UAS Quality Engineering

Revaldo Richie - 2602240631

1. A)

The improper alignment of holes in the brackets produced by WP Inc. can be attributed to
a combination of factors across materials, methods, machines, measurements, people, and
environment. These factors could be the primary reason for the problem with improper
hole alignment.

Firstly, the material used by the company may contribute to the inaccuracy in hole
positioning due to variations in quality. Ensuring high-quality material is essential for
achieving accurate hole alignment and preventing errors.

Secondly, the methods employed in the manufacturing process can significantly

contribute to the problem of improper hole alignment. Misalignment of progressive dies
during setup or operation can cause holes to be off-center, while variability in the
stamping, piercing, or bending processes can result in inconsistent hole placement due to
fluctuations in machine speed, pressure, or timing. the sequence of operations, such as the
order of stamping, piercing, and bending, can impact hole alignment if not optimized,
introducing stresses or distortions that affect accuracy. By carefully controlling and
standardizing these methods, WP Inc. can reduce variability and improve the precision of
hole alignment in their brackets.

Thirdly, the machines used in the manufacturing process are critical to ensuring proper
hole alignment, and several factors can contribute to misalignment issues. Incorrect
calibration of the press machine can lead to improper hole placement, as the machine
may not operate within the precise parameters required. Inadequate maintenance of the
machinery can result in inaccuracies, as worn-out or malfunctioning components can
affect the consistency and precision of the operations. Regular calibration and
maintenance of the press and other machinery, as well as ensuring the use of the correct
and well-maintained tools, are essential to maintaining accuracy and preventing
misalignment. By addressing these machine-related factors, WP Inc. can improve the
precision of their hole alignment and enhance overall product quality.

Fourthly, accurate measurement is vital for ensuring proper hole alignment in the
manufacturing process. Inaccurate measurement tools can lead to errors in checking hole
placement, allowing misalignments to go unnoticed and resulting in faulty brackets.
Regular calibration and verification of measurement tools are necessary to maintain their
accuracy. Implementing a detailed and consistent inspection process throughout
production can help identify and address alignment issues promptly. By ensuring precise
measurements and thorough inspections, WP Inc. can detect and correct misalignments
early, improving the accuracy of hole alignment and overall product quality.

Fifthly, the skills and actions of the workforce play a crucial role in ensuring proper hole
alignment in the manufacturing process. Variability in operator skill levels can lead to
inconsistent results, as more experienced workers may achieve better alignment than less
experienced ones. Human error during setup or operation, such as incorrect die alignment
or improper machine adjustments, can also contribute to misaligned holes. By providing
comprehensive training, standardizing procedures, and fostering clear communication,
WP Inc. can minimize human error and variability, leading to improved hole alignment
and product quality.

Lastly, the manufacturing environment significantly influences hole alignment in the

production of brackets. Factors such as temperature, humidity, and other environmental
conditions can affect the materials and machinery involved in the process. Fluctuations in
temperature or humidity levels can cause materials to expand or contract unpredictably,
potentially leading to inaccuracies in hole placement during stamping and bending
operations. Poor lighting conditions can also contribute to errors in manual inspections or
setups, making it difficult for operators to ensure proper alignment. Controlling and
maintaining stable environmental conditions within the production area is crucial to
minimizing these variables and ensuring consistent and accurate hole alignment in the
brackets manufactured by WP Inc.
 B)
In my opinion, A Gauge R&R (Gage Repeatability and Reproducibility) study is highly effective
for identifying the root cause of improper hole alignment. By analyzing data, it distinguishes
whether alignment issues stem from measurement errors, operator inconsistencies, or genuine
variations in the manufacturing process. This approach enables targeted improvements that
address the specific source of the problem.

Example scenario when using Gauge R&R

1. Data Collection: Suppose three operators measure the alignment of holes on ten parts, each three
times.

2. Statistical Analysis: Use analysis of variance (ANOVA) to separate the components of variation.
Repeatability: Measure the variation within the same operator's measurements.
Reproducibility: Measure the variation between different operators' measurements.
Part Variation: Measure the variation in the parts themselves.

