What are the key steps and tools for developing and documenting your quality system processes and procedures?

In my experience before looking at tools you must decide on the basics that your Quality Management system must deliver. Number one should always be to protect the consumer, especially in highly regulated industries where there safety risks such as pharmaceuticals and medical devices. Second should be regulatory compliance, if the FDA, FCC or OSHA have strict regulations they are in place to ensure the quality of the products we supply. The bedrock of most quality management systems are the fundamentals of managing change (change control, Risk Assessment, vendor qualification), managing unexpected issues (complaint, deviation and CAPA) and continuous improvement (management review, risk management, self inspection).

according to my experience in order to develop and document a quality system's processes & procedures involves a structured approach to ensure consistency, compliance, & continuous improvement. here are few important steps. 1. requirements- determine requirements like ISO 9001.14001,45001,customer and organizational own requirements with objectives ,conduct gap assessment. 2.process mapping-for critical to quality, map process for design, production, quality &interaction with other processes. 3.standardise processes use templates for same. adapts quality manual if required. 4. finally review & validate with stakeholders perform internal audits, refine documents, provide necessary trainings, manage document control and continually improve.

Key steps for developing and documenting quality system processes and procedures: ?? 1. Identify and define process objectives and requirements. ?? 2. Map out process flowcharts or diagrams to visualize workflows. ??? 3. Develop detailed procedures outlining each step and required inputs/outputs. ?? 4. Utilize quality management tools such as process mapping software or document management systems. ??? 5. Conduct reviews and validations with relevant stakeholders to ensure accuracy and completeness. ?? 6. Document revisions and maintain version control for ongoing updates. ?? By following these steps and utilizing appropriate tools, organizations can establish robust and well-documented quality system processes.

To develop and document your quality system, start by setting clear quality objectives and creating a quality policy with management approval. Map key processes and document them with Standard Operating Procedures (SOPs) and work instructions. Establish metrics and Key Performance Indicators (KPIs) to measure effectiveness. Implement training programs for employees and conduct regular internal audits to ensure compliance and address non-conformities. Use management reviews to assess performance and drive continuous improvement. Utilize tools like process mapping software, document management systems, and quality management software to support these efforts.

QMS Procedure should be written by the doers. The moto should be - Write what you do & do what you write. No copy paste from other firms procedure.

Il existe 3 types de processus : - les processus de réalisation, - les processus supports, - les processus de management. Commencez par lister vos processus de réalisation. En gros, c'est le couple produit/client. Que fait votre entreprise ? Que vend-elle ? Ensuite, déterminez vos processus supports. Pour les trouver, demandez-vous quels sont les besoins des opérationnels pour qu'ils réalisent un produit / service conforme. Ils auront besoin de Méthodes, de Compétences et de Moyens. Voici 3 familles de processus supports. Vous pouvez en diviser certains et en fusionner d'autres, vous êtes libre ! Enfin, déterminez vos processus de management. Souvent, on en retrouve deux : un processus "Piloter l'entreprise" et un processus "Améliorer"

Me apoyo en las normas técnicas, guías y documentos relacionados, para la determinación de los procesos, su secuencia e interacción. Tengo preparado un taller para mis clientes donde participa la alta dirección junto con los líderes de los diferentes procesos. Bajo un alcance definido, confirmamos los requisitos del producto o servicio que se brinda al cliente. Con esta información determinamos los procesos que son necesarios para asegurar entregar productos / servicios que cumplan dichos requisitos, incluyendo los legales y reglamentarios aplicables. Cada líder de proceso con su equipo "moldea" su proceso, completando la plantilla SIPOC. Verificamos y validamos el mapa de procesos y las caracterizaciones de cada proceso.

In my experience as an ISO standards advisor, I always emphasize to my clients the importance of adopting a process approach. It's crucial that everyone involved understands who the customers and suppliers are, the inputs and outputs, the responsible parties, and the applicable controls for each process. This enables individuals to comprehend their impacts upstream and downstream. Tools such as flowcharts, diagrams, matrices, and SIPOC models (Suppliers, Inputs, Processes, Outputs, and Customers) can be instrumental in mapping out processes and their quality interactions.

