Support processes and minimize risks

The parent standard of quality management, ISO 9001, specifies the processes required for a company to deliver consistent quality in services and products. Risk management is concerned here with the common challenges of everyday business - power or Internet failures, the loss of important customers or exceptional situations such as the Corona crisis. In addition to this organisational quality assurance through quality balance, risk management and others, it is also relevant in mechanical engineering how a company ensures that the statutory health and safety requirements are complied with so that neither the environment nor users are harmed by the product.

Here, the risk assessment of machinery and equipment is decisive. If a case of damage goes to court, the public prosecutor investigates on the basis of the risk assessment. If it is faulty or non-existent, companies are taking a major risk that can have consequences up to and including insolvency. Carrying out the risk assessment as part of the conformity assessment procedure is therefore a self-assurance for manufacturers. Without a risk assessment, on the other hand, no proof can be provided of what has been done to produce a safe product.

Declaration of conformity must refer to the current standards and directives

EU directives, which are implemented in national legislation, regulate the requirements for machines and systems. In order to achieve a high, consistent and safety-related quality, compliance with these legal requirements is mandatory. Directives define the general requirements - their harmonized standards define the how. They are published in the Official Journal of the EU and concretize the general legal requirements of the respective directive with special design descriptions.

However, these directives and the harmonized standards change: there is always a new interpretation of these laws, such as the guide for the application of the Machinery Directive. Keeping track of the updates is time-consuming - the responsibility in companies often lies with people whose core business is design and not the legal underpinnings. This is how mistakes happen: In practice, many declarations of conformity of machines refer to directives that are no longer up to date. Since the standard reflects the state of the art, these machines are based on an outdated status and should not have been placed on the market in purely legal terms. In the event of damage, this can have serious consequences for a company under liability law: Loss of reputation, recall actions and costly rectification of series products can lead to massive financial damage.

Quality management in mechanical engineering: This is how it works

A first step in quality management is therefore the knowledge of and compliance with current regulations. This ensures that all protective measures determined in the risk assessment for the safe handling or operation of the respective product are also guaranteed. This implementation of measures is important both for the manufacture of unique products and for series products. Particularly in the case of the latter, all must meet the requirements, regardless of when they came off the production line.

A process should therefore ensure the measures defined in the risk assessment: The defined physical protective devices must be installed and functional. User information in the form of pictograms must be placed at the points defined in the risk assessment. In addition, all other instructions for safe handling must be part of the operating instructions. And last but not least, the performance levels expected by the risk assessment must actually be achieved by the functional safety design.

Quality management is a constant companion in the specialist departments of mechanical engineers: in order to achieve consistent and best possible quality, checking qualitative and thus safety-related aspects is a permanent task and an iterative process in ever new loops.

Software makes it easier to check the measures

Software such as the CE-CON Safety tool can support the process of verification: From the idea to the delivery of a plant, it is ensured that everything required by the risk assessment is also complied with. Companies often still map this using Excel lists - however, the risk of errors is particularly high if not only they themselves are involved, but also external parties such as suppliers. Because they also have to meet standards and be able to prove it.

Via software, all measures taken in the risk assessment can be checked online as a checklist using any web-enabled device. A cloud-based tool is ideal for this: It enables collaboration between all departments and service providers involved in the value creation process. The cloud also makes it possible for several departments to always work on the same output status, while simultaneous processing takes place. This means that everyone has the necessary information available at the touch of a button: The manufacturer specifies all the measures for its safe product in the risk assessment - maintenance staff then quickly know that they have to work with respiratory protection, external staff can see how protective fences and light grids have to be installed, and can always access up-to-date data. And in advance, a cloud-based tool ensures that all areas such as electrical engineering, mechanics or hydraulics work on the same database during construction. At the same time, a database is created for future projects.

Software thus enables easier creation of the risk assessment of complex machines in the design departments, easy access to the measures to be implemented by manufacturing, easy access by technical editors - which is often taken over by external service providers. The final acceptance of the product at the customer's site is facilitated by access to the digital Compliance Manager: Quality managers can see here at the touch of a button via the verification documentation how the process was completed and that all health and safety requirements were met. The software also offers the option of storing information such as photos. Thanks to cloud-based access, this can be done from a computer in the office or a tablet on site at the machine.

Cloud solution minimizes effort and enables better collaboration

A cloud solution also makes sense because it does not incur any expenses for installation, maintenance and operation and thus there are no hidden costs. For example, the list of standards is updated automatically - the customer does not have to take care of this.

Permission management is also useful, so that user roles with customized rights can be created. These targeted roles help to support the process and the content depends on the access rights. In the case of a cloud solution, external users can be invited via read access.

In addition to good usability, it also makes sense to provide support: If a user has thematic questions that go beyond technical matters, such as the interpretation of a standard, specialist expertise is required. Ideally, software support can provide this - even if it is for a fee.

Conclusion

A cloud-based tool is a smart solution for machine builders to ensure that all measures required in the risk assessment have actually been implemented. It simplifies the work of quality management considerably and thus ensures that only safe machines come onto the market.