CASES

One standard solution - different use

One of the great strengths of D4InfoNet is that the same standard solution is used as a foundation for all our customers. A broad customer base means there are many different ways of working with D4InfoNet. To give you an idea how D4InfoNet can make a difference in your business, we have compiled some cases for inspiration.

Insights from real cases

See how Løgstrup Steel, NNE and Falck use D4InfoNet. The video below contains a compilation about how Løgstrup Steel, NNE and Falck use D4InfoNet. For more details, see the individual films.

Løgstrup Steel

Løgstrup Steel is a manufacturing company specialising in control panels and power switchboards for industry. Løgstrup Steel uses D4InfoNet to optimise their quality management and processes. D4InfoNet is used both in administration and production, where computers are installed. Hear Quality and Environment Coordinator Mick Larsen report on Løgstrup Steel’s use of D4InfoNet here.

NNE

NNE is a consulting engineering company within the Pharma industry. NNE is certified under a range of ISO standards, and quality is vitally important in everything they do. Hear Global Quality Director Henrik Feldthusen talk about how they use D4InfoNet as a tool to optimise quality management.

Falck

Falck helps people in need all over the world. They do this through five different business areas: Emergency, Assistance, Healthcare, Safety Services and Global Assistance.

Falck uses D4InfoNet globally and across business areas. In this video, Global QHSE Director Mette Bojsen explains how Falck is using D4InfoNet. We also visit an ambulance station, where they use D4InfoNet to make their work easier.

Easy Food A/S

“CERTIFICATION IS A LEARNING PROCESS THAT MAKES YOU SMARTER AND BETTER”

“In general, a good certification and auditing process is about openness and honesty that goes both ways. It’s not the enemy that comes to visit,” says quality assistant, Niels Ravn Schmidt from Easyfood A/S, which produces quality baked goods for Starbucks, McDonald’s and COOP, for example.

Kundeanmeldelse

WHY ARE YOU CERTIFIED?
One of our certifications, the FSSC 22000, is very broad and covers almost everything within European food safety. However, some customers require special certification, such as IFS, which is aimed towards the German/French market. We also have a McDonald’s certification, and as we are currently spreading to more markets in the world, there will probably be more certifications in the years to come.

WHAT DO THE CERTIFICATIONS MEAN FOR YOUR COMPANY?
We use quite a lot of resources on it. The IFS certification alone takes two full days to complete and, in addition, we have regular internal audits where we test according to the standard.

But the certifications make it easier to open doors. New customers know from the outset that we are certified at a higher level and comply with a certain standard, which means that we can begin discussing what they want to buy sooner, instead of spending time clarifying whether we have control of the production.

D4InfoNet  is easy and manageable. Here, all documents are in one place and they are easy to find by way of a good search function, for instance.

WHAT HAVE BEEN THE BIGGEST CHALLENGES IN REGARD TO CERTIFICATION?
I do not find certification a challenge, but rather a learning process that makes you smarter and better. The auditors know the ropes 100%, and I see it as a collaboration and a development process where, for each audit and each re-certification, we are going just that much deeper.

WHAT DO YOU SEE AS D4INFONET’S GREATEST STRENGTHS?
D4InfoNet is easy and manageable. Here, all documents are in one place and they are easy to find by way of a good search function, for instance. We can establish a setup and a structure that follow the standard, and just need to start at the top when we review the system or have internal audits. It’s very simple.

WHAT ARE YOUR BEST TIPS TO ENSURE A GOOD CERTIFICATION PROCESS?
In general, a good certification and auditing process is about openness and honesty that goes both ways. It’s not the enemy that comes to visit, so we show them everything, and we learn from it. Of course it’s a pity if there is a discrepancy, but then you know about it and can rectify it.

So my best advice is to be open and honest and to begin a constructive dialogue on improvements. And then you have to choose a digital management system that makes procedures, documents and daily reports available in one place, so you don’t have to open multiple systems.

 

About Easyfood A/S

Easyfood manufactures innovative quality baked goods within bake-off and convenience food and has about 350 products in their range. The company’s production and head office is in Kolding and they also produce internationally through partners. Easyfood employs 150 people and sells their products in 13 countries to customers such as Starbucks, Mcdonald’s, CircleK, 7-Eleven and COOP.

As a minimum, Easyfood complies with the Danish and European Food safety requirements and can, among other things, document this with a FSSC 22000 certification and an IFS Food certification.

Hvide Sande Shipyard, Steel and Service

“WE ARE STRONGER IN RELATION TO OTHER PLAYERS ON THE MARKET”

“You have to devote time and resources to carrying out a certification, but it pays off,” says Nikolaj Hviid, Technical Documentation Assistant in Hvide Sande Shipyard, Steel and Service.

