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The Internal Quality Audit Process for Orthopaedic Medical Device Companies: Risk Indicators and Uncertainties

FDA analysis of factory inspections has shown that manufacturers who do not have an adequate quality audit system usually do not have an adequate quality system. An evaluation of approximately 2,400 manufacturers that received cGMP-QSR inspections by FDA showed that manufacturers with an adequate quality audit system were in compliance with approximately 96 percent of the GMP requirements, while those that did not have an adequate audit system were in compliance with approximately 70 percent of the requirements.


Audit (from cGMP-QSR):A systematic and independent examination of a manufacturer’s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.

Audit (from ISO):A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements, and whether these arrangements are implemented effectively and are suitable to achieve objectives

Risk: A combination of the probability of occurrence of harm and the severity of that harm.

Notes on Affective Uncertainty: The effectiveness and compliance of a quality management system can be jeopardized by not enabling compliance through the use of the process approach, not understanding the operation and control of these internal steps, having incompetent individuals design and implement these procedures, by not measuring, monitoring and analyzing these processes in an honest and viable manner and by not listening to your internal and external customers.

A Useful Tool in a Risk-based Industry

The analysis and use of feedback data from product acceptance, audits, complaints, repairs and other sources are necessary parts of a self-correcting quality system. The audit of a quality system is one of the most important cGMP-QSR requirements. A quality system should change with the risks presented to an orthopaedic device company. Therefore, internal audits are the primary tool for assuring that quality system changes are not only correct, but also disinclined to present more risk when implemented and linked with other processes.

A quality audit is a documented, independent inspection and review of a quality system. The audit is performed on a periodic basis in accordance with written procedures. The objective is to verify, by examination and evaluation of objective evidence, the actual degree of compliance with those elements of the quality system under review. These audits are an essential part of every medical device manufacturer's effort to assure safe and effective devices. Regardless of how well a quality system is planned, monitoring of the system is required if the quality system program is to be effective in assuring that finished devices meet specifications.

If conducted properly, a quality audit can detect quality system defects. Isolation of high risk trends and correction of factors that cause defective products can help prevent the production of unsafe or nonconforming devices.