Clarification of requirements and responsibilities in the early stages of modernisation projects

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Jaakko Raudaskoski

CLARIFICATION OF REQUIREMENTS AND RESPONSIBILITIES IN THE EARLY STAGES OF MODERNISATION PRO-

JECTS

Diploma Thesis Faculty of Engineering and Natural Sciences Jouni Mattila Jari Seppälä

May 2021

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ABSTRACT

Jaakko Raudaskoski: Clarification of requirements and responsibilities in the early stages of modernisation projects.

Master thesis Tampere University

Master’s Degree Programme in Automation Engineering May 2021

Companies across sectors are increasingly willing to consider modernising existing machines as an alternative to buying new ones. By modernising a machine, a cost-effective solution can be achieved that will increase the lifetime of the machine by up to decades.

The introduction of the Machinery Directive (MD) has helped to increase the safety of new machinery, but its interpretability poses challenges for the modification of existing machinery.

The aim of this study is to clarify the requirements and responsibilities of the Original Equip- ment Manufacturer (OEM) in the early stages of modernisation projects. In this context, the early stages cover the project from the beginning to the writing of the contract.

The theoretical part of the thesis describes the machine related legislation and its origins in Finland and Europe. The section also describes the uniform European legislation linked to machinery through the MD. After this standardisation and harmonised European standardisation will be examined. Finally, the theory deals with the machinery risk assessment and the general obligations between different economy operators in relation to machinery.

The work clarifies the research question by opening sub-questions. Separate process and evaluation criteria will be created for evaluating the significance of a modification in machinery.

With regard to the interpretation of legislation and the machinery modifications, benchmarking is carried out with companies offering similar modification services.

A path to clarify the requirements and responsibilities of a OEM is created based on theory and benchmarking. The purpose of the process path is to indicate which activities need to be considered so that the OEM or modifier knows that they have fulfilled their role legally and have taken into account health and safety decrees in the early stages of the project.

Keywords: Safety, Modernisation, Machinery legislation, Risk assessment

The originality of this thesis has been checked using the Turnitin OriginalityCheck service.

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TIIVISTELMÄ

Jaakko Raudaskoski: Vaatimusten ja vastuiden selventäminen modernisointiprojektien alkuvaiheessa.

Diplomityö

Tampereen yliopisto Automaatiotekniikka Toukokuu 2021

Nykyään monilla eri aloilla toimivat yritykset ovat lisääntyvässä määrin halukkaita miettimään nykyisten koneiden modernisointia vaihtoehtona uusien ostamiselle. Koneen modernisoinnilla voidaan saavuttaa kustannustehokas ratkaisu, joka lisää koneen elinikää jopa vuosikymmeniä.

Konedirektiivin voimaantulo on auttanut lisäämään uusien koneiden turvallisuutta, mutta se ai- heuttaa haasteita käytössä olevien koneiden muutostöissä tulkinnanvaraisuutensa takia.

Tässä tutkimuksessa tavoitteena on selventää koneen valmistajan vaatimuksia ja vastuita modernisointiprojektien alkuvaiheessa. Alkuvaihe kattaa tässä yhteydessä projektin alusta aina so- pimuksen kirjoittamiseen saakka.

Työn teoreettisessa osuudessa kuvataan koneisiin liittyvää lainsäädäntöä ja sen syntyä Suo- messa sekä Euroopassa. Osuudessa kerrotaan myös eurooppalaisesta yhtenäisestä lainsäädän- nöstä, joka on sidoksissa koneisiin konedirektiivin kautta. Tämän jälkeen käydään läpi standardisointia ja Euroopan yhtenäistettyä standardisointia. Lopuksi teoria käsittelee koneisiin liittyvää riskinarviointia ja yleisiä velvoitteita talouden eri toimijoiden välillä koneisiin liittyen.

Työssä selvitetään tutkimuskysymystä alikysymysten avaamisen avulla. Koneiden muutoksen merkittävyysarviointia varten luodaan oma prosessi sekä arviointikriteeristöä. Lainsäädännön tul- kinnanvaraisuuteen ja koneiden muutostöihin liittyen suoritetaan vertailukehittämistä vastaavia muutostöitä tarjoavien yritysten kanssa.

Polku koneiden valmistajan ja haastatteluun nojaten vaatimuksien ja vastuiden selventä- miseksi luodaan teoriaan ja vertailukehittämisiin nojaten. Prosessipolun tarkoituksena on osoittaa mitä toimintoja pitää ottaa huomioon, jotta koneen valmistaja tai muutostyön tekijä tietää teh- neensä osuutensa lainmukaisesti ja ottaneensa huomioon terveyttä ja turvallisuutta koskevat sää- dökset projektin alkuvaiheeseen liittyen.

Avainsanat: Turvallisuus, Modernisointi, Koneiden lainsäädäntö, Riskinarviointi

Tämän julkaisun alkuperäisyys on tarkastettu Turnitin OriginalityCheck –ohjelmalla.

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PREFACE

I would like to thank everyone who has supported and advised me during this thesis. I want to thank Kalmar for giving me the opportunity to do this thesis on an interesting topic, especially in these challenging times. Thank you to the people in my target company’s safety team for supervising and advising during the work. In addition, I would like to thank my supervisor Jouni Mattila from the Tampere University for his valuable advice and quick answers during the process.

I would also like to thank my family and friends for allowing me to focus on other things alongside this project.

In Tampere, Finland, on 13h May

Jaakko Raudaskoski

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LIST OF FIGURES

Figure 1. Evolution of Machinery Directive ... 5

Figure 2. Intervention logic of the Machinery Directive (European Commission 2018). ... 7

Figure 3. Standards relations in global and European level (Finnish Standards Association SFS ry 2021b). ... 9

Figure 4. Risk assessment process with sub-steps. (Macdonald 2004) ... 14

Figure 5. Research development work process (In accordance with Kehittämistyön menetelmät 2014) ... 18

Figure 6. Modernisation process steps considered in this thesis. ... 22

Figure 7. Early stages process path in the modernisation projects. ... 24

Figure 8. Sub-process steps clarified more closely in this thesis. ... 25

Figure 9. The extra process for the projects where the machinery documentation is deficient. ... 28

Figure 10. Agreeing on responsibilities if the machine is manufactured by third party. ... 29

Figure 11. Legislative modernisation process flowchart. (CEOC International 2010) ... 31

