BUSD 2027 – Quality Management

Final Exam: Preparation

Instructions
• These questions are meant to help you prepare for your final exam

Questions
1. What is the difference between a product and a service?

According to Foster (2017), a product is a tangible item that is produced by a manufacturer

for sale in the market, whereas a service is an intangible activity or benefit that is provided
by one party to another. In terms of quality management, the methods and techniques used
to ensure quality in products may differ from those used in services due to their unique
characteristics.

2. State the three spheres of quality.

 Quality of design: This sphere refers to the degree to which a product or service
meets the needs and requirements of customers. It includes the design and
development of the product or service, as well as the identification and analysis of
customer needs and expectations.
 Quality of conformance: This sphere refers to the degree to which a product or
service meets its specified requirements and conforms to established standards. It
includes the production or delivery process, as well as the inspection and testing of
the product or service to ensure that it meets the desired quality standards.
 Quality of performance: This sphere refers to the degree to which a product or
service performs its intended function and meets the needs of the user over its entire
lifecycle. It includes the reliability, maintainability, and durability of the product or
service, as well as its ability to meet changing customer needs and expectations over
time.

3. Effectiveness refers to the efficiency with which a product achieves its intended
purpose.

In the context of quality management, effectiveness is one of the key dimensions of quality
and is often used to evaluate the performance of a product or service. Effectiveness is
measured by how well a product or service satisfies the needs and requirements of
customers and meets its intended purpose or function.

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Efficiency, on the other hand, refers to the ability to accomplish a task or achieve a goal
with the least amount of resources or waste. While efficiency is also important, it is not the
same as effectiveness, which is focused on achieving the desired outcomes and meeting
customer needs.

4. What is the mode of the following dataset: 3, 2, 4, 4, 5, 1, 3, 7, 8, 3, 10?

To find the mode of a dataset, we need to identify the value that appears most frequently in
the dataset.

In the given dataset: 3, 2, 4, 4, 5, 1, 3, 7, 8, 3, 10, the value "3" appears three times,
which is more than any other value in the dataset. Therefore, the mode of this dataset is 3.

5. A process chart used to monitor the average of the characteristic being

measured is known as X-bar or X Chart

 A process chart used to monitor the average of the characteristic being measured is
known as an "X-Bar chart" or "X̄ chart".
 An X-Bar chart is a type of statistical process control chart used to monitor the mean
or average value of a process characteristic over time. It is commonly used in quality
control and process improvement initiatives to detect any changes or variations in
the process performance and ensure that the process is operating within acceptable
limits.
 The X-Bar chart involves plotting the sample means on a chart over time and using
control limits to identify any signals or patterns that may indicate a shift or drift in
the process performance. The X-Bar chart is a useful tool for identifying and
addressing the sources of process variability and improving the overall quality and
consistency of the process output.

6. What are the dimensions of product quality?

According to Foster (2017), the eight dimensions of product quality are:

1. Performance: The ability of the product to perform its intended function.

2. Features: The additional characteristics or attributes that enhance the product's
performance and value.
3. Reliability: The ability of the product to perform consistently and without failure over
time.
4. Conformance: The degree to which the product meets its specified requirements and
conforms to established standards.
5. Durability: The ability of the product to withstand wear, tear, and damage over its
expected life cycle.
6. Serviceability: The ease with which the product can be repaired, maintained, and
serviced.

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 7. Aesthetics: The subjective visual and sensory appeal of the product, including its
design, style, and appearance.
8. Perceived quality: The overall customer perception of the product's quality based on
its reputation, brand image, and other factors.

7. What are the dimensions of service quality?

According to Foster (2017), the five dimensions of service quality, as identified by

Parasuraman, Zeithaml, and Berry, are:

1. Tangibles: The physical appearance of the service facility, equipment, personnel, and
communication materials.
2. Reliability: The ability of the service provider to deliver the service consistently and
dependably.
3. Responsiveness: The willingness of the service provider to respond to customer
needs, inquiries, and complaints promptly and effectively.
4. Assurance: The knowledge, competence, and credibility of the service provider, as
well as the ability to inspire trust and confidence in customers.
5. Empathy: The degree to which the service provider is able to understand and meet
the needs and expectations of the customer and provide personalized attention and
care.

8. If you select a physician based solely on reputation, you are basing your
decision on which of the following dimensions of service quality?

You are basing your decision on the "perceived quality" dimension of service quality.

Perceived quality is the overall customer perception of the service quality based on its
reputation, brand image, and other factors. It can be influenced by a variety of sources,
including word-of-mouth recommendations, advertising, and past experiences with the
service provider or organization.

