Um dos recursos mais importantes para os auditores da qualidade é o conjunto de normas e diretrizes que definem os requisitos, princípios e melhores práticas para a gestão da qualidade e auditoria. Essas normas e diretrizes são desenvolvidas e mantidas por diversas organizações, como a International Organization for Standardization (.ISO), a Sociedade Americana para a Qualidade (ASQ), ou o Instituto dos Auditores Internos (IIA). Eles fornecem uma estrutura e uma linguagem comuns para a auditoria de qualidade, bem como uma base para a certificação e a acreditação. Os auditores de qualidade devem estar familiarizados com as normas e diretrizes que se aplicam ao seu setor, setor ou domínio, e manter-se atualizados com quaisquer alterações ou revisões.
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ISO, in particular, has developed internationally recognized standards, including ISO 9001 for general quality management systems and ISO 19011 for auditing management systems. ASQ provides guidelines and resources for quality professionals, including auditors, to enhance their knowledge and skills in quality management. The IIA focuses on internal auditing practices and provides guidance relevant to both internal and external auditors.
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In my view, Quality auditors play a crucial role in ensuring that organizations adhere to established standards and processes. To perform their duties effectively, quality auditors should have access to various key resources. Here are some essential resources for quality auditors: Quality Management Standards Organizational Policies and Procedures Audit Checklists Regulatory Requirements Audit Software and Tools Training and Competency Resources Communication Tools Risk Management Tools Document Control Systems Access to Subject Matter Experts (SMEs) Historical Audit Reports Ethical Standards and Code of Conduct
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To my quality and audit colleagues as it's how I manage. I advise creating a digital library using tools like OneDrive for immediate access to essential resources. Include ISO standards for QHSE, risk, and business continuity, relevant to sectors like construction and facility management. Compile codes such as ASME, API, and various building and safety codes. Add authoritative books on ISO standards and writings from experts like Deming and Juran. Document personal insights and project data to enrich this repository, ensuring a robust reference for all stages of our careers.
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National laws are equally important. This will add specific requirements or regulations tailored to a country's legal framework or industry practices. Compliance with both international standards and national laws ensures comprehensive and legally compliant quality auditing processes.
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Auditors need to be familiar with industry standards and best practices to ensure that audits are conducted following recognized guidelines. Resources such as the Institute of Internal Auditors (IIA) Standards, ISO 9001, and COSO Framework are invaluable. In my experience when auditing internal controls, the COSO Framework provides a robust structure for evaluating the effectiveness of control systems. This ensures that my assessments are aligned with industry best practices and globally accepted standards.
Para os auditores da qualidade, livros e periódicos são um recurso valioso para aprofundar sua compreensão dos conceitos, princípios e técnicas de auditoria da qualidade. Esses materiais também podem fornecer insights valiosos de outros especialistas e profissionais. Alguns dos livros e periódicos mais respeitáveis e relevantes para auditores de qualidade incluem The ASQ Auditing Handbook de J.P. Russell e ASQ Audit Division, The Internal Auditing Handbook de K.H. Spencer Pickett, Quality Audits for Improved Performance de Dennis R. Arter, Quality Progress by ASQ, The Journal of Quality Assurance Institute by QAI Global Institute, e O Auditor, da AuditNet.
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In my opinion, beside the one highlighted one has to be abreast with publication and journal of Institute of Internal Auditors and Institute of Chartered Accountants of India. There is lot of experience being shared by author of the various articles published in it0 based on the real life experience of the role. Besides CPE is something that one should always go far as there are lot of programs being designed based on current affairs in the area of audit
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A Quality Philosophy that assumes further improvements are always possible & that Processes should be continuously re-evaluated & improvements shall be implemented. The seeking of small improvements in Processes & Product/Service with the objective of increasing quality & reducing waste.
Os auditores de qualidade podem se beneficiar de uma variedade de cursos e webinars que oferecem treinamento, educação e certificação em auditoria de qualidade. Esses cursos e webinars podem ajudar os auditores de qualidade a adquirir novas habilidades, atualizar as existentes ou se preparar para exames profissionais. Além disso, eles oferecem oportunidades de interação, feedback e networking com instrutores e colegas. Fontes populares e confiáveis de cursos e webinars para auditores de qualidade incluem ASQ Learning Institute, IIA Learning Solutions, QAI Global Institute, AuditNet, Coursera e Udemy.
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Medical device auditors have to stay updated with the rapidly changing regulations. So attending courses conducted by notified bodies is a necessity. Unless they are equipped with these changes, they cannot contribute to an audit. Plus the industry expects that they have the latest knowledge. Also webinars, articles and blogs or white papers is another way to keep updating yourself to be relevant.
