Deliverable Quality Audits

Making quality audits successful requires proper planning, execution, communication, and follow-up. A successful audit is not just about finding nonconformities but about adding value, improving processes, and building trust. Here’s a structured approach: --- 🔹 1. Pre-Audit Preparation Define Objectives: Clarify whether the audit is for compliance, improvement, certification, or risk reduction. Plan the Audit: Create an audit plan with scope, criteria, schedule, and areas to be covered. Know the Standards: Be well-versed in ISO standards, organizational procedures, and customer requirements. Select Competent Auditors: Ensure auditors are trained, objective, and independent from the process being audited. Communicate in Advance: Share audit schedules and expectations with auditees to reduce resistance and anxiety. --- 🔹 2. Audit Execution Start with Opening Meeting: Explain the purpose, scope, methodology, and expected outcome. Use Evidence-Based Approach: Verify compliance through records, observations, and interviews rather than assumptions. Ask Open-Ended Questions: Encourage discussion instead of “yes/no” answers. Observe Processes in Action: Don’t just check documents—see how the process is actually performed. Maintain Professionalism: Be objective, respectful, and supportive, not fault-finding. --- 🔹 3. Reporting Highlight Strengths as well as Gaps: Recognize good practices along with nonconformities. Be Clear and Specific: Report findings with evidence, not opinions. Classify Issues: Separate major, minor nonconformities, and opportunities for improvement. Provide Actionable Recommendations: Suggest practical improvements aligned with business goals. --- 🔹 4. Post-Audit Follow-up Closing Meeting: Present findings openly, answer questions, and agree on next steps. Corrective Action Tracking: Ensure issues are addressed with root cause analysis, corrective actions, and timelines. Verify Effectiveness: Re-check whether corrective actions solved the problem, not just closed the paperwork. Continuous Improvement: Use audit results as input for management reviews and strategic planning. --- 🔹 5. Best Practices for Successful Quality Audits ✅ Treat audits as a value-adding activity rather than fault-finding. ✅ Build a collaborative relationship between auditors and auditees. ✅ Use risk-based thinking—focus more on critical processes. ✅ Apply technology (audit software, digital checklists, data analytics) for efficiency. ✅ Promote a culture of quality where employees see audits as learning, not punishment.

🌈 ISO 9001:2015 Audit Checklist – A Practical Guide for Auditors & Quality Leaders An audit checklist is not just about ticking boxes — it’s a structured tool to evaluate whether the Quality Management System is truly effective, compliant, and delivering business value. 1️⃣ Context of the Organization (Clause 4) ✔️ Has the organization identified and reviewed internal & external issues that affect its QMS? ✔️ Are stakeholder needs and expectations (customers, regulators, employees, suppliers) identified and monitored? ✔️ Is the scope of the QMS documented, relevant, and communicated? ✔️ Are processes defined with inputs, outputs, responsibilities, and performance indicators? 2️⃣ Leadership (Clause 5) ✔️ Is top management actively demonstrating leadership and commitment to quality? ✔️ Is the Quality Policy relevant, communicated, and understood across all levels? ✔️ Are roles, responsibilities, and authorities clearly assigned and recognized by employees? 3️⃣ Planning (Clause 6) ✔️ Are risks and opportunities systematically identified and addressed? ✔️ Are measurable quality objectives established at different levels and reviewed periodically? ✔️ Is organizational change managed in a structured and controlled manner? 4️⃣ Support (Clause 7) ✔️ Are adequate resources available and maintained? ✔️ Is staff competence ensured through training, evaluation, and skill development? ✔️ Are employees aware of their contributions to quality and the impact of nonconformities? ✔️ Are documented information and records controlled, updated, and retained properly? 5️⃣ Operation (Clause 8) ✔️ Are operational activities planned and controlled to meet customer requirements? ✔️ Is customer communication effective for inquiries, contracts, changes, feedback, and complaints? ✔️ If applicable, is design & development managed with reviews, validation, and controlled changes? ✔️ Are suppliers evaluated, monitored, and re-evaluated based on performance? ✔️ Are production and service processes validated, traceable, and compliant with acceptance criteria? ✔️ Is customer property safeguarded and properly maintained? 6️⃣ Performance Evaluation (Clause 9) ✔️ Are KPIs and process performance monitored, analyzed, and acted upon? ✔️ Is customer satisfaction measured through surveys, complaints, and feedback? ✔️ Are internal audits planned, executed, and followed-up with corrective actions? ✔️ Are management reviews comprehensive, covering inputs & outputs? 7️⃣ Improvement (Clause 10) ✔️ Are nonconformities investigated with proper root cause analysis? ✔️ Are corrective actions implemented and verified for effectiveness? ✔️ Is continual improvement embedded in processes, culture, and business performance?