9. Data Analysis is a decision-making skill demonstrated by the ability to draw

conclusions based on data.

Data analysis involves collecting, processing, and interpreting data to gain insights and
inform decision-making.

10. To Randomly Sample means to sample in such a way that every piece of product
has an equal chance of being selected for inspection.

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Random sampling is a statistical technique used in quality control and process improvement
to ensure that the sample taken is representative of the population being studied. It
involves selecting a random subset of the population for inspection or analysis, with each
element having an equal probability of being chosen. By using a random sample,
organizations can obtain reliable and accurate information about the quality of their output,
and make data-driven decisions about process improvement and quality control.

11. Process stability means that the variation we observe in the process is Common
Cause variation.

Common cause variation refers to the natural variability that is inherent in a process, and is
often caused by factors that are within the control of the organization or system. Common
cause variation is expected and normal, and can be measured using statistical process
control (SPC) techniques to establish a baseline level of process performance. When a
process is stable, it means that the common cause variation is consistent and predictable,
and can be managed within the established control limits.

12. In a control chart, occurred if five points are in succession, either all above or
below the center line, we say a Run has occurred.

A run is a sequence of data points in a control chart that fall on the same side of the center
line and is an indication that the process may have shifted or changed. A run of five or more
points in succession is considered statistically significant and may indicate a shift in the
process mean or the presence of some other non-random source of variation. A run of this
length is also referred to as a "rule of five" in statistical process control (SPC) and is used as
a signal to investigate the process and take appropriate action to correct any issues that
may be affecting quality.

13. What are the steps in performing quality function deployment?

Quality Function Deployment (QFD) is a structured approach to identify and prioritize

customer needs and preferences, and to translate them into specific design requirements for
a product or service. The steps in performing QFD are as follows:

 Identify customer needs: Gather information from customers, focus groups, surveys,
and other sources to identify customer needs and preferences.
 Develop a house of quality: A House of Quality (HOQ) is a matrix that organizes the
customer needs into specific design requirements and identifies the relationships
between them. The HOQ includes columns for customer needs, design requirements,
and ratings of the importance of the customer needs and how well the design
requirements meet those needs.
 Identify relationships between customer needs and design requirements : The HOQ
matrix is used to identify the relationships between customer needs and design

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 requirements, including how well each design requirement satisfies each customer
need.
 Establish target values: Set target values for each design requirement based on the
customer needs and the relationship between the design requirements and customer
needs.
 Develop an action plan: Develop an action plan for each design requirement,
including specific steps to achieve the target value.
 Implement and evaluate: Implement the action plan and evaluate the effectiveness
of the product or service design in meeting customer needs and expectations.

By using QFD, organizations can better understand customer needs and preferences, and
design products and services that meet those needs while also improving quality and
reducing costs.

14. Briefly discuss the contribution of Philip Crosby to quality

He was a proponent of the Zero Defects approach to quality, which emphasized the need to
do things right the first time, every time.

Crosby's approach to quality was focused on prevention, rather than detection and
correction. He believed that quality was everyone's responsibility and that organizations
needed to create a culture of quality in which everyone was committed to achieving zero
defects. Crosby also developed the "Four Absolutes of Quality," which included:

1. Quality is defined as conformance to requirements.

2. The system for achieving quality is prevention.
3. The performance standard for quality is zero defects.
4. The measurement of quality is the cost of non-conformance.

Crosby's contributions to quality management helped to shift the focus of organizations

from detecting and correcting defects to preventing them in the first place. His emphasis on
prevention and creating a culture of quality continues to influence quality management
practices today.

15. Briefly discuss the contribution of W. Edwards Deming to quality.

He is best known for his work in Japan in the 1950s and 1960s, where he played a key role
in the country's economic recovery and the development of the Japanese approach to
quality management.

Deming's approach to quality was focused on continuous improvement and the need to
create a culture of quality in which everyone in the organization was committed to
improving processes and achieving customer satisfaction. He developed the "14 Points for
Management," which included:

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 1. Create constancy of purpose for improvement of product and service.
2. Adopt the new philosophy.
3. Cease dependence on inspection to achieve quality.
4. End the practice of awarding business on price alone.
5. Improve constantly and forever the system of production and service.
6. Institute training.
7. Institute leadership.
8. Drive out fear.
9. Break down barriers between departments.
10. Eliminate slogans, exhortations, and targets.
11. Eliminate numerical quotas.
12. Remove barriers to pride of workmanship.
13. Institute a vigorous program of education and self-improvement.
14. Put everyone in the company to work to accomplish the transformation.

Deming's contributions to quality management helped to shift the focus of organizations

from quality control to quality improvement. His emphasis on continuous improvement and
creating a culture of quality continues to influence quality management practices today.

Plan-Do-Check-Act (PDCA) Cycle is an improvement cycle based on the scientific method of

proposing a change in a process, implementing the change, measuring the results, and
taking appropriate action. It also is known as the Deming Cycle or Deming Wheel

 Plan — determine goals for a process and needed changes to achieve them.
 Do — implement the changes.
 Check — evaluate the results in terms of performance
 Act — standardize and stabilize the change or begin the cycle again, depending on
the results

16. State 6 key components found on a project charter.

A project charter is a document that formally authorizes a project and defines its objectives,
scope, and stakeholders. The six key components typically found on a project charter are:

1. Project title: The name of the project that succinctly describes the project's purpose
and scope.
2. Project sponsor: The person or group that provides the funding, resources, and
support needed to execute the project.
3. Project manager: The person responsible for leading and managing the project team
to achieve the project objectives within the specified time, cost, and quality
constraints.
4. Objectives and goals: The specific, measurable, achievable, relevant, and time-
bound (SMART) targets that the project aims to achieve.
5. Scope: The boundaries of the project, including what is included and what is
excluded, and the level of detail required to achieve the project objectives.

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 6. Stakeholders: The individuals or groups who have an interest in or are affected by
the project, including customers, suppliers, partners, employees, and regulatory
bodies.

17. A member of top management who is a resource to a project team and ensures
that the project team has access to a decision maker is known as Project Sponsor

The project sponsor is responsible for ensuring that the project is aligned with the
organization's strategic goals, providing the necessary resources and support, and removing
any obstacles that may hinder the project's success.

18. What is quality assurance?

Quality assurance is a set of activities and processes designed to ensure that a product or
service meets the required quality standards and specifications. Quality assurance focuses
on preventing defects and errors by establishing standards, processes, and procedures that
enable consistent quality performance throughout the product or service lifecycle. Quality
assurance includes activities such as quality planning, quality control, and quality
improvement, and it is aimed at providing confidence to customers and stakeholders that
the product or service will meet their expectations and requirements.

19. What is quality management?

Quality management is the process of planning, coordinating, and controlling activities to

ensure that a product or service meets the required quality standards and specifications.
Quality management includes a range of activities such as quality planning, quality control,
quality improvement, and quality assurance, and it is aimed at providing customers and
stakeholders with products or services that meet their needs and expectations.

20. What is three-way matching?

Three-way matching is a process used in procurement and accounts payable to ensure that
the received goods match the purchase order and the supplier's invoice. The three-way
matching process involves comparing the details of the purchase order, the goods received,
and the supplier's invoice to ensure that they match. This process is aimed at reducing the
risk of errors, discrepancies, and fraud in the procurement process.

21. What is quality control?

Quality control is the process of monitoring and verifying that a product or service meets
the established quality standards. It involves inspecting, testing, and measuring the product
or service against a set of predetermined criteria to identify any defects, nonconformities, or
other issues that could affect its quality.

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22. What is top management as per ISO 9001:2015?

According to ISO 9001:2015, top management refers to the people who direct and control
an organization at the highest level. This can include the organization's owners, board of
directors, CEO, and other executives who have the authority and responsibility to set the
organization's strategic direction, allocate resources, and make decisions that affect its
overall performance and success.

23. What are “interested parties” as per ISO 9001:2015?

"Interested parties" are individuals or organizations that can affect, be affected by, or
perceive themselves to be affected by an organization's quality management system (QMS)
or the products and services it provides. Examples of interested parties can include
customers, suppliers, employees, regulatory bodies, shareholders, and the local community.
These parties may have different needs and expectations that must be considered when
developing and implementing a QMS.

24. What are “requirements” as per ISO 9001:2015?

In ISO 9001:2015, "requirements" refer to the needs and expectations of interested parties
that an organization must meet or exceed to ensure that its products and services
consistently meet customer and regulatory requirements. Requirements can be defined as
customer needs, regulatory requirements, and other specified requirements that an
organization must fulfill to ensure its products and services meet the desired quality
standards.

25. Distinguish products versus services as per ISO 9001:2015.

The standard defines a product as the result of a process and can be either tangible or
intangible, while a service is an intangible output resulting from the delivery of a process.
The requirements for the planning, design, production, delivery, and post-delivery of both
products and services are covered in ISO 9001:2015. The standard emphasizes the
importance of meeting customer requirements and providing a consistent level of quality for
both products and services.

