Final Exam Review

Introduction to
Quality Management
Quality Management
Project managers should incorporate sound
quality management practices into their
work/project, etc.

Why bother: to meet customer, client, or

public requirements on time and within
budget.
Quality should be concerned with :

1. The product/service/process that is the

deliverable from the project.

2. The project management process itself.

What do we mean by “quality’?

• What is quality?
• Quality of life
• quality of the environment
• quality of service
• quality of product
• Hard to define
• Everyone wants quality work, performance, goods and services
Some Definitions
• Philip B. Crosby
• quality is defined as conformance to requirements, not as goodness
• W. Edwards Deming
• Quality means the effective production of the quality that the market expects,
it does not mean achieving perfection. He viewed quality
as a responsibility of management.
Some more definitions
• Farrell
• Quality means products, services, processes & conditions
that effectively, efficiently & consistently meet or exceed
the requirements & expectations of all customers
• Joseph Juran
• Quality is fitness for use. Freedom from deficiencies
(errors that require rework or cause product failure)
 The project management institute
says quality is

• The degree to which a set of inherent characteristics fulfills

requirements.
What does it really mean?
• Consensus is difficult to achieve
• manufacturers
• meeting a particular specification for a particular customer
• corporate customer
• product can be used for intended purpose
• consumer
• perception that standards have been met
Quality to Manufacturers

• buzz word to be used in ads

• quality sells
• quality is important in battling competition
• for manufacturers, the product must;
• be free of defects
• meet or exceed design requirements
• be perceived as being good value by end user
• on time delivery
• competitive pricing
Quality to Consumers
• consumer evaluates quality in a subjective manner
• quality perception is important.
• The product must
• look, feel, taste, smell, sound good
• do the intended job
• be good value for their money
• expectations differ between consumers
What does quality mean in

terms of Public Health?

Any ideas?
What does quality mean in terms of Public Health?

Does it mean PHIs inspecting restaurants,

meat packing facilities, fish plants, etc. to
make sure these places are doing quality
work?
What does quality mean in terms of Public Health?

Could it mean PH Inspectors doing quality

work?
What does quality mean in terms of Public Health?

Does it mean the public is assured that the

facts given to them by PHIs and other
government health officials are based on
reliable current data backed up by a good
quality program to ensure the best interests
of the public?
What does quality mean in terms of Public Health?

Could it mean all of these things and more?

• What does quality mean in terms of healthcare?

• Any ideas?
Where do quality and project management merge?

Every project aims to reach a certain

standard of quality.

-External, such as ISO certification, accreditation, etc

-Internal, quality standards of the organization

Where do quality and project management merge?
The project must define the standards that
each of the major deliverables or outcomes
must meet.
The project must define who needs to be
satisfied with the quality achieved.

Need to consult with unions in accordance to formal

agreements with management.
Quality versus project constraints
• Project constraints include time, cost and scope
• Quality may be closely associated with scope because both are tied to
customer/public requirements.
• A good project manager should never trade off quality at the expense
of the above three constraints.
Managing Quality
Performance criteria must be defined in the
planning phase.

Ensure this is made explicit and understood

by all stakeholders.
Managing Quality
Set up quality assurance mechanisms which
are transparent and require reporting to the
sponsor or project steering committee on a
regular basis.
Managing Quality
Ensure any variations from the quality plan
are logged, documented and resolved at a
high level.

A procedure to accept variations from the

quality plan should be formalized.
Quality partner

Some project teams will appoint a friendly

expert advisor who works confidentially with
the team to ensure problems don’t occur;
rather than wait for them to happen then
deal with them.
Aspects of Quality

• inspection
• quality control
• quality assurance
• quality system
Inspection
• process of measuring, examining, testing, gauging, or otherwise comparing
one or more units of product with the applicable requirements
• this is an acceptance function involving:
• receiving
• in process inspection & testing
• final inspection & testing
• control of nonconformances
• day to day monitoring
• etc
Quality control

The set of materials and practices used

throughout the measurement process to
ensure that each discrete part contributes
a minimum amount of error to the results.
Quality control

QC for the most part is a required part of

the QA program.

The choice of QC requirements depends on

the project being undertaken.
Quality assurance

A system of activities whose purpose is to

provide to the producer or user of a product
(or a service) the assurance that it meets
defined standards of quality with a stated
level of confidence.

(From JK Taylor. 1987. QA of chemical measurements.)

QA versus QC
The terms are often used interchangeably,
but they are quite different in meaning.

QA is concerned with the quality of the

information provided by the data.
QC is concerned with the quality of the
measurement process involved.
Quality system
This is the overall program that an
organization undertakes in regards to
quality issues. It encompasses QA and QC.

QS > QA > QC
Quality
Assurance
Quality Assurance
- management goals

The QA program should give management

the opportunity to provide input and take
responsibility at the planning,
implementation and assessment stages of
the project at hand.
Quality Assurance
- management goals

The QA staff and their relationships to

management and technical staff are
important to an organization in order to
ensure coordinated efforts and logical flow
of information.
Quality Assurance
- Division of responsibility
Divisions of responsibility among the
technical staff, management, supervisory
staff and contractors should be made clear.

The responsibility for quality lies with all

employees.
Quality Assurance highlights - Time Costs
There is a time cost to running a good QA
program.
In a lab setting, up to 20% of one person’s
time may be dedicated to the QA program

Up to 15% of total measurement time may

be related to QA through QC procedures.
Quality Assurance highlights - Time Costs
Organizations must add in the cost of time
to be spent on a QA program when they are
adopting one or developing their own.

The organization must be fully aware of the

time involved in this process and have
people dedicated to work on it.
The QA program - standards

It is often convenient to base the QA

program on a national standard.
Such as USEPA documents.

Standards can be embellished to create a

program tailored to an organization’s
philosophy.
The QA program contains
Management reviews
QA plans or procedures
Technical plans and procedures
Stepwise description of work

Audits or assessments, performance

evaluations, compliance evaluations
The QA program contains
Details regarding an employees
qualifications and training in order to
satisfy:

Safety requirements
Compliance with QA requirements
Efficiency
The QA program contains

A procurement system to ensure

suppliers provide the goods and services
required on time.
QA document control
A system for handling documents and
records to assure;

only the most recent version of a procedure

is being used,

they accurately reflect completed work.

Quality Assurance
- Records

Some programs require extensive

documentation and record keeping.

Especially those involved in enforcing

regulations.
Quality Assurance
- Records

A QA record is a completed document that

provides evidence of the quality of items or
activities or study (research) results.
Quality Assurance
– The QA Record
Includes plans and procedures used during
the project, raw data (if any), procurement
documents, computer documents, chain-of-
custody documents.

The record must be legible, accurate,

complete and secure.
Quality Assurance
- The QA Record
Provisions must be made for storage, length
of storage, preservation and disposition of
records, including electronic data.

Records must be traceable to samples,

sites, data, reports and the project they
represent.
Quality Assurance
– Work Processes
Must be documented to ensure that work is
performed as planned and/or that work can
be repeated if necessary.

Processes performed the same way each

time can be written up as a standard
operating procedure (SOP).
Quality Assurance
– Graded approach

This means the QA requirements should be

tailored to the needs or importance of the
specific project by undertaken.
Quality assurance
–Audits and assessments
Designed to be a review of routine work
or may involve visits to the laboratory or
field for an on-site evaluation.

Emphasize to project personnel the

importance of complying with the QA
program and documents
Quality assurance
–Audits and assessments

Audits can be internal (within organization)

or
External – Done by people external to the
defined organization
Types of audits
1.Typical written audit.
Auditors inspect records and documents for
evidence of compliance.

2. Surveillance audit.
Auditors observe work as it is being
performed.
Types of audits
3. Performance evaluations.

Procedure in which a system, process or

work group is evaluated against a
performance sample. If results are not
comparable to the standard, corrective
action is needed.
Types of audits
4. Data quality assessment

A set of data is evaluated against specific

criteria contained in a check sheet.

Note: the audit process often presents

a tense situation for those being audited.
 QA - nonconformance

A deficiency in characteristic,
documentation, or procedure that renders
the quality of an item or activity
unacceptable or indeterminate.

Nonconformance is considered a serious

deficiency and requires corrective action.
QA - nonconformance
Example

Measuring samples with an instrument that

doesn’t meet calibration requirements.
QA - Calibration

Users must demonstrate that measuring

systems are operating properly.

Equipment and instrumentation are

calibrated and checked at prescribed times
Quality
Control
Quality control

Must determine which parameters,

measurements systems, and sets of data
are critical and to what extent detection of
problems can be predicted using various
indicators.
Quality control

Results of QC determinations must fall

within certain limits of acceptance.
Quality control methods
1. Use reference material with certain well
established properties.
2. Confirm measurements/results using a
second method.
3.Use control chart to indicate trends.
4. Proficiency test the analysts.
5. Compare to other organizations/labs, etc
Typical control chart

Blue line is the average value

Green line is upper and lower limits
Black line with boxes are the measured data points
Why Implement a Quality System?
• Good business sense
• can assist you in producing & sustaining a higher quality of product & service. This can
lead to:
• customer satisfaction
• repeat business
• greater share of the market
• higher profits
• reduced costs for rework
• reduced costs of after sales service
• reduced customer complaints
• reduced scrap
Are additional staff needed?

May need to add an inspector (if none exists)

• may need to add more than one
• depends on complexity of the process

May need to add internal auditors

• different from inspectors
• ensure no conflict of interest
How difficult is Implementation?
• Can be straight forward

• disaster can result if

• inadequate planning
• lack of understanding
• lack of training
• requires a substantial amount of time, effort and conviction
How much does it cost?
• Varies with

• size of organization
• complexity of product or service
• requirements of the quality standard selected
• commitment & effort generated by management
• extent of inspection & control procedures already in place
Who is involved in implementation?
• Everyone
• To be successful, everyone must be committed to
• implementation
• maintenance
• continual improvement
• of the quality system
Who is responsible for Quality?
• Everyone
• misconception that only manager or quality dept. responsible
• similar to health and safety
• quality dept will have specific duties
• identify and document quality issues
• some companies don’t want process or line stopped
• need to have power of corrective actions necessary
• authority must be given
But

Does everyone adhere to producing

quality products/processes, etc?
China seizes more melamine-tainted milk powder
• BEIJING (Reuters, Feb 7 2010) - Chinese inspectors
tracing new cases of contaminated milk have shut
dairy firms in the northwest and seized 72 metric tons
of milk powder tainted with melamine, an industrial
compound that killed at least six children in 2008.

• Nearly 100 metric tons of tainted milk powder may

still be on shop shelves.
Melamine
• Is used in the manufacture of plastics

• It can cause kidney stones and kidney failure.

• It was added to watered-down milk (baby formula) to

fool inspectors testing for protein and stretch profits.

• Both melamine and protein are high in nitrogen.

Protein molecule Melamine molecule
End results (Feb 2010)

• 300,000 get sick, six children die.

• Dozens of officials, dairy executives and farmers were

punished.

• Two officials were executed over this scandal.

