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HEAD- QUALITY
ASTER INDIA
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Basic tools of Quality for Process Improvement
“The old seven”
“The first seven”
“The basic seven”

Importance of using tools –

1. For delivering effective presentation

2. Simple visual way of viewing data
3. Useful advice to teams trying to establish facts about what is happening
4. Displays large amount of data at a time
5. Presents data accurately

The 7 basic tools of Quality are:

• Histograms
• Pareto Charts
• Cause and Effect Diagrams
• Scatter Diagrams
• Control Charts
• Flow Charts
• Check Sheet
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Histogram
What is a Histogram?
▪ Histogram is a chart with columns which represents the distribution by mean.
▪ If the distribution is normal, the graph is in the shape of a bell curve.
▪ If not normal, it may take different shapes based on condition of the distribution.
▪ Histogram can be used to measure one variable against another.
Reasons for dissatisfaction of patients N =400

▪ There should be two variables. 120

100
111
100 93
▪ Data should be numerical 80
60
When is it used?
40 25 21
▪ It is used to communicate the distribution of data quickly and easily to others. 20 15 12 13 10
0
▪ Help in decision making.
▪ Graphically summarize large data.
▪ Compare performance to expectations or specifications.
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Pareto Chart
What are Pareto Charts?
▪ Pareto charts are used to identify and prioritize problems to be solved.
▪ Vilfredo Pareto, 1800, Italian economist noted “80% of wealth was held by 20% of population”.
▪ Juran applied the Pareto Principle, stating that 80% variation in process is by 20% of the variables.
▪ “Vital few” as opposed to “Trivial many”.
▪ 80/20 rule.
▪ Need not be 80/20, could be 75/25 or 70/30 or even 65/35 also and even disproportionate like 75/35.
▪ The concept is to prioritize and address the issue.

When is it used?
▪ Looking at data on the frequency of problems or causes.
▪ When there are too many problems or causes and you want to focus on the significant ones.
▪ When you want to analyse broad causes by looking at their specific components.
▪ To effectively communicate to others about the problem/ data.
 Pareto Chart
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Addressing these 3 issues out of 9, will solve 76% of the problems

Number 120 91% 94% 97% 100% 100%
In % Cumulative 82%
87%
S.No Reasons of 76%
(N=400) frequency 100 80%
patients
80 53%
7 Registration Time too long 111 28 % 28% 60%
60
3 Insufficient Doctors 100 25 % 53% 28% 40%
40
4 Insufficient Counter Staff 93 23 % 76%
20 20%
Problem mixing with ‘follow-up’
2 25 6% 82% 0 0%
patients
Too many patients at the same
6 21 5% 87%
time
No mike or display board to know
1 15 4% 91%
the token number
8 No name boards of the doctors 13 3% 94%
5 Staff not following the Queue 12 3% 97%
9 Others 10 3% 100%
Number of patients Cumulative frequency
10 Total 400
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Cause and Effect Diagram
What is a Cause-and-Effect Diagram?
▪ Dr. Kaoru Ishikawa
▪ Fishbone or Ishikawa diagram - It is a schematic way of relating the causes of variation in a process.
▪ A drawing to organize the contributing causes to a problem in order to prioritize, select, and improve the source of the
problem.
▪ Causes are broadly classified into 5Ms & E
Man (People)
Methods (Policies and Procedures)
Materials (Supplies)
Machine (Equipment)
Money
Environment

When is it used?
▪When identifying possible causes for a problem.
▪Identify areas for collecting data.
▪Good process knowledge from multiple stake holders.
▪Useful for teams: focusing a discussion and organizing large amounts of information coming from a brainstorming session.
▪Especially when a team’s thinking tends to fall apart, and concentration is lacking.
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Cause and Effect Diagram

Material People /Man Policies

New staff Staff can cut the queue

Registration at any time

Inadequate Irrespective of
stationeries Aggrieved Staff
appointment time
Registration
time too
Unnecessary information being Manual registration- No long
collected at the reg. counter computers

FIFO not followed

Inadequate signage /
Separate line for men instruction
and women

Procedures / Methods Plant / Machine

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Scatter Plots
What is a scatter plot?
▪ Scatter diagram shows co-relation between two variables.
▪ If correlated – does not necessarily mean a direct cause and effect.
▪ If one variable can be predicted based on the value of the other, then correlated.

