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LEGO Step 1 – Basic Level – Introduction machinery and equipment safety
1 Day Training
LEGO Basic Safety Training, June 6, 2013 Enrique GranadosCertified Machinery Safety Expert (TÜV Nord/Pilz),Machinery Safety Consultant Pilz de México, Convento de Actopan 36 Col. Jardines de Santa Monica, 54050Tlalnepantla, Edo de Mex
� Training IntroductionCourse Material and Certification
Course Material
Course handbook:
� Presentation reference material� Supplementary information� Exercise documents� Evaluation form
Certification of Completion
�Upon successful completion of your course, PILZ will issue youwith a Certificate
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� Training IntroductionTraining Instructor
Introduction to the Instructor
Attendee Participation
� Relate the issues covered to your workplace� Please comment if the course pace is unsuitable � Your feedback is very important to us!! Please
fill your Course Evaluation Form
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� Attendee Participation
Attendees are actively encouraged to participate in training and discussions
Questions and feedback are welcomed
Where…?
How…?
When…?
Why…?
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� Training Introduction
It sounds like English, but I can't
understand a word you're saying
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� The Company
“Ideas are nothing without action.”
Renate Pilz, Managing Partner, Pilz GmbH & Co. KG
“Ideas are nothing
without action.”
Renate Pilz, Managing Partner,
Pilz GmbH & Co. KG
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� The CompanyOstfildern, Germany: Headquarters
Safety Services teams supported Internationallly through:
� Services Research and Development
� Knowledge management
� Industry sector specialists
� Standards and best practise monitoring
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� The CompanyGlobal Player
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� The CompanySafety Services
We are the trusted provider of Safety
Services to leading national andinternational industrial companies:
� Viable solutions to the most complex safety issues
� Best manufacturing practises guarantee availability and productivity of plants
� Consistent focus on customer benefits
� Customer proximity through local knowledge, local resources and international support
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� Safety Services Machinery Life Cycle
We can implement the complete lifecycle or
provide discrete services at critical stages,
including from
� Risk Assessment
� Safety Concept
� Safety Design
� System Implementation
� Safety Validation
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� Safety Services PortfolioContinued
� Plant Assessment
Provides your organisation with an outline analysis of the safety status of all
machinery and equipment
� CE Marking
Management of activities and processes generating the necessary
compliance strategies, safety designs and documents
� International Compliance Management
Management of conformance with the ISO, IEC, ANSI and/or other standards
� ESPE Inspection
Operational safety of ESPE used to protect against mechanical hazards on
production plants
� Safety Training
Comprehensive range of training in relation to compliance and safety
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� The CompanyApprovals and Certification
Your trust is confirmed through external Accreditation
� EN 61508 through TUV� Machinery inspection through
DATech (Notified inspection body, type “C“)
Your expectations are met through internal management systems
� Competence Management� Service Quality Management� Project Management
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� Topics
Legislation
CE Marking
Safety Standards and Applications
Risk Assessments
Safe Guarding
Introduction to Safety
Safety Components
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Safety Validation
� Topics
Introduction to Safety
Motivation for SafetyKey Safety QuestionsBehavioural Based Safety
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� Motivation for Safety
General Benefits of Safety
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� Motivation for Safety
General Benefits of Safety
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� Motivation for Safety
General Benefits of Safety
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� Motivation for Safety
General Benefits of Safety
� A company performing strongly in safety has a better marketing image
� Increased Safety improve relationship with between workers, unions and the
employer
� Increased Safety improve individual and team morale
� Increased Safe practices reduces downtime and increases efficiency
� Reduced need for troubleshooting / reactive maintenance
� Creates a culture of accountability and care
� Best performing companies have best safety
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� Motivation for Safety
Economic: The total cost of accidents is like a floating iceberg
10% is visible and above sea level– Cost of recovering from injury– Employers liability– Third party / public liability– Product liability
90% is not visible and below sea level
Accident Costs
– Cost of recovering from injury– Product and material damage– Plant and building damage– Tool and equipment damage– managers’ time diverted– Emergency supplies– Clearing the site
– Production delays– Fines & Legal costs– Overtime work– Substitute labour– Investigation time– Clerical effort– Loss of expertise
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� Motivation for Safety
General Benefits of Safety
Risk Management Cost
Risk Reaction Cost Latency Cost Risk Reduction Cost
Insurance Premiums Emergency Healthcare Inspection fines and sanctions
Safeguarding Measures
Legal cost Accident compensation Loss of skilled workforce Safety Services
Heathcare On site Fines and sanction Loss of Image Safety Procedures
Loss of resourcesIncrease maintenance cost
Training
Direct Production loss Internal conflicts
Hidden production loss Production inefficiencies
Addional resourcesExtra Labour
Recover from loss of image Less Safety incentives
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� Topics
Introduction to Safety
Motivation for SafetyKey Safety QuestionsBehavioural Based Safety
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� Key Safety Questions
Questions to Address
1. Why should machinery/ plant be safe?
2. What is (machinery/ plant) safety?
3. What is the workers perspective?
4. What is an accident?
5. What is a hazard? What is a risk?
6. What are safety components?
7. Who should be carrying out safety functions?
8. When can a system / machine / plant be considered to have an acceptable level
of safety?
9. How much should be invested in safety?
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� Key Safety Questions
Question 1 Why should machinery/ plant be safe?
� It is the moral obligation of employers to provide safe work equipment, according to article 23.1 from the:
� UNIVERSAL DECLARATION OF HUMAN RIGHTS*Everyone has the right to work, to free choice of employment, to just and favourable conditions of work and to protection against unemployment
*Adopted by UN General Assembly Resolution 217A (III) of 10 December 1948
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� Key Safety Questions
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� Safety is the freedom of unacceptable risk
Question 2 What is (machinery / plant) safety?
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� Key Safety Questions
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Question 3 What is the workers perspective?
As a:� Machine manufacturer, Safety manager, Maintenance manager, Production
manager, Engineering manager or Plant engineeryou should be aware that the worker at the machine assumes that the machine is safe
However employee safety responsibilities include:� Recognizing safety hazards� Maintaining good housekeeping� Reporting safety hazards� Working safely� Using personal protective equipment (PPE)� Making the most of safety training
� Key Safety Questions
Workers Perspective??
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� Key Safety Questions
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An accident is any unforeseen or unexpected event that may or may notresult in injury or damage to property or equipment
FACT: In the time it took you to read this slide, about 10 Europeans suffered disabling injuries in accidents in industry
Question 4 What is an accident?
