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Jurnal Internasional
Jurnal Internasional
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Abstract
Purpose – In 2016, the ISO/TS 16949 quality management standard for the automotive industry evolved to
IATF 16949. The update brought new requirements that need to be analyzed before being implemented in
organizations. Therefore, the purpose of this article is to propose guidelines to assist organizations in the
automotive sector in the implementation of the elements added in the update to the IATF 16949 standard.
Design/methodology/approach – To fulfill this objective, the identification and analysis of the elements
added in the evolution from ISO/TS 16949 to IATF 16949 was carried out, and four case studies were conducted
in Brazilian automotive companies.
Findings – The main elements added to IATF 16949 with the update of the standard are the use of process
failure mode effects analysis (PFMEA) for risk analysis; the development of a communication channel for
employees to report cases of misconduct and non-conformities; procedures for controlling repaired/reworked
products and temporary changes; and the inclusion of autonomous maintenance for the full implementation of
total productive maintenance (TPM).
Originality/value – The main practical implication/contribution of the research is the proposed guidelines,
which can support managers and automotive companies that want to implement, or will go through, the IATF
certification process. The article’s originality lies in the combination of a theoretical framework and case study
analyses to develop the guidelines.
Keywords Quality management systems, ISO 9001, ISO/TS 16949, IATF 16949, Automotive industry, Brazil
Paper type Research paper
2. Theoretical framework
2.1 Quality management systems (QMSs) ISO/TS 16949 and IATF 16949
Quality management comprises a set of actions, procedures, practices and documents that
assist the organization in managing the quality of its products or services, with the main
objective of satisfying the needs of internal and external customers (Oliveira et al., 2013b). A
QMS can be considered a form of management that seeks continual improvement and
excellence in products and processes at all levels of the organization (Talapatra et al., 2018).
According to Presot et al. (2014), there are no defined rules on how to implement a QMS,
but good practices are considered essential for the success and maintenance of the system,
which can range from the commitment of top management to the level of employee
involvement in adhering to a culture of continuous improvement (Kartha, 2004; Kwon et al.,
2007). Commonly, the implementation of a QMS takes place based on the use of standards
(national or international), mainly due to the need for organizations to meet the demands of
several stakeholders (Barnes et al., 2004; Vitoreli and Carpinetti, 2013). The ISO 9001 and/or
ISO/TS 16949 standards are the most widely used in the development of QMSs. The former is
the only one within the ISO 9000 series of standards that is certifiable, while the latter is a
QMS standard specific to the automotive sector (Chiarini, 2019; Vanichchinchai, 2022).
BIJ Until the 1980s, it was common for automotive companies to suffer from a competitive
disadvantage since their suppliers worked with different quality standards at the same time.
In view of this, three “giants” of the automotive segment (Chrysler, Ford and General Motors)
joined forces to create an international standard that would follow ISO standards but that
was specific to the automotive sector (Rahman et al., 2020; Zakuan et al., 2012). As a result, the
ISO/TS 16949 standard was created in 1994 and underwent an update in 2016, now being
called IATF 16949:2016.
The high number of security recalls recorded in the US has recently led the NHTSA to
require car manufacturers to implement safety rules and standardize production. This has led
organizations to implement a QMS to create standardized production processes, with defined
rules, training and monitoring regarding the quality and safety of the final product
(Chiarini, 2019).
ISO/TS 16949 is a certifiable technical specification based on the ISO 9001 standard. ISO/
TS 16949 aims to guide automotive companies to follow a single quality standard, using
specific tools and methods, such as statistical process control (SPC), measurement system
analysis (MSA), process failure mode effects analysis (PFMEA), advanced product quality
planning (APQP) and production part approval process (PPAP) (Banduka et al., 2018;
Bevilacqua et al., 2011; Pop and Elod, 2015).
The implementation of ISO/TS 16949 by automotive companies represents a significant
opportunity for the standardization and improvement of production processes (Oliveira et al.,
2013a; Talapatra et al., 2020). Considering the specific characteristics and challenges of the
automotive industry, the use of ISO/TS 16949 represents a strategy to complement the
requirements of the international standard ISO 9001, aiming to provide customer satisfaction
by emphasizing the prevention of defects, the reduction of non-conformities and waste in the
supply chain (Civcisa and Grislis, 2014; Fonseca and Domingues, 2017; Lee et al., 2003).
Since its introduction, the ISO/TS 16949 standard has been identified as an instrument
within the automotive industry for unification and harmonization with other existing ISO
standards, such as ISO 9001, ISO 14001, ISO 45001, ISO 26000, etc (Barbosa et al., 2018;
Gonzalez et al., 2014; Wiengarten et al., 2017). Joshi et al. (2013) also mentioned that, in their
research on Indian automotive companies, the managers interviewed stated that they only
reached the desired quality level after the implementation of ISO/TS 16949.