Figure 12. Modernisation process flowchart from a safety point of view ... 41

Figure 13. Process to evaluate modification substantiality ... 42

Figure 14. Process path describing steps to clarify responsibilities, requirements, and safety issues. ... 43

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LIST OF TABLES

Table 1. Important directives in machinery sector ... 8 Table 2. Common standards used in machinery design processes ... 11 Table 3. Main findings from the benchmarking sessions (Kallio 2021;

Paakkunainen 2021) ... 37

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LIST OF SYMBOLS AND ABBREVIATIONS

CEN European Committee for Standardization

CENELEC European Committee for Electrotechnical Standardization

EN European standards

ETSI European Telecommunications Standards Institute

EU European Union

FLU Front Line Unit

ISO International Organization for Standardization

MD Machinery Directive

OEM Original Equipment Manufacturer OSH Occupational Safety and Health RTG Rubber Tyred Gantry crane STS Ship-To-Shore container crane

VTT Technical Research Centre of Finland

WED Work Equipment Directive

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1. INTRODUCTION

Nowadays modernisation of machines is constantly growing up. Reasons for this are to extend cranes' lifetime and improve productivity with lower cost. Sustainability is one big thing to keep cranes moving with extended lifetimes, instead of scabbing them and buying new ones. Also tightening carbon emission regulations from governments are nowadays pushing terminals to reduce their emissions, where modernisation of older machines comes as a relevant choice, assuming that the existing machine meets the po- tential for environmentally friendly machine operation.

Because the range of products and solutions in crane modernisations are wide and growing up, the safety and responsibility questions are also coming more relevant. There is not a simple guideline how the safety process should go in every modernisation project, and what are the responsibilities of each party involved. In the Machinery Directive (MD) is no clear description or interpretation about the modernisation of the old machines and the assessment of the significance of the changes.

Modification substantiality evaluation in different kind of modernisation projects is a crit- ical point in that sense, because if the modification can be seen as substantial the machinery must be CE marked again according to MD. That means that the agreed party or the authorized representative named by the Original Equipment Manufacturer (OEM) in a modernisation project is responsible for the CE marking process with a role of new machinery manufacturer according to legislation. The (new) manufacturer draws up a Declaration of Conformity and affix the new CE mark to the machinery.

While the Machinery Directive (2006/42/EC) is concerning on the safe design of new machines, the Work Equipment Directive (WED) (2009/104/EC) is concerning the safe use of the work equipment including machinery at the work. Basically, modification or upgrade projects for the machinery in use should be made according to directive (2009/104/EC). However, MD (2006/42/EC) states that if the modifications to the machinery in use are seen as substantial, machinery is considered as new machinery and conformity procedure must be done according to MD (2006/42/EC).

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The safety process and responsibilities in the modernisation project can be unclear to the parties involved in it, and therefore there is a need to describe the process and provide future development ideas to it. The main focus is to think about the process in customer view to produce understandable and clear information to them.

Kalmar is a part of Cargotec. Kalmar offers a different kind of solutions for ports, terminals, distribution centers and heavy industry. Kalmar is a global company, and their customers are located over the globe. One part of the Kalmar offering is to provide upgrades and modifications to the existing cranes. There can be many participants in the modification or upgrade process, and the agreeing on responsibilities is therefore important while it can be more complicated compared to the delivery of a new system or machine.

Safety aspect is also very important when machineries in use are being modified.

In Kalmar crane modernisation services, the operational environment is wide. Moderni- sation services are focused mostly on Rubber tyred gantry cranes (RTG), Ship-to-shore container crane (STS), reachstackers and straddle carriers. Most of the bigger modernisation implementations are developed to the RTG and STS cranes, since the service life expectancy and the machinery replacement timeline are longer.

Modernisations can be made to update or change cranes, powertrain or propulsion systems, electrical systems, physical dimensions, and performance, or to add safety solutions and automation. New implementations are getting designed continuously to satisfy customers’ needs and to provide keys to improve productivity in terminals.

Kalmar provides modernisation services to customers worldwide for cranes of all types and ages. Upgrades are not limited to just cranes which OEM is Kalmar, but also cranes which OEM is third party can be modernised.

One reason for the modernisation of machinery in use is to add safety to the operators and other peoples working in the impact area of the machinery. Legislation should be helping the designers, companies and operators that are maintaining or improving the machinery safety. Clarifications and interpretations for the current machinery legislation are definitely seen as necessary to be sure that the modifications to the machinery have been done legally.

The problem studied in this work focuses on the modernisation customer projects liabilities and responsibilities at an early stage of the process. The idea to the topic was sug- gested by Kalmar, while one of work tasks was to develop a process of how to define the substantiality in modernisations, which is also related to the subject of this thesis.

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The main question and sub questions that this research seeks to answer are:

1. Could it be possible to verify the process path from the start of the project to the quotation stage, and with help of it clarify that responsibilities and requirements have been fulfilled?

a. What are OEM responsibilities?

b. How to define whether the modification is substantial or not?

c. How to clarify the responsibilities between the participants in the early stages of project?

d. What is the minimum level of safety to be achieved?

The aim of this work is to define the process from the start of the project to the quotation phase, and all sub processes included in it. Sub processes will be developed and studied during the process, and the results will be presented at the end this thesis.

This study is organised in the following way. First the interpretation of legislation is carried out and discussed in a literature review together with other relevant topics. After literature review the research sub-questions have been studied and possible tools to clarify the process path have been presented. Related on a modification substantiality evaluation the recertification of an old machine has been studied and discussed. The responsibility issues between modernisation project participants have been also discussed and different ways of agreeing on them are being presented. Next the benchmarking sessions with other companies have been organised and the results have been evaluated and substantiality evaluation process results has been presented. Finally, the process path to clarify the early stages of a modernisation projects in safety and legislative aspect has been implemented.

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2. THEORY

2.1 Legislation 2.1.1 Common

Legislation is the most important part of any OEM operation. Legislation defines the rules and regulations that need to be followed during the tasks of any OEM sector. To machinery there are different kinds of legislation that they need to comply with depending on the continent and county where machines are planned to sell. In EU economy area MD is defining the basic requirements to ensure machinery users safety.

