Inspection Vs Audit: A Comparison of Compliance Assessment Processes

Inspection and audit are two distinct processes used to assess compliance with various guidelines and standards, including ISO 9001, FDA, EMA, and others. Here’s a breakdown of the key differences between inspection and audit based on these guidelines:

 

Purpose:

– Inspection: Inspections verify compliance with specific regulations or guidelines, focusing on identifying non-compliance issues and ensuring adherence to minimum requirements.

– Audit: Audits comprehensively assess an organization’s quality management system (QMS) against a specific standard or set of requirements, aiming to evaluate its effectiveness and identify areas for improvement.

 

Scope:

– Inspection: Inspections typically concentrate on specific processes, products, or facilities and may be conducted by regulatory authorities or external agencies.

– Audit: Audits cover an organization’s entire QMS, including processes, procedures, documentation, training, and performance metrics. They can be internal or external.

 

Frequency:

– Inspection: Inspections may be scheduled periodically based on regulatory requirements or triggered by specific events like complaints or adverse events.

– Audit: Audits are usually scheduled at regular intervals as part of a planned audit program. Internal audits are often conducted annually, while external audits may occur less frequently.

 

Approach:

– Inspection: Inspections involve physical examination, observation, and sample testing to ensure compliance with regulations.

– Audit: Audits entail a systematic review of documentation, interviews with personnel, process observations, and data analysis to assess compliance with the chosen standard.

 

Reporting:

– Inspection: Inspection reports primarily focus on non-compliance issues discovered during the inspection process, including recommendations for corrective actions.

– Audit: Audit reports provide a comprehensive assessment of an organization’s QMS against the chosen standard, highlighting both non-compliance issues and areas of good practice.

 

Consequences:

– Inspection: Non-compliance identified during inspections may result in regulatory actions such as warning letters, fines, or product recalls.

– Audit: Non-compliance identified during audits may lead to corrective actions, process improvements, or certification non-conformities. However, the consequences are generally not as severe as those resulting from regulatory inspections.

 

Read also: 

 

• 4 Types of FDA Inspections
• Audit and Inspection Readiness in Pharma
• Analytical Instrument Qualification vs System Suitability Testing