What Information Should Be Included in a Hold-Release and CAPA Document?

Hi all,

We had some hardened sugar bags piled up for awhile. We were able to get rid of them recently. 

What info do I need to include in Hold/Release and CAPA document? If you can share an example, it would be great! 

Hi ;)

I would suggest product on hold with concession procedure and log. 

Concession can be granted based on different factors, for example : 

• Product passed its BB date (based on organoleptic taste, supplier advise or micro testing) 
• Unexpected changes / differences in product packaging (colour variations, in this case customer should approached) 
• Product packaging damaged (damaged packaging but product is still fit for purpose
• Product is different than on QAS (Quality Attribute sheet) or product specification
• Product shelf life needs to be extended or reduced as per customer request

Your concession procedure should consider : 

• Responsibility 
• Definition of concession 
• List of requestors and requestees (who is allowed to ask and who is allowed to grant)
• List of possible concession and conditions 
• Link to concession log (Concession no., date, product code, supplier/customer details, product, location of product, QTY, Expiry date, Reason for concession request, concession approval/ rejection, Approval conditions/rejection reason, further actions if rejected. 

Include a possible reason for why the sugar became hard and unusable (i.e. bags were damaged, wet, etc). 

How are you going to prevent this issue again (i.e. adjusting the storage conditions, adding humidity control, working with the supplier)