What is the best way to incorporate multiple quality audits into your quality management system?

In my work last couple decades I have been extensively involved in the onsite Quality and HSSE audits, both internal and of my contractors. I found it of highest importance to seriously look at the human factors that lead to errors in any operations. As a matter of suggestions I can offer: - Create (or review) the daily check lists and pre-job for ALL assets and operational practices. - Enforce control over execution of check lists on location. This will require frequent audits by competent persons who randomly witness preparation of equipment before dispatching to sites. The post-job random reviews of the tools conditions after return to the base is also easy but effective method of enforcing the control of the QAQC process.

Defining the scope is essential to avoid taking on too much in one audit. It’s also a key part of the audit planning process. Having a well-defined scope provides structure for deciding what nonconformities to include and correct. It also provided the auditees guidance on what the auditor will be examining.

Target, tolerance and frequency. Target defines the range and depth Tolerance defines what to identify and qualifies its boundaries. Frequency defines how often or how many in a period of time.

First define the quality-related risks? Hm...Gee...You can design a quality risk-based audit system? Go figure? Define the system in detail and decompose your system into parts, diagrams, flows, operations, tasks, procedures, links, technology, interfaces and interactions; Figure out how to conduct inclusive system hazard, threat, vulnerability analysis and risk assessment; (many papers are accessible via LinkedIn); Perturb the system and identify system hazards, threats, vulnerabilities, develop adverse sequences, (including actions, decisions, inactions); Define risk criteria and identify current risks given minimal controls; Design controls to eliminate or control risks to acceptable levels (within adverse sequences (risks)...

Bien définir les objectifs avant de choisir les outils. Un audit auprès de nos clients me semble être la priorité. Ensuite, quels outils : cercles de qualité avec les clients, satisfaction des clients sur nos prestations, écoute et formation des collaborateurs, baromètres et débriefings avec les clients . Ils ont toujours beaucoup à dire et donnent très souvent les pistes de travail et même des solutions pour améliorer les process.

A good way to incorporate multiple QMS Audit, is to simplify your audit toolbox and extend your program over the year, increase frequencies and reduce the scopes of area / activities being audited, this is would make it light to perform and easy to follow up meanwhile it will create a culture of acceptance to audits and improvement.

Be brave and allow a little of unplanned scope: it's good to have a detailed plan to get the best out of the auditors' time but to also leave space and time for non planned areas where the auditor can "follow their nose" and have time to dig into things that the audit schedule might have missed. A skilled auditor will spot those "nuggets" of opportunities for improvement.

One way is to begin the process with collaboration with key personnel with a specific, assigned agenda, employing a systematic and well-integrated approach to specific quality objectives. Regularly reviewing and updating audit processes is helpful. Expect the unexpected! Adapting to changes is imperative.

I am currently facing a challenge at my workplace where audits are conducted for several subsidiaries with diverse audit scopes, from QMS, safety, and technical areas like Aviation and Medical. However, through simplifying audit components, expanding the audit program throughout the year, increasing the frequency of audits, and reducing their scope, we can conduct smoother internal audits that are easy to execute and follow up on. By fostering a culture of accepting audits and driving improvements, we can overcome this challenge with ease.

Use a centralized audit management system.?This will help to track audit plans,?schedules,?and findings,?and make it easier to identify trends and patterns. Train the auditors.?Auditors should be trained on the organization's QMS and audit methods and tools. Communicate the results of your audits.?This will help to raise awareness of quality issues and ensure that corrective actions are taken. Continuously improve your audit process.?Regularly review and update the audit process to ensure that it is effective and efficient.

Multiple quality audits can be incorporated into the QMS by integrating risk-based self-inspections. Establish a systematic schedule, document clearly, and foster cross-departmental collaboration. Prioritize self inspection frequencies based on identified risks, ensuring a dynamic and efficient allocation of resources. Regularly update processes to adapt to changing business needs and maintain a proactive approach to quality assurance.

1. Write an ISO 19011 compliant procedure which defines your grading scheme and acceptance criteria. Define objectives and KPIs. 2. Qualify your auditors to ensure common understanding. 3. Create an audit programm over 3 years, mainly to avoid too many audits running in parallel. 4. For audit planning start with the requirements from all applicable standards (not with the departments!). Then map your audits and audit questions to the requirements to demonstrate coverage. 5. Review and analyze your CAPAs from audits to learn about the quality of your audit process. 6. Create a meaningful report for the Management Review. 7. There are good tools on the market. Be sure that the selected tool supports integrated audits e.g. for MDSAP.

By integrating the audit methods and tools, the auditor can enhance the audit consistency and quality, and facilitate the comparison and integration of audit findings. Integration helps to ensure that the audit data are reliable, valid, and accurate, and that they provide a holistic and comprehensive view of the QMS performance and improvement.

