Research

By Mohamad-Ali Salloum, PharmD October 20, 2024
Introduction: In the realms of quality control and regulatory compliance, the terms “audit” and “inspection” are often used interchangeably. However, they represent distinct processes with unique objectives, methodologies, and outcomes. Understanding these differences is crucial for organizations aiming to maintain high standards and ensure compliance with regulations. 1.Definitions: Audit: An audit is a systematic, independent, and documented process for obtaining objective evidence and evaluating it to determine the extent to which audit criteria are fulfilled . Audits are comprehensive reviews of processes, systems, or organizations to assess their accuracy, efficiency, and compliance with established standards. Inspection: An inspection is the process of examining, measuring, and testing to determine whether an item or activity conforms to specified requirements2 . Inspections are typically more focused and specific, often involving physical examination and testing of products, equipment, or facilities. 2. Purpose: Audit: Primarily aims to improve processes by identifying weaknesses and opportunities for improvement . Inspection: Focuses on ensuring that products or services meet specified standards and requirements . 3.Scope: Audit: Broad in scope, covering various aspects of an organization, including financial, operational, and compliance areas . Inspection: Narrower in scope, typically limited to specific products, equipment, or processes . 4.Depth of Review: Audit: Involves a deep and thorough review of processes and systems . Inspection: Limited to checking conformity to specified requirements . 5.Formality: Audit: A formal and documented process with detailed reports and recommendations . Inspection: Can be less formal, with reports varying in detail . 6.Frequency: Audit: Conducted periodically, such as annually or quarterly . Inspection: Can be scheduled or unscheduled, depending on regulatory requirements . 7.Independence: Audit: Performed by internal or external auditors who are independent of the area being audited . Inspection: Can be performed by internal staff or external agencies, with varying levels of independence .
PubMed
By Mohamad Ali Salloum, PharmD January 30, 2022
This post will show you how to search for articles when you are doing literature review.
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