With the update of the standard to IATF 16949:2016, the IATF (an entity encompassing the
associations of automotive companies), seeking greater autonomy and agility, identified the need
to replace ISO/TS 16949 with IATF 16949 (IATF, 2018). According to the IATF (2016), the
transition started on January 2, 2017, and, from October 1, 2017, ISO/TS 16949:2009 certification
for maintenance audits was no longer carried out. In addition, since September 14, 2018, all ISO/
TS 16949:2009 certificates expired, so the standard has officially ceased to exist (IATF, 2016).
In order to create a more versatile and user-friendly standard, IATF 16949:2016 was
restructured from ISO/TS 16949:2009 and in accordance with ISO Annex SL (IATF, 2016).
Like the former ISO/TS 16949, IATF 16949 also maintains and establishes specific
requirements common to automotive companies. Therefore, the customer specific
requirements (CSRs) were maintained, with zero probability of ceasing to exist, further
reinforcing that the CSRs should be evaluated and included in the scope of the organization’s
QMS, seeking to ensure customer satisfaction (Chiarini and Cherrafi, 2017; IATF, 2018).
Although ISO 9001:2015 no longer requires quality manuals from companies, the
evolution from ISO/TS 16949 to IATF 16949 maintained this element as a requirement of
the standard (IATF, 2016). IATF 16949, together with the specific requirements applicable to
the customer, presents the definition of the fundamental requirements of the QMS, providing
a common quality approach for automotive and replacements parts companies (IATF, 2016).
It is worth noting that the figure of the top management representative is also no longer a
requirement of the standard after updating to IATF 16949 (IATF, 2016).
The evolution from ISO/TS 16949 to IATF 16949 brought the addition of some elements, From ISO/TS
including (1) “product safety,” which was included in order to meet the needs of having 16949 to IATF
documented processes to manage the safety of the product; (2) “corporate responsibility,”
which was added to reinforce the need for companies to implement policies against bribery
16949
and implement codes of conduct and ethics for employees; (3) “process owners,” which
defines, and makes managers responsible for, management activities within the company;
and (4) “risk analysis,” which includes the periodic assessment of lessons learned throughout
the production process and the maintenance of documented information as an internal source
of control of organizational knowledge. Risk analysis is present in several elements of the new
standard and, at a minimum, the lessons learned from product recall, product auditing,
repairs and returns, complaints, scrap and rework must be included in the risk analysis. In
addition, there should be a retention of the records of the risk analyses carried out, evidencing
the performance of such analysis (IATF, 2018).
The contingency plan is one of the elements of the standard that has undergone significant
changes, with new requirements added. According to the new standard, the contingency plan
must ensure that the organization applies a systematic approach to identify and address risks
in all manufacturing processes, including external risks. Among the new requirements there is
the need to carry out evaluations to measure the effectiveness of the relationship in the face of
operational failures and the need to conduct a critical analysis of the contingency plan annually.
If any failure in the contingency process is identified, the customer must be notified (IATF,
2016). Other elements added were “organizational knowledge,” “development of products with
embedded software,” “supplier selection process,” “directed buy,” “type and extent of control,”
“total predictive maintenance,” “temporary chance of process controls,” “control of reworked
and repaired products,” “manufacturing process audit,” and “warranty management system.”
All the above elements reinforce the importance of implementing the new standard, which
presents new concepts for risk analysis and preventive actions, as well as enhanced
monitoring and control of production processes, aiming for positive results in relation to a
company’s competitors, thus differentiating the new standard from the ISO/TS 16949 model.
This new approach establishes a basis for increasing the effectiveness of the QMS, generating
positive results and preventing negative effects for the organization as a whole (IATF, 2016).
2.2 Analysis of the elements added in the evolution from ISO/TS 16949 to IATF 16949
This section presents the description of the main elements added from ISO/TS 16949 to IATF
16949. The analysis of the added elements presented in this section was supported by the
literature review on QMS ISO 9001, ISO/TS 16949 and IATF 16949, as well as a structured
comparison between the ISO/TS 16949 and IATF 16949 standards. The changes that have
been added to the new structure of the standard are highlighted in Table 1.
In the update from ISO/TS 16949 to IATF 16949, the element “product safety” was
included, reinforcing the need to have documented processes to manage and guarantee
product safety (Pekovic, 2015; Talapatra and Uddin, 2019). In this sense, it is possible to
highlight the importance of actions such as the identification and control of product
characteristics related to safety, the definition of responsibilities and the analysis of the
requirements along the supply chain (IATF, 2018; Nagariya et al., 2021).
The “corporate responsibility” element was added to the IATF 16949 standard,
reinforcing the need for companies to implement ethical policies and codes of conduct. The
IATF indicates that this implies responsibility at all levels and functions of an organization,
so that all employees have to adopt an ethical posture and feel a responsibility to report any
behavior that compromises compliance with the organization’s code of conduct (IATF, 2018).
