Auditing IATF 16949:2016 Clause 10.0 - Improvement
by Walt Prystaj
Auditing Clause 10 of IATF 16949:2016, which addresses Improvement, focuses on how the organization identifies and implements opportunities for improvement to enhance its Quality Management System (QMS). Below is a detailed guide to auditing Clause 10.
Clause 10: Improvement
10.1 General
• Requirement:
o The organization must determine and select opportunities for improvement and implement actions to enhance customer satisfaction and system performance.
o Actions should address risks, opportunities, and the need for preventive measures.
Audit Approach:
o Evaluate how the organization identifies improvement opportunities, such as customer feedback, internal audits, and performance trends.
o Review documented evidence of actions taken to improve the QMS.
Questions to Ask:
o How does the organization identify and prioritize opportunities for improvement?
o What actions have been taken recently to address identified risks or improve processes?
Common Non-Conformances:
o Lack of documented improvement initiatives.
o No linkage between risks, opportunities, and improvement actions
10.2 Nonconformity and Corrective Action
• Requirement:
o The organization must react to nonconformities by:
-Taking action to control and correct them.
-Dealing with their consequences.
o Evaluate the need for action to eliminate the root cause to prevent recurrence.
o Implement any necessary actions and review their effectiveness.
Audit Approach:
o Review the organization's nonconformity and corrective action records, such as CARs (Corrective Action Requests).
o Verify the process for root cause analysis and the implementation of corrective actions.
o Check whether corrective actions are monitored for effectiveness and whether similar issues are prevented.
Questions to Ask:
o How do you determine the root cause of nonconformities?
o Can you provide examples of corrective actions taken and their effectiveness?
Common Non-Conformances:
o Ineffective or missing root cause analysis.
o Failure to implement corrective actions or monitor their effectiveness.
o Nonconformities repeatedly occurring due to ineffective prevention measures.
10.3 Continual Improvement
• Requirement:
o The organization must continually improve the QMS’s suitability, adequacy, and effectiveness.
o This includes considering the outputs of analysis and evaluation and the results of management reviews.
Audit Approach:
o Assess how the organization identifies areas for continual improvement (e.g., trend analysis, audits, customer feedback).
o Verify that improvement efforts align with strategic goals and QMS objectives.
o Check whether continual improvement is integrated into the organization's culture and processes.
Questions to Ask:
o What methods are used to identify continual improvement opportunities?
o Can you provide examples of recent improvements implemented and their impact?
Common Non-Conformances:
o Lack of evidence of continual improvement activities.
o Improvement efforts not aligned with customer satisfaction or QMS objectives.
o Poor use of analysis outputs to drive improvement.
Auditor's Checklist for Clause 10
Area Audit Focus:
Opportunities for Improvement Are opportunities for improvement systematically identified and prioritized?
Nonconformity Management Are nonconformities effectively controlled, root causes identified, and corrective actions taken?
Corrective Action Effectiveness Are corrective actions monitored and verified for effectiveness to prevent recurrence?
Continual Improvement Are improvement initiatives documented, measurable, and aligned with organizational objectives?
Common Findings and Recommendations
1. Findings:
o Reactive rather than proactive approach to improvement.
o Recurring nonconformities due to ineffective corrective actions.
o Lack of systematic approach to identifying and implementing continual improvement initiatives.
2. Recommendations:
o Implement a robust root cause analysis methodology (e.g., 5 Whys or Fishbone Diagram).
o Train staff on corrective action processes and follow up to ensure effectiveness.
o Use data from customer feedback, internal audits, and management reviews to drive improvement projects.
Example Evidence to Review
• Improvement Plans: Documents detailing how the organization plans to improve its processes and customer satisfaction.
• Nonconformity Records: Corrective action logs, root cause analyses, and follow-up activities.
• Trend Analysis: Data from customer feedback, process performance, and audit results showing improvement trends.
• Continual Improvement Initiatives: Examples of implemented projects, such as reducing defects, improving delivery times, or enhancing customer service.
Key Focus Points for Auditors
1. Proactivity vs. Reactivity:
o Does the organization proactively seek improvement opportunities or only react to issues as they arise?
2. Integration of Improvement:
o Are improvement efforts aligned with strategic objectives and customer requirements?
3. Follow-Up and Sustainability:
o Are corrective and improvement actions followed through to ensure sustained benefits?
Auditing Clause 10 ensures that the organization not only resolves issues but also proactively seeks to enhance its QMS, contributing to long-term success and customer satisfaction.
