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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]

http://www.iso9001group.com/

© The ISO 9001 Group. 2014 (0).

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. 2014 (0).

Drivers of Big Quality

© The ISO 9001 Group. 2014 (0).

BP Incident – 11 Lives Lost

© The ISO 9001 Group. 2014 (0).

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)

© The ISO 9001 Group. 2014 (0).

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. 2014 (0).


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. 2014 (0).


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. 2014 (0).


© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

United States Manufacturing

© The ISO 9001 Group. 2014 (0).

Economical Impacts of Big Quality

© The ISO 9001 Group. 2014 (0).

ISO Global Survey Results

© The ISO 9001 Group. 2014 (0).

ISO 9001 Growth World 1994 - 2012

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

Gross Domestic Product 2012

Trill

ion

2.8

7.7

0

1

2

3

4

5

6

7

8

9

USA China

GDP

© The ISO 9001 Group. 2014 (0).

Gross Domestic Product Growth - 2012

Perc

enta

ge

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

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

© The ISO 9001 Group. 2014 (0).

Big Quality Equals Better Business

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