Quality improvement

Tools &
techniques
Edited & prepared by
Dr. ADEL YOUNIS
Quality & BD Consultant
Quality
Improvement
Nov. 2016

Course agenda
 Why CI
 History
 Key Concepts of CI
 QC – QM tools
 ProMa
 AND
 KPIs
 RCA
 BCS
 Exam

What is continuous improvement ?
 Is the improvement of the process
continuously by eliminating wastes so
that, all process operate at the most
efficient and effective level.
 It can be identified by characterizing
organization’s business model.
 It can be applied on both micro and
macro processes within an organization
 It is linked with two key issues, customer
increased value, & reduction of wastes
resources.

QUALITY
IMPROVEMENT IS A
NEVER-ENDING
PROCESS

Historical view…
 In the past all the blame on lack of
process satisfaction was the employees to
be blamed of, “ lazy – unintelligent –
loyalty issues ….etc.”
 Deming hypothesis that 94% of the
problems related to process were not
employee related issues.
 PDCA – PDSA models
 Shigeo Shingo “POKE-YOKE / mistake
proofing” approach.

Key concepts of CI
 Cycle time reduction
 Employee involvement
 Increased profitability
 Value management

Continuous Improvement tools
Quality Control tools Quality management tools
Cause & affect
analysis
Check sheet
Control charts
Flow chart ≈
process mapping
Histogram
Pareto analysis
Scatter diagram
 Activity network
diagram
 Affinity diagram
 Interrelationship
diagraph
 Matrix diagram
 Priority matrix
 Tree diagram
 BCS
 KPIs
 RCA

ProMa
Process
Decision
Sub-process
Start – end
Document
Data
Data base
External data
Custom 1
Custom 2Custom 3
Custom 4
On-
page
refere
nce

I. Process Mapping
 Early used at the end of the 19th century by
industrial engineers, to simplify and
characterize work phases.
 By the middle of the 20th century and by the
enormous use of Information technology, the
purpose of using process mapping / flow
charts increased to include control and
performance management.
 In 1960 the American National Standards
Institute (ANSI), published their symbology
standard “ flowcharting symbols and their
usage”
1) History and purpose.

Uses of ProMas
Analytical
purposes
Learning
purposes
Auditing
purposes

 Analytical purpose
- Prepared to assist in planning process, or
improving an existing one, or understanding
why problems occurs
- Normally ProMas for analytical purposes are
rough, and quick sketches , and usually
named “problem prevention strategy”

 Learning purposes
- Performance based communication
- Targeting new employees for induction
training purposes “before demonstrating
specific details”.
- It is used as a handy reference for the
workers.

 Auditing purposes
- To assist auditors verify if the process
operates accordingly with the ProMas
- Most popular in industries like aerospace,
pharmaceutical, healthcare and
environment.
- Approved by the ISO as a main tool for
auditing.

Developing a process map
Defining the
work process
Diagraming the
process
Determine ways
to improve the
process

Defining the work process
It is important to identify at least the
following elements:-
- Inputs
- Outputs
- Inputs resourcing
- Customer “internal / external”
- Customer requirements for the outputs
- Process participants
- Process owners
- First and last operation in the process.

Early trials for ProMa diagramming

Process Decision
Sub-
process
Start – end Document
Data
Data base
External
dataCustom 1
Custom 2Custom 3
Custom 4
On-page
reference
Out page reference
most popular ProMa symbols in
modern use

Determining ways to improve process
Once the ProMas has been drown , it should be
Evaluated to state whether it reflects the actual
events or not, this may be due to one of the
followings:-
- Difficulty in identifying the process and sub-
process from the beginning to the end.
- Difficulty in identifying alternative paths,
inspection points, and ways to improve the
process.

Analyzing ProMa
• How many steps are there?
• How many hand offs are there? (Where a
piece of process transferred from one
person or department to another.) Are any
of these unnecessary?
• Could some tasks be carried out by one
person instead of several people?
• Is there any duplication of work?
• Are there any bottlenecks?
• How much error correction / rework is
being carried out?

