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- Keshav Ram Singhal
krsinghal@rediffmail.com
keshavsinghalajmer@gmail.com
Blog on 'Quality Concepts and ISO 9001: 2008 Awareness' at http://iso9001-2008awareness.blogspot.in

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Wednesday, October 16, 2019

Nature and impact of risk


Nature and impact of risk

Risks are basically threats that could stem from a variety of sources, including financial uncertainty, legal liabilities, strategic management errors, accidents and natural disasters. Risks can impact an organization in the short, medium and long term. Risks may relate to organization's processes, tactics and strategy. Strategy sets out the long-term objectives of an organization, and the strategic planning for an organization will typically be 3 or more years. Tactics define how an organization intends to achieve change. Tactical risks are typically associated with projects, acquisitions, mergers and development of products and services. Organization's processes are the routine QMS activities that are under the impact of risk. Risk impact is an estimate of the potential losses associated with an identified risk. It is a standard risk analysis practice to develop an estimate of probability and impact. Risk management is the process of identifying, assessing and controlling threats to an organization. Although ISO 9001:2015 QMS standard does not mandate a formal risk management, however the standard incorporates risk-based thinking in its requirements.

- Keshav Ram Singhal

Defining risk


Defining risk

Risk is generally defined as: (Exposure to) the possibility of loss, injury, or other adverse or unwelcome circumstance; a chance or situation involving such a possibility. Risk is an uncertain event or condition that, if it occurs, has an effect on at least one objective. Risk is also defined in various standards. According to the definition set out in ISO Guide, risk is the 'effect of uncertainty on objectives'. According to the definition set out in ISO 9000:2015 QMS standard, risk is 'effect of uncertainty'. In order to assist with the application of this definition, ISO 9000:2015 standard also add a few notes that mean:
- An effect is a deviation from the expected. It may be positive or negative.
- Uncertainty is the state, even partial, of deficiency of information (= meaningful data) related to, understanding or knowledge of, an event, its consequence, or likelihood.
- Risk is often described by reference to potential (= something to develop in future) events (= happenings) and consequences (= results or effects, typically that may be unwelcome or unpleasant), or a combination of these.
- Risk is often described in terms of a combination of the consequences (= results or effects, typically that may be unwelcome or unpleasant) of an event (= happening), including changes in circumstances, and the associated likelihood of occurrence (= an incident or event).
- The word 'risk' is sometimes used when there is the possibility of only negative consequences.

- Keshav Ram Singhal



Thursday, September 26, 2019

Risk-based thinking historical background, the 2008 global financial crisis and risk management


Risk-based thinking historical background, the 2008 global financial crisis and risk management

The earlier advent of risk management process was developed by insurance agents. They developed the technique to protect their insurance business from financial ruin by helping clients to minimize risks and thus reduce liabilities. The study of risk management began after World War II, but the discipline mostly began as a study of using insurance to manage risk. Later, from the 1950s to the 1970s, risk managers began to realize that it was too expensive to manage every risk with insurance, so the discipline began to expand to alternatives to insurance. For example, training and safety programmes were considered alternatives. The use of derivatives as risk management instruments arose during 1970s, and expanded rapidly during the 1980s, as organizations intensified their financial risk management. International risk regulation began in the 1980s, and financial firms developed internal risk management models and capital calculation formulas to hedge against unanticipated risks and reduce regulatory capital.

The global financial crisis in 2008 demonstrated the importance of adequate risk management. Improving risk management tools and practices were among the top priorities for institutional investors in the wake of the then global crisis. Since that time, global efforts were being made to address risks. In 2009, ISO 31000 and IEC/ISO 31010 were published. ISO 9001:2015 QMS standard also included the concept of risk-based thinking (RBT) that was published in 2015. ISO 31000 and IEC/ISO 31010 standards have since been revised and published as ISO 31000:2018 and IEC 31010:2019 standards respectively. ISO 31000:2018 standard provides guidelines on managing risk faced by organizations. The application of these guidelines can be customized to any organization and its context. IEC 31010:2019 provides guidance on the selection and application of techniques for assessing risk in a wide range of situations.