With the evolution of the standard, new responsibilities inherent to top management are
reinforced, such as the identification of “process owners” who are responsible for managing
activities within the company. In addition, this new requirement makes senior management
BIJ Corresponding requirement in
ISO/TS 16949 requirement IATF 16949 Evolution of the elements
Did not exist 4.4.1.2 – Product safety A new item regarding documented processes
for managing product and process safety was
added
Did not exist 5.1.1.1 – Corporate New reference to the need to define and
responsibility implement corporate responsibility policies
Did not exist 5.1.1.3 – Process owners Added an item that references the need for top
management to identify the owners of the
processes
Did not exist 6.1.2.1 – Risk analysis The standard adopted additional
requirements for risk analysis, including the
analysis of lessons learned from the
production processes
6.3.2 – Contingency plans 6.1.2.3 – Contingency plan The item was maintained with new elements
added, for example the need to periodically test
the contingency plans in relation to their
effectiveness, through simulations
Did not exist 7.1.6 – Organizational The element related to organizational
knowledge knowledge was included in order to retain
knowledge in the organization
Did not exist 8.3.2.3 – Development of The item was included in the standard with the
products with embedded intention of helping companies to ensure the
software quality of their products with embedded
software developed internally
7.4.1.2 – Supplier quality 8.4.1.2 – Supplier selection The requirement to perform an analysis of the
management system process process capacity at the supplier was included.
The requirement was also included to
implement and control changes in the
supplier’s production process and monitor the
logistics process
Did not exist 8.4.1.3 – Directed buy A new item that references suppliers
contracted directly by the customer (direct
buy), including that these suppliers must
follow the same rules as a supplier selected by
the company, according to item 7.4 of the
standard
Did not exist 8.4.2.1 – Type and extent of An item about the processes of identification,
control (supplemental) selection and control for outsourced activities
was included
7.4.1.2 – Supplier quality 8.4.2.3 – Supplier quality The item was revised and new requirements
management system management system were added, such as the supplier’s need to have
development its processes in compliance with IATF
requirements
7.5.1.4 – Preventive and 8.5.1.5 – Total predictive The item evolved from “preventive and
predictive maintenance maintenance predictive maintenance” to “total productive
maintenance,” now adding a reference to the
use of certain indicators that demonstrate the
results of maintenance activities, such as OEE,
MTTR and MTBF
Did not exist 8.5.6.1.1 – Temporary change The new item explores the temporary change
Table 1. of process controls element, requiring the company to identify,
Identification of the document and maintain a checklist of
elements added in the temporary changes
evolution from ISO/TS
16949 to IATF 16949 (continued )
Corresponding requirement in
From ISO/TS
ISO/TS 16949 requirement IATF 16949 Evolution of the elements 16949 to IATF
16949
8.3.2 – Control of 8.7.1.4 – Control of reworked The item was revised and added the element of
reworked product product implementing a risk analysis methodology for
the rework activity (e.g. FMEA)
Did not exist 8.7.1.5 – Control of repaired A control item for the repaired product was
product added, including the application of a risk
analysis methodology (e.g. FMEA)
8.2.2.2 – 9.2.2.3 – Manufacturing process The requirement to carry out a process audit
Manufacturing audit was maintained in all shifts in which
process audit production occurs
Did not exist 10.2.5 – Warranty management The item reinforces the “no trouble found”
system (NTF) concept for the analysis of parts under
warranty
Source(s): Authors, based on ISO/TS 16949:2009 and IATF 16949:2016 Table 1.
responsible for defining those responsible for each area of the management system, as well as
their competencies and responsibilities (IATF, 2018).
The need to identify, analyze, and consider real and potential risks was already foreseen
by the ISO/TS 16949 standard, but the organization’s need to plan and implement actions to
address risks and opportunities is an added requirement in the new standard. The current
“risk analysis” requirement includes periodic assessment of lessons learned throughout the
production process and the maintenance of documented information as an internal source of
organizational knowledge (IATF, 2016).
“Risk analysis” is incorporated into several elements of the new standard, such as the
lessons learned from product recall, product auditing, field repairs and returns, complaints,
scrap and rework. In addition, there should be a retention of the records of the risk analysis
carried out, highlighting the performance of such analysis (IATF, 2018).
The contingency plan is one of the elements of the standard that has changed
significantly, with new requirements added. In this sense, the contingency plan according to
the new standard must ensure that the organization applies a systematic approach to identify
and address risks in all manufacturing processes, including external risks (Pai and Yeh, 2013;
Talapatra et al., 2019; Taskinen, 2003; Yeh et al., 2013). The new requirements include the
assessment of the effectiveness related to operational failures and the need to conduct a
critical analysis that includes an annual contingency plan (Croom et al., 2017). Also, if any
failure in the process is identified, the customer must be notified (IATF, 2016).
The “organizational knowledge” element was included in the standard in order to help
organizations to retain knowledge regarding their processes (Shrivastava et al., 2006;
Talapatra et al., 2021). Companies must control and maintain the existing knowledge, taking
into account the context, size, and the complexities of their products and processes
(IATF, 2016).
The element referring to “product development with embedded software” was included in
the standard with the intention of helping companies to ensure the quality of their products
that have an interface with software. The standard reinforces the need to implement a process
for the development of products with embedded software, as well as self-assessment of the
capacity for software development (IATF, 2018).
