Cumulative Trouble

My director asked me to investigate where the industry stands regarding handling of stability chamber outages. They are convinced that we should be gathering cumulative outage information and tracking that information so that exposure times can be adjusted accordingly. For example, if a product exposed to 5°C for 2 years experienced a cumulative 37 hours above the required temperature then the actual final pull date should be 2 years and 2 days–technically pulling the material two days after its expiry.

I’ve polled on StabilityHub and I’ve asked peers from other companies that I met during past PSDG meetings, and the general consensus is that first, there is no guidance, and second, there have not been any known observations related to cumulative outages. Everyone I talked to, though, had been questioned about it in at least one audit, but not necessarily from a government agency. Still, everyone agrees it is a controversial topic with no clear resolution—only guaranteed headache and significant cost to implement, if we so choose.

What do I go to my director with? They are clearly on to something valid, but not necessarily something critical. They’re a real stickler and perfectionist.

Present a summary of polling and intelligence gathering to your director. Conclude that the issue is not new to the stability industry, but it is not something that has been adopted as of yet due to costs vs. the very low impact. Finally, show them that your thorough individual outage deviation reports account for chambers’ historical performance and appropriate action on frequent bad actors are taken as CAPA. What solution would you, our readers, propose?