Analyzing ProMa 2
• How long does each step take?
• What is the approximate time between
each step?
• Which tasks help to achieve the purpose
and which ones do not?
• Are we doing the right things in the
process?
• Are we doing things in the right order?
• Is the right person doing it?
• Should some tasks that are performed as
part of another process be performed
here?

Example of ProMa - anticoagulant blood testing
process carried out in a major hospital.
Patient
referred to
clinic
Patient
checks in
at reception
Blood
sample
taken
INR tests
carried
out
Result
given to
patient
New
appointment
made

Activity Network Diagram “AND”
History
- Developed by RAND corporation in
support of large and complex air force
contracts
- Simplified version of the PERT tool “
program evaluation and review
techniques” & CPM “ Critical Path
Method.

Key concepts of using AND
 Identifying process
 Identifying included activities
 Priority determination of activities
 Determination of slack time
 Determination of resources needed.
 Identification of involved people

How to use AND ?
1. Destruct main process into sub-process.
2. Destruct activities within each sub-
process into a group of steps.
3. Denote each step with a node
4. Determine parallel and series nodes
5. Identify involved people in each node.
6. Identify resources needed to complete
each node.

Task 1
Is to Create The Dependencies
By Indicating the Predecessors
For Each Activity

SUMMARY OF ACTIVITIES
Time Immediate
Required Predecessor
Activity Description (in days) Activities
A receiving supplies
B review of shipment
C review of documents
D incoming area receiving
E inform inspection committee
F testing if required
G if accepted
H if rejected
I communication with commercial dept
J warehousing

Time Immediate
A receiving supplies --
B review of shipment A
C review of documents B
D incoming area receiving C
E inform inspection committee D
F testing if required E
G if accepted F
H if rejected G
I communication with commercial dept. H
J warehousing G

Task 2
TEST THE LOGIC BY
CONSTRUCTING THE NETWORK
DIAGRAM

An Activity-On-Node (AON) Network
36
A B C D E F
G
H

Basic Rules for constructing AND
 Networks typically flow from left to right;
 An activity cannot begin until all of its preceding
activities are complete;
 Arrows indicate precedence and flow and can
cross over each other;
 Identify each activity with a unique number; this
number must be greater than its predecessors;
 Looping is not allowed;
 Conditional statements are not allowed;
 Use unique start and stop nodes.

Task 3
DETERMINE DURATIONS FOR
EACH ACTIVITY

Time Immediate
A receiving supplies ? --
B review of shipment ? A
C review of documents ? B
D incoming area receiving ? C
E inform inspection committee ? D
F testing if required ? E
G if accepted ? F
H if rejected ? G
I communication with commercial dept. H
J warehousing ? G

Task 4
FILL EACH NODE AS FOLLOWS
i
te ta

Activity time/sec
A: Open Dock 10
B: Check Box condition & Label 120
C: Scan Tracking label 10
D: Enter P.O # 20
E: Send to loading Rack 20
Total time 180
A B C D E

Activity B:
1
1.1
1.2 1.2.1 1.2.2
1.2.41.2.4C
1.2.2 check if damaged
1.2.3 return to carrier
1.2.4 move to activity C
1 : Mis-shipment
1.1: set a side & return to carrier
1.2 box damage
1.2.1 open box & check content

Activity C:
1 1.1
D
1 : P.O # on box
1.1: open box for P.O
1.2 : P.O present
1.3 :move to Activity D
1.4: move to sub-activity D1.1
1.2 1.4
1.31.3

Activity D:
1 1.1
1 : wrong / unconfirmed P/O
1.1: YES move to sub-activity D1.1
1.2 No, move to activity E
1.2

Calculate process cycle efficiency
Process Cycle Efficiency = 182 / 860 = .21, or 21%
Process cycle efficiency = te / ta x 100

Determining The Critical Path
• Critical activities have zero slack and cannot be
delayed without delaying the completion of the
process
• The slack for non-critical activities represents the
amount of time by which the start of these
activities can be delayed without delaying the
completion of the entire process (assuming that all
predecessor activities start at their earliest start
times);
• The longest path on the network;
• Could also be those activities with the least slack.

