ISO 9001: 2015 - Internal Audit Checklist for Production Process in Manufacturing
Master ISO 9001 production audits with this comprehensive tabular checklist. This guide provides practical audit questions aligned with ISO 9001:2015 standards, helping auditors evaluate manufacturing processes, verify worker competence, ensure traceability, and confirm quality controls. Quick reference format for easy on-site auditing.
📋 Quick Navigation
🔍 Operational Planning and Control (Clause 8.1)
Verify that production planning is systematic, documented, and communicated to all personnel. Check that workers have access to specifications and measuring tools needed for their jobs.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.1 | Do you have a daily/weekly production plan? Can you show me today's production schedule? | Documented production schedules, priority lists, communication systems ensuring workers understand daily targets, MES systems |
| 8.1 | Are product drawings or specifications available at the workstation? | Drawings posted on machines, digital displays, reference documents, quality standards visible to operators |
| 8.1 | Do workers have access to measuring tools (calipers, gauges, etc.) needed for their job? | Tools at workstations, organized tool trays, designated measurement areas, calibrated and functional tools |
⚙️ Control of Production and Service Provision (Clause 8.5.1)
Verify that production controls are implemented including work instructions, worker qualification, error-prevention methods, and verification of critical processes like welding and heat treatment.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.5.1 | Are work instructions or process sheets available at each machine/workstation? | Step-by-step procedures, operation manuals, illustrated instructions, digital job cards matching actual production methods |
| 8.5.1 | Are workers trained and qualified to operate machines they use? | Training records, competence certificates, skill assessments, qualification sign-offs, worker understanding confirmed through interview |
| 8.5.1 | What methods prevent workers from making mistakes (error-proofing/poka-yoke)? | Physical guides, jigs, fixtures, color-coded materials, visual aids, measurement templates, automatic shut-offs, alarms, checklists |
| 8.5.1 | For critical processes (welding, heat treatment), how is process performance verified? | Recorded parameters (temperature, time, pressure), verification tests, first-piece inspections, process capability studies, in-process monitoring |
Key Point: Production control effectiveness is shown through documentation, trained personnel, preventive measures, and verification records—not just procedures on paper.
🏷️ Identification and Traceability (Clause 8.5.2)
Ensure products are identified and traceable throughout production. This enables quick identification of affected items if quality issues arise and supports customer service.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.5.2 | How do you identify and label parts/materials during production? | Part numbers, batch codes, date stamps, serial numbers, barcodes on products or containers, legible identification throughout process |
| 8.5.2 | How do you identify approved, rejected, and under-inspection items? | Color-coded labels/tags, designated storage areas, quarantine zones, physical segregation, status tracking systems preventing accidental use |
| 8.5.2 | Can you trace this finished product back to its raw material batch or heat number? | Documentation linking finished product serial to raw material batch, heat certificates, supplier lot codes, complete traceability records |
Audit Tip: Trace 2-3 random products from finished goods back to raw materials. Practical verification is more effective than reviewing documentation alone.
📦 Customer Property Management (Clause 8.5.3)
Verify care and control of customer-supplied materials and tools. Damage or loss directly impacts customer satisfaction.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.5.3 | How do you identify and store customer-supplied materials or tools? | Dedicated storage areas, "customer property" labels, quarantine locations, organized kits, inventory logs with customer information |
| 8.5.3 | If customer property is damaged/lost, how do you inform the customer? | Notification procedures, documented incidents, damage reports, communication records, tracked losses, corrective actions implemented |
🛡️ Product Preservation (Clause 8.5.4)
Verify products are protected from damage, deterioration, or contamination during production, storage, and handling.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.5.4 | How are finished goods protected from damage during storage? | Protective packaging, foam inserts, plastic wraps, wooden crates, proper shelving, palletization, suitable storage locations preventing damage |
| 8.5.4 | How do you prevent rust, corrosion, or contamination of parts? | Humidity controls, protective coatings, desiccant packets, covered storage, ventilation systems, clean work areas, material segregation |
📞 Post-Delivery Activities (Clause 8.5.5)
Verify that warranty, installation, or maintenance services are defined and properly supported if applicable.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.5.5 | What warranty or after-sales support do you provide? | Warranty documents, customer service procedures, repair services, support hotlines, documented procedures |
| 8.5.5 | Are maintenance or installation services offered after delivery? | Service agreements, installation procedures, maintenance manuals, field support documentation |
🔄 Control of Changes (Clause 8.5.6)
Verify that production process changes are approved and documented before implementation to prevent unintended consequences.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.5.6 | When a production process is changed, who approves it? | Change control procedures, defined approval hierarchy, authorization records, change request forms, engineering/quality/management involvement |
| 8.5.6 | Can you show records of recent production changes and approvals? | Change control records with dates, signatures, change descriptions, impact assessments, evidence of actual implementation |
Audit Focus: Select one recent process change and verify it was approved, documented, communicated to workers, and workers were retrained if needed.
