Industrial owners and operators must comply with increasingly strict regulations. As a result, they are subject to strict compliance obligations governing: production facilities, quality systems, and all practices concerning the regulatory provisions imposed by authorities. Compliance is defined by equipment and systems qualification in the production process.
Project compliance is required at different levels, from the qualification of equipment testing to the validation of suppliers, compliance with standards, and control of industrial and environmental risks.
We support manufacturers in each of these areas, placing global regulatory quality and compliance at the heart of our actions.
Standards assessments and validation
Compliance regulations for manufacturers vary between borders, often changing from one country to the next. The diversity of local standards is particularly apparent in the energy sector, where, for example, there are numerous norms and standards for electricity networks. For this reason, complying with local standards to develop and/or modernise key industrial infrastructures can be a major challenge for operators.
To counter these challenges, we provide the following services:
- Analysis of standards as well as local and international regulations, based on our long-standing industrial expertise with an ever-expanding digital database
- Validation of project compliance with the relevant standards and submission of conclusions for corrective actions to be implemented to ensure compliance.
- Coordination of discussions between regulatory authorities and project stakeholders (investors, operators, etc.)
- Monitoring regulatory developments throughout the industrial asset lifecycle to ensure modernisation in line with potential upgrades imposed over time.
Tests and equipment qualification
Equipment certification is a strategic challenge for new installation projects, but also for large-scale maintenance work on operational sites (such as Grand Carénage for the EDF fleet). It takes place, either at the time of construction of the new installation or during the lifecycle of equipment in operation.
Equipment qualification activities can be managed directly by the operator or assigned to equipment suppliers or engineering companies. Excellent control of the qualification process is essential to ensuring equipment qualification meets optimal timeframes and costs.
Our experts have the skills to support our customers in implementing controlling qualification functions (initial, gradual) and monitoring qualifications.
Our offer includes the full range of tasks and deliverables for all types of equipment: electrical, instrumentation, HVAC (heating, ventilation, and air conditioning), mechanical, plumbing, pressure gates and reservoirs, including reactor cores.
Listen to our experts on equipment qualification a cornerstone challenge for New Nuclear.
Supplier qualification and monitoring
Pre-certification of a project’s suppliers is a crucial stage as their performance dictates that of the contracting party.
We tailor our solution to each industrial situation by performing FEMECA audits (Failure Modes, Effects and their Criticality) to mitigate supplier risk. Complexity, innovation, capability, and capacity are all assessment criteria used in diagnostic tools to make the best technical and economic decisions.
Once the list of contracts has been drafted, we intervene in the monitoring of integrated management systems for equipment assessment (quality control, document management) with technical support offering profiles with the relevant competencies and expertise to meet our customers’ needs.
Assystem’s teams offer a comprehensive quality performance solution for a project or supply chain.
Regulations and operating quality
To ensure consistency between internal and external requirements for complex projects, we implement a standardised methodology which aligns operations with regulations in force.
We achieve this by ensuring "regulatory consistency" of our customers’ projects thanks to our multifunctional, qualified teams, whose expertise is constantly updated according to the recommendations of national and international organisations (e.g., the SQEP (Suitably Qualified Experienced Personnel) model in the UK.
Assystem ensures it is constantly aligned with regulated operating models at an international level by using similar processes/protocols to address internal requests and demands from our customers. This approach ensures our engineers are compliant with local regulations and qualified for multi-project environments, providing internal transparency and a well-defined career development path.