� Key Safety Questions
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Question 4 Accidents Primary Causes
Primary Causes = Unsafe Acts and Unsafe Conditions
� Management need to concentrate on the nature of the accident rather than the outcome
� It must be clearly understood that the primary cause of the accident is not always necessarily the most important feature; secondary causes, usually in the form of system failures can continue unless action is taken
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� Key Safety Questions
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Unsafe Acts
� Working without authority� Failure to warn others of danger� Using unsafe equipment� Using wrong equipment� Failure to issue control measures� Horseplay � Etc…
Unsafe Conditions
� Inadequate or missing machine guards
� Defective tools or equipment� Fire Hazards� Ineffective housekeeping� Excessive noise� Poor ventilation and lighting� Etc…
Question 4 Accidents Primary Causes
� Key Safety Questions
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Management System Pressures
� Financial restrictions� Lack of commitment� Lack of policy� Lack of standards� Lack of training
Social Pressures
� Group attitude� Tradition� Society attitudes to risk taking� ‘Acceptable’ behaviour in the
workplace
Question 4 Accidents Secondary Causes
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� Key Safety Questions
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Question 5 What is a hazard? What is a risk?
Hazard:� ‘hazard’ means a potential source of injury or damage to health
Risk:� ‘risk’ means a combination of the probability and the degree of an injury or damage
to health that can arise in a hazardous situation
� Key Safety Questions
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Question 6 What are Safety Components?
Safety Control System
E-Stop
Light Curtain
Safety Sensors
Safety Mat and Bumper
Two Hand Control
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� Key Safety Questions
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Question 6 What are Safety Components?
Fixed and Mobile Guard Systems
� Key Safety Questions
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Question 7 Who should be carrying out safety functi ons?
Competence means having the necessary qualifications, experience and training to be able to: � Identify all hazards, � To assess the risk related to them and � To know what control measures will reduce risk to an acceptable level
According to European Legislation personnel responsible for safety “should be able to demonstrate competence”. � Qualifications, Example: Occupational Safety and Health (MIOSH)� Training: Demonstrates knowledge specific to particular machinery, products or
processes � Experience: Demonstrates knowledge gained through experience
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� Key Safety Questions
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Question 8 When is there an acceptable level of saf ety?
When can a system / machine / plant be considered to have an acceptable level of safety?� The machine/ system/ plant has been assessed� All hazards have been identified� Appropriate safety meassures have been designed to reduce the risk to an
acceptable level� A theoretical test and analysis of the performance of the new safety system has
been calculated� Safety system has been implemented� Practical tests of the safety system and fault simulation on original components,
especially in areas where doubt exists, have been performed� Validated components and principles have been used� All safety system, test, components etc... are properly documented� All of above has been done by competent people strictly following current
standards and directives
� Key Safety Questions
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Question 9 How much should be invested in safety?
This model links the cost of accidents and the cost of risk reduction.At point A the total costs are the lowest.
Safety resources
Cost
Total Cost
Total Accident Cost
Total Safety Cost
A
SAFETY IS AN OBLIGATION.
NOT AN OPTION!!!!!!!
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� Motivation for Safety
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Safety Costs Model for Decision Making
Safety
Level
CostRisk
Reduction
Cost
Risk
reaction
Cost
Risk
Management
Cost
High
High
Latency
Risk Cost
Optimal Economic Result
TOTAL
Cost
Current Situation
� Key Safety Questions
Safety First
You should quantify
the safety first !
There is always a safer way !!!!There is always a safer way !!!!
Or more ………
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� Topics
Introduction to Safety
Motivation for SafetyKey Safety QuestionsBehavioural Based Safety
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� Behavioural Based Safety
Figure 1: The Safety Triad
Person Environment
Behaviour
Knowledge, Skills, Abilities,
Intelligence, Motives,
Personality
Equipment, Tools, Machines,
Housekeeping, Heat/Cold,
Engineering, Standards, Operating
Procedures
Complying, Coaching, Recognizing, Communicating,
Demonstrating “Actively Caring”
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� Behavioural Based Safety
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Identifying barriers to safety
Safety behaviour is often uncomfortable, less convenient, and less fun.
� Behavioural Based Safety
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Seven Basic Principles of Behaviour Based Safety
� Focus Intervention on Observable Behaviour
� Look for External Factors to Understand and Improve Behaviour
� Direct with Activators and Motivate with Consequences
� Focus on Positive Consequences to Motivate Behaviour
� Apply the Scientific Method to Improve Intervention
� Use Theory to Integrate Information, not to Limit Possibilities
� Design Interventions with Consideration of Internal Feelings and Attitudes
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� Behavioural Based Safety
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“Beneficial change results from acting people into thinking differently rather than targeting internal awareness or attitudes so as to think people into acting differently”
Principle 1: Focus Intervention on Observable Behav iour
� Behavioural Based Safety
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� Place focus on external factors –
environmental conditions and
behaviours – which can be changed
upstream from a potential injury.
� Internal person factors are difficult to
identify, and if defined, they are even
more difficult to change directly.
Principle 2: Look for External Factors to Understan d and Improve Behaviour
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� Behavioural Based Safety
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� We do what we do because of the
consequences we expect to get for
doing it
� Activators (or signals preceding
behaviour) are only as powerful as the
consequences supporting them
� This principle is referred to as the ABC
model (three-term contingency)
Principle 3: Direct with Activators and Motivate wi th Consequences
� Behavioural Based Safety
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� We perform behaviour to receive
positive consequences or to avoid or
escape negative consequences
� The type of consequences (positive or
negative) controlling our behaviour
influences our attitude towards the
task
Principle 4: Focus on Positive Consequences to Moti vate Behaviour
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� Behavioural Based Safety
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� Objective and systematic observation
enables the kind of feedback needed
to know what works and what doesn’t
work to improve behaviour
� Behaviour can be observed and
measured before and after an
intervention process is put into effect
� Feedback can be used to improve
process
Principle 5: Apply the Scientific Method to Improve Intervention
� Behavioural Based Safety
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DO IT - Behavioural Based safety is a continuous 4-s tep process
DEFINE - Behaviour(s) to target
OBSERVE - To collect baseline data
INTERVENE - To influence target behaviour(s)
TEST - To measure impact of intervention
DOIT
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� Behavioural Based Safety
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Principle 6: Use Theory to Integrate Information, n ot to Limit Possibilities
� Theory – driven research can narrow the perspective of an investigator and limit
the breadth of findings possible from the scientific method
� Many important findings in behavioural science have resulted from exploratory
investigation – “I wonder what will happen if…”
� An intervention process that works well in one situation will not necessarily be
effective in another setting
� Summarise the relationships you observe between intervention results and certain
situational or interpersonal characteristics, thereby developing a research based
theory
� Behavioural Based Safety
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Principle 7: Design Interventions with Consideratio n of Internal Feelings and Attitudes
� Internal feelings or attitudes are influenced indirectly by the type of behaviour-
based intervention procedure implemented
� The way we implement an intervention process can increase or decrease feelings
of empowerment, build or destroy trust, or cultivate or stifle a sense of teamwork or
belongingness
� Implementing/refining intervention procedures should be based on both objective
behavioural observation and subjective evaluations of internal feeling states
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� True or False…
Inadequate or missing machine guards is a secondary cause of accidents.
