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Implementing a Quality Management System
World Quality Day Symposium – Nov. 10, 2011
A Financial PerspectiveBy
Cecil D. White
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Defining the QMS?
The benefits?
The Costs?
Is it worth it?
Presentation Topics
1
2
4
3
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What is a Quality Management System?What is a Quality Management System?What is a Quality Management System?What is a Quality Management System?
�Policies,
�Processes
�Procedures
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What is a Quality Management System?What is a Quality Management System?What is a Quality Management System?What is a Quality Management System?
�Required for planning and executing
business processes
�To meet customer requirements
�Accredited to International
Standards by a Registrar
ISO 9001:2008 is an example
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A Cultural Transition
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A PHILOSOPHY
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Change
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It Requires …..
1. Leadership
2. Determination
3. Resilience
4. Commitment
5. Engagement
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Requires Leadership
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RESILIENCE
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How to Engage your Employees?
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It Requires …..
1. Trust
2. Inspiration
3. Openness
4. Training
5. Incentives
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Create a Trusting Environment
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Be Inspirational
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Be an Excellent Communicator
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Create a Learning Evironment
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Offer Rewards & Recognition
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What are the benefits?
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�State of Preparedness
�Size of Organization
�Complexity of processes
Success Determined by
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ISO ISO ISO ISO STANDARD 10014:200610014:200610014:200610014:2006
Quality Management Guidelines
for
realizing financial and
economic benefits
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A Strategic Choice
� Effective Application of ISO 9000 QM
Principles = Financial & Economic benefits
� Financial benefit results from cost-effective
management practices within the
organization.
� Economic benefit results from improvements
in the overall worth and health of the
organization.
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ISO 9001 Management Principles1. Customer Focus
2. Leadership
3. People Involvement
4. Process Approach
5. Systems Approach
6. Continual improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships
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Derived Benefits� improved profitability, improved revenues, improved
budgetary performance,
� reduced costs, improved cash flow, improved return on
investment,
� increased competitiveness, improved customer retention and loyalty, improved effectiveness of decision making, optimized
use of available resources,
� heightened employee accountability, improved intellectual
capital, optimized, effective and efficient processes,
� improved supply chain performance, reduced time to market,
� enhanced organizational performance, credibility and
sustainability.
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Realization of Benefits
INPUTSINPUTSINPUTSINPUTS OUTPUTSOUTPUTSOUTPUTSOUTPUTSPROCESSPROCESSPROCESSPROCESS
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The Inputs1. Customer Focus
2. Leadership
3. People Involvement
4. Process Approach
5. Systems Approach
6. Continual improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships
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The Process
� Assess requirements,
� Plan activities,
� Allocate appropriate resources,
� Implement continual improvement
actions,
� Measure results to determine
effectiveness,
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Financial Benefits
� improved profitability,
� improved revenues,
� improved budgetary performance,
� reduced costs,
� improved cash flow,
� improved return on investment,
Output / Result
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Increased Productivity
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Everyone Wins
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Everyone Wins
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What are the costs?
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�State of Preparedness
�Size of Organization
�Complexity of processes
Costs Determined by
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Costs
1. Registrar
2. Internal
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Registrar1. Auditor’s Fees & Expenses
2. Application Fee
3. Registration Fee
4. Initial Assessment
5. Registration audit
6. Surveillance Audits
7. Re-registration
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Internal Cost1. Sensitization
2. Gap Analysis
3. Training
4. Documentation
5. Implementation
6. Internal Audits
7. Consultant
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Beware
of
The
Iceberg
Effect
Only
10%
Visible
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Is it worth it?
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Implementing ISO 9000:2001
A Case Study
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NHF 2003�Government Agency
�Startup company
�Provision of benefits
�Customer base – 150,000
�Single location
�Employees - 34
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Steps to ISO 9000 Certification1. Hire Quality Management Consultant
2. Conduct Gap Analysis
3. Establish Quality Policy
4. Redefine Business Processes
=> 3 Core Processes
� Individual Benefits
� Institutional Benefits
� Health Promotions
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5. Company Wide Quality Seminar
6. Prepare Quality Manual (electronic records)
5. Quality Policies
6. Quality Objectives
5. 21 Procedures
7. Establish Quality Metrics
8. Prepare Work Instructions
Steps to ISO 9000 Certification
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9. Quality Training for ALL
9. Audit Training (34 employees)
10.Appoint Lead Auditors
11.Conduct Pre-Assessment Audits (2)
12.Contract Registrar
� ISOQUAR Ltd (2005 – 2009)
� NCBJ (2009 – present)
Steps to ISO 9000 Certification
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13.Registration Audit
13.Audit Training (34 employees)
14.Conduct Internal Audits
13.2 per year
15.Surveillance Audits
13.2 per year
16.Re-Registration Audits
� 2008, 2011
Steps to ISO 9000 Certification
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How much does it cost?
•First Year – US$ 18,000
•Annual – US$ 5,000
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How much does it cost?
•First Year – US$ 18,000
•Annual – US$ 5,000
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Our Experience
�A QMS involves more that HARD
measures of quality
�SOFT Measures
�Teamwork
�Empowerment
�Management style
�Working environment
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Lessons Learnt
1.Shift in Management Philosophy
2.Culture of Continuous Improvement
3.Training is Key
4.Effective Communications
5.Recognition of Achievements
6.Results in Improved Productivity
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NHF UPDATE
�Expansion through Merger
�Mature organization
�Provision of benefits, Supply
Chain, Retail Pharmacy
�Customer base – 450,000
�Multiple Locations
�Employees - 250
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THE END