OCTOBER 03, 2024

By Anshul Mittal, Partner RSA Legal Solutions

THE Machinery and Electrical Equipment Safety (Omnibus Technical Regulations) Order, 2024, issued on 28th August 2024 by the Ministry of Heavy Industries, introduces a critical regulatory framework aimed at enhancing safety and ensuring compliance with Indian Standards (IS). This Quality Control Order (QCO) will come into force after one year of its issuance, giving manufacturers and industries time to align their products with the new requirements. The QCO mandates that machinery and electrical equipment used in various industrial sectors must meet stringent safety, performance, and labelling standards.

Industries Affected

This QCO has wide-ranging implications across multiple industries, ensuring that machinery and electrical equipment in these sectors adhere to modern safety standards. The industries impacted by this regulation include:

- Construction and Infrastructure: Machinery used for earthmoving, material handling, and building processes, such as cranes, excavators, and construction equipment.

- Power Generation and Electrical: Equipment used in power plants, substations, and energy distribution systems, including transformers, switchgear, and power converters.

- Manufacturing and Engineering: Metal cutting machine tools, weaving machines, packaging machinery, and other industrial machines used in manufacturing facilities.

- Mining: Heavy machinery and electrical equipment used in mining operations for excavation and material transport.

- Textile Industry: Weaving machines and embroidery machinery used in textile manufacturing.

- Public Works: Machines used in public works and infrastructure projects, such as concrete mixers, compressors, and diesel generators.

- Automotive and Transport Equipment: Specific machinery for automotive production and certain electrical equipment for vehicle assembly.

Applicability and Exemptions

The QCO covers machinery and electrical equipment used in various industrial sectors. It applies to products that are either manufactured in or imported into India, ensuring that they conform to the stringent safety requirements laid out in the relevant Indian Standards. However, certain categories, such as construction equipment vehicles governed by the Central Motor Vehicles Rules (CMVR), 1989, are exempt from the QCO's requirements. Additionally, machinery intended exclusively for export is also exempt.

Structure and Conformity Requirements

The machinery and equipment covered by the QCO are categorized into three schedules based on their conformity to safety standards:

1. First Schedule: This list comprises 20 items of machinery and electrical equipment that must comply with Type A standards, which focus on general principles of design, risk assessment, and risk reduction. The key standard for this schedule is IS 16819:2018, which aligns with international standards to ensure that the machinery is designed in a way that minimizes safety hazards.

2. Second Schedule: This schedule contains 53 generic safety standards (Type B), covering a broad range of safety aspects like ergonomic considerations and electrical safety. These standards are more comprehensive and apply to equipment across industries, ensuring that all products meet a base level of safety in areas like user interaction and power usage.

3. Third Schedule: The items listed here are required to comply with Type C standards, which are machine-specific and detail the safety requirements for particular types of machinery. In cases where there is a conflict between Type A, B, and C standards, Type C standards take precedence to ensure the most precise safety measures are applied to the equipment in question.

Labelling, Marking, and Certification

Each machine or piece of electrical equipment that falls under this QCO must meet specific labelling and marking requirements. This includes adherence to Scheme X under the Bureau of Indian Standards (BIS) Conformity Assessment Regulations, which provides detailed guidance on how products must be marked to indicate compliance with the applicable standards. Furthermore, manufacturers are required to maintain a technical file documenting the conformity of their products with the relevant standards, which serves as an essential record for both internal audits and market surveillance activities.

To comply with the QCO, manufacturers have two options for certification: they can either obtain a license to use the Standard Mark or apply for a Certificate of Conformity (CoC) if the product is not intended for continuous production. The Standard Mark signifies that the machinery conforms to the required Indian Standards, while the CoC serves as proof of compliance for specific batches or one-off productions.

Scheme X: Pathway for Compliance

Scheme X is the conformity assessment framework that supports the QCO, providing a structured process through which manufacturers demonstrate that their machinery and electrical equipment comply with Indian Standards. Under Scheme X, manufacturers must submit their products for testing and undergo factory audits to ensure compliance. The process involves the submission of an application along with a technical file that details the design, manufacturing process, and relevant test results of the product.