For the element “supplier selection process,” the inclusion of new control requirements
was observed, such as the need to assess the supplier’s process capacity, control of changes in
the production process, multidisciplinary decision-making, risk analysis and monitoring of
the logistics process (IATF, 2018).
BIJ As can be seen in the structure of the IATF 16949 standard, several new requirements
related to suppliers have also been added, including topics that address the element “direct
buy” (a supplier imposed by the customer), which should follow the same rules as any
supplier selected by the company. In addition, suppliers must comply with IATF 16949, and
the customer must be responsible for carrying out risk analysis and monitoring the results of
supplier certification (IATF, 2016).
Outsourced activity is defined as part of the function of an organization that is carried out
by an external organization. Outsourced activity was included in the evolution of the
standard in that the organization must have a documented process to identify, select and
control outsourced activities (Ketokivi and Heikkil€a, 2003). The process should also include a
risk assessment of the product based on monitoring the performance of the outsourced
service provider (IATF, 2016).
With regard to maintenance, with the evolution of the standard, the term “preventive and
predictive maintenance” has been changed to the element “total productive maintenance”
(TPM). This requirement requires the organization to develop, implement and maintain a
documented system of TPM (Pacaiova and Izarikova, 2019). The documents most
recommended to fulfill this requirement are: overall equipment effectiveness (OEE); mean
time to repair (MTTR); and mean time between failures (MTBF). It is also recommended to
use preventive and predictive maintenance methods, when applicable (IATF, 2016).
For the new element “temporary changes,” the company must identify, document and
maintain a checklist of changes. If required by the customer, there is a need to inform them
and obtain approval before shipping the product (IATF, 2016).
Regarding the elements “rework” and “repair,” the requirements of the IATF 16949 standard
recommend a risk analysis of processes, including traceability of the information identified
during the analysis (IATF, 2016). For the specific repair activity, a documented authorization
from the customer is required, approving the execution of the corrective actions (IATF, 2016).
With the evolution of the standard, the element “audit of the manufacturing process” is
now included in all production shifts, and an appropriate sampling of shift changes is
required. All the organization’s production processes must be audited over three years after
certification, including audits to implement risk analysis processes using tools such as
PFMEA, a control plan and similar documents (Banduka et al., 2018; IATF, 2016).
Regarding the “warranty management system” requirement, this reinforces the “no
trouble found” (NTF) concept for analyzing warranty parts. With this new concept, the
organization must include in its processes a method for analyzing warranty parts, including
non-conforming parts identified after their analysis (IATF, 2016).
The above analysis shows that significant changes have been inserted in the IATF 16949
standard; however, it should be noted that, among all the changes in the structure of IATF
16949, risk analysis is the element that is present in all areas of a company’s activity, being
considered therefore an essential requirement in all production processes (IATF, 2018).
3. Research method
This research adopts a qualitative approach as it allows the observation, description and
deep understanding of the studied element, which, in the present study, is companies
preparing to update their QMS based on IATF 16949 (Barzizza et al., 2001; Jupp, 2006; Kothari
and Garg, 2014). The case study method was chosen because it provides a rich set of data
from multiple sources of evidence, such as semi-structured interviews, document analysis
and on-site observation (Barratt et al., 2011; Stavros and Westberg, 2009; Yin, 2015). Figure 1
presents the methodological flow of this research.
As can be seen in Figure 1, the first step accomplished was the definition of the theme,
research question, objectives and research method. The second step involved elaborating the
From ISO/TS
16949 to IATF
16949
Figure 1.
Methodological flow
theoretical framework for QMSs ISO/TS 16949 and IATF 16949. Based on the theoretical
framework and the analysis of the standards, identification of the elements added in the
migration from ISO/TS 16949 to IATF 16949 was carried out (see Section 2). Subsequently,
the research protocol for the multiple case studies was elaborated (Yang et al., 2006; Yin,
2015). For the validation of the protocol, this study used three approaches to increase the
validity of the information: (1) the use of several sources of evidence, such as interviews, on-
site observations and document analysis; (2) the chain of evidence; and (3) a review of the
research protocol by specialists in the subject (De Massis and Kotlar, 2014).
The protocol for the multiple case studies was structured according to the results of the
analysis of the elements added to the IATF 16949 standard, which are presented in Section 4.
The structure of the case study protocol was reviewed by three specialists with over 10 years
of experience in implementing QMSs in automotive companies. The case study protocol is
presented in the Appendix Table A1.
It should be noted that all four case studies were conducted based on the research protocol.
We chose to utilize semi-structured rather than structured interviews, since semi-structured
interviews tend to provide greater flexibility to researchers, allowing them to address the
needs and characteristics of participating companies better, which enhances the study results
(Yin, 2015). Also, according to Yin (2015), a semi-structured interview guided by a protocol
with the ideas to be investigated is preferable to the use of closed questions.
The research data collection relied on the simultaneous use of three sources of evidence
(semi-structured interviews, on-site observation and document analysis), with subsequent
triangulation of the information that supported the development of the guidelines presented
in Section 4 (Yin, 2015).
