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

ProcessDecision

Sub-process

Start – endDocument

Data

Data base

External dataCustom 1

Custom 2Custom 3

Custom 4On-

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 used

ProMa

symbols

Early trials for ProMa diagramming

Process Decision

Sub-process

Start – end Document

Data

Data base

External dataCustom 1

Custom 2Custom 3

Custom 4On-page

reference

Out page reference

most popular ProMa symbols in

modern use

Diagraming the process

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

Exercise 1

2. AND

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.

Exercise II.

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 Required Predecessor Activity Description (in days) Activities

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 Required Predecessor

Activity Description (in days) Activities

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

1.2.4 1.2.4 C

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

1.3 1.3

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.

RCA

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

Measuring RCA success

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

KPIs

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.

Example

BCS

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

Thanks