When is it used?
Trying to determine if the two variables are related, such as:
▪ To identify potential root causes of problems.

▪ After brainstorming session and identifying causes and effects using a fishbone diagram, to determine whether a
particular cause and effect are related.

▪ To determine whether two effects that appear to be related both occur with the same cause.
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Scatter Plots
Patient hosp Time Spent by
Satisfaction Score Satisfaction Score
number doctor (In minutes)
5

Satisfaction score - 5 being the highest

1 24 5
2 8 1
4
3 9 1
4 22 4 3
5 10 3
2
6 19 4
7 10 2 1
8 16 4
0
9 13 4 0 10 20 30
10 15 3 Time spent by doctors (In minutes)
11 23 4
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Control Charts
▪ Influence of special causes on process and out of control situation.
▪ Monitor processes to show how the process is performing over time.
▪ Following needs to be calculated.
➢ Mean variable
➢ Upper control limit (UCL)
➢ Lower Control limit (LCL)
▪ UCL and LCL can be calculated based on:
➢ Data from scientific literature
➢ Historical data
➢ Statistical data like Standard deviation

▪ Control charts are made with the existing data. Suggestions, if necessary, are implemented based on the chart.

▪ Post Implementation, the mean and the control limits of the control charts will vary depending on the effectiveness
of the implementation

▪ They are helpful for analyzing a process before and after an improvement

▪ Helps to see how process mean and variability change as a result of the improvement.
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Control Charts

Date Hours Mean UCL LCL Date Hours Mean UCL LCL
01-02-21 5 5.86 10.59 1.14 12-02-21 5 5.86 10.59 1.14
02-02-21 5.5 5.86 10.59 1.14 13-02-21 6 5.86 10.59 1.14
03-02-21 5.5 5.86 10.59 1.14 14-02-21 6 5.86 10.59 1.14
04-02-21 5 15-02-21 5 5.86 10.59 1.14
5.86 10.59 1.14
16-02-21 4.5 5.86 10.59 1.14
05-02-21 7 5.86 10.59 1.14
17-02-21 5 5.86 10.59 1.14
06-02-21 5 5.86 10.59 1.14
18-02-21 6 5.86 10.59 1.14
07-02-21 5 5.86 10.59 1.14 19-02-21 5.5 5.86 10.59 1.14
08-02-21 6 5.86 10.59 1.14 20-02-21 6 5.86 10.59 1.14
09-02-21 6 5.86 10.59 1.14 21-02-21 5 5.86 10.59 1.14
10-02-21 10 5.86 10.59 1.14 22-02-21 5 5.86 10.59 1.14
11-02-21 11 5.86 10.59 1.14 23-02-21 5 5.86 10.59 1.14

Time between Glucose Measurements (in Hours) In this case, the variation was detected on February 11
because the corresponding data point was above the
upper control limit. Root cause for the variations needs to
be investigated.
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Flow Chart
What is a flow chart?
▪ Process flow chart or flow diagram.
▪ A powerful improvement tool to define, describe, and communicate clinical, administrative and operational processes.
▪ A flowchart represents an algorithm or process with the help of pictorial symbols.
▪ They trace the steps the “object” of the process goes through from start to finish (A lab test, a clinic visit, a specialty
visit, an imaging study, etc. ).
▪ Boxes of pictorial symbols connecting with arrows to represent sequence of activities.
▪ Flowcharts help in identifying points or bottle necks where problems might occur.
When is it used?
▪Develop understanding of how a process is done.
▪Study a process for improvement.
▪Communicate to others how a process is done.
▪When better communication is needed between people involved with the same process.
▪In order to document a process.
▪While planning a project.
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Flow Chart
BEGIN

ACTIVITY

DECISION NO DELAY ACTIVITY

Used to understand the current process
and identify opportunities for
YES improvement. It shows the workflow
through the process including all
ACTIVITY
activities, decisions, delays and
measurement points.

