Unit 5

Advanced Quality Tools

Process Capability
• A process is a unique combination of tools,
materials, methods, and people engaged in
producing a measurable output.
• Process capabilities compares the output of an in-
control process to the specification limits.
• Process capability is a measure of the relationship
between the natural variation of the process and
the design specifications.
• For example a manufacturing line for machine
parts. All processes have inherent statistical
variability which can be evaluated by statistical
methods.
Meaning
• Process Capability (Cp) is a statistical
measurement of a process’s ability to produce
parts within specified limits on a consistent
basis.
• To determine how our process is operating, we
can calculate Cp (Process Capability), Cpk
(Process Capability Index), or Pp (Preliminary
Process Capability) and Ppk (Preliminary
Process Capability Index), depending on the
state of the process and the method of
determining the standard deviation or sigma
value.
 Why Should I know the Capability of My
Processes?
1. Process capability measurements allow us to
summarize process capability in terms of
meaningful percentages and metrics.
2. To predict the extent to which the process will
be able to hold tolerance or customer
requirements. Based on the law of probability,
you can compute how often the process will
meet the specification or the expectation of
your customer.
3. You may learn that bringing your process
under statistical control requires fundamental
changes - even redesigning and implementing
a new process that eliminates the sources of
variability now at work.
4. It helps you choose from among competing
processes, the most appropriate one for
meeting customers' expectation.
5. Knowing the capability of your processes, you
can specify better the quality performance
requirements for new machines, parts and
processes.
 Measures of Process Capability
• Cp, Cpl, Cpu, and Cpk are the four most
common and timed tested measures of process
capability.
1. Process capability indices measure the degree
to which your process produces output that
meets the customer's specification.
2. Process capability indices can be used
effectively to summarize process capability
information in a convenient unitless system.
3. Cp and Cpk are quantitative expressions that
personify the variability of your process (its
natural limits) relative to its specification
limits (customer requirements).
• The above example shows the capability of the garage, the
example itself explains what is the process capability.  If
process spreads as Car B the garage capability will be low,
however, if a process is narrowed like C or D we could see that
the process is capable to perform as per customer's
expectations. 
• The Process Capability is a measurement of how the process is
performing with respect to the desired outcome. The
capability is defined as the voice of the customer over the
voice of the process. 
• Process Capability has two parts namely, the
process and its capability, which essentially
means how capable is the process of satisfying
the customer or whether the process is
capable enough.
• Talking about the process, it is often influenced
by many other factors and noises. 
Key Points to remember for Process Capability 
1. While we discuss process capability, we must
assure that data must be normal and in
control. If data is not normal and in control, it
is fruitless to check for the process capability. 
2. Process capability gives a long-term
performance once it is under the statistical
boundaries. 
3. It checks the ability of the process also the
ability of the people, machines, measurement,
and methods as well. 
4. Process Capability could have both side limits,
in manufacturing industries, for any
measurement, there would be upper and
lower specification limits.
5. In other industries, there might be a chance of
only a single limit, either maximum limit or
minimum limit. For example, the delivery of
the product should have only the maximum
limit, whereas passing an exam has a criterion
of minimum 60%. 
 What are the steps of Capability Analysis? 
1. Check the data type whether it is Continuous
or Discrete. 
2. If it is discrete data then apply the Capability
Analysis (Binomial). 
3. If it is continuous data then, check the process
stability. 
4. Process Stability can be checked by the I-MR
control chart.
5. If the process is not stable, then we cannot
calculate the process capability, we need to fix
or adjust the data as stable.  
6. If it is stable, then we check the process
normality. 
7. If the data is normal and stable, we can
calculate the Capability for normal data. 
8. If the data is not normal, first need to make
the data normal, if the data cannot be
normalized then use the Box-Cox
transformation. 
9. Once data is fixed to normal, calculate the
process capability. 
Reliability(Consistency /Trustworthiness)
• Reliability is the degree of consistency of a
measure. A test will be reliable when it gives
the same repeated result under the same
conditions.
• Reliability is the probability that the given
system will perform its required function
under specified conditions for a specified
period of time.
What is reliability?
• Reliability is a broad term that focuses on the
ability of a product to perform its intended
function.
