422 . Bevilacqua et al.
Table 3 Process development phase, extract from 7.1.1.1 PSGQ procedure, advanced productsquality planning, of the examined productive plant (continued)
Dept. in
charge
Dept. in
collaboration
Document and/or
data in input ctivity
Document and/or
data in outputQuality Production PFMEA
Control plan
Process flowdiagram
Productspecification
Editing and distributing tothe personnel involved inthe production and controlof the correct operativeinstructions
Mod. G: productionspecifications
Quality Analysis ofmeasurementinstruments,revisionapplicable
Verification of reliability ofmeasurement in relation totheir linearity, accuracy,repeatability
Quality recordapplicable
Production Logistic Product
preservation,revisionapplicable
Definition of packaging
characteristics in order to preserve the product and hisfunctional and dimensional
properties
Mod. G:
productionspecifications
Quality Quality record Reports about the activitiesand the results of workinggroups to the plant direction
Report on theactivity of theworking group
Figure 6 Scheme of the APQP product and process validation phase
The product control phases instead are the following:
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 weldthickness.
Destructive control of the welding on sample taken on the production line: one
sample for every 20 bars. The test realised are:
– buckling test
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Overview on the application of ISO/TS 16949:2009 423
– widening test
– radial expansion test.
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):
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):
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 part2 design or process modification
3 materials or suppliers variation
4 machines or tools variation.
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424 . Bevilacqua et al.
Table 4 Product and process validation 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 ctivity
Document and/or
data in outputMatrix of characteristics Preproduction
Quality Production PFMEA
Control plan
Process flowdiagram
Product specification
Editing and distributingto the personnelinvolved in the
production and controlof the correct operativeinstructions
Mod. G: productionspecifications
Quality Analysis of measurementinstruments, revisionapplicable
Verification ofreliability ofmeasurement in relationto their linearity,accuracy andrepeatability
Quality recordapplicable
Production
Logistic Product preservation,revision applicable
Definition of packagingcharacteristics in orderto preserve the productand his functional anddimensional properties
Mod. G: productionspecifications
Quality Quality record Reports about theactivities and the resultsof working groups tothe plant direction
Report on theworking groupactivities
Figure 7 Scheme of the APQP production phase
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Overview on the application of ISO/TS 16949:2009 425
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
collaboration
Document and/or
data in input ctivity
Document and/or data
in outputQuality Quality SPC
Productionspecification
Reduction of the productive processvariability with theassistance of the:
control charts
data processingand analysis
Quality recordapplicable
Marketing Quality Continualimprovement
Customer satisfactionassessment
Indicators forautomotive tubes
production processes
Figure 8 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
b for all other components/details.2 Authorised engineering change documents (written authorisation from customer for
incorporating product or process change in any component).
3 Customer engineering approval.
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426 . Bevilacqua et al.
4 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).
5 Process flow diagram (a copy of the process flow, indicating all the production
process steps in sequence, including incoming components).
6 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).
7 Control plan.
8 MSA studies (document that contains studies on Gauge R&R, bias, linearity,
stability for all the measurement and test equipment used).
9 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 customerspecifications, 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
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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:
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 groupsas 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
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428 . 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:
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
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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:
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 Occurrence Detection)
Failure causes with the highest RPN should be analysed first:
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 (crackfrom 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 safevehicle operation and/or involves non-compliance with government
regulation with warning
9
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
8
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430 . Bevilacqua et al.
Table 6 Severity rating scale – 7.1.1.1 PSGQ procedure, FMEA (continued)
Description severity (S) Criteria Rating
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
7
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
6
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
5
Very low Fit and finish/squeak and rattle item do not conform. Defect noticed by
most customers (greater than 75%).
4
Minor Fit and finish/squeak and rattle item do not conform. Defect noticed by 50%
of customers
3
Very minor Fit and finish/squeak and rattle item do not conform. Defect noticed by
discriminating customers (less than 25%)
2
None No discernible effects 1
Table 7 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 9
High: frequent failures Five occurrences in 100 events 0.67 8
High: frequent failures One occurrence in 100 events 0.83 7
Moderate: occasional failures Three occurrences in 1,000 events 1 6
Moderate: occasional failures One occurrence in 10,000 events 1.17 5
Moderate: occasional failures Six occurrences in 10,000 events 1.33 4
Low: relatively few failures Six occurrences in 10 million events 1.67 3
Very low: few failures Two occurrences in 1 billion events 2.00 2
Remote: failure is unlikely Less than two occurrences in one billion
events
2.00 1
Table 8 Detection rating scale – 7.1.1.1 PSGQ procedure, FMEA
Description detection (D) Definition Rating
Absolute uncertainty The product is not inspected or the defect caused by failure is not
detectable
10
Very remote The possibility of detecting failure with usual controls is very remote 9
Remote The possibility of detecting failure with usual controls is remote 8
Very low Product is 100% manually inspected in the process 7
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Overview on the application of ISO/TS 16949:2009 431
Table 8 Detection rating scale – 7.1.1.1 PSGQ procedure, FMEA (continued)
Description detection (D) Definition Rating
Low Product is 100% manually inspected using go-no-go or other mistake-
proofing gauges
6
Moderate Some SPC is used in process, and product is final inspected offline 5
Moderately high SPC is used and there is immediate reaction to out-of-control conditions 4
High An effective SPC programme is in place with process capability (CPK)
greater than 1.33
3
Very high All product is 100% automatically inspected 2
Almost certain The defect is obvious or there is 100% automatic inspection with regular
calibration and preventive maintenance of the inspection equipment
1
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 unacceptablerisk, with G in the highest range (9–10) 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:
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:
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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432 . Bevilacqua et al.
