Everything used to be better. Who hasn't heard this saying? It's often used when more and more processes and regulations take away the joy of work. But is it even possible to work these days without drowning in the jungle of processes? And why is it getting worse and worse?
What do process descriptions and German tax law have in common?
The sparkling wine tax was introduced by the Reichstag in 1902 to finance the imperial navy. What was intended as a temporary tax is still in force today. There are many examples like this. The state has also become accustomed to the solidarity surcharge and is reluctant to abandon it. So, at least until 2030, it will continue. The principle is incredibly simple: What you've got is what you've got!
What does this have to do with process descriptions? Process descriptions are essentially similar to laws. Processes are documented, accessible (possibly even trained), and adhered to by the people involved. The processes are constantly being improved, and unfortunately, in most cases, this means that processes are becoming increasingly complex. Following the principle: what you have is what you have, and then a little more.
Where does all this come from?
Documented processes help us make complex projects manageable. Processes describe an effective path to a solution. Therefore, it is important and sensible to have and follow good processes. If I look at the regulated market for medical technology, there are various reasons why processes are increasing. Companies are constantly faced with new standards and regulations. The standards newsletter brings to light what's new, and this naturally needs to be taken into account. The standards then flow into company processes, which naturally usually leads to more paperwork. Then there are the internal and external audits. Every auditor naturally finds something. What else would they be there for? And so one thing leads to another, and the process documentation grows. Contradictions during audits are rare. In some kind of audit situation by a notified body, a customer, or in the worst case, the FDA (American Food and Medicines Agency) it is not appropriate to offer resistance. During audits there is also the case that there are major audit findings. These can sometimes trigger moderate to severe earthquakes in the company. Task forces are formed to get to grips with the findings. In doing so, the aim is overshot and processes are created which are impossible for anyone to criticize again. In general there is a concern that mistakes will happen and things will go wrong. Particularly in large companies with complex structures this leads to everything being put into processes. This is to prevent someone from making their own decisions and making a mistake in the process. For example, there are processes for getting goods out of a tall cupboard when a ladder has to be used.
What are the problems with the process descriptions?
More is not always better. The more processes there are
there are, the more they need to be trained and observed. This can lead to the work taking significantly longer to complete. You can literally paralyze an organization with this. In my painful experience, the people who create process documentation are often not good writers. This leads to long passages of text with incomprehensible, contradictory and simply boring text. These are then, of course, not read (or liked to read). The fact that new processes need to be trained has not gotten around everywhere. Sometimes the writers find this difficult because they have described the process but are not familiar with it in detail. In this case, a short email with a reference to self-training is sufficiency. Then there are hardly any inquiries. Who is surprised? Creating process documentation is tedious and then you are glad when the process is approved. Who wants to think about training for this process?
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| Dipl.-Ing. Goran Madzar, Partner, Senior Systems Engineer E-mail: madzar@medtech-ingenieur.de Phone: +49 9131 691 240 |
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Do you need support with the development of your medical device? We're happy to help! MEDtech Ingenieur GmbH offers hardware development, software development, systems engineering, mechanical development, and consulting services from a single source. Contact us. |
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In my experience, there's an ever-increasing discrepancy between process descriptions and what's actually implemented in projects. And this discrepancy, in turn, leads to new problems in audits and thus to even more processes. It's almost a vicious circle.
What should you keep in mind?
I don't want to give the impression that I'm against trials. Quite the opposite. I'm a big fan of them. There are a few points to keep in mind.
- More isn't better. Lean is all the rage, but where do I see it reflected in our processes? Regular cleaning and decluttering are essential.
Perfection is not achieved when there is nothing left to add, but when there is nothing left to take away.” – Antoine de Saint-Exupéry, Terre des Hommes
- When creating process documentation, users and quality assurance staff must be involved. Only by striking this balance can process descriptions be ensured to be practical.
- If new processes are introduced, an impact analysis must be conducted. What impact will the introduction or change of processes have? The resulting impacts must be planned for and addressed.
- Think of your readers when writing. Make sure it's well-formatted, enjoyable to read, and not too long. Invest some time and consider how best to present your message.
- Train employees personally. Give them the opportunity to ask questions or express criticism. Address users' tricky questions.
- Don't overshoot the mark. Phrases like "Process step A must be completed before process step B may begin" should be treated with caution. Where does this requirement come from? Often, such a strict definition is neither required nor sensible.
- Document the source of the requirements. This makes it easier to understand where the requirement comes from during tailoring (deliberate omission).
- Work with simple process diagrams, which are easier to understand than long text descriptions. Establish a consistent style for documenting process descriptions.
Anyone who's made it this far is certainly qualified to read process descriptions in a company. Congratulations!
When it comes to processes and regulations, civil servants in Germany are, of course, still the measure of all things, and so I would like to end today with a few funny quotes from the world of civil service regulations.
If an employee dies during a business trip, the business trip is terminated.
If a staff council consists of one person, there is no need for separation by gender.
According to a decision by the Federal Social Court, wives who shoot their husbands are not entitled to a widow's pension.
From a pension law perspective, death represents the most severe form of incapacity for work.
Which child is the first, second, third, etc., depends on the child's age.
It is not possible to classify the death of a taxpayer as permanent occupational disability within the meaning of Section 16 Paragraph 1 Sentence 3 of the Income Tax Act and to deduct the increased allowance accordingly.
In this sense.
Best regards
Goran Madzar

