Application Note – Cleanroom N.04
Investigation about microbiological environmental monitoring excursions
The first step for investigating environmental monitoring excursion is to ensure that the excursion is not due to operator error. Many times a lot of energy is expended in investigating excursions that are not due to environment being out of control but due to analyst or laboratory errors. It is therefore important to identify true and false excursions.
The main points to investigate could be:
• Verify it is not an error
• Validate the microbial identification
• Separate excursions from Out of Specifications
• Developing and action plan when an excursion occurs:
(a) Are the counts correct?
(b) Is the identification correct?
(c) Is it an objectionable?
• Planning and investigation: Information to be collected
(d) Estimated causes
(e) Probable causes
(f) Root causes
• What are the corrective actions and how effective are they.