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The risk assessment

In this section you will be guided step by step through the risk assessment.

1. An introduction to risk assessment​

As part of the CE marking process, risk assessment plays a crucial role in identifying and managing potential hazards associated with a product's design, manufacture, use, and disposal.

Risk assessment is a systematic and iterative process that involves identifying, analyzing, and evaluating potential risks to human health, safety, and the environment throughout a product's lifecycle. It is an essential component of CE marking evaluations as it helps manufacturers and other stakeholders understand and mitigate the risks associated with their products. By assessing potential hazards and their likelihood of occurrence, risk assessment enables informed decision-making, leading to the development and implementation of effective risk control measures.

Purpose

The purpose of risk assessment in the context of CE marking is to ensure that products are safe, reliable, and fit for their intended purpose. It involves a comprehensive examination of all potential risks, including mechanical, electrical, chemical, and environmental hazards. Risk assessment considers various factors such as product design, manufacturing processes, materials used, foreseeable use scenarios, and any associated foreseeable misuse or reasonably foreseeable abnormal situations.

During the risk assessment process, relevant international standards and regulations, industry best practices, and scientific knowledge are taken into account. This approach allows for a systematic and consistent evaluation of risks, promoting harmonization and facilitating trade within the European Union.

Outcome

The outcome of a risk assessment is a risk analysis, which provides a detailed understanding of the identified hazards, their potential consequences, and the likelihood of those consequences occurring. This analysis forms the basis for risk evaluation, where the level of risk is determined, taking into consideration factors such as severity, probability, and the adequacy of existing risk control measures.

To meet the requirements for CE marking, manufacturers must demonstrate that they have conducted a thorough risk assessment and have implemented appropriate risk reduction measures. This involves adopting a proactive approach to risk management, continually monitoring and reassessing risks throughout a product's lifecycle, and ensuring that any necessary updates or modifications are made promptly.

💡 The risk assessment is an iterative process!​

Bear in mind, this is not a one-time process and ideally should be started early on in product development. Careful product design, taking into consideration the risks a machine may pose throughout its life cycle and mitigating those hazards early in the design process demonstrates industry best practice and results in a safe product from the start. It also simplifies the CE marking process.

As your knowledge of the normalized standards applicable for your product grows, or if standards are ammended, you may identify new risks which need to be investigated resulting in product improvements, upgrades and reassessment.

Identifying further risks and adding mitigation measures to your risk assessment demonstrates effective product development which is making your machine even safer.

You may choose to go through this process multiple times.

2. Risk Assessment according to DIN EN ISO 12100:2011-03​

The following procedure is used for the quantitative determination of the level of risk posed by hazards. The assessment is carried out individually for each hazardous situation.

To provide a better overview, CERTAIN calculates a total risk factor. The result illustrates the degree of hazard based on factors, where the highest occurring risk corresponds to factor 144, and the lowest is 3.

3 = lowest risk

144 = highest risk

The risk assessment is performed based on predefined parameters:

Based on these decision criteria, the level of risk is quantified using the following equation:

Risk Factor (R) = S x N x (F + A + P)

The reference table below describes the individual elements and the choice of factor value.

CERTAIN will undertake this calculation for you based on your inputs. This is described in in detail the steps that follow.

After each measure taken to mitigate risks, each individual hazard is reassessed and recalculated potentially resulting in the classification of the hazard as low to negligible after implementing several necessary protective measures.

💡 Assembly of machinery - Risk assessment​

When multiple individual machines are interconnected to form a assembly of machines, only the risks arising at the interfaces are considered.

The assessment of machine-specific risks should be performed by the manufacturer of each machine/component. Therefore, it is permissible to include only the external documentation of the individual machines in the overall documentation. These documents should at least include the "Declaration of Conformity" or the "Declaration of Incorporation" and the complete user information (operating manual or installation manual that indicates how the individual machine can be safely integrated or linked to other machines).

3. Begin the risk assessment​

On the right hand side you see the progress indicator. The fifth process step is for conducting the risk assessment. Click on Risk Assessment.

4. Adding your first product risk / hazard​

Click on 'Document a new hazard'

5. Define your own hazard or use a template​

Here you have the option to define a new product hazard from scratch or to use a template.

