This document proposes a research project to develop a new business model for contractor management in the oil and gas industry. It aims to provide a systemic solution using coordinated management between operators, contractors, and service providers. The model would utilize market forces to re-engineer safety towards a risk-based approach. Phase I would demonstrate the model and evaluation methodology. Phase II could help transition companies towards high reliability status characterized by mindfulness, flexibility, and prioritizing frontline expertise. The project expects to provide cost savings, quantifiably reduce risks, improve relationships, and help industry transition to more proactive safety practices.
How to Implement and Maintain an Audit-Ready QMS Leveraging TechnologyGreenlight Guru
Despite ever-changing and increasingly complex medical device regulations, many companies have built their compliance systems on risky paper-based quality systems or legacy, general-purpose software not built for med device. You can do better.
Inefficient systems increase your risk of noncompliance and increase your development time. That translates into missed sales opportunities and patients waiting longer for your new medical technologies.
So we’ll show you a modern, purpose-built software that ensures compliance with all the latest regulations to free up your engineers’ time, reduce risk, time to market, and help you pass audits with flying colors.
• Step-by-step instructions on how to implement and maintain an audit-ready QMS leveraging Jon’s S.M.A.R.T. quality management philosophy
• How to accelerate product development efforts — from napkin idea to 510(k) clearance to market release months or years quicker
• How to manage risk to drive the safety and quality of products and processes through QMS per ISO 13485:2016 & 21 CFR Part 820
• How to change their company’s focus from simply meeting regulations to building quality into their processes as a differentiator
• How to understand and stay ahead of the FDA and EU changing quality regulations as leaders instead of followers
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Successful EHS Auditing Insights from a Client's PerspectiveAntea Group
Antea Group presented a panel discussion at the 2016 Institute of Internal Auditors Environmental Health & Safety Exchange on how EHS audits fit into the full picture of an organization's risk, why audits are needed, what types of audits exist, and auditing methodology and communication. For more information, see http://us.anteagroup.com/en-us/services/operational-performance-and-assurance/environmental-audits-and-assessments
Business Process Managers are faced with two different tasks: Improve organizational performance by streamlining and automating workfl ows while ensuring compliance with regulatory and audit requirements. Both tasks involve the notion of process risk, and introduce a series of questions: Does the risk exposure of a
given process match the risk appetite of the enterprise? Are there better ways to mitigate certain risk factors by redesigning our processes? And how can we measure the level of compliance during the execution of a given process? Contemporary process modeling languages offer little help in identifying and mapping process risk. This session addresses a multiperspective approach to capturing and understanding process risk,
and illustrates ways to use this newfound information to create innovative process designs that address risk factors in a cost effective way.
How to Implement and Maintain an Audit-Ready QMS Leveraging TechnologyGreenlight Guru
Despite ever-changing and increasingly complex medical device regulations, many companies have built their compliance systems on risky paper-based quality systems or legacy, general-purpose software not built for med device. You can do better.
Inefficient systems increase your risk of noncompliance and increase your development time. That translates into missed sales opportunities and patients waiting longer for your new medical technologies.
So we’ll show you a modern, purpose-built software that ensures compliance with all the latest regulations to free up your engineers’ time, reduce risk, time to market, and help you pass audits with flying colors.
• Step-by-step instructions on how to implement and maintain an audit-ready QMS leveraging Jon’s S.M.A.R.T. quality management philosophy
• How to accelerate product development efforts — from napkin idea to 510(k) clearance to market release months or years quicker
• How to manage risk to drive the safety and quality of products and processes through QMS per ISO 13485:2016 & 21 CFR Part 820
• How to change their company’s focus from simply meeting regulations to building quality into their processes as a differentiator
• How to understand and stay ahead of the FDA and EU changing quality regulations as leaders instead of followers
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Successful EHS Auditing Insights from a Client's PerspectiveAntea Group
Antea Group presented a panel discussion at the 2016 Institute of Internal Auditors Environmental Health & Safety Exchange on how EHS audits fit into the full picture of an organization's risk, why audits are needed, what types of audits exist, and auditing methodology and communication. For more information, see http://us.anteagroup.com/en-us/services/operational-performance-and-assurance/environmental-audits-and-assessments
Business Process Managers are faced with two different tasks: Improve organizational performance by streamlining and automating workfl ows while ensuring compliance with regulatory and audit requirements. Both tasks involve the notion of process risk, and introduce a series of questions: Does the risk exposure of a
given process match the risk appetite of the enterprise? Are there better ways to mitigate certain risk factors by redesigning our processes? And how can we measure the level of compliance during the execution of a given process? Contemporary process modeling languages offer little help in identifying and mapping process risk. This session addresses a multiperspective approach to capturing and understanding process risk,
and illustrates ways to use this newfound information to create innovative process designs that address risk factors in a cost effective way.
