Business Excellence through

Integrated Quality Management

Systems in Healthcare

Chaitanya Baliga, ASQ –CQA,CQMOE,CSSGB

ASQ CANADA CONFERENCE

National Conference 2017

September 26, 2017

Atelier B, Canadian War Museum

11AM-12 noon

Canada Post Group of Companies

End-to-End Supply Chain

Canada’s leading supply

chain solution provider

Trusted by clients in E-

commerce, Retail,

Technology, and

Healthcare

B2C Final Mile Delivery

Canada’s leading

consumer delivery

network

Delivering more e-

commerce parcels

than anyone else in

Canada

Canada’s leading

integrated freight and

parcel solutions

provider

Customs clearance

and transport from US

to Canada

B2B/Urgent B2C Courier

Canadian Focus Largest Network Financial Stability

Canada Post Group of Companies delivers 75% of e-commerce shipments in Canada

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A paradigm shift is a major change in method and intellectual process in order

to accomplish a task. - Ray Kurzweil, The Law of Accelerating Returns

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First MechanicalWeaving Loom

First Assembly Line First ProgrammableLogic Control System

Cyber - Physical System

Industrial Revolution 1.0 Industrial Revolution 2.0 Industrial Revolution 3.0 Industrial Revolution 4.0

1784 1870 1969 2015

Industrial Revolution

Introduction of

mechanical

production facilities

using water and

steam power

Mass production with

help of electrical

power

Application of

electronics and IT

to automate

production

Merging of

real and

virtual worlds

with Cyber

Physical

System

Com

ple

xity

of

Technolo

gy

Quality Control

Quality Assurance

Physical System Cyber System

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Product Life Cycle

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Future Trends in HealthCare

• Global Optimization – global procurement and emerging

economies

• Pressure on cost and prices

• Launch of new services – local service provisions/spare

parts and one-stop shops

• New process Innovations

• Customer focus and customer –specific adaptation

• Efforts to reduce lead times, new forms of marketing and

distribution channels (e-commerce)

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Systems Approach

A model of an organisation by Harold Jack Leavitt – a systems approach, based on Leavitt, 1965, p. 1144.

Process

Structure

Technology

People

Goals and Task

Inputs:

Resources

Materials/

Capital/

Human

Outputs:

Products/

Services

Environment: Competitors, Regulations, Clients

Organizational Boundary

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EXTERNAL

ENVIRONMENT

INTERNAL

ENVIRONMENT

Regulated Industry

Technology in Industry 4.0

Smart building

Smart Mobility

SMART

Factory/Service

Social/ Business

Web

Smart Logistics

Smart Grid

Internet of Data

Internet of People

Internet of Things

Internet of Services

Increasingly digitalized processes

an exponential growth of sensible data! Process

Structure

Technology

People

Goals and Task

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Quality Policy and Quality Objectives

Quality Planning

• Systemic and Process Approach

Quality Assurance

• Proactive Upstream Approach

Quality Control

• Reactive Downstream Approach

Quality Improvement

• Improve System Efficiency and Effectiveness

Quality Management System

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Process

Structure

Technology

People

Goals and Task

Quality Policy and Quality Objectives

• Systemic and Process Approach

• Resource Management / Management Review Quality

Planning

• Proactive Upstream Approach

• Audits, Supplier Evaluation, Document Management, Training Quality

Assurance

• Reactive Downstream Approach

• Inspection / Sampling Quality Control

• Improve System Efficiency and Effectiveness

• Continuous Improvement, Non-conformance Management, Customer Feedback / Regulatory Compliance

Quality Improvement

Quality Management System

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Structure: Baldridge Criteria for Performance Excellence

Award process administered by the American Society for

Quality (ASQ) and managed by the National Institute of Science

and Technology (NIST)

Core concepts:

• Visionary leadership

• Customer-driven excellence

• Organizational and personal learning

• Valuing employees and partners

• Agility

• Focus on the future

• Managing for innovation

• Management by fact

• Social responsibility

• Focus on results and creating value

• Systems perspective

Process

Structure

Technology

People

Goals and Task

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Dimensions in Data Management

Relevance

Accuracy

Timeliness

Comparability

Usability

Accessibility

Interpretability

Coherence

Understandability

Completeness

Wisdom

Knowledge

Information

Data

Tacit Knowledge

Explicit Knowledge

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Data Gathering and Analysis

7 V’s of Big Data – Industry 4.0

Attributes Description Measure

Volume Data at “rest” 2.5 Quintilian bytes of data is created every

day: measured in Zettabytes (ZB) or even

Yottabytes (YB).

Velocity Speed in which data is accessible:

Streaming data.

50,000 GB/sec – estimated rate of global

internet traffic by 2018

Variety Data in many forms: Structured,

unstructured, text, multimedia, etc.

90% of generated data is “unstructured”

Variability Meaning of Data is constantly

changing

Impacts on data homogenization

Veracity Certainty of Data Poor data quality costs economy and

business

Visualization Large amounts of complex data

effectively conveying meaning

Charts and graphs

Value

Ability to achieve greater value

though insights from analytics

Predication capability with 97% accuracy

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Industry 4.0 Health Platform

Voice of Customer

Suppliers Manufacturing Sales/

Marketing Consumers/ Customers

Connected Product

Connected Product

Platform

Big Data

= Value

Recurring

Revenue

User usage

Monitoring

Support

Connected Customer

Value Chain Optimization

Besides B2B and B2C, there is M2M and bridging distances over and through complete value chains.

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*Source: The Fourth Industrial Revolution VINT Research report 3 of 4, 2014

Quality in Industry 4.0

Deep integration of quality management methods and

processes, such as quality risk analysis and validation.

Recurring

Revenue

User usage

Monitoring

Support

Connected Customer

Systematic evaluation

of online customer

feedback

- An early indicator for

quality issues and

future growth

Remote diagnosis and

maintenance of quality issues in

the field

- Increase quality of service and

cost reduction

Big Data

= Value

Systematic analysis of quality

sensors/cross-functional data

- Preventive / quality assurance

Durability and reliability data, defect / non-conformance data

- to predict performance and warranty costs

Value Chain Optimization

Validation of entire systems per customer function consisting of hardware, software,

and datasets to increase systems quality.

Supplier quality performance data along the value chain to identify and predict issues

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Digital transformations is the connection of hardware,

software and services to data and digital content.

End-to-End (E2E) Value Chain

Digitisation and integration of vertical and horizontal value chains.

Vertical Integration is from product development and purchasing, through

manufacturing, logistics and service. All data about operations processes, process

efficiency and quality management, as well as operations planning are available real-

time, supported by augmented reality and optimised in an integrated network.

Horizontal integration stretches beyond the internal operations from suppliers to

customers and all key value chain partners. It includes technologies from track

and trace devices to real-time integrated planning with execution.

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Product and Service Offerings Digitisation of products includes the expansion of existing products,

e.g. by adding smart sensors or communication devices that can be used with

data analytics tools, as well as the creation of new digitised products which focus

on completely integrated solutions.

– integrating new methods of data collection and analysis to generate data on

product use and refine products.

– Using global standards such as GS1® Global Trade Item Numbers (GTIN®),

GS1 Global Location Numbers (GLNs), and data exchanges such as the

GS1 Global Data Synchronization Network (GDSN®) by pharmaceutical,

medical device manufacturers and hospitals are

Note: Leverage standards as a foundation for collaboration across the value

chain – enabling new processes and capabilities that create both patient and

business value.

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Global Standardization in HealthCare

Improving patient safety and supply chain efficiency:

• Bedside scanning - reducing errors in the hospital;

• Targeted full recall administration: Efficient and effective recall administration

• Medication receipt authentication: Distributors, pharmacies, and hospitals could use

barcodes to track and validate all medications against data from manufacturers and supply

chain points – To deter counterfeit and compromised products to reach patients, and reimbursement fraud.