In addition to the MD the Occupational Safety and Health (OSH) legislation defines requirements to the employers and therefore in some form to the OEM as well. In the EU, the minimal requirements in terms of OSH in the working environments are introduced in the Framework Directive (1989/391/EEC) and more detailed regulations to work equipment in the WED (89/655/EEC) which codified version is (2009/104/EC). Directive (1989/391/EEC) could be stated as a basic law that every member state must transpose into part of their national laws. Every workplace is accountable for following these rules set in the national legislation. (Carsten Bruck 2017)

There are special directives to the sector that can be seen under acting elevated risk.

Work environments including lifting equipment are one of these sectors where the risk can be seen elevated. Also, mobile machinery creates additional risks to the people working around it. In Finland, the Work Equipment Decree (403/2008) corresponding to the WED with individual requirements to different machines and working conditions is formed regarding the safety of machines and tools in the workplace. To fulfill these requirements in workplaces it means that the current design of the machinery has to be upgraded to safer during the lifetime according to the national decrees. First Work Equip- ment decree in Finland was introduced in 1998 which removed the era of old requirements. In older machines (manufactured before 1995) this means that the upgrades to its safety by the workplace can be seen lacking when compared to the ones manufactured already under MD. It can be more reasonable to buy a new machine than trying to modernise e.g., forty years old machine to meet the requirements stated in the WED, at

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least if it is not modernised during its lifetime. Figure 1 shows the safety level development during machinery lifetime. (Työsuojeluhallinto 2009)

Figure 1. Evolution of Machinery Directive

Employers are responsible for ensuring that the machine meets the requirements of MD (manufactured after 1995) or WED (manufactured before 1995) depending on the machinery's age. Also, they need to take into account the special requirements coming from the working environment and to the needed actions if safety is noted in the place it should be. (Malm, Venho-Ahonen et al. 2010)

2.1.2 European Union machinery safety legislation

The basic EU legislation can be seen formed from the treaties of the EU introduced in Rome 1957. Over the years these treaties have been revised multiple times with new treaties to meet the needs of the current world. (Jespen 2016)

The current legislation was adopted in 2008 to help provide a wide range of products in the market area. This newest package of measures aims to improve the market surveillance, quality of conformity assessments and provides help and clarifications to the product legislation and to the use of CE mark. (European Commission 2021e)

The most powerful instrument in EU derivative legislation is regulation. Regulation is a law as such in member states, and so there is no national approval or implementation to

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be done by member states so regulation can be accomplished as uniform as possible.

National acts and regulations conflicting with EU set regulations must be repealed.

Directives are used to develop and harmonize national laws of the member states. Mem- ber states must amend their national legislation to achieve at least the minimum requirements set by directive. Directive itself can either demand that there cannot be deviations to the content of it or demand minimum requirements that must be achieved but not by one specific way, so member states can use their own forms and means to fill these.

There is generally a transition period when these requirements must be achieved. (Eu- ropean Union 2002)

Machinery sector is one of the most important ones inside EU, and due to numerous accidents caused by the use of machinery (European Commission 2019). The MD was published first time in 1989 (89/392/EEC) to ensure safe design of the machinery and to prevent fatal accidents. New directive (91/368/EEC) also introduced mobile machinery and goods lifting machinery as well as interchangeable machinery as part of the directive.

Directive (93/44/EEC) added person moving and lifting machinery as well as safety components for the first time to its scope. In directive (93/68/EEC) there was introduced CE marking related harmonised provisions. In the next directive (98/37/EC) were done only minor changes to the content. MD was remaining the same until the existing one (2006/42/EC) was introduced. MD new form was meaning that it was basically recasted.

In the directive (2009/127/EC) there were environmental aspects introduced to the one machinery group, and so the basic directive itself did not change. Intervention logic of

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the MD is presented in figure 2 (D 2006/42/EC). In Finland, the directive (2006/42/EC) was put into force with Machinery decree (400/2008).

Figure 2. Intervention logic of the Machinery Directive (European Commission 2018).

The four main points for the creation of MD originally were:

1. EU Member States are responsible for ensuring that machinery users can be safe and stay healthy.

2. Large numbers of accidents cause social costs that could be reduced by ensuring safe design and construction as well as by proper maintenance and installation of machinery.

3. Machinery sector is an important part of the EU community economy.

4. Barriers to trade are causing the lack of harmonization in machinery safety legislation and certification. (European Commission 2018)

MD applies to the machinery that has been put into service or placed on the market. This means when new machinery is taken into use or machinery is taken into use for the first time in the EU. Also, in some cases heavily modified machinery already put into service before can be seen as new machinery. (European Commission 2019)

Every member state of the EU must ensure safety to the workers, consumers and in general all people that are using the machinery. States are responsible for the use of the MD in their area and the market surveillance follows that products put in the EU market meet the latest provisions. (D 2006/42/EC)

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There are also other important EU directives that OEM’s might need to follow. These are not in the main focus on this diploma thesis, but the table 1 shows few of them that usually applies to the most type of the machines:

Table 1. Important directives in machinery sector

Directive Description

2014/35/EU Low Voltage Directive (LVD)

2014/30/EU Electromagnetic Compatibility Directive (EMC)

2014/68/EU The Pressure Equipment Directive (PED) Technically harmonized product standards aim to ensure free movement of goods inside the EU market. There are Essential Health and Safety requirements that the products put in the EU market must meet. The purpose of these requirements is to ensure safe use of the products in the market area. (Jespen 2016)

2.2 Standards

2.2.1 ISO and EN standards

Standards are specifications for products and products related activities such as testing and services. Standards can involve recommendations, requirements, or specifications to these activities (Finnish Standards Association SFS ry 2021c). Most areas of public concern can be influenced by standards, and that makes them so important tools. (Eu- ropean Commission 2021a)

Standards can be national, European, or international belonging to one or more of these categories. All European standards (EN) are adapted to the member countries standardisation as European member states are part of the same standardisation organisation European Committee for Standardization (CEN) as the EU. Member states can also implement their own national standards if it is nationally decided so (Finnish Standards Association SFS ry 2021a). In Europe Standardisation Organisations CEN, European Telecommunications Standards Institute (ETSI) and European Committee for Electro-

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technical Standardization (CENELEC) are responsible for European Standards (Euro- pean Commission 2021a). Figure 3 shows the relationship between global and European standards organisations.

Figure 3. Standards relations in global and European level (Finnish Standards Associ- ation SFS ry 2021b).