• Mathematically speaking, assuming that an
item is performing its intended function at
time zero, reliability can be defined as the
probability that it will continue to perform its
intended function without failure for a
specified period of time under stated
conditions
 Importance of reliability
• Reputation
• Customer satisfaction
• Warranty costs
• Repeat business
• Cost analysis
• Customer requirements
 Reliability and quality
• Even though a product has a reliable design,
when the product is manufactured and used in
the field, its reliability may be unsatisfactory.
The reason for this low reliability may be that
the product was poorly manufactured. So, even
though the product has a reliable design, it is
effectively unreliable when fielded, which is
actually the result of a substandard
manufacturing process.
• Although the terms reliability and quantity are
often used interchangeably, there is a
difference between these two concepts. While
reliability is concerned with the performance
of a product over its entire lifetime, quality
control is concerned with the performance of a
product at one point in time, usually during the
manufacturing process.
• Quality control is a single, albeit vital, link in
the total reliability process. Quality control
assures conformance to specifications. This
reduces manufacturing variance, which can
degrade reliability.
• Quality control also checks that the incoming
parts and components meet specifications,
that products are inspected and tested
correctly, and that the shipped products have a
quality level equal to or greater than that
specified.
• The specified quality level should be one that
is acceptable to the user, the consumer and the
public. No product can perform reliably
without the inputs of quality control because
quality parts and components are needed to go
into the product so that its reliability is
assured
 The Bath Tub Curve
• The bathtub curve is a type of model
demonstrating the likely failure rates of
technologies and products.
• Over a certain product lifetime, the bathtub
curve shows how many units might fail during
any given phase of a three-part timeline.
• The first downward portion of the curve is
called an “infant mortality” phase and shows
how a number of units would quickly fail due
to defects or other issues.
• The second part of the curve is the “normal
lifetime” or “useful lifetime” segment with a
low failure rate.
• The third part is an end-of-life increasing
failure rate.
• Together, these three segments look like a
bathtub with two steep edges and a flat
bottom.
1. Infancy / Green / Debugging / Burn-in-
period: 
• Many components fail very soon after they
are put into service. Failures within this
period are caused by defects and poor design
that cause an item to be legitimately bad.
These are called infant mortality failures and
the failure rate in this period is relatively high.
• Good system vendors will perform an
operation called "burn in" where they put
together and test a system for several days to
try to weed out these types of problems so
the customer doesn't see them.
2. Chance failure / Normal Operating Life: If a
component does not fail within its infancy, it
will generally tend to remain trouble-free
over its operating lifetime.
• The failure rate during this period is typically
quite low. This phase, in which the failure rate
is constant, typically represents the useful life
of the product.
3. Wear out / Ageing: After a component
reaches a certain age, it enters the period
where it begins to wear out, and failures start
to increase.
• The period where failures start to increase is
called the wear out phase of component life.
Taguchi’s Loss function
• Developed by Genichi Taguchi, it is a graphical
representation of how an increase
in variation within specification limits leads to
an exponential increase in customer
dissatisfaction.
• The common thinking around specification
limits is that the customer is satisfied as long
as the variation stays within the specification
limits.
• If the variation exceeds the limits, then the
customer immediately feels dissatisfied. The
specification limits divide satisfaction from
dissatisfaction.
• A real life example of the Taguchi Loss
Function would be the quality of food
compared to expiration dates.
• If you purchase an orange at the supermarket,
there is a certain date that is ideal to eat it.
That would be the target date. There will also
be limits for when to eat the orange (within
three days of the target date, Day 2 to Day 8).
• For this example, Day 5 represents the target
date to eat the orange. That is when the orange
will taste the best (customer satisfaction).
• You purchase the orange on Day 1, but if you
eat the orange you will be very dissatisfied, as
it is not ready to eat. This would fall below the
lower limit.
• On Day 3 it would be acceptable to eat, but you
are still dissatisfied because it doesn’t taste as
good as eating on the target date.
• If you wait for Day 5, you will be satisfied,
because it is eaten on the ideal date.
• If you wait until Day 7, you will be slightly
dissatisfied, because it is one day past the ideal
date, but it will still be within the limits
provided by the supermarket. If you wait until
Day 9, you will be very dissatisfied, as it will be
too far past the ideal date.