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As an auditor, ongoing professional development is crucial for staying current with industry trends and enhancing audit skills. For me, I do access CPD programs offered by professional bodies like the IIA. Participating in webinars, workshops, and certification courses keeps me updated on emerging audit techniques and regulatory changes, such as recent advancements in ESG, GRC and cyber risk assessment e.t.c.
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In my opinion, to be a successful quality auditor, one need to be in pace with what is happening around the world of internal audit. For it, beside perusing some recognized quality courses like CIA, CISA, CFE to be well versed with the subject, one need to actively participate in webinar or seminar hosted by this institute. Once should subscribe to internal audit journals and be part of audit groups over social platform or closed wats up group for exchanging of ideas. This would only help in exceling in the field of internal audit
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Definitivamente la actualización tiene que se continúa, este es un número de aprendizaje continuo, parte de decir, que cada auditora nos deja una enseñanza, y además de ellos, debemos estar a la vanguardia de los cambios, de las actualizaciones constante allí nos ayuda mucho los cursos, webinars, las técnicas de calibración de auditores.
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Before getting ready for the audit the auditor must complete all the required organizational quality system trainings. These trainings should be latest version of Internal /supplier audit procedure. While performing a technical audit of a process i.e. welding, passivation, sterilization, heat treatment auditor should undergo classroom, Instructor lead training by Organization SME or an external agency. In case process is special one an SME should accompany the audit.
Os auditores de qualidade exigem uma gama de ferramentas e softwares para facilitar e automatizar suas tarefas e processos. Essas ferramentas podem ajudá-los a planejar, executar, documentar, analisar, relatar e acompanhar auditorias de qualidade. Além disso, eles podem ajudar no gerenciamento de riscos, conformidade, desempenho e melhoria. Ferramentas e softwares populares para auditores de qualidade incluem AuditBoard, AuditDesktop, AuditMaster, AuditPro, AuditSoft e Excel.
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A comprehensive audit checklist tailored to the organization's specific System requirements is an invaluable tool for auditors. It helps ensure that all relevant areas are covered during the audit. Additionally, having standard audit report templates streamlines the reporting process and ensures consistency in documenting audit findings. Previous Audit Reports and Corrective Action Plans: Reviewing previous audit reports and associated corrective action plans provides auditors with insights into the organization's past audit history and the effectiveness of implemented corrective actions. It helps identify recurring issues, trends, and areas for improvement.
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In my opinion, Use of Various CAAT tools for instance IDEA, Audit 360, ACL, Excel incl power BI etc wherein lot of testing are embedded and can be accessed in a simple click would help quality auditors focusses on the other area which require more deep dive. Other tool Like Pentana audit work flow system assists in managing the entire audit life cycle through automated system. This would only helps quality audit spread it wings to other untouched area which could have been missed out of audit limitation.
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In the realm of quality auditing, access to advanced tools and software is paramount. As a seasoned quality auditor, I've found these resources indispensable for streamlining tasks. Platforms like AuditBoard, AuditPro, CaseWare and Excel not only facilitate planning and execution but also enhance documentation, analysis, and reporting. These tools play a crucial role in managing risks, ensuring compliance, and driving continuous improvement. As the auditing landscape evolves, staying adept with these tools is essential for delivering high-quality audit services.
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Different organization use different audit management tools and if there is no as such audit tool audit planning and management can be done on Microsoft Office. It is always good to have a audit checksheet to capture audit outcome/evidences in a organized way. Some auditor may also fill in audit check sheet on laptop which is fine. While performing audit on shopfloor always keep a notepad handy to capture any audit observation.
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Auditing for example ISO-13485 QMSs means to have a set of ~1,500 single requirements for a full audit. This also means asking the same questions again and again. During my time as a software engineer I learned that every task that you perform three times in the same way can be automated. So my claim is that an automated audit is possible - i.e. by the usage of AI. This software to my knowledge is not on the market so we auditors still need to ask the questions again and again. What a waste of time. For my work I created a list of ~8,000 questions that come out of the requirements and a randomized selection of the questions delivered to the auditee is giving me some spare time to not have to invent the wheel again and again.
Um quinto recurso crucial para os auditores de qualidade é a rede de comunidades e fóruns que os conectam entre si e com outras partes interessadas. Por meio dessas conexões, os auditores de qualidade podem compartilhar conhecimento, ideias, desafios, soluções e oportunidades, bem como encontrar mentores, colegas, parceiros ou clientes. Exemplos dessas comunidades e fóruns ativos e de apoio incluem Comunidades ASQ, Comunidades IIA, Fóruns do QAI Global Institute, Fóruns AuditNet, Grupos do LinkedIn e Subreddits do Reddit.