✅ Product Release and Inspection (Clause 8.6)
Verify that products conform to requirements before release to customers through inspection and approval processes.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 8.6 | Is finished goods inspection done before products are sent to customers? | Inspection procedures, final quality checks, dimensional verification, function testing, visual inspection records before finished goods storage |
| 8.6 | Who has authority to approve and release finished products? | Documented release authority, sign-offs on inspection records, quality engineer approvals, release checklists, prevention of unauthorized releases |
📏 Monitoring and Measuring Resources (Clause 7.1.5)
Verify that measuring instruments used for product verification are calibrated and maintained to ensure valid measurement results.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 7.1.5 | Are all measuring instruments (gauges, calipers, micrometers) calibrated? | Current calibration certificates, documented schedules, calibration service contracts, appropriate calibration intervals |
| 7.1.5 | Can you show calibration sticker or certificate on this measuring tool? | Calibration labels with expiration dates, color-coded tags (green=calibrated, red=out), digital tracking systems, all instruments currently calibrated |
Pro Tip: During audit, randomly select 3-5 measuring instruments and verify calibration status by checking certificates or labels.
👥 Worker Competence and Training (Clause 7.2)
Verify that personnel performing work affecting product quality are competent based on education, training, skills, and experience.
| CLAUSE | AUDIT QUESTION | WHAT TO LOOK FOR |
|---|---|---|
| 7.2 | Are machine operators trained on the equipment they operate? | Training records, training schedules, on-the-job training documentation, certification records for each operator |
| 7.2 | Can you show training records or skill matrix for production workers? | Training matrices showing equipment assignments, competence assessments, attendance records, certification dates, development plans covering technical and quality skills |
Interview Question: Ask random operator: "What is the maximum acceptable tolerance?" and "What do you do if a part is out of tolerance?" Answers confirm competence.
📌 Audit Best Practices & Common Findings
Before the Audit
| 📋 Review Documents | Study product specifications, procedures, and previous audit findings to understand baseline |
| 🗺️ Plan Your Route | Identify all production areas, key personnel, and equipment to audit efficiently |
| 🎯 Prepare Tools | Gather this checklist, measuring devices, camera for visual evidence, notepad |
| 📢 Set Expectations | Notify management of audit timing and scope in advance |
During the Audit
| 👀 Observe Actual Practice | Watch workers performing activities; don't rely solely on documentation |
| ❓ Ask Open-Ended Questions | Use "Show me..." and "Tell me how..." rather than yes/no questions |
| 🔍 Verify Compliance in Action | Select random products and trace them through the complete production process |
| 💬 Interview Workers | Speak with operators, supervisors, and quality staff about procedure understanding |
| 📸 Take Photos | Document visual evidence of controls, identifications, and storage conditions |
| ⚖️ Remain Objective | Look for facts; small gaps don't always indicate nonconformity |
After the Audit
| 📝 Document Findings | Record conformities, observations, nonconformities with clear evidence |
| 🏆 Classify Issues | Distinguish major (systemic) vs minor (isolated) nonconformities |
| 📢 Provide Feedback | Share findings with management; discuss improvement opportunities |
| ✏️ Request Actions | For each nonconformity, require documented corrective actions with root cause |
| ✅ Follow-Up | Verify corrective actions are implemented effectively |
🚩 Common Audit Findings (Watch for These)
| Missing/Outdated Instructions | Work instructions not available at workstations or outdated compared to current processes |
| Uncalibrated Tools | Measuring instruments expired or without current calibration certificates |
| No Training Evidence | No records showing operators trained on equipment or procedures they use |
| Poor Traceability | No clear product identification or inability to trace finished goods to raw materials |
| No Change Control | Process changes implemented without documentation or approvals |
| Missing Error-Prevention | No poka-yoke or preventive measures for critical processes |
| Poor Storage Conditions | Products exposed to damage, rust, corrosion, or contamination in storage |
| Unauthorized Releases | Products released without proper verification or management approval |
✨ Conclusion
This comprehensive ISO 9001 production audit checklist in tabular format covers all critical aspects of manufacturing from planning through product release. The quick-reference design enables efficient on-site auditing while ensuring systematic evaluation of all control areas. Effective internal audits verify that production controls are actively implemented and followed—not merely documented on paper.
Remember: The purpose of internal auditing is continuous improvement. Use findings to strengthen processes, prevent problems, and drive manufacturing excellence.
📚 Explore Related Audit Guides
This blog is part of a comprehensive ISO 9001 internal audit series:
