As environmental auditing navigates the global uncertainty of COVID 19, there are a few key points to consider in managing the associated risks. These risks may be regulatory, contractual, insurance related, business management, financing, and preventing environmental harm, among others. Many audits traditionally include a review of management system documents, interviews, and site attendance, however, this approach is currently influenced by government travel restrictions, border closures, social distancing requirements, cost, and availability of suitably qualified personnel. Although alternative methodologies may be suitable in certain circumstances, a risk-based approach to audits is advised to determine whether this is applicable, compliant, and cost-effective.
Kristin Keane is an internationally certified lead auditor with more than 20 years of experience working on environment, quality, and safety management systems, and is business consultancy co-founder of environment PACIFIC. Her auditing work had originally focused on regulatory compliance and best practice guidance related to environmental duty of care obligations; however, this scope has expanded considerably. Kristin draws on her qualifications and professional experience in biological sciences and business management to provide support to organizations regarding continuity planning, environment and social governance obligations, and risk management. These services are provided to a variety of sectors such as tourism, energy, renewables, telecommunications, government, resources, transport, ports, and global development projects.
After years of quality management system third-party auditing and consulting jobs, the presenter consistently observed that many organizations were weak in their approach, understanding, and application of “objectives” and how to properly use objectives to measure process effectiveness. This presentation addresses the three key parts of an objective and how to write and graphically display an effective objective. This presentation further promotes the use of “escapes” for process effectiveness measurement, explaining and demonstrating how to create a process effectiveness objective using the characteristics of the individual processes, including contracts, design, purchasing, production, test, inspection, and packing and shipping. The presenter further explains why use of “escapes” as a process effectiveness measure is easy to implement, effectively measures the individual process effectiveness, and takes minimal effort to maintain. Examples are provided throughout the presentation to ensure attendees can immediately apply the learned concepts so as to improve their own organization’s quality management system.
Frank Cain worked for Honeywell for 40 years on aerospace/NASA contracts, bringing ISO 9001 and AS9100 quality management systems (QMS) to the site. Serving as the management representative, he implemented the QMS infrastructure, trained the organization at large, was chairman of the procedure steering committee, and “father” of the root cause and corrective action process. He also served as the site manager for quality conformance for 12 years. Frank also teaches an ISO 9001/ISO 14001 course at University of South Florida for the College of Industrial Engineering; is a lead ISO 9001 and AS9100 auditor, consultant, and trainer; and has authored the books QMS Made Easy to Understand and Apply and Six Easy Steps for Organizations Self-Transition to AS9100D.
The audit process came of age in the 1920s following large-scale financial disaster and the Wall Street crash. Now, 100 years on, is there the same need for an effective audit of your quality management systems to prevent more customer-facing disasters? Using the 4P model and recent examples in the public domain we look again at the role of audit as a means of preventing disasters.
Paul Simpson is the current chair of ISO/TC 176 Subcommittee 2, the group responsible for maintaining ISO 9001, among other standards produced by the ISO technical committee. He also supports the development of standards for auditing, health and safety, and conformity assessment. Simpson is an executive and non-executive director specializing in risk, quality, and management systems, working with a mission to “keep it real.” He is an experienced developer of systems within organizations. With a first degree in engineering, Simpson has extended his postgraduate qualifications into fields of marketing and business as well as professional areas of auditing, health and safety, and quality. Throughout his career, he has been applying quality principles for risk management, quality planning, and business improvement to enable organizations to move forward with control.
Auditing Statutory and Regulatory Requirements in a Quality Management System | Joana dos Guimarães Sá
ISO 9001 requires organizations to demonstrate their ability to conform to the statutory, regulatory, and customer requirements, applicable to the products and services within the scope of its quality management system (QMS). Throughout the standard, ISO 9001 defines requirements to identify the statutory and regulatory (S&R) requirements, determine their applicability to its products and services, and define the processes needed to provide them and the means to demonstrate consistent ability to meet these requirements. In this session, the presenter will offer an overview of the recently revised paper of the ISO/TC’s 176 ISO 9001 Auditing Practices Group concerning auditing statutory and regulatory requirements in the context of a quality management system. We will address the varying complexity of S&R requirements in different organizational contexts, sources of information, QMS boundaries, evaluation for conformity vs. compliance, and liability. Finally, examples on the relation of S&R requirements and audit criteria set by ISO 9001:2015 are given.
