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On xx/xx/xx, a microbiology laboratory reported an out of action in a change room ISO 9 control room. Microbiologist #1 performed the monitored of sample point x, located in the gowning and degowning area. During the investigation, the investigators observed the event date with the following finding: - The personnel manufacture opened one door during the monitoring process of the sample point x. Microbiologist #1 noticed that and performed a sudden movement to the RCS equipment inadvertently. - Microbiologist#2 is monitoring in another control room at the same time that Microbiologist#1 is monitoring. Microbiologist #2 constantly opens the doors of the change room to prepare the sample and go to the other control room. Also, 4 sec before starting the monitoring process of point x, Microbiologist#2 opened the door to monitoring in the other control room. - Microbiologist#1 monitoring point x with a uniform plant that comes of no control area. Also, Microbiologist#1, used the RCS equipment close to the body.

The Change Control is a room for gowning and degowing process, has a separation area of gowning and de-gowning to enter the other control room. This Change Control has three doors, one to the hall (no control area) and another two for the control area (ISO 8). Also, the personnel enters to gowning and degowning area from the hall with a uniform plant and hairnet.

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