• China’s reputation for food quality is seriously
harmed.
2013 research report
8% of the patients still had kidney abnormalities one year
after diagnosis or treatment initiation. The lack of up-to-
date data on recovery status of the affected children
indicates the need for further investigation
No more melamine:
Then what came next?
• Hydrolyzate of bovine leather, Peter Leedham, a China-
based food testing executive, recently said in a NY
Times article Feb 18 2011.

• "Because it's actually protein and derived from a cow,

it's almost impossible to detect as an additive.”
 Hydrolyzate of bovine leather

• To find out if the substance has been added to dairy, authorities look
for telltale leather-curing residues. The protein extracted from cow
leather is not known to be dangerous to human health, but the curing
chemicals are, Leedham said.
 Hydrolyzate of bovine leather

• The China Daily newspaper said the chemicals could be fatal for
children in high doses and put adults at risk for osteoporosis.
Quality Project Management
Part 2
What is ISO
The International Organization for
Standardization is a global organization
headquartered in Geneva, Switzerland.

Its main goal is to develop consensus

standards for worldwide use.

ISO is actually from the Greek word isos which

means in English “equal.”
Members of ISO

The American National Standards Institute

(ANSI) is the U.S. member of ISO.

The American Society for Quality (ASQ) is a

member of ANSI and is responsible for
quality management standards.
ISO standards

ASQ publishes standards in the

ANSI/ISO/ASQ-9000 series that are the US
equivalent of standards published by ISO.

ISO 9000 series addresses quality

management systems.
ISO 9000 series standards
ISO 9000. Quality management systems
(QMS) – Fundamentals and vocabulary.

ISO 9001. QMS – Requirements.

ISO 9004. QMS – Guidelines for

performance improvement.
ISO 9001 – Specification Standard
If an organization wishes to become certified
it would have to conform to the requirements
of ISO 9001.

Organizations can self declare conformance

or hire a third party registrar to do it for
them. This is considered more objective.
 Benefits of ISO 9001 certification

It forces analysis of quality management

activities.

In the absence of a disciplined form of

management, quality is often assumed to be
being carried out, but this is not always the
case.

ISO presents no assumptions or promises, only

the facts.
Salmonella in the peanut
butter outbreak
Quality issues
Salmonella in the peanuts
Major outbreak in US and Canada began Sept 1
2008.

Enteritis caused by Salmonella typhimurium.

As of February 2009 600 people were affected,

More than ½ were children, 100s hospitalized,
8 deaths.
Peppers

2008

Peanut
Butter

2009
Spread of S. typhimurium in U.S. from Sept 1 2008 to Feb 8 2009
Salmonella in the peanuts
CDC traced the outbreak to one peanut
producing plant in Georgia owned by Peanut
Corporation of America.

Salmonella was found in its peanut butter,

peanut paste, and other manufacturer’s
processed foods that used its products.
Salmonella and QC
Major recall of over 400 peanut containing
products back to Jan 1 2008 began.

Investigations revealed Salmonella was isolated

from the implicated peanut butter/paste in its
internal quality control sampling program on at
least 12 occasions during the past year.
Salmonella and QC, what happened next?
No action was taken to:

1. Investigate the source of contamination

2. Review sterilization procedures
3. Re-clean the production machinery

The company underwent criminal

Investigation, charges filed, trial just ended.
Salmonella outbreaks
Estimates say in large Salmonella outbreaks for
every case identified by clinical culture there
are approximately 38 additional undetected
cases.

In this case we may have 600 cases X 38 =

22,800 cases in total, so far!
Food Borne illnesses costs $$$
Estimates of health care costs due to food borne
in the US are $7 billion/year. This is despite
intensive regulation of food production and
distribution.

Today almost all food consumed domestically is

grown and processed on a vast industrial scale
or increasingly, is imported.
Quality Failure

Unusually heavy contamination of a basic

foodstuff, or failure to remove contaminants
in a single production step can result in the
shipment of contaminated food to millions of
consumers as this case shows.
So, then, why did this outbreak happen?
You tell me.
What the US Food and Drug Administration
(FDA) said*
“The salmonella outbreak …represented far
more than a sanitary problem at one troubled
facility. It reflected a failure of the FDA and its
regulatory partners to identify risk and to
establish and enforce basic preventative
controls. And it exposed the failure of scores of
food manufacturers to adequately monitor the
safety of ingredients purchased from this
facility.”
So what happened with the Peanut Corporation of America
IMPORTANT NOTICE TO SALMONELLA CLAIMANTS
ASSERTING CLAIMS AGAINST PEANUT
CORPORATION OF AMERICA (PCA), PLAINVIEW
PEANUT CO., LLC (PLAINVIEW) OR TIDEWATER
BLANCHING CO., LLC (TIDEWATER)
In order to have your claim considered for payment from a fund established
for compensation of injuries or death resulting from an outbreak of
Salmonella, you must complete and return the Proof of Claim form and
attach the required documentation.
Even if you have previously filed a proof of claim, you must complete and
return this proof of claim form and attach the required documentation.
Alan Maxwell, Esq.
Weinberg, Wheeler, Hudgins, Gunn & Dial, LLC
950 East Paces Ferry Road, Suite 3000. Atlanta, GA 30326
Criminal trail also occurred
• The trial had the potential to make the outbreak the most influential
food-borne illness incident in America.

• Never before has a jury heard a criminal case in which a corporate

chief faced federal criminal charges for knowingly shipping out food
containing salmonella.
Criminal case concluded
Sept 19 2014
• The jury in the criminal case found company owner guilty
of 67 counts including conspiracy, interstate shipments
fraud, and the introductions of misbranded and adulterated
food into interstate commerce.

• Two others also found guilty of various charges.

• Defendants were given 30 days to file post trail motions.
On bail, sentence date not been set yet.
We want a new trial! October 8 2014

• Lawyers for the defendants are arguing for a new trial

because “extrinsic” evidence was considered by the jury,
specifically the fact that the outbreak involved nine deaths,
information which was not part of the trial but was brought
up during deliberations by jurors who did their own
research over the course of the seven-week trial.
 May 29 2015 decision
• Post-trial motions for acquittal, dismissal, or, in the
alternative, a new trial filed by defendants Stewart Parnell,
Michael Parnell, and Mary Wilkerson have all been
denied by U.S. District Court Judge W. Louis Sands.

• As many as 14 motions were settled by the judge’s ruling

on Thursday, although defense attorneys for the Parnell
brothers already indicated they planned to appeal his
decision to the U.S. Court of Appeals in Atlanta.
Owners have tried to sell vacant factory, no buyers. Some residents want it
torn down.
Sentence handed down
Sept 21 2015
• Stewart Parnell the former owner of a peanut company
in Georgia was sentenced to 28 years in prison on
Monday for his role in a salmonella outbreak that
killed nine people and sickened hundreds, a rare
instance of jail time in a food contamination case.
Peanut Corp America Sentencing:
• His brother Michael Parnell received 20 years in prison.

• Mary Wilkerson, a former quality control manager at the plant who

was found guilty of obstruction, was sentenced to five years in prison
Peanut Corp America Sentencing:
• The final two defendants in the Peanut Corporation of
America case, Daniel Kilgore and Samuel Lightsey,
were sentenced Thursday, Oct. 1 2015 in Albany, GA,
to six and three years in prison, respectively.

• The two men made plea deals with federal prosecutors

and testified at the trial a year ago.
Why
should I
worry

The
company
Will
protect
me!!
 Das Scandal
• Another case to look at is the 2015 Volkswagen scandal,
in which they engineered cars to give better (less)
emission readings for NOx when they car was being
tested for emissions. While driving emissions went
backup, allowing the car to perform better.
• WASHINGTON—The U.S. EPA accused Volkswagen AG
of deliberately dodging air-pollution rules on nearly half a
million cars sold since 2008.
• http://www.wsj.com/articles/auto-software-in-focus-after-
volkswagen-flap-1442945494
• German authorities have ordered a recall of all VW cars
fitted with the software, affecting all 8.5 million diesel
cars across the EU. The company says a fix could stretch
through 2016.

• The VW chief executive officer resigned over the scandal,

and four staff have been suspended.

• A spokesman for the prosecutors' office in Germany said

"more than two, but a lot fewer than 10" staff were being
targeted, the AFP news agency said.
Automobiles produced by Volkswagen sit in auto delivery towers at the company’s
headquarters in Wolfsburg, Germany. Photo: Bloomberg News
Ironically VW’s new passenger car registrations rose 8.4% in the EU
in September!
• Back to ISO
Benefits of ISO 9001 certification
ISO focuses on prevention not inspection.

Prevention is more effective in the long run,

then identifying and fixing defects as they
occur.

ISO 9000 is a framework for continual

quality improvement.
Benefits of ISO 9001 certification
The initial motivation is often commercial. In
many businesses international customers
favor suppliers that are certified.

Once organizations see the benefit of a

quality management system they may
continue regardless of commercial
pressures.
ISO 9004 – Guidance standard
It provides additional, useful information
about quality management.

Nothing in it is required for certification.

Basically it contains elements on which

international consensus could not be
reached, & thus couldn’t be put into 9001.
ISO 9001 & 9004
Neither one are performance standards.

They don’t address quality itself, but rather

the management processes necessary to
achieve quality.
ISO 9001 in brief
Quality policy: A statement from top
management.

Quality manual: A document that addresses

each clause in ISO 9001.

Specific procedures may be part of the

quality manual or be referenced in it.
ISO 9001 in brief

Quality objectives: Goals assigned to

organizational elements.

Quality procedures: Step-by-step actions for

each ISO 9001 requirement or any process
that affects quality.
ISO 9001 in brief

Forms, records, documentation: Provides

proof of performance
ISO Documentation Tiers

Policy Manual
Objectives
Procedures

Detailed
Instructions

Forms
Why Document?
Provides a basis for quality
• keep record of what you do so that it can be repeated.

• no variances mean a quality product.

