A non-conformity in a machine is not just a technical observation: it may be the sign of a real risk for both the operator and the company.
Many organisations detect these situations after an industrial machinery inspection, a health and safety audit, an internal review or a technical visit. At that point, common questions arise: what does this deficiency mean? Is it mandatory to correct it? Does it affect Royal Decree 1215/1997? Is a risk assessment required? Could it affect CE marking?
The answer depends on each item of equipment, its actual use, its condition, the available documentation and the associated risks. For this reason, non-conformities in industrial machinery have been detected. deben abordarse con criterio técnico, no solo como una lista de puntos pendientes.
What are non-conformities in industrial machinery?
Non-conformities are non-compliances, deficiencies or deviations from safety requirements, applicable regulations, technical documentation, guards, safe operating conditions or necessary preventive measures.
They can affect old machines, modified equipment, automated lines, manual workstations, imported machines or equipment which, despite having CE marking, has undergone changes in its conditions of use.
In practice, a non-conformity may indicate that the machine oes not provide an adequate level of safety against certain industrial machinery risks: entrapment, cuts, crushing, dangerous access points, electrical faults, improper use, lack of instructions or deficiencies during maintenance tasks.
Most Common Non-conformities in Industrial Machinery
Although each piece of equipment must be analysed individually, these are some of the most common deficiencies in industrial machinery más habituales:
- Lack of guards or physical protection in moving areas, transmissions, cutting elements or entrapment points.
- Guards overridden, bypassed or removed, leaving the operator exposed during operation.
- Emergency stops missing, incorrectly positioned or not verified, especially on machines with several workstations.
- Entrapment, cutting, crushing or shearing risks not controlled through suitable technical measures.
- Dangerous access to moving areas, without barriers, interlocks or sufficient separation.
- Lack of safety interlocks or systems that do not guarantee a safe stop when a guard is opened.
- Deficiencies in electrical systems or control panels, such as unsuitable wiring, lack of identification or damaged components.
- Absence of risk signage and visible instructions for safe use.
- Lack of manuals, instructions or technical documentation explaining limits of use, maintenance and safety.
- Old machines not adapted to Royal Decree 1215/1997, especially equipment manufactured before current requirements were applied.
- Modifications carried out without reassessing risks, such as process changes, automation, new tooling or extensions.
- Lack of ISO 12100 risk assessment, which is essential to identify hazards and define risk reduction measures.
- Incomplete or incorrect CE marking, or CE marking without a technical file, especially in new, imported, modified or self-built machinery.
- Risks during maintenance, cleaning, unblocking or format changeover, tasks in which hazards not considered during normal use often appear.
These situations do not always involve the same level of severity. Therefore, detecting the deficiency is not enough: the actual risk must be assessed.
Why is detecting the deficiency not enough?
An inspection can identify the problem, but the company needs to know what to do next.
To correct a non-conformity properly, it is necessary to:
- Analyse the actual risk of the machine.
- Assess the severity of the potential harm and the probability of it occurring.
- Define corrective measures for machinery that are both feasible and effective.
- Implement technical solutions adapted to the equipment.
- Document the action carried out.
- Verify that the machine is left in safe operating condition.
In many cases, the solution is not simply to install a guard. It may require redesigning an access point, incorporating interlocks, modifying an electrical manoeuvre, reviewing maintenance procedures or updating technical documentation.
Relationship between non-conformities, Royal Decree 1215/1997, ISO 12100 and CE Marking
Non-conformities may be related to different technical and regulatory frameworks.
The Royal Decree 1215/1997 applies to work equipment in use and establishes the minimum health and safety requirements for its use by workers. Therefore, when a machine is in service within a company, it may be necessary to review whether it complies with the applicable requirements. At Grupo TICE, we provide machinery adaptation to Royal Decree 1215/1997 services to help companies correct deficiencies and improve the safety of their equipment.
The ISO 12100 is a key reference for analysing hazards, estimating risks and defining risk reduction measures. A proper risk assessment according to ISO 12100 makes it possible to technically justify which risks exist and which measures should be applied.
The CE marking for industrial machinery applies especially to new, modified, imported or market-placed machines. It may also be relevant when significant changes are made to an existing machine. In these cases, it is essential to review the documentation, technical file, declaration of conformity and applicable requirements. You can find out more about our CE marking service for industrial machinery.
In addition, a machine with CE marking may still present non-conformities if it has been modified, maintained incorrectly or used under conditions not originally foreseen.
What should a company do after detecting non-conformities?
- Gather the available documentation: manuals, drawings, certificates, electrical diagrams and previous reports.
- Identify the affected machines and their actual use within the production process.
- Carry out a technical risk assessment according to the current condition of the equipment.
- Prioritise critical deficiencies according to severity and personnel exposure.
- Design corrective measures adapted to each machine.
- Carry out the technical adaptation of guards, access points, manoeuvres or safety systems.
- Issue a machinery technical report with the actions carried out and the final documentation.
- Establish periodic reviews para mantener el nivel de seguridad en el tiempo.
Quick Guide: From Non-conformity to Machine Adaptation
How can Grupo TICE Ingenieros help you?
At Grupo TICE , we help industrial companies resolve non-conformities detected in machinery after inspections, health and safety audits, internal reviews or technical assessments.
As a multidisciplinary B2B engineering company with over 20 years of experience, we provide support in:
- Machinery risk assessment according to ISO 12100.
- Industrial machinery adaptation to Royal Decree 1215/1997.
- CE marking for industrial machinery.
- Design and implementation of corrective measures for machinery.
- Preparation of technical reports and final documentation.
- Technical support for health and safety, maintenance, production and engineering managers.
