Refrigeration Breakdowns

[Ninja]

Howdy Boboo,
Please do. It is rare that after providing input and opinions that we get to see the end result. It is typically quite a treat to see how things turned out.

 

[Boboo]

Howdy Boboo,
Please do. It is rare that after providing input and opinions that we get to see the end result. It is typically quite a treat to see how things turned out.

For your valued input. This is how the document looks now.

 

[Steve Prevette]

Looks reasonable to me. There is a lot of responsibility placed on the QAO for verifications and judgements (example 5.11). Will the QAO have sufficient "oomph" when dealing with line management who says - we told the person who screwed up to not do it again, we are done with this" or words to that effect?

 

[Pjservan]

All valuable input above, however I have not seen any discussion on the impact onto your product. If the breakdown had an effect onto product then this can be added as criteria for issuance of corrective action request. I used to work with products that had to be frozen and our freezers were hook up to alarm systems. We used to have a log on each freezer and it was used whenever we had an instance of the alarm going off. The log recorded the actions taken; from simple actions such as "closing the door properly" to moving product to freezer #XXX due to breakdown. We escalated to NCMR if product quality was suspect and had the ability to raise these events to CARs as needed- individual case or trend.