3. Interpret Results:
High repeatability variation might indicate issues with the machinery.
High reproducibility variation might point to differences in operator techniques or understanding.
High part variation, after accounting for repeatability and reproducibility, suggests the root cause
lies in the manufacturing process.

Another quality that we can use to identify the root cause of the problem is Failure Mode and
Effects Analysis (FMEA). FMEA systematically evaluates potential failure modes of a process or
product and their effects on quality. It helps prioritize which failures are most critical and guides
the implementation of preventive measures.

Steps in FMEA:

 Identifying Potential Failure Modes: FMEA begins by identifying all possible ways in
which improper hole alignment can occur. This includes considering factors such as
misaligned progressive dies, variations in material properties, or inadequate machine
calibration.

 Determining Severity: Each identified failure mode is then evaluated to determine its
impact on product quality. For improper hole alignment, severity would assess how
significantly misaligned holes affect the functionality and performance of the bracket
once installed on the automobile.

 Assessing Occurrence Probability: FMEA assesses the likelihood of each failure mode
occurring. For example, if misalignment is due to inconsistent die alignment during
setup, the frequency of this occurrence can be estimated based on historical data or
process variability.
  Evaluating Detection Ability: The analysis also considers how easily or reliably each
failure mode can be detected through existing inspection or quality control processes.

 Prioritizing and Addressing Root Causes: FMEA calculates a Risk Priority Number
(RPN) for each failure mode by multiplying severity, occurrence, and detectability
scores. High RPN scores indicate critical failure modes requiring immediate attention.

 Implementing Preventive Actions: Based on the findings from FMEA, preventive actions
can be developed and implemented to mitigate the root causes of improper hole
alignment. This may involve refining manufacturing processes, enhancing training for
operators, improving maintenance schedules, or redesigning tooling and fixtures to
ensure more accurate alignment.

By utilizing FMEA, WP Inc. can systematically analyze the root causes of improper hole
alignment, prioritize corrective actions, and ultimately improve the reliability and consistency of
their manufacturing processes, leading to higher-quality brackets and increased customer
satisfaction.

Another alternative is by using Six Sigma, specifically through its DMAIC (Define, Measure,
Analyze, Improve, Control) methodology, provides a structured approach to analyzing and
addressing the root causes of problems such as improper hole alignment in manufacturing.
Steps of Six Sigma:

 Define: the problem of improper hole alignment is clearly defined and quantified. This
includes understanding customer requirements, defining specific metrics for alignment
accuracy, and setting project goals for improvement.
 Measure: Current performance metrics related to hole alignment are established and
analyzed.
 Analyze: Focuses on identifying the root causes of improper hole alignment. Statistical
tools and techniques, such as Pareto analysis, hypothesis testing (e.g., ANOVA), and
correlation analysis, are used to pinpoint factors that significantly impact alignment
accuracy.
 Improve: Armed with insights from the Analyze phase, the Improve phase focuses on
developing and implementing solutions to address root causes identified.
 Control: The Control phase ensures that improvements made are sustained over time.
Control measures are put in place to monitor key process indicators related to hole
alignment, establish standards and procedures, implement ongoing training programs, and
conduct regular audits to prevent regression to previous levels of misalignment.
By following the DMAIC approach, WP Inc. can systematically analyze the root causes of
improper hole alignment, implement targeted improvements, and establish controls to sustain
these improvements. This data-driven methodology helps to reduce variability, enhance process
stability, and ultimately improve the quality and reliability of their bracket products.
C)

Alignment Accuracy Rate: This measure quantifies the percentage of brackets produced
that meet the specified alignment criteria. It involves inspecting a representative sample
of brackets to determine how many have properly aligned holes according to design
specifications.
Defect Rate: The defect rate indicates the proportion of brackets that do not meet
alignment requirements or other quality standards after implementing process
improvements. It includes misaligned holes, as well as any other defects identified during
inspection. Monitoring the defect rate helps assess overall process quality and the impact
of changes on reducing defects related to hole alignment.
Process Capability Index (Cpk): Cpk is a statistical measure that assesses the capability
of a process to produce output within specification limits. It compares the spread of
process variation to the width of the specification limits for hole alignment. A higher Cpk
value indicates that the process is more capable of consistently producing brackets with
properly aligned holes. Monitoring Cpk before and after process improvements provides
a quantitative assessment of how effectively changes have enhanced process
performance.
Customer Complaints or Returns: Customer complaints or returns related to alignment
issues provide direct feedback on product quality from end-users. Tracking the number
and nature of complaints or returns due to misaligned holes helps gauge customer
satisfaction and highlights areas where further improvement may be needed despite
internal process changes.
Scrap and Rework Rate: This measure tracks the percentage of brackets that require scrap
or rework due to alignment issues. Scrap refers to brackets that cannot be salvaged and
must be discarded, while rework involves additional processing to correct alignment
problems.
2. A)