ISO 9001:2015 QMS standard does not require implementation of ISO 31000:2018 standard or application of IEC 31010:2019, however study of these standards may benefit each individual to understand risk management in a better way.

- Keshav Ram Singhal

How did you like this article, please let us know your comments. Thank you.



Monday, September 23, 2019

Risk-based Thinking - Introduction


Risk-based Thinking - Introduction

One of the new requirements of ISO 9001:2015 QMS standard is to show evidence of risk-based thinking (RBT) in the quality management system. How organization will do that? How to respond to the new challenges that ISO 9001:2015 QMS standard requires? People in the organization are facing with these questions.

ISO 9001:2015 QMS standard does not call for formal methods for managing risk. An organization is free to choose its method(s) to address risks and opportunities. Risk management is an increasingly important business driver these days and stakeholders, particularly customers, have become more concerned about risk. A risk-based thinking (RBT) enables an organization to consider the potential impact of all types of risks and opportunities on all processes, activities, products and services. Implementing a comprehensive approach to RBT will result in an organization benefiting from the actions taken to address risks and opportunities.

ISO 31000:2018 is an standard that describes risk management - guidelines. IEC 31010:2019 is an standard that describes risk management - risk assessment techniques. ISO Guide 73:2009 provides risk management - vocabulary. One may turn to ISO 31000:2018 and IEC 31010:2019 standards, but it is not as easy as it looks. There are many guidelines and techniques to choose from and many may be too complicated and not easy to implement. ISO 9001:2015 QMS standard does not require implementation of ISO 31000:2018 standard or application of IEC 31010:2019, however study of these standards may benefit each individual to understand risk management in a better way.

We will provide the necessary inputs on risk-based thinking (RBT) and risk assessment techniques in forthcoming articles, that may be applied to a quality management system. In the forthcoming articles, a simple method to determine risks and opportunities will be mentioned that can be followed for demonstrating risk-based thinking as required by ISO 9001:2015 QMS standard. This trainer has also prepared a seven-eight-hour vocational training, which can be conducted at your campus, for which you can contact this trainer. If you want to learn risk-based thinking and risk assessment techniques from home, you can also get training through WhatsApp or email.

By attending the training, a participant will be able to understand:
- Concept of risk-based thinking,
- ISO 9001:2015 QMS requirements related to risk-based thinking,
- Benefits of using risk-based thinking,
- An overview of various risk assessment tools - Techniques and methodologies that you may apply in your QMS,
- Using risk-based thinking to achieve better internal controls,
- Demonstrating risk-based thinking during audits (internal and external).

At the end of the training, an assessment questionnaire will be provided, so that your learning can be evaluated.

- Keshav Ram Singhal
Email -
krsinghal@rediffmail.com
keshavsinghalajmer@gmail.com



How did you like this article, please let us know your comments. Thank you.

ISO 9001: 2015 QMS Awareness related articles are aimed at spreading awareness on ISO 9001: 2015 QMS. These articles should not be used as an alternative to the ISO 9001: 2015 QMS standard. To implement the quality management system in an organization, one should also use ISO 9001: 2015 QMS standard, which you can get from the International Organization for Standardization (ISO) or its national member institution ('Bureau of Indian Standards' in India).

Wednesday, August 7, 2019

# 03 - ISO 21001:2018 EOMS Awareness - EOMS Principles


ISO 21001:2018 EOMS Awareness - EOMS Principles

ISO 9001:2015 QMS standard is based on seven quality management principles, however ISO 21001:2018 EOMS (Educational organization management system) is based on following 11 management principles:

(i) Focus on learners and other beneficiaries,
(ii) Visionary leadership,
(iii) Engagement of people,
(iv) Process approach,
(v) Improvement,
(vi) Evidence-based decisions,
(vii) Relationship management,
(viii) Social responsibility,
(ix) Accessibility and equity,
(x) Ethical conduct in education, and
(xi) Data security and protection.

1. Focus on learners and other beneficiaries – The primary focus of the EOMS is to meet learner and other beneficiary requirements and to exceed their expectations. This principle resembles with the customer focus principle of the QMS. An educational organization should understand current and future needs and expectations of its learners and other beneficiaries for its products, services, delivery, price, dependability etc. The organization should ensure a balanced approach, create awareness and communicate requirements of its learners and other beneficiaries throughout the organization. Its goal is to meet requirements of its learners and other beneficiaries. The organization should strive to exceed expectations of its learners and other beneficiaries.