Certain offers a library of predefined templates with commonly occuring hazards for you to use as reference and ammend to fit your product and application. We plan to grow this library as CERTAIN develops and also to provide you with the option to save your own hazard templates. Coming soon!

Section 1 - Product risk / hazard​

6. Begin at Step 1 - risk / hazard​

There are two sections here to complete. They are visible at the top of the screen. The first is to identify and describe the risk the product poses, the second is to identify and define the mitigating measures to reduce or eliminate that risk.

💡 What risks / hazards do I need to consider?​

At this point you need document the potential risks associated with your product. CERTAIN will help you by grouping the options and offering dropdown menus to choose from at every stage.

Here are some background areas to bear in mind when beginning this process.

  • Mechanical Hazards: Assess potential risks associated with moving parts, such as entrapment, crushing, shearing, or cutting hazards. Consider the machine's design, guarding mechanisms, emergency stop features, and the possibility of unintended movements.
  • Electrical Hazards: Evaluate electrical risks such as electrical shocks, short circuits or fires. Ensure compliance with relevant electrical safety standards, appropriate insulation, grounding, and protection against overloads or electrical failures.
  • Ergonomic Hazards: Consider risks related to ergonomics and human-machine interaction. Assess factors like repetitive motions, awkward postures, excessive force requirements, and any potential risks of musculoskeletal disorders for operators or maintenance personnel.
  • Thermal Hazards: Evaluate risks associated with high or low temperatures, such as burns, scalds, or exposure to extreme heat or cold. Consider proper insulation, temperature controls, and warning mechanisms.
  • Noise and Vibration Hazards: Assess potential risks related to excessive noise levels or vibration, which can lead to hearing damage, physiological effects, or reduced operational safety. Ensure compliance with relevant noise and vibration standards and implement suitable measures to mitigate the risks.
  • Chemical Hazards: Identify any hazardous substances involved in the machine's operation, such as chemicals, fuels, lubricants, or emissions. Assess risks associated with exposure, including toxicity, flammability, or potential environmental impact. Implement proper handling, containment, and ventilation systems.
  • Radiation Hazards: If the machine uses or emits any forms of radiation (e.g., ionizing radiation, laser radiation), evaluate the associated risks and ensure compliance with relevant radiation safety standards. Implement shielding, warning signs, and appropriate safety measures to protect operators and bystanders.
  • Safety-related Control Systems: Assess the effectiveness and reliability of safety systems, including interlocks, emergency stop functions, and safety monitoring devices. Evaluate their capability to detect and mitigate potential hazards or failures.
  • Operational Risks: Consider risks related to incorrect operation, improper maintenance, lack of training, or inadequate instructions and warnings. Evaluate the clarity and comprehensibility of user manuals, labels, and markings to minimize the potential for user errors.
  • Environmental Hazards: Evaluate any potential environmental risks associated with the machine's operation or disposal. Assess issues such as emissions, waste generation, energy consumption, and compliance with relevant environmental regulations.
  • IT Security: Evaluate any potential risks associated with all forms of network / internet connections. Hacking and cybersecurity has grown significantly in relevance and must be taken into consideration in all modern equipment and machinery.

Remember to consult applicable standards, guidelines, and regulations specific to your industry and the type of machine you are assessing. Engaging with experts in relevant domains, such as safety engineering or industrial hygiene, can further enhance the accuracy and effectiveness of your risk assessment.

7. Name the new hazard​

You have the option to name the identified hazard if required. This will help with managing and prioritising them into chapters later in the process.

8. Choose a hazard category​

A dropdown will open listing the available categories

9. Click and select a hazard origin​

💡 Hazard origin?​

This refers to the specific location, component, or aspect of a product or its operation that is associated with a particular hazard or potential risk.

By identifying the source of hazards, manufacturers can better analyze the risks associated with their product and implement appropriate safety measures to mitigate or eliminate those risks.

10. Click and select the hazard consequence​

A dropdown will open listing suggestions based on your category selection. You may choose multiple consequences from the list or add your own.

💡 Hazard consequence?​

This refers to the potential outcomes or impacts that can arise from a particular hazard associated with a product or its operation.

By evaluating the potential consequences, manufacturers can assess the severity of risks, prioritize safety measures, and ensure appropriate safeguards are in place to prevent or minimize harm.

