The NR-12 Norm Explained and Simplified - MACHINERY Safety IN BRAZIL

(Adapted from the article published by the Switzerland Global Enterprise on 20/09/2021. Which the Partner of the Ziel Engenharia Lucas Lorenz e Silva was the Author. The original article was published www.s-ge.com/en/publications which was coordinated and reviewed by Daniela Roosen-Runge from S-SE.)

Foreword With 210 million people, Brazil is a country with an enormous consumer market, and has large industrial complexes for the manufacturing of consumer goods, as well as being a strong exporter of food and raw materials. Brazil seeks to make industrial processes more efficient so that costs can be lowered, and the prices of products become more competitive, as well as a demand for safer machinery and equipment. Companies are increasingly engaged in reducing the number and the severity of work accidents, as well as meeting safety requirements in inspections, both from government inspectors, customer audits and independent certifications. Both countries have standards that guide the reduction of risks in machinery and equipment, which promote principles and methodologies for the elimination of hazards and for a sufficient reduction of risks. However, it is important to align the technical documentation of the machine, both in terms of translation into Portuguese, and for the specifics of local regulations.

Regulatory overview The main standard in Brazil for issues related to the safety of machinery and equipment is the Regulatory Standard No. 12 – Machinery and Work Equipment Safety, known as NR-12. This normative has requirements for a machine to be imported, marketed, manufactured, transported, installed and operated in Brazil.

NR-12: Origins and Purpose In Brazil, the work relationships are regulated by the Consolidation of Work Laws (CLT), which contains complementary obligations such as the Regulatory Standards, under the chapter of safety and medicine at work. The Regulatory Standards, identified by the acronym NR (Norma Regulamentadora), in Portuguese, consist in obligations, rights and duties that must be observed by employers and workers. Their purpose is to ensure the safety and health standard in the work environment, avoiding accidents and illnesses related to labour. Commissions and groups formed by workers, employers and government representatives produce and revise the Regulatory Standards, according to recommendations from the International Labour Organization (ILO), in an equal tripartite system. The first version of the Regulatory Standard nº12 Machinery and Work Equipment Safety (NR-12) was published in 1978 and its purpose was to regulate specific articles from the Consolidation of Work Laws - CLT. Between 1978 and 2010, the NR-12 suffered specific changes, driven by regional initiatives. In 2010 a tripartite group of work, with government representatives, employers and workers, approved a significant revision, considering suggestions received from society. In this new edition of the norm, a consolidation of technical references was carried out, including fundamental principles, protection measures and the establishment of several minimum requirements to prevent labour related accidents and illnesses. It also foresaw the employment of new and old machinery and equipment, and aspects to be observed in the manufacturing, importation, commercialization and exhibition. The 2010 revision was the major significant advancement to align local demands related to machinery and equipment safety with international standards. In the subsequent years, the norm suffered other changes that facilitated the exchange of technology avoiding technical barriers, as well as some that updated the standard to facilitate the understanding and application. The 2010 update was broadly aligned with the Machinery Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006, granting an acceptance advantage to machines that already bear the CE Marking. Market Trend for Machines compliant with NR-12 In Brazil, the engineering teams that prepare the specifications for machinery and equipment for the manufacturing processes increasingly include the full compliance with NR-12 in the technical specifications. NR-12 is the most important regulatory standard related to machine safety in Brazil, an item that must be met by the supplier through evidences in form of reports and declarations of the manufacturer or importer. In the area of process engineering equipment, compliance requirements of industrial plant components are frequently required in audits. In the automotive industry, manufacturers frequently receive external audits, both for ISO certification and labour inspectors, in which NR-12 items are frequently verified. It is also common for companies audited by labour inspectors to enter into an agreement to carry out adaptations of the machines in their production process within a schedule to fully comply with the NR-12, but also simultaneously seek greater process automation. Another topic of recent discussions in Brazil is the need for investment in sanitation, which is an example of sector that is related to welding technology and also requires machines that comply with the NR-12.

