Quality and Innovation Engineering OUTLINE

CdLM in Mechatronics Engineering

 process: definition, goal, performances, classification
 process description: C.I.A.O. critical factors, context, analysis
 process management phases:
- process definition: plan, design
- measurement definition: plan, design

Process Management
- measurement execution: plan, design
- measurement interpretation:
- stability
- compliance
- capability: capability indexes, process performance analysis
- management actions:
- control: correction, prevention
Dario Petri - improvement

dario.petri@unitn.it
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Note: pages with (E) in the title are elective
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ORGANIZATIONS AND PROCESSES PROCESS: GENERAL DEFINITION

according to the process approach (ISO 9000), a modern company is process: set of activities, time ordered and interrelated:
organized as a network of processes and the interactions between • with specified goals and
processes need to be considered • clear beginning and end,
Ex. of technical, economical, administrative processes: marketing, sales, purchase, research and development, • transforming inputs into outputs (products), using resources
product specification, design, supply, production process planning, production, production control, final testing, and satisfying constraints (of time, resources,…)
storing, packaging and shipping, distribution and selling, installation and use, assistance and maintenance, …
added value = output value – (input + resources) cost
Thus, organization management implies process management
input and resources must be available and goals constraints
compliant with process requirements
MANAGEMENT: inputs outputs
ensemble of activities (planning, organizing, motivating, monitoring, controlling, improving, …) process
a process can be divided into sub-processes
performed on given entities (inputs, activities, resources, organizations, …) to achieve
specified goals a sub-process is a process (set of ordered activities
aimed at a clear goal) which is part of a larger process resources
 PROCESS GOAL
general process goal:
to produce products of quality with minimum cost and time
cost of manufacturing a product is often a major component of its sales price
cost per produced unit C/N = F/N + V
• number of units N
• fixed cost (F): one-time expenditures (e.g. costs of equipment, tools, set-up)
• variable cost (V): recurring expenses required for making the product (e.g. costs of raw materials,
labor, overhead costs such as energy consumption, rent, …)
large fixed start-up costs are major barriers to starting business and requires
large production volumes
additive manufacturing allows low-volume production
PROCESS PERFORMANCES
performances: process characteristics related to process goals; they
reflect the degree to which the process achieve its goals
examples of process performances:
• productivity: # of product completed in a unit of time
strictly related: cycle time: time taken to complete one part or unit operation
• defect rate: # of wrong products/# of good products
• effectiveness: capability to achieve the fixed goals
in particular products quality is typically inversely related to process variations
• efficiency: capability to be effective with minimum use of resources
• reliability: capability to perform the required functions under stated conditions for a specified time
= time stability of quality characteristics
• flexibility: capability to change process organization without increasing the amount of defects
• versatility: capability to change product characteristics without increasing the amount of defects
versatile process requires a lower cost and/or shorter amount of time to adapt to product design
changes; typically additive manufacturing provides the ultimate versatility

process performances are often inter-related and affect the cost (e.g.
increasing product quality often reduces rate or increases cost)
process also exhibits:
• other relevant characteristics (environmental impact, safety (of workers), energy consumption,…)
5 • specific needs (materials, existing infrastructure, …) 6