11. Add your own hazard consequences​

If you wish to add your own product specific hazard consequences, do so in the space on the right and confirm each entry with enter.

12. Add the relevant live cycle phases​

Click and select the life phases during which this hazard is likely to occur.

A dropdown will open listing the standard life cycle phases. You may choose multiple phases from the list or add your own.

💡 Life cycle phases?​

This refers to the different stages or phases that a product goes through from its initial design and production to its use, maintenance, and disposal.

Considering the lifecycle and life phases of a product is important. Manufacturers assess and address potential risks and safety considerations associated with each stage. It involves taking into account the entire lifespan of the product, including its production, distribution, use, maintenance, and end-of-life management.

The lifecycle phases of a product typically include:

  1. Design and Development: This phase involves the conceptualization, design, and engineering of the product, considering safety aspects, risk analysis, and compliance with applicable regulations and standards.
  2. Production and Manufacturing: This phase encompasses the manufacturing, assembly, and quality control processes to ensure that the product is produced in accordance with the approved design, meets safety requirements, and maintains consistent quality.
  3. Distribution and Supply Chain: This phase involves the logistics, packaging, labeling, and transportation of the product, ensuring proper handling, storage, and documentation during distribution.
  4. Installation and Use: This phase includes the proper installation, setup, and operation of the product by end-users, considering factors such as user instructions, training, and potential risks during use.
  5. Maintenance and Servicing: This phase covers the routine maintenance, inspection, and servicing requirements of the product, including the provision of spare parts, repair procedures, and safety considerations during maintenance activities.
  6. Disposal and End-of-Life: This phase addresses the safe disposal, recycling, or environmentally responsible management of the product at the end of its useful life, taking into account regulations and best practices for waste management.

Considering the entire lifecycle of a product allows manufacturers to identify potential hazards, assess risks, and implement appropriate safety measures during the products life. It helps ensure that the product is designed, manufactured, used, and disposed of in a manner that minimizes risks to human health, safety, and the environment.

13. Add your own product specific life phases​

If required, you may define your own product life phases in the space on the right. Just type them in on the right and confirm each time.

14. Add your hazard description​

At this point you are required to describe the hazard briefly and clearly. It should reflect correctly the choices you made for hazard category, origin and consequence and occur in the chosen life cycle phase.

These details will all appear in the final created risk assessment document.

15. Add an illustration of the hazard​

A picture adds always helps describe a hazard. Here you have the option to add a photo or illustration of the hazard.

16. Describe your protection objective​

If deemed necessary, you may also use this field to reference those specific sections in the applied directive relating to this particular hazard.

17. Who could be impacted by this hazard?​

Describe the function of those who could be potentially impacted by this hazard.

Evaluating the risk factor​

💡 Risk factor (R) = S x N x (F + A + P)​

Once again to recap:

Risk Factor = hazard S everity x N umber of persons impacted x ( F requency + ease of A voidance/detection + P robability)

For your identified hazard, you will be required to rate each of these five variables.

A dropdown menu will provide the available options.

18. Hazard severity (S)​

Choose the hazard severity from the dropdown.

The value on the left will be used in the risk factor calculation.

19. Number of people impacted (N)​

Choose from the dropdown.

How many people may be directly or indirectly affected by an occurance?

The value on the left will be used in the risk factor calculation.

20. Frequency of exposure to hazard (F)​

Choose from the dropdown.

How often is one likely to be exposed to this hazard?

The value on the left will be used in the risk factor calculation.

21. Ease of avoidance or detection (A)​

Choose from the dropdown.

How easy to anticipate this hazard occuring and be able to avoid it?

The value on the left will be used in the risk factor calculation.

22. Probability / likelyhood (P)​

Choose from the dropdown.

How likely is it that this hazard could occur?

The value on the left will be used in the risk factor calculation.

23. Baseline initial risk factor​

The baseline initial risk factor is calculated and displayed. This is the starting point or baseline for your for risk mitigating measures.

💡 Baseline initial risk factor - The starting point​

There is no official predefined or specific target number or limit for this risk factor.

The manufacturer is responsible for setting its own acceptable level based on its own assessments, product knowledge and understanding of the applicable standards.

This will be further explained in the following section which involves defining the risk mitigating measures and reducing the risk factor to an acceptable level.

24. Click on next step to continue​

Continue to the mitigating measures by clicking on next step.

