What are the steps to audit a supplier's quality management system?

Great comments above… one thing to remember is, in addition to reviewing all applicable ISO and governmental requirements, also make sure to review and audit anything the supplier has committed to execute in their supplier quality agreement (which you’ve hopefully negotiated and signed with them).

Agreed. Audit objectives, scope and criteria are very important for any audit. As a part of planning we as a customer need to understand the overall rating and performance of the suppliers. Based on the performance we can allocate the required time to the different processes and also we can identify the right auditors.

Pre-Audit: -Define Objectives & Scope -Collect Documentation -Develop Audit Plan -Assemble Audit Team On-Site Audit: -Opening Meeting -Document Review -Process Observations -Nonconformity Identification Post-Audit: -Closing Meeting

Decide first it you will make a horizontal or a vertical audit. Then mention in your audit plan the points of the ISO NORM that you will audit. The audit plan will look totally different it is a survey audit or a recertification/reaccreditation audit with eventual extensions of the register.

Absolutely...Audit samples should be strategies basis process requirment.. identifying problem statement & timely audit execution helps to get required output..sampling can be of two types i.e. random to check the health of process and planned basis problem statement

Focus on a few areas: 1) Keep a reference of a checklist but we should use our experience. 2) Link the areas of concerns in the checklists. 3) Follow the approach: - Ask a question - Stop stop talking - Get the answer and clarification - Collect the required evidence - Go for the next question Usually auditors should speak around 20% and remaining 80% is expected from the auditees. 4) Select the sample very carefully based on the Critically, Issues or Customer requirements. 5) Don't deviate from the selected sample and scope.

Performing the Audit: Opening Meeting:?Meet with key personnel at the supplier's facility to introduce the audit team, explain the audit objectives and scope, and answer any questions. Document Review:?Review relevant documents such as the supplier's quality manual, procedures, records, and reports. Observation and Interviews:?Observe work processes and interview personnel to assess the effectiveness of the QMS in practice. Nonconformity Identification:?Identify any nonconformities with the agreed-upon requirements and document them objectively.

During the audit there are some points you must take care about 1- you are not coming to search for mistakes you role is to help the auditee to improve themselves 2- being friendly well help you gain their trust and accept the results 3- try to thank auditee for their efforts

All background information needs to be identified up front before you even develop an audit checklist or visit. Obviously, for suppliers you have worked with you will have more information. I would never audit until I know the capabilities of the shop and have received a QC Manual (not a QA Manual) of how they actually perform. Not interested in what you can do but how you actually comply with your own internal procedures (incorporating code and owner requirements) through a systematic quality program of checks and balances. If you don't measure it, it's not quality. Quality has to be measured against a Code, Standard, Specification, Drawing or Procedure.

*Begin with a thorough review of their documentation, ensuring compliance with industry standards. *Evaluate process controls, product inspections, and corrective action procedures. *Assess supplier performance data and customer feedback. *Conduct on-site inspections to verify adherence to quality protocols. *Lastly, analyze continuous improvement initiatives. Regular, systematic audits ensure ongoing quality and adherence to standards in the supplier's operations.

1. Prepare an Audit Report: Include a summary of the audit scope, objectives, methodology, and key findings. Clearly document nonconformities and suggest corrective actions. 2. Present the audit findings objectively, clearly explaining the nonconformities or areas needing improvement. Allow for discussion and clarification. 3. Develop Corrective Actions: These actions should address the root cause of the nonconformity and prevent its recurrence. Set realistic timelines for implementing the corrective actions.