To incorporate multiple audits into your quality management system, establish a structured framework. Clearly define audit objectives, scope, and criteria. Coordinate audit schedules, involve relevant stakeholders, and ensure consistency in audit processes. Regularly review and update your audit program to adapt to changes and improvements in your organization. Communication and collaboration are key for a successful multi-audit approach.

Implementierung einer geeigneten Auditsoftware, ein CAQ System wie bspw. Babtec, hilft ungemein bei der richtigen Pflege und Dokumentation von geplanten und durchgeführten Audits. Abweichungen, Feststellungen und Ma?nahmen k?nnen so gezielt bearbeitet werden. Festlegung der Verantwortlichkeiten und Hinterlegen der Nachweisdokumente wird vereinfacht.

The follow-up is particularly key since it takes the audit from being a mere tick-box exercise to an opportunity to identify and address areas for improvement. And more importantly, to talk about them together. Good follow-up provides a natural opportunity to educate everyone involved about your quality system, your business, and the concepts of quality management. In my mind, the follow-up shouldn’t be about just chasing down and verifying corrective actions, it should be a more global reflection on the system and business - with an opportunity for education and discussion.

#Incorporate risk assessment: Conduct risk assessments to identify and prioritize potential quality risks within the organization. This information can be used to inform the audit schedule and focus audit efforts on areas where the risk of quality issues is highest. #Utilize technology: Leverage technology to streamline audit processes and enhance data management. This may involve using audit management software to schedule audits, assign tasks, track progress, and report findings. #Involve external auditors: Consider engaging external auditors to conduct independent audits of the QMS. This provides an objective assessment of the organization's quality performance and can identify areas that may be overlooked by internal auditors.

By following up on the audit actions and outcomes, the auditor can ensure that the QMS is continually improved and aligned with the standards and requirements of the customers, regulators, and stakeholders. Follow-up helps to ensure that the audit actions and outcomes are implemented, monitored, verified, communicated, and documented in a way that is value-adding and improvement-oriented for the QMS and the organization.

Audits block resources from audited departments, QM, and 3rd party. This investment needs to pay out: Ideally the follow-up actions (CAPAs) lead to reduction of risks, reduction of processing times, less waste, higher level of trust etc. Be sure audit findings generate real improvements not just additional documentation.

Einer geeigneteAuditsoftware, ein CAQ System wie bspw. Babtec, sollte auch durch das Management als Tool angesehen werden um sich ein sauberes Bild des QMS machen zu k?nnen Das gelebte Nutzen der Audits Top Down ist ein wichtiger Schlüssel zum Verst?ndnis im Unternehmen.

The best way to incorporate multiple audits into the quality system is through an audit program. This tool allows us to group and schedule all the audit activities of an organization. Standards such as ISO 13485: 2016 already include it as a requirement, e.g.: 8.2.4 Internal audit An audit program shall be planned, taking into consideration the status and importance of the processes and area to be audited, as well as the results of previous audits. The results of the audits must be incorporated either as corrective actions or lessons learned into the organizations' quality system, since audits not only constitute a compliance measurement exercise, but also a tool for continuous improvement.

*Simplificando o processo* Ao longo dos anos acompanhando auditorias em diferentes tipos de processos e protocolos entendo que a melhor maneira de inserir diferentes auditorias no sistema de gest?o da qualidade é integrando ferramentas e simplificando o sistema de gest?o, consequentemente simplificando o processo de auditorias. Há uma tendência atual de padroniza??o de temas na estrutura das normas e protocolos de certifica??o e esse fato deve nos levar a refletir no como podemos pensar o sistema, de forma que haja convergência de requisitos de diferentes origens momento de especular uma auditoria e isso deve refletir em tratativas abrangentes e assertivas. Quanto mais complexo for o sistema de auditorias, menor será a aderência à ele.

Establish the audit process comprising all the categories of audits. Define clear scope and objectives for each audit The best part of this process is the higher level of steps can be similar like schedules, planning, auditor selection, reporting, escalation and NCs closure. Criteria and guidelines to be defined for different categories of audits. With this approach you can cover all with one process. You can also have an automated Audits process which will all types of Audits which should have the automatic trigger with other applications like CAPA, Change Mgmt, Documents control, Training etc. This automated QMS can help organisations to execute all activities in a closed loop way. You may check with ETQ QMS solutions to explore more.

The best effective way to integrate several quality audits into your quality systems is to create a methodical and structured process. Here are a few guidelines you can adhere to: 1. Identify the different types of audits required. 2. Create detailed plans for each type of audit. 3. Ensure that your auditors are trained. 4. Create a schedule that outlines when each type of audit will be conducted 5. Perform the audits according to the established plans and schedules. 6. Prepare comprehensive and actionable reports. 7. Monitor the effectiveness of these actions and ensure they are properly implemented and documented. 8. Regularly review the effectiveness of your audit process and make improvements as needed.

Very simple as this: Train your employees in the process, show them the benefits of having a clean and neat process as well as the result you want, then request and monitor self work audits, and finally work in any improvement left out during the implementation ??