TOF in Örnsköldsvik

A fair number of years ago, TOF awoke one May Day morning to the sound of a brass band tuning up outside his hotel window. However, said window was in Örnsköldsvik, Västernorrland County, Sweden  while TOF's brain was somewhere over mid-Atlantic, so however welcome the sound of brass bands might be in the early morning, it was not so much so under the jet-lagged circumstances.

Now the Swedishly challenged among TOF's readers may have noted an unconscionable concatenation of consonants in the name of the town Örnsköldsvik (which means "Ox-shield-bay"); to wit rnsk and ldsv. These might challenge even a Russian, the mightiest consonant cruncher this side of Polish. So even the Swedes care for their tongues by calling the town Ö-vik.

TOF does not say that the town is remote, but there is not much north of it except lots of north. On the road out of town -- TOF is not making this up -- there was a sign with an arrow pointing north reading "Santa Klaus".

But TOF, I hear you say, what were you doing in such a remote location as Örnsköldsvik, Västernorrland County, Sweden on such a nice May morning?


The answer is simplicity itself. The Long Arm of the US FDA had reached across the ocean to the wilds of norther Sweden and shut down a medical device assembly plant. The FDA has the power to audit any firm anywhere in the world if any of its products get a dry foot on US soil. The assembly plant in Stockholm had been audited and certain questions had been asked and, in a convulsive effort of passing the kronor, their answers were largely, "Oh, that's handled in the Ö-vik plant."

Ö-vik is on the coast just below
the northern border of the 3rd
county down. There isn't much
Sweden north of there, and darn
few Swedes.

How interesting, said the FDA. Where is this Ö-vik? You can tell the FDA auditors were truly dedicated because, unlike medical device plants on the French Riviera or on Tahiti, there is little incentive to visit Örnsköldsvik for any reason other than the professional.

When the auditors extended their reach to Örnsköldsvik, they discovered that the assembly workers there were using hand-written instruction sheets taped to the walls of their assembly bays. This is not allowed; so the auditors pulled the instructions from the walls, at which point no one could assemble the medical devices because they lacked the instructions. (You really don't want to depend on intuition or common sense when building such things any more than you ought to rely on hand-written -- hence, easily altered -- notes.)

They asked the FDA where they could turn for help and the FDA directed them to STAT-A-MATRIX, a consulting firm whose founding brothers had helped the FDA write the first GMP for medical devices. This was the firm for which TOF labored at the time.

And so a team of consultants was sent to Ö-vik to help them organize and write procedures and instructions to satisfy the GMPs, which by then, if memory serves, had grown up into ISO 13485, the standard for quality management systems for medical device manufacturing.

One of the team members was none other than TOF, who helped them flow chart their system and break it up into procedures. Which brings us back to the brass band.

The great metropolis of the north

TOF staggered bleary-eyed and headache-y to the window and looked down from his hotel room to see a knot of people, some with instruments, gathered in the dockyard at the end of the street. Then, as if they had been waiting for jet-lagged Americans to stick their heads out, the band struck up and a bunch of red banners were unfurled and waved.

May Day. The Socialist high holy day.

The little parade set forth down the street into town. TOF was tempted to call out to them, "Hey, that's all over with, or haven't you heard?" The Wall had come down; the Soviet Union was bust. The 30s had called and wanted their proletariat back. However, let us ascribe this to a certain dyspepsia of travel. One should not mock native customs.

The sun was already well up in the sky.

It was still up there when TOF went to bed at the end of the day. In fact, TOF never saw darkness the whole time he was there. It was no country for vampires. TOF was grateful it was not November. The vampires would be getting mighty thirst by then.

Some observations regarding Ö-vik.

A sense of unease grew over TOF as he went about his business at the hotel, in town, and at the plant. For a time, he could not put his finger on it, but then it came to him. This must have been the whitest and blondest place on the face of the Earth. There were no Africans, no Hispanics, no Asians. Swedes are not prejudiced because there is no one around to be prejudiced against. Except maybe Finns.

But then, we went looking for dinner that first day. TOF's two colleagues wanted "American" food. Why go to Sweden and look for American? Would you go to New Orleans and look for meat loaf? Nonetheless, they had heard of a pizza parlor in the town center; so we went.

The town was closed. The sidewalks had been rolled up. There were laws limiting the hours stores could be open (and limiting the number of sales they could run in a year, etc., etc. Consumers are really protected there.) We found the pizza place and walked in the front door, which was open despite being closed. A group of men in the back of the place had been talking. They all turned to look at us when we walked in, and one of them said, "We're closed" in a flat and firm voice. TOF's companions were disappointed, but TOF consoled them by asking how authentic a pizza in northern Sweden made by Turks would be. The Turks remained the only non-Nordics we saw the whole time.

When a Swede, or at least a northern Swede, wants to show he is paying attention, he does not nod his head and say un-hunh or I hear you, man like a normal American or a Californian. Instead, he gasps. Talking to people in the course of making the flow charts, TOF was under the continual impression that they were surprised at things. Even after he knew that the gasp was only uh-hunh, his social conditioning was that gasp=surprise. Caught unawares, TOF often looked over his shoulder to see what had surprised them. (Not as bad as in Tamil Nadu, where they bob their heads side-to-side and so seem to be rejecting everything you are saying....)

The plant's parent corporation was in Germany, where all the engineering was done. While TOF was disentangling the flow chart, the German engineers met with the Swedish manufacturers in the same room where TOF was marking up his flow chart. The Germans did not speak Swedish. The Swedes did not speak German. So they conducted their meeting in English. TOF may have been the only person in the room who understood what was going on.

At lunch in the cafeteria one day, TOF was regaled by a senior manager who told him how the Baltic was once a Swedish lake and Sweden included all of Finland, Estonia, etc. plus Pomerania. And someday would again. TOF had never encountered a Swedish imperialist before and had not thought such creatures existed.

At the end of the week took place what the plant manager called "The Return to Civilization," by which he meant Stockholm. Billy-Bob and Betty-Lou are not Swedish names, but if they were they would be the names heard in northern Sweden. These were the hillbillies of Scandinavia. Or so the Stockholmers implied. The Return to Civilization was a ritual and consisted of the following steps:

1) Get in a car and drive like a maniac to the airport. This requires weaving around logging trucks carrying multiple large trees, inasmuch as one is in the logging capital of the universe. The firs about the region were mighty tall and did not get smaller just because they were now horizontal and traveling at high speeds down winding two-lane roads. TOF was under no illusion about who would win, should a logging truck and the plant manager's car contest for the same location on the roadway.
2) Once at the airport, go straight to the lounge and get stinking drunk. Fortunately, steps 1) and 2) were not reversed.
3) When it is time for boarding, swarm the commuter plane like a mob at a rock concert and grab what seat you can. There were no assigned seats.
4) Fly to Stockholm, and hope that the pilot has not participated in step 2).

All this was many years ago. In the 1990s, ITOFRC. Everything is undoubtedly different now.