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Establishing a

Strong Quality Culture

Proven Strategies for Line Management and Independent Oversight Organizations

Corporate Office
4634 SW Long Bay Drive Palm City, FL 34990 (772)341-1093 - Phone (866)271-5199 - Fax rob.dle@dle-services.com www.dle-services.com


September 1, 2011

Strategies for a Strong Quality Culture This white paper is an introduction to a set of strategies for establishing a strong Quality Culture at nuclear power plants and Department of Energy (DOE) facilities. The strategies described herein were developed, used and refined through trial and error over the past 20 years by the founder of DLE Technical Services, a recognized industry subject matter expert in Nuclear Assurance, Rob De La Espriella. Rob spent over 15 years implementing QA Program requirements, developing advanced oversight strategies and coaching line managers on the principles for a strong quality culture at nuclear power plants, both as an inspector with the Nuclear Regulatory Commission and as a Site Quality Manager. The resulting approach took existing oversight organizations and transformed them into High Performing Organizations (HPO). Robs oversight groups were praised by the Institute of Nuclear Power Operations (INPO) in 2003 and 2005, and benchmarked by many other oversight groups in the US. In the next few sections well describe how to unlock the keys to transforming your Quality Culture by using proven strategies that include Deming Quality Principles, Juran Quality Control Principles, Balridge criteria for high performing organizations and others industry standards of excellence. The author added his own risk-informed, graded approach to conducting oversight that makes the most effective use of oversight resources, drives line ownership of quality and provides a significant costbenefit to the company by creating a proactive organization that anticipates and prevents issues, rather than documenting events after they took place.

Quality Management Systems

The Evolution of QMS and Oversight in the Nuclear Industry Quality Management Systems (QMS) include all of the programs, processes and procedures that flow down from Quality Assurance Program requirements in applicable regulations. It also includes additional standards and expectations put in place by management to achieve a desired level of performance and quality (the latter being driven by customer expectations). Since World War II there have been many advances in Quality Management Systems, driven by industry giants such as Deming, Juran, Balridge and Ishikawa. They established methods to help strengthen Quality Management Systems such as Total Quality Management (TQM), Quality Circles, Quality Control Practices and High Performing Organization Principles. In the past few decades TQM has given way to Six Sigma and Lean Manufacturing. In the commercial nuclear power industry, the Three Mile Island accident triggered billions of dollars of improvements in programs, processes and equipment and the establishment of the Institute of Nuclear Power Operations (INPO) to self-police the industry. Since the accident in 1979, nuclear industry processes and programs have evolved tremendously, arguably surpassing most other heavily regulated industries. However, one area has not evolved as rapidly as others: the Quality Culture and the oversight provided by Quality Assurance (QA) organizations. The Authors Footprint on QMS/Oversight The author entered the nuclear industry in 1983 as a Navy nuclear powered submarine officer. Since that time, the author has assessed performance at over 20 nuclear plants and DOE facilities. One of the common characteristics at the majority of sites was the lack of understanding of Quality Program requirements by line management. In addition, the Nuclear Assurance organizations (Audit groups, Quality Control, Surveillance departments) were not operated in a manner that resulted in adding significant value to the organization (far beyond meeting regulatory requirements for having an independent oversight organization). To this day, line managers frequently criticize their independent oversight organizations for adding little value, for being historians (documenting events after the fact) and circling bullet holes (pointing out the obvious). In 1990, Florida Power & Light (FPL) became the first corporation outside of Japan to win the Deming Prize, for outstanding Total Quality Management (TQM) practices. The author was on that Deming team and through extensive training and certifications as a Quality Improvement Team Leader and Root Cause Instructor, he developed a greater understanding of Quality at regulated nuclear power plants. In 1990 the author became an Audit Team Leader and root cause analyst for the 2

