Before a batch of medicine made in Germany may be sold, one named person must sign it off. The Medicines Act calls her die sachkundige Person, the qualified person. Die sachkundige Person nach § 14 ist dafür verantwortlich, dass jede Charge des Arzneimittels entsprechend den Vorschriften über den Verkehr mit Arzneimitteln hergestellt und geprüft wurde. She is responsible for making sure that each batch was made and tested according to the law on medicines. She must certify this for each batch in a running register before it goes on the market. Sometimes a batch is made in several stages or at other sites. The regulation on drug manufacturing then lets her use confirmations from other qualified persons. But sie ist für die Freigabe zum Inverkehrbringen der Charge insgesamt persönlich verantwortlich. She remains personally responsible for releasing the batch as a whole. Medicines may be placed on the market only after this release.
The Building and Its Paperwork
When a contractor finishes a public building job in Germany, the client typically requires the Revisionsunterlagen: plans of the building as built, operating and maintenance instructions, test certificates and data sheets. The city of Mülheim an der Ruhr publishes its requirements for tenders. The documents must arrive at least three weeks before acceptance, in two paper copies and a digital copy. Their content muss einem unbeteiligten Dritten den störungsfreien Betrieb eines Gebäudes ermöglichen. It must allow an outside party who was not involved to run the building without disruption. If the documents are missing or incomplete, the city can refuse acceptance and hold back part of the final payment.
The Release Dossier
A supplier to the German car industry may not begin series deliveries until its parts pass the Produktionsprozess- und Produktfreigabe, the production process and product approval, set out in Volume 2 of the German Association of the Automotive Industry. The first samples must be made vollständig mit serienmäßigen Betriebsmitteln und unter serienmäßigen Bedingungen, fully with series tooling under series conditions. One supplier guideline lists what goes with them: an inspection report with the measured value for every dimension on the drawing, the process flow chart, the control plan, and the approval status of the whole supply chain. Erstmuster ohne Erstmusterdokumentation können nicht bearbeitet werden. First samples without first-sample documentation cannot be processed. Every change to the product or the process must go through the procedure again, at least inside the supplier’s own plant.
Words for the Next Person in Line
etwas ausbaden müssen — to have to bathe something out: to bear the consequences. Duden: of something that one has caused oneself or, more often, that someone else has caused. The phrase goes back to the 17th century and originally meant to finish the bath.
die Zuarbeit — work done for someone who then builds on it
jemandem hinterherräumen — to tidy up after someone
Das ist hier kein Wunschkonzert. — This is not a request concert. You do not get to choose only the tasks you like.
The Joys of Duty
In Siegfried Lenz’s novel Deutschstunde, The German Lesson, of 1968, the young Siggi Jepsen must write an essay on a set topic: Die Freuden der Pflicht, the joys of duty. He hands in an empty notebook. As a punishment he must write it after all, and he writes down his memories of his father, the village policeman. The policeman’s task is to deliver to the painter Nansen a ban on painting imposed by the Nazis. The novel is still read in the upper grades of German secondary schools.
The father does his duty completely, and the novel asks what that duty served.
Every Author Answers for the Paper
The German Research Foundation’s code of good scientific practice of 2019 says of the authors of a publication: Sie tragen für die Publikation die gemeinsame Verantwortung, they bear joint responsibility for it, unless stated otherwise. Honorary authorship is not allowed. A leading position alone does not make anyone a co-author. The Deutsches Ärzteblatt called the affair around the researchers Herrmann and Brach the largest German forgery affair. Several hundred co-authors were checked. In 2002 the foundation excluded the Freiburg professor Roland Mertelsmann for five years as a reviewer and applicant because of serious flaws, and two other co-authors for two years each. The foundation’s president, Ernst-Ludwig Winnacker, told the Ärzteblatt: In der Wissenschaft ist das die Höchststrafe. In science, that is the maximum penalty.
As Well as He Can
How well must a German employee work? In 2003 the Federal Labor Court gave an answer that labor lawyers still quote: Der Arbeitnehmer muss tun, was er soll, und zwar so gut, wie er kann. The employee must do what he is supposed to do, and do it as well as he can. In 2008 the court dealt with a worker in a mail-order warehouse. His error rate was between 4.01 and 5.44 per thousand. According to the employer, the average of the 209 workers in the third quarter of 2004 was 1.34. A clearly higher error rate over a long period can point to a breach of duty, the court said. The employee must then explain it.
Who Pays for a Mistake at Work
In German labor law, an employee’s liability for damage he causes at work depends on how careless he was. The rule comes from the courts. In 1994 the Grand Senate of the Federal Labor Court applied it to all work caused by the business, even work that is not dangerous. For the slightest negligence, the employer bears the damage alone, as part of the general business risk. For medium negligence, employer and employee share it. For gross negligence and intent, the employee must in principle pay for all of it.
The Worker Checks His Own Part
In German manufacturing, Werkerselbstprüfung means worker self-inspection. Der Werker, der das Teil produziert, prüft es selbst. The worker who produces the part checks it himself. One definition states the rule in four words: Kein Weitertransport ohne positives Ergebnis. No onward transport without a positive result. The worker is to sign the check with his name. The method arose in the mid-1960s, and the trade journal Produktion calls it disputed.
Duty, Not Inclination
In 1785 Immanuel Kant published the Grundlegung zur Metaphysik der Sitten, the Groundwork of the Metaphysics of Morals. It is taught in upper-school philosophy classes, for example in North Rhine-Westphalia. Of kind acts done from inclination, Kant writes that such an act, so pflichtmäßig, so liebenswürdig sie auch ist, however dutiful and however kind it is, still has keinen wahren sittlichen Wert, no true moral worth.
In the Xenien, the satirical couplets of Goethe and Schiller published in 1797, a reply appeared under the title Gewissensscrupel, scruples of conscience: Gerne dien’ ich den Freunden, doch thu’ ich es leider mit Neigung, / Und so wurmt es mir oft, dass ich nicht tugendhaft bin. I gladly serve my friends, but sadly I do it with inclination, and so it often bothers me that I am not virtuous. The answer followed: Da ist kein anderer Rath, du musst suchen, sie zu verachten, / Und mit Abscheu alsdann thun, wie die Pflicht dir gebeut. There is no other advice. You must try to despise them, and then do with disgust what duty commands.