Relocation of Special Processes

Hi,

The company I'm working for are currently growing quickly. Due to this we are investing in new buildings and increasing the size of our buildings.
We are currently defined to be a single size location, as all our different buildings are within a closed area and all share the same address.

Due to the growth, a lot of our processes need to change location. Either to a new building or inside the same building.

For example our adhesive bonding (special processes) are changing from one building to another. What are the requirements that we need to follow when we change room of this process?

Regardless of what is required you should redo the validation. All kinds of things can change when you move equipment and processes. That goes double for out sourcing or even just a new supervision/operator team.

Process realization would need to be repeated so it is all running as with the original processes:

• New or relocated equipment? The answer to this drives some of the following points
• Different personnel? If yes, address that appropriately
• Environmental controls are correct for adhesive preservation
• Storage is adequate
• Date management is maintained
• Traceability of product is maintained in the new building
• If it's new equipment, make sure your new processes get set up with Planned Maintenance, calibration etc. as with the current location
• Non-conforming product arrangements are established
• Etc. Etc.
• Remember validation, as Bev said.

QualitySage said:

What are the requirements that we need to follow when we change room of this process?

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In addition to revalidate the processes, you need to inform, as appropriate, PRI Nadcap, your certification body and the customers involved.