DECISION NO ACTIVITY

YES

ACTIVITY DELAY

END
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Check Sheet
What is a Check Sheet?

▪ Defect concentration diagram

▪ A check sheet is a structured, prepared form for collecting and analysing data. This is a generic tool that can be adapted
for a wide variety of purposes
▪ A simple document used for collecting data in real time and at the location where the data is generated.

When is it used?
▪ When data can be observed and collected repeatedly by the same person or at the same location.
▪ When collecting data on the frequency or patterns of events, problems, defects, defect location, defect causes, etc.
▪ When collecting data from a production process.

Problems identified in the Wards

Staff not
punctual for
duty
Wrong diet
Missing CSSD
item
Late Discharges
Wrong
admission
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PROBLEM SOLVING TECHNIQUES

Every problem has a solution. You just have to be

creative enough to find it.

-Travis Kalanick,
Co-founder of Uber
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▪ Perfection of systems does not happen overnight

▪ Quality management strives to achieve continual improvement
▪ Essence of continual improvement is effective problem solving

▪ Correction - Action to eliminate a detected non-conformity.

▪ Corrective Action - Action to eliminate the cause of a detected non-conformity.
▪ Preventive Action - Action to eliminate the cause of a potential non-conformity.

(As per ISO 9000:2005 sec 3.6)

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ELECTRICAL FIRE

▪ Correction: Put off the fire immediately

▪ Corrective Action: Change the old wiring in the area
▪ Preventive Action: Thermographic testing of the electrical wiring at
predefined intervals

Thermography is a non-destructive test method to detect poor connections, unbalanced

loads, deteriorated insulation in energised electrical components. Heat generated is
related to the amount of current flowing and the resistance. As components deteriorate,
their resistance increases, causing a localised increase in heat.
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Structured Problem Solving

Traditional Approach Structured Approach

PROBLEM PROBLEM

SOLUTION
SOLUTION (PREVENT
(QUICK FIX) RECURRENCE/
OCCURRENCE)
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Traditional Vs Structured Problem Solving

Traditional Approach Structured Approach

▪ Jump to conclusions
▪ Treating the symptoms
▪ Not evidence/ data driven
▪ Short term focus
▪ No follow up
▪ Identifying root cause
▪ Identifying all associated causes
▪ Evidence/ data driven
▪ Long term focus
▪ Follow-up of recommendations
and implementations
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PDSA or PDCA Cycle

▪ Objective
▪ What changes are to ▪ Prediction
be done?
▪ Plan to carry out the cycle
▪ Next cycle
Act Plan (who, what, when, where)
▪ Plan for data collection

▪ Analyse data.
▪ Compare results to Study Do ▪ Carry out the plans.
predictions. ▪ Document observations.
▪ Summarize what was ▪ Record data.
learned.
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Steps in PDCA Problem Solving

1 DEFINE THE PROBLEM

2 ANALYZE THE PROBLEM

PLAN
3 GENERATE SOLUTIONS

4 SELECT THE SOLUTION

5 IMPLEMENT DO

6 EVALUATE THE RESULT CHECK

7 STANDARDIZE ACT
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1. Define the problem

▪ Most difficult and most important step.

▪ Problem well defined is problem half solved.
▪ Involves situation diagnosis to focus on real problem and not symptoms.
▪ Written down, clear, specific.
▪ Details of who, what, where and when.
▪ GEMBA- Walk the area, look for potential causes, observe, take inputs, pictures.
▪ Careful defining provide raw material for successful identification of root cause.
(Appropriate tools include brainstorming, fishbone, flow chart, pareto charts, check sheets and
histograms.)
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2. Analyse the problem- Root Cause Analysis

▪ Weed is the problem, which is above the surface and easy to see. SYMPTOMS

▪ Root is beneath the surface, its obscured and difficult to get to. ▪ Problem
reported
▪ Mistake in understanding is that RCA is to identify the root cause of the
problem.
▪ Analysis is actually breaking down into parts. CAUSES
▪ Reasons
▪ Root is a system and a combination of parts.
of the
▪ RCA is to understand all the pieces that contribute to the problem.
problem
▪ Not all the causes are equally important - need to treat the important. ▪ Root
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5 - Why Analysis – Needle Stick Injury
Problem: Housekeeping staff sustained needlestick injury while transporting the sharps to the
temporary storage area.
Why: Why did the housekeeping
The box was overflowing.
staff sustain needle stick injury?