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As a dedicated quality auditor, I emphasize the significance of community engagement. These vibrant platforms, such as ASQ and IIA Communities, QAI Global Institute Forums, AuditNet, LinkedIn Groups, and Reddit Subreddits, foster an environment where auditors can seamlessly exchange knowledge, tackle challenges, and explore opportunities. Actively participating in these forums not only enriches professional insights but also provides avenues for mentorship, collaboration, and networking. In the dynamic field of quality auditing, these communities serve as invaluable hubs for collective growth and success.
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Within organization there should be a forum where all organizational auditors can share their knowledge, skills, Best practices, Dos and Don't, Information on a new regulation/guideline. Auditor pool should be utilized and every auditor should be given ample opportunities to utilize their auditing skills. Auditors should also be appreciated for their efforts in making a effective Quality system.
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In my experience, effective risk assessment frameworks help in identifying, evaluating, and prioritizing risks. Access to resources such as the Risk Management Association (RMA) and industry-specific risk assessment frameworks is vital. For instance, using RMA’s risk assessment tools, I can systematically evaluate the bank’s credit risk, market risk, and operational risk, ensuring a thorough risk-based audit approach.
Como auditor de qualidade, um recurso valioso para se manter informado, atualizado, motivado e curioso sobre auditoria de qualidade é a seleção de blogs e podcasts disponíveis. Isso pode ajudá-lo a descobrir novas perspectivas, tendências, inovações e histórias relacionadas à auditoria de qualidade. Alguns dos blogs e podcasts mais interessantes e informativos para auditores de qualidade são The Audit Library Blog, The Audit Guy Blog, The Audit Room Podcast, Quality Conversations Podcast, Quality Matters Podcast e Quality Pod Podcast.
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Blogs and Podcasts helps by the following ways : 1. Industry Updates 2. Learn Best Practices in Industry 3. Know latest Audit Techniques and Methodologies 4. Learn from the interview with auditing experts 5. Learning from Regulatory and Compliance updates.
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Consulting with legal and regulatory experts ensures that audit findings are interpreted correctly within the regulatory context. Having access to in-house legal counsel or external regulatory experts is invaluable. For instance, when encountering ambiguous regulatory requirements, consulting with legal experts helps me to clarify interpretations and ensures that audit recommendations are compliant with the latest legal standards.
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Quality auditors shall have access to the following aspects: 1. Quality Management System (QMS) Documentation 2. Audit Checklists and Guidelines 3. Regulatory and Compliance Standards 4. Training Materials on Auditing and other applicable quality aspects 5. Audit Schedule and Records 6. Applicable Management system standard copies 7. Previous Audit reports and records 8. Access to Management if required 9. Auditor and Auditees RRAs 10. External references like Standards, legal amendments etc.
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Contextualization - one of the frequently overlooked resources for an effective audit. Knowing the Standards is one thing, however, they are a compilation of best practices and just recommend the way of Management System establishment. Audit is a tailored assessment. An auditor should do Home Work and understand the Context. A sign of a trusted Auditor is when they request, at least, your Code of Conduct, Quality Policy / Manual, Org Structure, etc. in advance, prior to the audit start. This is the best resource for an auditor to not just perform the assessment, but add value during to the company.
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Industry-specific publications and resources: These resources can provide quality auditors with insights into the specific challenges and opportunities faced by their clients. Government and regulatory websites: These websites can provide quality auditors with information on the latest regulations and requirements that apply to their clients. Mentorship and coaching: Mentorship and coaching from experienced quality auditors can help new auditors to develop their skills and knowledge.
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Drawing on my extensive experience, I have found that leveraging these resources significantly enhances the quality and impact of audit activities. These resources include regulatory frameworks, audit management software, industry standards, CPD programs, data analytics tools, risk assessment frameworks, relevant data, strong communication channels, legal and regulatory experts, and professional networking platforms.
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Un auditor de calidad requiere tener acceso a un sinfín de recursos enfocados a la mejora continua de su competencia en los sectores que califica, como la experiencia laboral y experiencia en auditorías; así como, su actualización constante en normativas, requisitos legales y otros requisitos relacionados a estos sectores. También complementar su competencia con formaciones, autoaprendizaje, participación en foros, conferencias y bibliografía. Otro aspecto relevante es la consulta continua a sitios web que le proporcionan datos e información al día, como ISO, IAF.
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