International Regulations The safety of machines and equipment must be considered from the conceptual design stage of the machine until its operation in the industrial plant. The correct identification of hazards and the effective reduction of risks is not a simple task, it is necessary to follow a methodology that guarantees results and that is applicable in several stages, such as in the design, manufacturing, commercialization, use and disposal phases.

Safety in Machinery and International Standardization

The use of established methodologies, guided by international standards and their national counterparts, makes the process of eliminating hazards and reducing risks in machinery and equipment much more efficient. The use by manufacturers of local standards aligned with international standards that harmonize technical specifications is extremely important to reduce commercial barriers between countries. As an example of a source of standards with application in several countries, we can mention the standards of the International Organization for Standardization-ISO, which is an independent, non-governmental international organization with a membership of 165 national standards bodies.

Main International Applicable Standard for Risk Assessment

In the case of machinery and equipment, the ISO standard that guides risk reduction from the design stage is ISO 12100:2010 Safety of machinery -- General Principles for Design -- Risk Assessment and Risk reduction.

The scope of this ISO standard states: “specifies basic terminology, principles and a methodology for achieving safety in the design of machinery. It specifies principles of risk assessment and risk mitigation to help designers in achieving this objective. These principles are based on knowledge and experience of the design, use, incidents, accidents, and risks associated with machinery. Procedures are described to identify hazards, estimate and evaluate risks during relevant phases of the machine’s life cycle, and for the elimination of hazards or sufficient risk reduction.”

This standard aims to help designers, manufacturers and any interested persons to interpret the essential safety requirements of machines.

Machine Safety Related Technical Standards

Some other standards can be used on more specific topics within the machinery risk reduction process. In the table below are examples of technical standards based on international standards related to safety in machinery and equipment. These standards are applied in the various stages of the life cycle of a machine, such as construction, validation, and operation.

Market Advantages for Machines in Compliance with Safety Regulations

From the point of view of the machine manufacturer's business value proposition, offering machines with a safety certification can be a competitive advantage by standing out from the competition, eliminating market barriers, or even meeting a demand from customers who have practices that actively promote the reduction of accidents or who want to reduce the risks of interdiction and fines in cases of local inspection during the life cycle of the machine. The behaviour of customers in Brazil generally follows one of the following alternatives: · Import or purchase machines with all the necessary documentation to comply with the NR-12. · Carry out the import of machines, with all the physical parts constructed in compliance with international standards, but the documentation and evaluation part of the compliance to the NR-12 are done in site, generally the translation related needs, and often using engineers from their own staff or hiring specialized companies in engineering documentation to ensure compliance. Attention to the negotiation of that aspect before acceptance of the purchase order.

Initial Checklist for NR-12 Compliance

The applicable regulatory standard in Brazil is the NR-12 – Machinery and Work Equipment Safety, and it is noted that many of the items in the standard are in line with the main international standards related to safety of machines. An example is that the NR-12 indicates that in its execution the following must be considered: “the characteristics of machines and equipment, of the process, risk assessment and the state of the technique” which are topics covered by the ISO 12100 standard. Despite the alignment between NR-12 and ISO standards, some items of NR-12 must be observed independently, such as those related to machine manuals and the link of a legally qualified professional in the country to be technically responsible for the installed safety systems for the machine. Below please find our concise Initial Checklist for NR-12 Compliance

