BIOPROSTHETICS Innovation Compaby by JAMES

DEPARTMENT OF MECHANICAL, ENERGY AND INDUSTRIAL ENGINEERING
GEME 425 TAKE HOME TEST
NAME: KEABETSWE JAMES

ID: 18001328
PROGRAMME; MECHATRONICS AND INDUSTRIAL INSTRUMENTATION
QUESTION 1
ENTERPRISE NAME: BioProsthetic Innovations
VISION STATEMENT: My vision aims to have created innovative and adaptable prosthetic
devices that closely resemble the organic movements of the human body to revolutionize the
prosthetics business in Botswana as a whole by the year 2030 and enable people with physical
limitations (disability) to fully integrate into society.
MISSION STATEMENT: To design, manufacture and provide the most advanced prosthetic
solutions available, empowering our clients with the freedom, confidence and independence to
live a full life in at least 70% of the medical facilities in Botswana.
VALUES:
1. INNOVATION: I believe in challenging the status quo and developing new and
innovative solutions that surpass our competitors’ and customers' expectations.
2. QUALITY: I am committed to the highest standards of quality in all aspects of our
business, from product design to customer service.
3. INTEGRITY: I am committed to upholding the highest ethical standards in all aspects
of our business, treating our customers, employees, and partners with honesty and
respect.
4. COLLABORATION: I believe in the power of collaboration and teamwork, working
closely with our customers, employees, and partners to develop the best possible
solutions for individuals with physical disabilities.
SMART OBJECTIVES
1. To develop and launch a new line of prosthetic solutions within the next 12 months,
providing a wider range of options for our clients to choose from.
2. To improve our delivery time by 25% over the next year, ensuring our clients receive
their prosthetic solutions in a timely manner.
3. To establish partnerships with local hospitals and clinics, increasing our presence in the
community and enabling us to provide better care for our clients within the next 6
months.
4. To invest in research and development, with the aim of introducing more advanced
prosthetic solutions that better mimic natural movement in Botswana’s medical sector
within the next 3 years.
QUESTION 2
PROPORTIONATE: Risk management activities must be Proportionate to the level of risk
within an organisation
ALIGNED: Risk management activities Aligned with business activities
COMPREHENSIVE: In order to be fully effective, the risk management approach must be
comprehensive, systematic and structured
EMBEDDED: Risk management activities need to embedded within the business processes
DYNAMIC: Risk management activities must be Dynamic, iterative and responsive to change
in the organisation’s processes
This acronym is relevant in the Risk Management process as it provides a framework for
organizations to identify and manage risks effectively.
Organizations can create a thorough risk management strategy using the PACED technique,
which enables them to identify potential risks, evaluate their impact, and put in place the
necessary controls or mitigations. This can assist businesses in reducing the possibility and
effects of risks on their operations, reputation, and financial position.
QUESTION 3
i. COSO II: The Committee of Sponsoring Organizations of the Treadway
Commission (COSO) published its Internal Control Integrated Framework
in its second iteration in 2004. It offers direction on creating, putting into
practice, and evaluating the success of internal control in businesses.
Internal control should be approached top-down and based on risk, with
risks being discovered, evaluated, and mitigated at every level of the
company, according to COSO II. Along with highlighting the importance of
governance and culture in risk management, COSO II also places a strong
emphasis on the integration of internal control with enterprise risk
management (ERM).
ii. ISO 31000: 2008 Standards: In 2009, the International Organization for
Standardization (ISO) published its standard for risk management The ISO
31000 standard offers concepts and recommendations for managing risk at
all organizational levels and for all different kinds of threats. The
significance of risk management as a tactical instrument for attaining goals
and making wise decisions is emphasized. Risk identification, analysis,
evaluation, treatment, monitoring, and review are all aspects of risk
management that are emphasized by ISO 31000 as being structured,
methodical, and iterative. Additionally, it emphasizes how crucial it is to
keep stakeholders informed and involved in the risk management process.
iii. British Standards: The British Standards Institution (BSI) has published
several standards related to risk management, including BS 31100:2011
Code of practice for risk management, BS ISO 31000:2018 Risk
management - Guidelines, and BS EN ISO 14971:2019 Risk management
strategies are used with regard to medical devices. These guidelines offer
direction on risk management in a variety of settings, including as
governance, project management, and product development. They stress the
significance of an organized and methodical approach to risk management
that is suited to the particular circumstances and goals of the company.
iv. IRM Standards (Institute of Risk Management): A professional
organization for risk management called the IRM has created its own set of
guidelines for risk management. The IRM guidelines put a lot of emphasis
on how risk management helps firms accomplish their goals and add value.
They stress the significance of a comprehensive and integrated risk
management strategy that takes into account all risk categories and their
interdependencies. The IRM guidelines also stress the significance of
culture and leadership in risk management, as well as the necessity of strong
internal and external collaboration.
B. The COSO II framework consists of five components:
Control environment
Risk assessment
Control activities
Information and communication
Monitoring
The steps in COSO II's risk management methodology include:
Creating the context entails defining the goals, parameters, and risk thresholds for the risk
management process.
Risk assessment entails locating, examining, and rating risks in light of their likelihood and
potential effects on the goals of the business.
Risk response: This entails creating and putting into action risk management strategies to
reduce, accept, or transfer the identified risks.
Control activities: Creating and putting controls in place to manage the risks that have been
identified.
Monitoring and review: This entail keeping an eye on the process' efficiency and making any
necessary correction
The ISO 31000 framework consists of three core elements:
1. Principles
2. Framework
3. Process
The risk management process in ISO 31000 involves:
1. Establishing the context: This involves defining the scope, context, and risk criteria for
the risk management process.
2. Risk assessment: This involves identifying, analysing, and evaluating risks based on
their likelihood and impact on the organization's objectives.
3. Risk treatment: This involves developing and implementing risk responses to manage
the identified risks.
4. Monitoring and review: This involve monitoring the effectiveness of the risk
management process and making necessary adjustments.
iii. British Standards:
The British Standards for risk management provide guidance on managing risk in various
contexts, including governance, project management, and product development. The risk
management process in British Standards typically involves:
1. Establishing the context
2. Risk assessment
3. Risk treatment
4. Monitoring and review
iv. Institute of Risk Management (IRM) Standards:
The IRM standards emphasize the importance of a holistic and integrated approach to risk
management that considers all types of risks and their interdependencies. The risk management
process in IRM standards typically involves:
1. Establishing the context: This involves defining the objectives, scope, and risk criteria
for the risk management process.
2. Risk identification: This involves identifying all types of risks that could impact the
organization's objectives.
3. Risk assessment: This involves analysing and evaluating risks based on their likelihood
and impact on the organization's objectives.
4. Risk response: This involves developing and implementing risk responses to mitigate,
accept, or transfer the identified risks.
5. Monitoring and review: This involve monitoring the effectiveness of the risk
management process and making necessary adjustments.

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DEPARTMENT OF MECHANICAL, ENERGY AND INDUSTRIAL ENGINEERING

GEME 425 TAKE HOME TEST

NAME: KEABETSWE JAMES

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