Section 2 - Hazard mitigating measure​

💡 Mitigation measures?​

Hazard mitigating measures refer to actions and strategies implemented to reduce or eliminate identified hazards associated with a product. These measures aim to reduce the risks and improve the safety of the product throughout its lifecycle. Here are some examples of hazard mitigating measures:

  • Design Modifications : Implementing changes to the product's design to eliminate or reduce hazards. This may involve adding safety features, improving structural integrity, or enhancing user ergonomics.
  • Safety Devices and Guards : Incorporating safety devices such as emergency stop buttons, interlocks, guards, or protective enclosures to prevent access to hazardous areas or reduce the likelihood of accidents.
  • Warning Labels and Instructions : Providing clear and comprehensive warning labels, safety instructions, and user manuals to inform users about potential hazards, safe operation practices, and necessary precautions.
  • Training and Education : Providing appropriate training and educational materials to users, operators, and maintenance personnel to ensure they have the necessary knowledge and skills to safely operate and maintain the product.
  • Maintenance and Inspection Procedures : Establishing regular maintenance schedules, inspection procedures, and maintenance protocols to ensure the ongoing safety and proper functioning of the product.
  • Risk Communication : Effectively communicating the identified hazards, associated risks, and necessary precautions to users, operators, and other relevant stakeholders to raise awareness and promote safe use.
  • Testing and Certification : Conducting appropriate tests, evaluations, and assessments to verify compliance with relevant standards and regulations, ensuring that the product meets specified safety requirements.
  • Quality Control and Manufacturing Processes : Implementing robust quality control measures and manufacturing processes to ensure consistency, reliability, and safety during the production and assembly of the product.
  • Supply Chain Management : Ensuring that the components, materials, and services obtained from suppliers or subcontractors meet required safety standards and specifications.
  • Feedback and Incident Monitoring : Establishing mechanisms to collect and analyze feedback from users and operators, as well as monitoring incidents and accidents, to identify potential hazards and implement necessary corrective actions.

25. Move to Section 2 - Hazard mitigating measures​

Based on the hazard you documented in section 1, you must now identify mitigating measures to address that hazard. This guide will walk you through how your identified measures are recorded in CERTAIN.

💡 The 3 step risk reduction process - The fundamentals​

The application of the principles presented in the harmonized standard DIN EN ISO 12100 helps to design machines to be inherently safe, before resorting to technical protective measures or user instructions. It stipulates that safety measures must be applied in the following order:

  1. Inherently safe design measures (INH)
  2. Safeguarding and complementary protective measures
  • Complementary mechanical protective measures (SMP)
  • Complementary control-related protective measures (CMP)
  1. Information for use
  • Personal protective equipment (PPE)
  • Pictograms (PIC)
  • Instructions for use in the operating manual (IU)

According to the hierarchy of measures, the specified order must be followed. It is not permissible to begin risk reduction with step 3, 'Information for use,' while disregarding steps 1 and 2.

These three steps are explained in more detail in the following sections.

⚠️ IMPORTANT​

According to the hierarchy of measures, the specified order must be followed. It is not permissible to begin risk reduction with step 3, 'Information for use,' while disregarding steps 1 and 2. (See Figure 1. - Source: DIN EN 12100:2010)

These three steps are explained in more detail in the following sections.

  1. Inherently safe design measures (INH)
  2. Safeguarding and complementary protective measures
  3. Information for use

This order of priority must be followed from top to bottom when defining mitigation measures.

26. Figure 1. - Source BS EN 12100:2010​

💡 1) Inherently safe design: (INH)​

An inherently safe design aims to avoid or reduce hazards from the outset by designing the machine in such a way that risks are eliminated or minimized as much as possible, preventing dangers before they occur. Below are some examples:

  • Reduction of Crushing Points

Example: Ensuring that moving parts of a machine are designed in such a way that no crushing or shearing points arise (e.g., by increasing the distance between moving parts or using protective devices, or by utilizing an enclosed tube motor instead of an open belt drive to transfer drive power from the motor to a conveyor belt).

  • Limiting the Speed or Force of Moving Parts

Example: In a press, the design could limit the maximum force or speed of the moving parts to reduce the risk of severe injuries.