Why: Why was the box There is a shortage in supply of

overflowing? puncture proof boxes.

The order for a new set of boxes was

Why: Why was there a shortage?
not placed by stores on time.
Why: Why was the order not
The storekeeper was on leave.
placed on time?
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5 - Why Analysis – Patient late to OT
Problem: Patient arrives late to OT from the ward. Surgeon, anaesthetist and the
team had to wait for the patient.

Why: Why did the patient arrive late to OT? Patient had to wait for the trolley.

Replacement trolley had to be brought

Why: Why did the patient wait for the trolley?
from another ward.
Why: Why did the patient need a replacement Screws of the side rail of the trolley had
trolley? dislodged.

Why: Why did the screws dislodge? Screws were not checked periodically.

Due to absence of preventive maintenance

Why: Why were they not checked periodically?
schedule.
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Other Problem-Solving Tools

PARETO CHART CAUSE & EFFECT DIAGRAM

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3. Generate Solutions

▪ Brainstorm solutions.
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4. Prioritize & select the best solution

LARGE
PLAN DO
NOW NOW
Impact

DON’T DO
DO LATER

SMALL
DIFFICULT EASY
Ease of implementation
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5. Implement the Solutions

▪ Involve the stakeholders.

▪ Appropriately communicate to the stakeholders and create ownership.
▪ Draw up the implementation plan and the timelines.
▪ Identify the implementation champion/ leader.
▪ The RCA team should be involved in implementation for better results.
▪ Verification - Did the solution get implemented?
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6. Evaluate the Result

Conduct a pilot study to assess the following:

▪ The changes after implementation.
▪ Effectiveness of the solution and whether any further solution needs to be
implemented.
▪ Validation - Has the solution produced the desired results?
▪ Whether the stakeholders and the RCA team are satisfied with the solution and
implementation.
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7. Standardise
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8. Implementation & Follow up

▪ Role of Quality Team is critical in follow up.

▪ Continuous audits for a certain period.
▪ Periodical audits after the standardisation is achieved.
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Quality tools for waste minimization & improved efficiency
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What is Lean?

Lean is a method for continuous improvement

and employee engagement.

Lean is an approach that allows us to solve the

problems that are important to leaders and as
an organization.
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Lean Thinking

The five key principles of Lean Thinking are:

1. Specify what creates value for the customer.
2. Identify all steps for value stream.
3. Create value flow.
4. Only make what is pulled by the customer just
in time.
5. Strive for perfection by continually removing
waste
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How does Lean define value?

Three general rules to be considered for value-added:

1. The customer must be willing to pay for the activity.
2. The activity must transform the product/service in some way.
3. The activity must be done correctly the first time.

Lean helps us to:

▪ Increase value by improving quality and reducing cost.
▪ Improve both simultaneously.
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Non-Value-Added Vs. Value-Added

Non-value-Add: Non-value-Add:
Value-Added
Pure Waste Business Req
▪ Activities that a
▪ Activities that must customer is willing
▪ Activities that the
be performed for to pay for, that
customer would
legal or regulatory/ contributes to the
not pay for
compliance reasons end product they
expect

