Your quality management processes are outdated. What tools and software can help you catch up?

I attended the ISO 9001 Lead Auditor training in 1990 in Singapore. I helped my company Conner Peripherals obtain ISO 9001 in 1991. Got into consultancy later where I helped many companies obtain their ISO certification. Some certified companies include Sony, Panasonic, Canon, Sumitomo, Omron, HP, Renesas and Alps Electric I delivered ISO 9001 Lead Auditor training in Malaysia, Thailand, China, Indonesia and Kyrgyzstan. Also conducted QMS training in Cambodia and Singapore Currently I am currently helping companies achieve the automotive QMS IATF 16949:2016. One of the key benefit is documenting the procedures and auditing against the documented procedures, customer requirements, standards requirements and applicable legal requirements.

I would like to provide my perspective in couple of ways. 1. We need to review the QMS comprehensively and address the gaps by making inline with current guidelines as well as the expectations of regulators and customers. 2. The second aspect is we need to upscale the people and their skillset in line with the current requirements and 3. The most important element is automation of processes, wherever it’s possible, which provides accuracy as well as avoiding manipulation, which gives more confidence to the customers and regulators.

De acuerdo con que el SGC es estratégico siempre y cuando se use como tal. El Gerente de planta debe usar el SGC como la herramienta de mejora continua para dar resultados. La regla de oro: “Documenta lo que haces y haz lo que documentas” y si auditas el SGC eliminas hallazgos con mejora continua y despliegas esas mejoras cada seis meses por cada due?o de procedimiento a sus interacciones, es una buena forma de mantener el SGC vivo. El SGC debe tener Idea, Mejora y Reflexión con KPI para medir su pulso. Los software modernos ayudan mas no resuelven todo, si el SGC no tiene mejora por los actores entonces decimos que el SGC es Corrupto. Es decir si NO se tiene la DISCIPLINA del monitoreo y REFLEXIóN constante, ese SGC tiende a fracasar.

Tools and software that can help organizations tackle outdated QM processes include: 1. Automating and enhancing quality processes through a Quality Management System (QMS) is essential. MasterControl, ETQ Reliance, and Trackmedium QMS are popular. 2. Analytics Tools: By using tools such as Tableau, Power BI, or Sisense, organizations can gain deeper insights into process efficiency, identify trends, and predict quality issues. 3. Communication and Collaboration Tools: Cloud-based platforms such as Microsoft Teams, Slack, and Asana allow teams to communicate and collaborate in real-time, facilitating faster issue resolution. 4. UiPath Process Mining reveals inefficiencies and bottlenecks by extracting insight from actual process execution.

Quality Management System (QMS) lies in its capacity to establish a methodical and organized approach to managing quality, ensuring consistent adherence to quality requirements and continuous improvement across all processes and operations within an organization.

Quality management concist of 4 pillars: Qulaity Planning, Control, Assurance and improvement. Some of the industry specific tools listed below, PCP - Process Control Plan, document concist of dimensional tolerances, process flow etc. EDB - Engineering Data Base, software used to record dimensional result during audit. MMS - Machine maintanance System, software used to record failure cause & actions during production. ISPC - Statistical Process control Charts, software which provide process performance chart designed to detect Special Causes of Variation and continuous process improvement and reduction of process variation to achieve process capability of Critical Parameters consistently above the minimum requirements specified.

We need to integrate all the QMS activities with customised applications to ensure the compliance and to avoid human intervention. Trackwise is most commonly used application for QMS handling and which gives ease in handling and tracking. How best we do integrated through comprehensive site master data with application is important factor for successful implementation.

1. SAP Quality Management: An integrated module within the SAP ERP system that covers quality control processes across various business areas. 2. Microsoft Dynamics 365 for Quality Management: A solution that provides features to manage quality processes, including tracking non-conformities and corrective actions. 3. MasterControl: A cloud-based Quality Management System (QMS) that helps organizations automate and manage quality and compliance processes. 4. ETQ Reliance: A QMS software offering functionalities for document management, audits, non-conformities, and more. 5. Sparta Systems TrackWise: A platform for quality and compliance management, with features for event tracking, deviation investigation, and change management.

