Machine risk assessment: legal and methodological framework for SMEs and micro-enterprises

Marc Duvollet
Aug 24
8 min read

Introduction

Assessing risks related to dangerous machinery is a major workplace safety issue in French industry. According to the French National Institute for Research and Safety (INRS), machinery is involved in 10 to 15% of workplace accidents with more than four days of lost time, representing approximately 55,000 accidents annually, including around twenty fatal ones. This statistical reality underlines the crucial importance of a methodical and rigorous approach to machine risk assessment, particularly for SMEs and micro-enterprises, which account for a significant proportion of these accidents.

This article aims to provide human resources managers, business leaders and junior prevention officers with a theoretical and practical framework for mastering machine risk assessment, based on the French and European legal corpus, current technical standards, and a cost-benefit analysis of the preventive approach.

1. Regulatory framework and legal obligations

1.1 The European base: the Machinery Directive 2006/42/EC

Machinery Directive 2006/42/EC, transposed into French law by Decree No. 2008-1156 of 7 November 2008, defines the scope of dangerous machinery and establishes the essential safety and health requirements. This directive applies to any machine defined as "an assembly equipped or intended to be equipped with a drive system other than directly applied human or animal power, composed of interconnected parts or components, at least one of which is mobile and which are joined together for a defined application".

Machinery covered by this directive must undergo a risk assessment by the manufacturer, evidenced by the CE marking and the declaration of conformity. This requirement extends to work equipment used in the company, creating a chain of responsibility between the manufacturer, importer and end user.

1.2 Employer obligations under the Labor Code

Article L4121-1 of the French Labor Code establishes the employer's general safety obligation: "The employer shall take the necessary measures to ensure the safety and protect the physical and mental health of workers." This obligation is specifically applied to work equipment in Articles R4321-1 et seq., which require:

Assessment of risks associated with the use of work equipment (article R4321-1)
Compliance of equipment with applicable technical regulations (article R4322-1)
Training and information for users (articles R4323-1 to R4323-3)
Preventive and corrective maintenance (article R4322-1)

Article L4121-3 specifies the general principles of prevention, including the assessment of risks that cannot be avoided, the fight against risks at source, and the adaptation of work to humans. These principles apply in full to the assessment of machine risks.

1.3 Criminal, civil and administrative responsibilities

Criminal liability of managers

Article 121-3 of the Criminal Code establishes the criminal liability of legal entities and their directors in the event of an accident at work. Recent case law confirms the courts' strict approach. The ruling of the Criminal Division of the Court of Cassation of March 15, 2022, reiterates that "awareness of danger is sufficient to establish inexcusable fault," even in the absence of a deliberate breach of a safety obligation.

Criminal penalties include:

Fines of up to 75,000 euros for individuals
Prison sentences of up to 3 years for manslaughter
Fines of up to 375,000 euros for legal entities
Additional penalties (prohibition from practicing, closure of establishment)

Civil liability and compensation

The employer's civil liability is automatically incurred in the event of an accident at work (Article L411-1 of the Social Security Code). This liability may be increased in the event of inexcusable negligence, allowing the victim to obtain additional compensation covering the entirety of the damage suffered.

Administrative sanctions

The labor inspectorate has extensive powers to sanction breaches of machine safety rules. Administrative sanctions include:

Formal notice to comply
Temporary cessation of activity (article L4721-1)
Offense reports sent to the public prosecutor
Referral to the interim relief judge for emergency measures

2. Technical standards and reference documents

2.1 ISO 12100 standard: general design principles

EN ISO 12100:2010 "Safety of machinery - General principles for design - Risk assessment and risk reduction" is the reference standard for machine risk assessment. It establishes a four-step methodology:

Determination of machine limits : usage, spatial, temporal and other limits
Identification of dangerous phenomena : energies, substances, dangerous situations
Risk estimation : combination of severity of damage and probability of occurrence
Risk assessment : judgment on the tolerance of residual risk

This systemic approach allows for a comprehensive risk assessment, a prerequisite for any effective preventive measure.

