Should They Cave to the Political Pressure and Cancel their CAPA?

We had a 36-hour blackout at our site caused by a massive storm affecting the entire region. Our generator kicked in and we thought everything was fine until it died after 10 hours due to widespread fuel shortages. That left us with a 26-hour deviation impacting all of our studies, including frozen and refrigerated materials supporting the commercial routine stability program. As a result, I initiated our stability investigation documentation in the corporate CAPA system as soon as the lights came back on. The next day, however, I was soundly rebuked for acting rashly and autonomously.

From management’s perspective the stability portion of this outage should have been incorporated into the larger site wide deviation documentation—which was initiated in the same CAPA system the day after I logged mine in. Our procedures specifically require a documented impact assessment and CAPA for such deviations. No one told us of plans for a site wide exception report, so I just followed procedure. Should I stick to my guns and press on with our independent investigation or cave to the political pressure?

It’s not political, it’s simply good business and fully compliant. The site-wide CAPA can easily capture your impact assessment details and appropriate corrective actions while avoiding individual exception reports from each quality department. I’m surprised you did not confer with your management before initiating yours, but I’m sure your system has the ability to cancel this stability specific entry with the recorded reason for cancellation referencing the site wide investigation report.