PROCESS PERFORMANCES (E) EX. PRODUCT REALIZATION PROCESS

A simplified description of the related sequence of sub-processes follows:
often process performance are not fully exploited due to: • communicate with customers to understand customer needs and expectations
• activities are not well understood/exploited • determine the requirements of customers, of regulators and of the organization
• achieved results are considered good enough  poor focus on improvement relative to the product
• review the product requirements to ensure they are understood and confirm the
• some activities are perceived as not critical, … capability to achieve them
 usually there are large improvement margins • plan product realization
• plan measurement, testing, verification, validation and criteria for acceptance
• plan and develop related documents
• design and development of product; identify purchase materials, components
and services, build prototypes to validate design and new processes
• release product information into the market to attract new customers; review the
requirements in order to match customer needs with product offerings and
confirm the capability to supply that product before entering into a commitment
• plan product realization once again and undertake production
• during production: maintain traceability of the product (if applicable), perform
measurement and monitoring processes and products at each stage of the
process; control the measuring and monitoring devices; record evidences
• if significant variations are found analyzing data, undertake corrective actions
• once all the product tests and verifications have been performed, ship the
product to the customer.
• customer communication to obtain feedback on product performance
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 PROCESS CLASSIFICATION (E) KINDS OF PROCESSES: FEATURES
processes are often classified considering the quantity of products since project batch mass continuous
different classes require different management strategies and different
technical skills product unique made to order made to stock commodity
customer singly few individuals mass market mass market
PROJECT: a temporary set of activities: demand infrequent fluctuates stable very stable
• designed and undertaken to produce (usually) a single product volume very low low to med high very high
• often solicited by a customer commission
variety infinite many, high low very low
PROGRAM: a set of inter-dependent projects system long-term intermittent flow lines process industry
equipment varied general-purp. special-purp. highly automated
type of work contracts fabrication assembly mix, treat, refine
conversely (strict sense) PROCESS is usually a set of repetitive, semi-
skills experts wide range limited range equipment
permanent or permanent, activities
craftspeople monitors
BATCH: process producing a small amount of products advantages custom work flexibility efficiency highly efficient
quality speed, low cost large capacity
MASS : repetitive process producing a large amount of products disadvantag. nonrepeating costly, slow capital invest. difficult to change
CONTINUOUS: continuous operation to avoid turning on/off costs
(ex. production of steel, plastic, chemical products) example construction printing, bakery autos, TV’s paint, oil, food

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(E) MANUFACTURING vs SERVICE PROCESS/PROJECT MANAGEMENT

project management is focused on the planning and design stages

comparison manufacturing vs service
based on products characteristics main project management activities:
• identify and characterize requirements
• prepare a plan that lays out achievable objectives
characteristic manufacturing service • implement the plan
• track the status and progress of work performed with respect to the goals
output tangible intangible
customer contact low high program management is concerned with a set of inter-dependent projects
uniformity of input high low
labor content low high
uniformity of output high low process management is focused on the execution stage
measurement of productivity easy difficult aimed at controlling, predicting and improving process performances
opportunity to correct high low
quality problems

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 (E) MANAGEMENT FUNCTIONS PROCESS MANAGEMENT
Ex. software production company: typical business goals, related project/process issues and examples
of product/process measurable properties useful for production process control (rather than It is a fact of life that inputs, activities and context (i.e. operating conditions)
characterizing the product/process) properties steadily fluctuates  process output (product) properties changes
Business Project Issues Process Issues Measurable Product and
Goals Process Properties once the process has been tuned to its designed model and settled down,
increase product growth product conformance n° of requirements process output quality is (usually) in inverse relation with variability
function product stability product size during process execution of inputs, activities and context properties 
product complexity
rates of change
% nonconforming process quality management is performed by monitoring, measuring,
reduce cost budgets efficiency product size analyzing and managing the variability of all factors:
expenditure rates productivity product complexity • related to Context, Inputs, Activities ( quality assurance) and Outputs (
rework effort
n° of changes
product quality control) (C.I.A.O.)
requirements stability • that significantly affect process behavior (called critical factors CFs
reduce time- schedule product rate elapsed time, normalized or dominant factors)
to-market progress responsiveness for product characteristics

improve product predictability n° of defect introduced  when describing processes, more than a flow chart of activities is needed
product - performance problem recognition effectiveness of defect
quality - correctness root cause analysis detection activities
- reliability
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PROCESS CONTEXT WORK ENVIRONMENT