O mapeamento de processos é a evidência documentada do passo a passo de tudo o que acontece nas organiza??es. Dever ser amplamente comunicado, treinamento e aperfei?oado. é importante que toda e qualquer interface entre eles sejam bem definidas, com responsáveis e atividades nomeadas, além dos treinamentos para saber quem e como agir nos casos de n?o conformidades. Qualifica??o de Fornecedores Qualifica??o de Equipamentos e Instrumentos Certifica??o de áreas Qualifica??o de Colaboradores Para cumprimento de processos da Qualidade, muitas vezes n?o podemos aceitar o menor pre?o como critério de aceita??o, mas o que atende aos requisitos mínimos de qualidade.

Developing and documenting a Quality Management System (QMS) and procedures involves several key steps and tools to ensure clarity, consistency, and effectiveness of the processes and interactions. This is achieved by following the next steps: Identify processes within the company or organization that contribute to product and/or service. Address a process map using flowcharts, VSM, or other visual representations to visually represent the process with its inputs, outputs, suppliers, and customers (SIPOC). Mention the objective of each process and its Key Performance Indicators (KPIs) to assure visual performance. Outline specific steps and guidelines in the Standard Operating Procedures (SOPs) and Work Instructions. Maintain it documented.

ISO 10013 es el documento que utilizo como herramienta de orientación para documentar y controlar la información documentada. Formamos diferentes equipos de trabajo con el personal de procesos que interactúan entre sí. Cada equipo determina la necesidad de documentar su proceso, por ejemplo, con un procedimiento documentado, instructivo u otro tipo de información documentada. Cuidamos que este tipo de información documentada incluya respuestas al qué, cómo, cuándo, quién. También determinamos la necesidad de contar con plantillas, formularios u otros similares, para registrar los respectivos sustentos de los controles realizados, por ejemplo, los que nos ayudan a evidenciar la conformidad. Validamos la documentación y aplicamos mejoras.

I find that it is essential to have a strong quality management system. Without this it is hard to pinpoint processes where improvements should be put in place and managed over time. Without this there will be errors and poor customer satisfaction. A solid QMS will avoid these issues. If you can grasp all the required parts of such a system, you’ll have the tools required to meet all your companies needs and deliver high-quality products manufactured right first time.

Use your mapping of the processes and interactions to inform your procedure writing; it should be clear to someone reading a procedure what they need to get started (the inputs) and what they need to produce for other procedures (the outputs). And anyone amending or reviewing procedures will need to know who the customers (internal or external) are for their procedure and what they expect or require.

In my experience as an ISO standards consultant, I emphasize the importance of documenting essential information in accordance with legal, operational, and customer requirements, or any other normative requirement in the case of ISO certification. My approach involves questioning the necessity of each document, assessing its usefulness and relevance. Additionally, I advocate for the modernization of documentation, accepting more flexible formats such as videos and audios, always adapting to the specific needs of stakeholders, including individuals with disabilities. The key is to ensure that documentation is effective and serves its purpose without falling into unnecessary redundancies.

From the output of your definition of your processes mapping and interactions in step 2 use these as a guideline for your documentation. Define specific forms or data and frequency that is used to collect evidence that the process is in control and compliant to requirements. This is to be reviewed by the process owner(s) and during Internal Quality Audits.

An excellent tool or strategy is the ALCOA principle used in the healthcare manufacturing industry. This is a principle that ensures records are: Accurate Legible Contemporaneous Original Accurate

In my experience as an auditor, I emphasize the importance of strategically documenting quality procedures and records. It is crucial to carefully determine what information is necessary for business continuity and compliance with applicable regulatory requirements. Additionally, I underscore the significance of establishing clear criteria for the format of documentation and record management, ensuring consistency and integrity. In today's diverse technological landscape, choosing effective methods for creating, storing, and safeguarding documentation is paramount. This approach aims not only to comply with regulations but also to contribute practically to the efficiency and continuous improvement of processes.

La organización debería establecer procesos para recopilar datos fiables y para convertir esos datos en información necesaria para la toma de decisiones. Esto incluye los controles para el almacenamiento, la seguridad, la protección, la comunicación y la distribución de los datos y la información a todas las partes pertinentes. Se requiere que los sistemas de información de la organización sean robustos y accesibles, para asegurar un control eficaz. Por ello, las organizaciones deberían asegurar la integridad, confidencialidad y disponibilidad de la información relativa a su desempe?o.

