1、 ISO 2012 Safety of machinery Risk assessment Part 2: Practical guidance and examples of methods Scurit des machines Apprciation du risque Partie 2: Lignes directrices pratiques et exemples de mthodes TECHNICAL REPORT ISO/TR 14121-2 Second edition 2012-06-01 Reference number ISO/TR 14121-2:2012(E) I
2、SO/TR 14121-2:2012(E) ii ISO 2012 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2012 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without
3、permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ISO/TR 14121-2:2012(E)
4、ISO 2012 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 T erms and definitions . 1 4 Preparation for risk assessment . 1 4.1 General . 1 4.2 Using the team approach for risk assessment . 2 5 Risk assessment process . 3 5.1 General . 3 5.2 Dete
5、rmination of the limits of the machinery 3 5.3 Hazard identification . 4 5.4 Risk estimation 6 6 Risk estimation tools 9 6.1 General . 9 6.2 Risk matrix 9 6.3 Risk graph .12 6.4 Numerical scoring .14 6.5 Hybrid tool .15 7 Risk evaluation .19 8 Risk reduction 19 8.1 General .19 8.2 Inherently safe de
6、sign 19 8.3 Safeguarding 20 8.4 Complementary protective/risk reduction measures 21 8.5 Information for use .21 8.6 Standard operating procedures 22 9 Risk assessment iteration .22 10 Documentation of risk assessment 22 Annex A (informative) Example application of the process of risk assessment and
7、risk reduction .23 Bibliography .38 ISO/TR 14121-2:2012(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committ
8、ees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Int
9、ernational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International
10、Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In exceptional circumstances, when a technical committee has collected data of a different ki
11、nd from that which is normally published as an International Standard (“state of the art”, for example), it may decide by a simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature and does not have to be reviewed until the
12、 data it provides are considered to be no longer valid or useful. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TR 14121-2 was prepared by Tech
13、nical Committee ISO/TC 199, Safety of machinery. This second edition cancels and replaces the first edition ( ISO/TR 14121-2:2007), which has been revised as follows: the examples previously given in Annex A, as well as the description of quantified risk estimation, have been deleted; the explanatio
14、ns of the methods or tools, taken from Annex A, are now presented in 5.3.5 for hazard identification and 5.4.4.1 for risk estimation; the terminology and criteria have been revised; Consequently, the information is given more clearly and completely, and in line with ISO 12100. (ISO 14121-1 was withd
15、rawn after having been replaced by ISO 12100:2010.) iv ISO 2012 All rights reserved ISO/TR 14121-2:2012(E) Introduction The purpose of risk assessment is to identify hazards, and to estimate and evaluate risks so that they can be reduced. There are many methods and tools available for this purpose a
16、nd several are described in this document. The method or tool chosen will largely be a matter of industry, company or personal preference. The choice of a specific method or tool is less important than the process itself. The benefits of risk assessment come from the discipline of the process rather
17、 than the precision of the results: as long as a systematic approach is taken to get from hazard identification to risk reduction and all the elements of risk are considered. Adding protective/risk reduction measures to a design can increase costs and can restrict the facility of use of the machine
18、if added after a design has been finalized or the machinery itself has already been built. Changes to machinery are generally less expensive and more effective at the design stage, so it is advantageous to perform risk assessment during machinery design. It can be useful to review the risk assessmen
19、t when the design has been finalised, when a prototype exists and after experience of the use of the machinery. Apart from the risk assessment made at the design stage, during construction and commissioning, the principles and methods presented in this document can also be applied to existing machin
20、ery during revision or modification of machinery or at any time for the purpose of assessing existing machinery, for example, in the case of mishaps or malfunctions. ISO 2012 All rights reserved v Safety of machinery Risk assessment Part 2: Practical guidance and examples of methods 1 Scope This Tec
21、hnical Report gives practical guidance on conducting risk assessment for machinery in accordance with ISO 12100 and describes various methods and tools for each step in the process. It gives examples of different measures that can be used to reduce risk and is intended to be used for risk assessment
22、 on a wide variety of machinery in terms of complexity and potential for harm. Its intended users are those involved in the design, installation or modification of machinery (for example, designers, technicians or safety specialists). Annex A provides a specific example for a risk assessment and a r
23、isk reduction process. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced docume
24、nt (including any amendments) applies. ISO 12100:2010, Safety of machinery General principles for design Risk assessment and risk reduction 3 T erms and definitio ns For the purposes of this document, the terms and definitions given in ISO 12100 and the following apply. 3.1 manufacturer supplier ent
25、ity (for example, designer, manufacturer, contractor, installer, integrator) who provides equipment or services associated with machinery or parts of machinery. Note to entry: A user can also act in the capacity of a supplier to himself. 4 Preparation for risk assessment 4.1 General The objectives a
26、nd scope for any risk assessment should be defined at the outset. The risk assessment based on ISO 12100 covers the whole machinery, including the control system of the machinery and should be carried out by the manufacturer. NOTE See Clause 1 for suggested uses/users of risk assessment. TECHNICAL R
27、EPORT ISO/TR 14121-2:2012(E) ISO 2012 All rights reserved 1 ISO/TR 14121-2:2012(E) 4.2 Using the team approach for risk assessment 4.2.1 General Risk assessment is generally more thorough and effective when performed by a team. The size of a team varies according to a) the risk assessment approach s
28、elected, b) the complexity of the machine, and c) the process within which the machine is utilized. The team should bring together knowledge on different disciplines and a variety of experience and expertise. However, a team that is too large can lead to difficulty remaining focused or with reaching
