How can you address quality issues identified during an audit?

To address the quality issues identified during the audit, you must take appropriate corrective measures to overcome and mitigate the identified discrepancies. Select the proper QMS to address the identified observations, and take appropriate corrective and preventive actions based on the impact of the identified observations.

The audit report (from the auditor) will have already classified the findings by severity. This is not for the auditee to do. The area of responsibility is defined during the root cause analysis. Defining who is responsible before determining the root cause is like putting the cart before the horse. To identify the root cause(s), there are various tools that you can use, including 5 Whys, Ishigawa (Fishbone) Diagram, Is / Is Not.

I agree with Richard Brett, auditors should classify audit findings. Yet, it’s the collaboration between the auditee and auditor that truly transforms the audit process. Once findings are laid out, with severity and impact, teaming up to create a targeted corrective action plan is key. This joint effort ensures that you’re not just addressing surface level issues, but you’re also digging deeper to eradicate the root causes. This will help you set a clear standard for compliance and performance. So, when it’s time for the next audit, you’re not just reacting, you’re proactively ahead, ready to showcase not only how you’ve addressed previous quality issues but also how you’ve strengthened your processes against potential future challenges.

I disagree that the audit report will categorize the identified issues, other than major categories. The audit report should identify departures to the standard or code and will only typically categorize them as findings, deficiencies, and recommendations, or similar terms, depending on the industry. The auditee will use their corrective action program to determine significance and then based on that, prioritize the corrections. Only significant issues will get a root cause as a true root cause analysis, is both labor intensive and expensive, so it is reserved only for the most significant issues, based on the risk and likelihood of the event returning, should the root cause not be identified.

Mes suggestions: -Il faut savoir et comprendre les résultats de l'audit. -Améliorer encore ce qui est déjà mieux et résoudre le problème en cas de non conformité. -Résoudre les problèmes selon sa gravité et leurs risques. -La prise en charge est faite par le responsable selon non-conformité. -Il faut d'abord résoudre le problème pour éviter le risque puis trouver la principale source et résoudre la source du problème afin d’éviter une répétition.

Addressing quality issues identified during an audit involves a systematic approach. Firstly, establish clear protocols for documenting and categorizing identified issues. Next, prioritize them based on severity and impact. Develop comprehensive corrective action plans, assigning responsibilities and timelines for implementation. Regularly monitor progress and adjust strategies as needed. Communicate transparently with stakeholders about findings and actions taken. Finally, conduct thorough post-audit evaluations to assess effectiveness and identify areas for further improvement. Consistent adherence to these steps ensures efficient resolution of quality issues and fosters continuous enhancement of processes.

Consider any lessons learned that may be applicable. Also consider if any procedures which may need updating. Determine if any additional training is required.

To be able to address issues during an audit findings, one must know and understand the nature and impact of the quality issue. Develop a corrective action plan and the responsible individuals to be involved. Implement and evaluate results for long term efficacy to avoid re-occurrence. Update records keeping and documentation

Depends on the issue identified...some are "broke-fix", while some may require cause analysis...all issues are not of equal importance..

Corrective actions should be split into three types: * Remedial - Fix the immediate issue * Corrective - Fix the underlying problem * Preventive - Resolve the root cause(s) and prevent recurrence, both in the same system or process and in similar or impacted systems and processes. As part of your preventive action plan, you need to carry out a full impact assessment. This is to fully resolve the underlying issue and to prevent unintended consequences from your actions.

Los pasos a seguir pueden ser: -Identificación del Incumplimiento: Comprenda por qué se produjo una desviación en un proceso con respecto a lo propuesto o esperado. Registre el evento, documente la información y la evidencia observada. -Investigación de las Causas: Aplique métodos conocidos de identificación y solución de problemas. -Definición de Acciones Correctivas: Establezca acciones que ataquen la raíz del problema para que no se repita. Asegúrese de que las acciones sean S.M.A.R.T. Incluya plazos, costos y responsables. -Verificación de la Eficacia: Compruebe si las acciones implementadas logran los resultados previstos y evitan que de repita. -Evalúe si las acciones correctivas y el plan general están alineados con su negocio

Identificar las discrepancias recurrentes y evaluar los elementos que generan su recurrencia para colocar barreras que permitan su mitigación

En el momento que el auditor te comente la no conformidad al finalizar la auditoría, es un buen momento para preguntar cualquier duda que se tenga sobre la misma y asegurarse que se ha entendido para luego poder implantar las acciones correctivas. Habrá que analizar cual es la causa raízde esa no conformidad y proponer las acciones correctivas para solucionarla y posteriormente hacer evaluaciones periódicas para confirmar que la acción implantada cumple su función.

