COVID-19: Remote Auditing During a Pandemic
Presenter: Kellan Ilse
COVID-19 is an unavoidable topic. In this session, the presenter will discuss how the pandemic has affected planned audits in 2020, focus on the response across the auditing industry, and examine remote auditing as one potential solution. Although remote auditing is not a new concept, experience has shown that few auditors and organizations had experience with remote audits prior to COVID-19. We will focus on discussing industry acceptance of remote auditing along with best practices when planning, performing, and hosting remote audits to ensure your next remote audit goes off without a hitch.
Pandemic Readiness and Your Emergency Response Plan
Presenter: Shawna Wagner
The presentation for pandemic readiness and your emergency response plan is aimed at educating any manufacturing site that may experience a global emergency, such as COVID-19, and how this works with their emergency response plan. The presenter will look at strengthening an emergency response plan and will provide examples that could be used as additions within it.
COVID–19 and the Food Industry
Presenters: Ajay Shah and Krutika Kachhy
COVID-19 is a new virus in the corona family that has been declared a global pandemic and causes severe respiratory tract infections in humans. It affects all aspects of daily life, including travel, trade, tourism, food supplies, and financial markets. As it is a respiratory virus, it spreads through droplets from an infected person. There are no recorded cases in the world of transmission of COVID-19 from food. In this session, the presenters will demonstration how by following strict hygiene, raising awareness and staff training for COVID-19, and conducting effective cleaning and sanitation, the food industry can form and follow a good, effective preventative action plan.
Emerging Remote Auditing Practices That Apply to Food Safety
Presenter: Dijana Green
During a global crisis, how do you meet an organization’s corporate policy when auditors are not allowed on site to conduct a food safety audit or if it is unsafe to travel? How do you quickly reposition yourself to ensure food safety audits continue? How do you avoid a significant build of up of supplier audits all due at the same time after a crisis? In this session, the presenter will demonstrate that remote online audits provide many benefits and allow food safety audits to be conducted in real time anywhere at any time. Business–critical requirements need to continue, and food safety audits are essential especially when the world practically comes to a standstill and food and beverage manufacturers continue to manufacture. We need to be confident food safety standards are being met and complied to even during a pandemic. Remote online audits can be very effective if carried out well by an experienced auditor. The security of carrying out remote online audits can be assured and guaranteed.
The Challenges and Benefits of Environmental Auditing Using Remote Methods
Presenter: Nigel Leehane
COVID-19 has resulted in an uptick in the use of remote methods for environmental (and other) auditing, bringing with it a range of challenges. This session will explore the options available for remote auditing and will reflect on the implications for delivering effective audits and fulfilling broader audit programs. This is an important topic, as current experiences of remote auditing, and its benefits, may lead to a permanent increase in the use of these methods.
Auditing in a Virtual World
Presenter: Sheronda Jeffries
Due to the COVID-19 pandemic, the workplace is evolving. “Auditing in a virtual world” is quickly becoming the new normal. In this session, the presenter discusses how auditors (certification body, internal and supplier auditors) quickly adapt and overcome the challenges of differences in time zones, communication styles, and most importantly, potentially a lack of familiarity and trust in technology and collaboration tools.
Remote Auditing: The Future of Auditing Is Now
Presenter: Kevin Campbell
In this session, the presenter covers the following topics:
- Remote vs. virtual auditing
- Auditor qualification
- Audit preparation
- Meeting audit objectives using information and communication technology
Audit Programs: Preparing for e-Auditing
Presenter: Shauna Wilson
Incorporating eAuditing into the audit program requires planning for technology, training of auditors, and the assessment of audit performance. This session discusses minimum criteria to expand your audit program, focusing on audit program elements such as Interested parties, audit process, technology, auditor capabilities, and risk assessment. The presenter will expand on:
1. Interested parties and necessary agreements
2. Reviewing a management audit plan with an example
3. Learning to conduct a risk assessment of the audit program
4. Discussing the auditor’s new capabilities and technology requirements
Setting Up Management Systems for Virtual Audits
Presenter: Chad Kymal
Virtual audits or remote audits are quickly becoming the “new normal.” Documented management systems which are web- or cloud-based greatly help organizations conduct these virtual audits. The organization of the documented information is key to the success of virtual audits. There are different types of functionality required in documented information software. This session will explain organization, types of functionalities, and how they can be used. The presenter will explore the different types of technology options for both documented information and electronic workflows. These are important for virtual audits and if set up correctly, they can also help organizations conduct their business more efficiently.