Management need to concentrate on the nature of the accident rather than the outcome.
Emergency Stops, Light Curtains and Safety Signs are not forms of Safety Components.
Primary Causes of accidents are Unsafe Acts and Social Pressures.
A machine has an acceptable level of safety when all hazards have been identified and adequately controlled.
�
�
�
�
�
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� Topics
Legislation
CE Marking
Safety Standards and Applications
Risk Assessments
Safe Guarding
Introduction to Safety
Safety Components
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Safety Validation
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� Topics
Legislation
Introduction to Safety LegislationAdvantages of Compliance
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� Introduction to Safety Legislation
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European Legislation
How has European Legislation come about?
� 1957 Treaty of Rome
� Old approach Directives
� Mid 1980’s Article 100a of Treaty of Rome introduced New approach Directives (now Article 95 of Amsterdam 1999)
� Objective: To promote freedom of goods, services, finance and people
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� Introduction to Safety Legislation
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European Legislation
� The EU Commission issues Directives� Approved Authorised Bodies (e.g. CEN, CENLEC) issue EU Normatives� A State sponsored body exists in each member state to secure Safety, Health and
Welfare at work, e.g. the HSA in Ireland� The Government transpose these Directives into Laws, while the HSA enforce the
Laws and issue Guidance Documentation
RECOMMENDATIONS
LAWS
EU NORMATIVES
AUTHORISED BODIES
EU DIRECTIVES
EU CommissionHealth & Safety
Authority
� Introduction to Safety Legislation
Machinery Directive must be implemented in law by all states in the European Economic Area. The directive deals with the requirements to achieve CE Marking
European Directives Geographical Scope
Austria
Belgium
Bulgaria
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
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� Introduction to Safety Legislation
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� Machinery Directive
� Low voltage Directive
� EMC Directive
� PED Directive
� ATEX Directive
(Note: There are 21 product directives issued that require CE marking of products.)
Key Legislation for CE Marking
� Introduction to Safety Legislation
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European Directives
90/396/EEC Appliances burning gaseous fuels
00/9/EC Cableway installations designed to carry persons
89/106/EEC Construction products
2004/108/EC Electromagnetic compatibility
94/9/EC Equipment and protective systems in potentially explosive atmospheres
93/15/EEC Explosives for civil uses
95/16/EC Lifts
2006/95/EC Low voltage equipment
2006/42/EC Machinery safety
2004/22/EEC Measuring instruments
90/385/EEC Medical devices: Active implantable
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� Introduction to Safety Legislation
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European Directives
93/42/EEC Medical devices: General
98/79/EC Medical devices: In vitro diagnostic
92/42/EEC New hot-water boilers fired with liquid or gaseous fluids (efficiency requirements)
90/384/EEC Non-automatic weighing instruments
94/62/EC Packaging and packaging waste
89/686/EEC Personal protective equipment
97/23/EC Pressure equipment
99/5/EC Radio and telecommunications terminal equipment
94/25/EC Recreational craft
87/404/EEC Simple pressure vessels
88/378/EEC Toys safety
� Introduction to Safety Legislation
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European Directives
Machinery Directive 2006/42/EC
The Machinery Directive is the instrument that all EU member states have adopted to establish the safety requisites machinery must posses in order to be introduced into the Community Market
Objectives� To ensure the free movement of goods in all the member states
� To ensure identical Safety requirements for machinery in every country
� To ensure a high level of safety
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� Introduction to Safety Legislation
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Machinery Directive
Responsibilities- Manufacturer
� A manufacturer is the person who is responsible for designing and manufacturing a product with a view to placing it on the Community market on his own behalf
� The manufacturer has an obligation to ensure that a product intended to be placed on the Community market is – Designed – Manufactured– Conformity assessedto the essential requirements in accordance with the provisions of the applicable Directives
� Introduction to Safety Legislation
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� To aid a supplier to fulfill the requirement of functional safety of machinery supplied to LEGO
� Based on the requirements of the MD 2006/42/EC
� The directives listed are not an exhaustive list.
LEGO Law and Standards Requirement Specification
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� Introduction to Safety Legislation
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� Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements.
� Penalties include– The illegal machine shall be recalled or replaced,– monetary penalties, (up to 20 000 € in Belgium, up to 5000 £ in the
UK) or even imprisonment – Equipment insurance coverage may be invalid.– In case of accidents or of controls from the authorities, the machine
may be blocked and withdrawn from the worksite, therefore causing a delay in the work and financial losses.
– The non-compliant machine may not be compatible with standard spare parts and/or accessories available in the EU.
Penalties for Non Compliance
� Topics
Legislation
Introduction to Safety LegislationAdvantages of Compliance
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� Advantages of Compliance
� Compliance with legislation. Legal protection
� Safe products make good business sense. Market perception
� Organizational culture
� Natural link between safety and reliability
� Employee well-being
� Points to other management failures
� Diagnosis easily possible
� Direct costs: compensation, insurance costs
� Indirect costs: downtime, investigation, replacement of staff, etc.
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� True or False…
The machinery directive ensured the free movement of goods throughout the world
The EU Commission issues Directives
Member states health and safety bodies transpose directives in to law
�
�
�
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� Topics
Legislation
CE Marking
Safety Standards and Applications
Risk Assessments
Safe Guarding
Introduction to Safety
Safety Components
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Safety Validation
� Topics
CE Marking
Regulatory OverviewOverview of Life ExampleCE Marking Examples
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� Regulatory Overview
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What is CE Marking?
CE marking is a documented physical examination and inspection of a machine, process or piece of work equipment carried out under the legislative framework of EU directives.
� Regulatory Overview
CE Marking Principles
� CE marking symbolises the conformity of the product with the applicable Community requirements imposed on the manufacturer
� The CE marking affixed to products is a declaration by the person responsible that:– The product conforms to all applicable Community provisions– The appropriate conformity assessment procedures have been completed
� Specific directives had been put in place providing the legal regulation for the affixing of the CE marking
� The CE marking is not a mark of origin, as it does not indicate that the product was manufactured in the European Community
� CE is only a claim by the manufacturer that the machinery is safe and that they have met relevant supply law. The user, also has to check that it is, in fact, safe before the machinery is used.
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� Regulatory Overview
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Scope of machinery that requires CE Marking
� Machines that are placed or put into service in the EU market for the first time
� In-house machinery where manufacturers put their own machinery into service
� Machinery Imported from outside the EU irrespective of age
� Machinery operating in the EU that was built prior to 1995 but has had significant modifications since being installed
� Machines altered beyond their original limits (e.g. Potential to Run Faster) where the Risk has increased from the original installation
.
� Regulatory Overview
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Who Does It Affect ?
The responsibility for demonstrating that the machinery satisfies the Machinery Directive rests on the machine manufacturer or the importer into the European Community.