process context is composed by (S.C.O.R.E.):
• Support: e.g. maintenance, procedures, management support, …
• Constraints: e.g. constraints on time and resources, regulations, …
• Organization, whose variables doesn’t interact directly with the process,
but affect its context (e.g. resources: turnover, downsizing, training, funds, facilities, …)
• Resources: we can distinguish physical, human and financial resources
• Environment: work environment includes physical, social and psychological factors
factors that may influence CIAO-CF variations:
• Resources: machines (e.g. degree of wear and choice of tooling), inputs
operators (e.g. how experienced and careful he/she is) process
• Environment (e.g. variations in temperature, humidity, voltage)
• Support: methods (e.g. type of machining operation)
• Inputs: materials (e.g. variations in surface smoothness and hardness)
resources support
environment constraints
context
organization
resource management = collection of processes
covering human, physical and financial resources
work (or operating) environment: set of conditions under which machines and
people operate and that influence their behavior (and consequently the obtained results )
include the following (mutually influencing) groups of factors:
• physical: related to physical environment
temperature, noise, light, humidity, hazards, cleanliness, vibration, pollution, accessibility, physical stress,
airflow, …
• social: related to interactions between people;
include the impact of the family, education, religion and peer pressure, impact of the organization’s ethics,
outputs culture and climate, …
• psychological: related to an individual inner needs and external influences;
include recognition, responsibility, achievement, advancement, reward, job security, interpersonal relations,
leadership, affiliation, self esteem, occupational stress, …. They tend to shape emotions, feelings,
personality, loyalty and attitudes of people and thus their motivation towards the job
aims of environment management:
- control the physical factors as required by law and as necessary for
people to perform their jobs as efficiently and effectively as possible
- create conditions that motivate people, also by removing or containing
15 de-motivating elements (e.g. friction and conflict in the workplace) 16
 MONITORING AND MEASUREMENT
MONITORING is concerned with continual surveillance of CIAO-CFs
with the aim to identify unusual occurrences or indicators of potential
relevant changes
Ex: monitoring processes employed to check that machines are functioning correctly, that processes are
under statistical control, that there are no detrimental conditions causing abnormal performance

Process
MEASUREMENT is concerned with periodical information acquisition
about CIAO-CFs and KPIs with the aim to support fact-based decision
making and consequent management actions (i.e. modification of the process activities or
the conditions under which they are performed)

Management
goals
measurements are strictly integrated with process activities
they are essential to: constraints decision
• monitor the process state

Phases
• detect trends actions measurements
• detect improvement opportunities
• detect, confirm, remove causes of wrong performances by inputs outputs
identification and modeling of cause-effect relationships process
• provide baselines and benchmarks
• estimate/predict costs, times, effort
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resources environ. support 17

PROCESS MANAGEMENT PHASES PROCESS MANAGEMENT PHASES

SUMMARY
model (inspired to the PDCA cycle) representing process management phases 1. define the process:
- plan process goals, identify key sub-processes and activities to be performed
- plan resources, support, inputs and environment; identify constraints
- define quality standards for key sub-processes (ex: % defects)
resources
constraints
2. define measurements:
act - identify critical factors (CFs) of CIAO
environment
support - plan how to integrate measurements in process activities
- design measurement procedures
- document how the desired quality is achieved (write procedures)
goals
define interpret 3. execute the process:
process measur. during activities execution collect measurement data about CIAO-CFs
4. interpret measurement data:
define execute analyze data to extract information useful for process management
measur. measur.
5. control the process (act):
execute if data suggest unexpected variations then identify and remove related
inputs products
process causes so stabilizing variability, else perform preventive actions
6. improve the process (act):
if data show stable variations, use them to identify actions to improve
performances, even updating process definition
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always validate changes by assessing the achieved benefits 20
 PROCESS ANALYSIS

PA (Process Analysis): a step-by-step breakdown of the phases of process

GOAL of PA: improve understanding about how the process operates with the
aim to determine potential targets and actions for process management
based on information returned by measurement interpretation