FDA Requirements for Supplier Management: A Primer from EduQuestEduQuest, Inc.
FDA requirements for supplier management are outlined by EduQuest president Martin Browning, who also provides practical advice for avoiding common mistakes companies make in managing relationships with third-party vendors, suppliers and auditors.
StrategyDriven Nuclear Regulator Service OfferingsNathan Ives
Complex issues challenge the efficient licensing and oversight of nuclear power plants.
Ensuring the safe use of radioactive materials for the generation of electric power is an objective shared by nuclear regulators. New technologies, aging infrastructures, specialized talent shortages, and shrinking budgets combine to challenge government leaders seeking to create the regulatory framework necessary to promote a safe and robust nuclear industry.
To meet these challenges, nuclear industry regulators must find cost effective ways to certify new technologies, approve changes to existing designs, license new operators, and oversee nuclear facility operations while building for themselves a workforce steeped in the knowledge of and respect for the uniqueness of nuclear power operations.
StrategyDriven advisors are seasoned nuclear professionals. As such, we have tailored our tools and methods to meet the unique needs of the nuclear industry and are committed to being exceptional teammates in your pursuit of excellence.
Presentation by Rachel Holloway, Department for Business, Energy, & Industrial Strategy, United Kingdom, at the RIA workshop which took place in Lima on 22-24 May 2017. Further information is available at www.oecd.org/gov/regulatory-policy/.
Collaboration & Technology Survey Analysis Pdfmariannevoss
results from an industry survey on sharing and collaboration on supply chain compliance, asking for input from company and other industry CSR leaders on their current collaboration practices and future aspirations, as well as their perceptions on drivers and/or barriers to sharing & collaboration.
Pharmaceutical 6 Sigma and QbD May 2005 Ball State UniversityAjaz Hussain
Pharmaceutical product and process quality – what is the current “sigma”?
Challenges in moving towards “6-sigma” levels?
What are the steps necessary for the pharmaceutical continuous improvement journey in the 21st Century?
7Epsilon Risk Based Thinking - ASQ International Conference on Quality Stand...Meghana Ransing
Learn how to use risk based thinking to trigger innovation and develop organizational knowledge in a connected enterprise environment. These slides are based on the presentation given at the ASQ International Conference on Quality Standards, Pittsburgh, USA. November 14-15, 2016.
This document will help you to understand the risk based thinking approach that has been introduced to the new revision of QMS ISO 9001:2015 as well as assist the organizations that tends to move toward implementing the new standard.
the first step is to understand what is the definition of risk! when we are going to apply this term, what are things to considered? if you thinking of establishing a specially designed procedure or form related to this term what are the main categories you should considered and how? what are the modules you shall use? ... etc.
Therefore, This document will answer ,at least, most of these questions.
Best of luck, Eng. Akram Malkawi, Amman, eng.karam@outlook.com/Mob. +962795705076
Value Engineering. Measuring and managing risks in the wind energy industryStavros Thomas
As wind turbines number increased around the world, the number of hazardous accidents is also rising, causing critics to question overall safety. A recent study from Anemorphosis Research Group reveals how wind power professionals manage risk, from current areas of concern to anticipated challenges.
Delays in the launch and execution of critical market research projects can slow down the decision-making process, resulting in missed opportunities and increased costs. Therefore, it is absolutely critical for bio-pharmaceutical companies to develop a tactical approach to expedite the market research approval process for quicker and more meaningful insights.