Table 9 Example of FMEA worksheet from the 7.1.1.1 PSGQ procedure
Company name
Indication of plant FMEA
FMEA number TX 0.35 TX 0.36
Revision 2 Date xx/xx/xx
FMEA type
roduct
MEA roduct
roduct: Muffler Tube Ø 30-76.1 Th. 0.8-4 (EN 1.4301-EN 1.4541-EN
1.4512-EN 1.4509-EN 1.4510)
FMEA rocess Welded tube production line TX 35 TX 36
Evaluation
Occurrence everity etection PN
Evaluation Values valuation Values Evaluation Values Evaluation
Resulting
value
Corrective
ctions
Remote 1 Slightly
perceivable
1 High 1 Low 1–50 None
Low 2–3 Little importance 2–3 Moderate 2–3 Medium 51–100 Medium term
Moderate 4–6 Moderately
severe
4–6 Low 4–6 High 101–200 Medium term
High 7–8 Severe 7–8 Very low 7–8 Very high 201–1,000 Immediate
Very high 9–10 Extremely severe 9–10 Unlikely 9–10
Working group
Name of responsible of all involved
departments
Component Subsystem
Failure
and/or
ossible
defect
Failure
and/or
ossible
defect
effects
Failure
and/or
ossible
defect
causes
Control
measurements
scheduled
Actual state
Corrective
actions
Improved
state
O
c c u r r e n c e
S e v e r i t y
D
e t e c t i o n
R P
I m
p r o v i n g m e a s u r e s
R e s p o n s i b i l i t y
D
a t e
O
c c u r r e n c e
S e v e r i t y
D
e t e c t i o n
1 Insertion
of strip in
production
line
1 Drawing
of strip
from
warehouse
1 Edges
oxidation
Non-
compliant
welding
Incorrect
or long
storage
Visual
inspection
2 9 1 18 Storage
check and
shorter stock
rotation
1 7 1 7
2 Strip
with
chipped
edges
Non-
compliant
welding;
non-
compliant
finishing
Chipped
blade
Visual
inspection
2 9 2 36 Increasing
control on
blades
quality
1 7 2 14
3 Strip
with too
much
flash
Non-
compliant
welding
Wrong
distance
between
blades
Visual and
tactile
inspection
4 7 2 56 Control of
blades
distance
2 5 2 20
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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 ofthe 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 (C p and C pk )
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 C pk in the
range of 1.33–1.67 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 company’s 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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The five parameters to investigate in an MSA are: bias, linearity, stability,
repeatability and reproducibility.
The basic parameters of the MSA are:
Stability: attitude of a measurement instrument to maintain constant the metrologicalcharacteristics. 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 (Benbowand 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
user’s 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:
2 2
GRR (EV) (AV)
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.
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Overview on the application of ISO/TS 16949:2009 435
The total variation TV is calculated as:
2 2TV (GRR) (PV)
In the AIAG MSA manual (third edition), the following criteria for the measurement
system acceptance are defined:
1 %GRR < 10%: acceptable
2 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.
3 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 processrelated 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
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436 . Bevilacqua et al.
Figure 12 Example of GR&R report
5 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:
planning
process development
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Overview on the application of ISO/TS 16949:2009 437
product and process validation
production.
The PPAP process flow and PPAP package formalised in a form called PSW, asinterpreted 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.
References
Automotive Industry Action Group (AIAG) (2002) Measurement System Analysis Manual (3rd ed.), Chapter III, pp.112–118.
Automotive Industry Action Group (AIAG) (2008a) APQP Manual (2nd ed.). Southfield, MI, p.115.
Automotive Industry Action Group (AIAG) (2008b) Potential Failure Mode and Effects Analysis. FMEA (4th ed.). Southfield, MI, p.151.
Batson, R.G. (2008) ‘A survey of best practices in automotive supplier development’, Int. J. Automotive Technology and Management , Vol. 8, No. 2, pp.129–144, DOI: 10.1504/IJATM.2008.018890.
Benbow, D.W. and Kubiak, T.M. (2005) The Certified Six Sigma Black Belt Handbook .Milwaukee, Wisconsin: ASQ Quality Press.
Bobrek, M. and Sokovic, M. (2005) ‘Implementation of APQP-concept in design of QMS’, Journalof Materials Processing Technology, Vol. 162–163, pp.718–724, DOI: 10.1016/j.jmatprotec.2005.02.225.
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