The companies studied were selected considering the fulfillment of the following selection
criteria: being companies operating in Brazil, specifically in the automotive sector; and with
QMS certification according to IATF 16949. Details about the characterization of the
companies can be found in Table 2 in Section 4.
In the research visits to participating companies, employees at different organizational
levels with experience and knowledge about the requirements of the IATF standard were
interviewed to enable a better understanding of the reality of the subjects researched (De
Massis and Kotlar, 2014). Specifically, we interviewed in each company at least the director
BIJ Information Company A Company B Company C Company D
(strategic level), the quality manager (tactical level) and one employee from the operational
level. These interviews were recorded and lasted between three hours in total (i.e. on average,
each interview lasted at least one hour) and followed the logical structure of the research
protocol.
The second source of evidence for the case study was on-site observation, which enabled
the researchers to observe directly the social, cultural and organizational aspects of the
company studied. The third source of evidence was the document analysis of reports, forms,
procedures and internal policies, among other relevant documents of the QMS. In this study,
the documents analyzed were those referring to the QMS, such as the quality manual, quality
policy and procedures, work instructions, records, risk analysis, production reports, results of
supplier audits, etc. In the present work, these three instruments (interviews, visits/on-site
observation and document analysis) were used as sources of evidence for data collection, and
the information obtained was triangulated in order to support a solid interpretation of the
reality studied (Yin, 2015).
After completing the case studies and the individual analyses of the participating
companies, a cross-analysis of these studies highlighted the convergences and divergences in
recommendations between the four organizations in the process of implementing IATF 16949.
Finally, the guidelines were proposed based on the experiences of the companies
participating in the research and supported by the scientific literature (implementation of the
items added from ISO/TS 16949 to IATF 16949). It is noteworthy that the results of the case
studies by themselves do not allow the generalization of this paper’s contributions (Yin, 2015).
However, the guidelines proposed in this study are strongly supported by the literature and,
accordingly, it is possible to generalize the results.
Item 4.4.1.2 – Companies A, B, C and D have operational Systematize the operational process of
Product safety training plans qualification
Table 3. The risks in companies B, C and D are Assign a multidisciplinary team to
Summary of guidelines periodically analyzed evaluate product safety
for item 4.4.1.2 (product Companies A, B, C and D have PFMEA for Use PFMEA for product safety analysis
safety) assessing product safety
5.1.1.1 – Corporate All companies have developed a procedure to Implement procedures to keep
responsibility describe the internal rules of the organization corporate responsibility up to date
Companies A, C and D provide their employees Implement a reporting system to
with a communication channel to report report inappropriate behaviors
Table 4. violations, or potential violations, of the code of
Summary of guidelines ethics
for item 5.1.1.1 Awareness training to disseminate the Standardize training processes for
(corporate company’s culture and corporate responsibility the company’s corporate
responsibility) responsibility
Another recommendation identified by companies A, B and C to meet corporate From ISO/TS
responsibility requirements was the establishment of an internal communication channel and 16949 to IATF
an ethics committee to impartially assess complaints that are made via the communication
channel, thus maintaining both the credibility of the communication and an ethical
16949
environment in the company.
4.2.3 Item 5.1.1.3: process owners. The main objective with the development of practices
related to the process owners is the definition of a management model that defines the
responsibilities of each manager and the control of production processes to be applied by
them in the maintenance of the needs of each company’s client(s). The summary of the
guidelines for the implementation of the process owners element is presented in Table 5.
Process owners are, together with top management, directly responsible for
organizational decision-making (Danilova, 2019). As observed in all the companies studied,
the top management has to assign the owners of the processes and the responsibilities of each
manager maintaining the indicators under their responsibility. For this, it is suggested to
develop a process map document describing the process inputs and outputs. The IATF
suggests the definition of the process owner, and all the companies studied decided to
implement process maps in order to define how to implement the rules, as well as the results
that each manager must control and achieve.
4.2.4 Item 6.1.2.1: risk analysis. The main objective with the development of practices
related to risk analysis is to prevent the occurrence of failures that may affect the quality of
the product and consequently have an impact on the satisfaction of the final customer. The
set of guidelines for implementing the risk analysis element is presented in Table 6.
The development of multidisciplinary groups and the use of FMEA is common in order to
carry out the risk analysis, mitigate problems and assess the possibilities of failures in the
process (Kumar et al., 2019).
It is recommended to carry out risk analysis through a multidisciplinary group at
intervals appropriate to each business model, as observed in all the companies studied. The
PFMEA base document can be used for risk assessment and must be updated whenever a
new risk is identified (Kumar et al., 2019). All the companies conducted risk analysis by means
of periodic audits of the product to assess the potential risks in the production processes.
4.2.5 Item 6.1.2.3: contingency plan. The main objective with the development of practices
related to the contingency plan is to prevent the occurrence of failures, delays and
misdeliveries of products to the final customer due to an external action, such as a lack of
energy or gas. The summary of the guidelines for implementing the contingency plan element
is presented in Table 7.
5.1.1.3 – All organizations adopt a procedure for the Standardize the appointment of Table 5.