  • Self-Locking Mechanisms

Example: Using mechanisms that automatically remain in a safe position in the event of a power failure (e.g., braking systems that stay locked when no power is supplied).

  • Avoiding Mechanical Hazards Through Design Solutions

Example: Using materials with high strength that withstand expected use without breaking or deforming, thus preventing hazards.

  • Reduction of Noise and Vibration Sources

Example: Inherently reducing noise by using vibration-damping materials or optimizing gears and bearings to reduce vibrations.

  • Use of Safe Energy Sources

Example: Instead of relying on pneumatic or hydraulic power, low-voltage electrical energy could be used to minimize the risk of electric shocks.

  • Avoidance of Hazardous Substances

Example: Replacing hazardous chemicals in a machine (e.g., lubricants or coolants) with more environmentally friendly and less harmful alternatives.

  • Ergonomic Design

Example: Designing machines to be easily accessible for operators and operable in a comfortable posture, reducing the risks of musculoskeletal disorders.

  • Reducing the Likelihood of Operator Errors

Example: Designing machines in such a way that it is difficult or impossible to operate them incorrectly. This could be achieved through a logical arrangement of controls or through intuitive user guidance.

Question: Is the integration of an emergency stop function considered "inherently safe"?

The integration of an emergency sto p function (emergency stop) is not considered an inherently safe measure. Instead, it falls under technical protective measures , which rank second in the hierarchy of risk reduction strategies according to DIN EN ISO 12100 , after inherently safe design.

Why is this the case?

  • Inherently safe design aims to eliminate or minimize hazards from the outset through the design of the machine, thereby eliminating potential hazards before they arise.
  • The emergency stop, on the other hand, intervenes when a dangerous situation has already occurred , aiming to stop the machine's operation as quickly as possible to prevent harm or injury. This means that the danger is already present, and this measure "controls" the hazard but does not prevent it through the machine’s design.

Classification of the Emergency Stop in Risk Reduction Measures:

In summary, while the emergency stop function is an important protective measure , it is not classified as inherently safe. It serves to limit damage, whereas inherently safe designs aim to prevent risks through the machine’s design from the start.

💡 2) Safeguarding and technical protective measures​

Here are some examples of technical protective measures that, according to DIN EN ISO 12100, are used as the second step after inherently safe design. These technical protective measures can be divided into supplementary control-related protective measures and supplementary mechanical protective measures.

2.1) Supplementary Mechanical Protective Measures (SMP)

Mechanical protective measures physically prevent access to hazardous areas or reduce the likelihood of dangerous situations occurring.

Examples:

  • Guarding Devices

    • Fixed or movable fences, grilles, or enclosures that prevent people from entering dangerous areas of the machine. These guards are often installed at access points to moving parts such as conveyors or presses.

  • Interlocked Safety Doors

    • Doors that can only be opened when the machine is in a safe condition (e.g., when it has stopped) and prevent the machine from operating when they are open. These are often combined with limit switches that prevent the machine from operating when the door is not closed.

  • Swiveling or Hinged Guards

    • Guards that can be moved to allow access to the machine, but automatically shut the machine down when opened or removed. They prevent access to dangerous areas during operation.

  • Catch Guards or Shields

    • Mechanical devices that reduce the risk of people being caught by moving parts by physically shielding these parts. Such shields might be installed in front of rotating machine components.

  • Spring-Loaded Protective Covers

    • Covers that remain in the safe position by spring mechanisms and must be manually retracted. Removing the cover automatically shuts down the machine when the operator enters the danger zone.

  • Machine Safety Doors with Locking Systems

    • Doors that remain locked while the machine is in motion and only open once all hazardous movements have stopped.

  • Covers and Guards for Hazardous Moving Parts

    • Fixed covers that prevent operators from accidentally coming into contact with rotating or moving machine parts, such as in cutting or grinding machines.

2.2) Supplementary Control-Related Protective Measures (CMP)

These measures involve the use of control systems that monitor and, if necessary, safely shut down the machine or control its movement.

Examples:

  • Emergency Stop Switch (Emergency Stop)

    • A switch that immediately stops the machine in case of emergency to prevent injury or damage.

  • Safety Light Curtains

    • Light barriers that monitor access to hazardous areas. If the light curtain is interrupted (e.g., by a body part entering the area), the machine stops immediately.