2.2 ISO 13849: Safety of control systems

EN ISO 13849-1:2015 "Safety of machinery - Safety-related parts of control systems" defines the safety requirements for machine control systems. It introduces the concept of "Performance Level" (PL), which quantifies the ability of a safety-related control system to perform a safety function under foreseeable conditions.

Performance levels range from PLa (low risk) to PLe (high risk), allowing protective measures to be adapted to the intensity of the identified risk.

2.3 CE marking: conformity and responsibilities

The CE marking certifies the conformity of the machine with the essential health and safety requirements of the Machinery Directive. It commits the manufacturer's responsibility with regard to the risk assessment carried out during the design phase. The user employer must ensure the presence of this marking and the consistency between the intended use and the actual use of the machine.

The absence of CE marking or the use of non-compliant machinery exposes the employer to criminal sanctions and constitutes an aggravating factor in the event of an accident.

3. Risk assessment methodologies

3.1 The FMEA method (Failure Modes, Effects and Criticality Analysis)

The FMEA method is a preventive analysis tool particularly suited to complex machines. It proceeds by functional decomposition of the machine and systematic analysis of potential failure modes.

AMDEC methodology:

Functional decomposition : identification of the main and auxiliary functions of the machine
Failure mode analysis : for each function, inventory of possible malfunctions
Assessment of effects : consequences of each failure on operator safety
Calculation of criticality : product of frequency, severity and detectability (C = F × G × D)
Risk prioritization : ranking in order of decreasing criticality
Definition of corrective actions : preventive measures proportionate to the level of risk

This quantitative approach allows for objective prioritization of prevention actions and traceability of decisions taken.

3.2 The HAZOP (HAZard and OPerability study) method

The HAZOP method, originally developed for the chemical industry, is effectively adapted to automated machines and complex systems. It is based on the systematic analysis of deviations from nominal operation.

Principles of the HAZOP method:

Team composition : multidisciplinary (design, operation, maintenance, safety)
System breakdown : identification of study “nodes” (functional subsystems)
Definition of parameters : safety-critical variables (pressure, speed, temperature, etc.)
Application of keywords : "more", "less", "no", "inverse", "other than"
Analysis of deviations : causes, consequences, existing safeguards
Risk assessment : severity and probability of identified scenarios
Recommendations : preventive and corrective actions

The effectiveness of the HAZOP method relies on the quality of the facilitation and the collective expertise of the analysis team.

4. Cost-benefit analysis of prevention

4.1 Direct and indirect costs of machine accidents

The economic analysis of machine accidents reveals a considerable financial impact for companies. The costs break down into:

Direct costs:

Work accident contributions and possible increase
Care costs and daily allowances
Permanent disability pensions
Staff replacement and training costs

Indirect costs (generally 4 to 10 times higher than direct costs):

Production shutdowns and productivity losses
Degradation of the company's image
Staff demotivation and turnover
Administrative and legal costs
Additional insurance costs

A 2023 INRS study estimates the average cost of a serious machine accident at 180,000 euros for an SME with 50 employees, rising to 500,000 euros in the event of death.

4.2 Return on investment of prevention

According to data from the French Health Insurance, investing in prevention generates a positive return on investment in 85% of cases. The cost-benefit ratio is generally between 1:3 and 1:7, meaning that one euro invested in prevention saves 3 to 7 euros in avoided accident costs.

Elements for calculating ROI prevention:

Cost of the risk assessment process: 0.5 to 2% of turnover
Savings achieved: reduction in AT/MP contributions, productivity gains, improved image
Payback period: generally less than 3 years

This economic approach justifies the integration of machine safety from the design phase of workstations and the choice of equipment that complies with safety standards.

5. Case law examples and accident cases

5.1 Case No. 1: Lack of training and fatal accident on a hydraulic press

Context: A metalworking SME with 25 employees uses a 200-ton hydraulic press for stamping metal parts. The accident occurred during manual stripping by a 22-year-old temporary worker who was not specifically trained for this operation.