Process owners appointing of process owners by top management process owners Summary of guidelines
All organizations use a process map document that Use the process map document to for item 5.1.1.3 (process
helps in the management of productive areas manage productive areas owners)
6.1.2.1 – Risk Organizations A, B and D perform the risk analysis with Implement the PFMEA process Table 6.
analysis a multidisciplinary group, based on the PFMEA Multidisciplinary teams to Summary of guidelines
document perform the risk analysis for item 6.1.2.1 (risk
Standardize risk analysis audits analysis)
BIJ The contingency plan is based on immediate actions that help companies to obtain a quick
response in the face of a crisis, such as the lack of water supply or energy and other situations
that may have a negative impact on the production flow (Reid, 2017a).
The contingency plan must be applied by companies to assist quick responses to
customers when an external failure occurs. An operating procedure should be used to
describe the internal actions to be performed in the event of a failure, such as a power outage,
lack of gas, etc (Reid, 2017b), following the examples of companies A, B and C. It is also
suggested to carry out simulations to check if the actions defined in the reaction plan are
really effective in case a failure occurs. The safety department should provide support and
check whether the reaction from the employee was in accordance with the training applied,
evaluating, for example, responses in situations of power failure. After this, the simulation of
the results should be analyzed in order to verify the effectiveness of the training.
4.2.6 Item 7.1.6: organizational knowledge. The development of practices related to
organizational knowledge helps to manage and maintain knowledge in the company itself.
The summary of guidelines for implementing the organizational knowledge element is
presented in Table 8.
Employee knowledge management positively impacts meeting the organizational needs.
People who receive professional training and courses develop knowledge to achieve the
company’s goals (Giraldo et al., 2019). In this way, as noted in companies A and B, it is
recommended that the company map employees’ positions and define internal policies to
foster the development of motivation programs and career plans.
Further, top management must use internal communication channels to promote
vacancies that can be filled by internal labor, thus strengthening the recognition process for
meritocracy and employee motivation, as observed in companies C and D.
4.2.7 Item 8.3.2.3: development of products with embedded software. No recommendations
were identified for carrying out the analysis of this element because the companies studied do
not have embedded software in their production processes.
4.2.8 Item 8.4.1.2: supplier selection process. The main objective with the development
of practices related to the supplier selection process is to guarantee the correct choice of
suppliers, thus guaranteeing the quality of the entire production process and consequently of
6.1.2.3 – Companies A, B and C use a procedure that Create procedures to deal with the
Contingency plan exemplifies the rules to be followed in case of external failures defined in the
Table 7. internal or external failures contingency plan
Summary of guidelines Companies A and C carry out simulations, such Test contingency plans through
for item 6.1.2.3 as lack of water or energy, to validate planned simulation
(contingency plan actions in case of failures, for example, in water
guidelines) supply
7.1.6 – Organizational Companies A and B have implemented a corporate Define a policy for mapping
Table 8. knowledge procedure that describes the rules of career plans, competencies and positions
Summary of guidelines backup plans, succession plans and recognition by
for item 7.1.6 meritocracy
(organizational Companies C and D use motivational messages Implement motivational
knowledge) disseminated by top management programs for employees
the final product (Adebanjo and Laosirihongthong, 2014). The summary of guidelines for the From ISO/TS
implementation of the supplier selection process element is presented in Table 9. 16949 to IATF
According to Sharma and Gupta (2019), the supplier selection process helps organizations
to regularly review and implement effective quality systems, leading to the development of
16949
standards with internal procedures for the supplier selection process.
The presence of a qualified engineer who performs periodic audits on suppliers is essential
for the company maintaining a robust supply chain (Lee et al., 2003). Another essential factor
for supplier selection is the creation and use of a manual (which is not a rule for IATF 16949)
that contemplates all the obligations of suppliers towards the company, for instance being an
IATF-16949-certified company. These practices were observed in companies A and D.
Following the example of company B, in the case of the supplier not yet being certified, a
schedule must be drawn up to monitor the evolution of IATF 16949 implementation.
4.2.9 Item 8.4.1.3: directed buy. The main objective with the development of practices
related to the directed buy process is to maintain the quality of materials obtained from
suppliers imposed by customers, under which the company does not have full control over the
supplier selection process. The summary of the guidelines for implementing the directed buy
element is presented in Table 10.
In view of the fact that suppliers considered directed buy are those imposed by customers,
the company must apply some activities to mitigate possible quality problems (Lee et al.,
2003). As performed in companies B and D, it is recommended that audits are carried out to
assess the production system and propose improvements if failures are identified or to
encourage a self-assessment if the supplier does not accept being audited.
Another recommendation (which is not an IATF requirement) is to propose a partnership
contract with the supplier, in which the quality criteria must be clarified and agreed between
the customer and the supplier, seeking to minimize negative impacts in case of the supplier
not meeting quality requirements. This practice is performed by company B.