International Organisation for Standardization (ISO) is the worldwide global standardisation organisation. In Europe approximately thirty percent of EN standards are implemented from ISO. European countries under the CEN organisation do not have to adopt ISO standards because they are always coming from CEN that has first adopted it. From the standard name can be seen information about it such as e.g., in standard SS-EN ISO 12100:2010 SS means national standard of Sweden, EN means European standard, ISO mean it is global standard and 12100 is the actual number of standard and last number is the year of it. (Finnish Standards Association SFS ry 2021a)

2.2.2 Harmonized standards and standard types in machinery

In EU harmonized standards mean standards that are created from the request of Euro- pean Commission and are related to the EU legislation. Harmonised standards are in form of EN standard, and all the European standard organisations must bring these standards into force at national level. When harmonized standards are demanded to bring into force National organisations must check that there is no controversy between old national standards and new EN-standard and in case of controversy exist, these national standards must be repealed. (Finnish Standards Association SFS ry 2021a) When in example OEMs are using harmonized standards, they can prove with these that the product follows the relevant EU legislation stated in standard. Use of Standards are

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not mandatory to demonstrate that the legal requirements of the product have been fulfilled unless it is referred to in legislation but by using the standard it is easier to follow that requirements have been fulfilled. (European Commission 2021b)

Safety of the machinery regarded standards are based on a MD (2006/42/EC). These standards help designers to ensure that the conformity and therefore essential safety and health requirements of the machine can be achieved properly. Standards referring to the MD are also voluntary to use, but with the use of these the conformity can be easier guaranteed. Most important standards regarding the MD are Harmonized standards. These standards also help others than just new machine OEMs in example the employers and service companies when machines are being modified. (D 2006/42/EC) To help get machines fulfilling the requirements of the MD, there has been created three types of standards. The basic type-A safety standard referring to the MD is Safety of machinery standard EN ISO 12100 (SIS-EN ISO 12100:2010). Type-A standards give basic concepts to the designers to meet the essential safety and health requirements demanded in the directive it refers to. While type-A standards give framework to meet the requirements and provide help to the risk’s reduction, it is not enough itself to ensure that conformity is met in the machine design process (European Commission 2021f).

This basically means that there needs to be a more detailed standards used to the specific machine type that is being designed. Type-B standards are generic standards that can be used also in many different types of machines. These standards are focusing on a specific safety device or safety aspect and have been divided into two categories based on these points (SIS-EN ISO 12100:2010). Type-B standard can confer a presumption of conformity if there is also done risk assessment or used type-C standard where it can be seen that the technical solution is suitable for the intended use in the machinery (Eu- ropean Commission 2021f). Type-C standards are specific to the certain types of machines and provide detailed information to help fulfill safety requirements to the type of machinery it is developed (SIS-EN ISO 12100:2010). When specific machine type information about the hazard’s prevention provided in the Type-C standard is used as a base in the OEM risk assessment it is enough to provide presumption of conformity (European Commission 2021f). Type-C standard is always taking the precedence of the type-A and B standard if there is deviation in the technical provision between standards. (SIS-EN ISO 12100:2010)

If there is a type-C standard available for the type of machine that is being designed, it could be used as a base to the whole designing process. Therefore, it is easier to be sure that the requirements have been fulfilled and conformity is met. Type-C standard

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usually refers to the relevant type-A and B standards and their sections in it, so it provides the best guidance of all standards to the OEM. EN 15011:2011 Cranes - Bridge and gantry cranes is the type-C standard that crane OEMs can use as a base in their design process.

Table 2 below presents some of the most common standards used in machinery design process:

Table 2. Common standards used in machinery design processes Type-A, Safe design of the machine Name of the standard

EN ISO 12100:2010 General principles for design — Risk assessment and risk reduction

Type-B standards Name of the standard

EN ISO 13850:2015 Emergency stop function

EN ISO 13851:2019 Two-hand control devices

EN ISO 13856-1/-2/-3:2013 EN 61496-1:2020

Pressure-sensitive protective devices Electro-sensitive protective equipment EN ISO 14118:2018 Prevention of unexpected start-up EN ISO 14119:2013 Interlocking devices associated with

guards

EN ISO 14120:2015 Fixed and movable guards

EN 547-1/-2/-3:2008 Human body measurements, access into machinery, access openings, anthropo- metric data

EN ISO 13854:2019 Minimum gaps to avoid crushing of parts of the human body

EN ISO 13855:2010 Positioning of safeguards with respect to approach speeds of parts of the human body

EN ISO 13857:2019 Safety distances to prevent hazard zones being reached by upper and lower limbs EN ISO 4413:2010 General rules and safety requirements of

hydraulics

EN ISO 4414:2010 General rules and safety requirements of pneumatics

EN ISO 13849-1:2015

EN / IEC 62061:2015 Safety-related parts of control systems Functional safety of safety-related electri-

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cal, electronic and programmable electronic control systems

EN 60204-1:2018 EN 60947-5:2020

Electrical equipment of machines Low-voltage switchgear and controlgear

Type-C standards Specific to the crane OEMs

EN 15011:2020 Cranes - Bridge and gantry cranes

European Commission publishes and updates a list of harmonized standards that refer to the MD and gives information when these standards have been withdrawn (European Commission 2021f). There is also other relevant information regarding the machinery and standards.

2.3 Risk Assessments in machinery design

Risk assessment is necessary to be done to meet the conformity for new machinery intended to be placed into the EU market. This is required in the MD (2006/42/EC) and it should be also done when modifications are made to the existing machinery. With the help of the risk assessment essential health and safety requirements can be determined (D 2006/42/EC; Malm, Venho-Ahonen et al. 2010). Macdonald (Macdonald 2004) notes that risk assessment must be assessed in the design phase by the OEM and by the end user in the application phase to also consider workplace specific risks.

