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Process Audit
Process Audit is a structured examination of a manufacturing or business process to verify its effectiveness, compliance, and consistency with predefined standards, procedures, and customer requirements. It ensures that the process is capable of consistently producing conforming products and supports continuous improvement initiatives.
It is an integral part of quality management systems and is frequently required by customers, industry standards (like IATF 16949), and internal compliance programs.
¶ What is a Process Audit?
A Process Audit checks whether:
- The process is being followed as per the documented procedures.
- The process is capable of achieving desired outputs.
- Opportunities exist for improving the process efficiency and effectiveness.
Process audits Majorly focus on the "how" — the procedures, controls, equipment, personnel, and environment used to produce a product.
¶ When is Process Audit Used?
Process audits are typically performed in the following scenarios:
- Internal quality assurance programs
- Customer requirements or audits
- Certification audits (e.g., ISO 9001, IATF 16949)
- Supplier qualification and monitoring
- Root cause investigations
- Introduction of new processes or changes
¶ Process Audit Classification and Frequency
| Audit Type | Purpose | Frequency |
|---|---|---|
| Systematic Audit | Routine checks of key processes | Monthly or quarterly |
| Special Audit | Triggered by customer complaints or issues | As needed |
| Layered Process Audit (LPA) | Multi-level audits involving all roles | Daily, weekly, monthly |
¶ Why Process Audits Matter
- Ensures process standardization and stability
- Detects systemic issues before they become product defects
- Drives continuous improvement culture
- Enhances supplier and customer confidence
- Supports compliance with certifications and regulations
¶ Key Inputs for Process Audit
- Work instructions / SOPs
- Control plans and FMEAs
- Operator qualification records
- Calibration logs and inspection sheets
- Process performance metrics (e.g., cycle time, scrap rate)
¶ Process Audit Reporting & Analysis
- Scored using compliance checklists (e.g., % score)
- Categorized by severity (minor, major, critical)
- Tracked in dashboards or audit software
- Linked to CAPA for non-conformities
- Audited trends visualized through Pareto or trend charts
¶ Tools Often Used
- Perfeckto QMS System for audit scheduling, execution, and tracking