The certification under Scheme X can be either for continuous production, where the manufacturer is granted a license to use the BIS Standard Mark, or for batch-specific production, where a Certificate of Conformity (CoC) is issued instead of the Standard Mark. Both certifications involve thorough testing and factory inspections, which may be conducted in-house or at BIS-recognized third-party laboratories.

Testing and Auditing

Scheme X places significant emphasis on testing and auditing to verify that both the products and the manufacturing processes adhere to BIS standards. Manufacturers are required to conduct product testing, either in their own laboratories or through third-party labs recognized by BIS. In addition to product testing, BIS may also conduct factory audits to evaluate the manufacturing infrastructure, quality control systems, and compliance with production standards.

Once a product is certified, manufacturers are obligated to maintain production records and testing documentation, which BIS may review during surveillance audits. This continuous monitoring ensures that certified products maintain their conformity to the relevant standards over time. Failure to maintain compliance can result in the suspension or cancellation of the license or CoC.

The QCO introduced by the Machinery and Electrical Equipment Safety (Omnibus Technical Regulations) Order, 2024, mandates compliance with Indian Standards, by following the structured certification process outlined in Scheme X. Without following the scheme, manufacturers would not be able to obtain the necessary certifications, such as the Standard Mark or Certificate of Conformity, which are essential for legal market entry in India.

The QCO defines the scope of safety requirements and essential standards that products must meet, while Scheme X provides the mechanism to ensure that these requirements are met. Through Scheme X, manufacturers undergo testing, audits, and assessments to prove their conformity with the QCO's standards. Scheme X also facilitates the renewal, surveillance, and enforcement of these certifications, ensuring that machinery and electrical equipment in the Indian market are consistently safe and reliable.

Way Forward: Preparing for Compliance with the Upcoming QCO

With the Machinery and Electrical Equipment Safety (Omnibus Technical Regulations) Order, 2024 set to take effect one year after its issuance, industries must take proactive steps to ensure they are prepared to comply with the new safety standards. To avoid disruptions in the supply chain and to maintain market access, manufacturers and suppliers across the impacted sectors should begin reviewing their product portfolios and production processes to identify items that fall under the QCO.

Here's how industries can prepare for the upcoming compliance requirements:

1. Conduct a Gap Analysis: Manufacturers should start by conducting a thorough gap analysis to compare current product standards with the requirements set by the QCO. This analysis will help identify areas where their machinery or equipment may fall short of the mandated Indian Standards, enabling early rectification.

2. Enhance Testing and Quality Control: Given the emphasis on testing and conformity under Scheme X, companies need to ensure their testing facilities are up to date and capable of meeting the necessary standards. If in-house testing is not feasible, manufacturers should engage with BIS-recognized third-party laboratories to ensure their products are adequately tested and certified.

3. Streamline the Certification Process: Companies should familiarize themselves with the application and certification process under Scheme X, including the submission of technical files, undergoing factory audits, and preparing for product inspections. Early engagement with experts will help manufacturers understand the detailed steps for obtaining the necessary certifications, such as the Standard Mark or Certificate of Conformity (CoC).

4. Invest in Compliance Infrastructure: To maintain long-term compliance, companies may need to upgrade their manufacturing processes, testing equipment, and quality management systems. Investment in technology and infrastructure now will help ensure that production lines remain operational and compliant when the QCO comes into effect.

5. Train Personnel: Compliance with the QCO and Scheme X will require a thorough understanding of the regulatory requirements by key personnel, including quality control teams, compliance officers, and production managers. Conducting training programs to ensure that teams are aware of the standards, certification processes, and penalties for non-compliance is essential.

6. Monitor Market Surveillance Requirements: As the QCO mandates continuous monitoring of certified products, companies must establish robust record-keeping and reporting practices. This includes maintaining accurate production records, test results, and certification documents for review during BIS surveillance audits.

By taking these preparatory steps, industries can ensure a smooth transition to the new regulatory framework, avoid penalties, and ensure uninterrupted access to the Indian market. The Machinery and Electrical Equipment Safety (Omnibus Technical Regulations) Order, 2024, represents a significant opportunity for industries to enhance product safety and align with international standards, thereby strengthening their market position both domestically and globally.

[The views expressed are strictly personal.]