  • Safety Relays

    • These monitor safety components like emergency stop switches or door interlocks and ensure that the machine is safely shut down in case of a failure or malfunction.

  • Two-Hand Control

    • Control elements that require the simultaneous pressing of two switches in a safe position to activate the machine, ensuring that the operator's hands are not in the danger zone.

  • Distance Sensors or Proximity Switches

    • These monitor the position of moving machine parts. If a safe position is left, the control system intervenes and stops the machine or prevents certain movements.

  • Speed and Direction Monitoring

    • A system that monitors whether the machine is operating safely (e.g., within a safe speed limit) and automatically shuts down or slows the machine when limits are exceeded.

Summary of Measures:

Mechanical protective measures use physical barriers that prevent direct access to dangerous parts of the machine or make contact more difficult through protective devices.

Control-related protective measures rely on electronic systems that monitor hazardous areas and shut down the machine when a problem is detected.

Both types of protective measures complement each other and contribute to risk reduction when inherently safe design measures alone are not sufficient to ensure an acceptable level of safety.

💡 3) Information for use​

The third level of risk reduction according to DIN EN ISO 12100 focuses on providing information to the user, which includes personal protective equipment (PPE), instructions for use in the operating manual (IU), and pictograms (PIC). These measures come into play when inherent safe design and technical protective measures cannot entirely eliminate hazards.

1) Personal Protective Equipment (PPE)

Personal protective equipment is used when hazards cannot be fully eliminated by inherently safe design and technical protective measures. PPE directly protects the operator from risks.

Examples:

  • Safety Glasses

    • Used to protect eyes from flying debris, sparks, or dangerous liquids, especially when working with grinders, chemicals, or welding equipment.

  • Protective Gloves

    • Provide protection against mechanical risks such as cuts, punctures, or abrasion, or from chemical risks caused by aggressive substances. These are essential when handling sharp or rough materials or chemicals.

  • Hearing Protection

    • Protects against noise-induced hearing damage in noisy environments, such as near presses, drills, or other loud machinery.

  • Head Protection

    • Protects against falling objects or when working in areas with overhead operations, such as on construction sites or near lifting equipment.

  • Respiratory Protection Masks

    • Shield against inhaling harmful substances like dust, gases, or fumes, commonly used when painting, grinding, or handling hazardous chemicals.

  • Safety Shoes

    • Footwear with reinforced toe caps and non-slip soles to protect against heavy or sharp objects and prevent slipping.

2) Pictograms (PIC)

Pictograms are visual warning signs or symbols directly placed on the machine to warn the user of specific hazards. They provide a quick and universal method to raise awareness of risks.

Examples:

  • Warning Sign: Electrical Hazard

    • A lightning symbol placed on electrical equipment to warn of dangerous voltage, indicating caution is required and PPE may be needed.

  • Mandatory Sign: Wear Safety Glasses

    • A symbol placed on machines that pose a risk to the eyes from flying particles, reminding users to wear safety glasses.

  • Warning Sign: Risk of Crushing

    • A symbol placed on moving machine parts, such as presses or robots, warning of crushing hazards. It often depicts two hands being squeezed between surfaces to increase awareness.

  • Mandatory Sign: Wear Hearing Protection

    • This pictogram instructs users to wear hearing protection in noisy areas. It is commonly found in workshops or on construction sites.

  • Warning Sign: Hot Surface

    • A symbol showing a hand above a hot surface, warning the user not to touch it to avoid burns.

  • Prohibition Sign: No Unauthorized Access

    • A pictogram indicating that unauthorized persons are prohibited from entering certain areas, such as zones where machines are running or hazardous work is taking place.

3) Instructions for use in the operating manual (IU)

The operating manual must provide clear and comprehensive information on residual risks identified in the risk assessment that can occur during machine use, along with instructions for safe handling.

Examples:

  • Safety Instructions for Operation

    • Detailed guidelines on how to operate the machine safely, such as the steps to start and stop the machine to avoid injuries.

  • Maintenance and Cleaning Instructions

    • Guidelines for performing maintenance and cleaning tasks safely, including when and how to disconnect power before cleaning or servicing parts.

  • Warning Notices for Specific Hazards

    • Warnings about particular hazards, such as moving parts that could cause crushing or cutting injuries, or hot surfaces that could cause burns.