29、 consensus. The composition of the team can vary during the risk assessment process according to the expertise required for a specific problem. A team leader, dedicated to the project, should be clearly identified as the success of the risk assessment depends on his or her skills. As risk estimation
30、 should be done by a team and generate consensus, it cannot be expected that the detailed results will always be the same with different teams analysing similar situations. However, it is not always practical to set up a team for risk assessment and it can be unnecessary for machinery where the haza
31、rds are well understood. NOTE Confidence in the findings of a risk assessment can be improved by consulting others with the knowledge and expertise such as that outlined in 4.2.2 and by another competent person reviewing the risk assessment. 4.2.2 Composition and role of team members The team should
32、 have a team leader. The team leader should be fully responsible for ensuring that all the tasks involved in planning, performing and documenting (in accordance with ISO 12100:2010, Clause 7) the risk assessment are carried out and the results/recommendations are reported to the appropriate person(s
33、). Team members should be selected according to the skills and expertise required for the risk assessment. The team should include those people who a) can answer technical questions about the design and functions of the machinery, b) have actual experience of how the machinery is operated, set-up, m
34、aintained, serviced, etc., c) have knowledge of the accident history of this type of machinery, d) have a good understanding of the relevant regulations, standards, in particular ISO 12100, and any specific safety issues associated with the machinery, and e) understand human factors (see ISO 12100:2
35、010, 5.5.3.4). 4.2.3 Selection of methods and tools This document is intended to be used for risk assessment on a wide variety of machinery in terms of complexity and potential for harm. There are also a variety of methods and tools for conducting risk estimation (see 5.4.4). When selecting a method
36、 or tool for estimating risk consideration should be given to the machinery, the likely nature of the hazards and the purpose of the risk assessment. Consideration should also be given to the skills, experience and preferences of the team for particular methods. Clause 5 offers additional informatio
37、n on criteria for the selection of appropriate methods and tools for each step of the risk assessment process. 4.2.4 Source of information for risk assessment The information required for risk assessment is listed in ISO 12100:2010, 5.2. This information can take a variety of forms, including techni
38、cal drawings, diagrams, photos, video footage, information for use including 2 ISO 2012 All rights reserved ISO/TR 14121-2:2012(E) maintenance information and standard operating procedures (SOP) as available. Access to similar machinery or a prototype of the design, where available, is often useful.
39、 5 Risk assessment process 5.1 General The following subclauses explain what has to be considered at each step of the risk assessment process as shown in ISO 12100:2010, Figure 1. 5.2 Determination of the limits of the machinery 5.2.1 General NOTE This subclause elaborates on some of the requirement
40、s of ISO 12100:2010, 5.3. The objective of this step is to have a clear description of the mechanical and physical properties, functional capabilities of the machinery, its intended use and reasonably foreseeable misuse, and the type of environment in which it is likely to be used and maintained. Th
41、is is facilitated by an examination of the functions of the machinery and the tasks associated with how the machinery is used. 5.2.2 Functions of the machinery (machine-based) Machinery can be described in terms of distinct parts, mechanisms or functions based on its construction and operation such
42、as power supply, control, modes of operation, feeding, movement/travelling, lifting, machine frame or chassis which provides stability/mobility, and attachments. When protective/risk reduction measures are introduced into the design their functions and their interaction with the other functions of t
43、he machinery should be described. A risk assessment should include a look at each functional part in turn, making sure that every mode of operation and all phases of use are properly considered, including the humanmachine interaction in relation to the identified functions or functional parts. 5.2.3
44、 Uses of the machinery (task based) By considering all persons who are intended to interact with the machinery in a given environment (for example, factory, domestic), the use of the machinery can be described in terms of the tasks associated with the intended use and the reasonably foreseeable misu
45、se of the machinery. NOTE See ISO 12100:2010, Table B.3 for a list of typical/generic machinery tasks. ISO 2012 All rights reserved 3 ISO/TR 14121-2:2012(E) Machinery manufacturer/supplier and user should communicate with one another wherever possible in order to be sure that all uses of the machine
46、ry, including reasonably foreseeable misuses, are identified. Analysis of tasks and work situations should therefore involve operation and maintenance personnel. The following should also be considered: a) information for use supplied with the machinery as available, b) the easiest or quickest way t
47、o carry out a task can be different from the tasks stipulated in manuals, procedures and instructions, c) reflex behaviour of a person when faced with a malfunction, incident or failure when using the machine, and d) human error. The consideration of individual conditions for the use/operation of a
48、machine are valid as far as this knowledge can reasonably be achieved by the designer/manufacturer. In those cases the manufacturer should consider the intended use and the reasonably foreseeable misuse. 5.3 Hazard identificatio n 5.3.1 General NOTE 1 See ISO 12100:2010, 5.4. The objective of hazard
49、 identification is to produce a list of hazards, hazardous situations and/or hazardous events that allows the possible accident scenarios to be described in terms of how and when a hazardous situation can lead to harm. A useful starting point for relevant hazards is ISO 12100:2010, Annex B, which can be used as a generic checklist. Other sources for hazard identification could be based on the information indicated in ISO 12100:2010, 5.4. NOTE 2 An example of a tool for hazard identification is given in 5.3.5. It is