obviously, PA assumes that process goals and constraints are known

Process
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Definition 22

PROCESS DEFINITION: PLANNING PROCESS DEFINITION: DESIGN

DESIGN:
GOAL of process definition: achieve a structured and disciplined context • model in detail the activities to execute process (e.g. using flow charts)
enabling effective process management
• identify system requirements (e.g. ISO 9001 and other relevant regulations) and
customer requirements (e.g. using QFD); ensure that the process fulfills them
PLANNING:
• identify achievable and measurable goals (e.g. performance goals) • define inputs, resources, environment and support CFs
• identify general characteristics of: • define the Key Performance Indicators (KPIs) (e.g. for a sales process, KPIs
‒ activities to be executed to achieve the goals (e.g. make-or-buy, in/out-sourcing) may be: confirmed orders/customer enquiries, customer complaints or order accuracy/total orders,
‒ inputs orders lost due to price/total orders; there may be other indicators related to delivery or the behavior
‒ resources and support needed to perform activities (e.g. skills of people) of sales staff in dealing with customers, …)
‒ environment • define the controls to be applied
• identify constraints due to costs, time, reliability, organization maturity, … • establish the issues that could jeopardize success
- identify failure modes and effects
assure that organization has abilities required to execute the process (e.g. - define failure prevention features to mitigate risks
machines, facilities, skills, funds)
• establish who does what, when, where, how, why (5W+H rule)
- conduct relationship analysis to establish conflicts of responsibility
• estimate the process added value
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• produce the relevant documents
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 MEASUREMENT DEFINITION: PLANNING
PLANNING measurements:
• identify causes of variations of output characteristics in context, input,
activities (CIA-CVs): selected properties and measurement rate depend on:
‒ sensitivity of the process output characteristics on property values
‒ range of variation of the property values
• identify output critical factors (O-CFs)
• define KPIs
• define specifications for CIAO-CFs and KPIs (both reference value and std_dev)
• plan how to integrate execution of measurement and process activities

Measurement
CIA-CVs identification performed by applying cause searching techniques
(Ishikawa, Pareto charts, stratification)
it is advantageous to identify separately:

Definition
• internal causes (related to activities)
‒ decompose process in sub-processes
‒ check if sub-process inputs and outputs are in control (using control charts)
• external causes (related inputs or context)
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Ex. of properties for: activities: duration; output: defect rate; resources: # of people, skills, training 26

MEASUREMENT DEFINITION: DESIGN

DESIGN measurements:
• define measurement procedures for CIAO-CFs and KPIs
• define needed resources and support

kind of measurement depends on organization maturity (e.g. see the

Capability Maturity Model)

Measurement
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Execution 28
 MEASUREMENT EXECUTION
measurements of CIAO-CFs are repeated at different time intervals in order
to collect historical data useful to predict process behavior (assuming statistical
stationarity of property variations)

collected data are not interpreted during measurement execution

(interpretation is performed in a following stage)

properly performed measurements satisfy the following criteria:

• objectivity: returned data depend only on the considered CIAO-CF (and the
reference), not on other properties

Measurement
– repeatability: consistent information is obtained if measurement is repeated
• inter-subjectivity: returned data are non-ambiguous (i.e. univocally
interpretable by different users in different places and times); it depends on:
– traceability of measurement results (i.e. they are related to a reference

Interpretation
through a documented unbroken chain of instruments calibrations)
– shared conventions pertaining communication
• measurement metadata (i.e. all relevant characteristics pertaining to measurement context
such as time, adopted procedure, environment conditions, …) are easily identifiable (they need to
identify possible causes of variations and for process improvement) 30
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MEASUREMENT INTERPRETATION MI-1. PROCESS STABILITY

two classes of causes of variations of CIAO-CFs are considered because
GOAL of measurement interpretation: extract information from measurement they require different process managing approaches:
data to support fact-based decision making required to manage process
(i.e. to control, predict, improve variability of CIAO-CFs) COMMON CAUSES (physiological: always presents)
produce random variations (called also natural patterns) within limits of CFs (stable CFs)
limits can be estimated from historical data
methods applied for measurement interpretation can be classified as:
if a CF is stable for enough long time (= exhibits stationary variations), it is
• basic (know also as seven tools of quality control)
expected to remain stable in the near future (e.g. few hours) 
• intermediate (estimation, DOE, variance analysis, …) we can predict consistently (= within given limits) its short-term future values
• advanced (multivariate analysis, advanced DOE, ..): for experts
process is said STABLE (in-statistical-control)
within given limits if all CIAO-CFs are stable
it is usually performed according to the following three perspectives:
• stability stable process management is based on consistent
prediction of its CIAO-CFs
• compliance
• capability Ex. of common causes: working conditions variations (lighting, noise,
dirt, …), vibrations, variation of input properties, sources of
measurement uncertainty, …
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 MI-1. PROCESS STABILITY MI-1. PROCESS STABILITY
SPECIAL CAUSES (pathological: can’t be predicted, expected) process stability is assessed by applying SPC techniques to all CIAO-CFs