Root Cause Analysis
 It is a method that is used to address the
problem of the non-conformance
 It is used to identify the root cause
 It is used to eliminate the root cause found &
prevent the problem from recurring
 It is NOT a Rocket Science.
 It is a systematic, quantified, documented
approach to identify, understand & resolve
the underlying causes.

A powerful tool used to identify,
record & visually represent the
possible causes of a problem
instead of a problem and their
effect appearing vast and
insoluble, root cause analysis
breaks down the problem into
smaller more easily handled
chunks”
PAUL WILSON, RCA (ASQC)

Why RCA ?
 To avoid short term solutions tends to lead
staff to repeat the same mistakes over
and over
 To improve efficiency and profitability
 To ensure that the same problem will
never happens again
 To save time and money

Practical guide to carry our RCA
1. Define the
problem
2.
Understand
the problem
3.Immediate
action
4. Corrective
action
5. Confirm
the solution

1. Identify the problem
 If the problem is not identified accurately,
the whole RCA process may be prone to
failure, this phase is usually used to define
how the RCA will be run as a process
 Using SMART approach is very useful

2. Understand the problem
 Check the information, check the real
data regarding the problem, gaining a
clear understanding of issues.
 Various tools and techniques can be used
in this phase, “ i.e. cause –effect / brain
storming…etc.”

3. Immediate action
 Implement temporary counter-measures
at the place of the problem,
 Be sure that these measures are
temporary, and another set of solution will
be scheduled accordingly

4. Corrective action
 Determine and prioritize the most
probable underlying cause of the
problem,
 Taking Corrective actions to at least
mitigate or preferably eliminate the
cause(s).

5. Confirm solution
 After measure have been applied the
success of the adapted approach should
be ensured
 Rules and control methods should be
established to avoid the problem ever
happening again.
 It is the most important phase in the whole
RCA.
 It is the one most even missed in the
whole RCA.

RCA, tools & techniques
1. 5 WHY’s Gemba Gembutsu
 Preferred in the production line problems
 Typically to practice asking 5 times why the
failure has occurred in order to get the root
cause.
 No special technique is required or
template is needed
 Date captured should be recorded in
check sheets
 Best used in simple RCA

Disadvantages of the 5 Whys Technique
 This time consuming brainstorming process may
be tedious for team members trying to reach
consensus. This is especially true for large teams.
 Results are not reproducible or consistent.
Another team analyzing the same issue may
reach a different solution. The particular
brainstorming process that was utilized may be
difficult, if not impossible, to duplicate.
 Root causes may not be identified. The 5 Whys
technique does not provide a means to ensure
that root causes have been identified.

2. Pareto Analysis
 It is an easy technique to use, helps to
choose the most effective changes to
make
 The main principle of doing only 20% of
the work, to generate 80% of the
advantage of doing the entire work

When to use Pareto Chart ?
 When analyzing data about the frequency of
problems or causes in a process.
 When there are many problems or causes and
you want to focus on the most significant.
 When analyzing broad causes by looking at their
specific components.
 When communicating with others about your
data.

Advantages of Pareto Charts
 The main advantages of Pareto charts are that they
are easy to understand as well as to present.
 Many managers prefer to see an analysis that is easy
to represent and understand and a Pareto chart is
strong tool for that.

Disadvantages of Pareto Charts
 Focusing on the Pareto chart alone may lead to the
exclusion from further consideration of minor sources
driving defects and non-conformances.
 They cannot be used to calculate the average of the
data, its variability or changes in the measured
attribute over time. Without quantitative data it isn't
possible to mathematically test the values or to
determine whether or not a process can stay within a
specification limit.

Cause & Effect diagrams
 Also known as fish backbone , and
Ishikawa
 Used for more complex RCA
 It identify all potential processes and
factors that could contribute to the
problem.
 6 M’s technique

Creating a Fishbone Diagram – Further Steps
 Continue adding sub-factors to your diagram until you no
longer get useful information as you ask, “Why is that
happening?”
 Analyze the results of the fishbone after team members
agree that an adequate amount of detail has been
provided under each major category. Do this by looking for
those items that appear in more than one category. These
become the „most likely causes”.
 For those items identified as the “most likely causes”, the
team should reach consensus on listing those items in
priority order with the first item being the most probable”
cause.