26. As per ISO 9001:2015, what does the element focusing on context looks at?

As per ISO 9001:2015, the element focusing on context looks at the organization's
internal and external environment, including the factors that may influence its ability to
achieve its objectives and affect its strategic direction. This includes factors such as the

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organization's culture, values, mission, vision, stakeholders, interested parties, and legal
and regulatory requirements. The organization needs to consider these factors when
determining its quality management system's scope and when planning, implementing, and
improving its processes.

27. How is “top management” expected to demonstrate leadership and

commitment with respect to the QMS?

By taking accountability for the effectiveness of the QMS, ensuring that quality objectives
are established, and communicating the importance of meeting customer and regulatory
requirements throughout the organization. Top management is also expected to provide the
necessary resources for the QMS, promote continuous improvement, and ensure that the
QMS is integrated into the organization's business processes. Finally, top management is
expected to ensure that customer focus, risk-based thinking, and a process approach are
ingrained in the organization's culture.

28. As per ISO 9001: 2015, what are some of the key information that
organizations need to make sure their employees are aware of?

As per ISO 9001:2015, organizations need to ensure that their employees are aware of the
following key information:

1. The quality policy and objectives.

2. The importance of meeting customer, statutory and regulatory requirements.
3. The processes, products and services being provided and how they relate to
customer requirements.
4. The significant environmental aspects and impacts associated with their work.
5. The hazards and risks associated with their work.
6. The roles and responsibilities within the organization, including their own role and
responsibilities.
7. The importance of effective communication and teamwork.
8. The consequences of non-conformity with the QMS requirements.

29. As per ISO 9001: 2015, quality is 80% planning and 20% communication, true
or false?

False. Quality is not strictly a matter of planning and communication but involves multiple
aspects such as leadership, customer focus, engagement of people, process approach,
improvement, evidence-based decision making, and relationship management. Planning and
communication are important components of quality management, but they do not
represent the entire scope of quality management.

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30. What is the essence of internal audits?

The essence of internal audits is to assess whether an organization's Quality Management

System (QMS) conforms to the requirements of the ISO 9001:2015 standard, as well as to
the organization's own documented policies, procedures, and objectives. The internal audit
process involves evaluating the effectiveness of the QMS, identifying areas for
improvement, and providing feedback to top management on the QMS's overall
performance. The objective is to ensure that the QMS is operating efficiently and effectively,
and that it is continuously improving.

31. What must an organization do for each internal audit?

According to ISO 9001:2015, an organization must plan, conduct, and report internal audits
to determine if the quality management system (QMS) conforms to requirements, is
effectively implemented and maintained, and is suitable to achieve the organization's
objectives. The organization must also determine the audit criteria, scope, frequency, and
methods, as well as select auditors and conduct audits that are objective, impartial, and
independent of the audited activity. Finally, the organization must report audit results to top
management and retain documented information as evidence of the audit program and its
effectiveness.

32. What is process capability?

Is the ability of a process to produce output that meets a customer's requirements. In other
words, process capability refers to the ability of a process to consistently produce products
or services that meet the desired quality standards. It is usually expressed as a ratio of the
allowable spread of a process to the actual spread of the process.

33. Who is a project leader?

Is an individual who is responsible for planning, executing, and closing a project. The
project leader may be an employee of the organization or an external consultant hired
specifically to lead the project. The project leader is responsible for coordinating the efforts
of the project team members, ensuring that the project stays on schedule and within
budget, and communicating progress to stakeholders. The project leader should have strong
leadership skills, be able to motivate the team, and have a good understanding of project
management methodologies and tools.

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34. What are the purposes of a sequence and interaction diagram?

In project management, a sequence and interaction diagram is used to visually represent

the order in which tasks or activities should be completed in a project. It illustrates the
relationships between tasks and shows which tasks are dependent on others. The diagram
can be used to identify the critical path of a project, which is the sequence of tasks that
must be completed on time in order for the project to be completed within the scheduled
time frame.

The purpose of a sequence and interaction diagram is to help project teams understand the
overall structure of a project and how different tasks and activities relate to one another. It
also helps to identify potential scheduling conflicts and delays and allows project managers
to make adjustments to the project plan to mitigate these risks. Overall, the sequence and
interaction diagram is a useful tool for project planning, scheduling, and management.

35. What is a schedule management plan?

According to Foster (2017), a schedule management plan is a subsidiary plan within the
project management plan that describes how the project schedule will be developed,
monitored, controlled, and communicated. It outlines the approach to be used for
developing the project schedule and describes the scheduling tools, techniques, roles, and
responsibilities to be used during the project.