Standard EN ISO 12100 describes that for the designer to be able to implement risk assessment and reductions for risk there should be made the following actions (SIS-EN ISO 12100:2010):

1. Determining the intended use and misuse of the machinery and the limits of the machinery

In the risk assessment process, there should be involved all the needed persons to achieve the best possible knowledge of the machine and therefore get comprehensive evaluations to the risk assessment. Intended use and also the limits of the machinery should be set to be clear and in the safe area. With proper user instructions the misuse can be significantly reduced. (SIS-EN ISO 12100:2010; Macdonald 2004)

2. Hazards and hazardous situations related to the machinery identified

If hazards are not identified, there is no way to provide reduction solutions based on them. Hazard identification can be divided into different categories such as hazards from

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the parts that do the work (e.g. blades, drills) or hazards from the parts (e.g., gears, pulleys) that transmit power. In the modernisation cases hazards could be usually identified from the list of planned works and modifications. Different types of hazards based on the type are already told in this document. Standards EN ISO 12100 and ISO/TR 14121-2 provide good information about the types of hazards and different ways to identify them. (SIS-EN ISO 12100:2010; Macdonald 2004)

3. Risk estimation for each hazard and hazardous situation identified in the previous paragraph

Risk estimation rates the risk that identified hazards present to the people exposed to the machinery and therefore to the hazard or risk to the machine itself. Risk can be formed by the function of different elements of risks which are: severity of the harm, probability of occurrence of harm, possibility to avoid the harm or limit it and the fre- quency and duration based on the need of persons to be in the hazardous area. (SIS- EN ISO 12100:2010; Macdonald 2004)

4. Risk evaluation and risk reduction decisions if it is seen necessary

Risk evaluation is carried out to make the decision for the need of risk reduction. Risk evaluation is done usually using a risk matrix where it can be seen if the risk is so major or catastrophic that it is unacceptable. Risk evaluation process includes the decisions of protective measures applied for the risks that cannot be accepted. Designed safety measures can bring more hazards or increase risks themselves so the designer must take that into account, and these should be added to the risk assessment. Risk reduction should be made so that the solutions are efficient but practical and they do not affect the use of the machinery harmfully. (SIS-EN ISO 12100:2010; Macdonald 2004)

5. Hazard elimination or adequate reduction with safety measures to the risks associated with hazards that cannot be eliminated.

If there are risks that cannot be eliminated or reduced adequately during the design process with safe design measures, there can be added safeguards or safety devices. For example, a safeguard can prevent access to the danger zone and an emergency stop can shut down a machine or its hazardous function. Residual risks should be informed to the peoples who it affects as well as the safety use of the machine to prevent those.

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Protective equipment information must be also instructed based on hazards that will re- main. Figure 4 below describes the risk assessment process.

Figure 4. Risk assessment process with sub-steps. (Macdonald 2004)

Risk assessment is an iterative process as it can be seen from the figure above. In many projects there can be lack of information while the assessment is done first time so nat- urally it completes during the project every time it is made towards the end of the project.

2.4 Obligations between economic operators

According to the New Legislative Framework of the EU, operators involved in the machine delivery process have general obligations to be fulfilled. (Jespen 2016) Roles and responsibilities may differ from the original standard roles based on who is taking responsibility at certain tasks.

Some of the machinery manufacturer obligations are in example:

1. Ensure that all the essential health and safety requirements set by MD are met in machine technical design.

2. Draw up and keep available technical documentation where the compliance with MD can be seen. Deliver instructions and safety related documents along with the machine

3. Carry out the conformity assessment procedure.

4. Draw up the EU Declaration of Conformity and affix CE-marking

5. From the machine must be able to also identify the manufacturer and particular machine with the help of e.g., serial number

(Jespen 2016; European Commission 2021d)

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Manufacturer is any legal person who puts a product into the EU market under his name or trademark. This does not mean that the manufacturer must necessarily manufacture the product himself but if it is marketed under his name, he is responsible overall for the product. Manufacturer can also be a legal person who modifies or in other ways changes the intended use of the product that new requirements come applicable. This means that manufacturer have the responsibility of product conformity by legislation (European Commission 2016). One important thing is to remember that the manufacturer must keep available all the necessary documents to prove conformity if it is needed. So e.g., if the product is manufactured by someone else and the legal person modifies it substantially and puts the product then on the market under own name, he must also have all the original documents available.

Importers have following obligations:

1. Ensure that imported products are compliant with the EU regulations

2. Manufacturer has carried out conformity assessment correctly for the product.

3. Technical documentation has been drawn up by the manufacturer, required markings attached to the product and deliveries other documentation such as safety information and instructions with the language demanded by the end country.

4. Mark their own identification to the product.

5. By the request from national authorities cooperate and provide information about the product conformity and technical documentation and if it is requested with the different language that authority understands. Therefore, all the necessary documentation must be kept available by the importer.

(Jespen 2016; European Commission 2021c)

The role of the importers is to work between manufacturers and distributors. Importers must know the legal requirements to ensure that the products are safe to use and in compliance with the legislation. Importers of the non-EU country products have the responsibility to observe that the manufacturer fulfills all the necessary requirements, and it is his responsibility to act if there are hazards caused by the product that could indicate it is not made in compliance with the EU legislation. (European Commission 2021c) Distributors main obligations are:

1. Ensure that the product has all the necessary markings, and its compliance is not affected by the handling of the distributor.

2. Make sure that the documentation along the product is written in language that consumers understand.

3. Help national authorities to receive documentation of the product with appropriate language if it is requested and either manufacturer or distributor are not able to do that.

(Jespen 2016; European Commission 2021c)

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Distributors can also be the manufacturer of the product if they affix their own name to it or market the product under their own name. This means that in that case they are responsible for the conformity of the product and CE marking of the product. (European Commission 2021c)

Authorized representative has following key obligations:

1. Keep the technical documentation and declaration of conformity available for the national authorities.

2. If requested reasonably by national authorities, provide them all the necessary documentation and information to demonstrate product compliance.

3. If requested by national authorities, cooperate with them in any matter to help eliminate risk posed by the product which they representative in that area.

(Jespen 2016; European Commission 2021d)

Manufacturer of the product whether or not placed in the EU can appoint authorized representative inside the EU to perform certain tasks related to placing the product on the market area. Representative can be an importer or distributor of the product. This does not include obligation on the technical documentation or technical requirements.

Authorized representative can affix the CE mark as well as draw up and sign the declaration of conformity. (European Commission 2021c)

2.5 Modernisation project safety and liability issues

Modernisation can mean machine refurbishment, changing its parts, installation of additional components or new safety components to it, upgrading the performance or using its parts to build a new machine (Sundquist, MetSta 2019). Modernisation is becoming more and more popular as the technology improves constantly, and machinery users are willing to boost efficiency and productivity of the existing machines. Usually there can be multiple different modifications to the machine for the same time and these can modify the original intended use or performance substantially (Malm, Venho-Ahonen et al.

2010). Finnish Metal Industry Standardization Association (Sundquist, MetSta 2019) mentions that the starting points of a safe design process are quality management of design process and implementation which refers to organised safe design process of the machine.

