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Copyright © 2012 Rockwell Automation, Inc. All rights reserved. Rev 5058-CO900C W09 - Safety Risk Assessments Determining Machine Safety Performance Levels and Safety Integrity Levels Mike Duta & Derek Jones November 2012
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Copyright © 2012 Rockwell Automation, Inc. All rights reserved. Rev 5058-CO900C

W09 - Safety Risk Assessments Determining Machine Safety Performance Levels and Safety Integrity Levels

Mike Duta & Derek Jones November 2012

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Functional Safety

2 2 2

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Functional Safety Standards

3 3 3

“Generic” Electrical Control Systems

IEC 61508

“Machinery” Electrical Control Systems

IEC 62061

“Process” Electrical Control Systems IEC 61511

“Machinery” Control Systems (All technologies)

ISO 13849-1

SIL

PL

ISO 26262 ASIL “Automotive” Road vehicles – Functional safety

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EU Legislation

4 4

National Regulations

European Regulations

European Directive

EN ISO 13849 (i.e. Standards)

NF EN ISO 13849 France DIN EN ISO 13849 Germany UNI EN ISO 13849 Italy ÖNORM EN ISO 13849 Austria

Machinery Directive "Aim: Harmonization"

"Each Country: Adoption"

CE - Information

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Directives vs. Standards

5

Directive = Law: Machine Directive 2006/42/EC. EMC Directive 2004/108/CE. (Electromagnetic Compatibility) Low Voltage Directive 2006/95/CE (Low Voltage Directive) ATEX Directive 94/9/EC (Classified Area – Explosives) Work Equipment Directive 89/655/EEC Framework Directive "worker protection" 89/391/EEC Essential Health and Safety Requirements Machine Directive - Annex 1

Standards (European Norms) = Technical Rules Standards contain compliance assumptions:

―EN ISO 12100– Risk Reduction and Risk Assessment methodology

―EN 62061, EN ISO 13849..... – Functional safety of control systems

CE - Information

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Common Essential Health and Safety Requirements

6

Machinery Directive

Directive on "the use of work equipment" UWED

89/655/CEE EHSR’s 2006/42/EC

EHSR’s – Essential Health and Safety Requirements CE - Information

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Machinery Directive - 2006/42/EC

7

Machinery Directive - 2006/42/EC For best info see: http://ec.europa.eu/enterprise/mechan_equipment/machinery/index.htm • Clear requirement for Risk Assessment at design stage • Full Quality Assurance Scheme for Annex IV machines • No Certificate of Adequacy option for Annex IV • Clarification and relevance updated • Covers partly completed machinery

Guide to Application of the Machinery Directive http://ec.europa.eu/enterprise/sectors/mechanical/files/machinery/guide_application_directive_2006-42-ec-1st_edit__12-2009_en.pdf

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Essential Health and Safety Requirements

8

In the Machinery Directive, Annex I – the general principles for conformance are communicated

A Risk Assessment must be carried out to determine the health and safety requirements which apply to the machinery. On Initial machines, the machine concept must be developed prior to the

initial risk assessment being performed – this would be an iterative process in the beginning stages of the project

The machinery must then be designed and constructed taking into account the results of the risk assessment

Steps Outlined for a Risk Assessment: • Determine the limits of the machinery –

(intended use and reasonably foreseeable misuse) • Identify the hazards • Estimate the Risks • Evaluate the risk with a view for determining if risk reduction is required • Eliminate the hazard or reduce the risks by the application of protective

measures

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Essential Health and Safety Requirements

9

Essential Health and Safety Requirements are comprised of 1 main section and 5 supplementary sections

• These sections outline requirements for the application and functional performance of the systems / machine / documentation

Essential Health and Safety Requirements - (Main Section) Supplementary Essential Health and Safety Requirements: • For certain categories of machinery • To offset hazards due to the mobility of machinery • To offset hazards due to lifting operations • For Machinery intended for underground work • For Machinery presenting particular hazards due to the lifting of

persons

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Essential Heath and Safety Requirements (EHSR’s)

10

EHSR’s cover topics such as these (not all inclusive – see Annex I) Definitions Principles of Safety Integration Materials utilized to construct machinery Lighting Ergonomics Control Systems (Safety and Reliability) – General and specific requirements Control Devices Starting & Stopping of the machinery Selection of Control Modes Failure mode considerations – component failure, machine breakup, etc. Risks related to a list of many aspects of the use of the machinery Guarding requirements Maintenance Information for use / Marking of machinery

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Essential Heath and Safety Requirements (EHSR’s)

11

To meet the EHSR’s – there are standards. (See List in the Official European Journal) – Part of resources EN Harmonized European Standards These standards are common to all EEA countries and are produced by the

European Standardization Organizations CEN and CENELEC. Their use is voluntary but designing and manufacturing equipment to them is the most direct way of demonstrating compliance with the EHSR’s.