36. What should be included in a human resource management plan?

According to Foster (2017), a human resource management plan should include the
following:

1. Roles and responsibilities: A clear definition of the roles and responsibilities of each
team member involved in the project.
2. Organizational structure: A description of the project team's organizational structure,
which outlines lines of communication and decision-making.
3. Staffing requirements: A list of the number of staff required for the project and their
specific roles and responsibilities.
4. Training and development: A plan for training and developing the project team
members.
5. Performance evaluation: A method for measuring and evaluating the performance of
the project team members.
6. Rewards and recognition: A plan for rewarding and recognizing the performance of
the project team members.
7. Compliance requirements: A list of compliance requirements and regulations that the
project team members need to follow.

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The human resource management plan ensures that the project team is managed
effectively and efficiently, and that the project's human resources are utilized to their full
potential.

37. What should be included in a procurement and cost management plan?

According to Foster (2017), a procurement and cost management plan should include the
following:

1. Description of how procurement activities will be managed and integrated into the
project.
2. Identification of key procurement requirements, including budget, schedule, and
quality standards.
3. Description of how contracts will be awarded, monitored, and evaluated.
4. Identification of potential risks associated with procurement activities and the
strategies that will be used to mitigate those risks.
5. Description of how changes to procurement activities will be managed and approved.
6. Identification of the key personnel responsible for procurement activities.
7. Description of how procurement activities will be integrated into the project schedule
and budget.

38. What should be included in a change management plan?

According to Foster (2017), a change management plan should include the following
elements:

1. Change control procedures: This outlines the steps and processes for reviewing and
approving changes to the project scope, schedule, and budget.
2. Impact analysis: This determines the potential effects of the proposed changes on
the project objectives, resources, and stakeholders.
3. Change authorization: This identifies the roles and responsibilities for approving and
implementing changes and the documentation required.
4. Change communication: This describes how the changes will be communicated to
stakeholders and how they can provide feedback or ask questions.
5. Change tracking and reporting: This outlines the methods for tracking and reporting
the status of changes and their impact on the project's overall performance.

By including these elements in a change management plan, project managers can ensure
that changes are properly evaluated, approved, and communicated to stakeholders,
minimizing the risk of scope creep and project delays.

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39. What should be included in a communication plan?

According to Foster (2017), a communication plan should include the following information:

1. Objectives: The purpose of the communication plan.

2. Audience: The target audience for the communication plan.
3. Messages: The key messages to be conveyed in the communication plan.
4. Channels: The communication channels that will be used to distribute the messages.
5. Frequency: The frequency at which messages will be communicated.
6. Sender and Receiver: The sender of the messages and the receiver of the messages.
7. Metrics: The metrics that will be used to evaluate the effectiveness of the
communication plan.
8. Risks: The risks associated with the communication plan and how they will be
managed.
9. Escalation: The process for escalating communication issues to higher levels of
management.
10. Approval: The approval process for communication materials before they are
distributed.

40. What is the ideal make-up of a process action team (PAT)?

According to Foster (2017), a Process Action Team (PAT) is a cross-functional team that is
established to address a particular quality issue or problem in a specific process. The ideal
make-up of a PAT should include members with diverse backgrounds and expertise related
to the process, as well as representatives from affected areas. Specifically, a PAT should
have the following members:

1. A team leader who is responsible for guiding the team, coordinating meetings, and
ensuring that the objectives are met.
2. Members from the process area, who have detailed knowledge of the process and
can provide insights into the root causes of the quality issue.
3. Members from support areas, who can contribute to the analysis and improvement of
the process by providing technical expertise, such as quality control or engineering.
4. A representative from the customer or end user of the process, who can provide
insights into their needs and expectations.
5. A representative from the supplier of the process, who can provide insights into their
capabilities and constraints.

The ideal make-up of a PAT may vary depending on the specific process and quality issue
being addressed. The key is to have a cross-functional team that can bring a variety of
perspectives and expertise to the problem-solving process.

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41. What details must be included in a process map?

According to Foster (2017), a process map should include the following details:

 The sequence of steps in the process

 The inputs to each step
 The outputs from each step
 The decision points or branching in the process
 The people or functions responsible for each step
 The time required for each step
 The metrics or measures used to monitor the process
 The customer requirements or expectations for the process.

Process maps can be created using various tools such as flowcharts, swim lane diagrams, or
value stream maps. The level of detail included in a process map will depend on the purpose
of the map and the complexity of the process being analyzed.