Graph Xbar-R Chart 2.1

Points above the UCL: This suggests that the process mean is consistently higher than
expected, indicating a potential issue or special cause variation that is causing the process to
produce results that are significantly above the average.
Points below the LCL: This suggests that the process mean is consistently lower than
expected, again indicating a potential issue or special cause variation causing the process to
produce results that are significantly below the average.
The analysis of the angle measurements between insert hole A and insert hole B from the 20
subgroups of size 5, taken during the production run, reveals that all the recorded values fall
outside the control limits. This consistent deviation indicates that the process is not in
statistical control and is subject to significant variability beyond the expected natural
variation.
The fact that all points are outside the control limits suggests that there is a persistent,
systematic issue affecting the alignment of the holes. This confirms the team's suspicion that
the alignment process is flawed, leading to off-center holes. Immediate investigation and
corrective action are necessary to identify and eliminate the root cause of this variability.
Addressing these issues is crucial to bring the process back into control and ensure that the
brackets meet the specified tolerance of 0.00° ± 0.30°, thereby resolving the customer's
bracket problems.
B)

Based on the analysis of the angle measurements between insert hole A and insert hole B,
which indicates that the process is out of control with significant variability, I propose the
following process improvement plan for WP Inc. to resolve the bracket alignment
problem:
1. Root Cause Analysis: Conduct a thorough root cause analysis using tools such as the
Fishbone Diagram (Ishikawa) and the 5 Whys technique to identify the underlying causes
of the misalignment. This will help in pinpointing specific issues in the process that need
to be addressed.
2. Equipment Calibration and Maintenance: Ensure that all bending presses and
associated equipment are properly calibrated to the manufacturer's specifications.
Implement a regular calibration schedule to maintain accuracy. Establish a preventive
maintenance program for the bending presses to ensure they are in optimal working
condition. This includes regular inspections and timely repairs or replacements of worn-
out parts.
3. Process Standardization: Develop detailed SOPs for the bending press operation,
ensuring that all operators follow the same procedures. This includes setup, operation,
and shutdown processes. Provide comprehensive training for all operators on the correct
use of the bending press, emphasizing the importance of alignment and the impact of
deviations on product quality.
4. Enhanced Measurement and Monitoring: Real-Time Monitoring, implement real-time
monitoring systems to continuously measure the angle between insert holes during
production. Use sensors and automated measurement tools to detect deviations
immediately. Control Charts, utilize control charts (X-bar and R charts) to monitor the
process mean and variability over time. This will help in early detection of any shifts or
trends indicating potential issues.
5. Process Improvement Initiatives: Evaluate the current process flow and consider
redesigning the process to minimize variability. This might involve changes in the
sequence of operations, improved fixtures, or more precise tooling. Statistical Process
Control (SPC), integrate SPC techniques into the production process to maintain control
and identify variations as soon as they occur. Regularly review SPC data to make
informed decisions on process adjustments.
6. Supplier Quality Management: Work with suppliers to ensure consistent quality of
materials used in the production of brackets. Variations in material properties can affect
the bending process and lead to misalignment. Conduct regular audits of suppliers to
verify that they meet quality standards and provide materials that comply with WP Inc.'s
specifications.
 By implementing these measures, WP Inc. can systematically address the root causes of
the bracket alignment problem, stabilize the production process, and ensure that the
brackets consistently meet the specified tolerance of 0.00° ± 0.30°. This will enhance
product quality, reduce customer complaints, and improve overall operational efficiency.
3. A)
1. Prevention Cost:
 Training and Education: Costs associated with training staff in proper inventory
management procedures to prevent errors in stocking and tracking medical
supplies.
 Quality Planning: Costs incurred in designing and implementing a more efficient
inventory control system to reduce errors and improve supply availability.
 Quality Improvement: Costs of continuous improvement efforts, such as
conducting process audits and implementing feedback mechanisms to enhance the
distribution process.
 Regular calibration and maintenance of medical equipment used in supply
distribution.