𝐖𝐡𝐚𝐭 𝐚𝐫𝐞 𝐤𝐞𝐲𝐬 𝐭𝐨 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐀𝐮𝐝𝐢𝐭 𝐏𝐥𝐚𝐧𝐧𝐢𝐧𝐠 𝐚𝐧𝐝 𝐄𝐱𝐞𝐜𝐮𝐭𝐢𝐨𝐧?🎯 Conducting an effective quality audit requires meticulous planning, structured execution, and proactive follow-up. Here’s a concise breakdown of the key steps involved in quality audit planning and execution: ❶Planning The foundation of a successful audit lies in defining clear objectives and a robust methodology. Here are 4 insights to guide the planning process: ➤Understand Audit Objectives: Clearly define what the audit aims to achieve—compliance, improvement, or risk mitigation. ➤Conduct a Risk Assessment: Identify potential risks to prioritize high-impact areas. ➤Define Scope and Criteria: Establish the boundaries and standards for evaluation. ➤Select the Audit Team: Ensure the team has the right mix of skills and experience. 𝙆𝙚𝙮 𝘾𝙤𝙢𝙥𝙤𝙣𝙚𝙣𝙩𝙨 𝙤𝙛 𝘼𝙪𝙙𝙞𝙩 𝙋𝙡𝙖𝙣𝙣𝙞𝙣𝙜: 1. Understanding the audit objectives. 2. Risk assessment. 3. Scope and criteria definition. 4. Audit team selection. 5. Developing the audit plan. 6. Data collection methods. 7. Stakeholder communication. ❷Fieldwork Fieldwork is the execution phase where evidence is gathered to meet audit objectives. The process involves: 🔹 Entrance Meeting: Align expectations, objectives, and scope with the auditee. 🔹 Evidence Collection: Gather data through interviews, observations, and document reviews. 🔹 Exit Meeting: Summarize preliminary findings and address any immediate concerns. ❸Reporting Clear and actionable reporting is critical for audit success. This step includes: ➤Drafting the Report: Document findings, non-conformities, and opportunities for improvement. ➤Stakeholder Review: Share the report with key stakeholders for feedback. ➤Final Report Communication: Deliver the finalized report to all relevant parties. ❹Follow-Up The value of an audit is realized when corrective actions are implemented effectively. 🔹 Review Corrective Action Plans: Evaluate proposed actions for adequacy and feasibility. 🔹 Monitor Implementation: Ensure timely execution of corrective actions. 🔹 Validate Results: Confirm that actions taken address the identified issues. 🔥 A well-executed quality audit not only ensures compliance but also drives continuous improvement. By following these structured steps, organizations can maximize the value of their audits and strengthen their quality management systems. 💡 What are your thoughts on this approach? Share your insights in the comments! ========================== 👉WhatsApp Channel for LinkedIn Post Update : https://lnkd.in/dHFC-mT9 🔔 Consider following me at Govind Tiwari,PhD if you like what I discuss and share here . #qa #qc #qms #Leadership #quality #iso9001 #career #technology #sustainability #QualityManagement #AuditFindings #ContinuousImprovement #TQM #QualityCulture #Leadership #qualityaudit #audit

📊 Quality KPI Series – Part 7: Quality Audit & Compliance Audits are more than a “check-the-box” activity — they are a strategic lens to evaluate systems, uncover risks, and ensure trust with customers, regulators, and partners. In this phase, KPIs focus on measuring the effectiveness, timeliness, and compliance of audit and regulatory practices. Here are 10 essential Audit & Compliance KPIs: 🔹 Number of internal audits conducted – consistency in self-checks 🔹 % compliance in external audits – external validation of systems 🔹 % of non-conformances closed on time – discipline in corrective action 🔹 Average audit completion time – efficiency in audit execution 🔹 % reduction in repeat audit non-conformances – learning from mistakes 🔹 % of suppliers audited annually – supply chain compliance 🔹 % compliance with regulatory standards – adherence to external requirements 🔹 % of audit risks mitigated – proactive risk management 🔹 % of audit recommendations implemented – turning findings into improvements 🔹 % of supplier/vendor audits completed on time – governance across the chain 💡 Consultant’s perspective: Effective audits are not about “passing or failing” — they’re about building resilience, closing gaps, and driving sustainable compliance. 👉 This is Part 7 of my Quality KPI Series (100+ KPIs). Earlier posts covered planning, control, and improvement. With this, we now bring in the lens of assurance and accountability. 💬 Reflection: Does your organization treat audits as an opportunity to learn or as a burden to clear? #QualityAudit #Compliance #KPI #RiskManagement #BusinessExcellence #Leadership

