SPC Unit 1 QnA
SPC Unit 1 QnA
SPC Unit 1
The essence of quality revolves around meeting customer expectations through these four
key activities:
2) Designing for Quality – Incorporating quality principles into the design and development
phase to prevent defects and ensure consistency in performance.
Toyota), Lean principles have since been adopted across various industries, including
healthcare, software development, and service sectors.
1) Identify Value
o Define what is valuable from the customer's perspective.
o Focus on delivering products or services that meet customer needs while
eliminating anything that does not add value.
3) Create Flow
o Ensure a smooth, uninterrupted workflow by reducing bottlenecks and delays.
o Implement strategies like continuous improvement and cross-functional
collaboration to enhance efficiency.
4) Establish Pull
o Produce only what is needed when it is needed, rather than pushing excess
production.
o Use a Just-in-Time (JIT) approach to minimize inventory and overproduction.
5) Pursue Perfection
o Continuously improve by identifying opportunities for optimization.
o Foster a culture of ongoing learning, problem-solving, and innovation to achieve
operational excellence.
1) SORT (SEIRI): Eliminate unnecessary items from workplace, leaving only the
essential items needed for current operations.
3) SHINE (SEISO): Clean and maintain workspace regularly to ensure safety and
visually appealing environment.
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
2) I – Inventory: Excess stock beyond immediate needs ties up capital and space while
increasing the risk of damage or obsolescence.
o Example: Overstocking perishable goods like dairy products results in spoilage
and financial losses.
4) W – Waiting: Idle time caused by delays, bottlenecks, or slow processes leads to wasted
resources and inefficiency.
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
7) D – Defects: Errors and quality issues requiring rework or causing waste of materials and
labour.
o Example: Mislabelling a product leads to recalls, returns, and dissatisfied
customers.
By eliminating these 7 Wastes, Lean principles enhance efficiency, reduce costs, and
improve customer satisfaction.
5. Difference between:
Lean Methodology Six Sigma Methodology
At Six Sigma (6σ) level, a process operates with 3.4 defects per million opportunities
(DPMO), achieving 99.99966% accuracy, ensuring near-perfect quality and minimal errors. It
is widely used in manufacturing, healthcare, IT, and business operations to optimize
performance and maximize customer satisfaction.
7. What is Lean Six Sigma? How does it combine Lean and Six Sigma methodologies?
Lean Six Sigma is a hybrid methodology that combines the principles of Lean and Six Sigma
to improve process efficiency, reduce waste, and enhance quality.
By integrating both approaches, Lean Six Sigma ensures faster, defect-free processes,
improving customer satisfaction and operational performance across industries like
manufacturing, healthcare, IT, and finance. The methodology typically follows DMAIC
(Define, Measure, Analyze, Improve, Control) for process improvement and DMADV (Define,
Measure, Analyze, Design, Verify) for new process development.
Six of the orders have problems and there are a total of 7 defects out of the 50 orders
sampled.
Therefore, DPU = 7/50 = 0.14.
On average, this is your quality level and each unit of product on average contains this
number of defects.
9. Define DPMO (Defects Per Million Opportunities) and explain its calculation.
Defects per million opportunities (DPMO) is the number of defects in a sample divided by
the total number of defect opportunities multiplied by 1 million.
DPMO standardizes the number of defects at the opportunity level and is useful because
you can compare processes with different complexities.
Each custom stationary order could have four defects - incorrect, typo, damaged, or
incomplete. Therefore, each order has four opportunities. Fifty orders are randomly selected
and inspected and the following defects are found.
o Two orders are incomplete.
o One order is both damaged and incorrect (2 defects).
o Three orders have typos.
If your process remains at this defect rate over the time it takes to produce 1,000,000
orders, it will generate 35,000 defects.
(P.T.O.)
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
Key Takeaways:
• FTY includes reworked units, while FPY measures only defect-free first-time outputs.
• RTY considers the entire process, making it more accurate for evaluating end-to-end
efficiency.
• Higher RTY means lower defects, less rework, and a more efficient process.