According to recent research by Best Practices, LLC, nearly three-quarters of the benchmarked study participants use review cycle time as a metric for determining if the market research approval process is functioning at an acceptable level. One tip that participants gave on how to control processes and to ensure high performance is to create checklists. Begin with checklists in pinch points that are most problematic, and then extend to entire process and operations. This report will help leaders to gain critical insights they need to compete successfully in a fast-changing market.
Download Full Report: http://bit.ly/2bfAhOc
FDA Requirements for Supplier Management: A Primer from EduQuestEduQuest, Inc.
FDA requirements for supplier management are outlined by EduQuest president Martin Browning, who also provides practical advice for avoiding common mistakes companies make in managing relationships with third-party vendors, suppliers and auditors.
StrategyDriven Nuclear Regulator Service OfferingsNathan Ives
Complex issues challenge the efficient licensing and oversight of nuclear power plants.
Ensuring the safe use of radioactive materials for the generation of electric power is an objective shared by nuclear regulators. New technologies, aging infrastructures, specialized talent shortages, and shrinking budgets combine to challenge government leaders seeking to create the regulatory framework necessary to promote a safe and robust nuclear industry.
To meet these challenges, nuclear industry regulators must find cost effective ways to certify new technologies, approve changes to existing designs, license new operators, and oversee nuclear facility operations while building for themselves a workforce steeped in the knowledge of and respect for the uniqueness of nuclear power operations.
StrategyDriven advisors are seasoned nuclear professionals. As such, we have tailored our tools and methods to meet the unique needs of the nuclear industry and are committed to being exceptional teammates in your pursuit of excellence.
Presentation by Rachel Holloway, Department for Business, Energy, & Industrial Strategy, United Kingdom, at the RIA workshop which took place in Lima on 22-24 May 2017. Further information is available at www.oecd.org/gov/regulatory-policy/.
Collaboration & Technology Survey Analysis Pdfmariannevoss
results from an industry survey on sharing and collaboration on supply chain compliance, asking for input from company and other industry CSR leaders on their current collaboration practices and future aspirations, as well as their perceptions on drivers and/or barriers to sharing & collaboration.
Pharmaceutical 6 Sigma and QbD May 2005 Ball State UniversityAjaz Hussain
Pharmaceutical product and process quality – what is the current “sigma”?
Challenges in moving towards “6-sigma” levels?
What are the steps necessary for the pharmaceutical continuous improvement journey in the 21st Century?
7Epsilon Risk Based Thinking - ASQ International Conference on Quality Stand...Meghana Ransing
Learn how to use risk based thinking to trigger innovation and develop organizational knowledge in a connected enterprise environment. These slides are based on the presentation given at the ASQ International Conference on Quality Standards, Pittsburgh, USA. November 14-15, 2016.
This document will help you to understand the risk based thinking approach that has been introduced to the new revision of QMS ISO 9001:2015 as well as assist the organizations that tends to move toward implementing the new standard.
the first step is to understand what is the definition of risk! when we are going to apply this term, what are things to considered? if you thinking of establishing a specially designed procedure or form related to this term what are the main categories you should considered and how? what are the modules you shall use? ... etc.
Therefore, This document will answer ,at least, most of these questions.
Best of luck, Eng. Akram Malkawi, Amman, eng.karam@outlook.com/Mob. +962795705076
Value Engineering. Measuring and managing risks in the wind energy industryStavros Thomas
As wind turbines number increased around the world, the number of hazardous accidents is also rising, causing critics to question overall safety. A recent study from Anemorphosis Research Group reveals how wind power professionals manage risk, from current areas of concern to anticipated challenges.
Delays in the launch and execution of critical market research projects can slow down the decision-making process, resulting in missed opportunities and increased costs. Therefore, it is absolutely critical for bio-pharmaceutical companies to develop a tactical approach to expedite the market research approval process for quicker and more meaningful insights.
