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September 5, 2024

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Eight (and a half) things that compliance and machinery safety consultants may not tell you

Tom Chaldecott, Machinery Safety and Legislation Consultant at Knox Thomas, provides insight on staying on top of compliance in manufacturing.

Within machinery safety and compliance, there are misconceptions that consultants may not disclose. Whether you’re navigating CE and UKCA marking or engaging in a PUWER assessment, understanding enables informed decisions. Here are 8 ½ things that compliance and machinery safety consultants may not openly share:

1. CE and UKCA marking: Self-certification

CE-UKCA MarkingThe process of CE and UKCA marking is often misunderstood. Many believe certification requires independent test houses or regulatory bodies, the reality is quite different.

CE and UKCA markings primarily involve a self-certification process. This means manufacturers or end-users are responsible for assessing conformity with regulations. External validation can offer additional assurance, it is often not mandated by law.

It’s important to note that self-certification doesn’t equate to a lax approach. On the contrary, manufacturers should focus on implementing robust processes for ensuring compliance, including comprehensive assessments and documentation of technical justifications.

2. Steps to compliance

In the pursuit of compliance, having a roadmap is essential. Contrary to the perception that achieving compliance is shrouded in mystery, the steps to compliance with regulatory requirements are transparent and outlined within freely available legislation.

  • Identifying applicable legislation and standards: The journey begins with specifying the relevant legislation and standards.
  • Conducting gap analyses: With requirements identified, the next step involves assessing the machine’s current state against the legislation and standards. This requires an examination of product design, construction and functionality. By identifying gaps early in the process, manufacturers can proactively address deficiencies.
  • Addressing non-compliances: After identifying non-compliances, the next step is to implement corrective measures, requiring modifications to design.
  • Compiling a technical file: Central to the process is the creation of a comprehensive Technical File that demonstrates the machine’s conformity. A Technical File serves as a repository of essential information, including specifications, design material, test reports, risk assessments, and compliance declarations.
  • The declaration of conformity & CE mark: The final step involves issuing the declaration of conformity and affixing the CE mark, affirming the product meets all applicable requirements. Declarations of conformity serve as legal documents attesting to the product’s compliance.

3. Minimal physical testing requirements

In CE and UKCA marking there exists a misconception regarding the extent of physical testing. While testing plays a crucial role in certain industries and scenarios, it’s essential to understand that it’s not always the predominant method used to achieve certification.

The CE and UKCA certification process often places more emphasis on documentation and adherence to standards than on physical testing alone. This approach recognises that comprehensive compliance encompasses various facets beyond just testing.

Documentation is vital the certification process. Manufacturers must compile a technical file that outlines the design, construction, and performance of their products.

By adherence to standards, manufacturers can demonstrate conformity with essential safety requirements. This alignment serves as a guiding framework for product development and facilitates smoother certification processes by providing clear benchmarks for evaluation.

4. Accessible legislation and standards

Credit: Alamy Stock

Accessibility to legislation and standards lists is key for compliance. Contrary to the perception that accessing such critical information is expensive, the reality can be more cost-effective.

Legislation and standards lists pertinent to compliance are readily available online from EU and Government websites. Both the EU and the UK provide comprehensive listings of harmonized (EU) and designated (UK) standards.

Access to standards is essential for achieving compliance. These outline specific requirements and technical specifications applicable to various machinery categories. But because all EU member states have national standards bodies, all these countries provide the facility for purchasing standards, and not all national standards bodies price the standards the same… It’s worth shopping around.

5. EMC compliance and assessment

There’s a misconception concerning Electromagnetic Compatibility (EMC), that achieving compliance necessitates extensive and compulsory testing. However, the reality is more nuanced, and understanding the distinction between testing and assessment can the process.

EMC compliance is crucial for products to operate reliably in their intended environments without causing interference to other electronic devices. While testing plays a vital role in verifying EMC performance, it’s not always mandatory. Instead, the emphasis is on conducting thorough assessments to demonstrate compliance with EMC standards.

The language used within EMC legislation underscores the importance of assessment rather than testing. This distinction allows manufacturers to adopt a more flexible approach, focusing on evaluating subcomponents or aspects of the product against EMC standards.