Joana dos Guimarães Sá is co-convener of ISO 9001 Auditing Practices Group, an informal group of ISO/TC 176 that provides practical advice, examples, and technical background to third-party QMS auditors on how to conduct audits. She represents Portugal as an expert at working group 1 of ISO/TC 279 on innovation management, which is the WG responsible for the development of ISO 56002:2019, “Innovation management systems—Guidance” and the forthcoming requirements standard ISO 56001. Her participation on the normative framework for innovation goes back to 2006 with the development of the Portuguese standards for innovation. Joana is executive development director at APCER, a Portuguese certification body. In this position, she oversees the development of new services and technical updating of existing ones in the fields of management systems, products, services, and process certification. Quality management systems, innovation management systems, sustainable forest management, and chain-of-custody are areas of her direct technical responsibility. She has been working in the certification business since 1998 and has been an auditor since 1994. She is currently a lead auditor for ISO 9001, ISO 14001, innovation management, forest management, and chain of custody for FSC and PEFC.
During the last several years, the presenter of this session has noticed a positive trend with his clients: The results of all-hazards risk assessments have provided the added benefit of identifying opportunities for process improvements and creating efficiencies by identifying systemic inefficiencies. Improving inefficiencies, therefore, has led to significant cost benefit and savings, functioning as a road map for creating value and eliminating or minimizing risk. In several cases these inefficiencies resulted in lost value of several million dollars, a significant loss by any measure. Risk, threat, and vulnerability assessments are often misunderstood and therefore misapplied. Risk assessment is not merely identifying risks and calculating a risk level—it is the entry point for identifying and quantifying all enterprise risks. Further, it is a process of continuous improvement which ensures accomplishment of the enterprise strategy.
Jeffrey A. Slotnick, CPP, PSP, is an internationally known senior enterprise security risk consultant with more than 28 years of experience, peer recognized as a thought leader and a critical architect in homeland security. As an ISO-credentialed lead auditor, Jeff is responsible for some of the latest advancements in all-hazards disaster resilience, organizational resilience management, ISO/ANSI standards development, resiliency information management processes, enterprise security risk management, and quality management systems. Jeff focuses on all facets of enterprise security risk management, including risk, vulnerability, and threat assessments; emergency response planning; business continuity planning; and physical security system master planning, design, and integration. He has extensive experience in the public works and utility field with specific expertise in water, wastewater, dams, transportation infrastructure, light and heavy rail, supply chain, religious institutions, schools, data centers, and medical facilities. Jeff is a senior regional vice president for ASIS International, faculty advisor for the University of Phoenix bachelor of science in cybersecurity and security management degree program, and a 19-year reserve law enforcement officer for the city of Centralia, Washington, USA.
This session will explain the links between quality infrastructure (QI) components at the national, regional, and international levels. The main idea of the QI map is to help decision makers develop an efficient and effective national quality infrastructure system that can serve the national quality objectives based on the actual needs of trade and industry to achieve a better life quality. The United Arab Emerates’ national QI system, the gulf QI system, and the Arab countries QI system will be presented as examples of the national and regional QI system and their link with international QI system. The session will also explain briefly the European QI system as a role model for facilitating trade.
Osama Ahmad Awad Melhem is a capability development senior specialist, acting director of the Conformity Assessment Bodies Services Department, and technical advisor for the Abu Dhabi Quality and Conformity Council (QCC). He has worked to establish and implement a system to improve Abu Dhabi certification bodies, inspection bodies, and testing laboratories and take them to world-class levels. He is also lead assessor and/or technical assessor with the Emirates National Accreditation System (ENAS) and Gulf Accreditation Center (GAC) in ISO/IEC 17020, ISO/IEC 17021, ISO/IEC 17024, ISO/IEC 17025, ISO/IEC 17043, ISO/IEC 17065, and ISO 15189.
Businesses and governments are demanding greater transparency, and so they rely on accredited certifications to make important decisions when developing their supply chains. Certified supply chains are a way businesses and governments can demonstrate they have compliant and transparent global supply chains. IAF CertSearch has been established by the International Accreditation Forum and its members so accredited certifications from around the world can be validated. This supports businesses and governments to develop and maintain supply chains that meet the world's highest international standards.
Nigel Johnston is the founder and CEO of QualityTrade, an IAF database management committee participant for the International Accreditation Forum (IAF). QualityTrade is a technology company which creates software exclusively for the accredited network to improve integrity and value of accredited certification. QualityTrade has worked with accreditation bodies since 2013 and more recently with the IAF in developing the world’s first global database for accredited certifications and the world’s first trade marketplace for certified companies, which includes more than 1 million trade opportunities. His passion is helping businesses and governments develop certified supply chains which have a positive economic, environmental, and social impact. Prior to founding QualityTrade, Nigel held the role of CEO at URM Group, a multinational environmental services group.
The vast majority of audits—most notably certification assessments—have taken place over the last year utilizing remote auditing techniques. The learning curve was sharp; participants scrambled to adjust to the new forum for auditing. In addition, some web conferencing apps were still in their infancy. One year later, it’s clear that remote auditing is not going away. Now is the time to step back and assess the challenges and the benefits. What did we learn? What things went wrong? How can we prevent repetition of our errors? And how can we utilize the new tools we’ve acquired to enhance our audit programs?