According to recent research by Best Practices, LLC, nearly three-quarters of the benchmarked study participants use review cycle time as a metric for determining if the market research approval process is functioning at an acceptable level. One tip that participants gave on how to control processes and to ensure high performance is to create checklists. Begin with checklists in pinch points that are most problematic, and then extend to entire process and operations. This report will help leaders to gain critical insights they need to compete successfully in a fast-changing market.
Download Full Report: http://bit.ly/2bfAhOc
With unprecedented change on the horizon, healthcare organizations are looking to redefine their workflows to focus on quality and efficiency.
Through utilizing SIMUL8 and Lean Six Sigma principles, ECG Management Consultants, Inc. has been able to help clinics and health systems to deliver on the new value proposition in the post-reform era.
Will I see you in Philadelphia next week? In case you don’t already know, I’ve been invited to speak at CBI’s Risk-Based Trial Management and Monitoring Conference.
I’m going to be sharing real world, pragmatic guidance that you can implement immediately to effectively influence your clinical trial performance.
My presentation, Practical Usage of KRIs and QTLs in Clinical Trials, will take place next Thursday, November 14th at 9:45am. I’m going to share with you:
• How to identify and close the gaps between risks and KRIs
• What the difference is between KRIs and QTLs, and how to use them effectively
• Useful examples of Centralized Monitoring findings from open data
• How to detect, combat and prevent fraud and sloppiness at an early stage
• How AI and ML advance risk-based approaches
So I can’t wait to see you at this informative and fun-filled industry expert forum,
– Artem Andrianov, CEO Cyntegrity
Developing End State Vision
Advice and Planning Strategy
Driving a Business Architecture
Provisioning a Portfolio of Projects
eGRC Operation Control
Minimizing Financial Risk
Aggregating Financial Risk
Managing Mainframe Entitlements
Implementing Data Governance
Understanding Data Lineage
Defining Global Customer Strategy
Accelerating Grassroots Adoption of IT Quality Transformation
CEPA Project Overview
1. BUSINESS MODEL TO RE-ENGINEER SAFETY
UTILIZING COORDINATED MANAGEMENT & MARKET
DRIVEN FORCES: RESEARCH PROJECT FOR RISK
BASED CONTRACTOR MANAGEMENT
Industry Issue
Problem to Be Solved
Project Overview
Functional Evaluation
Completed Evaluation Feedback
Phase I Deliverables
Phase II Steps Towards High Reliability
Project Benefits
2. 2012 Year of the Pipeline
• Oil producers could lose $72 billion over a nine-year-period if a pipeline to
carry Alberta bitumen to the West Coast isn't built,
• Easy access to international markets could add up to $131-billion (U.S.) to
Canada’s GDP between 2016 and 2030,”
o Expansion of Kinder Morgan’s existing Trans Mountain Pipeline
o Enbridge Northern Gateway Pipeline
• At stake is the ever widening differential between Brent crude and West Texas
Intermediate,
• Billions of dollars in potential investment that could be deferred,
• Ability to provide additional product to US Market – TransCanada Keystone,
and
• Numerous high profile events are eroding public trust and creating
increased regulatory pressures.
3. Erosion of Public Trust
The operating environment of the North American oil and
gas industry experienced a monumental shift on 20 April
2010 with the loss of control of the BP Macondo Well in the
Gulfof Mexico. The blowout killed eleven workers and
created the largest oil pollution disaster in US history. That
event was followed by several notable pipeline incidents
including the Enbridge Line 6B leak in Michigan, the Pacific
Gas and Electric rupture in San Bruno, California, and the
Plains Midstream Rainbow Line spill in Alberta. These events
and others demonstrate the need for the energy sector to put
renewed focus on safety and environmental protection.
4. Customer
Contractor Subcontractor
Customer
Customer
Customer
Questions 2000 plus
Compliance Review
Quarterly metrics
Audit Verification (3-5 days)
Currently poor or
NOT managed
Training Review
Leading Indicators
Work/Stewardship
Inspections
Investigations
Rule Enforcement
Permits
Status quo – Passive Compliance Model with
Evaluation & Mitigation
• Focus is on administrative tasks
• Not sustainable by customer or contractor
– expensive and labor intensive,
• Empirical evidence demonstrates a 100%
false positive return creating a false sense
of assurance, and
• Direct experience supports ineffectiveness
of approach.
