Not sure what I should provide here as evidence.. should I have a risk assessment where I will list and risk assess each equipment?
the interpretation says ;
Edited by Dorothy87, 14 June 2023 - 02:34 PM.
Posted 14 June 2023 - 02:33 PM
Not sure what I should provide here as evidence.. should I have a risk assessment where I will list and risk assess each equipment?
the interpretation says ;
Edited by Dorothy87, 14 June 2023 - 02:34 PM.
Posted 14 June 2023 - 02:56 PM
The clause in question states "The design and construction of equipment shall be based on risk, to prevent product contamination...."
This is all going to be based upon what you actually produce, of course. Is the design and the condition such that it will not pose a risk to product contamination?
I suppose you COULD do a risk assessment on every piece of equipment, but you probably already have sufficient evidence for suitability.
1. Certification of the equipment to a sanitation/hygienic standard? Check.
2. Results of preventive maintenance actions/GMP inspections that show that the equipment has no issues that may pose a risk to product contamination? Check.
3. A policy/procedure that states that temporary repairs will be made with materials suitable for food contact? Check.
Marshall
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