• mistakes are not made as frequently if you write it

down.
Documentation Tiers
• documents are put into levels or tiers

• first tier - quality manual

• policies & objectives
• what is done
Documentation Tiers (cont.)
• 2nd tier - quality procedures
• how it is done and by whom
• inspection instructions
• calibration instructions
• process instructions
• work instructions
• workmanship standards

• 3rd tier - detailed instructions

Specific Documents
• quality manual
• quality procedures
• quality program plan
• inspection instructions
• workmanship standards
• process or work instructions
• quality system forms
Quality Manual
• contains all company policies and objectives

• quality policies
• describe what is done by the company to ensure
quality
• provide an overview of your quality system
Quality Manual (cont.)
• manual defines what is done

• should be prepared by a quality steering committee

• should be coordinated by quality management rep

• does not usually have attachments
Quality Procedures
Define how policies are to be accomplished
Defines who will accomplish
Define how it is done and by whom
Should be developed by the departments
involved
Should be coordinated by steering
committee
Quality Instructions
• contain specific details on how a task must be performed
• should be developed by the individual(s) actually performing
the function

• reviewed by the supervisor

• approved by the department manager
Document Attachments & References
• attachments often required
• helps reader understand document better
Distribution
Quality manual
– senior managers
• department heads
• Supervisors

• Quality procedures and instructions

• department heads
• supervisors
An Overview of ISO
Quality Procedures &
Instructions
Procedures
Procedure Development
• must define how a particular activity must be performed

• must define who will perform the activity

• procedures contain more information than the quality manual

Procedure Structure
Organize material into the following sections

• Objective of the document

• Scope: the extent to which the procedure applies
• Definitions
• include any unique acronyms
• include any definition which will assist the reader
Procedure Structure (cont’d)
• Responsibilities
• who is responsible for tasks
• who is responsible for providing additional information

• Procedure
• detail the actions to be performed
Procedure Structure (cont’d)
• References
• identify any documents which you have referred to in the
procedure

• Attachments
• list all forms, samples or similar attachments
Instructions
Instructions
If no formal written instructions exist - get some

• have individual who performs the work to

write down brief step by step description of
what is done

• gather all notes and memos that have been

generated throughout the years

• use the two sources to come up with the

main body of the required instruction
Instruction Format
• purpose
• define the methodology
• define personnel responsible

• scope
• to what does the instruction apply

• definitions
Instruction Format
• Responsibilities

• instruction
• step-by step process put here

• References
• Attachments
Benefits of good instructions
Can be used as training aids.

Can be used as orientation for new employees.

Helps employees understand the function better.

Instructions: How much detail?
Depends on

• education of the workforce

• complexity of the product

• complexity of the process

How instructions become effective

Employees need to know why instructions

exist, and what it actually means to them.

How do you do this?

How instructions become effective

Give information sessions to employees:

12 - 15 employees at a time.
The amount of detail depends on the education
level of the workforce and complexity of the
product and processes.
Use Flow Charts
Flow charts can help in understanding process flow & decision making
• illustrated picture of the process
• shows activities
• shows the sequence
• a deployment flow chart is useful when documenting
procedures
• shows who is responsible for each task in the process
Deployment Flow Chart
How is it made?
1. Define the process boundaries (starting
point/stopping point).
2. Describe the process in operation.
3. Draw the People Coordinate.
4. List major steps in the process.
5. Draw the flow chart, using symbols
6. Study the flow chart.
A simple deployment flow chart
Another deployment flow chart
 Yes No

Start Task Make a

Decision

Conduct a
Report End of
Meeting Out Process
 PHI Water test
Homeowner

Explain procedures Collect sample

ES
Over phone Y
Does
homeowner
Bring to lab
understand?
Repeat
instructions Lab does test
NO
Report sent
Asks for explanation Calls PHI
Explanation given
Water must be
boiled!!
 A flow chart is a picture of a process.
Choosing the style and depth of detail depends
on the purpose of the flow chart.
Everyone involved with the process should help
in construction and agree on a picture.
A flow chart is a dynamic tool which should be
changed when process changes are made.
Constructing a Flow Chart
• define the boundaries or scope of process

• observe process in operation

• walkthrough, ask questions, take notes, draw sketch
Constructing a Flow Chart
• draw the people coordinate

• names of positions/departments

• write names in boxes from left to right

• in order that they appear in the process

Constructing a Flow Chart
• draw the flow chart; left to right, top to bottom

• list major steps in process

• study the flow chart - can you improve process?

How to study the flow chart
• are there any steps which indicate wasted time?
• Are there any steps which indicate wastes effort?
• Is there complexity?
• Is there redundancy?
• Are there opportunities to improve communication?
Don’t be afraid to ask for help
from experts
Managing Performance to
Improve Health
Grace Duffy & John Moran
Chapter 2
What is performance management?
• The practice of actively using performance data to
improve the public’s health
• Used to establish performance targets and goals
• Used to prioritize and allocate resources
• To inform about needed adjustments or changes in
policy/program directions to meet goals
• To improve the quality of public health practice
What are the components of performance
management?
Performance standards. Establishment of
standards, targets and goals to improve public
health practices
Examples:
 Employ one epidemiologist on staff per every 100,000
population served.
 For health dept surveys (of the public) regarding
service 80 % or more should respond “good” or
“excellent”
United States National Public Health
Performance Standards Program

Developed in collaboration with the US

Centers for Disease Control

Based on 10 Essential Public Health Services

US Essential public health services
• Developed by the Core Public Health Functions
Steering Committee in 1994

• Included reps from national organizations

and federal agencies
• Charge: To provide a description and
definition of public health
• Developed the “Public Health in America”
statement
 Public Health in America
statement
Vision:
Healthy People in Healthy Communities

Mission:
Promote Physical and Mental Health
and
Prevent Disease, Injury, and Disability
 Public Health in America. What
does Public Health entail?
 Prevents epidemics and the spread of disease
 Protects against environmental hazards
 Prevents injuries
 Promotes and encourages healthy behaviors
 Responds to disasters and assists communities
in recovery
 Assures the quality and accessibility of health
services
10 Essential Services of Public Health
• Monitor health status • Enforce laws and
• Diagnose and regulations
investigate • Link people to needed
• Inform, educate, and services / assure care
empower • Assure a competent
• Mobilize community workforce
partnerships • Evaluate health
• Develop policies and services
plans • Research
What are the components of performance
management?
Performance measurement. Various measures
to assess achievement of standards

Example: a large city of 2 million has 12 trained

epidemiologists on staff in their overall health
department. Is this enough based on the
previous standard/goal?
National performance measures
• A good example of a national system of performance
measurements is the US Tracking Healthy People
2010.

• Further information can be found at

• http://www.healthypeople.gov/Document/tableofcontents.htm#trackin
g
Tracking healthy people 2010-leading
health indicators
• Physical Activity
• Overweight and Obesity
• Tobacco Use
• Substance Abuse
• Responsible Sexual Behavior
• Mental Health
• Injury and Violence
• Environmental Quality
• Immunization
• Access to Health Care
What are the components of performance
management?
Reporting of progress. Documenting, reporting
and sharing of information

How a public health agency tracks and reports

progress depends on the purpose of its
performance management system and the
intended users of performance data.
What are the components of performance
management?
• Quality improvement process. Establish
program/process to manage change and achieve
quality improvement in public health policies,
programs or infrastructure, based on performance
standards, measurements and reports
Where can we apply performance
management?
• Public health capacity
• Health status
• Management practices
• Human resource development
• Customer (the public) focus and satisfaction
• Financial systems
• Data and information systems
At what levels can performance
management operate?
• Program
• Organization
• Community
• Provincial
How can performance management
positively influence a public health
agency?
• Better return on dollars invested in health

• Greater accountability for funding, increase in public’s

trust in the health agency

• Reduce duplication of efforts

• Increased emphasis on quality rather than quantity

How can performance management
positively influence a public health
agency?
• Improved problem solving

• Increased sense of cooperation and teamwork

• Better understanding of PH accomplishments and

priorities among employees, partners and public
Performance management:
Results in public health
• Improved delivery of services; including essential
public health services, programs

• Improved administration/management, contracting,

tracking/reporting and coordination

• Improved policies or legislation

(From a 2002 US survey of PM of State Health Authorities)

Performance management:
Results in public health -
examples
• Tennessee: Improved outcomes in rates of
immunization

• North Dakota: Improved performance in several

maternal and child health indicators

• New Jersey: Improved nursing home performance,

including inspection results
Performance management:
Results in public health- examples

• Massachusetts: Increased funding for substance abuse,

tobacco reduction, breast cancer, pregnancy
prevention and school health

• Texas: Increased awareness of and accountability for

the provision of public health services among program
managers and staff
 Examples from Florida Dept of
Health
• Between 1991 -98 syphilis rates dropped 87%

• In same period tuberculosis rates dropped 33%

• Infant mortality rates among minority populations dropped more than

in any other state
Florida’s success was due to:

• A movement away from a focus solely on quality assurance to a more

comprehensive quality improvement process (QIP)
Florida’s QIP
Florida’s quality improvement process
implemented various components of
performance management:

 Emphasis on customers (public)

 Examining processes
 Involving employees
 Making decisions based on data
 Setting benchmarks
The Quality Improvement Process
• An established QIP brings consistency to the
agency’s approach to managing performance,
motivates improvement and helps capture
lessons learned.

The QIP may focus on one aspect of

performance (such as the public’s satisfaction)
or cut across an entire health department
The performance management cycle

• This process is linked to the concept of continuous

quality improvement

• Developed by Edward Deming in the 1950s

Performance management cycle
• Main ideas
• Discarding defective products creates more waste than
doing it right the first time.

• Defects can be avoided and quality improved indefinitely if

root causes are discovered and addressed through ongoing
evaluation processes.

• All business processes should be part of an ongoing

measurement process with feedback loops.
Public health performance should be
managed for:
• Structures such as financial and information services

• Processes such as health promotion and epidemiology

services

• Outcomes such as heath status and cost savings

Scope of PH performance
management
• Larger: To improve state, (provincial) or local PH
agency collaboration or efficiency

• Smaller: To improve performance of one aspect

within a smaller system. Examples
• Improve outcomes of anti-smoking campaign
• Improve restaurant owners compliance with an agency’s
food safety campaign
 Lean Sigma
Rebuilding Capability in Healthcare
Lean Sigma. Fundamental notion.
• Is a business initiative or an underpinning to the way an organization does
business, or at least goes about changing their business model.

• It can work equally well in various aspects of healthcare,

• It is fundamentally a different way of thinking and for many organizations

can become a compulsory leadership competency.

• It can be thought of as a form of performance management.

Why traditional healthcare models are struggling
• Performance in healthcare is not where it needs to be.

• Resource overloading. Hard to get team time to even start a project.

• Most improvement is incremental. Little in the way of breakthrough

change.

• Savings are hard to come by.

• Difficult to attribute any measured success to specific changes made.

• Improvements often fail to stick.
Does organizational change lead to
performance improvement
• Not always.
• Change is continuously happening but performance improvement
doesn’t necessarily follow.

• Reasons
• Disparate change groups. In many hospitals there are multiple
change groups; management, quality team, nursing, medical, etc. They
are often disconnected silos. Quality team often plays second to the
operations team.
• Uncontained change. Change made by many disparate groups in an non-
uniform, uncontained, and often poorly understood way.

• If a process is always in flux, it is hard to get an idea on how well it can

truly perform. Potentially well-performing process may get overwritten
by a poorer one.

• What happens in hospitals is no standardization across units, or shifts, or

people on the same shift, and the process never truly improves. (referred
to as 1-sigma churn)
W.E Deming’s marble in a funnel experiment to demonstrate
uncontained change.

• Roll a marble down a funnel to hit a target on the floor.

• By changing the dropping process (height, location, etc.) to improve it

(hit the target), it only made things worse. Too much change after change
didn’t help reach the target goal.

• Only after the operator lets the process settle, and doesn’t keep changing
parameters will the process begin to perform consistently and better.

• It is difficult to get the feel of a process if it is constantly in flux

(changing).
No adjustments Make adjustments every drop
• No standard change approach. Difference in approach between groups,
within groups, even within an individual, using different approaches at
different times.

• No accountability to follow a standard approach.