Impacted multiple
customers with
various scoring
schemes
Safety Leadership Training
Contractor Orientation
Pre-Qual list
5. Use of contractors has been identified as a significant contributor to a company’s risk
profile. Louis Auger of Shell Canada states “80 percent of his company’s safety incidents
involve contractors”. Contractor risk is well known throughout industry and was further
verified with the investigation in the Gulf of Mexico disaster with recommendations that
include:
• “Implementing much greater oversight of contractors current practices; and
• Requiring contractors to develop and implement audit-able safety processes, including
identification of key indicators --- processes which BP can review.”
• Although the investigation team has taken a broad approach to making recommendations within
the intent of its terms of reference, the team believes that as the findings in this report are
considered and discussed, they may give rise to broader systemic responses or
recommendations associated with broader industry issues. These issues might include industry
working practices; training and competency assessment; and interfaces among operators, drilling
contractors and service providers.”
Need to Think & Operate Differently
6. Contractor Management Survey
• Survey document finalized and trial data gathered
• Scores are out of 7 ( 1 – strongly disagree to 7 – strongly agree)
• Contractors report little operational value with current contractor management systems
0
0.5
1
1.5
2
2.5
AVG
MODE
7. Problem To Be Solved
• Status quo approach is not working,
• There are broad systemic issues impacting the ability to reduce serious injury and fatality rates,
• Traditional audits focus primarily on management systems not verification of actual practices. Correlation
between audit results and incidents show very little predictive value.
• Current health and safety evaluations are propagating a false sense of assurance,
• A reliance on a safety approach that only addresses problems after they manifest is wholly inadequate to
ensure safety,
• Conventional illness and injury rates are not adequate indicators of catastrophe,
• Over 50% of fatalities involve Contracting Companies/Contractor relationship
• Need to implement a much greater oversight of health and safety current practices, and
• One of the most important challenges in trying to measure safety performance is how and what we measure.
9. Project Abstract
• Demonstrate a business model that provides a systemic solution via contractor
management strategies,
• Enabling methodology of the project provides a high degree of confidence with
respect to accurate safety evaluations and effective risk mitigation,
• Utilizes a coordinated management structure between Associations, Operating
Companies, Contractors and Industry Service Provider(s),
• Makes use of vested interests and market driven forces to re-engineer safety
towards a risk-based management model, and
• Encourages the development and sustainability of a high reliability organization
10. Research is based upon work conducted by:
• Andrew Hopkins “The Problem of Defining High
Reliability Organizations”,
• Cooke and Rohleder “Learning From Incidents: From
Normal Accidents to High Reliability” and
• Nancy Levenson et.al. “Moving Beyond Normal
Accidents and High Reliability Organizations: A Systems
Approach to Safety in Complex Systems”.
11. A Critical Disconnect
The Legacy of the High Reliability Organization Project March 2011
Mathilde Bourrier - Department of Sociology, University of Geneva.
There is a wide gap between the level of knowledge published
and debated in the academic circles on these issues and the level
of knowledge transfer that has actually occurred from these
circles to the industry or regulatory circles.
Hopkins (2001, p. 72) is right when he observes that ‘this is not
just a theoretical debate. There are practical consequences for
the way we go about accident prevention’
13. Focus on practical value first and always with respect to operation
o Emphasis on evaluation process first; transparency and collaboration tool second
o 6 critical audit-able processes
o It is about “on-the-ground safety”
o Creates an active/directive system to produce continuous improvement.
Demonstrates functional cultural attributes
o Mindfulness – always asking “what can go wrong?”
o Organizational Learning
o Sensitivity to Operations – risk identification and control integrity (exposure)
Simple and efficient
o Tell, show and demonstrate;
o Strips away extraneous activities (minimum data entry produces maximum value)
Basic terms of reference
o Aligns objectives for all stakeholders to provide common measuring criteria
o Provides capability to measures “HOW” the process of doing safety.
o Ability to leverage commonly agreed upon measurements
Functional Evaluation
14. Game Changing Differentiators
Passive Compliance Active Compliance
• Emphasis is on “what” elements of SMS are in
place. (Necessary but not sufficient)
• Examines “HOW” program functions as to
INTENT. (Adds sufficiency to SMS)
• Compliance to administrative requirements. • Compliance to effective process.