Thus, measuring process yield helps in identifying inefficiencies, improving quality, and
optimizing operational performance.
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
The Cost of Quality (COQ) refers to the total cost incurred to ensure that a product or
service meets quality standards. It includes the costs associated with preventing defects,
appraising quality, and addressing defects when they occur. COQ is a critical metric in
quality management as it helps organizations identify areas for improvement and reduce
unnecessary expenses.
1. Prevention Costs
- Costs incurred to prevent defects from occurring in the first place.
- Examples: Training, process improvement, quality planning, and preventive maintenance.
2. Appraisal Costs
- Costs associated with measuring and monitoring activities to ensure quality.
- Examples: Inspection, testing, audits, and calibration of equipment.
A Scenario:
A company manufactures 1,000 units of a product:
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
12. What is DMAIC? Briefly describe each phase in the DMAIC cycle.
DMAIC is a structured problem-solving methodology used in Six Sigma to improve
processes by reducing defects and variations. It consists of five phases: Define, Measure,
Analyse, Improve, and Control.
Phases of DMAIC: -
1) Define
o Objective: Identify the problem, project goals, customer requirements, and
business objectives.
o Key Activities:
▪ Define project scope and objectives.
▪ Identify customer needs (Voice of the Customer – VOC).
▪ Develop a high-level process map (SIPOC – Suppliers, Inputs, Process,
Outputs, Customers).
o Example: A company wants to reduce order delivery time for online purchases.
2) Measure
o Objective: Quantify the current performance and collect data to identify
baseline metrics.
o Key Activities:
▪ Identify key performance indicators (KPIs).
▪ Collect data on defects, cycle time, or errors.
▪ Calculate process capability (e.g., sigma level, defect rates).
o Example: Measure the average delivery time and number of late deliveries in a
month.
3) Analyse
o Objective: Identify the root causes of defects or inefficiencies.
o Key Activities:
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
▪ Use tools like Fishbone Diagram, 5 Whys, Pareto Chart to find root
causes.
▪ Perform statistical analysis to determine process bottlenecks.
▪ Validate cause-and-effect relationships.
o Example: Analysis shows warehouse delays and incorrect address entries as
major causes of late deliveries.
4) Improve
o Objective: Develop and implement solutions to eliminate root causes and
improve performance.
o Key Activities:
▪ Brainstorm and test improvement ideas (pilot solutions).
▪ Optimize process flows and eliminate inefficiencies.
▪ Implement automation or standardization for consistency.
o Example: Introduce an automated address verification system and optimize
warehouse sorting.
5) Control
o Objective: Sustain improvements by monitoring process performance and
preventing regression.
o Key Activities:
▪ Develop control charts and dashboards.
▪ Implement standard operating procedures (SOPs).
▪ Train employees and ensure process adherence.
o Example: Set up monthly audits to ensure delivery times remain within the
target.
VOB represents the expectations, goals, and priorities of the business, focusing on
profitability, growth, and sustainability. It ensures that the organization’s strategic
objectives, financial health, and market positioning are met.
Key Aspects:
- Revenue growth, cost reduction, and profit margins.
- Compliance with regulations and industry standards.
- Customer retention, competitive advantage, and brand reputation.
- Employee productivity, innovation, and operational efficiency.
Example: A company sets a target to reduce operational costs by 15% and increase
customer retention by 10% within a year.
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
Key Aspects:
- Process cycle time, defect rates, and rework.
- Adherence to quality standards and efficiency benchmarks.
- Capacity utilization and waste reduction (Lean principles).
- Automation and process optimization to improve performance.
Example: A manufacturing unit monitors its defect rate in production and finds that 2% of
products fail quality checks, leading to increased rework costs.
15. How does Kano Analysis explore and measure customer needs?
The analysis categorizes features into five types based on how they impact customer
satisfaction. Here are the key categories:
These are essential features that customers expect to be present. When they are present,
customers don't necessarily become more satisfied, but if they are missing, dissatisfaction
increases.
2] Performance Needs (More is Better): These features directly correlate with customer
satisfaction. The more you have of these; the more satisfied customers will be. Their
absence doesn't necessarily cause dissatisfaction, but their presence adds to satisfaction.
