Shiny new CAPA system! - Easy way to close the old one?

[Spelexus]

New user so please bear with me... In my current role I have inherited a monstrosity of a non-conformance / CA / PA system which is heavily overloaded, (100's of outstanding investigations and quarantined product). I have applied my previous experience to design a replacement system which I believe will work well with the correct training and support, however what options do we have with the existing outstanding issues? If we track these to closure the same resource issues which have contributed to killing this system will blight the new one before it is even established.
I'm looking for your thoughts on the acceptability of 'drawing a line in the sand', recognising we have lost the opportunity to investigate these previous issues appropriately, and closing them, scrapping all associated product. We are a high volume low cost manufacturer and this could work from a business perspective but I am concerned about justification of this approach to a Regulatory Body.
Anyone with experiences to share?

 

[Wes Bucey]

I make the first presumption that quarantined "suspect" material is NOT representative of material actually shipped to customers. Any such incidences MUST be tracked down (albeit with your new system) and resolved to prevent possible life, health, safety issues. I do not accept that any opportunity to correct such error is ever passed, especially since the corrective action may be one of recall of product in field.

Second presumption: you can make an easy distinction between customer-generated CAR and internally-generated CAR - if yes, transfer customer-generated CAR to new system. (new system should have process to weed out invalid complaints from customers and give detailed response WHY they are invalid before going through a complete CAR process.)

Third presumption: you can make a distinction of products which may trigger regulatory review (toxic substances, tax considerations like inventory tax, required scrapping procedures to assure no nonconforming product can EVER be used, etc.) If yes, deal only with the ones which are affected.

For all quarantined product which was merely "suspect," it seems to me you could go through an expedited process to determine if the products in question are ACTUALLY nonconforming. Those actually nonconforming can go through a simple triage

1. still manufacturing? run it through new system - especially consider preventive action
2. ceased manufacturing, but could affect product in field? run it through new system - only corrective action may be recall - no preventive action
3. ceased manufacturing, none can be affected in field? scrap and forget.

Tell us about your new system and how it will eliminate the expensive parts of the process you are replacing.