• This can lead to frustration in individuals and between groups.

• Tools focus. Majority of people making changes in hospitals have never
been formally trained in any improvement methods beyond basic
techniques.

• Only simple tools are employed often missing the linkage between tools
so they build on one another. Organizational infrastructure at program
levels fails to prioritize, align, and appropriately resource change.

• Projects get handed to untrained, inexperienced project leaders lacking

date-driven, systemic approaches. They basically ‘wing it.’
• Reliance on benchmarking. What might be the best practice (benchmark)
for one organization may not be for yours.

• An evidence-based answer may not be the answer to your specific

question.

• Working hard, but perhaps not working smart.

• Changes not based on data, good data, or the right data.

• Having a lot of data doesn’t mean it is valuable information.

• Sometimes it is just the wrong question being asked. Often, ‘why do we

care?’ is the question to be asked in healthcare settings. This often gets to
the root cause of an issue.

• Changes made based on symptoms, not causes.

• Systems versus processes. Processes are what is supposed to be happening
and how it occurs. Systems are the things that support processes. (Ex.
ordering equipment, receiving it, delivering to specific dept is a process,
tracking this is the system.)

• Often times the system gets blamed when what really failed was the process.
And not all problems get resolved if you put in place a new system. (Ex.
Electronic medical records system.)
• Focus on people, not on process. Doing this is coming a the problem from
the wrong end. The initial focus should be on the physics and engineering of
the process, the mechanics, activities, layout, triggers, flow, roles,
accountabilities, metrics.

• Simply changing the head of the emergency dept or surgical suite may not
solve any problems or make improvements.

• Healthcare’s most valuable asset, the people working within, is successful

despite the processes, not because of them.
• Lack of context for solutions. Changes made on conjecture without context
of any kind in high-stress environments are likely to fail when glitches come
along.

• Changes are not based on any form of evidence and thus are prone to a
reversal of subjective opinion and support.

• Focus tends to be on people, not the process, so process context is lost when
people are the primary focus.
Structuring Change
Structuring Change
• Change should be transparent and contained. It should occur in
visible pieces or packets (call it a project).

• All these projects should be clearly defined and scoped, not overlap,
counteract or clash with each other, and no two groups should be
working on essentially the identical problem.

• Change follows a predetermined path (set of milestones, or roadmap),

progress is obvious and visible and understandable to all.
• Aligned. Change projects are created and driven directly from the strategy
and/or market needs.

• Projects are born from strategy and are the strategic projects.

• Balanced and meaningful. Change should target all relevant business

aspects, ex. operations, quality, finance. One is not sacrificed for the sake of
the other.
• Change should be:

• Made in light of the appropriate context. Solutions are based on a clear

understanding of the voice of the customer/client/patient and any relevant
data.

• Appropriately scoped and focused. Broader context must be considered,

think of it as a beginning to end process.

• Lasting and sustainable. Identify and tackle the root causes of issues
needing change.
• Appropriate methods and tools within projects and across projects
(program level).
• Use tools that are objective and data driven.

• Professional leaders and change agents. These are professionals, full-time,

highly trained, and qualified employees.
Change categories
• 1. Needed improvement on key business metrics.

• 2. Major strategic infrastructure change required to build or rebuild

our organization to take a new required form for future success.

• 3. Performance sustainability and consistency. Not all change is good

or needed. This category is the ability to maintain a stable performing
status quo, if the first two categories are not needed. Business as usual.
Achieving balance in an organization
• Strategic change
• Performance improvement. (Lean Sigma fits here)
• Operational sustainability

• An organization that balances these three components can execute its

strategy

• An organization cannot be the best at everything. This leads to many

of the problems mentioned earlier.
Blue Ocean Strategy*
• Traditional businesses swim in a “bloody red ocean of competition,”
while they should try and swim into a blue ocean of uncontested waters.

• Rather than try to win the game you are playing (against the odds) try to
find a different game to play that few or no one is playing and thus
greatly increase your odds of business success.

• *From Blue Ocean Strategy book by Kim and Mauborge

Lean Sigma: The Program
• Deployment. Organization leadership required.

• Lean Sigma. Includes multiple methods. Lean, Six Sigma, Project

Management, Change Management, Voice of Customer, Concept design,
Performance Management, etc.

• Program. It is a business initiative, or way of doing business, through a

focused organizational infrastructure.

• LS is a fundamentally different way of thinking, for many organizations

it is a compulsory leadership competency. It is a key component of
leadership itself.
• Lean Sigma programs are most successful when initially launched as a free-
standing infrastructure in parallel to the main organizational leadership
structures.
• After 2-3 years the programs consolidate into one.
• In LS approach there is no distinction between quality and operations
improvement, because quality of care is created in operations.

• Role of any hospital or health system:

• To provide the best patient care today (short-term performance and

consistency)
• To provide the best patient care tomorrow (long-term growth and
sustainability)
Lean Sigma program-level infrastructure:
The Steering Group
• The Steering group or committee governs the program, sets it direction,
selects projects and project leaders.

• The Steering group manages the overarching deployment, timelines,

resourcing and course correction.

• Usually meets monthly after the initial first few months of program
commencement.
 Steering Group membership
• Executive champion for the program, usually a VP. Acts as chair.

• Other key executives. Medical, clinical, finance and support function

operations (pharmacy, diagnostics, materials/purchasing, etc.).

• Director of lean Sigma. Begins with Executive champion (above) but

eventually a full-time person is selected.

• Finance representative.
• Human resource representative - a critical role.
• Key change leaders. Ex. medical quality and clinical quality directors.
Focus on Process
• LS is a process improvement methodology

• A process is a sequence of activities with a definite beginning and end,

including defined deliverables. What travels through the process is
referred to as an ‘entity.’ Ex, an order, a patient, a bill.

• Breakthrough change is made process by process and as a result the

organization continually improves.

• The changes to the process along they way are significant, not just try
something and hope it works,
Breakthrough change examples
• Process Metric Result
• Emergency Dept: length of stay 40% reduction

• Emergency Dept. Left without being seen 80% reduction

• Medication delivery Time from order written 60% reduction

to nurse made aware

• Radiology (X-ray) Capacity Five-fold increase

 Project Tiers
• Tier 1: Projects. Geographically well defined and relatively small in scope.
Some may target an improvement in accuracy or reliability of a process. Ex.
Reduction in incidents of catheter acquired urinary tract infections.

• Tier 2. Programs. Includes multiple smaller projects. Often addresses a series

of linked processes, across depts and/or functions. Begin with a discovery
event then break it down in appropriate subproblems and projects
appropriate to tackle.

• Tier 3. Complex programs. Highly interrelated subproblems and processes

that cannot be resolved independently of each other. Ex. Patient placement
and staffing.
Tier 1 Example. A change in protocol lead to a dramatic decrease postoperative UTIs at Stony Brook University
Hospital, Long Island, NY,

In the US Urinary tract infection (UTI) accounts for up to 40 percent of health care-associated infection,
and up to 80 percent of UTIs are catheter-associated (CAUTI).
Identifying opportunities
• LS focus is on maintaining a meaningful set of potential projects at all
times.

• Any hospital or health service has many hundreds of processes, but is

made of a relatively small number of core or critical processes, which
are the building blocks of the organization.
Core processes for a hospital
• In the system (Admitting). Scheduling, arrival, registering, etc.

• Treatment. Emergency room, surgery, diagnostics, mental health, etc.

• Direct support: Food delivery, pharmacy deliveries, etc.

• Indirect support: IT, payroll, finance, mail room, etc.

• Out of system: Departure, billings, follow-up.

 Metrics used to develop and scope LS projects
• Lead time. The time it takes for a patient to progress the length of a process or
hospital stay.

• Patient left without being seen.

• Cycle time. The time between patients as they pass a certain point in the process. Ex.
Blood collection.

• Throughput. Number of patients seen per hour/ per day/per week etc.

• Accuracy. Percentage of orders processed correctly.

• Work content. Ex. Hands-on time spent by nurse per patient.
 Setting appropriate goals.
• Aim for a low goal. You’ll probably not achieve it, or achieve it and not
value it, or struggle to maintain it.

• Aim for a high (loftier) goal. There’s a higher chance to achieve it, and then
you’re more likely to maintain it.

• A recommended way is to set the goal at 50% of the way between current
performance and optimum performance (known as entitlement).
Ex. Patient registration is at 92% accurate now, optimum is 100%, therefore
set goal at 96%, midway between the two.
Lean Sigma Project Leaders
• In LS project leaders are referred to as Belts.

• Master black belts. Full-time employees, who may undertake project

work for half their time but are generally focused on mentoring other
belts.

• Black belts. Typically full-time employees whose primary focus is project

work. (The black or green belt acts as the facilitator for the team)

• Green belts. Part-time project leaders. Focused on smaller, simpler

processes. Fixing smaller pieces of the target process.
Project team

• Made of key representatives from the functions involved in the process.

• Usually 3-7 members plus the belt.

• Team members must remain consistent for duration of project and others
must be available to take on any of their other organizational roles.

• Project champion is usually not part of the team.

• In LS work is done in the meetings, not between meetings.

 LS Change must be…
• Transparent and contained.

• Aligned with the business purpose and direction.

• Balanced and meaningful.

• Made in light of appropriate contest.

• Appropriately scoped and focused.

• Lasting and sustainable.
Lean Sigma further explained
• Lean Sigma as described by Wedgewood (2015) is a tight integration of
two well recognized and used methodologies:
• Lean
• Six Sigma

• Both are business process improvement methodologies.

Lean versus Six Sigma
• Lean looks at what we shouldn’t be doing and aims to remove it.

• Six Sigma looks at what we should be doing and aims to get it right from
the beginning.

• Lean Sigma becomes a way of thinking in an organization. LS goes

moves from a problem to an implemented solution by way of a sequence
of questioning or flow of critical thinking. Change is thus managed
throughout the project.
A Lean Sigma roadmap to successful change

• Define. Is this the right project? Is it the right project for now?

• Measure. How is the process performed? How well is the process performed.

• Analyze. Why is the process performing this way?

• Improve. What should the new process be to perform the right way? At this
stage the newly performing process is operating.

• Control. The performance is at the level it needs to be. Performance is stable

and guaranteed.
Measuring performance
• It may be that the process under investigation is working better than
anticipated, therefore it’s better to focus the project somewhere else,
rescope the project, or stop it entirely.

• If a process is changed it has a better chance to remain operating if

those involved feel it works better than if someone is continually
tinkering with it.
 Data analysis to identify problem causes
• One way is to use a funnel approach.
• Identify as many possible problems/issues (referred to as Xs) as you can, and
then narrow them down to few key critical ones and then work to fix them.

• Examples from Emergency Dept. data.

• The length of stay as shown by date in the emergency dept varies by doctor.
• Length of stay in the ED is longer on night shift than day shift.
• Variation in triage time is higher on the night shift
• Wait time for a room varies by day of week.
Lean Sigma, final thoughts
• As a leader its important to remember that the best solution is that one
that gets implemented and actually sticks.

• Also as a leader you don’t often get the best view of how the work is
done and how it might be done better.