This could affect: � Original Equipment Manufacturers (OEM’s)� Machines Imported into the European Union� Machines built for own use� Machines built for sale into the European Union� Machines altered beyond their original limits� New machines (currently being place in the market or put into service)� Old machines (if being place into the market or substantially modified)
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� Regulatory Overview
CE Method Flowchart
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� Regulatory Overview
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Requirements of the CE Marking Process
The Manufacturer (or other) must:
� Assess Machinery/ Plant against current legislation to establish which directives are applicable i.e. Machinery Directive, LVD, EMC, ATEX, etc.
� Carry out Risk Assessment� Carry out Risk Reduction (Correct and validate any failures)� Validate the machinery against the Essential Health and Safety Requirements
(E.H.S.R’s)� Verify that machine/ plant is compliant� Compile a Technical Construction File� Draw up an EC Declaration of Conformity stating which directives are applicable� Affix CE Plate
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� Regulatory Overview
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CE Plate Example
2009Year:
Type:
Serial Number:
Pilz-Ident-No.:
Manufacturer: Authorised Representative:
Plastic Extrusion
E320-450-348
P.13849.CH
Pilz IrelandModel Farm Road
Cork, IrelandTel: +353 21 4804940Tel: +353 21 4804994
DanGyo MachineryNan Chenglou
325234 Wenzhou, ChinaTel: +353 21 4804940Tel: +353 21 4804994
� Topics
CE Marking
Regulatory OverviewHow To Comply with DirectiveCE Marking Examples
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� How to Comply with the Directive
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Overview
Risk Assessment at the Design Stage:
� Apply safety at the design stage� Identify the risk to health and safety posed by the Machine � Reduce risks as far as possible by design
Self Assessment Procedure:
� For most items of machinery (with certain exceptions of those listed in Annex IV –more dangerous machinery with special requirements), the manufacturer can self-certify that they design their products to meet the requirements of the Directive and sign a Declaration of Conformity.
� The conformity process will involve using harmonised norm standards.
� How to Comply with the Directive
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Self-Assessment Procedure
Machinery manufactured in conformity with specified transposed harmonized standards will be presumed to comply with the essential health and safety requirements covered by those standards.
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� How to Comply with the Directive
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Structure of Standards
The structure of the European harmonised standards contains many interlinking standards, which allow the build of a machine without special designed machine safety standards.
� Topics
CE Marking
Regulatory OverviewOverview of LifecycleCE Marking Examples
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� CE Marking Examples
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Introduction Article 2 of Machinery Directive
The different scenarios for certification:
� Machines imported from outside the EEA with manufacturers knowledge� Machines imported from outside the EEA without manufacturers knowledge� Machines designed and built in the EEA� Subassemblies built in the EEA� Assembly's of machines built in the EEA� Machines built for customers own use in the EEA
� CE Marking Examples
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CE Marking Example 1
A non-EEA manufacturer wishes to market machinery in the EEAMade outside EAA
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� CE Marking Examples
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CE Marking Example 1Requirements
� When a manufacturer of a non-EEA country sells machinery for use on the territory of the European Union, he must comply in full with the technical and administrative requirements of the Directive in Article 5.
� CE Marking Examples
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CE Marking Example 2
The origin non-EEA manufacturer does not wish to market machinery in the EEAMade outside EAA
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� CE Marking Examples
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CE Marking Example 2Requirements
� A company located in the EEA may buy new machinery directly from a non-EEA country without the non-EEA manufacturer even knowing where it is going.
� This is also the case when an “old” machine would be moved inside a company from a plant outside the EEA to a plant inside the EEA.
� In this case this “old” machinery has to be regarded as “new”.
� The machinery directive stipulates that in this case, the user who places the product on the market is regarded as a manufacturer. He will be responsible for modifying the machinery if it does not comply with the technical requirements.
� CE Marking Examples
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CE Marking Example 3
Building a Machine or partly completed machine for Manufacture either within or outside the EEA
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� CE Marking Examples
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CE Marking Example 3Requirements
� The machinery directive treats anyone assembling machinery or machinery parts from various origins, or a user building a new machine for his own use, as a manufacturer .
� Whether or not the subassemblies come from a supplier established in the EEA is immaterial here.
� CE Marking Examples
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CE Marking Example 4
Design of a new assembly from part ly completed machines
+ +
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� CE Marking Examples
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CE Marking Example 4Requirements
� The assembler, who may be a manufacturer, assembler, engineering company or the end-user himself, designs a new assembly from several machines.
� If the assembler controls the whole project, he is regarded as responsible for supervising safety. He may buy or import subassemblies which may or may not be compliant and bear CE marking.
� CE Marking Examples
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CE Marking Example 4Requirements
� It is very important that the project manager takes care of safety from the moment the orders are placed and specifications drawn up for the components.
� It is unrealistic to assume that an assembly of machines that comply individually with the Directive will form an assembly that also conforms.
� Safety is not cumulative. The project manager must anticipate putting together an overall technical file. This overall technical file is not the sum of the documents provided by the various suppliers.
� The technical file has to describe the overall risk analysis which by definition is beyond each subassembly supplier. In fact a large part of the suppliers’ technical documentation is irrelevant to the objectives of the technical file set out by the Directive.
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� CE Marking Examples
91
� The purchase order placed with the supplier from the project manager should clearly define the nature of the safety information to carry out his overall risk analysis. There are probably many operating parameters or technical features of the subassemblies which can influence the final result.
� This information must be available or at least kept at his disposal. The same applies to instruction manuals. A manual for a complex assembly is more than a compilation of the subassembly manuals.
CE Marking Example 4Requirements
� CE Marking Examples
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CE Marking Example 5
Development of complex assemblies including (retrofit/upgrading)
+
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� CE Marking Examples
93
� "EC" declaration of conformity for assemblies of machines– In the case of assemblies of machines resulting from the joining of several
machines, the "manufacturer" may be the prime contractor who coordinates and supervises the production of the assembly.
– The end user will often be this prime contractor. An "EC" declaration of conformity might be signed jointly by several parties. In this case, it is safe to assume that the latter have committed themselves to being jointly and severally liable.
CE Marking Example 5Requirements
� CE Marking Examples
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CE Marking Example 5Requirements
� The project manager may also come onto the scene several years after the machinery has been put into service if, for example, he is modernizing a production line by installing a common control system for several machines.
� The problem lies with the use of machinery covered by Directive 2009/104/EC , as amended.
� It stipulates that “the employer shall take the measures necessary to ensure that, throughout its working life, work equipment is kept, by means of adequate maintenance, at a level such that it complies with” the European Directive applicable to it when it was first put into service or, failing this, with the technical annex to Directive 2009/104/EC, as amended”.
In the case of an “essential modification” Pilz can take over the responsibility for the conformity assessment procedures. In this case access to all safety related documents has to be guaranteed or Pilz may prepare missing documents.
