Frank has tried a little of each

Frank Winther-Hinge is employed as Director of Strategic Compliance and Risk Management - a new area at AlfaNordic. The competencies are not new, but have previously been distributed in several departments. Increasing demand for risk analyzes for production plants in particular has now made the area a priority with a whole new business area.

Frank originally trained to be an electrician, but immediately after, he acquired a degree as an electrical engineer. He wrote his final project with NNE Pharmaplan (then NNE, Novo Nordisk Engineering, editor’s note). He was told that there was no job for him, but Frank nevertheless put his CV in a clip-on picture frame and gave it to the then CEO at NNE and attached a nail and a note saying that if he (the CEO) were to hang the frame behind his door, all he had to do was look at it when – at some time of another – he needed to hire an enterprising young engineer. Two months later Frank was on the payroll.

You have been around?

There is absolutely no red thread through my career. I started at NNE as a project manager for minor electrical projects and was assigned to various plants at Novo Nordisk for 6 years. Because of my interest in business processes, business analyses and economics, I was later appointed Executive Assistant to a vice president at NNE. My weakness, that is, not being an ex. cand merc. or cand oecon, now became my strength. I could look at the company from an angle that was different from the angle that a typical consultant would see it, and I could challenge it from an engineer’s world. The result was that after 2 years I was offered the job as Executive Assistant to NNE’s Chief Financial Officer, a job that in the nature of things mostly covered financial aspects.

In order to gain more experience and theory for my work, I obtained a degree of Executive MBA. My final project adressed management in an international company. I finished the project in 2007 and was immediately after that asked whether I would take on the role as project manager for the integration of NNE and the newly acquired Pharmaplan (a subsidiary of Fresenius). After a successful integration, I became financial director for the new German company and associated 5 subsidiaries (Russia, India, Malaysia, Switzerland and The Czech Republic). I moved to Germany for a year and a half. Unfortunately, the foundation for a business had disappeared at the same time as the economic crisis made its entry in Europe, so after four to five organisational changes, I went back to Denmark and was instead appointed management consultant at NNE Pharmaplan In Denmark.

As a management consultant, I helped our colleagues in Russia and India operate according to the management values that were part of the company culture. I flew back and forth to Russia for a year, and after that, I was ready to try something new, and I was employed as CFO in an architectural – RH-Arkitekter. It was an exciting and challenging job. After a year and half, my tasks were completed, and combined with a financial downturn in the architectural business I chose to stop, and quickly got in touch with AlfaNordic where I started working on assignments; at the beginning as a consultant and now as a permanent employee.

What was your first assignment for AlfaNordic?

A GAP analysis for Bavarian Nordic which I started in May of 2013.

When did you become permanently employed?

In October this year.

Have you already started working on projects? Are you in the middle of something right now?

Yes, I already work with a number of customers and at the same time, we are building a business area from scratch. We have the competencies in-house, but they must be unified, structured and perfected. Right now, I am working on assignments with some of the big pharmaceutical companies in Denmark – for example, Leo Pharma and Bavarian Nordic. We are going to perform a risk assessment for for Leo Pharma on the production of one of their many products. I have just participated in the conclusion of a project for Novo Nordisk where we performed a thorough risk assessment on all their production plants in China, Brazil, France, USA and Denmark. And on top of all that, I am drawing up standards, customer presentations et cetera. So I am not bored, he says with a smile.

Vi kan præsentere en fremgangsmåde, der giver mere indsigt i arbejdet med risici i processerne i hverdagen, og som skaber en ensartet forståelse blandt operatører, specialister og proces ansvarlige på, hvordan man får en bedre og mere sikker produktion.

Why is there a need for AlfaNordic to expand with a special department within Risk Assessment (Risk Management)?

Our customers (pharma and biotech) have always focused on risk assessments because of their work with medical products, but they want a more standardised method – an easier way to approach risk issues. Our starting point is the FMECA model which originates from the American military back at the end of World War 2. At a later stage, NASA used the model for sending people to the moon and then the car and aviation industries followed suit. In the 90s, it was Introduced into the pharma industry via Q9; it is however not yet as fully integrated in the production businesses as we see it in for example the aviation industry where risk assessments are part of the culture. We can present a methodology that offers a better insight into the work with risk assessments in the processes in everyday life and which creates a homogeneous understanding among operators, specialists and process-responsible staff of how to achieve a better and more reliable production. Today, you have to perform a risk assessment on your pharmaceutical production. It doesn’t say how but you must be able to document it. This is where we can enter the scene with our methodology and we have and have had quite a few assignments under these auspices. That is why we think that the market can support a separate department at this time.

At the present time, are you performing risk assessments primarily on existing plants or on new plants?

Both. We can offer to create – in cooperation with our customers’ employees – a standardised risk assessment model which can be used across the departments. A management tool for creating a reliable production and a culture to maintain it.

How do you describe the risk assessment process in practice in the customer’s company?

