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.

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.