4] Indifferent Needs:
These features don't particularly impact customer satisfaction, whether they are present
or absent. Customers are neutral about them.
Importance of CTQ:
• Aligns Business Goals with Customer Needs: Ensures that quality efforts focus on
aspects important to customers.
• Improves Customer Satisfaction: Helps deliver consistent quality, reducing defects and
dissatisfaction.
• Enhances Process Efficiency: Identifies key focus areas, reducing waste and optimizing
performance.
• Facilitates Measurement and Control: Converts subjective customer expectations into
objective, measurable metrics.
A CTQ Tree breaks down customer needs into drivers and then into specific requirements
that must be met to ensure quality.
17. "What is a problem and goal statement in context of DMAIC. Describe things to keep in
mind while defining a problem statement.
Additionally highlight the issues with the following problem statement:
"Patient satisfaction is low, and we need to improve it."
Problem Statement
• Defines the current issue, including who, what, where, when, and impact of the
problem.
• Must be data-driven and objective to support root cause analysis.
Goal Statement
• Specifies SMART (Specific, Measurable, Achievable, Relevant, Time-bound)
objectives to address the problem.
• Clearly defines the expected outcome after improvement.
A Project Charter is a formal document that outlines the objectives, scope, stakeholders,
and key details of a project. It serves as an official authorization for the project, providing a
clear direction and defining roles and responsibilities.
In DMAIC, the project charter is developed during the Define phase to establish the
foundation for problem-solving efforts.
1] Project Title & Description – A brief overview of the project, including the problem being
addressed.
2] Business Case – Justification for the project, explaining its impact on the organization.
3] Problem Statement – A clear and measurable description of the issue that needs
resolution.
5] Scope – Specifies the boundaries of the project (what is included and excluded).
6] Team Members & Roles – Identifies key stakeholders, including project leaders and team
members.
7] Milestones & Timeline – Defines key deliverables and the expected timeline for project
completion.
8] Constraints & Assumptions – Lists limitations, risks, and underlying assumptions that
may affect the project.
9] Metrics & Success Criteria – Defines how project success will be measured (e.g., defect
reduction, process efficiency).
10] Approval & Sign-Off – Includes authorization from senior management or project
sponsors.
Main
components
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
19. Explain SIPOC (Suppliers, Inputs, Process, Outputs, Customers) with an example.
This SIPOC model helps in understanding the process flow, identifying key stakeholders, and
improving efficiency.
2) Generates Multiple Ideas Quickly – Promotes rapid idea generation without immediate
evaluation, allowing a broad range of solutions.
4) Overcomes Mental Blocks – Helps break rigid thought patterns and encourages out-of-
the-box thinking.
5) Identifies Root Causes and Solutions – Can be structured using tools like mind maps,
affinity diagrams, or the 5 Whys technique to analyze problems deeply.
How It Works:
1. Define the Problem: Clearly state the challenge or goal.
2. Generate Negative Ideas: Think of ways to make the situation worse.
3. Reverse the Ideas: Convert the negative ideas into positive solutions.
4. Evaluate and Implement: Select feasible ideas for process improvement.
Example:
Negative Ideas:
- Make patients fill excessive paperwork.
- Have only one doctor for all cases.
- Delay test results indefinitely.
- Lose patient records frequently.
Reversed Solutions:
- Digitize patient records for quick access.
- Increase staff and optimize scheduling.
- Implement automated test result tracking.
- Use an electronic medical record (EMR) system.
By flipping the negative ideas, organizations can uncover practical and innovative solutions
for efficiency improvements.
22. What is process mapping? Explain any type of a process map with an example.
Process mapping is a visual representation of a workflow, or a sequence of steps involved in
a process. It helps in understanding, analysing, and improving a process by identifying
inefficiencies, bottlenecks, and redundancies.
A flowchart is one of the most common types of process maps, depicting steps in a process
using symbols such as circles (start/end), rectangles (process steps), diamonds (decision
points), and arrows (flow direction).
