When cleanroom is first being constructed, the certification is done at the â?oas-builtâ? condition where there are no equipments, process and operators.
Before the production line is being setup inside the cleanroom, the Engineering team like the process and equipment will define requirements such as the process flow, layout, equipments and tools needed. The facility team will support on the utilities need such as power point and vacuum lines. This overall plan will be drafted in a master layout and usually coordinate by the IE (Industry Englineer) personnel. The QA, Contamination Control and Safety personnel will then review and provide the approval for the setup plan.
After the line setup completion, the Quality, Contamination Control & Safety personnel will respectively responsible to perform the physical audit and to provide the approval or certification before releasing to actual production.
For example, the Quality will verify the equipments and tools compliances accordance to standard procedures, the Contamination Control to verify the cleanroom performance at the â?oAt Restâ? condition, and the Safety officer to verify the setup such as the emergency exit, emergency evacuation plan and fire extinguisher are accordance to all safety requirement and regulation.
As a result, all the aspects of cleanroom, safety, equipment, tools and process need to be treated equally important to ensure a success product manufacturing.