There are 3 types of Standards: Type A. Standards: Cover aspects applicable to all types of machines. Type B. Standards: Subdivided into 2 groups.

Type B1 STANDARDS: Cover particular safety and ergonomic aspects of machinery.

Type B2 STANDARDS: Cover safety components and protective devices. Type C. Standards: Cover specific types or groups of machines.

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Standards - EN, ISO and IEC

12

Type A EN ISO 12100 Safety of machinery. Basic principles – Risk assessment and risk reduction

Type B EN ISO 13849-1 - Safety related parts of control systems EN ISO 13850 - Emergency stop function EN / IEC 62061 - Functional safety of electrical control systems EN / IEC 60204-1 - Safety of machinery. Electrical Equipment EN 574 / ISO 13851 – Two hand controls Type C EN ISO 2860 - Earth Moving Machinery EN ISO 8230 - Safety requirements for dry-cleaning machines

EXAMPLES

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Standards for Functional Safety

13

EN ISO 12100

EN 60204

EN 61508

EN ISO 13849-1&2 IEC 62061-1 ISO 23849

EN ISO 13849 IEC 62061

EN ISO 13849 IEC/EN 62061

Other safety type standards EN ISO 14122 - Safety of machinery. Means of access to machinery ISO 14120 EN 953 - Safety of machinery --Guards EN 614-2 - Safety of machinery. Ergonomic design etc.,.etc....

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Design and Risk Assessment of the Machine

14

EN ISO 12100: 2010 - Safety of machinery -- General principles for design -- Risk Assessment and Risk Reduction

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849 and EN/IEC 62061 - Design of Safety-related Control Systems for Machinery

15

Methodology using: • Safety related control functions • System-based approach Qualitative Index of Safety: Safety Integrity Level (PL or SIL) • PL/SIL assessment methodology • Architecture orientated • Quantitative indication of safety reliability • Requirements for avoidance control of systematic failures

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 12100 – Safety of machinery -General principles for design - Risk assessment and risk reduction

16

Basic terminology, methodology and Technical principles

Hazard types: Mechanical, electrical, thermal, noise, vibration, radiation, materials and substances, ergonomic, slips trips and falls, environment.

Risk reduction

Protective measures

Inherently safe design measures

Provisions for maintainability

Preventing electrical hazards

Minimizing the probability of failure of safety functions

Safeguarding and protective measures

Signals, signs and warning devices

Indexes to more specific B type standards

EN ISO 12100 provides the frame work for the design of the risk reduction elements:

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Risk Reduction – Safety System Design

17

Time to use our brains!

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 12100: Safety of Machinery – Risk Assessment and Risk Reduction

18

• General principles • Risk estimation • Checklists of hazard types, hazardous events and hazardous situations

Risk Severity of Harm

PROBABILITY OF OCCURRENCE

Exposure to the hazard

Occurrence of the hazardous event

Possibility of avoidance

IS A FUNCTION

OF AND

See ISO TR 14121-2 for worked examples of methodologies

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Fundamental Process

19

(3) Risk Evaluation

(1) Hazard Identification

(2) Risk Estimation

Risk Reduction

Risk Tolerable

Acceptable

Unacceptable

Define the Machine Characteristics and Limits (LOM)

Next Hazard

Risk Analysis

Risk Assessment

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

An Example The Starting Point – Risk Assessment

20

EN ISO 12100 Safety of machinery — General principles for design — Risk assessment and risk reduction ISO TR 14121-2: Safety of machinery — Risk assessment — Part 2: Practical guidance and examples of methods OSHA 29 CFR 1910 Subpart O - Machinery and Machine Guarding ANSI B11.0-2010 - Safety of Machinery; General Requirements and Risk Assessment CSA Z434-04 – Safeguarding of machinery ISO 10218-1&2: Safety requirements for industrial robots

Task Analysis

Hazard Identification

Risk Estimation

Risk Evaluation

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Risk Assessment and Risk Reduction

21

Hierarchy of measures for risk reduction • Inherently safe design measures

• Safeguarding and protective measures

• Information for use / training / PPE etc.