Denise Robitaille is the chair of ISO/PC 302, the project committee that revised ISO 19011, which provides guidance on auditing. She is an active member of ISO/TC 176 Auditing Practice Group that develops papers providing guidance on auditing. Denise has participated internationally in standards development for more than 18 years and is a Fellow of the American Society for Quality as well as an Exemplar Global-certified lead assessor. She is internationally recognized for her work and is a frequent speaker at conferences. Denise has authored a dozen books, including The 9 Keys to Successful Audits, and she has contributed more than 100 articles to various publications on a variety of quality-related topics. She continues to help companies achieve ISO 9001 registration and to improve their quality management systems.
It is important to review the definition of auditing from ISO 19011:2018 advising auditors “to determine the extent to which audit criteria are fulfilled.” It is the first sin of auditing, then, for auditors to go looking for how the organization has not fulfilled the criteria, i.e., look for non-conformities. The differences between auditing and inspection must be kept in mind: Audits look at processes, and the intent of processes is to deliver outputs (products and services) meeting requirements. The inspection looks at the product or the service. We expect inspectors to protect the client/customer from a non-conforming product and so expect them to catch such products. Not so from auditors. Auditors are committed to the process and continual improvement. From this understanding of looking for conformity flows the correct attitude toward the audit, its dos and don’ts. In this session, the presenter offers experience from more than 20 years in this business of implementing process-based management system approach and meeting customer objectives.
IJ Arora is the president and CEO of Quality Management International Inc. (QMII). He has a 32-year record of achievement in the military, mercantile marine, and civilian industries. IJ serves as a team leader for consulting, advising, auditing, and training in management systems, specializing in several ISO and industry-specific standards. He is an Exemplar Global-certified lead auditor and a member of the US TAG to ISO/TC 176, the committee responsible for the ISO 9000 family of standards. IJ is a popular speaker at several universities and forums on management systems, conflict management, crisis communication, and leadership, and his writing has appeared in numerous industry publications.
In this session, the presenter will discuss all types of disruptors—not only the ones associated with technology—and interpret the concept of business agility drift along with agility vs. fragility positions. Further, the material tackles how business agility perspectives make online auditing agile and successful. The concept definition, benefits, and challenges of online auditing will be elaborated and explained. In conclusion, some crucial issues as well as key success factors will be addressed to help auditors and certification bodies successfully embrace remote auditing..
Mohammad Abu Hammour is president of the International Business Agility Institute (TIBAI) and the lead author of the forthcoming article, “Agility and the Covid-19 Pandemic,” scheduled to appear in The Lancet. He is the founder and technical author of the first standard in the world that addressed business agility (PAS1000, “Business Agility Concept and Framework”) along with the British Standards Institution (BSI). Mohammad also possesses the IP/copyright registration certificate for the development of strategic and operational business agility frameworks.
COVID-19 led to the introduction of remote audits at the certification auditing stage. This resulted in limited prior planning, audit frequency, and/or cycle disruption. Overall, remote audits have limitations, barriers, and challenges. The purpose of this presentation is to elaborate on this and to understand the impact and changes on the third-party auditing activities in an effort to address this unprecedented situation. We will highlight the challenges of the altered processes and most importantly mention the benefits of re-establishing the regular and/or normal audit cycles and/or types.
Mohammad M. Niazi is operations manager–assurance for SAI Global, where he leads a strong team of more than 20 third-party auditors. He has more than 19 years of experience as a lead auditor, consultant, and trainer in the fields of quality, environmental, and health and safety and has led third-party auditing teams in more than 300 organizations. Mohammad is a third-party lead/verifying auditor for ISO 9001, ISO 14001, AS/NZS 4801, OHSAS 18001, and ISO 45001, leading audits in large, diversified industries with extensive experience in engineering, consulting, construction, facilities management, automotive, and electrical industries providing risk-based process auditing.
Although feelings about the events at the workplace may have a non-normal distribution, spanning from "fear" to "euphoric, " few experience the latter emotion about a QMS audit. The curve is asymmetrically skewed to the left. Why is that so, despite the fact that the knowledge, skills, abilities, and competencies identified in ISO 19011 are all well-intentioned? As we already know, an emotionally charged atmosphere is hardly conducive to a good audit. Is there something that the auditor can do? If so, what is it? That is the focus of this session; uncovering the triggers, and tips on how to deal with them.