• Make sure you understand your customer/client/patient needs. Identify

the true c/c/p and consult them.
• Don’t make the mistake by delivering things to your c/c/p they don’t
really need.
• Base decisions and changes on reliable data, thus removing subjectivity.
• “Eighty-five percent of problems in performance can be attributed to poor
processes rather than people. The role of the manager, then, is to change
the process, not badger the people.”

• Dr. W. E. Deming (1900-1983)

• American engineer, statistician, professor, author, lecturer, and
management consultant. Regarded as the father of the quality movement.
So, where’s your marble going to end up?
 Quality, Safety, and Standards
Organizations COVID-19 Impact
Assessment: Lessons Learned
and Compelling Needs

This discussion paper is part of the National Academy of

Medicine’s Emerging Stronger After COVID-19: Priorities
for Health System Transformation initiative
By C. Clancey et. al. July 26 2021
• The quality and safety focus of the American health care system has a
long history, dating back to the 19th and early 20 th century.

• Quality of care is generally understood as providing the right care for the
right person at the right time—every time.
Main drivers of Quality measurements,
Improvements and Safety standards
1. Survey, certification, and accreditation of facilities, laboratories, health
plans, and providers

2. Quality measurement, incentives, and payment reforms

3. Public ratings of providers and facilities

4. Quality improvement learning and action networks.

• In 1990, the National Committee for Quality Assurance (NCQA) was
established as a nonprofit organization that accredits quality programs for
health plans, physicians, and other providers. NCQA developed the first set of
standards for health plan quality using a set of evidence-based requirements
and measurements.
• Despite the establishment of standards to ensure high quality care
throughout the 1980s and 1990s, numerous academic research studies
demonstrated the substantial burden and threat that poor-quality care
(often described as overuse, underuse, and misuse) continued to have
on public health.

• The National Academy of Medicine, report “To Err is Human” in

1999, demonstrated that most Americans receive less than 60% of
recommended care.
 Social Determinants of Health
• An integral part of delivering high-quality health care includes gaining an
understanding of the social determinants of health (SDOH) of patients and
communities in their respective contexts.

• SDOH are defined by the World Health Organization (WHO) as the

“conditions in which people are born, grow, live, work, and age”
• An important dimension of quality measurement involves recognizing
the challenges that communities of color, as well as people with low
incomes, low levels of education, and other social drivers of health,
experience in achieving optimal health and health care.
Communities of Colour
• Communities of color and communities that have been made to be
vulnerable experienced higher incidence of infection with COVID-19 than
their White peers. The most proximal cause was the exposures of these
communities to sources of COVID-19 infections because of their
concentration in person-facing essential jobs in the service sector,
including workers in public transit, transportation, logistics, food,
beverage, janitorial services, and childcare and social services.

• These communities often experience higher barriers to accessing quality

care.
• The pandemic demonstrated the stark divide between our public health and
clinical care systems. For decades, public health has been underfunded at all
levels of the government, which hampered U.S. pandemic preparedness and
response.

• In addition, the quality and safety focus areas for public health and clinical
care have been poorly aligned, with health systems focused more on specific
clinical areas such as treatment for acute cardiac conditions and avoidance of
localized nosocomial infections.
• Public health systems are traditionally more focused on communicable disease
control and prevention of chronic disease and injuries.

• There was no existing data infrastructure across these systems that included key
variables and metrics around readiness to inform preparedness and the response
capacity of the health care system.
 System weaknesses
• Among the weaknesses highlighted by the pandemic was the inability of the
U.S. to develop clinical guidelines, related decision supports, and quality
measures, quickly.

• These same weaknesses have contributed to the inability to develop and

deploy digital quality measures across care settings pre-pandemic.
• To increase the ability to care for patients with COV-ID-19, hospitals canceled
elective surgeries and, where possible, expanded the physical capacity to care
for the expected influx of patients and to separate physically those infected
with COVID-19 from other patients.
• To safeguard the health and safety of health care workers, patients, and their
family members, many hospitals limitation of visitors and other personnel in
direct patient care areas and implemented universal symptom screening of all
entering a facility.
Health sector response
• 1. Survey, certification, and accreditation of facilities, laboratories,
health plans, and providers.
•
2. Quality measurement, incentives, and payment
reforms.
•
3. Quality improvement learning and action networks.
 Survey, certification, and accreditation:
Hospitals
• Hospital accrediting bodies had to shift their focus and operations rapidly in
response to COVID-19. One of the largest AOs, the Joint Commission,
suspended routine in-person surveys for health care organizations to enable
health systems to prepare and implement rapid COVID-19 response efforts.

• Limited accreditation surveys resumed in June 2020, with virtual surveys being
tested in several sites. The resultant impacts of virtual surveys on the public’s
health and safety remain unknown and should be studied.
 Future attention
• Attention should also be paid to the effectiveness of accreditation requirements
to determine which requirements should be retired in favor of standards that
reflect health care system readiness for future pandemics and are more likely
to support quality and safety.
Survey, certification, and accreditation:
Nursing homes
• Prior to COVID-19, fewer than 4,000 of the nation’s 15,400 Medicare-
certified nursing homes voluntarily reported health care-associated infections
(HAIs) to the CDC’s National Health Safety Network (NHSN), which
provides health care facilities with a system to track infections and prevention
measures.
Outcome
• The CDC developed a new COVID-19 module for reporting data that
subsequently became required for reporting on May 8, 2020.

• Under this rule, noncompliance on reporting standards could result in the

imposition of civil money penalties. Within weeks, at least 95% of nursing
homes began to report data in the four pathways within NHSN’s Long-term
Care Facility Component, providing valuable information on:

1. resident impact,
2. facility capacity,
3. staff and personnel supplies and PPE,
4. ventilator capacity and supplies.
 Nursing home surveys during pandemic
• Survey findings of nursing homes often pointed to a breakdown
in basic infection control processes such as proper hand hygiene, doffing and
donning PPE, social distancing, staff screening, and precautions.

• The findings point out that it is not sufficient to just have regulations in place.
Training, technical assistance, oversight, and enforcement must also be in
place to ensure adherence to quality and safety standards
 Quality measurement, incentives, and payment
reforms.

• Quick pandemic action halted quality efforts that were not specifically
necessary during the pandemic so that providers could focus on caring for
patients. Health care quality data reporting was mostly suspended.

• While there were no direct measures associated with pandemic performance,

quality measurements can indicate poor systemic performance during a
pandemic.
Typical and common TV news report during the pandemic
• While some measures were suspended, other quality measures and incentives
were developed to encourage clinician participation in deploying novel
treatments and therapeutics.

• Examples:
• Incorporation of patient and personnel vaccination as part of quality measures
in nursing homes and dialysis facilities.
• Merit based Incentive Payment System Program offered credit for clinicians
participating in COVID-19 clinical trials and registries. In March 2021,
Medicare began paying approximately $40 per required dose of COVID-19
vaccines.
Quality improvement learning and action networks.
Quality improvement networks were activated immediately to provide training
and support to the health care system, with particular attention to nursing
homes.

Quality Innovation Network-QIO and the CMS Quality Improvement

Contractors, focused their technical assistance on providing nursing homes
with onsite or virtual training in areas of identified concern, particularly in
COVID-19 outbreak hotspots.
Opportunities for Improvements in Quality,
Safety, and Standards Sector
• Urgent actions:
1. ensuring strategy and infrastructure preparedness;
2. digitizing and sharing critical information across sectors;
3. improving population health measures;
4. streamlining metrics;
5. addressing inequities that can be taken to transform readiness, bolster the
public health infrastructure, and improve health outcomes.
 1. Ensuring strategy and infrastructure
preparedness

• Revisit the consensus definition of preparedness at the national, state, and local
levels, with attention to planning and execution and robust health surveillance
and vulnerability detection.
Challenges to address
• Simultaneous threats to public health in the form of:
• climate change,
• regional and ecological reservoirs of known and novel disease,
• national and regional outbreaks and epidemics,
• global pandemics,
• mass refugee migration, and cyberthreats.
 Metrics to consider
• Develop short-term metrics to assess interventions with rapid results over the
days and weeks immediately following an emergency.

• Develop long-term metric measures such as six-month hospitalization and

mortality following disasters or changes in health indicators for those
developing chronic diseases after an emergency.

• Develop a preparedness measurement strategy to potentially capture the

emerging capacities of virtual care and telemedicine.
2. Digitizing and sharing critical information across
sectors
• Develop timely access to accurate digital information and efforts to increase
access to this information.

• Develop a system of data integration to deliver the right information to the

right place at the right time and from every setting where health care is
provided.

• Transmit data across local, state, and regional public health departments,
schools, outpatient health delivery entities, and short-term and long-term
institutional living facilities.
 3. Improving population health measures
• Create and implement local, state, and regional metrics for population health
status and assessment of vulnerabilities using sensible geographic
demarcations.
• Investments in the public health entities serving highly vulnerable areas
followed by direct financial incentives and additional investments for
improved performance and decreased population vulnerability over time.

• Develop a new system of metrics that increases the use of digital measures.
 4. Streamlining metrics
• The process for data capture, implementation of novel measures, and removal
of measures that are no longer useful must be addressed.

• Learning from COVID-19 by evaluating current measures post-pandemic to

determine if there was any relationship or predictive value to the measures and
the success of nursing homes, hospitals, or other care settings to manage
patients with COVID-19.
 5. Addressing inequities
• Segregation in care, derived from structural racism in housing and lack of access
to adequate care, is a substantial driver of racial and ethnic health care
disparities.
• Develop and use patient reported outcome measures focused on the experiences
of discrimination in health care delivery,
• Provide antiracism training in staff training, and accreditation, board
certification, and continuing education for individual and institutional health
care providers
Final thoughts
• Post-pandemic activities must include collective and earnest efforts to address
inequities and health disparities (racism) that existed prior to COVID-19.

• Investing in the expansion of digital data capture in public health and

congregate settings.

• Strengthen and modernize the quality measurement strategy and infrastructure.

• Investments in and design of new models and standards for collaboration

between health care and public health systems should be significantly
increased.
• Develop cross disciplinary and multidisciplinary leadership training
programs and experiences to foster shared learning by health care
business leaders, public health leaders, and clinical leaders.
Metric

 A metric is a verifiable measure stated in either

quantitative or qualitative terms.
• “95 percent inventory accuracy”
• “as evaluated by our customers, we are providing above-
average service”
Metric

 A metric is a verifiable measure that:

• captures performance in terms of how something is being
done relative to a standard,
• allows and encourages comparison
What is a “metric”?

A metric can be though of as a substitute performance measure:

• Metric is a standard of measurement.

• In quality management, we use metrics to translate

customer/client/publics needs into producer (meaning a lab,
government environment office, health dept, etc) performance
measures.
Identifying effective metrics

 Effective metrics satisfy the following

conditions:
• performance is clearly defined in a measurable
entity (quantifiable).

• a capable system exists to measure the entity.

• Ex: Quality control microorganisms used in a lab.

 Effective metrics allow for actionable
responses if the performance is
unacceptable.