Supplier's Declaration of Conformity (NOT Mandatory for supplier, highly recommended) A specific certificate is not mandatory or literally foreseen in the NR-12 for the manufacturer of the machine to issue, nevertheless a Declaration of Conformity, listing all the regulations applied to the machine construction, is highly recommended, as the importer and the user of the equipment may not have sufficient technical capacity to judge on acceptance whether the machine was constructed in accordance with the applicable standards. The moment the buyer accepts the machine and starts using it, he becomes responsible for the machine and is subject to inspection notices and fines. Therefore, the lack of a certificate is a major risk factor for the buyer and user of the machine. Imported machines manufactured in accordance with ISO 12100 related to risk assessment and risk reduction and following the guidelines of the ISO 13849 for the safety-related parts of control systems, are considered compliant with most of the safety requirements of the NR-12, and has a better chance to achieve a complete compliance enabling an engineering registered in Brazil to issue a technical term of responsibility (ART) for the machine. Specific types of machines, that has a specific applicable harmonized European type “C” standard are also close to full compliance to the NR-12. Operating Instructions (Mandatory FOR IMPORTER and operation) Consists of a set of operating instructions (manuals) in the official language of the country translated to Portuguese. The machinery and equipment shall have instructions manuals provided by the manufacturer or the importer with safety information concerning all stages of use. The manuals shall: · Be written in Brazilian Portuguese, with legible type and size characters; · Be objective, clear, unambiguous and easy to understand; · Have highlighted signs or warnings regarding safety; and · Be available to all users in the workplace. The manuals of the machinery and equipment manufactured or imported shall follow the applied national or international standards. (The ISO 12100 standard brings many of the guidelines for the elaboration of manuals). Operational Safety Procedures (MANDATORY FOR IMPORTER AND OPERATION) A set of work and safety operational procedures based on the risk assessment of the machine – as required by ISO 12100. Safety procedures with detailed and standardized description of each task, based on the risk analysis, are expected here. Safety-Related Parts of Control Systems and Risk assessment Report (MANDATORY FOR IMPORTER AND OPERATION)

This requirement defines the required safety category as per ISO 13849-1 for the machine or the equipment. The engineer in Brazil, who issues the technical term of responsibility (ART) for the machine, usually translates, or generates the Risk Assessment Report confirming the required safety category for the machine to category its application for inspectors and auditors. If the machine is not manufactured in accordance the ISO 13849, the engineer should not issue the Technical Term of Responsibility, as the equipment is likely not be compliant to the NR-12. The safety systems must be selected and implemented in order to follow the following requirements: a) Have a safety category according to the risk assessment regarding official technical standards; b) Be under the technical responsibility of a legally qualified professional; (It means that an engineer registered in the Brazilian Regional Council of Engineering (CREA) must issue a Technical Term of Responsibility (Anotação de Responsabilidade Técnica – ART) to certify it.). c) Have technical compliance with the control system to which they are integrated; d) Installation that cannot be neutralized or bypassed; e) Remain under automatic surveillance, i.e. monitoring, if indicated by the risk assessment and according to the required safety category, except for exclusively mechanical safety devices; and f) Stopping dangerous movements and all the other risks when failures or abnormal working conditions occur. Visible Machine Information (MANDATORY FOR IMPORTER AND OPERATION) The machinery and the equipment produced as from the effective date of this Standard shall have indelible information in a visible place, containing at least: a) Official company name, National Registry of Legal Entities (CNPJ), and address of the manufacturer or the importer; b) Information on type, model and capacity; c) Identification or serial number and year of manufacture; d) Registration number of the manufacturer or the importer in the CREA (It means that the importer or the manufacturer must be registered in the Brazilian Regional Council of Engineering (CREA) and e) Weight of the machinery. The manufacturer is highly likely to have such a sign on the machine with most of the information, however a new sign with ALL of the items above, in Portuguese, must be generated and applied to the equipment locally.

Hazard and Risk Signaling (MANDATORY FOR IMPORTER AND OPERATION) The inscriptions shall clearly indicate the risk and the part of the machinery or equipment to which they relate and shall not be used only the inscription of “danger”. These must be in Brazilian Portuguese.

Conclusion

The reduction of risks in machinery and equipment is one of the objectives of companies, both manufacturers and companies that depend on machinery and equipment in their manufacturing processes. Understanding the alignment between international and local standards can facilitate the trade of machinery and equipment between countries, yet local peculiarities must be observed to avoid problems during the delivery of a new machine or even as a differential to make a sale. The Brazilian industry has great potential for acquiring machines that meet the principles of risk reduction and several industrial areas are already standing out for adopting practices that guarantee machines in compliance with the law when purchased. There is a great possibility of gains in the cooperation between Swiss and Brazilian companies in favour of safer machines that meet the efficiency and quality challenges of the Brazilian industry.