Develop an audit checklist encompassing areas like supplier performance, compliance, production processes, and product quality. Conduct thorough on-site or remote audits, evaluating the supplier's adherence to the defined criteria. Document findings, noting areas of compliance, non-compliance, and potential improvement opportunities. Report the audit results in a structured manner, providing a summary of findings, highlighting strengths, weaknesses, and areas for corrective action. Offer actionable recommendations and collaborate with suppliers to implement necessary improvements, ensuring ongoing quality enhancements and supplier performance alignment with organizational standards. Regularly review and update the audit process to adapt

Report the audit The third step is to report the audit results and recommendations. You need to prepare a formal audit report that summarizes the audit objectives, scope, criteria, schedule, methods, evidence, findings, and conclusions. You also need to provide recommendations for corrective or preventive actions, if any, to address the nonconformities or improvement opportunities. You need to submit the audit report to the supplier and other relevant stakeholders, such as your management or customers, and ensure that they understand and accept the report.

Audit Reporting: Prepare a comprehensive audit report:?The report should summarize the audit objectives, scope, criteria, findings, and conclusions. It should also include all CARs and any recommendations for improvement. Discuss the report with the supplier:?Discuss the audit findings with the supplier's management team and agree on a plan for addressing the identified non-conformances. Follow up on the corrective action plan:?Monitor the supplier's progress in implementing the corrective actions and ensure that they are effective in addressing the identified problems.

Certainly, reporting the audit results is a critical phase. Drafting a comprehensive audit report, including objectives, methods, evidence, findings, and recommendations, ensures transparency and clarity. The report serves as a valuable tool for communicating outcomes to the supplier and relevant stakeholders. Offering clear recommendations for corrective or preventive actions aids in addressing nonconformities or improvement opportunities, fostering a collaborative approach toward quality enhancement. The report's acceptance and understanding by all stakeholders are crucial for implementing effective changes.

The follow up audit is a crucial phase in the post audit process, occurring subsequent to the supplier’s submission of corrective action plan. The nature of follow up audits, whether conducted through virtual evidence review or an on-site verification, is determined by the criticality of the findings and the organisation can choose the appropriate method. This verification ensures that the corrective measures are not only proposed but also successfully implemented.

This is one area I have seen that is ignored by many organizations and then they generally pay a high price for it. Supplier qualification is not a once done activity. There are many variables like changes at the supplier, technology evolution, your customer needs change and changes to regulatory requirements to say the least. That’s why it’s important that you audit your suppliers based on their performance and impact on your product and business at certain frequency. The depth and frequency shall be determined based on the above factors. This includes a full re-qualification when your requirements significantly change or there is a significant change at the supplier.

Absolutely, the follow-up stage is pivotal in ensuring sustained improvements. Continuously monitoring and verifying the implementation of corrective or preventive actions by the supplier is key to gauging their effectiveness. Assessing the impact and benefits of the audit on both the supplier's QMS and your own quality objectives contributes to ongoing quality enhancement. Providing constructive feedback and recognition to the supplier and the audit team, along with documenting lessons learned or best practices, creates a feedback loop that fosters continuous improvement in future audits.

Check with the supplier timely whether the improvement is going on or not. Ask the supplier if you need any help or documents or training.

Monitor the progress in implementing the corrective actions. Conduct a follow-up audit, if necessary, to verify the effectiveness of the corrective actions. Once all nonconformities have been adequately addressed, close the audit and provide a final report.

Documentation Review: Review the Quality Manual:?Assess if it clearly outlines the supplier's quality policy, objectives, and processes. Evaluate Procedures:?Ensure procedures are documented, comprehensive, and aligned with the quality manual and relevant standards. Analyze Records:?Verify that records are accurate, complete, and maintained according to established procedures. Identify Gaps and Inconsistencies:?Look for any discrepancies between documented procedures and actual practice.

True...Audit report is a important way forward for improvement areas.. the report should contain below important points. 1) Objective should be specific related to problem statement 2) Scope of audit should be mentioned precisely 3) Source 4 ) Sample size 5) Graphical presentation with specific observation 6 ) POA and improvements suggestions will add more value add to audit report.

The key element is to define the purpose of the audit. Is it about hard quality and/or improvement of it. However, nowadays I would start with alignment of the Code of Conduct. After completion of the actual audit it is important to document the areas of concerns and agreed actions with time line.