  • Instructions for Required PPE

    • Clear statements on the types of PPE that must be worn when working with the machine, such as safety glasses and gloves for a grinding machine.

  • Safety Guidelines for the Environment

    • Instructions for safe machine placement (e.g., ensuring a safe distance from other equipment or walls) and appropriate lighting and ventilation for the work area.

  • Explanation of Pictograms and Warning Signs

    • Clarification of the meaning of the pictograms and warning signs placed on the machine where users should be aware of residual risks.

  • Guidelines for Operator Training

    • Recommendations or requirements that operators must be adequately trained before operating the machine to prevent misuse.

Summary of Measures:

  1. Personal Protective Equipment (PPE) directly protects the user from specific hazards that may occur during machine operation, such as mechanical, chemical, or thermal risks.
  2. Pictograms (PIC) are visual symbols that quickly and clearly alert users to hazards or mandatory safety measures (e.g., wearing PPE).
  3. Instructions for use in the operating manual (IU) provide detailed information on safe operation, maintenance, the use of PPE, and warnings about particular dangers.

These measures complement inherently safe design and technical protective measures to ensure a comprehensive safety strategy.

27. Click on "Type of hazard mitigation"​

Click and select the type of hazard mitiagtion from the dropdown menu.

28. Performance Level requirement (PLr)​

In cases where simple mechanical protective safeguards cannot be applied but functional safety using a control system can, then a Performance Level requirement (Plr) must be derived for this system according to the standard EN ISO 13489-1.

In this special case, CERTAIN will determine the Performance Level requirement (PLr) for you based on your selected hazard criteria and their severity.

Control systems are designed with a specific Performance Level (PL) in mind, ranging from PL a (low) to PL e (high). The choice of control system functionality and components, their quality, latency and levels of built in redundancy combine to give a control system safeguard a specific performance or PL.

An experienced control systems engineer is trained to design a safeguard to meet a PLr level specific to the application.

Based on your risk assessment, CERTAIN will derive the PLr and include it in the risk assessment documentation.

Three of the five hazard variables are used to calculate the PLr.

The Performance Level requirement is derived using decision tree pictured below.

Risk parameters:

PL - Performance Level: a to e

Risk Level: H = high risk, L = low risk

S - Severity of injury:

S1 = minor (normally reversible) injury

S2 = severe (normally irreversible) injury, including death

F - Frequency and/or duration of exposure to hazards:

F1 = rare to frequent and/or short duration

F2 = frequent to continuous and/or long duration

P - Possibility for avoiding/detecting hazards: (Alt. name"A" in the risk factor calc)

P1 = possible under certain conditions

P2 = hardly possible

Risk graph according to EN ISO 13849-1:2009

29. Describe your hazard mitigation measure​

Briefly describe a hazard mitigation measure you can use the following format:

"[ Name of the Hazard Mitigation Measure ]" is a safety measure implemented to reduce or eliminate the risk associated with [ describe the hazard ].

It involves [ briefly describe the action or mechanism of the mitigation measure ].

The purpose is to [ explain the intended outcome or objective of the measure, such as preventing accidents, protecting users, or minimizing potential harm ]."

30. Pictogram​

If you selected "pictogram" from the mitigation measure list then at this point you can search the pictogram database here and choose the applicable signage.

The list of pictograms reflects ISO 7010 - The technical standard for graphical hazard symbols on hazard and safety signs.

You can add multiple pictograms. Simply select them one after another.

You may also choose to leave this field blank.

💡 Hazard re-evaluation - Recap​

Each measure you define here is intended to reduce or eliminate a hazard. Using the same evaluation scales and calculation as before, you now have to re-evaluate the hazard with your new mitigation measure in place. The previous evaluation criteria are carried over from one evaluation to the next.

31. Re-evaluate the hazard​

With the mitigation measure in place, re-evaluate the hazard by re-rating the five variables once again.

32. Residual risks​

Describe any residual risks remaining.

💡 Residual risks - what are they?​

Residual risks are those risks that cannot be eliminated entirely or reduced to an acceptable level by design, protective measures, or warnings. These risks may arise from various factors, including inherent limitations of the product, reasonably foreseeable misuse, or the nature of the hazards involved.