• Personal Protective Equipment

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Protective Measures and Safety Related Control Systems - EN ISO 13849-1

22

Protective measures hazards that will be addressed by a safety related control system

Requirements for access into robot enclosure • Cleaning • Teaching • Maintenance

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Protective Measures and Safety Related Control Systems - EN ISO 13849-1

23

Functional requirements specification

1. Automatic mode – Lock the guard door when closed unless power is OFF and motion is stopped.

2. Automatic Mode - Isolate power if guard door is not closed.

3. Teach Mode - Allow power for robot teaching only with safe limited speed conditions and with local control enabling device activated and guard door open

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849-1 Recommendations for its Practical Use

24

1 – Automatic mode - Lock the guard door when closed unless power is OFF and motion is stopped.

Robot axis power status

Robot axis motion status

Release of stored energy

Lock release request

Robot in home position

Guard unlock Command Status

ON NOT STOPPED NOT RELEASED OFF

ON NOT STOPPED RELEASED OFF

ON STOPPED NOT RELEASED OFF

ON STOPPED RELEASED OFF

OFF NOT STOPPED NOT RELEASED OFF

OFF NOT STOPPED RELEASED OFF

OFF STOPPED NOT RELEASED OFF

OFF STOPPED RELEASED ON

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849-1 Recommendations for its Practical Use

25

Guard Door Status

Guard Lock Status

Output Actuators Status

OPEN UNLOCKED OFF

OPEN LOCKED OFF

CLOSED UNLOCKED OFF

CLOSED LOCKED ON

2 - Automatic Operation Mode - Isolate power if guard door is __not closed and locked

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849-1 Recommendations for its Practical Use

26

Safe Speed Guard Door Status

Manual Local Control Priority Enabled

Output Actuators Status

NO CLOSED NO OFF

NO CLOSED YES OFF

NO OPEN NO OFF

NO OPEN YES OFF

YES CLOSED NO OFF

YES CLOSED YES OFF

YES OPEN NO OFF

YES OPEN YES ON

3 - Teach Mode - Allow power for robot teaching only with safe limited speed conditions and with local control enabling device activated and guard door open

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849-1 Recommendations for its Practical Use

27

Safe Speed Guard Door Status

Manual Local Control Priority Enabled

Output Actuators Status

NO CLOSED NO OFF

NO CLOSED YES OFF

NO OPEN NO OFF

NO OPEN YES OFF

YES CLOSED NO OFF

YES CLOSED YES OFF

YES OPEN NO OFF

YES OPEN YES ON

Teach Mode Safety Function: Allow power for robot teaching only with safe limited speed conditions and with local control enabling device activated and guard door

open

Safe Speed Sensing

Door Closed Sensing

Manual Local Control

Logic Solving

Output Actuation

Shaft Encoders

Guard Interlock Switch

3 Position Enabling Device

Safe Speed Control Unit

Contactors

Safety Related Electrical Control System: Safe Limited Speed

What is the required Performance Level (PL)?

Fully decompose the safety function

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849-1 Recommendations for its Practical Use

28

Safe Speed Guard Door Status

Manual Local Control Priority Enabled

Output Actuators Status

NO CLOSED NO OFF

NO CLOSED YES OFF

NO OPEN NO OFF

NO OPEN YES OFF

YES CLOSED NO OFF

YES CLOSED YES OFF

YES OPEN NO OFF

YES OPEN YES ON

Teach Mode Safety Function: Allow power for robot teaching only with safe limited speed conditions and with local control enabling device activated and

guard door open

Safe Speed Sensing

Door position Sensing

Manual Local Control

Logic Solving

Output Actuation

Shaft Encoders

Guard Interlock Switch

3 Position Enabling Device

Safe Speed Control Unit

Contactors

a - Safe Limited Speed

Decomposition of Teach mode safety function

c – Guard door closed sensing

b – Enabling function

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849-1 Recommendations for its Practical Use

29

Safe Speed Guard Door Status

Manual Local Control Priority Enabled

Output Actuators Status

NO CLOSED NO OFF

NO CLOSED YES OFF

NO OPEN NO OFF

NO OPEN YES OFF

YES CLOSED NO OFF

YES CLOSED YES OFF

YES OPEN NO OFF

YES OPEN YES ON

Teach Mode Safety Function 1: Safe Limited Speed.

