Big “Q”uality Equals
Better Business
The ISO 9001 Group
2002 Timberloch Place, Suite 200, The Woodlands, Texas 77380. www.iso9001group.com. Phone: 281-402-6800. Email: info@iso9001group.com
So God Made The Quality Manager
Published on 3/19/2013 by Mike Micklewright and Quality Digest
© The ISO 9001 Group. 2011 (0)
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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.
© The ISO 9001 Group. 2011 (0).
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Quality Progress Featured Article –
September 2013
© The ISO 9001 Group. 2011 (0).
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From Quality Manager to Risk Manager
 Quality Managers are Business and Risk Managers
 Quality Managers need to have a seat at the table where
decisions are being made that will have an impact on
operations
 The experience, skills, education and training of a Quality
Manager are ultimately geared towards business and risk
management
 The Quality Manager often has a keen understanding of
the flow of the organization’s business processes
 Quality Manager Stand Up!
© The ISO 9001 Group. 2011 (0).
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Drivers of Big Quality
© The ISO 9001 Group. 2011 (0).
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BP Incident – 11 Lives Lost
© The ISO 9001 Group. 2011 (0).
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BP Incident – 4.9 Billion Barrels Spilled
© The ISO 9001 Group. 2011 (0).
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Deepwater Horizon Study Group Final
Report
published 3/1/2011
 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)
© The ISO 9001 Group. 2011 (0).
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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
© The ISO 9001 Group. 2011 (0).
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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
© The ISO 9001 Group. 2011 (0).
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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.
© The ISO 9001 Group. 2011 (0).
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Shale Gas Production
Proved Shale Gas Reserves
140,000
131,616
120,000
100,000
97,449
80,000
60,644
60,000
40,000
20,000
34,428
23,304
0
2007
2008
2009
2010
2011
Billion Cubic Feet
© The ISO 9001 Group. 2011 (0).
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United States Manufacturing
 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
© The ISO 9001 Group. 2011 (0).
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Prepared For Big Quality
© The ISO 9001 Group. 2011 (0).
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ISO Global Survey Results
© The ISO 9001 Group. 2011 (0).
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ISO 9001 Growth World 1994 - 2012
© The ISO 9001 Group. 2011 (0).
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ISO 9001 Certifications 2009 - 2012
400,000
350,000
328,213
300,000
250,000
334,032
297,037
257,076
USA
200,000
China
150,000
100,000
50,000
28,935
25,101
25,811
26,177
0
2009
© The ISO 9001 Group. 2011 (0).
2010
2011
2012
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Gross Domestic Product 2012
$18
$16
16
Trillion
$14
$12
$10
8.11
$8
$6
$4
$2
$0
USA
© The ISO 9001 Group. 2011 (0).
China
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Gross Domestic Product Growth - 2012
GDP
9
7.7
Percentage
8
7
6
5
4
3
2.8
2
1
0
USA
© The ISO 9001 Group. 2011 (0).
China
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Changes In Big Quality
© The ISO 9001 Group. 2011 (0).
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Management System Standards
 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
© The ISO 9001 Group. 2011 (0).
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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
© The ISO 9001 Group. 2011 (0).
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Certification Bodies
 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
© The ISO 9001 Group. 2011 (0).
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Business Processes
 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
– Budgeting
• Allocation of funds for required resources
– Project planning
– Risk management
– Health, Safety and Environment
– Recruitment and Hiring
– Employee Orientations
– Oversight Activities
© The ISO 9001 Group. 2011 (0).
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Personnel Training & Competency
 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
© The ISO 9001 Group. 2011 (0).
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Risk Management & Contingency
Planning
 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
© The ISO 9001 Group. 2011 (0).
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Control of External (Outsourced)
Processes
 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
© The ISO 9001 Group. 2011 (0).
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Restrictions On Exclusions
 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
© The ISO 9001 Group. 2011 (0).
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Top Management Leadership
 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
© The ISO 9001 Group. 2011 (0).
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Management of Change
 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
© The ISO 9001 Group. 2011 (0).
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Operational Planning & Controls
 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
© The ISO 9001 Group. 2011 (0).
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Compliant Versus Certified Management
Systems
 Larger organizations are using small to mid sized
organizations as part of their supply chain more than ever
 They want to reduce their cost, but not increase their risk
 Increasingly accepting of “compliant” management
systems vs. “certified” management systems
 Removes the barriers for small to mid-sized organizations
to compete without the cost for certification
 Levels the playing field
© The ISO 9001 Group. 2011 (0).
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Big Quality Data
 Big Q means Big Data
 Need to have the ability to capture more data, analyze it and
disseminate it quickly
 Wikispaces
– www.wikispaces.com
– Similar functionality of ERPs like Microsoft SharePoint that cost
$30k or more
– Cost between $0 - $83 per month for 100 users
– Update documents anytime, from anywhere
– Version control
– Organize work groups
– Video, Calendars, Visitor Counters to make more engaging
– Secured permission based
© The ISO 9001 Group. 2011 (0).
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Engaging The Workforce
© The ISO 9001 Group. 2011 (0).
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The Millennial Workforce
 Need to be prepared to engage with the millennial
workforce (1980 – early 2000’s)
Characteristic
Focus
Confident
Not afraid to do what they think is right. If they are trained
properly, will be less prone to buckle under pressure to shortcut
Self Focused
May not necessarily be concerned with overall good of organization.
More oversight will be required.
Low Attention Span
Volumes of procedures won’t work. Less documented procedures.
Engaging content such as video and audio.
Jump from Job-to-Job
May increase the amount of change that needs to be managed.
Capturing processes and procedures will help stabilize.
Want Flexibility
Want information on demand when they need it or want it. Provide
it to them via intranet, secured websites, etc.
Short Term Focus
Focused short term (money, fame & image). Can be countered
through increased monitoring, engagement regarding long-term
focus.
Open Minded
Open to new processes, procedures, etc. Be prepared to explain the
reasoning behind them.
© The ISO 9001 Group. 2011 (0).
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More Engagement
 Social networking is not going away
– Face book (Say what’s on your mind)
– Twitter (140 characters)
 Quality Managers will need to consider how they can use
internal social networks to engage their workforce
 People want more information, but in a manner that takes
less effort on their part
– Less words
– More Video
– More Audio
 Information on demand
© The ISO 9001 Group. 2011 (0).
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Big Quality Equals Better Business
 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
© The ISO 9001 Group. 2011 (0).
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Question & Answer
Please feel free to ask any questions at this time.
© The ISO 9001 Group. 2011 (0).
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