42. Step 4 of QMS implementation speaks to training. What are the key steps
involved in training?

According to Foster (2017), the key steps involved in training during QMS implementation
are as follows:

1. Identify training needs: The organization should identify the training needs of its
employees based on their roles and responsibilities in the QMS implementation
process.
2. Develop a training plan: A training plan should be developed that outlines the
training needs of each employee, the training objectives, and the training methods
that will be used.
3. Conduct the training: The identified training should be delivered to employees using
the methods outlined in the training plan. The training may be conducted in-house or
externally.
4. Evaluate the training: After the training has been delivered, it should be evaluated to
ensure that it was effective in meeting the training objectives. This evaluation may
include testing, observation, or feedback from participants.
5. Document the training: Documentation of the training should be maintained,
including records of who received the training, what was covered, and when the
training took place. This documentation should be available for internal and external
audits.

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43. You have been hired as a Quality Consultant to do a follow-up on the
implementation of the QMS of XYZ Ltd. What actions would you take, assuming
you were hired just after the implementation had gone live?

As a Quality Consultant there are several actions to take in order to ensure that the system
is functioning as intended and meeting the needs of the organization. These actions include:

1. Conduct a review of the QMS documentation : I would review the QMS documentation
to ensure that it accurately reflects the processes and procedures being followed by
the organization. This would include reviewing the quality manual, procedures, work
instructions, and other relevant documents.
2. Verify that the QMS is being followed: I would observe the processes and procedures
being followed by the organization to ensure that they are consistent with the QMS
documentation. This would involve conducting process audits and verifying that the
necessary records are being kept.
3. Evaluate the effectiveness of the QMS: I would analyze the data being generated by
the QMS to determine if it is effectively meeting the needs of the organization. This
would involve reviewing metrics such as customer satisfaction, product quality, and
process performance.
4. Provide feedback and recommendations: Based on the results of the review,
verification, and evaluation, I would provide feedback to the organization on areas
where the QMS is functioning well and where improvements could be made. I would
provide recommendations on how the organization can improve the QMS to better
meet its needs and the needs of its customers.

Overall, my goal as a Quality Consultant would be to ensure that the QMS of XYZ Ltd. is
effectively meeting the needs of the organization and that it continues to improve over time.

44. In advance of a QMS project launch, only key people should be informed, true
or false?

False. In advance of a Quality Management System (QMS) project launch, it is important to

inform all relevant stakeholders and employees within the organization, not just key people.
This includes employees who will be directly involved in implementing and maintaining the
QMS, as well as those who will be indirectly affected by it.

45. Differentiate between stated and implied customer requirements.

Stated customer requirements are those requirements that are explicitly communicated
by the customer to the organization. These requirements may be documented in a contract,
purchase order, or other communication from the customer. For example, a customer may

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state that they require a product to be delivered within a certain timeframe, or that the
product must meet certain specifications.

Implied customer requirements are those requirements that are not explicitly
communicated by the customer, but are still important to meet their needs or expectations.
These requirements may be inferred based on the customer's past behavior, industry
standards, or other contextual factors. For example, a customer may not explicitly state
that they require a product to be easy to use, but this may be an implied requirement based
on the nature of the product and the expectations of the customer.

46. State the legal requirements that are established by society.

1. Compliance with laws and regulations: Organizations must comply with all applicable laws,
regulations, and standards related to their industry, operations, and products or services.
2. Protection of human rights: Organizations must respect and protect the human rights of their
employees, customers, and other stakeholders. This may include ensuring fair treatment, non-
discrimination, and freedom from harassment or abuse.
3. Environmental protection: Organizations must take steps to protect the environment and
minimize their impact on natural resources. This may include complying with environmental
regulations, implementing sustainable practices, and minimizing waste and pollution.
4. Health and safety: Organizations must provide a safe and healthy work environment for their
employees, customers, and other stakeholders. This may include complying with occupational
health and safety regulations, providing appropriate training and protective equipment, and
ensuring that products or services are safe for their intended use.
5. Ethical business practices: Organizations must conduct their business in an ethical and
responsible manner. This may include avoiding conflicts of interest, practicing transparency and
accountability, and avoiding bribery or other corrupt practices.

Overall, these legal requirements are established by society to ensure that organizations operate in a
responsible and sustainable manner, and to protect the rights and interests of all stakeholders.

47. The simple definition of quality implies “the customer’s definition of quality is
the only one that counts”, true or false?

True. This means that the ultimate judge of quality is the customer, and that an
organization must strive to meet or exceed their expectations in order to be considered
successful.

48. What is the knowledge gap as per the Gap Model of Quality?

The knowledge gap is the first gap identified in the model and refers to the difference
between what an organization knows about its customers and what it needs to know in
order to meet their expectations.