Day 154/365 – Types of Audits in Manufacturing Audits aren’t “gotchas”—they’re a structured way to keep quality, safety, and delivery predictable. Here are the core audit types you should weave into your operating system: 1. Product Audit – Checks finished goods against specs and customer requirements. 2. Process Audit – Verifies that the process is being followed (SOPs, control plans, WI) and is capable. 3. System Audit – Evaluates the management system (e.g., ISO 9001, IATF 16949) for conformity and effectiveness. 4. Compliance Audit – Confirms legal, regulatory, and customer-specific requirements (EHS, statutory, RoHS/REACH). 5. Supplier Audit – Assesses supplier capability, quality, delivery (PPAP, APQP, OTIF, PPM). 6. Internal Audit (1st party) – In-house audits to drive continuous improvement and readiness. 7. External Audit (2nd/3rd party) – Customer or certification-body audits for approval/recertification. 8. Safety (EHS) Audit – Identifies hazards, verifies controls, and assures safe work practices. 9. Energy/Environmental Audit – Reviews energy use, waste streams, emissions, and reduction opportunities. 10. Layered Process Audit (LPA) – Short, high-frequency checks by multiple layers of leadership to sustain standards. Why it matters • Prevents defects, escapes, and surprises • Builds customer trust & certification readiness • Exposes systemic gaps for targeted kaizen Common mistakes • Treating audits as events, not routines • Findings without owners, actions, or due dates • Auditing paperwork, not the process at the gemba Useful KPIs • Audit closure effectiveness (% closed on time) • Repeat findings rate • Process conformance score / LPA compliance • Supplier PPM & OTIF trend post-audit Pro tip: Pair audits with 5 Whys, error-proofing, and visual controls so findings translate into permanent fixes. Hashtags #Day154 #ManufacturingExcellence #Audits #QualityManagement #ISO9001 #IATF16949 #LayeredProcessAudits #LeanManufacturing #EHS #ContinuousImprovement #OperationalExcellence

The Value of Investigative Quality Audits A robust Quality Management System is the foundation of success for any organization hoping to deliver products or services that meet or exceed customer expectations. As part of a comprehensive continual improvement process, investigative quality audits are useful tools for identifying, fixing, and preventing deviations from established quality standards. Investigative quality audits go beyond routine quality control activities, aiming to uncover the root causes of quality deficiencies, non-conformances, or deviations. Unlike traditional quality audits designed to assess compliance with established requirements or standards, investigative quality audits specifically target underlying quality and efficiency issues that ultimately impact customer satisfaction. Investigative quality audits foster a culture of continuous improvement by identifying areas for enhancement and optimization. By examining processes, procedures, and performance metrics, organizations can implement corrective actions and preventive measures to mitigate quality issues and drive operational excellence. Proactively identifying and fixing quality deviations mitigates the risk of product recalls, regulatory non-compliance, and damage to an organization’s reputation. Investigative quality audits identify potential risks, vulnerabilities, and opportunities for improvement, thereby safeguarding against costly quality-related incidents. While compliance with quality standards is essential, investigative quality audits go beyond compliance, focusing on optimizing quality outcomes. By aligning with industry best practices and customer requirements, organizations can ensure that their products or services consistently meet or exceed quality expectations. So what methodologies can be used for investigative audits? 1. Root Cause Analysis Investigative quality audits employ root cause analysis to identify the underlying factors contributing to quality deviations or non-conformances. By tracing issues back to their origins, organizations can implement targeted corrective actions to address systemic weaknesses and prevent recurrence. 2. Process Mapping and Flowcharting Mapping out workflows enables auditors to identify logic gaps, inefficiencies, and bottlenecks. Investigative quality audits leverage process mapping and flowcharting techniques to visualize operations, pinpoint areas of concern, and optimize process performance. 3. Cross-functional Collaboration Effective investigative quality audits require collaboration across departments and functional areas. By engaging stakeholders from production, quality assurance, engineering, procurement, and other areas, organizations can gain diverse perspectives as input to audit findings and recommendations. Input from the people actually doing and observing the work on a daily basis can provide critical real-time data on which to base audit examination. #myqcoach #audits #ASQ