• There is little value in a metric which identifies

nonperformance if nothing can or will be done to
remedy it.

• EX: Quality assurance at a Microbiology lab

shows that we have 20% false positive water
tests for bacteria, but we can’t do anything about
that.

Quality Metrics
True versus substitute performance
measures
 Public/Customers - use “true” performance measures.
 Ex: The water from our municipal supply smells and
tastes good.

 Producers - use “substitute” performance measures.

• these measures are quantifiable (measurable units).

EX: The coliform level in our water is 0/100 mL sample at least 9

times out of every ten samples (or 90 %).
and
The chemical concentrations in our water are all below CCME
maximum guidelines 95% of the time.
 Quality metric data may be used to:

• Recognize trends in performance.

• Compare alternatives.
• Predict performance.
Acceptable ranges
 In practice, identifying effective metrics is often difficult.
• Non-performance of a metric does not always lead to customer dissatisfaction.

 Producers typically identify ranges of acceptable performance for a

metric.
• (a) For services, ranges often referred to as break points.
• (b) In manufacturing, these ranges are known as targets, tolerances, or specifications.
Break points
 Break points are levels where improved performance
will likely change customer/client behavior.
 Example: A health inspector on average waits three
days for a water test result from the lab to come back
to him/her.
• Waits longer than 4 days -- inspector is very
unsatisfied
• Waiting between 1-3 days-- inspector is satisfied.
• Waiting just 1 day– Inspector is very satisfied.

 Should the lab try to reduce average wait time for

water test results from 3 days to 2 days?
 They’d have to consider extra shifts, expense, etc to
do this. Is it worth it? Can they actually do it?
Human Error: Models and
Management
By James Reason
BMJ March 2000
Human error problem
 The human error problem can be viewed in two ways:

 The person approach and the system approach.

 Each model gives rise to quite different philosophies of error

management.

 Understanding these differences has important practical

implications for coping with the ever present risk of mishaps in
clinical practice.
Person approach
 Focusses on errors arising primarily from aberrant mental
processes such as forgetfulness, inattention, poor motivation,
carelessness,
negligence, and recklessness.

 Associated countermeasures are directed mainly at reducing

unwanted variability in human behavior.

 Methods include poster campaigns that appeal to people’s

sense of fear, disciplinary measures, threat of litigation,
retraining, naming, blaming, and shaming.
 System approach
 The basic premise in the system approach is that humans are
fallible and errors are to be expected, even in the best
organizations.

 The system approach concentrates on the conditions under

which individuals work and tries to build defenses to avert
errors or mitigate their effects.
Person approach evaluated
 Seeking to uncouple a person’s unsafe acts from any institutional
responsibility is clearly in the interests of managers (in many
situations).

 What is blameworthy and what is blameless? In the aviation

maintenance industry some 90% of quality lapses were judged as
blameless.

 Effective risk management depends crucially on establishing a

reporting culture. Without a detailed analysis of mishaps, incidents,
near misses, we have no way of uncovering recurrent error traps.
Person approach evaluated
 A serious weakness of the person approach is that by
focusing on the individual origins of error it isolates unsafe
acts from their system context.

 It is often the best people who make the worst mistakes and
far from being random, mishaps tend to fall into recurrent
patterns.

 Greater safety occurs when using an approach that seeks

out and remove the error.
 Defense layers
 High technology systems have many defensive layers: some are
engineered (alarms, physical barriers, automatic
shutdowns,),others rely on people (surgeons, anesthetists, pilots)
and others depend on procedures and administrative controls.

 The layers are like slices of Swiss cheese, having many holes—
though unlike in the cheese, these holes are continually opening,
shutting, and shifting their location.

 Problems happen when the holes in many layers momentarily line

up to permit a trajectory of accident opportunity—bringing hazards
into damaging contact with victims.
The Swiss cheese model (By J. Reason) of how defenses, barriers, and safeguards may be penetrated by an
accident trajectory
 Active failures
 The holes in the defense layers arise for two reasons:
active failures and latent conditions.

 Active failures are the unsafe acts committed by people who

are in direct contact with the patient or system. They take a
variety of forms: slips, mistakes, procedural violations.

 Active failures have a direct and usually short-lived impact on

the integrity of the defenses.
 Latent conditions
 Latent conditions are the inevitable “resident pathogens” within
the system. They arise from decisions made by designers,
builders, procedure writers, and top level management.

 Latent conditions have two kinds of adverse effect: they can

translate into error provoking conditions within the local
workplace (time pressure, understaffing, inadequate
equipment, fatigue, and inexperience) and they can create
long-lasting holes or weaknesses in the defenses
(untrustworthy alarms and indicators, unworkable procedures,
design and construction deficiencies)
 Latent conditions may lie dormant for years but can be
identified and remedied before an adverse event occurs.

 Understanding this leads to proactive rather than reactive risk

management.

 Do we keep swatting the mosquitos to prevent bites or drain

the swamp where they breed.
Error management- High reliability organizations
 High reliability organizations—systems definition:
 They operate in hazardous conditions but have fewer than
their fair share of adverse events.

 They include: US Navy nuclear aircraft carriers, nuclear

power plants, and air traffic control centers.

 They manage complex, demanding technologies so as to

avoid major failures and maintain the capacity for meeting
periods of very high peak demand.
High reliability organizations

 They expect to make errors and train their workforce to

recognize and recover them.

 Instead of making local repairs, they look for system reforms.

 A system/organization’s reliability is “a dynamic non-event.”

Dynamic because safety is preserved by timely human
adjustments; it is a non-event because successful outcomes
rarely call attention to themselves.
Healthcare applications
 A high reliability organization anticipates the worst and equips
themselves to deal with it at all levels of the organization.

 This approach the author contends can be applied to

medicine and clinical practice.

 Though a hospital is far removed from a nuclear power plant

just as many potential (but different) problems could occur.
The key is making the system as robust as is practicable in
the face of its human and operational hazards.
The Swiss cheese model of defense quickly became adopted during the CoVID pandemic
Quality Improvement Made Simple
By The Health Foundation
UK National Health Services
April 2021
Introduction
 There is no universally accepted definition of ‘quality’.
However, the majority of health care systems around the
world have made a commitment to the people using and
funding their services to monitor and continuously improve
the quality of care they provide.

 In previous lectures we have looked at the notion of quality,

quality control, quality assurance, quality improvement and
quality management and how these concepts fit together.

 This lecture will focus on how quality improvement can work

Healthcare Quality
 United Kingdom National Health Service (NHS) definition
of healthcare quality:

 Care that is effective, safe and provides as positive an

experience as possible by being caring, responsive and
personalized.

 Care should be well-led, sustainable and equitable

(reducing variation and inequalities)
 What does Quality Improvement Involve?
 Quality improvement is about giving the people closest to
issues affecting care quality the time, permission, skills and
resources they need to solve them.

 It involves a systematic and coordinated approach to solving

a problem using specific methods and tools with the aim of
bringing about a measurable improvement.
Examples of what QI can do
 Improve patient access to their Doctor/GP.

 Streamline the management of hospital outpatient clinics.

 Reduce falls in care homes.

QI Potential
 QI allows the potential to create a health care service
capable of ensuring:
 no needless deaths
 no needless pain or suffering
 no helplessness in those served or serving
 no unwanted waiting
 no waste
 no one left out
How to Improve Quality

 A long-term, integrated whole-system approach is needed

to ensure sustained improvements in health care quality

 Establishing effective leadership for improvement

 Creating governance arrangements and processes to

identify quality issues that require investigation and
improvement
What does QI involve?
Identifying the quality issue

Understanding the problem from a range of perspectives

Developing a theory of change

Identifying and testing potential solutions

Implementing the solution

Understanding the Problem
Before thinking about how to tackle an improvement problem, it
is important to understand how and why the problem has
arisen.

Take the time to do so, use a variety of data and in

collaboration with a range of staff and patients.

Use a cause and effect or ‘fishbone’ diagram, to identify all

potential causes, not just those that are most obvious.
Example of a cause and effect or fishbone
diagram

The Problem
 Process mapping
 After identifying likely causes to the problem investigate them
further, such as patient interviews, surveys and process mapping.

 Process mapping is a tool used to chart each step of a process. It

is used to map the pathway or journey through part, or all, of a
patient’s health care journey and its supporting processes.

 Process mapping is especially useful to engage staff in

understanding how the different steps fit together, which steps add
value to the process, and where there may be waste or delays.
Example of a
process map
Designing Improvement
 It is important to allow enough time to design an
improvement intervention and plan its delivery.

 A driver diagram is a useful way of capturing these key

issues and identifying the activities required to tackle them.

 A logic model, is a tool which sets out a theory of change

about how an intervention is supposed to work.
Example of a
Driver
Diagram
Logic Models
 The following slide is a logic model detailing possible steps
to address mental health and its relationship with chronic
disease prevention and health promotion.

 Logic models can be seen and referred to as road maps.

Example of
a Logic
Model
Data Measurement
 Measurement and gathering data are vital elements of any
attempt to improve performance or quality and are needed
to assess the impact against set objectives.

 Measuring for improvement aims to identify the changes that

occur while the intervention is being tested so that the
intervention can be refined over time in response to these
data.

 Identify a baseline and then carry out measurement at

Date measurement using statistical process control
Important to measure ‘what would have been’ without the
intervention, bearing in mind any potential external causes of
change seen in measurement.

This can be done using statistical process control (SPC), a

method that examines the difference between natural variation
(common cause variation) and variation that can be controlled
(special cause variation).
SPC uses control charts that display boundaries
(control limits) for acceptable variation in a process.
Improving reliability
 Ensuring reliability mitigates against waste and defects in the system
and reduces error and harm.

 Analysis of high reliability organizations, many of which can be found

in industries that have developed and sustained high levels of safety,
such as commercial aviation and nuclear power industries, has
identified a number of common attributes and behaviors. Such as:

 staff routinely looking for and reporting minor safety problems and
sharing a willingness to invest time and resources in identifying and
learning from errors.
 Demand, capacity and flow
 Some backlogs and delays in health care services are attributable to
resource shortages or increases in demand. An example is the
backlog of appointments and procedures created by the COVID-19
pandemic.

 However, not all delays are the result of capacity problems. It may be
that the capacity is in the wrong place or is provided at the wrong
time.

 it is necessary to measure the demand (the number of patients

requiring access to the service) and the flow (how and when a need
for a service is met).
Relational aspects of improvement
 Evidence about successful quality improvement indicates that the
method or approach used is not the sole predictor of success, but
rather it is the way in which the change is introduced.

 Factors that contribute to this include leadership, effective

communication, staff engagement and patient participation, as
well as training and education.

 Clinicians (doctors) are more likely to engage with the process if

the motivation and reasons focus on improving the quality of
patient care rather than on cost-cutting measures.
Relational aspects of improvement
 Ensure all relevant staff are engaged, not just clinicians.

 Managers can help to ensure that improvement is

embedded into standard practice.

 Non-clinical staff, who are often the first point of contact for
patients, play a key role in improving care.