Since the TMI accident in 1979, billions have been spent on improving the commercial nuclear industry

oversight organization at FPL. In 1992 he began a four-year tour of duty at the US Nuclear Regulatory Commission and was responsible for conducting oversight at the Millstone Nuclear Plant in CT. While at the NRC, the author collected a TQM Award, several other performance awards, a Meritorious Service Award nomination and was selected as a Role Model for the NRC in 1995. In 1996 the author returned to FPL and in three years rose from Audit Team Leader to Independent Safety Engineering Group Supervisor to Audit Supervisor to Site Quality Manager. As a key player in oversight organizations for over 15 years, the strategies developed by the author resulted in high performing oversight organizations that proactively identified issues, drove performance improvements and dramatically increased the value of the independent oversight organizations. In 2003 and 2005, the Institute of Nuclear Power Operations (INPO) graded the Quality Management System and oversight strategies the author put in place at FPL as Strengths for overall effectiveness. Following the 2003 and 2005 INPO reports, many industry peers benchmarked the authors oversight organization. In 2005, the World Association of Nuclear Operators (WANO) enlisted the author to participate in an assist visit to Slovenia at the Krsko Nuclear Plant as a Nuclear Assurance expert from the US. Additionally, WANO requested the author to coach and mentor a Quality Manager from South Africa for six weeks in response to a request from Eskom to send their new Quality Manager to one of the strongest Nuclear Assurance programs in the US. In 2007, the author (now the President of DLE Technical Services) was contracted to bring these oversight strategies to the Department of Energys (DOE) Quality organization at the Yucca Mountain Project (YMP). After the 24 month Organizational Development engagement at the YMP, the DOE formally recognized the author for a night and day difference in performance in the oversight organizations, and for contributions towards improving Nuclear Safety and Quality cultures at YMP. In 2008, DLE Technical Services was contacted by Eskom to help establish the Nuclear Assurance organization for the new construction of the first ever Pebble Bed Modular Reactor project. (Unfortunately Eskom tabled the project in late 2008 for economic reasons). In 2009, after a national search, CH2M Hill offered the author the position of Director of Nuclear Quality and Culture for the new construction of 10 nuclear reactors in the United Arab Emirates, to establish the QMS for that project (the author declined the offer). In 2010, DLE Technical Services was contracted by Uranium Disposition Services to evaluate the Quality Assurance Program for the new Depleted Uranium Hexafluoride Conversion Facility in Paducah, KY. In 2011, DLE Technical Services was contracted to develop a strategy for diagnosing the QMS at Atomic Energy of Canada Limited (AECL). 3

Strategies for Establishing a Strong Quality Culture

After decades of developing, implementing, assessing and overseeing Quality Management Systems, the author has summarized some of the more important strategies that he developed for strengthening an organizations Quality Culture and establishing high performing independent oversight organizations.

Establish Top Management Support & Infrastructure for Quality Adopt and standardize Principles for a Strong Quality Culture Define managements commitment to Quality. Define workers commitment to Quality. Define the defense-in-depth approach to identify and correct conditions adverse to quality. Lay out expectations for line management ownership of quality. Define the Quality Assurance organizations roles and responsibilities for providing value-added quality. Reinforce that improving quality can lower overall operating costs. The principles must also be translated into a policy or procedure such that management can be held accountable for the contents. The performance appraisal system must also evaluate line ownership of quality.

Management must live up to its commitment to Quality in every decision they make

Define the criteria for High Performing Quality Management Systems Leadership Customer Focus Strategic Planning Organizational Structure Process Management and Control Leader and Worker Development Performance Management Continuous Improvement

Strengthen Performance Improvement Processes Corrective Action Programs Human Performance and Error Prevention Programs Operating Experience and Lessons Learned Programs Root Cause & Apparent Cause Tools & Techniques Change Management 4

Strategies for Establishing a Strong Quality Culture (Contd)

