Consent Decree of Permanent Injunctions appear too frequent in FDA Regulated Industries, Why?
Whether in the medical device, pharmaceutical or the food manufacturing industry, a company usually has had many violation corrective action chances before they get a consent decree of permanent injunction. At this point a third party reviews current deviations and often identifies a weak or non-existent root cause analysis program.
Now don’t get me wrong, this is often when our TapRooT® Root Cause Process gets recommended as a possible option and we gain a new client. However, I would prefer working with an FDA regulated company to develop effective corrective actions before they get in trouble. Or at least when they get their first FDA Finding.
Often FDA findings are found by an external audit. To remain independent, the auditor turns over the findings through proper protocol and the company involved must provide proof that the causes were found and that the corrective action is effective. So if this protocol is followed, how did we get to a permanent injunction? Can the repeat findings be purely an Enforcement Needs Improvement Root Cause for policies not followed?
I suggest Enforcement needs improvement is not the only problem. To find out what your company might be missing in your RCA process. Find a course close to you and send one of your key quality or safety problem facilitators. Here is our upcoming courses link: http://www.taproot.com/store/Courses/
To get you thinking about possible gaps in your root cause analysis program, view this presentation given at our 2012 TapRooT® Summit. http://www.taproot.com/content/wp-content/uploads/2012/02/RileyandGorman.pdf
Then check out the quality track in the upcoming 2014 Summit in April. http://www.taproot.com/products-services/summit