Circumstances of the accident: The operator attempted to free a part stuck in the die without locking out the machine. The press restarted automatically, causing the operator to be fatally crushed.

Technical analysis: The expert report reveals the absence of safety devices compliant with ISO 13849 (PL d level required), the impossibility of simple lockout, and the absence of presence detection in the hazardous area.

Court decision: The criminal court sentenced the manager to an 18-month suspended prison sentence and a €50,000 fine for involuntary manslaughter. The company was fined €200,000. The case was found to have committed gross negligence, increasing the compensation to €890,000.

Total cost: 1.2 million euros (compensation + fines + legal fees + production shutdowns)

5.2 Case No. 2: Accident on conveyor and lack of maintenance

Background: A food company with 80 employees operates an automated conveyor for packaging products. The accident involved an experienced maintenance technician working on a recurring breakdown.

Circumstances of the accident: During a breakdown intervention, the agent bypassed the safety devices to quickly access the jamming point. His hand was caught in the drive mechanism, causing the amputation of three fingers.

Technical analysis: The investigation highlights the wear of protective devices, the absence of preventive maintenance in accordance with the manufacturer's manual, and lockout procedures not followed out of habit.

Court decision: The criminal court acquitted the manager of the criminal charge but upheld the company's civil liability. Inexcusable negligence was not established, as the accident was partially the result of the victim's carelessness.

Total cost: 350,000 euros (compensation + increase in AT/MP contributions + compliance costs)

5.3 Jurisprudential teachings

These cases illustrate the increasing severity of the courts in matters of machine safety. The criteria for assessing inexcusable fault are evolving towards a presumption of employer liability, particularly in cases of:

Failure to comply with applicable safety standards
Lack of specific training in machine risks
Lack of preventive maintenance
Habitual circumvention of protective devices

6. Practical recommendations for SMEs and VSEs

6.1 Structuring the evaluation process

The implementation of an effective machine risk assessment approach is based on a structured organization:

Phase 1 - Initial diagnosis:

Comprehensive inventory of work machines and equipment
Verification of regulatory compliance (CE marking, instruction manuals)
Identification of risky work situations
Constitution of the multidisciplinary evaluation team

Phase 2 - Risk Assessment:

Application of AMDEC or HAZOP methods depending on complexity
Risk rating according to a grid adapted to the company
Prioritization of action priorities
Assessment documentation (regulatory traceability)

Phase 3 - Action plan:

Definition of preventive measures in order of priority
Budgeting and investment planning
Training staff on new equipment and procedures
Implementation of monitoring indicators

6.2 Integration into corporate strategy

The effectiveness of the approach requires its integration into the company's overall strategy:

Visible involvement of senior management
Allocation of specific budgetary resources
Continuing training for supervisors and prevention officers
Regular communication on the results obtained

6.3 External support

SMEs and VSEs can rely on external expertise:

CARSAT/CRAMIF prevention services
Consultants specializing in machine safety
Vocational training organizations
Sectoral professional networks (UIMM, federations, etc.)

Conclusion

Machine risk assessment is a legal, technical, and economic imperative for industrial companies. Beyond regulatory compliance, it represents a strategic investment that generates long-term value. Mastering assessment methods (FMEA, HAZOP), applying technical standards (ISO 12100, ISO 13849), and integrating a cost-benefit approach allow SMEs and VSEs to develop an effective safety culture.

The shift in case law toward increased managerial responsibility reinforces the urgency of a proactive approach to machine safety. Analysis of accident cases reveals that organizational failures (training, maintenance, procedures) predominate over technical defects, highlighting the importance of the human factor in prevention.

The success of the approach rests on three pillars: the technical expertise of the assessors, the managerial commitment of management, and the active participation of operators. This long-term, systemic approach constitutes the foundation for effective prevention of machine risks and sustainable industrial performance.

In a competitive economic environment, companies that integrate machine safety as a competitive advantage benefit from improved productivity, a stronger employer image, and greater business sustainability. The initial investment in risk assessment thus constitutes a lever for the company's overall performance.