Fishbone diagrams do provide value in that they:
 organize potential causes,
 help a team to think through causes they might
otherwise miss, and
 provide a living document that shows the status of all
potential causes and whether they have been
proved/disproved/acted upon.
Advantages of Cause & Effect technique

Limitations of Cause & Effect technique
 they create a divergent approach to problem solving,
where the team expends a great deal of energy
speculating about potential causes, many of which
have no significant effect on the problem.
 This approach may leave a team feeling frustrated
and hopeless.
 the team needs to closely look at the evidence in
order to separate fact from opinion.

Fault Tree Analysis (FTA)
 first introduced by Bell Laboratories and is one of the most
widely used methods in system reliability, maintainability
and safety analysis.
 It is a deductive procedure used to determine the various
combinations of hardware and software failures and human
errors that could cause undesired events (referred to as
top events) at the system level.
 The deductive analysis begins with a general conclusion,
then attempts to determine the specific causes of the
conclusion by constructing a logic diagram called a fault
tree. This is also known as taking a top-down approach.

 The main purpose of the fault tree analysis is to help
identify potential causes of system failures before the
failures actually occur.
 It can also be used to evaluate the probability of the top
event using analytical or statistical methods.
 After completing an FTA, you can focus your efforts on
improving system safety and reliability.
Fault Tree Analysis (FTA – 2)

Steps to create FTA
1.Define the fault condition, and write down the top level failure.
2.Using technical information and professional judgments,
determine the possible reasons for the failure to occur. These are
level two elements because they fall just below the top level
failure in the tree.
3.Continue to break down each element with additional gates to
lower levels. Consider the relationships between the elements to
help you decide whether to use an "and" or an "or" logic gate.
4.Finalize and review the complete diagram. The chain can only be
terminated in a basic fault: human, hardware or software.
5. If possible, evaluate the probability of occurrence for each of the
lowest level elements and calculate the statistical probabilities

And gate - represents a condition
in which all the events shown
below the gate (input gate) must
be present for the event shown
above the gate (output event) to
occur. This means the output
event will occur only if all of the
input events exist simultaneously.
Or gate - represents a situation in
which any of the events shown
below the gate (input gate) will
lead to the event shown above
the gate (output event). The
event will occur if only one or any
combination of the input events
exists.

Medical Device Fault Tree
Analysis

 FTA focuses on the judgment of experts from varied disciplines
and provides a common language and perspective for the
problem.
 Both agreements and differences in opinion on the inputs and
importance are accounted for in FTA.
 Members are not likely to feel threatened, due to the focus on
how the system operates, not personnel.
 Graphic description clearly communicates the possible causes
of failure.
Advantages of Fault Tree Analysis

 FTA relies on several expert opinions and judgments
at several stages. This makes it very prone to
inaccuracy.
 In large systems, computer algorithms are needed to
accomplish the quantitative analysis.
Disadvantages of Fault Tree Analysis

RCA Significance
Consequence or severity of problem
Likely hood Critical High medium low
Almost
certain
v. high
risk
v. high risk high risk Low risk
Likely v. high
risk
high risk Moderate
risk
Low risk
Possible high risk Moderate
risk
Moderate
risk
Low risk
Unlikely Moderat
e risk
Low risk Low risk v. Low risk
Rare Moderat
e risk
Low risk v. Low risk v. Low risk

RCA Hints & Tips
 It is important to select the right team
 Don’t jump into solutions, the problem
and its solution may be not obvious
 Suggest improvements that can be
implemented
 Having a facilitator with experience in the
RCA process
 Take responsibility of actions under control

Pitfalls of RCA
I. Not understanding the problem, and so
not identifying it correctly
II. Not asking for help
III. Not considering all possible failure
modes / causes
IV. Not identifying all root causes
V. Adopting a remove/replace mentality
VI. Silver Bullet theory
VII. Jumping to conclusions
VIII. Tearing a system apart without a plan

What is KPIs ?
 Key Performance Indicators (KPIs) are
quantitative and qualitative measures
used to review an organization's progress
against its goals. These are broken down
and set as targets for achievement by
departments and individuals. The
achievement of these targets is reviewed
at regular intervals.