Eliminate Minimise Optimise

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Eight Wastes of Lean
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Eight Types of Waste
Types of waste Brief Description Healthcare Example
Time spent doing something incorrectly, inspecting Surgical case cart missing an item; wrong medicine or wrong dose
Defects
for errors, or fixing errors. administered to patient.
Doing more than what is needed by the customer or Doing unnecessary diagnostic procedures; producing medications that are
Overproduction
doing it sooner than needed. not used before the orders change or patient is discharged.
Unnecessary movement of the “product” (patients, Poor layout, such as the catheter lab being located a long distance from the
Transportation
specimens, materials) in a system. ED; patients moving from building to building to receive cancer treatment.
Employees waiting for a patient information, or work to do; patients
Waiting Waiting for the event to occur or next work activity.
waiting for an appointment, care, or discharge.
Excess inventory cost through - financial costs,
Inventory Expired supplies that must be disposed of, such as out-of-date medications.
storage and movement costs, spoilage, wastage.
Lab employees walking miles per day due to poor layout; walking to find
Unnecessary movement by employees in the
Motion missing supplies, equipment, or medication; unnecessary clicks in an EMR
system.
system.
Doing work that is not valued by the customer or is
Entering data into a computer system that is never seen or used; Excessive
Over processing caused by definitions of quality that are not aligned
warnings in an EMR system that physicians and nurses just click through.
with patient needs.

Waste and loss due to not engaging employees, Employees get burned out and stop giving suggestions for improvement or
Human potential
listening to their ideas, or supporting their careers. quit their job.
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What is Value Streaming?

▪ A group of excellent departments – not necessarily a system that performs best.

▪ Each department plays a role in the overall patient experience and care.
▪ Problems or waste are often found in the interactions between departments - Lack of focus on
patient’s pathways or value stream.
▪ Value stream is an end-to-end flow of a patient or a process.
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Visual Management 5S

▪ Reducing Waste through Visual

Management.
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First S : Sort ( Seiri )
Sort out unneeded items that are no longer needed and taking up space or keep items based on frequency of
use.

Benefits
Eliminate clutter
Saves floor space
Improves safety
Saves searching time
Eliminate excess inventory
Eliminate lockers, shelves
Prevents drug mix up
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Second S : Store (Seiton)

Store is to arrange materials so that:

▪ It is easy to find
▪ Effort is reduced
▪ Access is easy no blocked material
▪ To ensure FIFO
▪ Both the worker and the material are safe
▪ Errors are reduced
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Third S : Shine (Seiso)

Focuses on cleanliness
▪ In Healthcare shine is more correctly oriented toward
infection control.
▪ Cleaning should be considered as an opportunity for a
team, to show pride in their workplaces by keeping it clean
at all times.

Examples:
Operation was successful but the family was unhappy. Because
under the bed there was litter and dust balls. Patient and
family felt neglected and disrespected.
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Fourth S : Standardize (Seiketsu)

Standardize through visual methods, proper

marking of locations to identify one from
another.

Example
A laboratory bench with marked locations for
specimen drop - off and supply storage.
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Fifth S : Sustain (Shitsuke)

▪ To prevent 5s from becoming one time event we need a

plan for sustaining and continually improving.
▪ Have a formal audit plan to see if the new standards are
being followed.
▪ This should be done periodically in a schedule basis.
▪ Coach the employees to maintain the same.
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References:

1. Where is preventive action?, John E. Jack, Charles A. Cianfrani, http://asq.org/quality-

progress/2016/03/standards-outlook/where-is-preventive-action.html
2. CAPA Process (Corrective Action & Preventive Action), Bill Greenwood, www.thebcma.org
3. Root cause analysis processes and methods, http://asq.org/learn-about-quality/root-cause-
analysis/overview/conducting-root-cause.html
4. TQM in the Service Sector, R.P Mohanty & R.R Lakhe, Jaico Publishing House
5. Total Quality Management, V.S Bagad, Technical Publications Pune
6. Juran’s Quality Handbook, 6th Edn, Joseph M. Juran & Joesph A. De Feo, Tata McGraw-Hill
7. Learn Quality Tools, http://asq.org/learn-about-quality/quality-tools.html
8. Quality Improvement tools & techniques, Peter Mears, McGraw-Hill
9. Root cause analysis – A Tool for Total Quality Management, Paul F. Wilson, Larry D. Dell, Gaylord F.
Anderson
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