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� CE Marking Examples
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CE Marking Example 6
Users building machinery for their own use made in the EEA
� CE Marking Examples
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CE Marking Example 6Requirements
� Article 2 of the machinery Directive requires users building machinery for their own use to comply with the Directive.
� This does not concern modification of machinery in service but rather design of entirely new equipment.
� Although there is no problem of freedom of movement since the machinery is not being placed on the market, the machinery Directive is applicable to ensure that this type of new machinery is as safe as that available on the market.
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� CE Marking Examples
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CE Marking Example 6Requirements
� “Where neither the manufacturer nor his authorised representative established in the Community fulfils the obligations of Article 5 (completing the CE process), these obligations shall fall to any person placing the machinery or safety component on the market in the Community. The same obligations shall apply to any person assembling machinery or parts thereof or safety components of various origins or constructing machinery or safety components for his own use”.
� CE Marking Examples
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Key Points
� “No manufacturer, whether domiciled in the EEA or not, can invoke the previous paragraph to artificially discharge himself from his responsibilities to a third party (retailer, wholesaler, user, etc.). This would be a clear misuse of the law intended to circumvent the application of the Directive. Only the person who places the machinery on the market can avail themselves of their own risk”.
� This person decides to assume the full responsibility of a manufacturer even though they are not one.
� Since the possibilities for initiating legal proceedings against a manufacturer established outside the EEA are relatively limited, it is likely that the direct importer or user will have to face the consequences alone of non-conformity or an accident.
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� Who of the following are responsible for CE Marking Machinery?
O.E.M’s
Plant Operators
Direct Machine Importers
Maintenance Departments
Machines Designed by Manufacturers for own use
Yes
Yes
Yes
No
No
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� Topics
Legislation
CE Marking
Safety Standards and Applications
Risk Assessments
Safe Guarding
Introduction to Safety
Safety Components
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Safety Validation
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� Standards
Definitions
� Standards ensure minimum desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability - and at an economical cost
� Standards are formal documents containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose
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� Standards
The main reasons are: � Worldwide progress in trade
liberalisation� Interpenetration of sectors� Worldwide communications systems� Global standards for emerging
technologies� Developing countries worldwide.
Why Standards?
For example, the format of the credit cards, phone cards, and "smart" cards that have become commonplace is derived from an ISO International Standard. Adhering to the standard, which defines such features as an optimal thickness (0,76 mm), means that the cards can be used worldwide
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� Standards
Standards for Safe Construction of Machines & Plant s
� INTERNATIONAL � EUROPE � NATIONAL
� IEC / ISO Standards � EN / ISO / IEC Standards
� DIN / EN / ISO IEC Standards
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� Standards
104
Application of Legislation and Standards
Training (Additional measures)
Inform and warn (Residual Risk)
Risk Reduction Safeguards
Risk Reduction Design
Limits of Acceptable Risk
Risk Assessment
Machine Limits
ISO 3864
ISO 11428
ISO 14120
ISO 13854
EN ISO 12100
EN ISO12100
EN ISO 12100
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� Topics
Safety Standards and Applications
Key Machine Safety StandardsCase examples
105
� Key Machine Safety Standards
� European Normatives provide a presumation of conformity to the Machinery Directive
� Application of appropriate Normatives can be used for complaince with specific EHSR‘s
� Type C standards can allow a presumption of conformity for a whole machine
Overview
106
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� Key Machine Safety Standards
A Type Standard ExampleEN ISO 12100
EN ISO 12100 Safety of machinery- General principles for design – Risk Assessment
The standard covers:
� Safeguarding and complimentary protective measures
� Selection and implementation of guards and protective devices
� Requirements for the design of guards and protective devices
� Safeguarding for reducing emissions
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� Key Machine Safety Standards
A Type Standard ExampleEN ISO 12100
Safeguarding for reducing emissions (examples)
� NoiseAdditional protective measures include, for example:
– enclosures– screens fitted to the machine;– Silencers
� VibrationAdditional protective measures include, for example, damping devices for vibration isolation between the source and the exposed person such as resilient mounting or suspended seats.
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� Key Machine Safety Standards
B Type Standard ExampleEN ISO 13857
Safety of Machinery - Safety distances to prevent hazard zones being reached by the upper and lower limbs.
This standard is used to establish adequate safety distances to be determined to prevent danger zones being reached based on the upper limbs of persons of 3 and/or 14 years old and above.
The distances detailed in the standard are based on persons who try to reach danger zones without additional aid and under the conditions specified for the different reaching situations.
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� Key Machine Safety Standards
C Type Standard ExampleEN ISO 10218-1/2
� Movements (normal or unexpected) of any part of the robot arm (including back)
� End-effector failure (separation)� Hot surfaces associated with the end-
effector; or associated equipment or workpiece
� The rotational motion of any robot axes
Robots and Robotic Devices - Safety Requirements for Industrial Robots
These standards have been created in recognition of the particular hazards that are presented by industrial robots and industrial robot systems.
These can include
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� Key Machine Safety Standards
111
� EN 953 - General requirements for design and construction of Guards.
� EN 349 - Minimum gaps to avoid crushing parts of the human body.� EN ISO 13849 - Safety-Related Parts of Control Systems� EN ISO 13850 - Emergency Stop
� EN 60204 -1 - Electrical equipment on Industrial Machines� EN ISO 13857 - Safety distances to prevent hazard zones being reached by upper
and lower limbs.
� EN 1088 - Interlock devices associated with Guards.� EN 1037 - Safety of machinery - prevention of unexpected start up.
Common Standards to Consider with Machinery
� Topics
Safety Standards and Applications
Key Machine Safety StandardsCase example
112
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� Case Example
Injection Moulding Machine
113
� Case Example
114
� Specifies the essential safety requirements for injection mouldingmachines for the processing of plastics and/or rubber.
� The safety requirements for the interaction between injection mouldingmachines and ancillary equipment are specified.
EN 201 Plastics and rubber machines - Injection Moul ding Machines -Safety requirements
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� Case Example
115
Contents� Scope� Normative references� Terms and definitions� List of significant hazards� Safety requirements and protective
measures� Verification of the safety requirements
and/or protective measures� Information for use
EN 201 Plastics and rubber machines - Injection Moul ding Machines -Safety requirements
� Case Example
116
EN 201 Plastics and rubber machines - Injection Moul ding Machines -Safety requirements
Normative ReferencesThe following are some standards which are indispensible for the application of EN201� EN 349 Minimum gaps to avoid crushing of parts of the human body� EN 574 Two-hand control devices — Functional aspects — Principles for design� EN 953 Guards — General requirements for the design and construction of fixed
and movable guards� EN 983 Safety requirements for fluid power systems and their components —
Pneumatics� EN 1088 Interlocking devices associated with guards – Principles for design and
selection� EN ISO 13732-1:2008 Ergonomics of the thermal environment — Methods for the
assessment of human responses to contact with surfaces — Part 1: Hot surfaces� EN 60204-1:2006 Electrical equipment of machines — Part 1: General
requirements
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� Topics
Legislation
CE Marking
Safety Standards and Applications
Risk Assessments
Safe Guarding
Introduction to Safety
Safety Components
117
Safety Validation
� Topics
Risk Assessments
Risk Assessment Methods
118
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� Risk Assessment Definitions
119
What is a Risk assessment?