4.2.10 Item 8.4.2.1: type and extent of control (supplemental). The main objective with the
development of this item is to monitor the outsourced activities in order to maintain the
8.4.1.2 – Supplier All companies have engineers who audit Implement an audit system for selecting
selection process suppliers to assess the production process suppliers
Companies A and D use a manual that is Systematize criteria for selecting suppliers Table 9.
previously agreed with each supplier Summary of guidelines
Company B developed a schedule to Accompany the evolution of the actions for the item 8.4.1.2
monitor the suppliers’ IATF 16949 resulting from the audits of the suppliers (supplier selection
implementations with schedules process)
8.4.1.3 – On-site visits to suppliers are applied by Implement an audit system for suppliers
Directed buy company A considered direct buy
Companies B and D utilize the supplier’s self- Systematize audits on direct buy suppliers
assessment methodology, without the need for by self-assessment
on-site visits Table 10.
Company B utilizes a contract between supplier Define a contract establishing quality Summary of guidelines
and customer for quality compliance agreements between customer and direct for item 8.4.1.3
buy supplier (directed buy)
BIJ quality of the final product. The summary of the guidelines for the implementation of the type
and extent of control element is presented in Table 11.
Suppliers of outsourced activities must meet customer requirements and follow the same
quality standards as the customer, maintaining safety in the products supplied.
Regarding the practice of outsourced activities, observed only in companies A and B, it is
suggested that the company classify the suppliers into groups based on a critical assessment
of the service, which should indicate how critical it is to the quality of the final product. Based
on this, it is recommended to define which activities can be outsourced and monitor them
monthly for greater product control.
4.2.11 Item 8.4.2.3: supplier quality management system (QMS) development. The
management of the supplier selection process is important to guarantee the quality of the
products supplied and is essential for the maintenance of the QMS. The main objective of this
element is to control quality and maintain a partnership relationship with the supplier so that,
in case of failures, the receipt of non-compliant parts is avoided. The summary of the
guidelines for implementing the supplier quality management system element is presented in
Table 12.
The main objective of the development of practices related to the supplier management
process is to monitor the quality level of the materials supplied and to maintain the quality
system of the suppliers according to the requirements established by the company (Kros
et al., 2019).
All the companies studied recommended conducting annual supplier audits to assess the
entire production process and the QMS. An annual audit is not an IATF requirement, but the
companies studied consider this best practice in order to follow up with suppliers and ensure
their quality performance.
It is also recommended to monitor the quality of purchased materials. For this, company D
decided that is important to implement a robust database across the entire company that
makes available globally the results of the analysis of each supplier, including the monthly
results, to assist in the decision to accept or not a supplier for a new proposal of material
supply.
8.4.2.1 – Type and extent of Company A controls all outsourced processes, Standardize methodology for
Table 11. control (supplemental) whereas company B controls only for items contracting third-party
Summary of guidelines considered critical for the business services
for item 8.4.2.1 (type Companies B and D monitor suppliers Monitor the results of
and extent of control) monthly with an action plan outsourced activities monthly
4.2.3 – Supplier quality All companies use the annual Systematize supplier audits at least annually
management system audit methodology
Table 12. development All companies carry out Monitor the results of products sent by
Summary of guidelines monthly monitoring for each suppliers monthly
for item 8.4.2.3 supplier
(supplier quality Company B uses an electronic Implement a database of product quality
management system system to monitor suppliers results sent by suppliers and make it
development) available to all collaborators
4.2.12 Item 8.5.1.5: total predictive maintenance (TPM). TPM is a new element in IATF From ISO/TS
16949 that aims to lead companies to establish internal processes to control maintenance 16949 to IATF
activities using indicators to monitor processes such as MTBF and MTTR, among others.
The summary of the guidelines for implementing TPM is shown in Table 13.
16949
The implementation of TPM in organizations occurs at several levels or phases, starting
with the autonomous maintenance performed by the operators. Subsequently, at each level,
new activities are added until the company reaches the full implementation of all TPM pillars
(Pacaiova and Izarikova, 2019).
In order for TPM to be implemented, it is suggested (based on the practices observed in
companies A, B and C) that operational training be applied on a routine basis so that
operators are aware of the importance of maintenance activities. During the training,
companies A, B and C use pictures and real cases to illustrate “before” and “after”
improvements, thus helping employees to understand the importance and benefits of TPM.
Following the example of all the companies studied, it is also suggested to use monthly
indicators such as MTTF, MTTR and OEE to control the production and delivery of parts
within the time determined by the customer, which demonstrates, for example, the average
time to failure of a piece of machinery or the average time spent to repair a machine. These
indicators and the action plan are available in the production area to provide adequate
information to the employees.
4.2.13 Item 8.5.6.1.1: temporary change of process controls. The development of practices
related to the temporary change of process controls aims to establish a process that maintains
the quality of the products in the event of a temporary change in the production process. The
summary of guidelines for implementing a temporary change is presented in Table 14.
To control temporary change, a technical feasibility analysis should be carried out by a
multidisciplinary group, which will indicate whether the change can be implemented or not. If
any change cannot be made, technical explanations must be recorded regarding why a
particular change cannot be implemented (Guerrini and Pellegrinotti, 2016). This practice is
highly recommended by company B. In addition to this practice, it is also recommended that a
global database be created and maintained with open access to all employees, thus avoiding
repeated requests, as observed in companies C and D.