Constantemente, é como um dever de casa! As revis?es s?o fundamentais para desenvolvermos a??es para mitiga??o de riscos, melhoria de processos e satisfa??o de clientes internos e externos, além da garantia de monitoramento do que acontece em tempo real, com a??es de contingência mais rápidas e assertivas, além de evitar que efeitos adversos graves e em alguns casos que incapacite o cliente ou cause a sua morte. Por isso, critérios, métodos e responsáveis por aprova??o de produtos e servi?os devem ter sempre a aten??o redobrada e olhar crítico do todo.

Recomiendo considerar una matriz de revisores y aprobadores, esto permitirá tener una mayor trazabilidad del documento aprobado y vigente.

I stronlgy believe, that communicating and training on quality documentation is crucial for ensuring understanding, consistency, and compliance among employees. Relevance can be expressed in the following points: 1) Ensures understanding and consistency in following quality procedures, reducing errors and enhancing efficiency. 2) Enhances compliance with regulatory requirements and fosters accountability among employees. 3) Promotes a culture of quality and continuous improvement within the organization. 4) Supports adaptability to changes in procedures or regulations through effective training. 5) Aids in employee development and retention by demonstrating commitment to their growth and skill enhancement.

Communication can often be most effectively be included within templates - it's best if the majority of the time, the person following the procedure only has to refer to the template (whether that is a traditional form or the interface of a system) to complete the activity correctly.

In my experience as an auditor, I emphasize the importance of establishing effective strategies to communicate and train on quality documentation. Ensuring that information is available and accessible to relevant individuals is crucial for the success of the Quality Management System (QMS). In this regard, I have observed the effectiveness of using various tools such as intranets, newsletters, meetings, webinars, and e-learning platforms. Additionally, I stress the need to continuously assess and enhance the knowledge and skills of the personnel, ensuring a comprehensive understanding and effective implementation of the QMS documentation.

Effektive Kommunikation und Schulung sind essenziell, um die Implementierung und Einhaltung Ihrer Qualit?tsstandards sicherzustellen. Entwickeln Sie ma?geschneiderte Trainingsprogramme, die auf die verschiedenen Rollen und Verantwortlichkeiten innerhalb Ihrer Organisation abgestimmt sind. Nutzen Sie moderne Lernmethoden und -technologien, wie z.B. gamifizierte Lernplattformen oder VR-Trainingsumgebungen, um das Engagement und die Lernretention zu maximieren. Ein fortlaufendes Feedback-System erm?glicht es Ihnen, Schulungsinhalte kontinuierlich zu verbessern und an die Bedürfnisse Ihrer Mitarbeiter anzupassen.

Implementar os processos em fases para garantir uma transi??o suave e para resolver problemas à medida que surgem. Capacitar os funcionários sobre os novos processos e procedimentos.

Throughout years of working experience in Quality Assurance, updating and improving quality documentation involves several key steps: 1. Review current documentation. 2. Gather stakeholder input. 3. Identify improvement opportunities. 4. Prioritize updates. 5. Develop revised documentation. 6. Review and approval. 7. Communicate changes. 8. Monitor implementation. 9. Foster continuous improvement. Eg: At a medical device manufacturing company, the QA team reviewed and updated critical procedures following regulatory audit findings. We collaborated with stakeholders to revise documentation, ensuring clarity and compliance. Through targeted communication and monitoring, we improved process adherence and regulatory compliance. :-)

One thing I found useful was putting an email at the end of each procedure in writing to send suggestions for improvement. Having this communication with those who actually carry out the process is fundamental.

In my role as an auditor, I recognize the significance of regularly updating and enhancing the quality documentation within the Quality Management System (QMS). Monitoring and evaluating the performance and effectiveness of the QMS is essential for identifying gaps, issues, and improvement opportunities. I have found tools such as indicators, surveys, feedback, corrective actions, and reviews to be valuable in this process. Additionally, my experience emphasizes the importance of ensuring that all stakeholders possess the necessary competencies and awareness of their contributions to the QMS, addressing any identified gaps through appropriate actions.

Hoje utilizamos o QRCode para os procedimentos e instru??es de trabalho, assim, no final de cada consultoria, deixamos disponíveis em cada área o documento vinculado ao código. As atualiza??es de vers?o ou processo acontecendo, a organiza??o gera um código que alerta que o documento está sendo atualizado e quando aprovado, disponível para treinamento e utiliza??o.

Algo que suelo ver cuando realizo auditorias, es que algunas empresas manejan un periodo de revisión de sus documentos y lo incluyen en el encabezado de sus documentos esto permite conocer si el documento está próximo a ser revisado.