We are living the digitalization era so to be future fit we need to equip the QMS with digital toils and systems that will help on the non added value activities so we can keep the focus on what matter the most : the improvements.

In my experience, the best way to choose software to effectively implement and manage a quality management system is not to use pre-packaged software. such as software developed by software companies. I suggest that any software should be done step by step with the participation of quality management system specialists. Although this activity may be very time-consuming, it makes for a dedicated software for the organization. This issue is more important for large organizations.

1. Quality Management Software (QMS) 2. Six Sigma Tools (e.g., DMAIC, DFSS) 3. Lean Management Tools (e.g., Value Stream Mapping, Kaizen) 4. Total Quality Management (TQM) Tools (e.g., PDCA Cycle, Quality Circles) 5. Statistical Process Control (SPC) Software 6. Root Cause Analysis (RCA) Tools (e.g., Fishbone Diagram, 5 Whys) 7. Failure Mode and Effects Analysis (FMEA) Software 8. Corrective and Preventive Action (CAPA) Software 9. Document Control Software 10. Risk Management Software

Quality management system becomes outdated when it no longer aligns with actual process flow. Or when one needs to maintain a separate process just for updating QMS and not for actual improvement. However , this can be prevented by keeping things aligned, fill the gaps, keep it agile and make the system so robust that it syncs with actual process and meets changing requirements as well.

The best way to achieve is with Integrated systems. Dynamic Generation of PQR with statistical analysis for every batch release will address many challenges. This can only be achieved with integrations across all automated solutions like eQMS, LIMS, EBMR in Production, QA and Laboratory.

To maintain quality management processes, we need to focus on behavioural aspects improvement along with electronic tools implementation. To implement the softwares or electronic tools are used by people only. Quality is everyone’s responsibility. So focus on behavioural based improvement tools to have employee ownership in view maintaining quality need to be focused. Though we have procedures in place, the use of procedure at workplace need to be focused by taking ownership by employees. Also, we can implement quality management software’s to have electronic systems.

As a Lean practitioner I’d vote for six sigma. If applied properly with the right level of sponsor support, it’s probably the best approach to identify waste, reduce variation and improve the overall process performance while always having the customer in mind. It can help any team to logically define a problem or challenge, find the root causes and establish best practices to ensure the solutions stay in place.

To modernize outdated quality management processes, select tools and software based on key considerations: Specific Needs: Identify tools that meet your organization's quality management requirements. Usability: Prioritize intuitive tools with easy implementation to minimize learning curves. Compatibility: Choose software compatible with existing systems and capable of seamless integration. Features: Assess tools for essential features like nonconformity tracking, document management, and data analysis. Support: Select vendors offering reliable technical support and regular updates for long-term effectiveness. By focusing on these factors, you can effectively upgrade and optimize your quality management processes.

Choose tools/software which are end user-friendly, do very well synchronisation of data in real time.Use mobile based QMS app for realtime on ground catch up things and it shows interactive dashboard for schematic visualization. App will keep end user accountable and traceable.

In my experience understanding the tools you have available too you is paramount. Even the tools included with basic Microsoft business/365 apps can be highly tailored, customized, and automated for your needs. Many of these tools can be connected and integrated directly in to the Microsoft architecture. In today’s age, you might not have to spend as much as you think creating highly reliable and efficient systems.

Before selecting any tool, it's crucial to assess your specific requirements, integration capabilities, scalability, and user-friendliness. Additionally, consider the level of support and training provided by the software vendors. Pilot programs or free trials can be useful to evaluate the compatibility of a tool with your organization's processes before making a full commitment.

Definindo qual o objetivo do software ou ferramenta, e focando em qual melhoria ele trara para o setor, é importante analisar o cenário, local de trabalho e de acordo com a necessidade implementar um software/ferramenta que tenha os requisitos que ir?o suprir a demanda.