Safe Speed Sensing

Logic Solving

Output Actuation

Shaft Encoders

Safe Speed Control Unit

Contactors

Safety Related Electrical Control System: Safe Limited Speed

What is the required Performance Level (PLr)?

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849-1 - PL allocation

30

PLr allocation for each safety function For example PLr for safe limited speed function = PL?

EN ISO 13849-1 risk graph

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849-1 Safety of Machinery – Safety Related Parts of Control Systems

31

Then we choose the most suitable combination of Structure (Category), Reliability (MTTFd) and Diagnostics (DC) To achieve that Performance Level (PL)

Shaft Encoders

Safe Speed Control Unit

Contactors

Safety Related Electrical Control System: Safe Limited Speed

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849-1 Safety of Machinery – Safety Related Parts of Control Systems

32

See annex K Shaft Encoders

Safe Speed Control Unit

Contactors

Safety Related Electrical Control System: Safe Limited Speed

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849-1 Recommendations for its Practical Use

33

Shaft Encoder 2

Safe Speed Control Unit 2

Contactor 2

Shaft Encoder 1

Safe Speed Control Unit 1

Contactor 2

Shaft Encoders

Safe Speed Control Unit

Contactors

Safety Related Electrical Control System: Safe Limited Speed

MTTFd of Channel 1

MTTFd of Channel 2

PFHd or MTTFd at Subsystem level Shaft Encoder 2

Safe Speed Control Unit Contactor 2

Shaft Encoder 1

Contactor 2

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849-1 Recommendations for its Practical Use

34

Derek Jones 09/09/2010

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

EN ISO 13849-1: SISTEMA Calculation Tool

35

SISTEMA (available in multiple languages)

• PL Calculation software for EN ISO 13849-1

• Free to use

• Data Libraries available

• Independent

• Maintained

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Where can you download SISTEMA and Data?

36

Rockwell Automation Safety Resource Center at: : http://discover.rockwellautomation.com/SA_EN_Functional_Safety.aspx

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

Overview of SISTEMA

37

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

IEC 62061 – Machinery safety related E/E/PE control systems

38

IEC EN 62061 risk chart

Safety Integrity Level SIL allocation for each safety function For example safe limited speed function = SIL?

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

IEC 62061 – Machinery safety related E/E/PE control systems

39

Shaft Encoders

Safe Speed Control Unit

Contactors

Safety Related Electrical Control System: Safe Limited Speed

SIL 3 required for the Safety Function: Teach mode – Safe limited speed

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

IEC 62061 – Machinery safety related E/E/PE control systems

40

SIL 3 required for the Safety Function: Teach mode – Safe limited speed

Shaft Encoders

Safe Speed Control Unit

Contactors

Safety Related Electrical Control System: Safe Limited Speed

Subsystem SIL CL = 3

PFHD = 4.3 x 10-8

Subsystem SIL CL = 3

PFHD = 1.50 x 10-9

Subsystem SIL CL = 3

PFHD = 3.38x 10-9

Total PFHD = 4.788 x 10-8

SIL achieved = 3

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

The real world - HRN From Risk assessment to PL

41

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

The real world - HRN From Risk assessment to PL

42

Risk Assessment of overall machine

HRN Hazard rating number

Risk Reduction of overall machine

By inherently safe design of

machine and its control system

Guards & protective devices

Information & PPE

Design of safety Function(s)

ISO 13849-1

Or IEC 62061

SISTEMA

Qualitative information

Hazard Identities

Map HRN to ISO13849 / IEC 62061

Risk Graph PLr / SIL Safety Integrity

Requirement

Safety Functional Requirement

Did I increase or reduce The original HRN?

Severity? Probability?

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

The real world - HRN From Risk assessment to PL

43

Risk Assessment of overall machine

HRN Hazard rating number

Risk Reduction of overall machine

By inherently safe design of

machine and its control system

Guards & protective devices

Information & PPE

Design of safety Function(s)

ISO 13849-1

Or IEC 62061

SISTEMA

Qualitative information

Hazard Identities

Map HRN to ISO13849 / IEC 62061

Risk Graph PLr / SIL Safety Integrity

Requirement

Safety Functional Requirement

Did I increase or reduce The original HRN?

Severity? Probability?

Copyright © 2012 Rockwell Automation, Inc. All rights reserved.

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Rev 5058-CO900C

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