The implementation of new approach directives in the EU such as the MD complicated the engineering design process with new essential requirements. This affects also significantly to the manufacturers or companies providing modernisation and modification services to the machines in use. There is some information available on how to ensure legal and safe machines can be formed while modifying it. It is in the high interest of the

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companies to know how they can be sure that all the needed requirements are fulfilled, and regulations followed.

As it is said in Occupational Safety and Health legislation, working equipment must be maintained safe during its lifetime with the help of service and maintenance. As machinery safety level must not decrease from original (Sundquist, MetSta 2019). Modernisa- tion works are usually done to increase the safety of the machine but as they in many cases bring new features to the machine, it may become even less safe than the original most likely in cases if there is not a good enough process concerning the safety of the machinery behind it.

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3. IMPLEMENTATION OF RESEARCH

In this chapter is explained the chosen research strategy to this study. Also, the research and data collection methods are explained.

3.1 Research strategy

There are lots of different research strategies. For example, Case study, Action research, Constructive research, and Service design (Ojasalo, Moilanen et al. 2014). The strategy for this research is chosen to be a case study. Case study is a good choice for the strategy in cases, where in-depth investigation is wanted from the organisation. Case study goal is to produce researched information from the target. Figure 5 shows one example of the research development work process. (De Massis, Kotlar 2014; Ojasalo, Moilanen et al. 2014)

Figure 5. Research development work process (In accordance with Kehittämistyön menetelmät 2014)

In case study is used multiple types of evidence to get the best possible solution for the research problem or question. (Gillham 2000) This is one thing that the case study can be seen suiting to this specific research as the data is collected e.g., from interviews, documents and research made as well as from benchmarking.

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3.2 Research methods

In this research the qualitative method will be used in the case study approach. This means that the current situation and state of the process will be evaluated with the help of evidence that people will tell and that way the current situation can be understood.

Qualitative method enables to carry out investigations, investigate situations with little pre information or information at all, find out what really happens by investigating the organisation, see the perspective of the people involved in the process and instead of just analyzing the results the process leading to them can be researched. (Gillham 2000) After the first orientation for the studied process in practical and through theory is done the development task will be clarified and data collected with multiple methods described earlier. After that there will be more clarifications made during the process before development models or proposals for the process can be done (Ojasalo, Moilanen et al. 2014).

Theory part of this work is used as a general source of information regarding the legislation and requirements that machinery OEMs face. Research and preliminary studies for the modernisation process flow and responsibilities clarification can be found and to which are referred in the execution part of the research where interpretation will be made.

Studies in the workplace have been started already before the research for the process clarification focusing on the sub-processes which belong under the main process

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4. EXECUTION OF THE RESEARCH

In this chapter the current situation of the process is described based on the materials and notices made while working on the subject. Description of the current situation is made to understand it and to bring up the challenges discovered in it. Research process and development work done within the subject is also described. As the path describing the responsibilities and requirements in the early stages of the modernisation project includes the safety and legislation aspect steps from the start of the project to the agreement signing step that means that there are steps where a concrete development and process of executing step can be done and also steps where interpretation regarding legislation can be done from OEM perspective to clarify it.

4.1 Current state and background

In this section the current situation is described, and the process path is described from the start of the project to the agreement phase.

Kalmar has a wide range of different modernisation products and services available. The Crane Modernization Services organisation was still some years ago a new team with fewer people working in it. Currently the team has grown up and there are people from other European offices also working with these services. Front line Units (FLU) are the main contacts to the customers locating in their county or business area and heavily involved in the project execution. Local FLU’s and customers can do their own projects, so it is important that they inform Kalmar central department regarding the OEM matters.

As the modernisation business grows and moves forward, it means that the range of products and services is growing as there are more resources to investigate and implement new products and services for customer’s needs.

As the business is moving forward there are some things relating to modernisation safety and legislation issues raising their head. Safety and responsibility matter in machinery modernisation can be more complicated as in manufacturing of new machines because the age and condition can vary a lot. Therefore, it is important to have a clear understanding and clarifications about the legislation concerning machinery. Modernisation services can be divided to automation and intelligent service systems where either automation or functions are added to make the machine more efficient and productive or more concrete retrofits or modernisations are offered where e.g., power unit or electrical

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drives are updated, or the diesel engine is completely getting rid of and crane is being modified to run with electricity.

Kalmar has a wide range of machines where upgrades can be done. The most important ones are the machines with more expected lifetime such as RTG and STS. Customers are ready to invest in machines that can be kept running still for many years with modernisation services. The MD is regulating the design of the CE-marked machines taken into use after 1995 and for machines taken into use before 1995 the WED states general requirements. This means that there can be different situations and combinations of regulations affecting the machine that is being modernised. In general, all the machines in use at the workplace are under regulations of Occupational Health and Safety regulations and WED that employers must follow, but if there is planned to do upgrades to the machines the manufacturing years and CE marking comes into question.

So, there are many things that need to be taken into consideration as seen above. The business model in the modernisation services considers also third-party machines, which is one additional thing as the configuration of the machine can differ from Kalmar machines and in large modifications the question of new CE-marking and therefore becoming as the new manufacturer arises. As Kalmar is a global operator there can be people all over the world participating in the projects. That means that the way of working with taking all of these presented points into account is important. Generally, if the machine breaks or serious hazard arises, and the cause can be due to modifications made to the machinery national authorities are most likely interested that is the machine made in conformity with EU regulations and how the possible new hazards or increased risks after modifications have been removed or reduced to an adequate level. If the case goes in front of court and OEM has not fulfilled the obligations as it should have, there can be significant amounts to be paid for liability of damages.

These things in mind it is important to know the liabilities as well as the possible risks as an OEM. Clarification of requirements and responsibilities will be made by describing the process from the start of the project to the point where agreement is written.

4.2 Process path and challenges observed

This thesis provides information regarding the safety and conformity of machinery and also clarifies responsibility and obligation topics related to the modernisation projects.

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The modernisation project process steps to which under the research sub-questions can be seen belonging are presented in the figure 6 below.

Figure 6. Modernisation process steps considered in this thesis.