2. Visionary leadership – Visionary leadership is to engage all learners and other beneficiaries in creating, writing, and implementing the organization mission, vision and objectives. This principle resembles with the leadership principle of the QMS. We understand that leaders establish unity of purpose and direction of the organization. Leadership in an educational organization should create and maintain the internal environment in which people can become fully involved in achieving the EO's objectives. Top management of the EO needs to play leadership role through management commitment, focus on learners and other beneficiaries, policy, planning, responsibility and authority, effective communication and management review. Therefore, the leaders of the EO should (i) be proactive, (ii) understand and respond to changes that are visible in the educational industry environment, (iii) establish clear vision of the EO, (iv) build trust, eliminate fear and motivate people.

3. Engagement of people – It is essential for the organization that all individuals involved are competent, empowered and engaged in delivering value. This principle resembles with the engagement of people principle of the QMS. There are various activities in an EO that are performed by the people. People at all levels are essence of the EO. Without engagement of people, nothing can be achieved. People of the EO need to be competent. They should be empowered and engaged in delivering value. Their engagement at all levels in the EO enable their abilities to be used for the EO's benefits. Top management of the EO should make sincere efforts to maximize engagement of people in the EO by taking steps to empower and motivate them and by providing ways to increase their skills and knowledge. If people of the EO are competent, empowered and engaged throughout, it will enhance EO's capability to create value and achieve its objectives.

4. Process approach – Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system, including input and output. This principle resembles with the process approach principle of the QMS. A desired output (consistent and predictable result) can be achieved more efficiently when all related resources and activities are understood and managed as a coherent system that functions as interrelated processes.

ISO 21001:2018 EOMS promotes the adoption of a process approach. It is the intention of the standard that the EO must adopt process approach when developing, implementing and improving the effectiveness of its quality management system. The main objective behind adoption of process approach is to enhance satisfaction of its learners and other beneficiaries by meeting their requirements.

To function effectively and efficiently, an EO has to determine and manage numerous linked activities. What is a process? An activity that comprises set of interrelated or interacting activities which transform inputs into outputs can be termed as a process. In EO's activities, output from one process can form the input to the next process. The application of a system of processes within an organization can be said the 'process approach'. Process approach requires determination of processes, interaction of determined processes and their management. Management of determined processes and the system as a whole can be achieved using a PDCA methodology with an overall focus on 'risk based thinking'. Risk based thinking helps at preventing undesirable outputs.

Process approach is helpful in ensuring: understanding and consistently meeting requirements, consideration of processes in terms of added value, the achievement of effective process performance, and improvement of processes based on evaluation of data and information.

5. Improvement – Successful organizations have an ongoing focus on improvement. This principle resembles with the improvement principle of the QMS. Improvement is the process of a thing or system changing or moving from one state to another state considered to be better from the first state, usually through some action intended to bring about that better state. The concept of improvement is important to all EOs as well as to individuals.

Successful EOs have all time continual focus on improvement. Improvement is essential for every organization to be successful to maintain its level of performance, to react to changes in its conditions (internal and external) and to create new opportunities. Improvement is necessary for growth and success of an EO.

6. Evidence-based decisions – Decisions and curricula based on the analysis and evaluation of data and information are more likely to produce desired results. This principle resembles with the evidence-based decision making principle of the QMS. Desired results or intended outputs are likely to be obtained when decisions based on analysis and evaluation of data and information are taken. Decision making becomes easier if there is analysis and evaluation of data and information.

Decision making always involves some uncertainty, so it can be termed as a complex process. There are multiple sources of information, multiple sources of inputs and a number of interpretations that can lead to a subjective decision. It is always better to have an evidence-based decision making as facts, evidence and analysis of data and information lead to greater objectivity and confidence in decision making.

Proper use of statistical techniques will ease analysis of data and information that will lead to evidence-based decision making. Decisions taken based on analysis of data and information will lead to the right path for consistent improvement of the EO's system including processes and resulting product and services.