� An overall process comprising of a risk analysis and a risk evaluation. (Definition from EN ISO 12100:2010 – Safety of machinery - General principles for design -Risk assessment and risk reduction)
� EN ISO 12100:2010Risk assessment is a series of logical steps to enable, in a systematic way, the examination of the risks associated with machinery. Risk assessment is followed where necessary by risk reduction
� Risk Assessment Methods & Systems
120
Overview of Risk Assessment Methods
Risk Assessment
� A comprehensive estimation of the probability and the degree of the possible injury or damage to health in a hazardous situation in order to select appropriate safety measures
Purpose
� Identify hazards with equipment� Estimate the risk� Evaluate the risk� Determine countermeasures to reduce/ eliminate risk
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� Risk Assessment Methods & Systems
Overview of Risk Assessment Methods
121
� Risk Assessment Methods & Systems
122
Methods for Hazard Identification & Analysis
Methods for Risk Assessment can be grouped into 2 p rinciple types
� 1. Deductive methods: – The final event is assumed and the events which could cause this final event are
then sought– Fault Tree Analysis
� 2. Inductive methods: – The failure of a component is assumed. The subsequent analysis identifies the
events which this failure could cause– Preliminary Hazard Analysis– Risk Matrix– HAZOP
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� Risk Assessment Methods & Systems
123
Fault Tree Analysis
� Fault tree diagrams (or negative analytical trees) are logic block diagrams that display the state of a system (top event) in terms of the states of its components (basic events)
� An undesired effect is taken as the root ('top event') of a tree of logic
� Each situation that could cause that effect is added to the tree as a series of logic expressions
� Risk Assessment Methods & Systems
124
Preliminary Hazard Analysis
� An initial system safety study of potential system hazards
Risk = Probability x Severity = R = P x S
� Identify, for all phases of life of a machine, the hazards which could lead to an accident
� Qualitative evaluation of the degree of possible injury or damage to health� Methods which can be used to evaluate the risk include:
– Risk Matrix– Hazard Rating number
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� Risk Assessment Methods & Systems
125
Risk Matrix
� This method is based on the definition of risk (A combination of the probability and the degree of the possible injury or damage to health) and the principle of Iso-risk contour
Risk = Probability x Severity = P x S
Iso – Risk Contours
PROBABILITYNEVER
0
SE
VE
RIT
Y
R1
R2
R3
� Risk Assessment Methods & Systems
126
� The aim with this WRA is to improve your working environment during the change-over and the maintenance which also prevents that you will develop a work-related nuisance.
� Yes/No Questionnaire with the following sections:– Machines– Other kinds of Hazards– Internal transport– Impact on movements, fall– Working positions – Working environment
LEGO Workplace Risk Assessment
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� Risk Assessment
127
Points to Remember
� The machine’s risk assessment should cover all phases of its life.
� It should also cover all personnel who will interface with the machine during this life span.
� Take into account correct use and reasonably foreseeable misuse.
– Reasonably foreseeable misuse is defined in EN ISO 12100 as use of a machine in a way not intended by the designer, but which may result from readily predictable human behaviour.
� Topics
Legislation
CE Marking
Safety Standards and Applications
Risk Assessments
Safe Guarding
Introduction to Safety
Safety Components
128
Safety Validation
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� Topics
Safe Guarding
Introduction
129
� Safe Guarding
130
Finding a BalanceReduce Risks as far as is reasonably practical
Machinery
Tolerability Factors
Quality/Rigour
Safety FunctionsProbability
(assuming failure of safety function)
Consequences
Safety Requirements
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� Safe Guarding
131
� Safe Guarding
132
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� Safe Guarding
Die
Stripper plate
133
� Safe Guarding
134
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135
� Safe Guarding
� Topics
Legislation
CE Marking
Safety Standards and Applications
Risk Assessments
Safe Guarding
Introduction to Safety
Safety Components
136
Safety Validation
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� Safety Components
137
� Safety components are the means by which we can apply appropriate safety to machinery in a practical sense
� Through on-going technological advancements we have more and more flexibility in the way we apply safety to machinery
� This allows us to produce more productive and user friendly machinery and production lines
� More importantly we can now manufacture SAFER machinery and production lines
Overview
Safeguarding
Guards
Safety Devices
� Safety Components
Safeguards are provided to protect persons from hazards which cannot be removed or designed out
Two types of safeguards exist, guards and protective devices
Guards are defined as:� “physical barrier, designed as part of the machine, to
provide protection.” EN ISO 12100
Protective Devices are defined as:� “safeguard other than a guard” EN ISO 12100
Overview
138
Safeguarding
Guards
Safety Devices
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� Safety Components
139
Safety component means a component:
� Which serves to fulfil a safety function, and
� Which is independently placed on the market, and
� The failure and/or malfunction of which endangers the safety of persons, and
� Which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function.
