The Best 3 Types of Quality Audits as per FDA Guidelines.

In this article, you will learn the main 3 types of quality audits according to FDA requirements and cGMP Good Manufacturing Practices.

WHAT TYPES OF QUALITY AUDITS MUST YOUR ORGANIZATION ACCOMPLISH?

Even though audits are common activities for many industries in general, this article aims more specifically to the GMP Quality Audits necessary and required by the cGMPs and the QMS Quality Management System.

Sometimes initial audits are followed by a risk-based requirement of additional recurrent re-auditing activities based on a lapse of time or triggered by some quality key indicators as complaints, field actions, CAPA investigations, non-conformances, out of specifications, etc.

TOP 3 TYPES OF QUALITY AUDITS:

1. Planned Audits. It refers to different audit activities that are planned, documented, and scheduled. The scope of the planned audit is to reduce surprises by anticipating and having all the necessary resources on hand, such as documentation, materials, and a strategy to use these resources.
2. Predictive Audit.  It is intended to determine the condition of quality systems in order to estimate when a next audit should be performed. Moreover, this technique boosts cost savings over routine or time-based audits, because inspections are performed only when warranted.  Thus, it is regarded as condition-based audits carried out as suggested by key indicators of a quality system. Predictive audits allow scheduling of inspections, preventing unexpected quality system failures.
3. Condition-based Audit (CBA) is a strategy that monitors the actual condition of the quality management system and its resources to decide what audit needs to be done. CBA establishes that audits should only be done when certain conditions and quality key indicators show signs of decreasing performance or upcoming failure in the company quality management system.

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 ramon.cayuela@ciqa.net.

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REFERENCES: Types of Quality Audits

STATUTORY AND REGULATORY REQUIREMENTS

TITLE 21–FOOD AND DRUGS

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

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.22

2 CFR § 200.501 – Audit requirements

httpss://www.law.cornell.edu/cfr/text/2/200.501

For more information about the types of Quality Audits, refer to:

httpss://www.intertek.com/auditing/gmp/

httpss://haccpmentor.com/gmp/gmp-audit/

httpss://ispe.org/initiatives/regulatory-resources/gmp/audit-considerations

httpss://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

httpss://www.fda.gov/media/90179/download

httpss://www.orielstat.com/blog/what-is-mdsap-certification/

httpss://www.bsigroup.com/en-US/medical-devices/Our-services/Medical-Device-Single-Audit-Program/

httpss://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-single-audit-program-mdsap