Document all the corrective action plans, train the staff to avoid reoccurrence and asses the viability of the implemented action plans

Inicialmente luego de una auditoria se deben identificar los problemas que hayan sido hallados durante la auditoría, es decir identificados y definidos como también evaluar su origen. Por otro lado se deben investigar soluciones las cuales posteriormente serían implementadas. Una vez se lleve a cabo una acción correctiva del problema se debe realizar un seguimiento y verificar que se estén teniendo los resultados esperados. Finalmente se esperaría aprender de este problema y mejorar continuamente los procesos.

Review your quality systems and see if there are gaps. We follow ISO 17025, and there are systems in place to identify these gaps. Training, training, training, and more training.

IEC/ISO 17025 requires us to validate our systems, in reference to that standard, all corrective action plans should be validated and verified to meet the exact purpose of there implementation. Then we would be assured of consistency in our processes

Respond, do not react. A response requires thoughtful study of the issue and a plan to address what was observed. This study may result in corrections & improvements. It may also indicate no further action is necessary at which point you can respond in writing to that fact. Reactions include argument, polite disagreement, agreeing to the problem, immediate corrections, immediately issuing non-conformance reports & any other quick actions taken to make the audit finding go away. * A significant problem w/ reacting is you commit yourself to actions you may later find to not be correct or in the best interests of the company. Audit processes provide time to respond. Use it to respond thoughtfully. * sometimes you do have to react

Certainly! Addressing quality issues identified during an audit is crucial for maintaining the integrity of the audit process and ensuring accurate financial reporting. Here are steps you can take: - Carefully review the audit findings to understand the specific quality issues identified. This includes examining any deficiencies, discrepancies, or deviations from established standards. - Ensure that the corrective measures address the root causes and prevent recurrence. - Enhance internal controls, processes, and training to prevent similar issues in the future. Remember that Open communication and a commitment to quality are essential throughout the process. 🌟

Spot on Jerry. This is very sound advice, it appears that this is a reoccurring issue across industries? In commercial shipping, usually TMSA type reviews it is not uncommon to come across procedural updates that, at best, do not add any value and, at worst, are (potentially dangerously) contradictory; when raised the Operator invariably submits: "Oh we know but Company 'X' Oil Major auditor wanted it".

Make sure you are within the requirements of the standards your company is following / implementing. It can also depend also on customer / clients preference as sometimes they require that your laboratory or Quality system complies to that standards or certain standards.

IEC/ISO 17025 requires and update of quality procedures and systems only if there is need for an update, when the current system is outdated, when the current technology doesn't meet the market requirement, when the current system doesn't meet customer demands, when the system doesn't match the specifications of machine used. If all the requirements are met then the systems remains valid. All systems must be validated and verified before commissioning

Follow the basics/ Fundamental requirements to avoid any failure of Audit/ CAP required. Unfortunately if any Auditor address any quality issues during an audit, create a corrective action plan outlining specific steps to rectify each issue. Implement process improvements, provide additional training if necessary, and establish preventive measures to avoid recurrence. Regularly monitor and reassess to ensure sustained quality improvements.

In my experience as an auditor and assuming you hire competent auditors, any auditor should make suggestions for improvement in their audit report and follow through on any necessary corrective action. Otherwise you are wasting your money on auditors. Unfortunately, many businesses just go through the motions so they can say they have an audit/corrective action program and think of it as a necessary evil instead of a legitimate way to improve and stay out of trouble. Just ask Boeing how they're doing.

Actually, I disagree with separating corrective actions from preventive action. Especially because preventive actions must become part of the system, while corrective actions will not necessarily become part of the system.

Identify the root cause of each issue to understand why it's occured.Implement preventive measures to avoid similar issues in the future.

Addressing quality issues identified in an audit , is an ongoing process. It requires commitment towards continuous improvement . Whether it is an internal or external audit , both auditors and auditees should collaborate to make sure CAPAs are implemented and contribute towards a sustainable quality management system. It is social responsibility of all personnel of organization to maintain transparency with all stakeholders in terms of compliance challenges.