� Annex V Provides a list of Safety components
Machinery Directive 2006/42/ECNew Definition: Safety Component Article 2(c)
Safeguarding
Guards
Safety Devices
� Safety Components
140
� Removable mechanical transmission devices guards� Persons detection protective devices d� Power-operated interlocking movable guards� Logic units to ensure safety functions� Valves with additional means for failure detection
intended for the control of dangerous movements on machinery
� Guards and protective devices designed to protect persons against moving parts involved in the process on the machinery
� Monitoring devices for loading and movement control in lifting machinery
� Restraint systems to keep persons on their seats� Emergency stop devices� Two-hand control devices
Indicative listing of Safety Components covered by the Machinery Directive 2006/42/EC in Annex V:
Safeguarding
Guards
Safety Devices
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� Safety Components
141
This standard has been modified to take into consideration the changes to the fixing requirements of the new Machinery Directive.The standard defines the types of Guards as:� Fixed Guards� Enclosing Guards� Distance Guards� Movable Guards� Power Operated Guards� Self Closing Guards� Control Guards� Adjustable Guards� Interlocking Guards� Interlocking Guards with Guard Lock
EN 953 Safety of Machinery - General requirements fo r the Design of Fixed and Movable Guards
Safeguarding
Guards
Safety Devices
� Safety Components
142
� Climbing on guards shall as far as practicable be inhibited by design
� Guards must offer adequate viewing to minimise the need to remove them
� Guards must be designed to prevent parts of the body from reaching danger zones
� Verification that guards comply shall be by measurement
� Safety Distance Tables– Low Risk
– Where there is a low risk from a friction or abrasion hazard
– High Risk– Where there is a high risk from an
entanglement hazard
General Requirements
Safeguarding
Guards
Safety Devices
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� Safety Components
143
Fixed Guard� Must be kept in place permanently e.g. welded� Held with fasteners making it impossible to remove
without the use of tools (not with a coin or nail file)� Where possible be unable to remain in place without
their fixings
Fixed Guard Types� Enclosing Guard� Distance Guard
Fixed Guard
Fixed Guarding
Interlocking Guards
Adjustable Guards
Moveable Guards
Interlocking Guards with Guard Locking
Guards
� Safety Components
144
Fixed Guard Example
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� Safety Components
145
Movable Guard � Guard generally connected by mechanical means
(hinges or slides) to the machine frame or an adjacent fixed element
� Can be opened without the use of tools
Movable Guard Types� Power Operated Guard � Self Closing Guard� Control Guard
Moveable Guard
Fixed Guarding
Interlocking Guards
Adjustable Guards
Moveable Guards
Interlocking Guards with Guard Locking
Guards
� Safety Components
146
Moveable Guard Example
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� Safety Components
147
Adjustable Guard� A guard which is adjustable as a whole or
incorporates adjustable parts� Allow access to areas only where it is strictly
necessary� Adjustable manually or automatically� Reduces the risk of ejection� Not be easily removed� Easily adjustable
without the use of tools
Adjustable Guard
Fixed Guarding
Interlocking Guards
Adjustable Guards
Moveable Guards
Interlocking Guards with Guard Locking
Guards
� Safety Components
148
Adjustable Guard Example
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� Safety Components
149
Guard associated with an interlocking device so that:
� Hazardous machine functions covered by the guard cannot operate until the guard is closed
� A stop command must be given when the guard is open
� Closing the guard does not itself initiate the operation of the moving parts within the danger zone
Interlocking Guard
Fixed Guarding
Interlocking Guards
Adjustable Guards
Moveable Guards
Interlocking Guards with Guard Locking
Guards
� Safety Components
150
Interlocking Guard Example
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� Safety Components
151
Guard associated with an interlocking device and a guard locking device so that:
� Parts must be prevented from moving while the danger zone is being accessed
� A stop command must be given when the guard is open
� Closing and locking the guard does not itself initiate the operation of the moving parts within the danger zone
Interlocking Guard with Guard Locking
Fixed Guarding
Interlocking Guards
Adjustable Guards
Moveable Guards
Interlocking Guards with Guard Locking
Guards
� Safety Components
Interlocking Guard with Guard Locking Example
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� Safety Components
153
� Interlocking Devices
� Light Curtains
� Safety Mats
� Two Hand Control
� Safety Scanners
� Mechanical Trip Devices
� Safety Strips
Safety Devices
Safeguarding
Guards
Safety Devices
� Safety Components
154
“Mechanical, electrical or other type of device, the purpose of which is to prevent the operation of machine elements under specified conditions (generally as long as a guard is not closed)”
Guarding Associated with Interlocking Devices
� Movable Guard
� Interlocking Guard
� Interlocking Guard with Guard Locking
Interlocking Devices
Interlocking Devices
Safety Sensors
Two Hand Control
Light Curtains
Emergency Stop
Safety Control Systems
Safety Devices
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� Safety Components
Interlocking Devices Examples
155
� Safety Components
156
Application
� Regular Access is required to hazardous areas� Only suitable if there is no risk of material being
ejected from the machine
Light Curtains
Interlocking Devices
Safety Sensors
Two Hand Control
Light Curtains
Emergency Stop
Safety Control Systems
Safety Devices
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� Safety Components
157
Three types available
� Type I� Type II� Type III
Two Hand Controls are only of value to one operator
Other safeguards should be considered when appropriate
Two Hand Control
Interlocking Devices
Safety Sensors
Two Hand Control
Light Curtains
Emergency Stop
Safety Control Systems
Safety Devices
� Safety Components
Two Hand Control
158
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� Safety Components
159
Pressure Sensitive Mats� Cease dangerous functions of machinery when
pressure is applied� Placed around hazardous areas of machines� Used in conjunction with other safety measures� Can withstand large forces
Safety Sensors - Safety Mats
Interlocking Devices
Safety Sensors
Two Hand Control
Light Curtains
Emergency Stop
Safety Control Systems
Safety Devices
� Safety Components
160
Safety Laser Scanners � 180 degree scan� Safe zone� Warning zone� Trip zone� 2 Dimensional Scan� Programmed to “see” static objects in its path� Suitable for unmanned guided vehicles or areas
around large machinery
Safety Sensors - Safety Scanners
Interlocking Devices
Safety Sensors
Two Hand Control
Light Curtains
Emergency Stop
Safety Control Systems
Safety Devices
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� Safety Components
161
Emergency StopOverview
Interlocking Devices
Safety Sensors
Two Hand Control
Light Curtains
Emergency Stop
Safety Control Systems
Safety Devices� Positive Mechanical Action� An actuator that performs an emergency stop
command must remain latched-in� To reset emergency stop command the actuator will
need to be (unlatched)� The control device that generates the emergency
stop signal must maintain the emergency stop command until it is reset
� Resetting the control device shall only be by a manual action
� Resetting the control device shall not by itself create a restart
� Safety Components
162
Emergency StopThree Categories of Stops (IEC 60204-1 & NFPA 79)
Interlocking Devices
Safety Sensors
Two Hand Control
Light Curtains
Emergency Stop
Safety Control Systems
Safety Devices� Category 0
“Stopping by immediate removal of power to the machine actuators (I.e. an uncontrolled stop)”
� Category 1“a controlled stop with power available to the
machine actuators to achieve the stop and then removal of power when the stop is achieved”
� Category 2“a controlled stop with power left available to the
machine actuators”
Category 0 & Category 1 are Emergency Stops
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� Safety Components
163
Emergency StopActuators Types
Interlocking Devices
Safety Sensors
Two Hand Control
Light Curtains
Emergency Stop
Safety Control Systems
Safety DevicesDifferent forms of Emergency Stop Actuators� Mushroom push-buttons� Wires, Ropes� Foot pedals� Handles
� Safety Components
164
Emergency StopColours
Interlocking Devices
Safety Sensors
Two Hand Control
Light Curtains
Emergency Stop
Safety Control Systems
Safety DevicesEmergency Stop Colours
� Actuator Colour – Red� Background Colour – Yellow
Additional Items to consider:� Labels� Marker flags on wires or ropes
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� Safety Components
165
Safety Relays� Suitable for all safety levels
Safety PLC� Complex Safety Solutions
SafetyBUS� Simplifies the implementation of safety systems
Safety Control Systems
Interlocking Devices
Safety Sensors
Two Hand Control
Light Curtains
Emergency Stop
Safety Control Systems
Safety Devices
� Safety Components
166
Safety Relays� Suitable for all safety levels of lower complexity
Safety PLC� Complex Safety Solutions� Extremely Flexible, with diagnostic value
Safety Fieldbus systems � Simplifies the implementation of safety systems� De-centralised network of safety inputs and outputs
Safety Control Systems
Interlocking Devices
Safety Sensors
Two Hand Control
Light Curtains
Emergency Stop
Safety Control Systems
Safety Devices
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� Safety Components
Safety Control Systems Examples
167
� Safety Components
168
Additional Measures
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� Safety Components
169
On Completion of a Risk Reduction it may be:� Necessary to provide additional safety
measures due to residual risk
Additional Measures can include:� Personal Protection Equipment� Safe Working Procedures� Fixed Warning Signs� Training
Additional Measures
“Okay, I’ve put the warning signs inside the grinder. You can turn it on now.”