We first acquire a full description of the plant and we then draw up a production flow where we record every detail of the process. We look at each individual step and identify areas where things can go wrong; and what errors may occur.

We give a general presentation to the employees who have been chosen to participate in the analysis. Before this, all relevant material has been identified and collected. This may for example include documentation and previous risk assessments / analyses. Everything produced during the years. It is important that we don’t ask the same questions that others have asked earlier. That will result in a lack of confidence. When we meet with the employees, we explain the sequence of events and make it clear why we are meeting and what the point of the risk assessment is. It is about avoiding making mistakes. Sometimes I show examples of errors that happened in other companies.

What examples?

There are many. One of the examples that I use is for example the world’s biggest chocolate manufacturer who found out that they had salmonella in their chocolate. Another example is a big manufacturer of breakfast cereals who found glass particles in their cereals. There are numerous examples of products where no records were made as to whether a given product has been stored at the right temperature. The result of this was that they had to recall entire lots. There are also funny examples of products being delivered in wrong places because an operator did not want to wear warm outdoor clothing before be delivered the products in cold storage.

Vi har nogen gange fået at vide, at vi gerne må være afslappet klædt på, så vi ikke ligner en flok McKinsey-folk.

The risk assessment can at times be suspected to constitute an efficiency improvement exercise? How do you relate to that?

During the facilitation process in connection with performing a risk assessment, the most important fact to emphasise is that we do not represent for example the authorities, an efficiency bureau or the like. The customers are actually aware of this. We have sometimes been told that we can dress casually so that we do not look like a bunch of McKinsey people.

I actually think that we establish the necessary trust relatively quickly. We quickly tell them about our background and we tell the involved employees that they should come out and say all the things they normally are not allowed to say, he says this with a twinkle in his eye. What can go wrong? What errors can be made in this production? It can be totally absurd things. When the big errors occur, what goes wrong is typically the things you never saw coming. The assessment is never better than the input we receive, so good input is alpha and omega. We can contribute with our experience, processes, our way of looking at things, but if we do not establish the trust then all this is not worth anything. This is one of the reasons why we put high emphasis on getting together a broad spectrum of people from a given production.

What is it that seems appealing to you, working as a consultant?

Different assignments and different customers. What immediately gets me going is the execution of the projects – the contact to the customer, and the fact that we make a pronounced difference already from our first visit. Time is also of the essence to me. Our projects have relatively short execution durations – typically from 3 to 6 months. When we start an assignment, we have the management’s attention; everybody is focused, but it fades more and more the longer the project Is drawn out, and it gets increasingly more difficult to get the customer to make decisions on the long projects. This is usually not such an issue on the short projects, and the short projects also offer bigger variations in the assignments.

How many hours do you spend working as a consultant?

I work a lot – but it is also my hobby. As we all know, it’s important to find something which is fun to do, in that way you don’t have to go to “work” ever again. He smiles. I have always worked a lot. Right now it probably amounts to about 200 hours a month, but I reckon that it might be a little less over time. That is what I am aiming for – It is actually a bonus target that my manager has set for me.

…jeg er god til at tage en kompleks opgave, dele den op og sætte den i system – akkurat som at skulle spise en elefant; den skal spises i små bidder

What are your main competencies? What is it that you are primarily good at?

I am good at employee management, and I am good at taking a complex task, breaking it down and systematising it – exactly like having to eat an elephant; you have to eat it in small bites. I am very structured, and I am good at acquainting myself with new things. I also think my career reflects this. A great part of what I do is about acquiring knowledge about a complex task, imparting the knowledge so that everybody understands the issues and then solving them.

What about your spare time?

I spend that with my family. I share my life with Mia and together we have 3 children. The oldest has just moved out of the house and has started as a law student. We often have long talks about this. I play a little golf…let me emphasise the “a little”. My equipment is not as worn as it should be. I jog a couple of times a week and then I lift weights together with my son who has unfortunately outgrown me in size and strength. The time with my youngest daughter is often spent at the dining table and preferably with long discussions about the puzzling (according to her father) world of mathematics.

We live in Bagsværd, in a house that we built ourselves. My family also owns a house in the south of France. We love to spend time there. This goes well with my newly developed interest in wine and my small wine collection.

Where do you think AlfaNordic is heading and what challenges lie ahead?

The competency that AlfaNordic posses-ses is not a typical focus area. All that documentation is often regarded as a necessary evil. It requires a completely special type of employee. They must be specialists and perhaps also a bit nerdy. These are people who are able to work long hours alone and who can find themselves in a chaotic situation in a company, concentrate on something very specific and get it solved so that the company can move on. For periods of time, AlfaNordic employees are lonely riders. We don’t have many projects where 5-10 people are working together. We must be able to attract the type of employees who are not so easy to track down. It is a constant challenge.


AlfaNordic Group er et high-end GxP konsulenthus som arbejder indenfor life science branchen. Vi er specialister indenfor fremstilling af farmaceutiske produkter og medical device


Kontakt Frank Winther-Hinge

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