Training Auditors for a Virtual World
Presenter: Karen Rawson
This session is a companion presentation to “Auditing in a Virtual World.” As the business world adapts to the necessity of working remotely, auditors need to make adjustments as well. How will you train and prepare your audit teams to have the skills and confidence they need to audit in new ways?
In this presentation, program managers and auditors will learn:
- How to assess your organization’s readiness for virtual auditing
- Six tips for audit program effectiveness using virtual audit methods
- Four essential skills for internal auditors to master *before* conducting virtual audits
The presenter will share techniques gained from years of experience with organizations large and small.
New Audit Technology
Artificial Intelligence 101 and Auditing at a Glance
Presenter: Alka Jarvis
With a changing business environment, it is critical to have auditors who are competent with the new technologies and know the areas to review while auditing. Artificial Intelligence (AI) is here and it will ultimately have a huge effect on the world economy. PwC estimates that AI could add about $15.7 trillion to global GDP by 2030. With the fast adoption of AI technology by industry, are quality management systems auditors ready to conduct audits that will benefit the companies being audited? The presentation will cover key areas for the auditors to review in fast–paced AI technology, where the majority of mature companies are predicted to gain a competitive edge.
Made in World-Wide: Leveraging Industry 4.0 Technologies and Virtual Audits
Presenter: Fayzee Ahmed
It is difficult to label a product with made in “xyz” country. Large multinationals no longer build many of the assemblies and major components that comprise their products. There are many examples of high–visibility recalls in history, either due to defective purchased materials or failure to comply with statutory and regularity requirements. Recalls are expensive and damaging for the brand name. Therefore, managing supplier quality is as crucial as managing quality in your own shop. In this session, the presenter shares success factors to consider in managing a diversified global supply chain. Having crucial components of supplier quality in place ensures competitiveness. Industry 4.0 technologies have enhanced the real-time visibility of the entire supply chain. These technologies can be leveraged to make informed decisions in managing suppliers and implementing proactive actions to prevent disruptions. COVID-19 has led to emergence of social distancing, resulting in support for carrying out virtual audits. Sophisticated technologies allow us to maintain the integrity of virtual audits. However, the jury is still out whether virtual audit will become a new normal for carrying out second–party audits.
Beyond the Normal Audit—Enhance the Value of Audits with Analytics and AI
Presenter: Jochen Kleboth
Data science and artificial intelligence (AI) are already changing the way we produce food in many aspects, including the way we grow, process, and distribute food. Everywhere data and new data analytic methods on demand. This trend is also true for the certification business and lets us develop new solutions to analyze audit data and make audits more valuable for the food chain. AI–powered dashboard tools for auditors, producers, retailers, and certification bodies have been developed to allow stakeholders to systematically analyze food safety and audit data, find anomalies and risks, predict audit outcomes, and to benchmark those risks and findings. The systematic use of food safety and audit data has the potential to significantly enhance food safety with more targeted and efficient audits and to distribute important food safety information more effectively along the food chain. In this session the presenter will discuss how the near future will go beyond the normal audit with advanced analytics and AI, discussing the prerequisites and possibilities to analyze audit data and how this supports strategic and tactical decision–making.
The Now of Auditing and Certification in the Age of Hyperconvergence?
Presenters: Harry van Enckevort and Andrew Baines
Advances in science, technology, and digital capabilities are coupling with advances in data sciences, algorithms, and computing capabilities. This is transforming what can be done by whom or what, where, when, how fast, and for what purpose. The opportunity and need for “what’s possible” solutions have been brought forward unexpectedly. However, the building blocks of one envisaged future are here, at hand, making that future increasingly feasible and likely and also bringing it closer. This future challenges the meaning of assurance and auditing, and how auditing might be done. In this session, the presenters outline that future and ask some questions.