 Breaking down traditional hierarchies for this

multidisciplinary approach is essential.
Patient involvement
 Discuss what matters most to patients and where they think
improvement efforts should be focused.

 Trust, openness and an ability to listen respectfully are key to

the success of these discussions.

 Confront any power imbalances among participants, to avoid

making it difficult for some participants to contribute equally.
 Effective team building

 Treating each other with respect and courtesy, listening carefully to the
views of others and valuing their ideas, regardless of their hierarchical
position.

 Foster a willingness to learn together and a sense of humility among

members.

 Any team disagreements should be resolved through open discussion.

 Ask questions clearly and frequently.

 Share knowledge and thoughts in a focused and timely fashion.
Quality Improvement Approaches and Methods
 Many of today’s quality improvement approaches and methods
were originally developed in industry and have been adapted for
use in other sectors, such as health care for the past 30 years.

 Quality improvement techniques pioneers include W Edwards

Deming, Joseph Juran and Kaoru Ishikawa (fishbone diagram).

 More recently, Don Berwick has become known for his work in
the US, leading the pioneering work of the Institute for
Healthcare Improvement.
Model for Improvement
 Continuous improvement where changes are tested in small
cycles that involve planning, doing, studying, acting (PDSA),
before returning to planning.

 Key questions:
 What are we trying to accomplish?
 How will we know that a change is an improvement?
 What changes can we make that will result in improvement?
LEAN method (began in the Japanese auto industry)
 Lean emphasizes the patient’s central position to all activities and
aims to eliminate or reduce activities that do not add value to the
patient.
 Five principles
 Defining what is value-adding to patients.
 Mapping value streams (pathways that deliver care).
 Making value streams flow by removing waste, delay and
duplication from them.
 Allowing patients to ‘pull’ value, such as resources and staff,
towards them, so that their care meets their needs.
 Pursuing perfection as an ongoing goal.
Clinical microsystems
 These are small groups of people who work together
regularly to provide care to a specific group of patients.

 Focuses on patients, people, patterns, processes and

purpose.
Experience based co-design
 It aims to improve patients’ experience of services,
through patients and staff working in partnership to
design services or pathways.

 Data are gathered through in-depth interviews,

observations and group discussions and analyzed to
identify ‘touch points’ – aspects of the service that are
emotionally significant.
Examples of experience based co-design
Improving patient care can reduce costs and boost
productivity.
 The potential for cost savings can be realized by
addressing:

 delays, such as waiting lists for diagnostic tests

 reworking, in other words, performing the same task more
than once
 overproduction, such as unnecessary tests
 unnecessary movement of materials or people
 defects, such as medication errors

Have you had
any
experiences
here?

Can you see

any
places/ways for
improvement?
Hazard Analysis Critical
Control Point
From CFIA website
 Goal is to find, correct and prevent hazards throughout
the food production process.

 Hazards include biological, chemical and physical

hazards.

 In use worldwide since the 1960s.

 In 2005, HACCP became mandatory in
Canada for federally-registered meat and
poultry establishments.

 In federally-registered fish establishments, the

principles of HACCP are followed under the
Quality Management Program, or QMP.

 HACCP is not mandatory in federally-

registered dairy, processed product, egg,
honey, maple and hatchery establishments.
However, the CFIA strongly recommends that
these establishments adopt HACCP.
Seven universal principles used in
every country that follows HACCP
system
1. Hazard analysis. Identify all possible hazards. Make
a plan. Example. Salmonella bacteria may survive
due to inadequate cooking time or temperature.

2. Identify critical control points. Example. The cooking

step.
3. Establish critical limits for each CCP.
Ex. 85°C
internal temperature needed to kill
Salmonella
in turkey. Cooking time depends on
weight. Leg
must move easily, no pink juices
apparent, meat
must be tender.*
5. Establish corrective actions. Example.
Cook turkey longer if temperature is not
achieved and/or leg doesn’t move easily or
juices still pink.

6. Establish verification procedures. Are tests,

procedures etc. working right. Example. Is
the thermometer reading accurate
temperatures?

7. Record keeping.
http://haccpcanada.net/
 Design Thinking in
Healthcare
Many aspects of design and design thinking can be
incorporated in improving quality in hospitals and healthcare in
general

Incorporating material from FutureLearn and

Saint George’s, University of London, and other sources.
Design thinking introduction
 Design thinking is a process for creative problem-
solving.
 It involves asking the right questions.

 It involves tackling problems from a new direction.

 Three aspects are:

 Design thinking aims to find out how people think,
behave and act in an effort to understand what they
really want and need.

 Design thinking takes a holistic approach.

 The emphasis of design has shifted from ‘things’, to

services and experiences.

 The modern day user experience is sometimes more

important than the product itself.
 Design thinking is not a fixed approach, rather it is a
set of tools, methods and ways of thinking that can be
applied in many different aspects to many different
challenges.

 Consider it a strategic tool, integrated into a bigger

vision of how people experience the world around
them.
Design and Healthcare
 Designers recognize that healthcare providers operate in
a particular set of conditions that are not easily paralleled
in other industries, including commerce and business.

 As more designers spend time in health and social care

environments, the culture and methods of design in
various areas (industry to architecture)are evolving to
meet the unique challenges of health and social care.
Problems of Problem Solving
 Many health and social care systems are inherently
inefficient and struggle to cope with increasing and
changing demand.

 Ageing populations (in many countries-not all), long

term conditions and co-morbidity has put the
government health services under unprecedented
strain.
 Patient expectations are changing.

 People embrace ‘digital’ in almost every part of our

lives (smartphones, tablets, wearables)

 People not only want, but demand, more involvement in

their care, including how and when it is delivered.

 Patients want and, increasingly, expect to be able to

manage routine healthcare services online.
 Badly designed technology can increase inefficiency,
and end up requiring costly ongoing ‘fixes.’

 Digital innovations need to be based around real

human need and behavior, and built with the
involvement of the people that will use them.

 Innovation still fails in health and social care.

Reasons?
Barriers to innovation
 Procurement: The emphasis on cost over quality makes it harder to
ensure that service users are being properly safeguarded and cared for.

 Poor execution: Too much emphasis on generic management

consultants.

 Work culture: Protectionism, people worried about their jobs or their

egos get in the way. People tire of being told how to ‘improve’ by distant
managers at the top of the chain.

 Legacy infrastructure: Health systems and pathways which are not fit for
purpose anymore; for staff, hospitals or patients. Systems simply
Why Design Thinking
 Design thinking offers different ways to develop
services around people’s needs, to work openly and
collaboratively, reducing risk through iterative
development, continual testing, user feedback and
improvement.

 One of the most powerful tools of persuasion is

demonstration. Design is all about making things
visual, tangible and real as quickly as possible to show
Design thinking allows:
 Focusing on user needs

 Reducing risk through user testing

 Creating tangible outputs as early as possible

Examples of Strategic Design in Healthcare
 Mayo Clinic Center for Innovation (MCCI) (US): Offers a
multidisciplinary team to turn innovative ideas for
medical practice into practical solutions that change
how patients receive healthcare.

 It incorporates its own purpose-built incubator - a studio

where patients can walk through and use prototypes of
new products and services.

 See following photos.

Inside MCCI
Inside MMCI
Inside
MMCI
United Kingdom Digital Services Design Principles
See Link
https://www.gov.uk/guidance/government-design-principles

1.Service design starts with identifying user needs.

2. If we’ve found a way of doing something that works, we should make
it reusable and shareable instead of reinventing the wheel every time.
3. Let data drive decision-making, not hunches or guesswork.
4. Do the upfront hard work to make things simpler.
5. The best way to build good services is to start small and iterate
wildly. Test and retest.
6. Accessible design is good design. Everything we build should be as
inclusive, legible and readable as possible.
7. Understand the context in which people are using our services.
Are they in a library? On a phone? Are they only really familiar with
Facebook? Etc.

8. Build digital service (something that helps people to do

something) not just websites.

9. Use the same language and the same design patterns wherever
possible. But when this isn’t possible make sure our approach is
consistent.

10. Share what we’re doing whenever we can. With colleagues,

with users, with the world.
Jefferson Health Design Lab
 Established by a practicing emergency clinician who wanted to learn skills
for problem-solving in the ER, the lab began as an elective course in design
thinking for undergraduate medical students and has evolved into a creative
lab that uses human-centered design to reimagine healthcare inside and
outside the walls of the hospital.

 https://www.healthdesignlab.com/

 Watch the video talk below by Dr. Bon Ku of the Health Design Lab
 ‘Inspiring the Future of American Health Care’, He talks about how
design thinking prevented him from ‘burning out’ as an emergency
physician.
User-centered Design
 Focuses on the user of a product, service or process to
maximize revenue or efficiency through a good user
experience.

 The over-arching philosophy is that the experience is

built around the user, to the point the user barely
notices the process, as the experience is easy,
enjoyable and seamless.

 Within the design industry, user-centered design is as

User-centered good design example
 Apple iphones/ipads (this is not an ad, just a good
example)
 Excellent reliable product/performance

 Highly engineered

 A whole experience is built around it: iconic Apple stores to

iTunes, to slick packaging, white classic ear buds (air

pods), apps, etc.
 Whole beginning-to-end experience, from consideration,

to purchase, to use, to renewal (repurchase).

User-centered bad design example
 Users should not do the design. The design should be done
for them, the user. In this humorous cartoon Homer Simpson
is given the chance to design a car by his brother. It was a
bad idea.

 https://www.youtube.com/watch?v=WPc-VEqBPHI
Double Diamond Design Process
 The Double Diamond is a schematic meant to visually
convey a design process.
 The two diamonds represent a process of exploring an issue
more widely or deeply (divergent thinking) and then taking
focused action (convergent thinking).
Or Solution
Problem

Problem
definition at
cross point
 Discover. The first diamond helps people understand, rather
than simply assume, what the problem is. It involves speaking
to and spending time with people who are affected by the
issues.
 Define. The insight gathered from the discovery phase can
help you to define the challenge/problem in a different way.
 Develop. The second diamond encourages people to give
different answers to the clearly defined problem, seeking
inspiration from elsewhere and co-designing with a range of
different people.
 Deliver. Delivery involves testing out different solutions at
small-scale, rejecting those that will not work and improving the
ones that will.
Discovering and defining the problem
 Design projects usually start with a problem defined by
a client (ex. health authority). The double diamond
illustrates a process of better understanding what the
problem is from the user’s (patient) point of view. The
is the discover phase or the first part of the Double
Diamond.

 The design team will then be able to address the true

problem. This is the problem definition will eventually
will allow people to start building solutions.
Underlying Principles of Design
 Design is user-centered. (this does not mean the user designs the
system though).

 Design communicates visually. Use fewer words, more diagrams

and sketches. Demonstrating rather than telling, be simple about it.

 Design is collaborative. The more involved the better the process

and result.

 Design is iterative. Ideas are refined and iterated through

prototyping, sometimes many times over.
Who are the Users in Health and Social Care
 Users of a product or service are the people who interact
with that product or service.
 The end users in healthcare are patients.

 The people who make the product or service work.

