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Big “Q”uality EqualsBetter Business
The ISO 9001 Group
2002 Timberloch Place, Suite 200, The Woodlands, Texas 77380. www.iso9001group.com. Phone: 281-402-6800. Email: [email protected]
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Biography
Oscar Combs, President & Senior Consultant of The ISO 9001 Group, a management system
consulting firm based in Houston, Texas, which helps companies manage their risks and improve
operations through providing customized consulting, auditing and training services.
Oscar has successfully led and managed Quality and HSE Departments for major corporations,
such as Nabors Industries and Fugro before starting The ISO 9001 Group. Oscar has over 19
years of experience providing consulting, auditing and training to organizations such as:
Transocean, Hewlett-Packard, The Department of Veteran Affairs, Cameron, Halliburton and
numerous other medium and small size organizations throughout the United States and abroad.
Oscar has acquired invaluable national and international business experience, which he utilizes on
a daily basis to assist The ISO 9001 Group client organizations in overcoming their management
system challenges.
Oscar has developed and successfully implemented ISO and API management systems in
over 50 sites throughout North America, South America, The Middle East, and Africa.
Oscar has achieved ISO 9001 Certification of 16 sites in just an astounding 12 months with zero major findings by the
certification body, has a 100% success rate of achieving certification for clients and has logged over 100 audit hours.
Oscar is a Senior Member of the American Society for Quality and served as the Programs Committee Chair for ASQ’s
Houston Chapter 1405. Oscar also conducts keynote presentations for several organizations such as, The American Society
for UBM Canon, Occupational Health & Safety.com and Human Resources.com.
Oscar’s articles have been published by publications such as, Quality Progress (QP) and Quality Digest.
Oscar earned his MBA from the University of Houston. He earned his Bachelor’s of Science in Business Management from
the University of Phoenix. He has undergone specialized training in the areas of: Quality Management, ISO 9001 and ISO
14001 Lead Auditing, Root Cause Analysis, Project Management, OSHA Compliance, Operational Safety Management and
Behavioral Based Safety. He is certified by RAB-QSA as a Principal Management Consultant. He maintains various industry
memberships with organization such as, Society of Manufacturing Engineers, The Association for Operations Management
(APICS). Oscar also sits on various industry boards and committees.
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Drivers of Big Quality
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BP Incident – 11 Lives Lost
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BP Incident – 4.9 Billion Barrels Spilled
Disaster was preventable had existing progressive guidelines and practices
been followed
Resulted from multiple violations of the laws of public resource development
and proper regulatory oversight (U.S. Mineral Management Service)
Failure to contain, control, mitigate and plan rooted in a culture of
organizational malfunction and shortsightedness
There were multiple opportunities to properly assess the likelihoods and
consequences through Risk Assessment and Management
Identical blow out occurred 8 months earlier offshore Australia (Montara
Commission of Inquiry 2010)
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Deepwater Horizon Study Group Final Report published 3/1/2011
When given the opportunity to save time and money and make money,
tradeoffs were made
There were no perceived downsides associated with uncertain things (risk)
Result of a cascade of deeply flawed failure and signal analysis, decision
making, communication, organization and managerial processes
At the time of the Macondo blowout, BP’s corporate culture was one of risk-
taking and cost-cutting
It is the underlying “unconscious mind” that governs the actions of an
organization and its personnel
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Deepwater Horizon Study Group Final Report published 3/1/2011
Product Failures
– Blow Out Preventers failed initially and in following days
– Oil spill containment devices failed
– Killing the well with heavy mud failed
Multiple tests failed to disclose the breach of hydrocarbons that entered the
well
All of the approved plans and preparations for controlling and mitigating failed
or were ineffective
Emergency control equipment were destroyed, damaged or were not activated
$42.2 Billions spent, damage to the environment, the economy and the oil and
gas industry
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Deepwater Horizon Study Group Final Report published 3/1/2011
Industry Recommendations Made
– Upgrade selection of people
– Training for normal, emergency and abnormal activities
– Employee Competency
– Mentoring
– Collaboration
– Implement Risk Assessment and Management (RAM)
– As Low As Reasonably Practicable (ALARP)
• Expected level of residual risk involved with a system or operation
– Focus on Best Available and Safest Technology (BAST)
• Safe and Environmentally conscious operations.