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49. How is quality defined as per ISO 9001:2015?

ISO 9001:2015 defines quality as "the degree to which a set of inherent characteristics fulfill
requirements." This definition emphasizes the importance of meeting customer
requirements and expectations, as well as the need to consider the inherent characteristics
of products or services that contribute to their quality.

50. What is a normal distribution?

A normal distribution is a probability distribution that is symmetric and bell-shaped. The

distribution is characterized by its mean, which represents the average value of the data,
and its standard deviation, which represents the degree of variability or dispersion of the
data.

In a normal distribution, the majority of the data points fall within one standard deviation of
the mean, and the probability of a data point being a certain distance from the mean can be
calculated using the standard normal distribution table.

51. State one reason why statistics could sometimes be unreliable in the
workplace.

The data used to generate the statistics may not be accurate or complete. Data collection
errors, sampling errors, and bias can all contribute to inaccurate or incomplete data, which
in turn can lead to unreliable statistics. Additionally, statistics can be misinterpreted or
misused, which can also contribute to their unreliability.

52. What is systematic sampling?

Systematic sampling is a probability sampling technique where a researcher selects every

Nth member of a population after a random start. The sample size is determined by dividing
the total population size by the desired sample size. For example, if a researcher wants to
sample 100 individuals from a population of 1000, they would select every 10th person after
a random start.

The advantage of systematic sampling is that it is relatively easy to implement and less
time-consuming than other probability sampling techniques. However, it is important to
ensure that the random start is truly random and that there is no pattern or bias in the
selection of the sample members.

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53. In interpreting control charts, what are some signals that might be of concern
to you?

Control charts are used to monitor and track process performance over time. The following
are some signals or patterns that might be of concern when interpreting control charts:

1. Points outside of control limits : If any data point falls outside of the control limits, it
suggests that the process is out of control and needs to be investigated. Control
limits are usually set at three standard deviations above and below the mean, so any
data point outside of this range is considered unusual and potentially problematic.
2. Trending: If there is a consistent upward or downward trend in the data, it suggests
that the process is gradually shifting over time. This can be an indication that there
is a problem with the process that needs to be identified and corrected.
3. Run of data points: A run of data points that fall on one side of the centerline can
indicate a shift in the process mean. If there are seven consecutive data points that
fall above or below the centerline, this is known as a "run of seven" and is
considered statistically significant.
4. Cycles: If the data on the control chart shows a repeating pattern or cycle, it
suggests that there is a systematic variation in the process. This could be due to
seasonal effects, equipment changes, or other factors that are affecting the process
performance.
5. Unusual patterns: Unusual patterns on the control chart, such as sudden spikes or
dips, can indicate that something unusual has happened in the process. It may be
necessary to investigate the cause of these patterns to prevent them from recurring
in the future.

54. What is a process run?

In statistical process control, a process run refers to a series of consecutive data points that
fall on one side of the centerline of a control chart. A run can be defined as a sequence of
data points that are either all increasing or all decreasing, relative to the process mean.

55. What is a process drift?

A process drift is a gradual shift in the performance of a process over time. It refers to a
change in the process mean, which is the average value of the process output. Process drift
can occur due to various reasons, such as changes in the input variables, changes in the
operating conditions, or wear and tear of equipment.

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56. From a control chart, how can you determine that a process is displaying
erratic behavior?

A control chart is a graphical representation of the process data over time, which can help
identify whether a process is displaying erratic behavior. The following are some indicators
of erratic behavior in a control chart:

1. Points outside of control limits : If any data points fall outside of the control limits, it
indicates that the process is out of control and is displaying erratic behavior.
2. Non-random patterns: If the data on the control chart shows patterns that are not
random, it suggests that the process is not behaving as expected. Examples of non-
random patterns include runs, cycles, and other unusual patterns.
3. Lack of consistency: If the data on the control chart shows a lack of consistency,
with data points scattered widely and not following a clear pattern, it suggests that
the process is unstable and is displaying erratic behavior.
4. High variability: If the data on the control chart shows high variability, with data
points scattered widely around the mean, it suggests that the process is not stable
and is displaying erratic behavior.