2. Appraisal Cost:
 Inspection and Testing: Costs related to inspecting and testing inventory accuracy
and condition before stocking carts.
 Quality Audits: Costs of conducting regular audits to verify inventory records
against actual supplies on carts and in storage.

3. Failure cost:
a) Internal Failure Costs:
 Cost of reordering medical supplies due to incorrect inventory counts or
stockouts.
 Expenses related to disposing of expired or damaged medical supplies.
 Costs of reprocessing or restocking carts due to errors in stocking or inventory
management.
 Administrative costs associated with generating and processing lost charge
reports.

b) External Failure Costs:

 Costs associated with incorrect patient billing and subsequent corrections.
 Patient dissatisfaction and potential impact on patient outcomes due to supply
shortages or errors.
 Potential legal costs and liabilities related to billing errors or quality issues.
 Reputation damage and loss of patient trust resulting from quality-related
incidents.

4. Intangible costs:
  Loss of Reputation: Costs associated with potential damage to the hospital’s
reputation due to billing errors or delays in patient care caused by inventory
issues.
 Patient and Staff Frustration: Intangible costs related to dissatisfaction among
patients and medical staff due to delays or shortages in medical supplies.

B)
Quality costs play a crucial role in decision-making within the context of medicinal
supplies distribution in a hospital setting. Quality costs provide a structured approach to
decision-making in hospitals, ensuring that resources are allocated efficiently to enhance
operational performance, maintain high-quality patient care, and achieve sustainable cost
reductions over time. Here are a few ways that quality cost can help in decision-making
for this case:
 Quality costs help identify where resources are being spent due to poor quality.
By categorizing costs into prevention, appraisal, internal failure, and external
failure costs, hospitals can pinpoint specific areas causing the most financial
strain.

 Hospitals can use quality costs to prioritize investments in improvements. For

instance, if appraisal costs (like auditing and inspection) are substantial,
management may decide to invest in better technology or training to reduce these
costs and catch errors earlier. Prevention costs (such as training programs or
system upgrades) can also be justified if they lead to significant reductions in
failure costs.

 Tracking quality costs over time allows hospitals to assess the effectiveness of
their quality improvement initiatives. For example, if the hospital invests in a new
inventory management system aimed at reducing stockouts and billing errors,
they can measure how this investment impacts failure costs and overall
operational efficiency.

 Quality costs provide insights into process inefficiencies and bottlenecks. By

analyzing where failure costs originate (such as incorrect inventory counts or
delays in restocking carts), hospitals can redesign processes to improve accuracy,
reduce waste, and enhance patient care delivery.

 Understanding quality costs helps hospitals manage risks associated with poor
quality. It allows proactive measures to prevent issues before they escalate,
thereby protecting the hospital’s reputation and patient satisfaction.
  Quality costs inform strategic decisions by aligning quality improvement efforts
with organizational goals. Hospitals can use this data to set targets for reducing
overall quality costs while maintaining high standards of patient care. It helps in
balancing cost containment with service excellence.

4. A)

Photo 4.1 Toro Company’s Website

The Toro Company currently maintains ISO 9000 quality certifications in two major
areas of the company: its three commercial turf care products design and manufacturing
facilities (Tomah, Shakopee and Bloomington) and all of its irrigation division’s
operations.

Each certification required aggressive effort and thorough preparation. Approximately 20

assessment criteria had to be met, followed by a rigorous audit. To ensure objectivity, this
“test” was conducted by an independent team of certified auditors, Lloyd’s Register
Quality Assurance. Following certification, The Toro Company must submit to ongoing
sustaining audits to ensure quality standards are being met. If not, certification can be
revoked.

Summarized Steps of how Toro Company achieved ISO 9000 Certification:

 Establishing a Quality Management System
 Gap Analysis and Planning
 Training and Awareness
 Implementation and Operational Control
 Internal Audits and Management Review
 Preparation for Certification Audit
B)
Toro had to review and document every aspect of its manufacturing processes, from
design and development to production and customer service. This required significant
time and resources to create and maintain comprehensive documentation that met ISO
requirements.