variations that are outside the historical base subgroup sample distributions are obtained when sampling a specified CIAO-CF
they are evidence of unexpected events  two situations may occur:
stable CF unstable CF
process is said unstable (out-of-statistical-control or not-in-control)
unstable process is managed by detecting and removing special causes

Ex. of special causes: machine malfunction, poor adjustment of equipment,

machine fault, computer crash, power outages, changes in operating procedures, …

empirical law: any non-controlled process

tends to became unstable
(an interpretation of the 2nd law of thermodynamics:
the total entropy can never decrease over time for an isolated system)

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MI-1. PROCESS STABILITY MI-1. PROCESS STABILITY

a stable CIAO-CF is modeled as a stationary random process (in particular,
its pdf, mean and variance are independent of time) Examples of criteria for detection of instability
the pdf of a non-stationary CF change over time (a unique pdf doesn’t exist) 
detection rule remarks
using histogram as estimate of a “unique pdf” is meaningless
1 point > 3 from the CL the strongest evidence of lack of control
histogram is used only for stable CIAo-CFs 9 consecutive points on the same side of the CL (either side) shift

6 points in a row, all increasing or decreasing continuous trend up or down

14 points alternating up and down systematic, predictable variation

2 out of 3 points > 2 from the CL (same side) small shifts in the data

4 out of 5 points > 1 from the CL (same side) small shifts in the data

8 consecutive points > 1 from the CL (either side) data lies near the control limits

the more rules applied the greater the chance for instability detection,
but also for false positive
which rules apply depends on the selected tradeoff between the two risks

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 (E) MI-1. PROCESS STABILITY MI-2. PROCESS COMPLIANCE
procedure to assess process stability: PROCESS COMPLIANCE: degree to which the measured values of CIAO-CFs
comply with design specifications

non-compliances are often due to instabilities  detection of non-compliance

is an early warning useful to prevent instabilities
possible non-compliance can be due to limited:
• ability of the organization to properly execute the process as defined
(referred also to the process context)
Ex.: lack of people awareness, insufficient training, inadequate tools or facilities, problems in
technology transfer, inadequate management support
• commitment to the process as defined resulting in poor and
inconsistent execution
Ex. This may happen when the intended tools are not being used, or procedures other than those
described in the process definition are followed
• monitoring of the process, resulting in evolution from a controlled state to
a chaotic state; periodic reviews of the process status, formal assessments,
37 and benchmarking are needed 38

(E) MI-2. COMPLIANCE MEASUREMENT PLAN (E) MI-2. COMPLIANCE MEASUREMENT PLAN
some entities and attributes useful to address questions related to
ability and commitment for a software production process measuring commitment to “use” process definition involves:
ability commitment - breadth of use (how widely used) - depth of use (thoroughness)
Are all requisites for successful process execution in Is the process being executed faithfully? Are the tools,
place? (personnel, tools, facilities, procedures, …) methods, practices, and work plans being used? - frequency of use (how often used) - duration of use (how long in use)
Entities Attributes Entities Attributes
People skills People effort assessing process execution requires the definition of criteria that must be
experience time
training satisfied in order to be able to state that a process is executed as defined
quantity
Tools accessibility Tools use: how widely questions that provide insights on the use of process definition:
adequacy how frequently
utility how long • poor questions: “Do you use tool X?” or “Do you use procedure Y?”
skills
Procedures coverage Procedures awareness • good questions: “How often do you use tool X?” or “What/how much
sufficiency use: how widely
quality how frequently training has been received?”
documentation how long
Facilities space Facilities use: how widely properties related to ability and commitment:
computers how frequently
technical support how long • are not performances, but address reasons why a process might not be
sufficiency
performing as it should
Work plan targets Work plan awareness
work breakdown use: how widely • knowledge of their value provides contextual information useful to
structure how frequently interpret data on performances and act properly
applicability how long
understandable
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doable
 MI-3. PROCESS CAPABILITY MI-3. PROCESS CAPABILITY
capable process: stable and compliant process capability is quantified by the histograms of all CFs and reporting:
i.e. the process is capable to fulfill specifications • control limit CL and natural limits (lower and upper control limits) LCL, UCL
• target T and specification limits (lower and upper specification limits) LSL, USL
1. in control and compliant
(capable of meeting specifications) usually T = (LSL + USL)/2
2. stable but not compliant due note: no relation exists between natural limits and specification limits
to excessive common cause when CL= T the process is said centered
variations which need to be when CL  T the process is said off-centered or biased
reduced

