Practical Guidance

Make hold-time definitions unambiguous

Practical Guidance

Define the events behind the timestamps before evaluating the interval.

Name the start event

“End of production” can mean different things to different teams. Decide which event starts the dirty hold-time clock and how it is recorded for the equipment concerned.

Name the end event

Specify what counts as the start of cleaning and when a cleaning cycle is complete. Define the conditions under which cleaned equipment is stored and the event that ends the clean hold time.

Test the operating instructions

Walk through a delayed shift, an interrupted cleaning cycle and a change in equipment availability. The procedure should make the status and escalation route understandable in each case. Record any assumption that still needs study evidence.

RECOMMENDED PRACTICE

This article offers editorial working suggestions. It does not replace the original source, site procedures or a documented scientific assessment.

Related regulatory requirements

More in Practical Guidance