Symptomatic Solutions: the Slow, Gurgling Death of a Factory

Want to lower costs?  Want to reduce the risk of problems with FDA?  Train as many people in your organization as possible to write good Root Cause Analyses.  You will eliminate repeat errors, save prodigious quantities of money, and improve critical thinking skills.

An effective Root Cause Analysis (RCA) is required by FDA when investigating deviations, OOSs, or CAPAs.  Our plant wasn’t doing as well as we needed to do.  Our RCAs were cosmetic in nature.  Worse than that, the same errors kept coming up again and again, each time in a slightly different form.

I decided that all the managers and experienced technicians should know how to write good RCAs.  I didn’t like the idea of having only an elite few investigation writers.  I wanted to use RCA as a vehicle for improving critical thinking skills in most of the plant.

We trained everyone on RCA, but the message didn’t seem to get through.  This was frustrating.  We had spent all that time and money on good training, but nobody used it. 

OK; lesson One for the Newbie manager:  simply training everyone doesn’t mean that they are going to pick up the gauntlet and implement the training. 

They need follow-up to make sure that the training gets used.  Large organizations need to have the dots connected for them on a daily basis until they understand exactly how the training needs to be applied to their specific situation.

I wouldn’t recommend this in general, but I chose to focus on RCA and review every investigation.  Normally a plant manager doesn’t wade into that level of detail.  Good managers are good delegators.  It’s not a good idea to spend a disproportionate amount of time on one small aspect of the plant when you’re supposed to be running the whole operation.

But I could not stand watching those investigations get filed away with so many symptomatic solutions.  Somehow I had the feeling that if we could find a way to get those investigations done right the first time, we could achieve great things. 

The task turned out to be much harder than I thought.  It had more layers of complexity than I had imagined.  But it also had far more benefits than I’d thought possible. 

Here’s what happened.  I inserted myself into the RCA investigation process.  Every investigation had to come to me before it was filed.  I took the time to review every investigation in detail.  If it didn’t have a true root cause indentified, I sent it back to the originator.  If the logic that led to the conclusion was flawed, I sent it back.  If the corrective action did not provide a high degree of assurance that we’d never see that root cause again, back it went.

The reaction was both intense and extensive.  Everybody wanted to know why the plant manager was so interested in a “paperwork exercise”.  You could see them rolling their eyeballs.  Surely this flavor of the month would blow over quickly enough.

I didn’t say anything.  Why, I don’t know.  Maybe I didn’t think explanations would ever be sufficient. 

The employees had to feel the benefits of true root cause solutions before they could really understand their worth; because, being honest, RCA is time consuming.   You have to put a lot of work in up front to get very delayed gratification.  The benefits aren’t immediately obvious when you’ve got empty trucks that need to get filled with product.

The first investigations I reviewed required several iterations before they were finally done right.  I marked up the investigations with hints, questions that needed to be answered, and alternate explanations that needed to be eliminated.  Incredulity reigned.  The boss had lost it.

There were a few people, though, that sort of got it.  I worked with them to hone their skills.  After several rounds they began to turn in investigations that needed only minimal revisions.

Slowly, painfully, others began to come around.  Eventually most of the investigations needed only one revision.  When we got about half the people on board, things began to speed up.  When 80% of the investigations began to come through right-the-fist-time, I felt that it was time to hand off the review to someone else.

The results were clear and measureable.  We not only got better investigations, we got quicker investigations.  We not only got better corrective actions, we got lowered costs as well.  Critical thinking became a commonly used tool set in our plant.

You could sense the change that came into the workplace.  Conversations with the technicians started to occur at an entirely different level than before.  They really started thinking through the problems that occurred in the operation.  People started coming to me with SOLUTIONS rather than problems!

The interesting thing was that quality RCAs seemed to gain a momentum of their own.  Their value became palpable to all.  We didn’t have to remind people every time a problem surfaced.  In short, good critical thinking skills became a habit in our plant.

How about you?  Do you have a similar story?  What has worked best for you?  Comment below.