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Deepwater Horizon Study Group Final Report published 3/1/2011
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Shale Gas Production
23,30434,428
60,644
97,449
131,616
0
20,000
40,000
60,000
80,000
100,000
120,000
140,000
2007 2008 2009 2010 2011
Proved Shale Gas Reserves
Billion Cubic Feet
Resurgence of Made In America
– More companies are bring manufacturing jobs back
Increase in natural gas production
Increasing demand for a management system driven supply chain
Increased use of small to mid-sized organizations to reduce cost
– API Spec Q1, API Spec Q2
– ISO 9001, ISO 29001
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United States Manufacturing
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Economical Impacts of Big Quality
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ISO Global Survey Results
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ISO 9001 Growth World 1994 - 2012
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ISO 9001 Certifications 2009 - 2012
28,935 25,101 25,811 26,177
257,076
297,037
328,213 334,032
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
2009 2010 2011 2012
USA
China
16
8.11
$0
$2
$4
$6
$8
$10
$12
$14
$16
$18
USA China
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Gross Domestic Product 2012
Trill
ion
2.8
7.7
0
1
2
3
4
5
6
7
8
9
USA China
GDP
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Gross Domestic Product Growth - 2012
Perc
enta
ge
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Changes In Big Quality
API Spec Q1 Ninth Edition has over 80 new clauses and
5 new sections
API Spec Q2 was introduced for Oil & Gas service
organizations
ISO 9001 undergoing a major revision to be released in
2015
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Management System Standards
API and ISO
– Integration of QMS into all core business processes
– Personnel Training & Competency
– Risk Assessment & Management
– Contingency Planning
– Control of External (Outsourced) Processes
• Inclusion into internal audit planning
– Restrictions on exclusion to requirements
– Top Management Leadership and Commitment
– Management of Change
– Operational Planning & Controls
– Control of Production and Services
– More Oversight of Critical Suppliers
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Management System Standards
Certification bodies such as API and ISO certification bodies have become more stringent
Passing certification audits are becoming more difficult due to increased scope of management system standards
Rates are increasing due to increased program administration and enforcement
API has increased their rates by 25% - 200%
The same can be expected by ISO certification bodies
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Certification Bodies
Big Q will mean the integration of your QMS into all core business processes
Processes that were traditionally not audited, will now be included in the audit
scope
– Sales
– Finance & Accounting
– Outsources Processes
– Risk Management
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Business Processes
Big Q will mean a properly trained and competent workforce
Establishing experience, skill and educational requirements for each position
prior to hiring
Hiring personnel based upon established requirements
Establishing comprehensive training requirements for each position
Establishing new employee orientation programs focused on specific job tasks
– Not just payroll and insurance
Performing competency monitoring and testing
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Personnel Training & Competency
Big Q will mean proactive risk assessment of activities
Identifying the probability of the risk becoming realized
Determining the impact to internal \ external parties if it does become realized
Establishing controls into business processes to manage risk
– As Low As Reasonably Practicable (ALARP)
Monitoring and testing controls to determine if they will be effective in case the
risk does occur
Establishing contingency plans and emergency response plans (back-up
plans) to the established controls
– Based upon worst case scenario
– Five What If’s
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Risk Management & Contingency Planning
Big Q will mean thinking of outsources processes as internal processes
Outsourcing does not relieve the responsibility of its organization or liability
Increased scrutiny and oversight will be required of suppliers of outsourced
processes beyond
– Past relationships
– Cost
– Delivery times
Outsourced processes will be included in internal audit planning
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Control of External (Outsourced) Processes
Big Q will mean organizations will be able to claim less exclusions to
management system requirements
Exclusions must not affect ability or responsibility to meet customer and
applicable regulatory requirements
– Outsourcing a process will not qualify as an exclusion
– Design and Development
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Restrictions On Exclusions
Big Q will mean not only Top Management commitment, but Leadership
Top Management will be expected to demonstrate not only through memorandums and newsletters, but through:
– Establishment of a culture of compliance
– Leading by example
– Placing more value on doing things right the first time vs. doing things quickly
– Maintaining profitability through reduction of waste vs. taking short cuts that create waste
– More focus on long-term results vs. short-term gains
– Establishing a preventive action culture vs. corrective action culture
– Capturing lessons learned and incorporating back into business processes as necessary
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Top Management Leadership
Big Q will mean organizations must manage first recognize change and then
manage it
– People
– Processes, Procedures
– Risk
– Training
– Technology
– Work Environment
– Supply Chain
– Scope of Work
– Laws and Regulations
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Management of Change
Big Q will mean more operational planning and controls
More planning must be done around the actual operations
– Required resources (people, equipment, work activities)
– Project \ Quality plans
– The Quality Manager involved in operational planning
More onsite oversight by The Quality Department to ensure employees and
suppliers are complying with system requirements
More preventive actions
Sharing of potential risks throughout similar operations within the organization
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Operational Planning & Controls
Big Q means doing things right the first time
Quality Managers with a business & risk focus
Better Business Equals
– Top Management leadership
– Management of Change
– Integration of QMS into all core business processes
– Risk assessment and management
– Contingency planning and testing
– Training and competent personnel
– Operational planning and controls
– Control of external (outsourced processes)
– Restrictions on exclusions to management system requirements
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Big Quality Equals Better Business
Please feel free to ask any questions at this time.
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Question & Answer