Rai Chowdhary has served in various roles across multiple industries, starting his first assignment as project engineer with Westech Systems Inc. on a NASA project to make silicon crystals on board the Space Shuttle during the mid-1980s. As an engineer he invented new technologies for making solar cells, medical devices, and lead-free non-toxic radiation shielding products; as a business leader he led the implementation of initiatives at Fortune 500 companies to deliver top quartile performance. In his current role as CEO of The KPI System, Rai is focused on adding value to small, medium, and large organizations through continual improvement, audits, and building robust supply chains. He is certified as a Six Sigma Black Belt, quality engineer, quality manager, and Exemplar Global auditor for quality management systems as well as ISO 13485.
Internal audits can become "ho-hum" when the same auditors ask the same questions of the same people year after year. Instead, internal audits should be a valuable tool for management to gain insight into risks and opportunities to provide value to customers and to the business. The chance to serve as an internal auditor can be a valuable opportunity for growth and influence if your audit program is regularly monitored and improved. Here are seven practices that high-performing audit teams regularly use to build the value of internal auditing for both your business and for your individual audit team members.
Karen Rawson, vice president of The DESARA Group, specializes in implementing quality and information security management systems in the information and communication technology (ICT) industry and beyond. With more than 10 years of experience training auditors using ICT and as a key developer for the ICT industry virtual instructor-led training courses, she has both the knowledge and the experience needed in training auditors how to implement effective audits using ICT. The DESARA Group offers virtual and on-site training on multiple standards and performs internal audits and improvement projects with clients. Rawson is a TIA Fellow, a certified TL 9000 expert, a key developer of the sanctioned TL 9000 training courses, and a supervisory master trainer. As a past member of the TIA/QuEST Forum Leadership Council, she has been a multi-year recipient of the COO/CEO award.
Auditing has been taken over by the pandemic. Remote auditing was once a method not considered seriously by registrars—until now. Hesitancy over how to replace the guided tour and interview employees prevented remote audits from moving forward. Technology used to lag in providing innovative methods in which to carry out a remote audit and adequately capture the manufacturing floor. But now everything has changed! In this session, the presenter will provide insight into auditing methods to capture a good review of processes, on-site/off site audit comparisons, and more than 10 years of remote audit results.
Having worked in quality for more than 30 years, Shauna Wilson holds Exemplar Global’s Principal QMS Auditor certification. Her research into virtual team communication and development of virtual auditing methods, as well as her auditing experience, has made Shauna the leading expert in remote auditing. She earned a master’s degree in engineering focused on organizational performance technologies and instructional design. Shauna wrote InterneTeaming.com: Tools to Create High Performance Remote Teams and co-authored eAuditing Fundamentals: Virtual Communication and Remote Auditing. Shauna has been featured in Quality Progress, The Auditor Online, and ASTD’s InfoLine. Shauna served as the U.S. expert for PC/TAG 302 for the ISO 19011:2018 auditing management systems guideline. She is currently serving as ASQ Portland section chair.
Food manufacturing is defined as a process industry. As a result, food safety auditors benefit from adopting a process approach for auditing. The presentation will explain the process approach and how it works for auditing a food safety management system (FSMS). A process approach demands risk-based thinking to improve process outputs and prevent undesirable results. As organizations evolve from a procedure-based FSMS to a process-based FSMS there is a paradigm shift from uniformity of routines to uniformity of outputs. When auditors fully understand the process approach the benefit is a higher level of confidence to ensure an organization has a robust FSMS. This presentation will explain the concept and supporting tools such as Turtle and SIPOC diagrams, Plan-Do-Check-Act (PDCA) methodology, the use of risk registers, and context of the organization (interested parties, external issues, internal issues) analysis. It will also describe process-based auditing techniques for how to follow audit trails across integrated processes and measures to verify they meet defined objectives and requirements.
Colin Christmas joined EAGLE in 2019 as a managing director to support EAGLE’s international growth. He is an experienced professional with more than 20 years in the food industry working for Nestlé. Colin had the privilege to live and work in numerous countries around the world, which helped him develop an excellent understanding for process, systems, and standardization while working with different cultures. He has a bachelor’s degree in computing and business analytics from The University of Huddersfield, with specialization in quality control, quality management systems, and business process management. He also has program completion certificates from Wageningen University and Research for Food Safety Management and from the London Business School for an executive leadership program.
These days, food businesses and their contexts, supply chains, etc. are more complex. This has led to more complex food safety and quality management systems and, by default, more complex audits. This session is aimed at seeing the system/the big picture, sharing practical tips on using the process-based approach, and helping auditors find their direction and pace throughout the audit process to help them deliver their audit objectives which, in turn, should help the auditee achieve their objectives, too.
Ray Haddad loves talking food protection! Since 2007, Ray has specialized in food safety, food defense, and food fraud prevention. He has also worked in quality roles, auditing, training, consulting, and supporting various organizations, from small family-owned to multinational food businesses, intergovernmental organizations, and regulators in New Zealand, Southeast Asia, and the Middle East. Ray is the principal trainer and managing director at Food Surety Limited, an organization committed to supporting food professionals to do what is right with confidence, so they can be successful and fulfilled protecting consumers everywhere.