Hvide sande Kundeanmeldelse

WHY ARE YOU CERTIFIED?
We work in an industry where both authorities and customers make high demands on our documentation on, e.g. safety and quality. That’s why we have a whole series of certifications that cover different areas of our business.

WHAT DO THE CERTIFICATIONS MEAN FOR YOUR COMPANY?
There is no doubt that the certifications give access to larger markets. We can document in a far better way that we have control of the processes and we are stronger in relation to other players on the market. For example, we have just been certified for EXC4, which means that our welding quality enables work on submarines and in reactors that may contain radiation. It is the most difficult certification of its kind in the world to achieve and sends a strong signal to our customers that we are specialists who know our stuff.

WHAT HAVE BEEN THE BIGGEST CHALLENGES IN REGARD TO CERTIFICATION?
Essentially, in terms of mechanics and systems, it is simple to install a digital management system and carry out a certification. It is the people and everyday life that demand the greatest effort and cultural change has been the greatest challenge.

We are a company in western Jutland. You do not go headlong into something new here, so it has been a challenge to get everyone to work according to fixed procedures instead of inventing the wheel every time, but we have succeeded.

Among other things, the solution has been thorough training and a persistent quality department that is good at getting stuck in. We have also been very careful to avoid falling into the classic trap, where you have to lean over backwards in order to suit the system. It has to be the other way round. The system must suit the processes and procedures that are natural and effective for us here in the company.

WHAT DO YOU SEE AS D4INFONET’S GREATEST STRENGTHS?
The greatest force of D4InfoNet is that we got rid of outdated paper versions of guides, etc. Now we know that we always use the applicable documents when we begin working on a new case.

The overview is also a great advantage. We gather discrepancies in D4Flow and use D4KeyFigures to see if, for example, there are many supplier errors or errors on the drawings. Then we can identify the problem and do something about it.

In addition, we have been given better control of the project flow. The entire registration of a new case takes place in D4InfoNet, and the hand-over from the technical project manager to the production manager and the other key people also takes place in the system. All information is entered in one place and everyone has access to it in real time.

We plan to start using a new feature so we can send documents for the training of employees. Once they have acknowledged that they have read and understood the document, we can document that changes to the procedures have been spread out into the organization, as required by the standard. It is also a smart feature for training new employees.

WHAT ARE YOUR BEST TIPS TO ENSURE A GOOD CERTIFICATION PROCESS?
My advice to others who are facing certification is, first and foremost, to make sure that they devote enough resources before they begin. It takes time to implement a new system and new processes, but the effort ultimately pays off.

Good preparation and management of the process is also important, and you have to make sure you have the right skills available, take some courses or hire external consultants. It is also advisable to run a pre-audit, so you know that everything is working before the certification is landed.

And then it’s really a lot about involving and listening to the employees along the way and making sure it is easy for them to get the help and support they need.

About Hvide Sande Shipyard, Steel and Service
Hvide Sande Shipyard, Steel and Service builds, repairs and services ships, and also manufactures advanced aluminum and steel constructions. With their central location in relation to the wind and offshore activities in the North Sea, this is also where the company has some of their biggest customers. The White Sands Shipyard, Steel and Service was founded in the 1950s and has approximately 160 employees.

The company uses D4InfoNet in the steel department, which is certified according to ISO 9001 in quality management as well as EN-1090-1 for the execution of steel and aluminum constructions and ISO 3834-2-2015 for fusion welding of metallic materials.

www.hvsa.dk

HEKA DENTAL A/S

ONE SYSTEM THAT HANDLES BOTH DOCUMENT MANAGEMENT AND VALIDATION

When Heka Dental A/S needed to invest in a digital platform, the choice fell on D4InfoNet because it is a simple and

user-friendly system that can also validate the company’s software. “We were given a good offer on a standard solution that was most suitable for us,” says quality manager, Claus van der Goot.

Validering

WHY ARE YOU VALIDATED?

It is a requirement from the authorities that we comply with EN/ISO 13485, which is a standard for the production of medical equipment and there is a requirement that we test, validate and verify everything we do – including our software.

Validation provides us with certainty that the software does what we want it to do. We do not have defective items and the documentation is always correct. However, we don’t only consider certification and validation as a question of complying with the authorities’ requirements. We also consider it as an opportunity to strengthen our processes and we use it actively as a reason to improve and develop our company.

 

HOW HAVE YOU FOUND THE VALIDATION PROCESS TO BE?