example of a CF of
not capable process

3. compliant but not stable due to special cause variations, which need to be
eliminated
4. out of control and not compliant; common cause variations need to be
reduced and special causes eliminated 41 42

MI-3. PROCESS CAPABILITY MI-3. CAPABILITY RESTORATION

example of a CF of capable process
problem-solving process: it is known to be stable (presumably by the use of control charts)
histogram shows the empirical distribution of measurements of
elapsed time between a problem’s evaluation and its resolution
the mean and control
limits represent what
the process is able to
accomplish, as it is
currently defined and
executed.
Frequency
(not mutually exclusive) actions that can be performed (also simultaneously)
to restore capability when one or both of the natural limits of a CF fall
outside the specification limits:
find causes of variability and act to:
• reduce process variability or
• shift process mean
otherwise (if possible):
• relax specifications
LSL shift mean USL USL*
reduce variability
change
specs

elapsed time between problem identification and resolution 43 44

MI-3. PROCESS CAPABILITY ANALYSIS MI-3. PROCESS CAPABILITY INDEXES

PCA (process capability analysis) assumes that the process is stable

Capability indexes for CIAO-CFs:
GOALS: • shows how well a process is performing w.r.t. specification limits
• assess the process capability • use both process variability and specifications
• perform short-term prediction (e.g. few hours) of process performances • typically consider normally distributed data
• identifying CIAO-CFs that allow process capability improvement
CAPABILITY INDEX (CP) is defined assuming:
PCA considers data subgroups of CIAO-CFs related to:
• bilateral (two-side) specifications and
• short-term variations (i.e. variations within subgroups): time is not relevant • centered process ( = T = (LSL+USL)/2)
• same operating conditions: settings are not changed during data acquisition
(e.g. same operator, batch of material, machines, …) CP = (USL – LSL)/6

PCA does not take into account for possible shift and drift between subgroups CP = allowable spread / natural (actual) short-term spread

PCA is performed using process capability indexes that are: Cp does not account for possible process bias: considers only dispersion of data
• indicators of the process maturity  it provides information only about potential (=the best) process capability
• related to non-compliance or defect rate
45 46