Certainly, reviewing the audit process and performance is vital for ongoing refinement. Analyzing results and feedback allows for identifying strengths, weaknesses, opportunities, and threats that inform improvements. Evaluating the adequacy, efficiency, and effectiveness of the audit plan, methods, resources, and tools provides insights into optimizing the entire process. Implementing changes or enhancements based on this review ensures a continual evolution of the audit approach, enhancing its quality and value over time. This cyclical improvement process contributes to the overall effectiveness of future audits.

What I think is, elevating the audit system involves instituting a continuous improvement cycle. Embrace planning, doing, checking, and acting on results and feedback. Cultivate a positive supplier relationship built on trust and mutual benefit. Promote a culture emphasizing quality and excellence, positioning audits as learning and improvement opportunities. Shifting from a compliance focus to a collaborative, growth-oriented approach fosters a resilient audit system and a culture conducive to sustained improvement mutually.

Improvement should be a continuous cycle. We should always improve on our supplier management chain. Look out for things which needs immediate addressing. Try to keep it simple by using Pareto principal. Make sure we are not repeating the mistakes of last year.

I always include these in my “lessons learn, or opportunities for improvement reviews”… Ask yourself and your audit team - how can we improve: 1. **Feedback Integration:** Integrate feedback from stakeholders and suppliers into the audit process, adapting and refining based on insights gathered. 2. **Training and Awareness:** Provide continuous training to audit teams, emphasizing the value of audits for improvement rather than just compliance, fostering a culture of learning. 3. **Collaborative Initiatives:** Encourage joint improvement efforts with suppliers based on audit findings, fostering a culture of shared success and problem-solving.

Auditing a supplier's quality management system (QMS) is crucial to ensure that they meet the required quality standards and comply with your organization's expectations. Here are the key steps to audit a supplier's quality management system: 1-Define Audit Objectives 2-Establish Audit Criteria 3-Plan the Audit 4-Notify the Supplier 5-Review Documentation 6-Conduct an Opening Meeting 7-On-Site Inspection 8-Evaluate Process Effectiveness 9-Document Findings 10-Hold a Closing Meeting 11-Issue an Audit Report 12-Follow-Up on Corrective Actions 13-Close the Audit 14-Provide Feedback and Recognition 15-Continuous Improvement By following these steps, you can conduct a thorough and effective audit of a supplier's quality management system.

Most missed item during QMS audits, it often relates to a thorough examination of the effectiveness of corrective actions. Auditors might sometimes focus on identifying nonconformities but may not delve deep enough into evaluating the corrective actions taken by the supplier to address those nonconformities. It's essential to assess not just the presence of corrective actions but their adequacy and sustained effectiveness in preventing recurrence. Additionally, ensuring that preventive actions are considered to avoid potential issues in the future is crucial. Auditors should pay special attention to the continuous improvement aspect of the QMS.

First, get ready by learning about their industry and gathering needed info. Plan what you'll do and how. During the audit, look at their documents, talk to people, and watch their work to see if it matches standards. Afterward, write a report on what you found—what's good and what needs fixing. Work with the supplier to fix any issues, keep an eye on progress, and finalize the report once everything's done. Good communication and teamwork with the supplier are key for a smooth audit.??

Maintain professional communication and objectivity throughout the audit process. Focus on evidence-based findings and avoid assumptions. Collaborate with the supplier to identify and implement effective solutions. Follow up with the supplier to monitor their progress in implementing corrective actions.

1. Define Audit Objectives: Clearly outline the purpose, scope, and objectives of the audit. Identify the specific areas and processes within the supplier's quality management system that you intend to examine. 2. Plan & conduct Audit: Develop an audit plan that outlines the scope, criteria, and schedule for the audit. Identify key processes and areas to be examined, and allocate resources accordingly. 3. Evaluate Compliance:Assess the supplier's compliance with applicable quality standards and regulations 4.Identify NC's:Document any Nc's or areas where the supplier is not meeting the required standards. 5. Communicate Findings: Provide feedback to the supplier on the audit findings. Follow up with the supplier for Corrective actions