Previously, all our documentation was Word documents that had to be signed every time something was changed – and that was often. It was a huge job to keep control of it all and, therefore, we decided to find a digital solution that could meet our needs for both document management and validation as a standard solution.

When we were ready to implement the validation, we just called D4. They gave me a test protocol and the only thing I had to do was to give them access to the system with user names and passwords. They then handled it all and were able to send a report to me in the course of a couple of days.

In regard to validation, the challenge is mostly in avoiding that small spreadsheets or programmes are used round and about in the organisation, because everything has to be validated, of course. It is also important that you don’t make small changes in the code, which collides with the validation, because you then need to implement a new one and that can be expensive.  Consequently, we have chosen to adapt to the standard solution and we are delighted about that. It suits our needs very well.

WHAT DO YOU SEE AS D4INFONET’S GREATEST STRENGTHS?

When we searched the market, we looked at a couple of American systems, among others, but they were too expensive and with the time difference in relation to support, it would just be too inconvenient.

We ended up choosing D4InfoNet because it is a simple and user-friendly system that can validate our software as a whole. We received a good offer on a standard solution that was most suitable for us, and D4 has implemented the system and carried out the validation quickly and without problems. It also means a great deal that they have experience with our industry.


WHAT ARE YOUR BEST TIPS TO ENSURE A GOOD VALIDATION PROCESS?

You need to make sure that the digital management system you buy contains validation, because otherwise the company has to do the validation itself. This costs manpower, time and perhaps external consultants as well.

 

About Heka Dental A/S

Since 1965, Heka Dental A/S has delivered patient chairs for dentists across most of the world. The products are based on high quality, design, reliability and ergonomics and, today, Heka Dental is a market leading supplier in Scandinavia. The company is family-owned and all production, development and administration takes place in Denmark. Delivery, installation and servicing are handled by a large network of dealers.

www.heka-dental.dk

VITREX MEDICAL A/S

“SIMPLE VALIDATION WITH STANDARD TEST PROTOCOL”

The test protocol is the most important thing to have in place when IT systems and software are to be validated. Vitrex Medical A/S uses D4InfoNet’s standard version. “It describes in detail what to check and test, and it also describes the expected result. And then it’s just about verifying that it matches reality,” says Quality & System Manager at Vitrex, Peter Jørgensen.

Certificering & Validering

WHY HAVE YOU VALIDATED D4INFONET?

As a medical equipment manufacturer, there is an EU legal requirement that we comply with the ISO 13485 standard. This implies, among other things, the validation of the software and IT equipment we use in our production and quality management. In this way, we can document that all processes work as they should and that we deliver products free from defects.

We also produce for the United States, where the US Food and Drug Administration (FDA) requires validation.

HOW HAVE YOU FOUND THE VALIDATION PROCESS TO BE?

The most important thing about validation is to have a test protocol made according to which you can test the systems. If you do not have specialists employed in software, it may be a challenge and you may need to buy external consultants, but we were so fortunate that we could use the standard protocol in D4InfoNet.

Part of the validation takes place at D4InfoNet, which hosts our solution and therefore takes care of the part that regards the server. We handle the user part ourselves and that is perfectly simple. The test protocol from D4 describes in detail what to check and test, and it also describes the expected result. And then it’s just about verifying that it matches reality.

 

WHAT DO YOU SEE AS D4INFONET’S GREATEST STRENGTHS?

We have spent two working days on the latest validation and it has been both simple and inexpensive in comparison to similar systems on the market. For example, this is because the standard test protocol and the simple setup do not require external consultants. An important aspect of our choice of D4 is that they have a good reputation and know our industry.

WHAT ARE YOUR BEST TIPS TO ENSURE A GOOD VALIDATION PROCESS?
Firstly, it must be made clear whether validation is at all a requirement from the authorities in the field in which you are working. Maybe it’s not necessary at all.

It is also important to carry out a careful risk assessment of your production and, on that basis, assess whether a test protocol such as the one in D4InfoNet can be used, or whether an external consultant should be brought in. There is no reason to invent the wheel if a workable protocol already exists.

“An important aspect of our choice of D4 is that they have a good reputation and know our industry”.

About Vitrex Medical A/S
Vitrex develops, manufactures and sells a wide range of disposable equipment for the hospital and healthcare sector. The products include pipettes, test tubes and surgical tools, such as those used for diabetes treatment, intravenous treatment, blood sampling and surgeries. Vitrex delivers to markets all over the world – Europe, the United States, South America, Southeast Asia, the Middle East, Africa and Australia. The company was established in 1967 and the head office is in Herlev.

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