Overview on the Application of ISO 16949 in a Worldwide Leader Company in the Production of...

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 410  Int. J. Productivity and Quali ty Management, Vol. 7, No. 4, 2011  Copyright © 2011 Inderscience Enterprises Ltd. 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, 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 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

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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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434 . 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:

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.

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