Quite a November or The Stark Difference Between Private Enterprise and the State

November started out nice. I had a birthday, turned 26, big party with the Fam, lots of fun. Little did I know that things would go downhill fast.

The last day of October marked the last day that my car was legal, I had to re-register it. This is just another way that the state makes you pay more for doing well economically. I have a model 2001 Toyota, not the newest but not bad, and the state “assessment fee” is $150, but then they add insult to injury by tacking on a “registration fee” of $26.50. Not to mention the state mandated safety check where my two rear tires and my windshield (which has developed a crack) didn’t pass. Add on another $200 to my state mandated tab. Now I’m fuming because I’ve been running all around town all day, so you can imagine my dismay/anger when I see the line of 10 people waiting in front of me at the DMV. 10 people in front of you at the restaurant, 20 to 30 min; 10 people in front of you at the grocery store, 15 to 20 min; 10 people in front of you at the DMV, an eternity. Needless to say having my son create a dirty diaper right before I saw someone didn’t help.

Why do we put up with this? Shouldn’t I be able to decide when my tires are too bald to drive on, shouldn’t I be able to decide when the crack in my windshield impairs my vision and becomes dangerous? And what exactly is an “assessment fee”? It’s the first week in Nov. and I’m already out $400 bucks that could have gone to Christmas. Damn the man.

Private enterprise is far more efficient than the state, and I’m not just talking about lines here. I work in a FDA regulated industry. It didn’t used to be regulated but that’s another story. Years ago our company decided that in order to legitimize our new industry a standard would have to be developed and set. So rather than reinvent the wheel we asked Underwriters Laboratories to come and audit our company and search for quality related issues. They have been doing this for years.

  • They are prompt in the conduct of the audit.
  • They call and make appointments.
  • They send the same auditor out each time so the audits are more efficient and we don’t always have to start over.
  • They finish the audits in 1 or 2 days depending upon the complexity of the audit.
  • They focus on quality processes not paperwork, they focus on the customer not the regulations.

Yesterday the FDA showed up for a surprise inspection. This always makes me nervous, not that I am guilty of any wrong doing; I always try to comply with the regulations, but the regulations can and have in the past been interpreted in contrary ways depending upon the auditor. This is the 3rd time they have inspected our firm and the 3rd team of inspectors, so that’s 3 different interpretations of the same confusing regulatory language.

 Each time they take 2 days reading over our paperwork trying to understand what it is that we do. They then spend a week or more asking questions and interrogating me and my staff. All the while they have a smug attitude and a superior nose about them. Our first inspection the inspector casually mentioned that if she wanted to she could fine us millions of dollars to put us out of business without having to actually shut us down, this was before she had even looked at our process or our paperwork. We gave her a nickname, Wilbur, and made fun of her the entire time she was there without her knowing. Yeah, I know it’s childish and petty, but you do what you can to enact some sort of revenge.

My wife who is pretty tolerating by nature has turned to calling them fascists. She was in the office lobby when the recent Gestapo goosestepped in and announced that they would like to see if our papers were in order. After letting me know that they were here she asked them if they had made an appointment.

“No, We don’t have to.”

At that point my wife clicked her feet together did a curt bow and marched away mumbling to herself.

The difference between private enterprise and the state is unbelievable.

  • These inspectors will be here for a week or more. Partially because they have to start from scratch and partially because they don’t have to be fast.
  • They focus on paperwork, not quality. Our company has a joke: “We could take our devices out back and wash them with the garden hose as long as the hose is validated.”

Since the FDA has begun regulating us they have increased our expenses and done nothing to improve the quality of our product. This didn’t shock me, I expected it, but my wife was finally convinced of the uselessness of government regulations. So in a way it was a good thing. Being an anarchist I often run into opposition trying to explain my disdain for the Feds so it was nice that my wife was finally on my side.

Though November started good, but quickly turned sour, I am optimistic that the month will end in happiness and full bellies. I love Thanksgiving.

November 12, 2003