Toro needed to conduct extensive training programs to educate employees about ISO
9000 principles, quality management practices, and their roles in ensuring compliance.
This included training on document control, internal auditing, and continuous
improvement processes.

Toro had to invest in upgrading facilities, implementing new quality control measures,
and hiring additional staff to support ISO compliance efforts. This required careful
budgeting and resource management to balance short-term costs with long-term benefits.
Toro had to ensure that its suppliers also met ISO standards to maintain consistent quality
across the supply chain. Meeting customer expectations for ISO certification involved
demonstrating compliance and transparency in quality management practices.

Toro implemented robust document control procedures to manage documentation related

to processes, procedures, work instructions, and quality records. This included
maintaining document revisions, controlling access, and ensuring documents were
updated as needed.

C)
ISO standards provide technological, economic and societal benefits.
For businesses, the widespread adoption of International Standards means that suppliers
can develop and offer products and services meeting specifications that have wide
international acceptance in their sectors. Therefore, businesses using International
Standards can compete on many more markets around the world.

ISO 9000 certification offers significant benefits to businesses by enhancing quality

management, customer satisfaction, operational efficiency, market reputation, and access
to global markets. It provides a structured framework for achieving sustainable growth,
mitigating risks, and maintaining a competitive edge in today’s dynamic business
environment.

List of benefits:
 Enhanced Quality Management
 Increased Efficiency
 Improved Customer Satisfaction
 International Recognition
 Continuous Improvement
 Legal and Regulatory Compliance
Overall, implementing ISO 9000 can provide a structured framework for organizational
improvement, leading to better business practices, enhanced customer satisfaction, and
sustainable growth.
Real Life Example: Toro Company

Photo 4.2 Toro Company’s Website

D)
The implementation of ISO 9000 has proven highly effective in enhancing operational
excellence and customer satisfaction for businesses worldwide. I consider the
effectiveness of ISO 9000 for businesses to be exceptionally high. By adjusting to ISO
9000 standards, businesses can streamline processes, minimize errors, and optimize
resource utilization. This not only enhances operational efficiency but also boosts
customer satisfaction by delivering products and services that consistently meet or exceed
expectations. Overall, I rate the effectiveness of ISO 9000 certification for a business
9/10.

ISO 9000 fosters a culture of quality within organizations, promoting employee

engagement and empowerment through clear roles, responsibilities, and standardized
procedures. Moreover, ISO 9000 certification enhances credibility and competitiveness in
the global market, demonstrating a commitment to quality assurance and customer-
centric practices. Allowing businesses that already achieve ISO 9000 certification to get
the upper hand in the market due to its high credibility.

A real-life example is Cisco Systems, a global leader in networking equipment and

telecommunications services. Cisco implemented ISO 9000 across its operations,
focusing on standardizing quality management practices and improving process
efficiency. As a result, Cisco achieved significant reductions in product defects,
streamlined its supply chain operations, and enhanced customer trust through consistent
delivery of high-quality products and services.

The ISO 9000 certification not only strengthened Cisco's market reputation but also
positioned the company to compete more effectively in the global marketplace by
meeting stringent quality standards and customer expectations. This success underscores
how ISO 9000 can drive tangible improvements in organizational performance and
customer relationships, ultimately contributing to sustainable business growth.

Another example from a well-known company is Toyota Motor Corporation, which

implemented ISO 9000 standards across its global manufacturing facilities. By adopting
rigorous quality management practices and emphasizing continuous improvement,
Toyota significantly enhanced product reliability, reduced defects, and optimized
manufacturing processes.

This approach not only bolstered Toyota's reputation for producing high-quality vehicles
but also strengthened its relationships with suppliers and customers worldwide. The ISO
9000 certification enabled Toyota to maintain consistency in delivering superior products
while achieving operational efficiencies and cost savings. This success demonstrates how
ISO 9000 can serve as a cornerstone for organizational excellence, driving innovation,
customer satisfaction, and sustained competitive advantage in the automotive industry
and beyond.