Early stages of the modernisation project refer to steps presented in the figure 6 above in this thesis. The focus on these steps is safety related to maintain the discussion under the topic of this research. First step in modernisation projects is preliminary study. In Kalmar view this means that as being in most of the cases in the role of OEM Kalmar is working along with the customer to get the basic concept or product structure preliminary figured out. The tasks under this step depend on the scope of modernisation and the matter that is the studied implementation completely new or is there existing similar projects executed. In the modernisation safety point of view important things are evaluation of the machine condition at the workplace and other data collection of the machine, possible repairs and maintenance works that need to be done before the project, risk assessment of the machine, legislation issues based on the machine manufacturing year and therefore the regulations which should be followed at minimum. It can be seen also that the type of modernisation that the customer is looking for is not possible or profitable due to e.g., high risks or very expensive and complicated configuration.

Second step is a request for quotation coming from the customer. In this step the customer should tell their requirements needed for the system. The target and scope of the quotation must be clarified as well as technical and safety requirements. Regarding the scope also the minimum level of safety should be determined based on the machine age and regulations such as national requirements. If it is seen so during the substantiality decision process or otherwise that the machine needs to be CE marked again or at the

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first time this should be considered as it can affect the design and create extra costs as well.

The third step is submitting the quotation. Project implementer should provide precise information about the scope of the project and also provide information about the modifications that are not safety wise possible, or they need some extra work to be investi- gated more properly for ensuring the safety. Obligations between participants should be clarified and written in the quotation especially if separate agreements will be not made.

This means that if new CE marking is needed, the process to ensure the conformity of the machine after modifications or upgrades must be agreed and presented especially if the customer is taking the responsibility of the machine by starting as a new manufacturer.

Fourth step is the order, and this phase should not bring any major tasks in the process.

Main thing is to ensure that the participants have understood the scope and safety matters correctly and the obligations are clear and verified.

Fifth step is the agreement which will close the project path in this thesis. In bigger projects agreements are usually done to verify the obligations and responsibilities. As Kal- mar is usually the OEM this means that the responsibilities include the original machine and the modification that will be implemented if not agreed otherwise. This means that the obligations responsibilities must be agreed with full understanding about the current state and condition of the machine, risk assessment provides good information to that.

The implementation of the updated risk assessment should be agreed while agreement is being done. In the agreement specified list of the project scope will be provided including their safety aspects. There should be also described what directives will be followed and is the modification being done according to MD or WED. Also, the CE marking process and conformity assessment procedure will be agreed if CE marking process is necessary. Harmonized and other standards to which will be followed can be described also.

The general modernisation process path to the agreement stage can be seen in figure 7. Red line surrounds the process steps, and under each step there are safety and responsibility related steps surrounded by a dashed line with the main step. Blue lined box under the main process path includes the most important safety related steps and tasks for clarification of obligations and responsibilities. From the tasks inside the blue box will be chosen the ones that need the most clarification or internal alignment, and they will be presented in a form of a process where the steps are organised in the correct timeline in the project perspective. This is done to be able to clarify the process path correctly

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later on, while these sub-steps are unclarified yet in Kalmar’s view. After the sub-process steps have been clarified the modernisation project safety related path can be created so people working in these projects can clarify how the safety related modernisation projects could be handled in OEM view to ensure all the regulations and obligations are fulfilled in the best possible way.

Figure 7. Process path describing early stages in the modernisation projects.

From the blue lined sub-process have been formed the steps that are presented in the figure 8. First step of the process is to clarify how standards and directives affect the modernisation of an old machine. Main focus is to clarify how old and current standards should be considered. Second step is to clarify minimum level of safety to be achieved.

The third step is to clarify different methods on how contracts can be agreed between modernisation participants. In the fourth step the process to evaluate the substantiality of planned modifications to the machinery is presented.

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Figure 8. Sub-process steps clarified more closely in this thesis.

After the steps have been clarified and presented, the Kalmar framework regarding the safety and liability in modernisation is being clarified and compared with the results received from the benchmarking.

4.3 Clarification of sub-process steps

4.3.1 Clarifying the correct standards and directives

When modernising old machines there are questions raised about how new and old standards should be used when implementing a modernisation. First it should be evaluated in a preliminary study that will the modification be substantial or not and therefore will there be a new machine created or not. This means that in case a new machine will be formed in the modernisation project, there must be followed the regulations of the MD and therefore by using a directive supporting harmonized standards in the design process there will be a presumption of conformity received. It is not mandatory to use standards but will make it easier to prove a declaration of conformity. It is good to remember that the old remaining parts must also fulfill the regulations of MD (Specially if the machine is not being CE marked before).

And because MD only applies in new designed machines, if there will not be a new machine there should be followed minimum requirements stated in the WED. WED (2009/104/EC) is focused on the working environment and therefore is more general than MD. As Technical Research Centre of Finland (VTT) study (Malm, Venho-Ahonen

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et al. 2010) mentions, the current safety level may not be decreased during the modernisation and the WED sets out the general obligations to the safety level. In any case if the machine will be CE marked or not the partly completed machinery that is planned to assembly with the machine must be made in compliance with the MD.

So, it can be stated, that if the machine will not become a new one, the minimum require- ment is to maintain the current safety level. WED still regulates that the machine must be kept safe with means of maintenance and possible upgrades, so the current standards can be used as a guideline especially when the customer wants to upgrade the machine as close to the level stated in current standards as possible. If the machine will become new, it should be made in compliance with the regulations of MD (2006/42/EC) and to achieve the compliance with the MD the use of latest harmonized standards in the design will give the presumption of conformity. Also, if the machine is CE marked before and there are no substantial modifications planned to it, the compliance with the MD must be set according to that MD version that was in force and referred to when the machine was first put into service.

4.3.2 Minimum level of safety

Minimum level of safety is important to know so there is some defined level that must be at least maintained when the modernisation works are being planned to the machinery.

In all circumstances it is stated that at the minimum the regulations in the WED (2009/104/EC) must be met, so that sets out the frame to health and safety requirements in case if the machine is CE marked or not. If the modification is being seen as a substantial one, the requirements set in the MD Annex I must be met to ensure the essential health and safety of the user. But the MD (2006/42/EC) Annex I states that:

The essential health and safety requirements laid down in this Annex are manda- tory; However, considering the state of the art, it may not be possible to meet the objectives set by them. In that event, the machinery must, as far as possible, be designed and constructed with the purpose of approaching these objectives.

Which means that it may be not possible to fully meet the objectives with the current state of the art, but it should be the goal to be reached.