When conducting a risk assessment for CE marking, manufacturers are required to identify and evaluate all potential hazards associated with their products. They are expected to then implement appropriate measures to eliminate or minimize these risks as much as possible. However, if some residual risks still remain, manufacturers are expected to provide clear information and instructions to users on how to minimize or mitigate those risks even further.

It's important to note that CE marking does not imply that a product is entirely risk-free, but rather that it complies with the applicable EU safety requirements and that residual risks have been adequately addressed and communicated. Users and consumers are responsible for understanding and following the provided instructions and taking necessary precautions to minimize any remaining risks.

33. Applied standards​

If needed and using the standards search tool you can add harmonized standards which are relevant to the specific hazard and measures you have applied. EN ISO 1211:2010 is always listed here by default.

💡 Researching harmonized standards - an iterative process​

It is important that you demonstrate that you have considered and referenced those standards relevant to your product and the risks that your product may pose.

This is an iterative and repeating process. As hazards are identifed, standards researched, measures implemented and risks re-evaluated, your product is further developed and becomes inherently safer.

34. Select the standard to add it to your standards list.​

It will be added to the list at the bottom and referenced in both your risk assessment document and final declaration of conformity.

35. Remaining Risk Factor - new​

The recalculated risk factor is displayed at the bottom of the screen

💡 Remaining Risk Factor (R)​

CERTAIN allows you to simply research, design, document and re-evaluate risk until you decide that the remaining risk factor achieved is at an acceptable level for the product in question.

This "acceptable" level is not defined in any standards or regulations. You define the scale and the final decision is at your own discretion.

You must however demonstrate that you have considered the hazards in the context of the applicable standards and deem them adequately mitigated.

36. Click on - Save​

At this point you must save your hazard evaluation and mitigating measures. Do not forget this step or exit the browser without clicking on Save

You may return to, edit, reevaluate, delete or add an additional hazard at any time.

37. Click on - Save​

At this point you must save your hazard evaluation and mitigating measures. Do not forget this step or exit the browser without clicking on Save

You may return to, edit, reevaluate, delete or add an additional hazard at any time.

38. Risk sufficiently mitigated?​

When you finally save a hazard to your project, you must decide and confirm whether the risk mitigation measures you have documented sufficiently reduce the risk to a level you consider acceptable. Check the box if yes.

If more measures still have to be defined, save without checking the box. You can return and continue working on your hazards and measures at any time.

39. The hazard summary page​

Once a hazard is saved, you return to the hazard summary page. This lists all the hazards and their details entered for the product to this point.

Those hazards you confirmed as sufficiently mitigated are marked green. The rest remain red.

40. Display the mitigation measures​

Click on the drop down arrow to list all the your defined measures for each hazard.

41. Organising your hazard list with drag and drop​

You can change the position of any hazard in the list using drag and drop. With this function you can add and prioritize a hazard subsequently in your risk assessment.

The order the hazards appear in this list is the order they will appear in the final risk assessment document created for you by CERTAIN.

42. Creating hazard chapters​

In order to better organise your list of hazards you may group them into chapters which you can name and arrange as you wish.

These chapters can be used to group specific hazard types, reflect specific areas in the machine or simply to help you organise work in progress as a to-do list.

These chapters may be moved using drag and drop to any position in the list.

The order with which the chapters and hazards are listed in the summary here, is the order with which they will appear in in the final risk assessment document.

Click on create chapter.

43. Enter the chapter details​

Name the chapter and enter a short description.

Click on create chapter.

44. Your new hazard chapter is added​

The newly added chapter is visible at the bottom of the hazard chapter list.

45. Drag and drop your hazards into your new chapter​

Simply pull the relevant hazards using drag and drop into the new chapter.

46. Rearranging chapters​

Chapters too may be rearranged by dragging and dropping them in the order you need them in the final risk assessment document.

47. Save the risk assessment​

To make sure all updates and chapters have been recorded and correctly positioned in the right oder, click on save risk assessment.

💡 Adding Hazards and mitigation measures - showing dilligence​

CERTAIN allows you to add as many hazards and correcting mitigation measures as you have identified and defined.

The more potential hazards you identify and successfully mitigate, the safer your product will be.

The completeness of your documentation and level of detail will help you demonstrate your dilligence and attention to detail in the event of a product investigation following a safety related incident.

(v0.0.3b)