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
Structure:
The diagram resembles a fishbone, where:
• The head represents the main problem or effect.
• The bones represent major categories of causes.
• The sub-branches list potential causes within each category.
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
24. What is a Pareto chart, and how does it follow the 80/20 rule?
A Pareto Chart is a bar graph that represents the frequency or impact of different causes of a
problem, arranged in descending order.
It is based on the Pareto Principle (80/20 Rule), which states that 80% of the effects come
from 20% of the causes.
By identifying and focusing on the vital few causes (late deliveries and defective products in
this case), businesses can prioritize improvements that will have the most significant
impact on reducing complaints.
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
25. Define a run chart and explain its purpose in process monitoring.
A Run Chart is a simple line graph that plots data points over time to analyse trends,
patterns, or variations in a process. It helps identify whether a process is stable or
experiencing irregular fluctuations.
Example:
26. What is a tier chart, and how does it differ from other visual tools?
A Tier Chart is a structured visual tool used in performance management and continuous
improvement frameworks. It organizes and escalates information across different levels
(tiers) of an organization to ensure effective communication, problem-solving, and decision-
making.
• Tier 1 (Operational Level): Daily frontline meetings for immediate issue resolution
(e.g., team huddles).
• Tier 2 (Department Level): Departmental performance reviews, tracking key metrics.
• Tier 3 (Managerial Level): Management reviews for cross-functional alignment.
• Tier 4 (Executive Level): Strategic decision-making based on aggregated data from
lower tiers.
Example:
A manufacturing plant uses a Tier Chart for daily production reviews.
• Tier 1: Operators discuss machine breakdowns.
• Tier 2: Supervisors analyse recurring downtime trends.
• Tier 3: Managers decide on preventive maintenance strategies.
• Tier 4: Executives allocate budgets for machine upgrades.
Additionally, whiskers extend from the box to show variability outside the upper and lower
quartiles, and outliers (extreme values) are marked separately.
Example:
A company tracks monthly delivery times (in days) for two courier services:
• Service A: Box plot shows a narrow range (consistent performance).
• Service B: Wider IQR and outliers (higher variability in delivery times).
From the chart, the company can choose the more reliable service (Service A) or investigate
and improve the issues causing variability in Service B.
Thus, Box-Whisker Charts are essential for identifying variability, detecting inconsistencies,
and making data-driven decisions in quality control and process improvement.
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
28. Define multivariate charts and explain their importance in data analysis.
Multivariate charts are graphical tools used to visualize and analyse data that involves more
than one variable.
• Within Units (Positional): This refers to variations within a single batch or unit of
production. The example shows cookies within the same batch having slight
differences (presumably in size, shape, or color). This could be due to
inconsistencies in ingredient distribution, oven temperature variation within a batch,
or placement on the baking sheet.
• Between Units (Cyclical): This refers to variations between different batches or units
of production. The example shows a more noticeable difference in the cookies from
Batch 1 versus Batch 2. This could be caused by variations in raw materials, changes
in equipment settings between batches, or even environmental fluctuations
affecting the dough.
• Temporal (Shift-to-Shift): This refers to variations occurring over time, such as across
different days or shifts. The example suggests a gradual change in the cookies over
the two days. This could be attributed to factors like machine wear, changes in
operator technique across shifts, or even seasonal variations in ingredients.
(P.T.O.)
Credits: Rutuja Babar Ma’am and Sunil Shirvaiker Sir
29. What is FMEA? List the key steps involved in performing FMEA.
Failure Modes and Effects Analysis (FMEA) is a systematic risk assessment tool used to
identify potential failure modes in a process, product, or system, analyse their effects, and
prioritize them for preventive action. It helps in improving reliability, safety, and quality by
proactively addressing possible failures before they occur.
Example:
In an automobile braking system, an FMEA might identify a failure mode such as "brake fluid
leakage."
• Effect: Reduced braking efficiency → risk of accidents.
• Causes: Faulty seals, wear and tear, improper maintenance.
• Actions: Use high-quality seals, implement routine inspections, and enhance
maintenance training.