� Safety Components
170
Additional Measures
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� Can you identify each guard type?
Fixed Distance Guard Self-Closing Guard
Adjustable Guard Tunnel Guard
171
� Topics
Legislation
CE Marking
Safety Standards and Applications
Risk Assessments
Safe Guarding
Introduction to Safety
Safety Components
172
Safety Validation
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� Topics
Safety Validation
Introduction to Safety Validation
173
� Introduction to Safety Validation
Overview
Definition:A Safety Validation process is a documented examination of a machine, process or piece of work equipment carried out under the guidelines of national and/ or international standards comparing the actual status with a desired result
Purpose:The purpose of the Safety Validation is to check for proper implementation of safety design by verifying the machine safety functions with the requirement specifications
Validation can be delivered as a service as part of system implementation project or as a stand-alone service assuring machinery safety
174
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� Introduction to Safety Validation
Requirements for Validation
Tasks performed for validation depend on the machine in question and the life cycle but may include:
� Review of machine risks
� Mechanical guarding examination
� Safety related Control-circuit examination
– Electrical examination
– Fluid power system examination
� Safety related Software examination
� Functional safety test
� CE Marking Validation
– Installation examination (EMC, LVD, other EU directives)
– EHSR examination (Noise, Ergonomic,…)
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� Introduction to Safety Validation
Relevant Standards
IEC 62061: Safety of machinery – Functional safety of safety-related electrical,electronic and programmable electronic control systems
ISO 13849-1 Safety of machinery - Safety related parts of control systems Part 1: General Principles for Design
ISO 13849-2 Safety of machinery - Safety related parts of control systems Part 2: Validation
EN 60204-1:2006 Safety of machinery – Electrical equipment of machines – Part 1: General requirements
IEC 61508-2 Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems
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� Introduction to Safety Validation
Relevant Legislation
� Europe
– EC Directive 2006/42/EC Annex I (Machinery Directive)
– EC Directive 2009/104//EC Annex I (Use of Work Equipment Directive)
– EC Directive 2006/95/EC (Low Voltage Directive)
– EC Directive 2004/108/EC (EMC Directive)
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� Introduction to Safety Validation
178
Machinery Directive
� All machinery being placed into Service in the EC must comply with the essential health and safety requirements (EHSR’s) listed in Annex I of the Machinery Directive 2006/42/EC.
� This applies to assemblies of machines, complete machines and partly completed machines.
� The manufacturer or the authorised representative is responsible for the compliance of the machine.
� The Essential Health and Safety Requirements (ESHR) validation list outlines the requirements listed in Annex I of the Machinery Directive
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179
Use of Work Equipment Directive (UWED)
� A UWED Validation is an assessment of a machine to ensure conformance to the requirements of the Use of Work Equipment Directive (UWED) 2009/104/EC.
� The directive states that users of machinery must establish compliance of all work equipment irrespective of age.
� It is especially applicable to machines equipment put into service before January 1995 (pre Machinery Directive) or work equipment that is not subject to the Machinery Directive.
� The UWED has been transposed into national law in the EU member states. However, each state is free to increase local requirements and add additional obligations. Therefore, check compliance of the checklist with the applicable national law also.
� Technical documentation of the machine is required for the Validation.
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Electro Magnetic Compatibility (EMC)
� Compliance verification of each relevant component� Adequate installation according to the manufacturers’ requirements� Validated on site at the existing machine� A checklist can be created for use on site
Critical issues may be:� Grounding and filtering on frequency converters� Surge suppressors on contactors and valves� Grounding on electronic components like controller, HMI� Shielding � Separated cables for run of power and control signals � Proper size and star topology on grounding and bonding� Grounding of metal components (wiring duct, cabinets, …)� Shielding of high frequency cables of drives/ motors� Correct fixation of electrical connections and earth� Large-area connection of shielding
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Low Voltage Directive (LVD)
Can Be used for Machinery Directive 2006/42/EC or LVD 2006/95/ECAccording to IEC 60204-1: chapter 18 the following verifications shall be completed:,
The verifications shall always include the items a), b) and f) and may include one or more of the items c) to e):
a) verification that the electrical equipment complies with its technical documentation;
b) in case of protection against indirect contact by automatic disconnection, conditions for protection by automatic disconnection shall be verified according to 18.2;
c) insulation resistance test (see 18.3);d) voltage test (see 18.4);e) protection against residual voltage (see 18.5);f) functional tests (see 18.6).
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Other Validation Requirements
Pneumatic Validation� The construction and design of the pneumatic equipment shall be validated against
the requirements of the Machinery Directive (MD), the standard ISO 4414: Pneumatic fluid power - general rules and safety requirements for systems and their components, and may also include the additional pneumatic requirements of the specific machinery standard(s)
Hydraulic Validation� The construction and design of the hydraulic equipment shall be validated against
the requirements of the Machinery Directive (MD), the standard ISO 4413: Hydraulic fluid power - general rules and safety requirements for systems and their components: and the additional hydraulic requirements of the specific machinery standard(s)
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Other Validation Requirements
Mechanical Safety Guarding Validation� The construction and design of the mechanical safety gates and fences shall be
validated against the requirements of the Machinery Directive (MD) and the applicable standards – EN 953: Safety of machinery – Guards – General requirements for the design
and construction of fixed and movable guards– ISO 13857: Safety of machinery - Safety distances to prevent hazard zones
being reached by upper and lower limbs– EN 349: Minimum gaps to avoid crushing of parts of the human body– The additional requirements of the specific machinery standard(s) may also be
required
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Other Validation Requirements
Ergonomics Validation� Assesses the construction and design of the machine and the working issues and
positions will be validated. All negative body burdens and stresses for the operator shall be discovered. (EN 13861 Safety of machinery - Guidance for the application of ergonomics standards in the design of machinery)
Noise Validation� Noise measurements can be completed according to several standards also
depending on the size of the machine and the environment it is located(EN 11200, EN ISO 3744)
PL/SIL Validation� Verification that the installed Safety Control system meets the required PL/SIL.
(PL : ISO 13849-1, SIL: IEC 62061)
03-06-2013
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� Introduction to Safety Validation
185
EN 13861 Table A.1 Example
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pres
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