Internal auditing is a powerful but underrated business tool for helping you comply with both your occupation health and safety as well as food safety obligations. In this session, the presenter will use his experience to look at the advantages and possible pitfalls involved with internal auditing, and why conducting internal audits effectively is an important part of meeting your obligations under the relevant legislation.
Daniel McConville is the director of McConville Risk Solutions and has extensive experience in food and hospitality providing both food safety and occupational health and safety (OHS) services to a number of industries. McConville Risk Solutions are recognized as food safety specialists and work with some of Australia’s largest providers. As a tertiary qualified food safety and OHS professional, Daniel has expertise in developing and implementing food safety management systems and occupational health and safety management systems (OHSMS) to a range of industries including education, hospitality, health and aged care, local government, facilities management, and food manufacturing. Prior to commencing McConville Risk Solutions, Daniel worked for the Willis Group, the world’s third-largest insurance broker, in their workplace risk team, during which he worked on several projects for major companies.
You may or may not be familiar with this classic corrective action: “We brought it up at the team meeting, we told them not to do it again, and we re-trained everyone.” This came up recently during a robust discussion between auditors, and that got the presenter wondering: What is the wider view on when questionable corrective action becomes an audit non-conformance? Listen to the story in this session so far and ponder the question: “Which way will you lean?"
Wendy Edwards has more than 30 years of experience as an auditor, consultant, and in-house quality professional, specializing in high and low-risk food industries. She is currently the head of food safety and quality for a New Zealand-owned business which employs 1,500 people across three countries and generates revenue of around $300 million NZD per annum. Manufacturing operations in New Zealand and Australia are SQF-certified and export food to around 18 countries. In 2019, Wendy was recognized by SQFI as the SQF Practitioner of the Year.
Food safety auditing is a technically challenging and complex endeavor involving quality and safety checks at multiple points along the food supply chain. In this session, the presenter will draw on deep practical experience to address the differences and similarities in auditing farms/feedlots, abattoirs, wholesalers, retailers, and restaurants.
Thea Laufs’ mission throughout the last 28 years has been to improve the food safety culture and assist with the food safety and quality standards trend setting in South Africa. Her experience and expertise include more than 25 years of auditing across all the industries including but not limited to food and packaging manufacturing, QSR, restaurants, hotels, abattoirs, and farms. In addition, she is an internationally certified lead auditor in food safety and quality. She participates on various industry committees (SANS, SAATCA, RMMA, FSSC, etc.) and is always keen to share her technical expertise and guidance to industry. In 2009 Thea acquired the agency for Africa for CPG Global and has grown her client base through her dedication, commitment, and passion for the industry. Her vast experience and knowledge base was the reason she was appointed technical director for food safety for CPG internationally back in 2015.
This session will discuss the importance of CAPA management and how software can help manage the workflow and processes associated with CAPA. A software system can simplify the process by streamlining communication, compiling the data in one place, offering better visibility into the process, and sharing of the CAPA information.
Shamonique Schrick is solutions architect at SafetyChain. With degrees in biochemistry and molecular biology, and more than 10 years of experience as an auditor, food safety expert, and quality specialist, she has a wealth of knowledge to share. Shamonique supports customers in everything from reporting and analysis of data, standardization across processes and facilities, identifying best practices, and the blueprint process. Besides her work at SafetyChain, Shamonique has also worked as a food safety specialist and supplier quality specialist at Cargill, supplier quality auditor for TreeHouse Foods, and microbiologist at MillerCoors.
This session will focus on techniques to help auditors get more practical value while conducting audits of management systems based on ISO 14001 and ISO 45001. The presenter will review basic good auditing principles, look at some suggestions on setting up an internal audit program, and discuss the use of a systematic method to estimate the amount of time needed to complete an effective audit. The presentation will then go into some tips on ways to plan and prepare for audits to make the best use of allocated audit time, and will finish with recommendations on how to write findings that focus specifically on gaps in system process effectiveness.
Rick Gehrke has 25 years of experience in environmental, health, and safety with work in diverse industries, including food production, automotive and aerospace manufacturing, government and defense, electric power generation, chemicals, and more. He is a veteran EHS consultant, auditor, and trainer. Prior to joining Intertek Alchemy, he worked for Intertek as green services associate program manager. Rick is an Exemplar Global-certified management systems lead auditor with experience in ISO 14001, OHSAS 18001, ISO 45001, ISO 50001, LEED green building certification, business development, and certification program management. He is a U.S. Air Force airborne operations veteran.
In this session, the presenter will discuss the initial idea, evolution, and development of the new international standard for occupational health and safety performance evaluation. This standard provides guidance to help measure all the positive things a business does to maintain effective OH&S performance. The presenter will also provide an update on all the other international occupational health and safety management standards that are under development by ISO/TC 283.