In India and also in other countries, it is seen that large and medium-sized organizations are using statistical tools, however there is a need to increase awareness for using statistical tools among people working in EOs.

7. Relationship management – For sustained success, organizations manage their relationships with interested parties, such as providers. This principle resembles with the relationship management principle of the QMS. This principle resembles with the evidence-based decision making principle of the QMS.

An EO and its learners and other beneficiaries are interdependent. Learners or other beneficiaries can affect a decision or activity of an EO. And also interested party or parties can be affected by a decision or activity of an organization. Interested parties can influence the performance of an organization. A mutually beneficial relationship between the EO and its learners and other beneficiaries enhance the ability to all to create value to each other.

To get maximum benefits of relationship management on EO's performance, it is necessary for the EO to manage its relationship with its learners and other beneficiaries

8. Social responsibility – Socially responsible organizations are sustainable and ensure long-term success. The practice of social responsibility does not limit only to corporations, companies or NGOs, presently EOs are also responsible for all the impacts that cause their operations towards their publics, the society at large and the environment.

9. Accessibility and equity – Successful organizations are inclusive, flexible, transparent and accountable, in order to address learners’ individual and special needs, interests, abilities and backgrounds. In fact accessibility and equity are principles of social justice. Equity relates to fairness that recognizes, some people are more disadvantaged than others in being able to access services and facilities and therefore there is a responsibility to address this lack of equity. Accessibility is the capacity of people, those have to physically enter a premises, building or space and also to use a facility or service.

10. Ethical conduct in education – Ethical conduct relates to the ability of the organization to create an ethical professional environment where all interested parties are dealt with equitably, conflicts of interests are avoided, and activities are conducted for the benefit of the society. Ethical conduct in education is a well founded norm that makes the actions right and wrong. It helps categorise different values such as integrity, discipline and honesty among others and apply them in daily lives. Ethics influences behaviour and allows an individual to make te right choices.

11. Data security and protection – The organization creates an environment where all interested parties can interact with the educational organization in full confidence that they maintain control over the use of their own data, and that the educational organization will treat their data with appropriate care and confidentiality. Data protection and cyber security for the education sector has much importance. EOs at all levels are open to attack from cyber criminals and ill-prepared and under-resourced to meet the requirements of today’s more stringent data protection laws, so the EO should create such environment where all interested parties can interact with the EO in full confidence that the EO maintains control over the use of its own data, and that the EO will treat their data with appropriate care and confidentiality.

Abbreviations -
EO = Educational organization
EOMS = Educational organization management system
QMS = Quality management system

Best wishes,

KRS


Monday, August 5, 2019

#02 - ISO 21001:2018 EOMS Awareness - Potential benefits of implementing ISO 21001:2018 EOMS


Potential benefits of implementing ISO 21001:2018 EOMS

There are so many benefits to an educational organization that implements ISO 21001:2018 EOMS including:
- Better alignment of the organization's objectives and activities with the organization's policy, mission and vision,
- Increased social responsibility by making available inclusive and equitable quality education for all,
- More personalized learning and effective response to all learners and particularly to learners with special education needs, distance learners and lifelong learning opportunities,
- Fair and accurate processes and evaluation tools to clearly show and enhance effectiveness and efficiency,
- Improved credibility of the educational organization,
- A means that helps the educational organization to clearly show its commitment to effective educational management practices,
- An organization culture for improvement,
- Combination of regional, national, open, proprietary, and other standards within international structure or set-up,
- Increased participation of interested parties, and
- Encouragement of excellence and innovation.

'Inclusive and equitable quality education' is the sustainable development goal (SDG) of the United Nations that says, "Goal 4: Ensure inclusive and equitable quality education and promote lifelong learning opportunities for all." Quality education and lifelong learning opportunities for all are central to ensuring a full and productive life to all individuals and to the realization of sustainable development.

The term 'personalized learning' refers to a diverse variety of educational programs, learning experiences, instructional approaches, and academic-support strategies that are intended to address the distinct learning needs, interests, aspirations, or cultural backgrounds of individual students.