MI-3. PROCESS CAPABILITY INDEXES MI-3. PROCESS CAPABILITY INDEXES

• if Cp > 1, process is said capable for off-center (biased) processes and/or unilateral (one-side)
specifications:
• if Cp < 1, variability exceeds specification (a significant amount of defects is expected)
CPL = ( -LSL)/3σ = allowable lower spread/actual lower spread
• if Cp = 1, process is just meeting specifications
CPU = (USL− )/3σ = allowable upper spread/actual upper spread
for normal process, Cp allows to estimate the expected percent of defects CPk = min(CPL, CPU) accounts for both spread and centering of the process
USL-LSL 6 8 10 12
CPk = CP(1−k), where k = 2T- /(USL−LSL) 0<k<1 relative bias
CP 1.00 1.33 1.66 2.00
defect rate 0.27% 64 DPMO 0.6 DPMO 2 DPBO CPk is an index of both process dispersion and centering
it provides information about actual process capability
for centered processes: CPL = CPU = CPk = CP
DPMO: defective parts per million opportunities for off-centered processes: Cpk < Cp (biased processes exhibit more defects)
DPBO: defective parts per billion opportunities 
if CPk > 1 the process is said capable LSL USL
the actual spread is small w.r.t. the specification width,
and it is well centered w.r.t. the specifications
usual requirement for supplier qualification:
Cpk > 1.33 (expected goal 2.0)
for unilateral spec limits:
47 only CPU or CPL is considered 48
 SIGMA RATE SIX SIGMA PROCESS MANAGEMENT
sigma rate: n° of  between the process mean and the nearest
Six Sigma is a TQM approach (introduced by Motorola in 1986)
specification limit
• it introduces an empirically based 1.5 shift in the mean (bias) to take
SR = min {( -LSL)/σ, (USL- )/σ} = 3  CPk
into account for long-term CIAO-CF variations (the standard deviation tends to
Sigma Ratios increase over time and/or the mean tends to move away from the target)
Note: about the “defective parts per million opportunities“ of Industries
(DPMO) as quality metric • it assumes a long term sigma-ratio 6-1.5=4.5  3.4 DPMO (normal pdf)
Note: While the definition of defect is usually clear, the concept
of opportunity is often less clear.
Ex: in a help desk, opportunity is usually defined as a single
customer contact, regardless the number of questions asked
during the contact. If opportunities is related to the total number
of raised questions, the DPMO related to a given number of
errors decreases (and the related sigma level increases)
Ex: a satellite may have hundreds of main components and
sub-assemblies, and thousands of circuits. If opportunities are
defined at the circuit level, the DPMO related to a given
number of defects decreases.

49 50

SIX SIGMA PROCESS MANAGEMENT SIX SIGMA PROCESS MANAGEMENT

According to the Six Sigma approach, the organization:
defect rate for normal processes (DPMO) for different sigma-ratios
• defines an appropriate sigma level (not necessarily equal to 6) for its most
(with 1.5 shift of the mean)
important processes and strive to achieve it;
• adopts a set of techniques and tools (mainly statistical);
• adopts an expertize certification system for its employees; sigma- long-term short-term long-term
DPMO
expertize levels: Executive Leadership, Champions, Master Black Belts, Black Belts, Green Belts; level sigma Cpk Cpk

there is no standard certification body; certifications are offered by various quality associations and 2 0.5 308 103 0.67 0.17
other providers against a fee; 3 1.5 66.8 103 1.00 0.50
• uses the five phases DMAIC (define, measure, analyze, improve and control)
4 2.5 6.21 103 1.33 0.83
management cycle
5 3.5 233 1.67 1.17
The standard ISO 13053-1:2011 “Quantitative methods in process improvement - Six Sigma - Part 1:
6 4.5 3.4 2.00 1.50
DMAIC methodology” describes the methodology
7 5.5 19 10-3 2.33 1.83
Six Sigma is mostly applied in large organizations but many of its tools
and techniques work well in small to mid-size organizations.
Criticisms: DPMO: defective parts per million opportunities
• 1.5 sigma shift is arbitrary (it is based on short-term rather than long-term variations)
• over-reliance on statistical methods
51 52
(E) MI-3. PROCESS CAPABILITY INDEXES (E) MI-3. CAPABILITY INDEXES ESTIMATION
Estimators of capability indexes are obtained by replacing μ and σ with
for non-normal data distribution, we can:
the sampling average x and standard deviation s, respectively
•transform data so that they become almost normal (e.g. Box-Cox transformation)
For normally distributed process data, the sample Cp is distributed as a Chi-square r.v., while CPL and
or CPU are distributed as non-central t r.v. Approximate confidence limits are available in the literature.
•develop different indices, e.g. non-normal Cpk: Most estimates are valid only if the sample size is "large enough“
Cnpk=min[USL−p0.995−median, median−LSL−p0.005]/3 (generally at least 50 independent data are needed)

Ex: For a certain process: USL = 20, LSL = 8.

