Business Continuity for IVD manufacturers - Our most severe risk is fire

J

jpal2

Hi,

We are a small single-site IVD manufacturer currently drafting a Business Continuity Plan.

Our most severe risk is fire. The greatest impact of this would be destruction of the premises and loss of stock. What contingencies have people put in place for this? It does not appear to be practical for a company of our size to outsource manufacture (validation/regulatory issues).

Does anyone have any experience of this?

Thanks!
 

Al Rosen

Leader
Super Moderator
jpal2 said:
Hi,

We are a small single-site IVD manufacturer currently drafting a Business Continuity Plan.

Our most severe risk is fire. The greatest impact of this would be destruction of the premises and loss of stock. What contingencies have people put in place for this? It does not appear to be practical for a company of our size to outsource manufacture (validation/regulatory issues).

Does anyone have any experience of this?

Thanks!
What requirement within the standard are you addressing?
 
J

jpal2

We are not meeting any specific requirement of the standard. However it was mentioned by the auditor in a recent audit.

We suspect it may be something that may be necessary from an insurance point of view sooner rather than later and it would make good business sense to put a plan in place.

Does anyone in medical devices have any experience in devising a plan such as this?

Any help would be great!
 
Top Bottom