The three characteristics that shape the
definition of Taguchi loss function are:
1. Nominal, where the best characteristic or
target value is the median of the specified
upper and lower acceptable limits, and the
losses owing to deviance from the target
value rise proportionate to the extent of
deviance on either side of the mean.
2.Smaller-the-Better, where the ideal target value or
best quality standard is zero, and the higher the
actual value, the higher the private and social costs.
Examples of such instances include heat loss in heat
exchanger, or carbon dioxide emissions. 
3.Larger-the-Better, where the ideal characteristic or
best quality standard is infinity, and the higher the
actual value, the better, and the lower the actual
value, the more the private and social costs. Examples
of such instances include maximizing product yield
from a process, agricultural output, and the like. 
 Business Process Management
• Business process management is a discipline
in operations management in which people
use various methods to discover, model,
analyze, measure, improve, optimize, and
automate business processes.
• Business Process Management is how a
company creates, edits, and analyzes the
predictable processes that make up the core of
its business.
Business Process Management Life Cycle
 Benefits of Incorporating Business Process
Management?
• Gain control of chaotic and unwieldy processes
• Create, map, analyze, and improve business
processes
• Run everyday operations more efficiently
• Realize bigger organizational goals
• Move toward digital transformation
• Improve and optimize tangled operations
• Closely track individual items as they move
through a workflow
 Types of Business Process Management
1. Integration-Centric BPM:
• This type of business process management
system handles processes that primarily jump
between your existing systems (e.g. HRMS,
CRM, ERP) without much human involvement.
2. Human-Centric BPM:
• Human-centric BPM is for those processes that
are primarily executed by humans. These often
have a lot of approvals and tasks performed by
individuals.
3. Document-Centric BPM:
• These business process management solutions
are required when a document (e.g. a contract
or agreement) is at the heart of the process.
• They enable routing, formatting, verifying, and
getting the document signed as the tasks pass
along the workflow.
• Most business process management systems
will be able to incorporate elements of each of
these, but each one will usually have one
specialty.
 Corrective action and Preventive action (CAPA)
• Corrective and preventive action (CAPA, also
called corrective action/preventive action or
simply corrective action) consists of
improvements to an organization's processes
taken to eliminate causes of non-conformities
or other undesirable situations.
• Corrective Action Preventive Action (CAPA) is a
process which investigates and solves
problems, identifies causes, takes corrective
action and prevents recurrence of the root
causes.
• The ultimate purpose of CAPA is to assure the
problem can never be experienced again.
 CAPA is split between two distinct but related
functions.
1. Corrective Action (CA) is an extension of Root
Cause Analysis (RCA).
• The first goal of CA is to find the root cause,
base event or error that preceded the
problem.
• The second goal is to take action directed at
the root cause or error.
2. Preventive Action (PA) is similar to Lessons
Learned / Read Across. PA resembles the
replication activity of Design for Six Sigma
(DFSS).
• Another example of PA in industry is Yokaten,
a Japanese term used by Toyota, describing a
sharing across the organization.
• The primary goal of PA is to inform an
organization and prevent the problem from
returning in other facilities lines or products.
 Objectives of CAPA Implementation 
1. Addresses requirements of the quality system
regulation
2. Evidence that appropriate sources of product
and quality problems have been identified.
3. Tracking of Trends (which are unfavorable)
are identified.
4. Verify that appropriate Statistical Process
Control (SPC) methods are used to detect
recurring quality problems.
5. Actions address the root cause and preventive
opportunities.
6. CAPA process actions are effective and
verified or validated prior to implementation.
7. Corrective and preventive actions for product
and quality problems are implemented and
documented.
Corrective Action Process
1. Locate and document the root cause of the
nonconformity.
2. Scan the entire system to ensure no other similar
nonconformity could occur.
3. Analyze the effect such a nonconformity may have
had on a product or service produced before the
nonconformity was discovered, and take action
appropriate to the severity of the situation by either
recalling the product, notifying the customer,
downgrading or scrapping product.
4. Establish thorough follow-up to ensure the
correction is effective and recurrence has been
prevented.
Preventive Action Process
• Take proactive steps to ensure a potential
nonconformity does not occur.
• Employ process and system analysis to determine
how to build in safeguards and process changes to
prevent nonconformance.
• For example, use a failure mode and effects analysis
to identify risks and potential deficiencies and to set
priorities for improvement.