Producing the technical file is an integral part of the planning and is a process that evolves as the machine takes shape in its design, testing and installation phase.
During the planning phase, Asotech professionals produce all the design and documentary documents that make up the technical file: from the use and maintenance manual, including technical illustration, to the FMEA analysis, up to the spare parts catalogue and the risk analysis.
Asotech produces the technical file in line with European regulatory standards, regulations in continuous evolution that require constant updating of skills and standards. Relying on our professionals, through the regulatory monitoring service, allows you to keep the necessary documentation in the company up-to-date and in order.
Using variables and probabilities, the methodology underlying the risk assessment makes it possible to provide clear indications on what are the dangers that corporate activities run and on which urgent action is necessary, also determining the severity of the impact of the consequences in case a harmful event actually occurs.
The procedure can be generically schematized in 3 phases:
1. Identifying the main company processes/areas;
2. Risk mapping and identifying risks with a clear and immediate representation of the range of threats that can be encountered;
3. Qualitative or quantitative risk assessment (risk scoring).
We are therefore not only able to detect any anomalies that could compromise the safety of the project, but we are able to implement corrective solutions aimed at solving the problem detected in a timely and effective manner thanks to the internal team of engineers and designers.
We are also able to validate the interventions carried out in the analysis, design and construction phase to ensure the safety of the project and all the necessary certifications to be able to use the machine built.
This consists in the creation of a series of documents that ensure taking over and the execution of all corrective actions necessary for the safety of the machine, giving objective evidence of achieving the safety objective.
The technical file includes:
Risk analysis •
Compilation of RES •
Use and maintenance manual •
Checking safety circuits •
Calculation of the Performance Level •
Possible validation of the Software Safety part •
Drafting of the declaration of conformity •
Project documents•
Our experience in drafting Technical Documentation and in Risk Analysis and our transversal skills on Complete Solutions allow us to offer the service tailored to your needs.
