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Updated: Apr 19, 2026

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
Published on: August 11, 2017
Failure analysis in the identification of synergies between cleaning monitoring methods
Greg S Whiteley1, Chris Derry2, Trevor Glasbey3
1University of Western Sydney, Richmond, New South Wales, Australia; Whiteley Corporation, North Sydney, New South Wales, Australia.
Background:
The 4 monitoring methods used to manage the quality assurance of cleaning outcomes within health care settings are visual inspection, microbial recovery, fluorescent marker assessment, and rapid ATP bioluminometry. These methods each generate different types of information, presenting a challenge to the successful integration of monitoring results. A systematic approach to safety and quality control can be used to interrogate the known qualities of cleaning monitoring methods and provide a prospective management tool for infection control professionals. We investigated the use of failure mode and effects analysis (FMEA) for measuring failure risk arising through each cleaning monitoring method.
Methods:
FMEA uses existing data in a structured risk assessment tool that identifies weaknesses in products or processes. Our FMEA approach used the literature and a small experienced team to construct a series of analyses to investigate the cleaning monitoring methods in a way that minimized identified failure risks.
Results:
FMEA applied to each of the cleaning monitoring methods revealed failure modes for each. The combined use of cleaning monitoring methods in sequence is preferable to their use in isolation.
Conclusions:
When these 4 cleaning monitoring methods are used in combination in a logical sequence, the failure modes noted for any 1 can be complemented by the strengths of the alternatives, thereby circumventing the risk of failure of any individual cleaning monitoring method.
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