Re-focus the Independent Oversight Organization A. Establish a clear target for independent oversight resources: Nuclear Safety Equipment Reliability Risk to Workers and Equipment Regulatory Risk B. Use a Risk-Informed Approach for QA Activities: Establish initial and continuing training for oversight personnel on understanding the components of RISK (in practical terms, rather than in Probabilistic Risk Assessment terms), and how to use these practical risk concepts in daily applications. For example: 1) Focus on critical tasks that impact error rates: Work preparation Work performance Work feedback Focus on critical programs, processes and procedures that maintain a defense-in-depth for preventing events or mitigating consequences of an event: Engineered controls Administrative controls Oversight controls Focus on critical programs and processes that affect nuclear safety: Conduct of Operations Equipment Reliability Program Design Control/Configuration Management Programs and processes that maintain facilities and equipment Integrated Work Management Systems Corrective and Preventive Maintenance Corrosion Controls

Oversight organizations can focus on Risk and adding value while meeting its regulatory requirements



Strategies for Establishing a Strong Quality Culture (Contd)

B. Use a Risk-Informed Approach for QA Activities: (Contd) 4) Focus on programs and processes that manage risk to workers: Integrated Safety Management System (ISMS) Human Performance and Error Prevention Emergency Preparedness Training and Qualifications Focus on programs and processes that capture problems and drive continuous improvement: Corrective Action Program/Trending Self-assessment Program Operating Experience/Lessons Learned Causal factors and root cause analysis tools Focus on assessing the risk of multiple activities in the aggregate, not just the risk for each individual activity. Focus on assessing line managements capabilities of assessing risk on a real time basis and implementing appropriate countermeasures and management oversight. Establish Routines that Focus on Risk: Establish planning and scheduling strategies that place oversight personnel in the right place at the right time, focused on the most valuable activities at any given time: Merge audits, assessments and inspections into a hybrid approach that is flexible enough to follow the facility schedule, and efficient enough to meet all oversight requirements without duplication of effort. Shape checklists and inspection plans to focus the various oversight groups on the high risk activities at any given time, avoiding oversight that does not have a specific purpose or goal.


With the proper focus, independent oversight groups add significant value to the facility




Strategies for Establishing a Strong Quality Culture (Contd)

C. Define and Implement Proactive Oversight: Establish guidelines for management and oversight personnel to prevent rather than react to events. Provide guidance on conducting oversight at the most optimal time such that issues are identified before they can result in more serious consequences (in the right place at the right time). For example: 1) Establish plans for managing high-risk contributors to the sites Equipment Reliability Index. Establish oversight approach for high-risk logic ties on the site schedule for outages and operations (Primavera 6 or equivalent) and management of any changes to the logic. During refueling outages, establish specific plans to oversee maintenance and verify functionality for critical components whose failure during the startup can result in extending the outage. Continually evaluate line managements oversight of construction, installation, operation and maintenance of safety-related structures, systems and components, or any activities that could jeopardize the equipments ability to perform its intended safety functions.

Place oversight personnel in the right place at the right time




D. Daily Use of Causal Analysis Tools: Personnel that routinely evaluate problems or address Condition Reports must be trained to focus on identifying and addressing underlying causes, rather than addressing just the symptoms. However, experience has shown that the training provided on causal analysis and problem solving tools and techniques must be simple enough such that the techniques can be readily learned and used on a routine basis (and without requiring forms, computer software or manuals). The following small set of causal analysis tools can help personnel analyze data and identify underlying causes for the vast majority of problems encountered: Pareto Diagrams Affinity Diagrams Barrier Analysis Cause and Effect Analysis Fault Tree Analysis Events and Causal Factors Charting

Strategies for Establishing a Strong Quality Culture (Contd)

E. Strengthen Working Relationships Between Oversight and Line Organizations: Strive to establish excellent working relationships between line and oversight organizations. The value of working together is the establishment of a defense-in-depth model where all groups work together to identify and address problems. By identifying gaps to excellence, oversight will help the organization to continually improve performance F. Improve the Communication of Issues to Line Management: Independent oversight organizations must effectively characterize and communicate issues in terms that can be readily understood and acted on by management (e.g., highlighting the specific risk to equipment and personnel, identifying the liabilities incurred by the organization, identifying challenges to scope, schedule and cost, and listing the positive gains or competitive advantages of any recommendations). Merely stating the infraction or the gap to compliance is not enough to elicit the appropriate response.