David Solomon has worked in the building and construction industry for more than 32 years. He is the Master Builders Association of NSW executive officer of safety and risk as well as a fellow and dual international ISQEM Safety Award Distinction recipient (2015 and 2016) for his commitment and involvement in developing a positive safety culture in the building and construction industry. David was recently appointed to the board as an international director of ISQEM. David is recognized as a standards expert who is the chairman of Standards Australia’s Occupational Health and Safety Management Committee, and Standards Australia’s ISO 45001 international head of delegation. He is the convenor of ISO/TC 283/WG 4 leading the working group responsible for the development of a new standard ISO 45004, “OH&S Performance Evaluation,” which is intended to complement ISO 45001. David is a director on the board of the Crane Council of Australia as well as an Exemplar Global-certified management systems specialist (lead), a master OH&S auditor, and their ISO 45001 exam and scheme chairman. He is also the chairman of PwC’s External Advisory Board for their certification accreditation body. He regularly reviews documentation for Australian state and national government departments, including auditing, safety, and transport for relevance, corporate governance, and compliance.
More and more organizations worldwide are implementing different types of management systems. Some are doing this to meet the demands of their customers or, just as importantly, to help drive continual improvement within their organization. By combining several different management systems, the organization is essentially “Integrating” them into one system. In doing this, the organization faces many challenges and opportunities. This also brings about challenges and opportunities for auditors as they determine whether the systems conform to the standards and the organization’s defined requirements, and that the integration is effectively implemented and maintained. This presentation looks at the risks and opportunities for the audit program and for auditors when conducting audits of an integrated quality and environmental system. ISO 19011:2018, “Guidelines for Auditing Management Systems” is a standard that helps organizations establish an audit program and helps auditors to prepare for and conduct effective process-based integrated audits. After attending this presentation, the attendees will enhance their personal knowledge as they conduct integrated audits in the future.
Richard A. Litts is the founder and president of Litts Quality Technologies Inc. Rick has many years of corporate, manufacturing, and consulting experience. He is an Exemplar Global quality management systems registered lead auditor, a PROBITAS Authentication AS9100 aerospace experienced auditor (AEA), and an IAQG-qualified AS9100 aviation, space, and defense auditor. Rick has been a member of (and the AS9100 subject matter expert) on a committee to protect impartiality for an international QMS registrar. He is an U.S. expert representative for the U.S. Technical Advisory Group (TAG) to the International Organization for Standardization (ISO)/PC 302 Committee. He is a senior member of ASQ, an ASQ-certified quality engineer, and a certified quality auditor.
This session provides an overview of integrated risk management (IRA), the benefits of IRA, and an overview of some of the methodologies that can be used to assess risks within an organization. The presenter will provide an example of how IRA can be used to evaluate some of the typical safety and environmental risks arising in a warehouse used for the assembly and storage of goods. Finally, we will discuss some of the key factors in IRA success and how digitization can be used as an organizational enabler to help continually improve and maintain an organization’s ISO management system.
Craig D'Souza is the managing director of E-Risk360 and a governance, risk management, and compliance (GRC) professional with training across ISO management system assurance and certification. He is registered with Exemplar Global as a lead auditor in management systems including quality (ISO 9001: 2015), EMS (ISO 14001: 2015), and OH&S (ISO 18001/AS 4801/ISO 45001). Craig’s main areas of focus is providing integrated risk management consulting, auditing, and training solutions across these areas, focusing on quality, environmental, and occupational health and safety risks. He has worked with start-ups as well as across small, medium, and large global private and publicly listed high-growth ASX companies. In addition, he has worked at both the state and national levels of the Australian government.
The AIAG-VDA FMEA handbook is the result of the collaboration between OEMs and tier one members of the Automotive Industry Action Group (AIAG) in the United States and Verband der Automobilindisturie (VDA) in Germany. The AIAG-VDA DFMEA format has brought about key changes in the FMEA methodology with its seven-step implementation process. These fundamental changes will have a significant effect in the FMEA methodology for years to come and will also impact automotive, aerospace, and all other industries that use FMEAs. This new format is already being used my most of the tier ones based on the trainings and implementations that Omnex has been providing for them. Auditors will soon be presented with the AIAG-VDA FMEAs in their current and upcoming audits. This session will address the key changes and 20 key audit points for auditing the new AIAG-VDA FMEA format. Commonalities between the audit points of AIAG-VDA FMEA and AIAG 4th edition FMEA will be discussed.