Overall, if a control chart shows any signs of non-randomness, lack of consistency, or

instability, it suggests that the process is displaying erratic behavior and requires
investigation and corrective action

57. Why is it necessary to perform a process capability study?

A process capability study is a statistical analysis that measures how well a process is
performing relative to its specifications or requirements. There are several reasons why it is
necessary to perform a process capability study, including:

1. Quality improvement: A process capability study can help identify sources of

variability and help reduce defects or errors in the output. By improving the quality
of the process, it is possible to improve the overall quality of the products or services
produced.
2. Cost reduction: A process capability study can help identify inefficiencies or waste in
the process, which can lead to cost savings. By improving the process, it is possible
to reduce the amount of rework, scrap, and other forms of waste, which can result in
significant cost savings over time.
3. Customer satisfaction: A process capability study can help ensure that the products
or services produced meet the customer's requirements and expectations. By
producing high-quality products or services that meet customer needs, it is possible
to improve customer satisfaction and loyalty.

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58. What is a world-class capable system?

A world-class capable system refers to a process or system that is able to consistently

produce products or services that meet or exceed the highest industry standards. A world-
class capable system is one that is capable of producing products or services with very high
levels of quality, efficiency, and reliability.

59. What is a check sheet?

A check sheet is a simple tool used to collect and organize data. It is a form or template
that is designed to facilitate the collection and analysis of data related to a specific process
or problem. The check sheet is usually in the form of a table or a graph with categories or
factors on the left side and the corresponding number or tally marks on the right side.

A check sheet is used to:

1. Collect data: A check sheet is used to collect data about a specific process or
problem. It helps to gather data quickly and easily in a structured format.
2. Organize data: A check sheet helps to organize the collected data in a logical and
structured way. It enables the user to group and categorize data according to
specific factors or variables.
3. Analyze data: A check sheet makes it easy to analyze the collected data. It enables
the user to see patterns, trends, and correlations in the data.
4. Identify problems: A check sheet helps to identify the causes of problems in a
process or system. By collecting and analyzing data, it is possible to identify areas
where the process or system is not performing optimally.

60. What is a balanced scorecard?

A balanced scorecard is a strategic management tool that is used to measure and track an
organization's performance in multiple areas. It is a framework that translates an
organization's strategy into a set of performance measures that can be tracked and
monitored over time.

The balanced scorecard typically includes four key perspectives:

1. Financial perspective: This perspective measures the financial performance of the

organization, including metrics such as revenue, profitability, and return on
investment.
2. Customer perspective: This perspective measures how well the organization is
meeting the needs and expectations of its customers, including metrics such as
customer satisfaction, loyalty, and retention.
3. Internal process perspective: This perspective measures the efficiency and
effectiveness of the organization's internal processes, including metrics such as cycle
time, quality, and productivity.

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 4. Learning and growth perspective: This perspective measures the organization's
ability to learn and innovate, including metrics such as employee engagement,
training, and development.

By measuring performance across these four perspectives, the balanced scorecard provides
a comprehensive view of an organization's performance and helps to ensure that all areas of
the organization are aligned with its overall strategy. The balanced scorecard is a useful tool
for setting goals, monitoring progress, and making strategic decisions based on data-driven
insights.

61. A soda manufacturing company produces bottled soda with the intention of the
volume of each bottle to be between 30cl and 36cl. 10 bottles are sample for
inspection each day and for 10 days. The grand mean of the all the sampled
bottled volumes is 33cl and the estimated standard deviation is 3. Compute the
capability index of this process.

The capability index is a measure of how well a process is able to meet customer
requirements. It is calculated by comparing the spread of the process to the tolerance
specified by the customer. The capability index can be calculated using the following
formula:

Capability index = (Tolerance / 6 * Standard deviation)

Where:

 Tolerance is the allowable range of values for the process output

 Standard deviation is a measure of the variation in the process output

In this case, the tolerance is the difference between the upper and lower limits of the bottle
volume, which is 36cl - 30cl = 6cl. The estimated standard deviation is given as 3cl.

Substituting these values into the formula, we get:

Capability index = (6 / (6 * 3))

Capability index = 0.33

Since the capability index is less than 1, it indicates that the process is not capable of
meeting the customer's requirements with a high degree of confidence. This means that the
process needs to be improved in order to reduce the variation and improve the quality of
the bottled soda.

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62. Is the above process capable? Why or why not?

The above process is not capable of meeting customer requirements because the calculated capability
index is less than 1. Specifically, the calculated capability index is 0.33, which is less than 1. This means
that the process is not capable of producing bottles of soda that consistently fall within the required
range of 30cl to 36cl with a high degree of confidence.

A capability index less than 1 indicates that the process is not capable of meeting the customer's
requirements with a high degree of confidence. In this case, the process needs to be improved in order
to reduce the variation and improve the quality of the bottled soda. Some possible ways to improve the
process include reducing variability in the manufacturing process, adjusting the process settings to
better control the output, and implementing statistical process control methods to monitor the process
and identify sources of variation.

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