Process Audit Best Practices

PROCESS AUDIT CHECKLIST (COMMON POINTS) IN MANUFACTURING SECTOR: 1. Process Control Are standard operating procedures (SOPs) available and followed? Is process capability (Cp, Cpk) monitored and within acceptable limits? Are control charts used for critical process parameters? Is there evidence of regular calibration of equipment and gauges? Are process changes documented and approved through change control? 2. Material Handling & Storage Are materials labeled correctly (name, batch, status)? Is FIFO (First-In-First-Out) or FEFO (First-Expiry-First-Out) followed? Are storage conditions (temp, humidity) monitored and maintained? Are rejected or non-conforming materials segregated and labeled? 3. Operator Competency & Safety Are operators trained and certified for the tasks they perform? Are safety PPEs being worn and used correctly? Are safety instructions and emergency procedures visible? Is there a system for reporting and investigating near-misses and incidents? 4. Equipment Management Is there a preventive maintenance schedule and is it being followed? Are breakdowns recorded and analyzed for recurrence? Are start-up and shutdown procedures standardized? Are critical spare parts available and tracked? 5. Quality Assurance Are in-process inspections conducted as per the control plan? Are inspection tools calibrated and used properly? Are quality issues tracked using root cause analysis tools (5 Why, Fishbone)? Are quality records complete and traceable? 6. Production & Planning Is actual vs planned production tracked? Are downtimes recorded with reasons? Is the takt time, cycle time, and lead time monitored? Are WIP levels controlled and visualized (kanban, signage)? 7. Waste Management & 5S Is workplace organization (5S) maintained? Are waste bins labeled and segregated? Are daily 5S audits conducted and actioned? Are there visible signs of lean practices (kaizen, visual boards, etc.)? 8. Tooling & Fixtures Are tools and fixtures stored properly with visual controls? Are they identified and logged for use and maintenance? Is there a system for tool calibration and wear tracking? 9. Documentation & Records Are process-related documents current and controlled? Are logs (production, quality, maintenance) filled accurately? Are version-controlled work instructions available at workstations? 10. Environmental & Regulatory Compliance Are emissions, effluents, and noise levels monitored and controlled? Is compliance with environmental regulations documented? Are MSDS (Material Safety Data Sheets) available and up-to-date?

Internal Audit Process: 1. Planning Phase Objective: Establish a clear understanding of the audit subject and develop a roadmap (audit program) for executing the audit effectively. Key Activities: > Initial Contact & Information Gathering: Understand the size, responsibilities, and procedures of the audited unit. > Risk Assessment: Performed to identify high-risk areas for focus. > Audit Objectives & Methodology: Defined and documented through the audit program. > Notification Letter: Sent to leadership to inform them of the audit. May include a pre-audit questionnaire or document request list. > Entrance Meeting: Discuss audit scope and objectives. Explain methodology and timeline. Identify scheduling concerns (e.g., staff availability). Encourage input on known risks and areas of concern. 2. Fieldwork Phase Objective: Evaluate internal controls, compliance, and operational effectiveness through testing and inquiry. Key Activities: > Testing & Documentation Review: Examine transactions, records, and procedures. > Staff Interviews: Conducted to gain deeper insights into practices and control execution. > Disruption Minimization: Work is coordinated to limit interference with operations. > Ongoing Communication: Frequent updates and discussions with audit clients. > Collaborative Analysis: Observations and issues are discussed with management to identify root causes and explore solutions. 3. Reporting Phase Objective: Present audit findings, recommendations, and management’s corrective action plans in a formal written report. Key Activities: > Draft Report: Initially shared with local management for review. > Management Response: Required for each recommendation, including: Action plan. Responsible person. Implementation date. > Exit Meeting: Held if needed to address concerns and clarify findings before finalizing the report. > Final Distribution: The final report is sent to Management and Boards. 4. Follow-Up Phase Objective: Ensure that corrective actions are implemented effectively and that issues are resolved. Key Activities: > Verification Procedures: May involve document review, staff interviews, or re-auditing specific processes. > Ongoing Tracking: Open findings are tracked and presented at each Institutional Audit Committee (IAC) meeting. > Escalation for Delays: If action plans miss deadlines, the responsible party must submit a written explanation. Repeated delays require in-person explanation to the IAC.

How to Conduct Effective Internal Audits: Internal audits aren’t just a compliance requirement they’re a strategic tool for continuous improvement, risk reduction, and operational excellence. To ensure your internal audits deliver real value, follow these three critical phases: ✅ 1. Pre-Audit (Planning & Preparation): ◾ Define the scope, objectives, and criteria ◾ Review past audits and key documents ◾ Develop audit checklists and communicate with auditees ⚙️ 2. In-Process Audit (Execution): ◾ Conduct an opening meeting ◾ Observe processes, review records, and interview staff ◾ Document findings objectively (non-conformities, observations, OFIs) 📋 3. Post-Audit (Reporting & Follow-up): ◾ Hold a closing meeting to present findings ◾ Prepare a clear, concise audit report ◾ Ensure timely corrective and preventive actions (CAPA) ◾ Follow up to verify effectiveness Pro Tips: ◾ Maintain objectivity and confidentiality ◾ Use technology to streamline documentation and tracking ◾ Foster a culture where audits are seen as a tool for growth, not inspection ◾ Effective internal audits help organizations stay compliant, improve processes, and build a culture of accountability and excellence. #InternalAudit #AuditExcellence #QualityManagement #Compliance #RiskManagement #ContinuousImprovement #ISO9001 #AuditorLife #ProcessImprovement #HSE #InternalControls #OperationalExcellence #QHSE #Leadership #CorporateGovernance #CAPA #AuditTrail #ProfessionalDevelopment

🔍 Ever felt like a mfg. process runs perfectly one day and fails the next? That’s exactly why we need structured process audits, not just to check products, but to evaluate what’s impacting consistency from the mfg. processes. Traditionally, many quality leaders follow the 6M approach: Man, Machine, Material, Method, Measurement, and Mother Nature (Environment). Each ‘M’ helps uncover gaps that could lead to process failures. I’ve now extended this to a 7M Categorization with Maintenance as the 7th "M" for its crucial role in ensuring uptime, reliability, and process health. ✅ However, depending on your audit focus and criticality, you may also consider Morale or Management as your 7th M! especially in audits that assess culture, leadership support, or team motivation. This flexible 7M approach ensures a well-rounded process evaluation that leads to process improvements, not just compliance. 📌 A must-have checklist for your next process audit! 👉 Would you add any other "M" or any other categories to this list? Share your thoughts in the comments! #processaudits #audits #manufacturing

Driving Operational Excellence with the 7M Process Audit Framework In manufacturing and operations, consistency and quality don't happen by chance — they are the result of disciplined process control. One powerful tool we use to ensure this is the 7M-based Process Audit Check Sheet. 💡 The 7M categories — Man, Machine, Method, Material, Measurement, Mother Nature (Environment), and Maintenance — help us take a holistic view of our operations. From operator training to machine condition, from SOP compliance to environmental factors, every element is audited for performance and compliance. ✅ Regular audits using this framework help us: Detect process deviations early Maintain quality and safety standards Drive continuous improvement Ensure readiness for customer and regulatory audits It’s not just a checklist — it's a mindset of proactive control and process ownership. #ManufacturingExcellence #ProcessAudit #QualityManagement #7MFramework #LeanManufacturing #ContinuousImprovement #OperationalExcellence #QMS #Production #Manager #Productionmanager