Chad Kymal is the CTO and founder of Omnex Inc., an international consulting and training organization headquartered in the United States. Chad is also the CEO of Omnex Systems, an enterprise quality and IMS software provider. He is on the ISO/TC 176, ISO/TC 207, and PC 283 committees for ISO 9001:2015 (quality management), ISO 14001:2015 (environmental management), and ISO 45001 (health and safety management systems). Chad is also the U.S. expert for the ISO 10013 documented information update. He is a certified lead auditor for IATF 16949, ISO 14001, ISO 9001, FSSC 22000, HAACP, ISO 45001, and AS9100. Chad teaches these and many other courses for Omnex, such as integrated management systems. Chad and Omnex teach, implement, and audit AIAG 4th Edition FMEAs, AIAG-VDA FMEAs, and SAE J 1739 FMEAs. Chad, along with Greg Gruska of Omnex, originally discovered the linkages between the PFMEA and DFMEAs in the 1980s and 1990s.
In this session, the presenter talks about the integration of management systems from a practical perspective with some real-life examples. The attendees will get to know the many benefits an integrated management system brings to organizations and teams and how an integration of the auditing process and the audit team helps efficiency and continuous improvement. Some tips on how to tackle challenges, especially those of virtual remote audits, will be shared.
Nancy Nouaimeh is an accomplished chartered business excellence and total quality management professional with more than 18 years of experience and a proven record of significant achievements. She holds master’s degrees in TQM and agronomic sciences and bioengineering. In her current job as AVP–quality, safety, and performance excellence at a leading food services management company in Dubai, Nancy leads improvement projects through innovative and integrated approaches. She is an expert in ISO standards and auditing (ISO 22000, ISO 9001, ISO 14001, and ISO 45001). She is also a subject matter expert, senior assessor, and judge for national excellence, innovation, and quality professional awards.
The auditing profession faced considerable challenges in 2020. Workplace closures, temporary or otherwise, and travel constraints during the COVID-19 pandemic restricted access to workplaces, forcing many audit firms to consider remote auditing techniques in an attempt to maintain their service and the quality of their assurance. This was no more evident in 2020 than in Melbourne, Victoria, Australia, which endured a strict 112-day lockdown complete with curfews and severe travel restrictions. This presentation outlines Verus’ experience adopting, trialling, and evaluating different technologies to support remote auditing and how the industry can improve its effectiveness as the pandemic continues to affect the auditing profession in 2021 and beyond.
Cameron Clark is a highly experienced auditor with more than 10 years as a certified Exemplar Global auditor for OHS management systems, completing large and small audit programs as part of self-insurance requirements, management system certification, and internal assurance programs. Cameron is also a Queensland government-approved self-insurance auditor. Cameron works carefully with organizations to identify the objectives of their audit program, refining audit approaches to better engage with those being audited, and minimize the strain and anxiety that audit programs can cause to deliver a beneficial program that focuses on improvements that can have a truly material impact on an organization’s performance. His auditing experience has been drawn from a wide variety of industries in Australia, including from defense, air transport, local government, healthcare, manufacturing, property management, transport and logistics, retail, and finance. Cameron’s cross-sector experience affords him the ability to quickly and easily adapt audit programs so that they are tailored to specific activities, risks, and environments that enhance the quality of information from assurance programs and enable organizations to make decisions driven by high-quality information.
The ongoing global pandemic has been a sad reminder that plans are always vulnerable to unexpected and tragic disruption. In the realm of business, having a robust business continuity management system (BCMS) helps ensure that organizations are aware of their internal and external risks and are taking steps to address them in advance. In this session, the presenter will offer a look at BCMS and how a standard such as ISO 22301 can help organizations improve their resiliency.
Dhiraj Lal is the executive director of Continuity and Resilience (CORE). He has worked with the American Express Global Financial Centre (BCM Head for 3 years), Standard Chartered (5 years, Abu Dhabi and Dubai), and Citigroup (10 years, last as regional head of audit, covering also business continuity. He is a former chair of the BCI Forums in Delhi and the UAE. As Asia’s first BCM technical expert, he was invited by BSI in 2007 to help assess two of the first 10 organizations in the world to be BCM certified. He has twice been invited to present at BCI World and also by itSMF (UK), Data Centre Dynamics (UK), DRI Asia (Malaysia), ISACA (UAE), DRI (US), and also various conferences in the UAE, KSA, and India. He is a contributing author to the Definitive Handbook of Business Continuity Planning, and co-author of the Step by Step Guide—AE/SCNS/NCEMA 7000:2015, Implement BCM the UAE Way!
Health care delivery organizations are complex adaptive systems that operate in highly complex and unpredictable environments. The science of those systems assumes that much of organizational life is uncertain and unpredictable, hence it cannot be standardized and controlled. The COVID-19 pandemic is a powerful reminder that we live in a highly complex and unpredictable world; for health care delivery organizations, effective responses to the pandemic have required departures from many conventional practices. This presentation will tackle the quality management, risk management, environmental management aspects, and how to plan while meeting the clinical standards.