Observations provide x = 16, s=2.
CP = (20−8)/(62) = 1.0
Thus, the process is capable if it is located at the midpoint,
T=(USL+LSL)/2=14
But x = 16  T
We have: k = 2 |T−x|/(USL−LSL) = 4/12 = 0.33 and
CPk=CP(1−k)=0.67 CPU=(USL−x)/3s = (20−16)/(32) = 0.67
CPL = (x−LS)/3s = (16−8)/(32) = 1.33

53 Thus, we need to reduce the variability or/and center the process. 54

(E) MI-3. CHECKING PROCESS CAPABILITY MI-3. PROCESS PERFORMANCE ANALYSIS

procedure to check process capability:

GOAL of PPA: assess process capability when stability is not ensured

(e.g. in a short pre-production run; at the start of each day; at the start of each shift of production)

PPA is applied to both in-control or not in-control processes

PPA considers:
• long-term (e.g. 1 week or longer) variations of CIAO-CFs, under different
operating conditions (i.e. different operators, materials, tools, adjustments, …) 
both within and between subgroups CIAO-CF variations (the whole
time information associated to data is neglected)
• both random variations due to common causes, and shift (bias) and drift
due to special causes

55 56
MI-3. PROCESS PERFORMANCE ANALYSIS

Process performance indexes Ppu, Ppl, Ppk are defined using the same
formulas related to Cpu, Cpl, and Cpk, but considering the overall st-dev overall
• Ppk quantifies the actual long-term capability (within and between subgroup variations)
• Cpk quantifies the actual short-term capability (only within subgroup variations)
if the process is stable with negligible variations over time:
Cpk and Ppk should be almost equal (shift and drift between subgroups are negligible as

Control and
compared to the variations within the subgroups themselves)

Improvement
time 57
Actions 58

ACT: CONTROL - IMPROVEMENT ACT: CONTROL - IMPROVEMENT

management actions:
• may affect all CIAO-CFs
• have corrective, preventive, improvement goals
GOAL of CONTROL actions:
• for unstable process (unexpected variations of CIAO-CFs are identified)  correction:
detect and remove sources of unexpected variability (= special causes)
• for stable process (variations of CIAO-CFs are within predefined ranges)  prevention:
actions aimed at assuring the future capability of the process
GOAL of IMPROVEMENT actions: improve performances of stable process
(e.g. reduce defect rate, increase product quality, reduce costs, …)
using knowledge about the process goals, the current process configuration and
data on CIAO-CFs, improvement actions are aimed at:
• reducing variability due to common causes (e.g. using new tools)
• reducing times and/or costs, increasing performances
two kinds of process improvement:
• incremental (I): gradual changes of characteristics
• radical (R): it is typically the result of by process re-engineering
process re-engineering is aimed R

performance
at modifying the process design I
(e.g changing working methods, ...);
the new process model need to be validated
R continuous
potential advantages of improving actions I improvement
must be validated
59
60
time
 (E) AN IMPROVEMENT PROCEDURE (E) MANAGEMENT ACTIONS: SUMMARY
procedure to measure, control and improve process:
1. define the problem and identify the related critical factors
2. collect data
3. generate possible solutions (changes in the process)
4. solution assessment and choice based on costs and benefits
consider costs of resources, training, new tools and instrumentation, …
costs must be justified by benefits:
• economic return
• customer satisfaction
• competitive advantages, such as organization innovation (increase flexibility, productivity) and/or
competence enhancement
5. solution implementation
6. measurement of performance changes
7. result analysis and possible revision
8. return to 1. for a new improvement cycle

62

(E) EXERCIZE

Il gestore della pizzeria “Bella Napoli” ha seguito un corso sulla

gestione per la qualità e, essendo rimasto molto interessato
all'argomento, si prefigge di individuare le proprietà del principale
processo della sua impresa: la produzione di una pizza.
A tal fine richiede l'aiuto di un consulente.

In qualità di consulenti dell'impresa vi è richiesto di individuare

le caratteristiche del processo di produzione di una pizza.
Allo scopo si considerino con particolare attenzione i seguenti aspetti:
• input, output, risorse, condizioni del processo
• definizione, pianificazione, progettazione del processo e delle misure

63