• Uses injury statistics (TRIF, DAFW) to determine
success.
• Uses risk based measures to determine
success.
• Relies on correlation for appearance of
effectiveness.
• Uses cause & effect demonstrated through the
process of creating safety.
• Relies on an approach that only addresses
problems after they occur. Challenged in
obtaining near miss reports.
• Achieves between 600% and 800% increase in
reporting hazards before they manifest.
• Provides superficial indications of culture • Provides objective (deep rooted behavioral)
measures of culture.
• Creates a false sense of assurance • Provides an accurate assessment and a highly
focused and directive risk mitigation strategy
15. Completed Evaluation
It was refreshing to see where CEPA is trying to take conventional
thinking in the HSE world…We will know what our high risk
hazards are, what tasks would be considered critical and be able to
design our engineering solutions, training and competency programs
and other controls to those concerns. I fully support this approach. I
would encourage industry to move to a set of key performance
indicators that are designed to drive the right solutions. This should
be the reduction of risk, not the manipulation of the total recordable
injury rate.
Post Debrief
16. Phase I Deliverables
• Demonstrate a business model that provides a systemic solution to Health
and Safety Evaluations and contractor management strategies.
• The enabling methodology provides a high degree of confidence with
respect to accurate health and safety evaluations and effective risk
mitigation processes with shared risk activities.
• The solution utilizes a coordinated management structure between,
Operating Companies, Contractors and Industry Service Providers.
• It makes use of vested interests and market driven forces to re-engineer
safety to a risk based management model.
17. Phase II Steps Towards High Reliability
Phase II (pending approval) runs concurrently with a few chosen
companies that are forward thinking and want to evolve their organization to
one of high reliability status. High reliability organizations are characterized by:
Ability to provide high quality and high reliability
Capability to work in high risk environments with high efficiency,
High sensitivity to operations,
Ability to constantly confront the unexpected and operate with remarkable
consistency and effectiveness,
Exhibit “mindfulness” a combination of high alertness, flexibility and
adaptability
People at all levels of the organization value quality
Defer to experts on the frontline
Achieving a state of ‘high reliability’ provides significant competitive advantages.
19. Opportunity to Control the Conversation
• Demonstrate leadership, while everyone else is talking CEPA is taking action,
• CEPA is seen as taking meaningful, universally understood and scientifically
supported action to reduce high consequence exposure both internally and with
contracting companies with shared risk scenarios,
• Ability to control the conversation:
o Provide meaningful results – better data with risk based performance
metrics,
o Speak directly to culture demonstrated through the process of creating
safety,
o Supported by documentation that meets commonly held terms of
reference, and
o Capability to impact industry systemically to create an environment that
encourages and sustains the creation of high reliability organizations.
20. CEPA Member Benefits
The Operating Company accrues seven key via the business model:
1. Opportunity to outsource HSE contractor management and obtain significant cost
savings,
2. Significant and quantifiable results in reducing shared risk to as low as reasonably
practicable,
3. Removes operators from the situation of having to dictate solutions,
4. Reduces or reallocates head count for greater returns on safety investment,
5. Provides practical value for both Operators and Contractors improving the relationship,
6. Reduces threat of increased regulatory measures by focusing attention to “on-the-
ground” methodologies to identify and mitigate high consequence risks, and
7. Fully utilizes an existing resource and infrastructure to provide cost effective solutions.
21. We Need Concrete Solutions That
Work In The Real World With
Meaningful Results
Victor Hugo said you can stop an invasion of armies, but you can never stop
an invasion of ideas. There’s nothing more powerful than an idea whose time
has come.
Editor's Notes
Document approval set for Feb 15
Documentation was finalized and released April 9