Quality Management and Innovation: Implementation and Analysis Report

This report provides a comprehensive overview of quality management and innovation, focusing on key concepts and methodologies. It begins by defining risk-based thinking within the context of ISO standards, emphasizing its importance in operations, management, and performance evaluation. The report then delves into breakthrough improvement using Six Sigma, detailing its implementation process, team structure, and methodologies such as DMADV and IDOV. Furthermore, it examines the significance of quality audits, outlining their purpose, benefits, and the role they play in ensuring compliance and driving continuous improvement. The report also discusses the concept of contextual intelligence, highlighting its relevance in identifying internal and external factors that impact an organization's ability to deliver quality results. Finally, it references ISO 9001:2015, ISO 45001:2018, and ISO 14001:2015, emphasizing the need to consider the context of the organization to meet quality standards and stakeholder needs. The student assignment is contributed to Desklib, a platform offering AI-based study tools for students.

Running Head: QUALITY MANAGEMENT AND INNOVATION
QUALITY MANAGEMENT AND INNOVATION
NAME OF THE STUDENT
NAME OF THE UNIVERSITY
AUTHOR NOTE

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Table of Contents
Answer to the question 1.................................................................................................................2
Risk-based thinking Definition....................................................................................................2
Organization................................................................................................................................2
Addressing Risk by Management................................................................................................2
Plan..............................................................................................................................................2
Control.........................................................................................................................................3
Performance evaluation and improvement..................................................................................3
Answer to the question 2.................................................................................................................3
Answer to the question 3.................................................................................................................4
References........................................................................................................................................5

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Answer to the question 1
It has been noted always that the risk has been a prominent factor related to the ISO
standards. However, newer versions are given even more importance in terms of quality and
management standards. Updated version of ISO 9001:2015 and 14001:2015 requires the
companies to use the application of risk-based thinking in the areas of operations, management
and evaluation of performances. (Tracy, 2020)
Risk-based thinking Definition
In the previous standard version of the ISO which was the preventive action has been
replaced by the newer version of ISO 9001:2015’s risk based thinking. While evaluation of the
Quality management controls in terms of establishing processes and bringing on any
improvement or controls, the company has to evaluate their risks. This is what the risk-based
thinking is all about. However, it does not limit itself to just show the negative aspect, therefore,
it can be used to highlight the positive attribute of the opportunities (Hill, 2020).
The areas where the risks are supposedly to appear are:-
Organization- Here, the ISO requires the company to identify the risk that are related to the
context of the organization and it also helps in identifying the risks that are related to the quality
of the products manufactured.
Addressing Risk by Management- The management of the company are supposed to
identify the risks related to the quality of the products and be prepared with the measures as well.
Plan- here lies the part to address the situation where the risks have already appeared.

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Control- Here, implementation is the key, where all the actions that has been planned during
planning one has to implement it in the same way.
Performance evaluation and improvement- Identifying and tracking the risks and
opportunities that has been identified and also making sure the improvement is taking care of.
Answer to the question 2
Breakthrough implementation of sig sigma and change methodology is adopted at the
time when there is requirement of improvement in the key business areas and the percentage of
improvement varies from fifty percent to ninety-five percent (Whatissixsigma.net, 2020). Then a
team gets prepared that includes those who are a black belt and green belt level of six-sigma and
around a group of seven to eight members are formed in order to rectify and remove the
problems that are creating defects in the quality of the products. The projects that require
breakthrough improvement are selected by the senior management team and who are termed as
the steering group for the breakthrough six- sigma group. They act as the person who gives
instructions.
The time that are allotted for such major improvement generally varies from four to
twelve months. This is considered to be a very close and special project that is carried on a very
temporary basis. The investigation and the research for the said project varies to various
functions of the organization, where each and every aspect is considered in order to foster
improvement. The focus of the team lies in either the process or the product. The projects that
are chosen for the breakthrough improvement, has a particular areas that has the ability to yield
the most in both the production as well as the quality improvement. The methodologies that are
used for the six-sigma is either of DMADV and IDOV. (Isixsigma.com, 2020)

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Answer to the question 3
Quality audit is the process, which enables the business to understand and review as to
whether they are being able to meet certain requirements and standards or not. The standards
may vary as to whether the company has set them or it has been driven by the industry standard.
In order for the Quality management strategy to succeed there is an extreme compulsion of the
compliance, product and also the audits of the process (Qualityamerica.com, 2020). Leaders
analyse the data taken from these audits and therefore, accustomed to the changes that are needed
to modify customer outcomes (IQMS Manufacturing Blog, 2020).
There can be given five reasons to show the requirement for the implementation of the
quality audit:-
 Timely measurement of major or minor non-uniformity with the standards and
quick actions to be taken
 In order to build the manufacturing indispensable knowledge base, audit is
important to track down quality performances
 Easy to maintain the high level of safety and health at workplace as there are
frequent checks that are going on
 Provides recommendation for improving the quality based on the data available
 Comparing the Key performance indicators and the customer metric with the
center as well as on the plant-wide basis.
Answer to the question 4
In the new ISO 9001:2015, ISO 45001:2018 and ISO 14001:2015 there has arisen a new
requirement related to the determination of the context of the organization. However, this

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concept in not very new to those who are into business planning and strategy building. It is also
known as contextual intelligence. However, this concept is new in terms of its getting
amalgamated in ISO system of management standards. In this context, it is desired by the
management to identify the internal and external issues that might have an impact over the
organization ability to deliver quality results. Apart from that, the organization also has to
identify the needs of all the interested parties into accounts in order to identify the stakeholders
of the business and identify their requirements that will ultimately influence the management’s
decision making ultimately leading it towards its quality and standards.

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References
Hill, E. (2020). ISO 9001:2015 revision explained: Risk-based thinking. [online]
Quality.eqms.co.uk. Available at: https://quality.eqms.co.uk/iso-9001-2015-revision-explained-
risk-based-thinking [Accessed 20 Feb. 2020].
IQMS Manufacturing Blog. (2020). 5 Reasons Why Quality Audits Need To Become Routine In
Manufacturing. [online] Available at: https://erpblog.iqms.com/5-reasons-quality-audit-routine-
manufacturing/ [Accessed 20 Feb. 2020].
Isixsigma.com. (2020). Breakthrough Improvement – iSixSigma. [online] Available at:
https://www.isixsigma.com/dictionary/breakthrough-improvement/ [Accessed 20 Feb. 2020].
Qualityamerica.com. (2020). Characteristics of Quality Audits. [online] Available at:
https://qualityamerica.com/LSS-Knowledge-Center/qualitymanagement/
characteristics_of_audits.php [Accessed 20 Feb. 2020].
Tracy, R. (2020). What Does “Risk-Based Thinking” Mean Within the New ISO Standards?.
[online] Blog.etq.com. Available at: https://blog.etq.com/what-does-risk-based-thinking-mean-
in-the-context-of-new-iso-standards [Accessed 20 Feb. 2020].
Whatissixsigma.net. (2020). Breakthrough Improvement. [online] Available at:
https://www.whatissixsigma.net/breakthrough-improvement/ [Accessed 20 Feb. 2020].