Clinicians, caregivers, cleaners, porters, receptionists,
administrators, volunteers or even family members.

 A well-designed product or service should work for all of

these people (users).
Services
 Services involve a number of people with quite varied roles,

interests and specialisms.

 Example:

 A child goes to the emergency room with a broken

collarbone. Child (and parent) will interact with a receptionist

or nurse, a triage nurse, a paramedic or doctor, possibly a
student nurse, a radiology receptionist, and a radiographer
(for X-rays)
 They may have also seen their family doctor (GP) as well.

 Inventory management has made sure that there is a stock of

child-size slings available.

Visualization
 Use different ways to visualize a patient’s journey through a
healthcare system. Sketches, cut out printed materials,
LEGO, Plasticine (modelling clay).

 Have everyone involved in a patient’s journey be involved in a

mapping session. Including doctors, nurses, consultants,
administration staff, physiotherapists, patients themselves.
LEGO block office set-up
Plasticine
coronaviruses
Simple sketch
to visualize a
patient
journey
Collaboration
 In health and social care, any innovation or problem-solving
involves a range of interests.
 Who would you need to report back to?
 Share learning with.
 Get buy-in from.
 Who could be a block to innovation?
 Is there anyone outside of your area of work who could provide
key information or inspiration, or who might think differently?
 All perspectives are valid, and there is no hierarchy of ideas.
Often times receptionists are the gatekeepers in healthcare.
They often are the first person a patient meets.
Iteration
 Iteration is the repetition of a process.

 Designers will develop ideas and concepts, test them with

users, then use the feedback to change and improve the
solution in its next iteration.

 Build simple prototypes and allow users to interact with it. If

you’re designing a service, you might create a ‘walk-through’
prototype, mocking up a clinic with paper signs and tape on
the floor for walls.
Whole System Thinking
A way of looking at a service as
part of a wider, interdependent set
of sub-systems, relationships and
interactions, rather than as an
isolated process.
DISCOVERY PHASE

Discovery Phase-Approaches/Methods
 Ethnography:
 Immerse yourself in an environment and watch people interact
with the situation and with other people (You may use video or
audio) to gain a deeper insight into how people react to a
situation, product, service or process.

 In-situ interviews:
 Shadow a worker and talk to them about their tasks. This
captures some immediate feelings, anxieties and reactions to
a situation. It captures non-verbal cues as well.
Discovery Phase-Approaches/Methods
 Journey Mapping
 A visual representation of the journey a user goes through
from start to finish, often using post-it notes, mapping out each
step of the journey. Shows where the key touchpoints are,
where there are goals, inefficiencies and frustrations.
Discovery Phase-Approaches/Methods
 Personas
 Create a set of hypothetical service users — these might be based on
real users, or potential users of a new service, to allow us to test our
assumptions. The personas play out the users stories.

 Use personas to consider extreme users or situations, for example,

patients who experience frequent pain as a result of a chronic condition.

 User stories
 Short descriptions of the actions of a particular user or group of users
that explain how they came to interact with the product or service, from
the perspective of the user.
An example of a persona
Discovery Phase-Approaches/Methods
 Empathy Map
 Visually map out what users see, hear, think and do and
how they feel about something, and how different users
empathize with each other.
 Why do people behave in a certain way?
 Questions your own assumptions?
 Be curious about others.
 Know the difference
 Empathy means people feel with you.
Sympathy Empathy
 Discovery Phase-Approaches/Methods
 Empathy Map examples. Consider an out patients clinic.
Assume you are a patient waiting to be seen.

 Sit in a waiting room for two hours.

 Ask for help locating an appropriate washroom.
 Ask if you can make a call on the office phone because you
do not have one and it is getting late.
 Start acting as if you are getting weak or in pain and time how
long it takes for someone to check on you.
Empathy mapping example
The designer is discussing with staff how patients use a commode, not
always an easy thing to do or feel comfortable about.
Discovery Phase-Approaches/Methods
 Scenarios
 Imagine or create different scenarios and walk real users
through those scenarios or use personas to imagine how they
might respond in different situations.
 Example:
 In an outpatient department present a persona with three
different scenarios.
 Losing their appointment letter
 Attending an initial cancer screening appointment
 Being called in to get the results of a lab test for tuberculosis
Discovery Phase-Approaches/Methods
 Service Safari
 Walk through the area under study. Take photos, record
audio, pick up artefacts (pamplets). See what you discover.
This helps to experience the user journey.

 Desk Research
 Read literature, websites, etc. Check user reviews of these
services. This helps to understand what is being done
elsewhere.
Discovery Phase-Approaches/Methods
 Project Space
 Locate a big wall or board where you can stick up photos,
images, maps and lots of post-its. People should be able
to move around, interact with each other and with the
evidence, etc.

Not always easy to find such a

space as this though.
DEVELOP PHASE

Develop Phase
 Allows you to:
 Learn from tangible prototypes
 Build solutions that work for users, with live feedback

 Reduce risk and cost through testing and iteration

 Reduce the time needed for implementation, by testing how elements of the
solutions work within current processes, systems and environments
 Gain buy-in from users and prospective users through collaboration and
giving people space to interact with tangible prototypes and feed into the
development process

 Identify where the real value lies

Develop Phase
 Designers can draw on successful methodologies used in the
business world, such as LEAN and AGILE.

 LEAN theory is a way of thinking about business processes that

focuses on achieving the most value for users or customers and
eliminating waste and inefficiency. Testing is to enable learning,
rather than to validate a finished product.

 Failure is considered a positive and natural part of the

development process, and the methodology builds in the
flexibility for development to change if something doesn’t work.
Develop Phase
 Using LEAN the process of testing, failing and learning
can ultimately reduce risk and create a better service in
many aspects of healthcare.
Develop Phase
 AGILE (Began in software development world)
 Is a way of working that does not stipulate or prescribe an
end result, but allows solutions to evolve through
collaborative, cross-team working, and testing, with a
continuous process of learning, iteration and improvement.

 Those working in healthcare interact with IT systems that

are not fit for purpose, but are too expensive to change or
fix, and which have not been designed in collaboration with
users. Agile methodology aims to avoid this.
Develop Phase
 Both LEAN and AGILE can make use of another design idea
- the Minimum Viable Product (MVP)

 A MVP is the most basic version of your solution that you can
make ‘live’ i.e. that you can put out to market or put into
practice for real users to interact with it.

 For healthcare professionals with limited spare time or

resource, the MVP is an essential tool, but can sometimes be
hard to communicate to budget-holders who want to know
what the finished product will look like, and how much it will
Develop Phase
 Rapid Testing
 Good designers should be able to find a way to prototype or
test anything; a product or service. (this of course is different
from randomized control trials for drugs and vaccines as the
CoVID pandemic has made us all aware).

 This is a cardboard prototype of a

take home patient sampling system
A simple mock-up of a portable insulin device that allows people
to give feedback on the size, the contents of the pack, and the
labelling.
Prototype actual floor model and cardboard model for changes
to improve performance (decrease wait times, etc.) at
Whittington Pharmacy Hospital in North London
CBRM Health Care Redevelopment Project
 This project includes the eventual building of a clinical services
addition that will include an emergency department, critical
care department, 72 in-patient beds and surgical suites at the
Cape Breton Regional Hospital. Plus an expansion of Glace
Bay Hospital’s emergency department and surgical services.

 The project has taken over the warehouse area of the former
Scotsburn Dairy in Sydney where two and three-dimensional
mockups of future hospital rooms are temporarily housed.
Troy Penney, clinical director, CBRM Health Care Redevelopment Project, shows a
mockup unit
CBRM Health Care Redevelopment Project
 Staff of the Highland Arts Theatre in Sydney helped create a full-
size mockup of various hospital rooms that will be found in both
facilities, from patient rooms, and emergency rooms to a suite of
operating rooms.

Nurses, doctors, technicians and patients have been walking through

the spaces looking for problems.

“what we’re trying to do here in the redevelopment project is to get it

right so we can provide space that will be effective and efficient to
use so we can provide the best care possible”
Dr. E. MacMullin, Senior Med Director of the project
Kayla Cormier, technical director at the Highland Arts Theatre, moves the model of a CT
A mockup of a typical preparation/recovery room that you might find in any hospital
CBRM Health Care Redevelopment Project
 “it’s allowed us an opportunity to really get into the space
and mockup and pretend that we’re using it in real life. And
that allows us to make changes ahead of the construction.”
Cathy Lynn Howley, director of preoperative services

For more details see here:

https://www.saltwire.com/atlantic-canada/news/mockups-allo
w-cape-breton-medical-professionals-to-see-spaces-before-th
eyre-built-100651848/
 Develop Phase. Additional approaches
 Concierging:

 Test your MVP by literally walk them through the process

and ask for feedback along the way.

 Appropriation:

 Look at existing solutions and use what work for your

users. Learn from others, build on that learning. This can

save time and money.
 Blueprinting:

 A service blueprint is a highly detailed, visual tool that

maps out the end to end service, including all user

interactions, bottlenecks and other problem areas.
Delivery Phase
Delivery Phase
 Delivery is the business phase. It's about getting things live
and continuously evaluating and integrating them.

 Understand that in almost all countries and jurisdictions health

care is driven by policy and politics.

 If design and design thinking is understood as a value process

then it has the capacity to inspire and enable change. The rate
of change is limited by budgets, culture and politics.
An example of a urine sample collection cup – PeeCanter-
after other models did not work with users.
© Alpha Laboratories
Delivery Phase
 Phasing:
 A way to launch your MVP in stages, adding additional
layers of complexity each time.

 This is an ongoing process, adding features or services, or

rolling out your solution in different geographies or to
different departments in a phased approach.
Delivery Phase
 A/B testing:
 This is a simple way of finding out which version of a service
your users prefer, A or B.

 It uses small, simple changes to get very quick feedback

about what works best, and allows you to make rapid
improvements with minimum fuss.

 This is all happening when the solution is ‘live’, when real

people are using the product or service.
Delivery Phase
 A/B testing examples:

 Ex: If you’re redesigning a patient questionnaire, you can trial

two different versions of the questionnaire, and observe how
patients respond, and which version gives you the information
you need.

 Ex: If you’re redesigning a process for transporting patients

from one place to another. You might test the process at
different times of day to see what works best.
Delivery Phase
 Feedback loops:
 A means of building continual learning into your development.
There are many ways to do this.
 Examples:
 User-led evaluation with group feedback sessions.
 Observing users/patients as they use the product or service.
 Talking to users/patients as they go through the journey.
 Talking to people who help users, like porters, social workers,
etc.
 Direct feedback via social media, telephone, online reviews,
comments boxes.
Design thinking conclusion
 Design thinking is very accessible. If you have a pen, some
post-it notes, and a wall, you can try most of the methods
discussed.

 Gather a small ‘team’ together and start to brainstorm ideas

about the problem you want to tackle.

 Collaboration lends itself to creativity. There are ways and

means to test your assumptions and start to solve a problem
with only a small investment of time.
Members of Nova Scotia Health’s Eastern Zone medical team are shown in a mockup of an operating
room.
WRONG