In the VTT (Malm, Venho-Ahonen et al. 2010) research it is also said that a higher safety level than stated in the MD cannot be required if the working environment does not require that. Thus, in case the customer sets really high safety requirements it can be

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reasonably justified referring to this information that the customer requirements might be unrealistic. In general, the safety level may not be decreased from the existing.

4.3.3 Different ways to agree on responsibility

In machine modernisations agreeing on the responsibility issues between project participants is important as the responsibility issues can be seen more complicated compared to the delivery of the new machine. When dealing with used machines the employer is in general responsible for the safety of the machine. However, a machine OEM is still responsible for the product and therefore if the OEM is a participant that executes modernisation work, this raises a question how the responsibilities can be agreed between customer and executor when executor of the modernisation project is at the same time the OEM. This section focuses on the modifications made by only OEM and it is referring to the internal report (Internal report 2016) ordered in the past from the VTT. Following discussion is general, containing different kinds of possible modifications that could be made to the machines.

If the machine is made by Kalmar and the modification works are executed by Kalmar the responsibility of the modification and original machine can be usually agreed to be on Kalmar. As an OEM the information from the original machine, its maintenance and earlier modifications should be available, so the risk levels stay acceptable when there is a good reference while the project planning is being made. If the maintenance has been deficient or there are earlier changes made by the customer or third party, there should be good documentation available to decide if the modifications are reasonable to do without major risks involved. In any case careful inspection of the machine should be made to evaluate the possible harmful effects that earlier modifications or lack of maintenance can cause to the machine. This in mind there could be risks so high occurred that it is reasonable to settle a different agreement on the reliability regarding the modifications that are planned to be made by OEM. Also, Kalmar can offer rebuild services to bring the machine up to date and to fix earlier modifications made by third parties before the modernisation services are offered. Careful planning and risk assessment can be

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done at the same time. Figure 9 clarifies the project path and tasks regarding these sce- narios.

Figure 9. The extra process for the projects where the machinery documentation is deficient.

If the machine is originally made by a third party this complicates the situation of agreeing between participants' responsibilities in the modernisation project as Kalmar is not responsible for the original machine and not as familiar with the machine compared to their own machines. Most important thing is to understand the machine and its condition, so complete documentation of the original machine should be received to properly evaluate the planned modification works and their safety and also inspection to the original machine should be made carefully. According to inspection possible inadequacies can be fixed then by Kalmar or OEM with correct measures. In third party cases the agreement should always include the points where the possible inadequacies and the way of dealing with those are stated. In ideal cases the third party would provide information and share their thoughts about agreeing on the responsibilities. At least it is good to inform the OEM about the planned modifications by the customer. At the end of the day the customer is reliable for keeping the machine safe when it is in service under WED. In this case the modifications should be separated if possible, to the original machine and its function with no overlaps between Kalmar and OEM. Therefore, it could be agreed that Kalmar is responsible for the executed modifications only.

In case the modification is seen as substantial this complicates the situation. Modification substantiality evaluation process in bigger modification should be first made carefully

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based on the information available to see if there can be clearly seen a new machine build. In this case the new manufacturer has to be decided. The role of manufacturer can be continued with OEM or the new manufacturer can be Kalmar, customer or authorized representative named by the OEM. It is not ideal trying to attach the CE Mark for a modified machine because the responsibilities and documentation needed for drawing up the Declaration of Conformity may not be available anymore or reached. As the International Confederation of Inspection and Certification Organisations (CEOC International 2010) informs application of the MD for a modified old machinery may be legally incorrect due to inability to supply the documentation needed according to MD anymore. Figure 10 clarifies the responsibilities and agreeing regarding these cases.

Figure 10. Agreeing on responsibilities if the machine is manufactured by third party.

There can be challenges to settle the agreement in a way that satisfies all participants because in modernisation projects there can be lack of information and documentation regarding the old machines. Company internal framework of go and no-go decisions and the way of working to ensure the best possible outcome in modernisation projects regarding any circumstances are therefore important to have.

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4.3.4 Process to recognize substantial modifications in Kalmar modernisation projects

As it is seen in this study modifications to the machinery that is already in use can affect their conformity and in case the modifications are substantial enough the modified machinery can be considered as new and therefore new conformity assessment is needed.

There were a few relevant sources where the topic had been discussed and in some of them the process on how the modifications' substantiality can be evaluated was presented. But as the studies were very indicative it was determined that our own internal process on how to decide modifications substantiality was necessary to be made.

The basic questions were arising from the MD (2006/42/EC) section §140:

Thus machinery that was subject to the provisions of the Machinery Directive when it was first made available must be maintained in a state of conformity with the essential health and safety requirements of the Machinery Directive that were applied when it was first placed on the market or put into service. This also applies whenever machinery is modified by the user during the course of its lifetime, un- less the modifications are so substantial that the modified machinery must be con- sidered as new machinery and be subject to a new conformity assessment ac- cording to the Machinery Directive.

Which was leading to a question on how the substantiality can be interpreted and defined. This point of the MD confuses rather than clarifies the process where some kinds of changes are planned to be made in the existing machinery. Also, MD was not clearly providing any interpretations regarding the substantial changes leaving the final decision to be made with help of national authorities. The process to recognize substantial changes was made with the help of a safety team as there were many challenging questions to be answered.

This subprocess of this study was started by gathering all relevant sources that were processing the similar subject. The problem was clearly recognized in a similar way but there were actually very few solutions how it could be handled correctly. After the sources were found it was time to find the relevant information that was used as a starting point and therefore the first conclusions were made on how the process could be built up.

From the CEOC (CEOC International 2010) study a flowchart that is presented in the

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figure 11 was found and it gave good general information on how the modification substantiality may affect the project execution in a legislative manner and therefore to the regulations that must be followed.

Figure 11. Legislative modernisation process flowchart. (CEOC International 2010) Based on the CEOC flowchart the framework to the substantiality decision process was started to be thought of. It was noticed that from the substantial modification decision it would be good to have a sub-process where the decision criteria and in more in-depth process could be then made. The first step was to think how the significance can be evaluated. It was decided that every modification should be listed and then identify all the hazards that each modification creates. After the hazards have been identified then depending on the hazards significance it should be evaluated that can the risks of hazards occurring be eliminated or adequately reduced. This way each modification can be

Clarification of requirements and responsibilities in the early stages of modernisation projects

Jaakko Raudaskoski