By conducting assessments reviewing subcomponents against EMC standards, manufacturers can identify potential sources of electromagnetic interference and implement appropriate mitigation measures. This approach not only enhances product reliability but also minimises the need for costly and time-consuming testing iterations.

Many components, such as motors and power supplies, already undergo EMC testing as part of their certification process. By incorporating certified components into designs, manufacturers can streamline overall compliance efforts.

6. Essential health and safety requirements

Credit: Alamy Stock

In machinery compliance the EU’s Machinery Directive and the UK’s Supply of Machinery (Safety) Regulation have explicit essential requirements.

The Machinery Directive establishes a framework for ensuring the safety of machinery placed on the market within the European Economic Area (EEA). These requirements encompass aspects of machinery design, operation, and maintenance, including:

Safety Components and Systems: The Machinery Directive mandates the incorporation of safety systems designed to minimise risks. These may include interlocking mechanisms, emergency stops, and protective barriers aimed at preventing hazardous area access.

Hazard Assessment and Mitigation: Manufacturers must conduct assessments to identify potential hazards associated with machinery. Based on the findings of these assessments, appropriate measures must be implemented to appropriately minimise or eliminate risks.

Ergonomics and Human Factors: Consideration must be given to ergonomics in machinery design to ensure operator comfort, efficiency, and safety. Factors such as control placement, visibility, and accessibility play a crucial role in reducing the likelihood of accidents.

Instructions and Warning Signs: Clear and comprehensive instructions for machinery operation and maintenance must be provided. Additionally, appropriate warnings should be displayed to alert operators to potential hazards.

 7. Abundance of guidance documentation

Access to guidance documentation is invaluable for navigating the intricacies of CE and UKCA legislations. A wealth of freely available guidance documentation exists, offering invaluable insights and support.

One of the key pieces of legislation that benefits from such guidance is the Machinery Directive. Understanding this legislation can be a daunting task. Enter freely available guidance documentation. Numerous resources, often provided by governmental agencies, industry associations, and regulatory bodies, offer detailed explanations, interpretations, and examples pertaining to the Machinery Directive and other relevant legislations. These guidance documents provide clarification of requirements, breaking down the complex language of legislative texts into digestible and comprehensible information. Of particular note is the Machinery Directive Guide.

8. RoHS and WEEE exemptions

RoHS (Restriction of Hazardous Substances) and WEEE (Waste Electrical and Electronic Equipment) directives mitigating the environmental impact of electrical and electronic products. However, most machinery safety consultants recognise that these directives may not uniformly apply to all categories of industrial machinery. Instead, exemptions exist, particularly for large fixed installations and tools.

Understanding RoHS and WEEE Directives: The RoHS directive restricts the use of certain hazardous substances, such as lead, mercury, and cadmium, in electrical and electronic equipment to reduce environmental pollution and promote recycling. Compliance can often be achieved by assessing sub-component documentation. Similarly, the WEEE directive mandates the manufacturers financial contribution to recycling and disposal of waste electrical and electronic equipment to minimise environmental harm and conserve resources.

8 ½. The UKCA marking dilemma: Is it worth the effort for machinery safety consultants?

Tom Chaldecott at Knox Thomas

Earlier this year developments surrounding the UKCA marking have sparked considerable debate and confusion among manufacturers and consultants alike. The UK government’s decision to indefinitely accept CE marking into the UK has cast a shadow over the necessity of the UKCA marking, leaving many to question its relevance.

For most, the reality is that the UKCA marking is functionally dead. With the UK government’s stance on accepting CE marking, the question naturally arises: why opt for the UKCA mark at all? The answer, it seems, boils down to marketing or branding purposes rather than regulatory necessity.

For manufacturers and businesses, the addition of the UKCA mark alongside the CE mark only serves to introduce potential costs and administrative nuances. From a regulatory standpoint, CE marking holds the same legal weight as UKCA marking within the UK market, making the latter redundant in many respects.

In essence, the UKCA marking dilemma highlights the complexities and ambiguities inherent in navigating regulatory compliance in a post-Brexit world. While the UK government’s decision to accept CE marking offers a degree of continuity, it also raises questions about the long-term viability and relevance of the UKCA marking in the UK market.

Conclusion

In conclusion, transparency and understanding are paramount in navigating the complexities of machinery safety and compliance. By shedding light on these 8½ aspects, manufacturers can approach compliance endeavours with greater confidence and clarity.

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