• Traceability of medical devices: Supply chain partners could use barcodes to track

medical devices through the supply chain according to their risk category, and for the

appropriate class of products

• Inventory management collaboration between dispensing / usage points and

manufacturers, and product availability data from manufacturers to pharmacies and

hospitals;

• Transaction automation: Automated transaction and data-sharing that eliminate manual

data entry, validation and correction, reducing errors and costs

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Business Models and Customer Access

Disruptive digital solutions - complete, data-driven services

and integrated platform solutions

Disruptive digital business models - focused on generating

additional digital revenues and optimising customer

interaction and access.

Information

Technology Business/ Office

Process Automation

Operational Technology Industrial / Engineering/

Factory Process

Automation

Internet of

“Things”

Digital Ecosystem

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*Source: The Fourth Industrial Revolution VINT Research report 3 of 4, 2014

Industry 4.0 Impact on Healthcare

Remote patient monitoring with smart phone

and smart body sensors! Key Impact: For example: Compliance with Health Insurance Portability and Accountability Act

(HIPPA) throughout the Value Chain

• Secured communication channel to protect patient

confidentiality and sensitive patient health data – Cyber Security: Data needs to be encrypted, transmitted and decrypted

Privacy Legislation

Contractual Agreements

Standards/

Guidelines

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Some of the risks that come with regulations failing to keep up with new

healthcare technology affect security and data privacy, increase the costs

of healthcare, and limit the user experience.

Regulations

As technology has improved, it is easier and easier for hackers to gain

access to private information.

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Process

Structure

Technology

People

Goals and Task

Impact on Quality Management System

People - Competence

-Leadership

-Culture

- Collaboration

Technology - Application Development

- Connectivity

- Scalability

Process - Compliance

-Management System

- Data Analytics

Innovative new quality

management approaches!

Innovative quality

methods such as

real-time community

feedback, big data,

or predictive

quality management

enable next-level

quality performance.

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Big Data

= Value

Business Excellence Approach for Integrated Quality

Management System

Inputs

Internal Data Sources

Audits

Inspections

CAPA/ NCR

Customer Agreements

Customer SLA’s

Service Levels

Operational Metrics

Change Control

External Data Sources

Changing Regulations/

Quality systems

Guidance Documents

Industry Trends

Customer Requirements

Compliance

Planning

Continuous

Improvement

(CI) Projects

Quality

Assurance

Other Projects:

Business

Development/

Solutions

Qu

arte

rly C

heck

-In

Management

Review

Outputs

Reduce Risk

By Analytics

Risk

Repository

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Big Data

= Value

Analytics – Information Optimization Value

Difficulty

Descriptive

Analytics

- What happened?

Diagnostic

Analytics

- Why did it happen?

Predictive

Analytics

- What will happen?

Prescriptive

Analytics

- How can we

make it happen?

Approach

Performance

Compliance

1 Broken

2 Point Solutions

Minimized Quality Approach

• Regulatory Scrutiny High

• Fire-fighting

• Defensive culture

3 Fully Engaged

Expected Approach

• Well Defied QMS

• Sufficient Staff/Skill Sets

• Adequate Data processing

4 Process Driven

Compliance

Sustainable Compliance

• Efficient Data Centre

• Fast Effective Quality

decision

• Continuous improvement

Prevent

Integrate

Remediate

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Quality Control

Integrated Quality Management System

Business Excellence

Quality Assurance

Compliance

THANK YOU FOR YOUR ATTENTION

Chaitanya Baliga 31

The mind of the beginner is empty, free of

the habits of the expert, ready to accept, to

doubt, and open to all the possibilities.

ZEN MIND, BEGINNER'S MIND By SHUNRYU SUZUKI