Internal Audits & Corrective Actions
Module 5: Internal Audits & Corrective Actions (CAPA)
This module explores internal audits, annual audit planning, audit execution, results documentation, root cause analysis, development and monitoring of corrective and preventive actions.
Section 1: Fundamentals of Internal Audits
1.1 What is an Internal Audit?
An Internal Audit is a systematic and independent examination of your quality management system to verify that it conforms to ISO 9001 requirements and is effectively implemented and maintained.
Key Characteristics:
- Systematic: Planned, organized, follows a defined process
- Independent: Conducted by someone not directly responsible for the audited area
- Objective: Based on evidence, not opinions
- Confidential: Results are for internal improvement, not public
Why Internal Audits Matter:
- Early detection: Find problems before external auditors
- Continuous improvement: Systematic approach to identify opportunities
- Compliance verification: Ensure meeting ISO 9001 requirements
- Risk identification: Discover emerging issues
- Proof of commitment: Documentation showing seriousness about quality
Section 2: Audit Planning
2.1 Annual Audit Plan
A structured approach requires planning audits across the organization.
Elements of an Audit Plan:
- Audit schedule: Which areas, when, by whom?
- Audit criteria: Which standards/requirements are audited?
- Audit scope: Which processes are covered?
- Auditor qualifications: Who is qualified to audit?
- Duration: How long for each audit?
- Frequency: Based on risk (critical processes more frequently)
Example Annual Audit Plan:
| Quarter | Process | Auditor | Scope |
|---|---|---|---|
| Q1 | Design Control | Audit Manager | New product design process |
| Q1 | Document Control | Quality Manager | Documentation system |
| Q2 | Manufacturing | Operations Director | Production process |
| Q2 | Inspection & Testing | Quality Manager | In-process, final inspection |
| Q3 | Training | HR Director | Competency, training records |
| Q4 | Customer Relations | Sales Director | Complaint handling, satisfaction |
2.2 Audit Preparation
- Notify auditees: Give 2-3 weeks notice
- Provide audit criteria: List what will be audited
- Collect background: Review prior audit results
- Develop checklist: Specific questions/areas
- Arrange logistics: Scheduling, access, documentation
Section 3: Conducting the Audit
3.1 Audit Execution
Opening Meeting:
- Explain audit objective, scope, timeline
- Present audit team
- Address questions
- Agree on schedule
Information Collection:
Three primary methods:
- Document Review (30% of time): Inspection reports, test data, training records, maintenance logs
- Interviews (40% of time): Open-ended questions, active listening, probe deeper
- Observation (30% of time): Walk production floor, observe work, compare procedures vs. actual practice
Section 4: Root Cause Analysis
4.1 The 5-Why Technique
Simple but powerful technique: Ask "Why?" repeatedly until you find the root cause.
Example (Paint Drips):
Q1. Why do parts have paint drips? A1: Spray pressure was irregular Q2. Why was pressure irregular? A2: The pressure regulator was not working properly Q3. Why was the regulator not working? A3: It hadn't been cleaned or maintained recently Q4. Why hadn't it been maintained? A4: The maintenance schedule didn't include regulator cleaning Q5. Why not? A5: ROOT CAUSE: The maintenance procedure wasn't updated when equipment was upgraded 6 months ago
Lesson: Fix the root cause (update procedure) not the symptom (adjust pressure)
4.2 Ishikawa Diagram (Fishbone)
Visual tool to identify causes of a problem. Categories (for manufacturing):
- Materials: Wrong material type, defective material, contamination
- Methods: Incorrect procedure, insufficient instruction
- Machines: Equipment failure, calibration drift, wear
- Man-power: Operator error, inadequate training
- Measurements: Inspection error, wrong tool, calibration issues
- Environment: Temperature, humidity, lighting, noise
Section 5: Corrective & Preventive Actions (CAPA)
5.1 What is CAPA?
- Corrective Action: Action taken to eliminate cause of a detected non-conformity so it doesn't happen again
- Preventive Action: Action taken to eliminate cause of a potential non-conformity before it occurs
Key Difference: Corrective = fixing what happened. Preventive = preventing what could happen.
5.2 CAPA Process (6 Steps)
Step 1: Problem Definition
Describe clearly what (not why yet):
- ❌ Poor: "Quality is bad"
- ✅ Good: "5 out of 100 parts produced on March 14 had paint drips"
Step 2: Root Cause Analysis
Use 5-Why or Ishikawa to identify underlying cause, not symptom.
Step 3: Corrective Action Plan
Define specific, measurable actions to correct root cause:
| Action | Responsible | Target Date | How to Verify |
|---|---|---|---|
| Update maintenance schedule | Maintenance Mgr | March 25 | Verify schedule updated |
| Train all paint operators | Training Coord | March 28 | Signed training records |
| Clean regulator, verify pressure | Paint Lead | March 20 | Manometer reading acceptable |
| Produce test parts, verify quality | Quality Mgr | March 21 | 100% test parts acceptable |
Step 4: Implement Actions
Execute the plan, document completion.
Step 5: Verify Effectiveness
After implementation, verify the action actually worked:
- Collect additional data (produce 200 parts, inspect for drips; defect rate should be zero)
- Monitor over time (SPC chart should show no out-of-control signals)
- Examine similar processes (if cause was systemic, were other areas affected?)
Step 6: Document and Communicate
Ensure everyone knows:
- What the problem was
- Why it occurred
- What action was taken
- That it's now fixed
5.3 CAPA Follow-up and Closure
A CAPA can only be closed when:
- ✓ All planned actions have been completed
- ✓ Effectiveness verified (data shows problem fixed)
- ✓ Similar issues verified (systemic approach)
- ✓ Procedures updated if necessary
- ✓ Training completed if necessary
- ✓ Documentation complete and archived
Common Mistake: Closing CAPA based on action completion, not effectiveness verification. This recreates the problem later!
Conclusion: Audits and CAPA as Continuous Improvement
Internal audits find problems. CAPA fixes them. Together, this system creates systematic continuous improvement.