Wearable Technologies Empowering the Worker
Presenter: Lance Bauerfeind
This session will demonstrate how wearables fit into the puzzle that is digital transformation. Companies worldwide are now jumping on board to implement wearable technologies into their businesses. They are realizing huge productivity and efficiency gains and see it as a key strategy for them in the future. Being able to carry out remote calls to experts and audits/inspections, to name a few, entirely hands-free, getting and delivering the information they need at the time they need it is key to their success.
The Internet of Things (IoT) and the Management of Risk
Presenter: Craig D’Souza
For risk managers, the Internet of Things (IoT) has traditionally been seen as a potential liability and security concern. However, with the implementation of appropriate systems, safeguards, and security protocols, the Internet of Things (IoT) is being used to manage risks now more so than ever before. One example is IoT technologies being used to monitor and manage physical and social distancing during COVID-19 restrictions. IoT offers exciting potential with very real benefits for the risk profession and the community at large. This presentation highlights some applications with IoT across a range of industries.
How to Conduct a Successful Audit
Presenter: Daniel McConville
Auditing can be difficult at times, making sure you ask the questions and gather the evidence, all within possibly a short time frame. In this session, the presenter will provide insight into what is required to ensure your audits are done successfully, with a minimum of fuss and less stress! From planning and preparation through to writing the report, these components make up a successful audit. The presenter will share lessons learned from being the auditor and the auditee to help you conduct a successful audit.
Consulting? Or Adding Value? Where Do You Stand?
Presenter: Wendy Edwards
Consulting? Or adding value? Where do you stand? This presentation offers a light-hearted reflection on a controversial topic that can divide colleagues and unleash passionate speeches about conflicts of interest.
Consulting? Or adding value? As an auditee, the presenter will share her views. As an auditor, where do you stand?
Value-Added and Risk-Based Auditing
Presenter: Greg Hutchins
This presentation describes a step-by-step process that can be used for performance, risk management, ISO management systems, and risk-based audits based on ISO 19011:2018. All ISO 9001:2015 and ISO 14001:2015 auditors should understand how to conduct risk-based auditing (RBA) on risk-based thinking (RBT) and similar risk-based requirements. This presentation explains and shows you how value-added auditing is planned, conducted, and reported. The presenter will also discuss key topics such as defining RBT, reasonableness, risk controls, etc. Value-added auditing has a process-based emphasis cutting across appraisal and auditing functions. Why? Because more businesses are run along core processes.
Assessing the Effectiveness of an Organization’s Self-Management
Presenter: Robert Freeman
Management system standards such as ISO 9001, ISO 27001, ISO 45001, etc. are written to serve as systems or platforms an organization can apply to support their effective self-management. As self-management is the intent, whether it is effective or not, the process used for assessing these standards or any set of requirements should also use techniques intended to verify self-management is taking place while also validating the effectiveness of that self-management. The goal of this presentation is to help the auditor understand how the purpose of the management system standard is applied within the organization, and why it should be an integral part of the methods used to assess that management system and the organization’s effectiveness. This session will outline the steps an auditor would consider when evaluating a management system, with the effectiveness of self-management being accounted for and used to aid in the overall conclusion regarding that system. It will also emphasize or highlight how to think about and complete the necessary tasks. By helping the auditor work through the series of events related to intentionally assessing the self-management of an organization, they can have a higher degree of confidence in the conclusions reached. This will also provide a higher degree of confidence in that management system by the organization and possibly their interested parties.
Business Continuity Audit
Presenter: Jorge Bravo
ISO 22301 is a management system for business continuity that prepares the organization for eventual interruptions (disruptions) in the delivery of its products and services. Auditing the system contributes to its improvement. What will it be like to remotely audit such a system in times of extreme crisis? In this session, the presenter will “inject” the ISO 19011 standard into a ISO 22301 system and see how it works.
Overcoming Common Barriers to ISO Standards Implementation
Presenter: IJ Arora
A process-based management system defines the key processes established within the organization. Using rigorous process analysis, a management system is developed that has low implementation costs and is documented only to the extent necessary for control. Users improve the resulting system to add value and reduce costs while conforming to the chosen ISO standard or to any combination of management system standards. The barriers to ISO standards implementation can be overcome through systematic implementation by identifying key processes, working with process owners to analyze key processes, designing new key processes, simplifying documentation, and using and continually improving the system.
Revision of ISO’s Annex SL High Level Structure for Management System Standards
Presenter: Nigel Croft
Annex SL of the ISO directives specifies criteria for the development of ISO’s 40+ management system standards (MSS). It includes the so-called high level structure (HLS) that defines the common terms and definitions, clause sequence, and some common text to promote a harmonized “look and feel” to these standards. This presentation will explain how Annex SL is currently being revised, the timeline, the changes that are likely, and their implications for management system auditors.
Enhanced Innovation Management Capabilities: ISO 56002, “Innovation Management Systems—Guidance”
Presenter: Joana dos Guimarães Sá
According to ISO 56002, “An organization’s ability to innovate is recognized as a key factor for sustained growth, economic viability, increased well–being, and the development of society.” Innovation becomes more complex and difficult to achieve by organizations in a global and rapidly changing environment. Innovation can be managed more effectively and efficiently using a systems approach. ISO 56002, “Innovation Management Systems—Guidance” allows the organization to determine its innovation vision, strategy, policy, and objectives, and to establish the support and processes, culture and collaboration needed to achieve the intended outcomes. In this session, the presenter offers an overview of ISO 56002, how it was developed, its foundational principles, key attributes, and main features.
IAF CertSearch: The Global Certification Database Users Need to Develop Certified Supply Chains
Presenter: Nigel Johnston
IAF has developed the world’s first global certification database. The database is a game changer for users, helping them verify certifications across their supply chains and establishing confidence that the certification is valid, the certification body is accredited, and the accreditation body is a current IAF MLA signatory member all in one process. This presentation will provide an update on the global database and highlight the benefits it offers users and the global accredited network of accreditation bodies, certification bodies, and certified organizations.
Quality (ISO 9001)
Moving Past the Minimum QMS Requirements for Improvement
Presenter: Buddy Cressionnie
Now that you have successfully achieved certification to the revised ISO 9001 and aviation, space and defense (ASD) standards, what are the next steps for your organization? A QMS isn’t intended to sit on a shelf between revisions. Rather, it requires maintenance and continual improvement to ensure it effectively meets business needs. Often, leadership openly wonders why QMS certification doesn’t result in the improvements it envisioned. Many times, leadership stopped implementation or improvement activity after receiving certification. The key is not looking at a QMS as a project with a beginning and an end, but as a business system providing substantial benefits when time and effort are applied to it.
ISO 9001 Auditing Practices Group
Presenter: Denise Robitaille
Technical experts have developed an impressive assortment of papers on a variety of aspects of auditing. Although the primary focus is on ISO 9001, there are many other papers covering auditing topics that have relevance across a myriad of sectors, schemes and industries. These technical experts are drawn from both ISO/TC 176 and IAF. This presentation will introduce attendees to the Auditing Practices Group (APG) and highlight some of the benefits to be derived from accessing their bounty of guidance papers.
Managing the Unanticipated Risk
Presenter: Lorri Hunt
ISO 9001:2015 introduced the concept of taking actions to address risks and opportunities. Included in this new concept was the requirement to evaluate the effectiveness of actions taken to address identified risks and opportunities. It can probably be said that none of these approaches considered a pandemic that would have far reaching implications across the world. Now that the world has been faced with an issue that has affected almost every business industry and type of workforce, organizations are faced with an opportunity to use requirements in ISO 9001:2015 to manage unanticipated risk. This presentation will show an approach for applying the requirements of organizational knowledge to help ensure that information is available that details how to manage unplanned changes. The presenter will also outline the steps that an organization can take to make the actions taken to address risks and opportunities more robust, and review methods to use to maintain the integrity of the quality management system during challenging times.
The Role of Audits in ISO 9001:2015—Are You a “Quality” Auditor?
Presenter: Paul Simpson
For as long as quality management systems standards have been around there has been a need to audit them to ensure the systems are working as intended. This applies equally to internal and supplier audits and audits supporting third-party conformity assessment. There is far too much variability in the current process, and this means interested parties are less able to rely on audit results. In this session, we look at some of the causes of this poor reputation and the areas to focus on to improve the credibility of a “quality” audit.
Are You Ready for FDA FSMA Audit?
Presenter: Gina Reo
In 2016, the FDA implemented the new Food Safety Modernization Act (FSMA), including the hazard analysis and risk-based preventive, to help industry manage potential hazards in producing safe food products. This presentation will examine new FDA authority and introduce examples of preventative controls, leading to minimal recommended preparation steps for handling the new FDA FSMA requirements, including managing Form #483 for non-compliances. Highlights will include an intro to what to do on an audit; how to be ready; what is fair game for review; critical documents required; vital food safety plan; focus on hazards or hazard analysis risk preventative controls (HARPC); supply chain preventative controls; and the importance of managing the audit, sampling, swabbing, warnings, and wrap–up meeting.
OHS (ISO 45001)
ISO 45001:2018 The First International Standard for Safety Management Systems
Presenter: David Solomon
In this session, the presenter provides an overview of the dates and milestones relevant to ISO 45001 and delves into the relationship between clauses. He goes on to explain the importance of the high-level structure (HLS) and its intended function to make integration with other management system standards (MSS) easier. The presentation closes with a consideration of the clause priorities and the weighting that should be given to each section of the standard.
ISO 45001 and Mental Health: Yes, It’s In The Standard!
Presenter: Rick Gehrke
This presentation will discuss how the ISO 45001 standard includes responsibility and requirements to protect and promote the mental health of workers and others who can be affected by an organization’s activities. We’ll look at the applicable definitions and requirements, talk about audit trails and interactions between system processes, and look at the benefits to organizations that can come from harnessing the full power of their management systems to pursue continual improvement in mental health performance. We will also discuss the crafting of audit findings to present related nonconformances to the auditee in order to provide the best possible input for effective corrective actions.
Environment (ISO 14001)
Regulatory Preparation for an ISO 14001 Audit in the United States
Presenter: Melike DeGregorio
This presentation focuses on how to better be prepared for an ISO 14001:2015 audit at a U.S. facility. It offers a general overview of environmental programs and environmental regulatory preparation, U.S. regulatory process, tools to effectively conduct facility research at federal and state levels, and reviews sample scenarios.
How to Conduct an Effective Environmental Site Inspection
Presenter: Melike DeGregorio
This session focuses on how to conduct a site inspection of the internal and external grounds of a facility to effectively identify the problematic areas with environmental regulatory violations. The presenter will demonstrate how to conduct an effective site tour, which areas to inspect, and how to effectively inspect them. Numerous and most common violations observed on general environmental programs such as universal waste and hazardous waste management, housekeeping, air permits, SPCC, Stormwater, etc. are shared, and plenty of real-life examples are provided.
Risk Avoidance A Breakthrough Approach to Risk Management and Risk-Based Thinking
Presenter: Tom Taormina
With the 2015 revision of ISO 9001, ISO/TC 176 essentially threw a hand grenade over the transom to the quality community. They replaced the soothing and nurturing requirement for preventive action with a new term, “risk-based thinking.” Not only do we not connect quality metrics to business success, there is nothing specific in classic quality management that has a direct correlation to risk abatement. This presentation will give quality professionals a new perspective of “risk” based on the author’s 40+ years in quality management and nearly 20 years as an expert witness in products liability.
Risk Assessment as a Gateway to Efficiency and Innovation
Presenter: Jeffrey Slotnick
Risk, threat, and vulnerability assessments are often misunderstood and therefore misapplied. As this presentation shows, 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. Hazard risk assessments have provided the added benefit of identifying opportunities for process improvements and creating efficiencies by identifying systemic inefficiencies. Improving inefficiencies have led to significant cost benefit and savings. Essentially, the risk assessment becomes a road map for creating value while eliminating or minimizing risk. It takes leadership and commitment for this process to be effective. The result is protection of the enterprise from known risks and value creation. The beauty of this process, in addressing known risks and preparing for them, comes from creating high-functioning processes and teams which create the capacity for managing unknown events when they present themselves.
Step It Up: Add a Dash of Resilience to Your Risk Management
Presenter: Donna Stockwell
Upper management talks dollars and cents, while operations talks probabilities. How do the two groups talk and understand each other to forge the company ahead? It all centers around risk, with a tough layer of resilience. Natural disasters are not the only cause of business disruption. The presenter will talk about the strength and robustness of your risk management system, and go beyond your emergency response plan and contingency plans to incorporate a resilience plan that will take you through unexpected and unknown times, and find not only a quick recovery but opportunities you never knew you had!