Rola Hammoud, MD, DA, MHM, FACHE, is an anesthesiologist and chief medical executive at Clemenceau Medical Center in Dubai, as well as the president of the Lebanese Society for Quality and Safety in Healthcare. She is American board-certified in healthcare management from the American College of Healthcare Executives and is certified from the Harvard School of Business in the management of health care delivery for executives. Dr. Hammoud holds a master’s degree in hospital management from the ESA Business School and University Paris VII (France), as well as a teaching diploma and a mediation diploma. In addition, she is an academic lecturer on patient safety and risk management and a reviewer for anesthesia and quality journals. She is a speaker on healthcare quality and accreditation and an expert on the national committee for the Lebanese accreditation standards development as well as a training faculty for the surveyors of the Lebanese Ministry of Public Health. Dr. Hammoud founded the Lebanese Society for Quality & Safety in Healthcare in 2012 and was elected twice as its president
Innovation management is a key ingredient for organizations that wish to grow and develop new markets and offerings. The key to successful innovation is imbuing a sense of “intrapreneurship” throughout all layers of the company. In this session, the presenter explains the nature of innovation on the operational level, shows how the organization can develop intrapreneurs, and offers a perspective on why implementing and auditing against the ISO 56000 family of standards on innovation management can help jumpstart this process.
Alice de Casanove is in charge of innovation culture at Airbus North America, where she fosters a relevant mindset to accelerate future businesses. She leads the cultural roadmap for digitalization and anchors Airbus values. Alice plays a determinant role in the publication of the ISO reference on good practices in innovation management (ISO 5600 series). Since 2013, she has chaired the international committee gathering more than 50 countries in close coordination with WTO, OECD, WIPO, and the World Bank. Alice began her career in a video deep-tech start-up before joining French telecom manufacturer Sagem to manage and develop the value of their Innovation portfolio. She later develop video technologies for Actimagine, which became the Nintendo Europe R&D Center. Alice graduated from Telecom Paristech and is finishing a Ph.D. on the relationships between large corporations and start-ups within Lorraine University.
In this session, the presenter will talk about supply chain risk management (SCRM). The presentation will answer:
• What is SCRM?
• What is the U.S. SCRM Presidential Order?
• What is today’s sourcing business model?
• What is “old school” and “new school” SCRM?
• How is “make or buy” now evaluated?
• What are 30 sourcing strategies?
• What is the future of SCRM?
Greg Hutchins, PE CERM is the founder of Certified Enterprise Risk Manager (CERM) Academy. His company was among the first companies (in 1987) to provide audit training with one of the first ISO 9001 certification bodies in North America (AGA Labs) and was first approved by the Department of Homeland Security for Critical Infrastructure Protection: Forensics, Assurance, Analytics. They have been conducting risk audits for 20 years. Greg is the author of Value Added Auditing, Risk Based Auditing, Supply Chain Risk Management, and ISO 31000:2018.
What do very successful companies do that others do not? Communicating directly via a shared dashboard is easier and more powerful than you may think. In this session, the presenter will discuss dashboards—a simple but extremely effective tool that can be used by all management levels. This presentation will explain how to set up a dashboard that is convenient and specific to your company and expand your dashboard from a modest quality-specific monitoring panel into a complete, business-intelligent instrument.
Donna Stockwell is a professional engineer and certified lead auditor. She helps teams at all levels of the organization understand what makes a good quality organization overall, as well as the individual requirements to make it happen. She also trains team members in a variety of ISO products.
Risk-based auditing is one of the most critical elements in the internal and external auditing of all management systems. Its importance has grown for several reasons: management systems are now based on Annex SL, which demands a risk-based approach; ISO 19011, “Guidelines for Auditing Management Systems,” also demands a risk-based approach; and the fact that present business in highly risky. The challenges from the perspective of internal and external auditors are to have audited organizations consider emphasizing this competence, developing existing internal and external auditors to better perform such audits, and training them accordingly. In this session, the presenter will discuss why risk-based auditing is required and what considerations must be taken during a risk-based audit (e.g., auditor selection, audit planning, audit performance, audit reporting, and audit close-out).
Shibu Davies currently leads the certification and auditing business unit of TUV Middle East (a member of the TUV NORD Group) in the Gulf Cooperation Council (GCC). He is a senior assessor of ISO 9001, ISO 14001, and ISO 45001/OHSAS 18001. In addition, Shibu is a senior trainer for these schemes under IRCA. He has represented various technical work groups and steering committees in the auditing and certification segment. He is presently the technical advisor for Emirates International Accreditation Centre. His experience includes consulting, training, and auditing in various industry segments across the GCC. He is quite well-known as a speaker in the region in this segment and has a technical YouTube Channel with title Doctor ISO.
MCI Middle East
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