G. Expect QA to Help Drive Performance: The nuclear industry has established a continuous improvement philosophy to prevent complacency. Continuous improvement is crucial to the industry as any events experienced by the weakest link in the nuclear fleet can result in dramatic impact and significant cost to the rest. (i.e. TMI accident, Browns Ferry fire, Davis-Besse reactor vessel head degradation). QA organizations should be an integral part of continuous improvement by focusing on issues that drive improvements in nuclear safety and quality, not merely on compliance with minimum standards. By identifying the gaps to excellence, oversight will help the organization to continually improve performance.

Benefits of Strong Quality Cultures

Prevent significant events from occurring through improvements in Quality and Nuclear Safety cultures and high performing oversight organizations. Enhance the Quality values and beliefs that drive behaviors in all employees in the company. Continuously improve Quality Management System programs and processes. Provide a competitive advantage to the company by realizing the cost-benefits of a strong QMS.

The strategies outlined in this white paper can be seamlessly integrated into existing Quality Assurance programs such as 10CFR50 Appendix B, NQA-1 and DOE Order 414.1c. They are applicable to organizations that are responsible for the Quality Program, and can also be used by regulatory oversight organizations such as the Nuclear Regulatory Commission and the Department of Energy. At the heart of these strategies is a value system where all employees understand that Quality is an integral part of core business, and that there is a direct correlation between quality and cost & profitability. Also, where all employees are focused on quality and the prevention of events through the proactive identification and resolution of underlying causes for conditions adverse to quality. Lastly, the changes brought about by the transformation to a strong quality culture are sustainable. But a great deal depends on emotionally intelligent, transformational leaders within the organization, and the message they send such that employees value and believe in the competitive advantage of a strong Quality Program. Ultimately, the transformation to a strong Quality Culture enhances the companys ability to protect the health and safety of the public, as well as provides the company with a strong competitive advantage driven by quality improvements and reduced operating costs.

Call DLE Technical Services and let us help you with transforming your Quality Culture!

WHY DLE Technical Services?

Who We Are: DLE Technical Services is a full-service project management company with expert organizational development strategies for diagnosing and addressing latent organizational weaknesses.

Our Mission:

Our mission is to assist our clients in gaining a competitive advantage through cost effective solutions that drive Breakthrough Performance and Cultural Transformations.

Our Core Values:

We focus on the client We are passionate about our work We move with speed and flexibility We are creative and innovative We care about our employees We trust and respect our clients and each other "DLE Technical Services and its subsidiaries will be regarded as the best and most sought-after Project Managers and Organizational Development experts in the federal procurement system.

Our Vision:


What makes us unique is that we bring proven industry standards of excellence to bear on all our projects; Leadership, Customer Focus, Strategic Planning, Organizational Structure, Workforce & Leader Development, Process Management & Control, Performance Management and Continuous Improvement.


Company Data
Company Name: Principal: Contact Information: DLE Technical Services, LLC Rob De La Espriella 4634 SW Long Bay Drive Palm City, FL 34990 (772) 341-1093 Office (866) 271-5199 Fax www.dle-services.com SBA 8(a) Small Disadvantaged Business Veteran Owned Small Business Minority Owned Business Size Standard <$4mm 41-2194259 March 1, 2006 623686834 4D0A4 Frank Velasco
Business Opportunity Specialist Small Business Administration South Florida District Office 100 So. Biscayne Blvd, 7th Floor Miami, Florida 33131 Phone: (305) 536-5521 ext. 122 Fax: (202) 481-1970 E-mail: frank.velasco@sba.gov

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