Best wishes,

KRS


#01 - ISO 21001:2018 EOMS Awareness - ISO 21001:2018, Educational organizations - Management systems for educational organizations


ISO 21001:2018, Educational organizations - Management systems for educational organizations

ISO 21001:2018, Educational organizations - Management systems for educational organizations - Requirements with guidance for use, is a document published by International Organization for Standardization (ISO) that provides a common management tool for organizations providing educational products and services capable of meeting requirements of learners and other beneficiaries. ISO 21001:2018 is aligned with ISO 9001:2015 QMS standard.

A few articles/write-ups will be provided in this blog to increase awareness.

Best wishes,
KRS


Friday, March 22, 2019

What does leadership matter in ISO 9001:2015 QMS?


What does leadership matter in ISO 9001:2015 QMS?

Leadership matters much in ISO 9001:2015 QMS. It is the core of the system. Leadership is one of the QMS principles on which ISO 9001:2015 QMS standard is based. If we read the standard, we note that clause 5 of the standard mentions leadership requirements also.

Leaders establish unity of purpose, direction and engagement of people in the organization that align organization's strategies, policies, processes in achieving quality objectives. Leaders focus on communication by listening to the people and defines a strategic plan or direction of the organization. Leaders help people to work in a team.

Leaders in an organization should create and maintain the internal environment in which people can fully engage themselves to achieve organization's quality objectives. For this top management of the organization needs to play leadership role through its commitment, action and communication. They should communicate to the people in the organization the importance of meeting requirements. They need to establish quality policy, ensure ensuring establishing quality objectives at relevant functions, levels and processes, ensure availability of resources and conduct management reviews.

The leaders of the organization should:
- be proactive,
- understand and respect to changes that are visible in the industry environment,
- establish clear vision of the organization,
- build trust, eliminate fear and motivate people.

Benefits that may be derived from the use of 'leadership' principle include:
- Employee's motivation towards organization's goals and objectives
- Better understanding of organization's objectives
- Better communication within the organization

In this connection a leader should practice 5-E of leadership, which are as under:

1. Equality: Everyone is equal. Don't be Biased. Be fair in your acts.
2. Expectations: Be realistic at setting expectations, objectives and goals. Have an eye on expectations, objectives and goals. Understand the strengths, weaknesses and areas of improvement of your team.
3. Emotional Intelligence: Understand that people have emotions and even you do. Use them intelligently.
4. Empower: Empower your people. Be a catalyst for your team members. Be their coach and mentor.
5. Evolve: Evolve everyone of your team to work as a team member. And when they are evolved as a team, you are evolved as a leader.

Clause 5 of ISO 9001:2015 QMS standard deals with the requirements related to leadership that describes what the top management's role should be. All requirement in this section are meant for the top management. ISO 9001:2015 QMS standard requires increased role for the top management. Leadership is the central theme of the quality management system and PDCA cycle that is applied to the quality management system.

The relevant sub-clauses are as under:

5 Leadership

5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus

5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy

5.3 Organizational roles, responsibilities and authorities

To understand the relevant requirements, please refer to the standard.

Best wishes,

Keshav Ram Singhal



Tuesday, March 19, 2019

TOP 20 Quality Management Blogs on the web


TOP 20 Quality Management Blogs on the web


Founder of Feedspot, Mr Anuj Agarwal has sent me an email congratulating me as selection of this blog on QMS Awareness as one of the TOP 20 Quality Management Blogs on the web. Please visit feedspot blog by CLICKING HERE.



Quality Management Blogs

Feel happy,

Keshav Ram Singhal

Saturday, February 2, 2019

Techniques to establish quality objectives and monitor results


Techniques to establish quality objectives and monitor results

Please read my earlier blog post 'ISO 9001:2015 QMS - Quality objectives and planning to achieve them'.

An organization should use suitable techniques, such as SMART (setting quality objectives that are Specific, Measurable, Achievable, Relevant and Time-bound), Balance Score Cards, Dashboard, Brainstorming etc. The evaluation of results on achieving specified quality objectives should be part of management review, performance appraisals or can be done through other means, such as ongoing review, feedback meetings etc. Whenever there is any change, quality objectives should be updated or added to as necessary.

The organization should also take into consideration factors such as the organization's capabilities, constraints, customer feedback, other issues etc.

Best wishes,

Keshav Ram Singhal