KPI characteristics
 Relevant to and consistent with the specific
process target
 Focused on process added value items rather
than non-critical outcomes
 Understood – individuals and groups know
how their behaviors and activities contribute
to overall process goals;
 Realistic –Specific – Attainable – Measurable -
Timely achievable
 Used to identify trends may be compared to
other data over a reasonably long time and
trends can be identified;

 Agreed – all contributors agree and share
responsibility within the process;
 Reported – regular reports are made
available to all interested parties;
 Governed – accountability and
responsibility is defined and understood;
 Assessed – regular assessment to ensure
that they remain relevant.
KPI characteristics - 2

How to build a KPI
Measure
description
Measure owner
Measure
formula
Measure RAG
status

Levels of KPIs
Entry level KPI
Mid level KPIs
Advanced level
KPIs

Entry level KPI
Measure
Description
 Why did you
choose this
particular
measure?
 Why will it help
you
Measure Formula
 What’s the target?
 What’s the actual?
 Where do we find the data?
Measure Owner
 Who is going to gather the
data?

Mid level KPI
Measure Description
 Why did you
choose this
particular
measure?
 Why will it help you
Measure Formula
What’s the target?
What’s the actual?
What’s the exact source of the
information? Is there both a formula and
a data source where I can get the
information consistently?
Measure Owner
 Who is going to gather the data?
Measure RAG Status
 At or above target is green.
 Within 90% may be yellow.
 Below 90% may be red.

Advanced level
KPI
Measure Description
 Why did you
choose this
particular
measure?
 Why will it help you
Measure Formula
Measure formula
 What’s the target?
 What’s the actual?
 What’s the exact source of the information?
(formula and data source)
 How would I chart the information?
 These highly productive charts should go
beyond the target and the actual. This may
be benchmark information, or you may be
looking at both monthly actual and year-to-
date information compared to the last year.
 This helps you get more specific with your
measure
Measure Owner
 Who is going to gather the data?
Measure RAG Status
 At or above target is green.
 Within 90% may be yellow.
 Below 90% may be red.

Benefit, Cost , Speed….why?
Problem ONE
'chase many rabbits
catch
none' syndrome
Problem TWO
“Managing
expectations”

BCS
 Be of great benefit to the business.
 Cost very little.
 Be quick to implement. (Speed)

How to implement BCS ?
 add three columns to the end of your list of
solution of Problems
 Benefit:
- 10 = huge benefit and alignment with business / process objectives.
- 1 = negligible benefits and / or relevance to the business / process' goals
 Cost:
- 10 = practically free.
- 1 = capital expenditure proposal required with poor payback period.
 Speed:
- 10 = it can happen today!
- 1 = it will take a long time to matriculate through the various departments
and committees to get signed off

BCS, tips for implementation
 you can choose any numbers between 1
and 10, the above descriptions are to
indicate each end of the spectrum
 Calculate the BCS score by multiply the
three numbers together, to get a value
between 1 and 1000
 Ranking the scores from height to low “a
clear priority list”
 BCS approach isn't 100% objective

BCS Parameters
Benefit
Customer Growth / Monetary
Payback
10 50% Growth in a year
9 25% Growth in a year
8 10% Growth in a Year
7 1 day payback
6 1 week payback
5 1 month payback
4 1 year payback
3 2 years
2 5 years
1 Unknown
Cost Currency
10 Free
9 20
8 100
7 200
6 500
5 1000
4 2000
3 5000
2 >5000
1 Unknown
Speed Implementation Time
10 1 hour
9 1 Day
8 1 Week
7 1 Month
6 3 Months
5 6 Months
4 1 Year
3 2 Years
2 5 Years
1 Unknown

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