5.1.5 – Total Companies A, B and C have implemented TPM Systematize operational Table 13.
productive through various operational training programs training on TPM Summary of guidelines
maintenance All companies carry out monthly monitoring to keep Monitor monthly the for item 8.5.1.5 (total
maintenance activities, such as MTTF, MTTR and results of TPM activities productive
OEE, under control maintenance)
8.5.6.1.1 – All organizations control temporary Perform technical feasibility analysis when
Temporary changes in their processes, analyzing the it is necessary to implement a temporary
change feasibility of the change change
Companies C and D maintain a database of Systematize a database with lessons Table 14.
lessons learned so that they can be learned and history, with a description of Summary of guidelines
consulted by employees the proposed changes, accessible to all for item 8.5.6.1.1
employees (temporary change)
BIJ 4.2.14 Items 8.7.1.4 (control of reworked product) and 8.7.1.5 (control of repaired product).
The reworked and repaired product control process provides for the establishment of a
system for monitoring reworked and repaired parts, thus avoiding the sending out of
products that do not meet the specifications of the final customer. The summary of the
guidelines for implementing reworked and repaired product control is presented in Table 15.
Activities such as rework and repair must be controlled in companies in order to avoid
sending parts to the end customer with lower quality than specified. An important factor to
always consider is that the customer must be informed before the parts are reworked or
repaired, and only with the customer’s approval can the product be released and sent to the
final customer.
After performing the rework or repair activity, an evaluation on the final product must be
performed to make sure that the product continues to comply with all other specifications
defined by the customer (Trofimova and Panov, 2019). In addition to formal customer
approval, which is not an IATF requirement, companies A and B identify all parts reworked/
repaired using a specific label on the parts, so that the customer can easily identify products
that have been reworked or repaired.
4.2.15 Item 9.2.2.3: manufacturing process audit. The manufacturing process audit item
deals with the monitoring of the production process through periodic audits to assess the
QMS implemented in the company’s manufacturing processes. The summary of the
guidelines for implementing the manufacturing process audit is presented in Table 16.
Conducting periodic process audits allows the monitoring of production results, the
identification of possible changes in the process and the identification of opportunities for
improvements in the production process (Artamonov and Lomazova, 2019).
In order to control the manufacturing process, all the companies studied conduct a process
audit in all operational shifts. It is also recommended to use the audit results in presentations
at management review meetings. In this way, top management is involved and can support
manufacturing in implementing improvements in the production process, as observed in
companies C and D.
8.7.1.4 – Control of Companies A and B request the Implement the customer’s prior approval
Table 15. reworked product customer’s approval before performing process for performing rework and/or
Summary of guidelines 8.7.1.5 – Control of the rework/repair repair activities
for items 8.7.1.4 repaired product Companies A and B implement a process Systematize a process for identifying
(control of reworked of traceability for reworked and repaired reworked parts
product) and 8.7.1.5 parts
(control of repaired Companies C and D do not rework their
product) products
5. Conclusions
The evolution from ISO/TS 16949:2009 to IATF 16949:2016 has led automotive companies to
initiate the migration process to the new requirements of the standard. IATF 16949:2016 is
based on process risk analysis, features more reliable measurement systems and meets
specific customer requirements.
This article was developed with the main objective of identifying and systematizing,
based on four case studies, guidelines for the implementation and management of the
elements added to IATF 16949. In order to fulfill this objective, we first conducted an in-depth
study comparing ISO/TS 16949 and IATF 16949 to identify and discuss the elements added.
Multiple case studies were also conducted in four automotive companies that have
implemented the IATF 16949 standard. The case studies made it possible to identify
recommendations when implementing of the standard. Through the critical analysis of the
migration from ISO/TS 16949 to IATF 16949, the literature review and the cross-analysis of
cases, it was possible to systematize the experiences of the participating companies and
propose guidelines for updating the elements added to IATF 16949 in the evolution from ISO/
TS 16949.
10.2.5 – Warranty Companies A and B carry out a technical Conduct technical visits to customers
management system visit to the customer to evaluate when there are complaints regarding Table 17.
suspicious products product quality Summary of guidelines
All companies prepare a report Elaborate reports with the evaluations for item 10.2.5
confirming or rejecting the suspected of the defective product under warranty (warranty
part failure in the product management system)
BIJ have been added/updated based both on empirical and academic analyses. Thus, this article
helps to fill a research gap regarding the process of updating the QMS to the new IATF 16949
standard.
It should also be noted that the article presents guidelines on how to implement the new
requirements of the IATF 16949 standard, since this information has not previously been
identified in the international scientific literature available on the subject, making the results
unique and innovative for the topic.
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Appendix From ISO/TS
16949 to IATF
16949
Data collection instruments
Interviews
Elements added Top Middle On-site Document
to IATF 16949 Practices manager manager Operational observation analysis
Corresponding author
Marcio C. Machado can be contacted at: marciocmachado@uol.com.br
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