Top 5 Reasons to Establish When is Necessary a Quality Audit.

5 reasons to determine when is Necessary a Quality Audit


In this article, you will learn when is necessary a quality audit as per cGMP Good Manufacturing Practices.

An audit shall be done based on one or more of the following 5 triggers or reasons:

  1. QA, supplier, or manufacturer recommendation,
  2. Whenever a change is introduced to a process that may affect its operation, etc.
  3. Risk evaluation of potential failures or FMEA analysis
  4. Evaluation of the historical data.
  5. Lapse of time for a re-audit.

More specifically, an audit must be performed on any process, area, equipment, or machinery related to the following areas:

  • Specification criteria for raw materials, internally/externally manufactured components, or internally/externally finished products
  • Packaging or labeling information, process, or materials.
  • The shelf life of raw material, components, or finished products
  • Process parameters
  • Tools or consumables (i.e. wipes, gloves, shoe covers, etc.)
  • Equipment or equipment settings
  • Qualified cleanrooms
  • Cleaning processes of the manufacturing environment or manufacturing equipment
  • Facilities or utilities
  • Locations for manufacturing, testing, sterilization, or warehousing
  • Environmental conditions of manufacturing, testing, or storage,
  • Control of monitoring processes for the manufacturing, testing, storage, or distribution environment
  • Suppliers or external manufacturers
  • Line re-configuration as it relates to operators changing from a seated to standing position, updates to the line and station layouts, or re-sequencing of process steps
  • Throughput time as it relates to changes to the material storage time between processes
  • Product handling techniques as it relates to material storage and conveyance
  • Working with multiple lots at different stations.
  • Layouts in areas of product handling like manufacturing and warehouse
  • Any change that can potentially impact form, fit, or function and the quality of the product.
  • Changes related to supplied items, raw material, components, or finished products in regards to:
    • manufacturing or assembly processes
    • control or monitoring processes
    • cleaning processes
    • product handling
    • inspection or release processes
    • configuration check inspections
    • sample size or sampling plans
    • method of testing (e.g. physical, analytical, microbiological)
    • packaging or labeling processes
    • sterilization process
    • storage, shipment, or distribution processes.

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CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at


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PART 820 Medical Devices

820.22 Quality audit. Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance


2 CFR § 200.501 – Audit requirements


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Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!