QMS is much more broader term than anticipated, Quality of Management ranges from operations to service sectors and what not. Following are the best & basic tools for elevating the QMS and can also be worked out with different softwares 1) Risk Assessment and Management (FMEA, DFMEA etc.) 2) Digitised Data Management (SAP, ORACLE etc.) 3) Training Management 4) Integrated Data and Document Management. 5) 3-5 years plan with Elevation projects. 6) Continuous Improvement Culture.

Let's not forget that non-conformances create the opportunity for improvement. Utilise this to the advantage. Just like us, we learn from mistakes and never let it happen again!

A continuous update to the existing Quality Management System (QMS) is mandatory. For this to happen there need to be a formal periodic process of review of QMS ought to be taken up with senior quality and site management such as Executive Management Reviews or a review after internal quality audits observation trending and based on outcome suitable changes and updates to be made to the QMS.

Follow always itreative process PDCA and if we find some issues in CHECK....then ACT on it for continual improvement...update your product and process methodology. Always keep mindset of evolving state...for getting excellence for customer products and services.

Neben den sehr sinnvollen und wichtigen Inputs vergisst man gerne, dass es oft die einfachen Dinge sind, die langfristig Erfolg und Mehrwert generieren. Bei allem Bestreben Verbesserungen zu erreichen sollte man nie vergessen, die beteiligen Kollegen mit ins Boot zu holen. Der Input der Kollegen, die sp?ter im Prozess arbeiten bringt h?ufig mehr als der tollste agile Ansatz beim Versuch den Prozess zu verbessern. Kommunikation und transparenter Umgang mit den Informationen sowie echtes miteinbeziehen der Kollegen bringen einen gro?en Mehrwert für alle und schaffen gleichzeitig Akzeptanz für die Arbeit des QM da sich die Kollegen verstanden, geh?rt und wertgesch?tzt fühlen.

Quality management is a set of tools and processes utilized by organizations to deliver their products and services of consistent and high quality on time. The 7 QC Tools listed below are very helpful: ? Cause & effect diagram ? Control chart ? Pareto chart ? Stratification ? Check sheet ? Histogram ? Scatter diagram Software applications that facilitate a systematic approach to managing quality within organizations are : a)CAPA software b)Change management QMS tool for training management c)Supplier management QMS tool d)NCR Management tool. The tried & tested methodologies like DMAIC,SPC&SQC can also be implemented. Microsoft Dynamics ERP provides a robust Quality Management module which helps to track and correct the non conformances.

No software in this world can by itself help you bring your SOPs to the current state. The first step is to review the processes which are outdated based on audit results, customer complaints and internal feedback. Then you need to sit with the stakeholders who are involved in those processes and map them out. A comparison between the current actual state versus what is documented will help you update your processes to bring them to the current state. You can also use this opportunity to remove any fat in the process and streamline them. Once that's done you can use any good EQMS to release and control these SOPs. Once you digitize and enable mandatory regular reviews you can avoid such an issue of your processes being outdated.

Desde mi experiencia como Asesora y Auditora en sistemas de gestión, puedo agregar estos aspectos fundamentales para mantener actualizados y eficaces los procesos en una organización. 1. Involucrar a todos los niveles de la organización en la actualización del sistema, esto implica la capacitación continua del personal en los principios y prácticas de gestión, así como la promoción de una cultura de mejora continua en toda la empresa. 2. Mantenerse actualizados de los avances tecnológicos y las mejores prácticas en el campo de la gestión para integrar nuevas herramientas y enfoques. 3. Comunicación transparente y colaboración entre las diferentes áreas para garantizar una implementación efectiva y el cumplimiento de los estándares ISO.

Hold on there, cowboy! Let’s not assume and jump straight to problem-solving mode. What do you mean by the quality processes are “outdated"? Are we talking about tech that's so last century, or is it more about our processes being old and cumbersome that they no longer serve the business? If we're dealing with a clunky, old QMS software that's slower than a tortoise, then yeah, exploring newer, more reliable software might be a game-changer. But if the issue lies with our "processes" being out of touch, then slapping a tech Band-Aid on it isn’t going to help much. We need to strip things down and really look at what we're doing—update, streamline, and optimise the processes so they can serve our current needs better.