Planning to combine a series of complete or partly completed machines to create a single production line?
Here’s how and why the UK Conformity Assessed (UKCA) regulations apply.
Even though each individual piece of equipment will have been UKCA marked by its original equipment manufacturer (OEM) or supplier, when you integrate several individual pieces of equipment into a production line, they form a new system.
And you, as the end user, are responsible for applying the UKCA mark to that new system.
In fact, HSE advises that for the production line as a whole, you must:
- Apply UKCA marking
- Issue a Declaration of Conformity (DoC)
- Produce and keep a technical file
- Potentially revise the instructions
This article will run through what your technical file should contain for UKCA marking production lines, and why it’s important.
What is Your Technical File?
Your technical file contains all the essential documentation you need to demonstrate your production line as a whole complies with the required UKCA regulatory requirements.
While technical files for individual pieces of manufacturing and R&D equipment will include much more in-depth information on the design, manufacturing and operational safety of the equipment, your technical file for your production line as a whole needs only to include:
- Design details and drawings of control systems and parts you’ve had to modify
- A Declaration of Conformity for each complete machine that makes up the line
- A Declaration of Incorporation for each partially completed machine that makes up the line
Note that production lines made up of manufacturing and R&D equipment require much more extensive documentation than the average piece of equipment. This is due to the risks involved in operating this equipment and the need for more thorough safety assessments.
Below, we’ll run through the key elements your technical should include, as outlined by HSE.
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1. Design Details and Drawings of control systems and parts you’ve had to modify
Design Details
Start with a comprehensive overview of the design of the production line as a whole. This should include:
- Detailed descriptions of its layout, the flow of operations and each piece of equipment’s role within that line (including their functions and how they interconnect)
- Specifications for each individual piece of equipment, including dimensions, capacities, and performance characteristics, as well as the materials used, operational limits and environmental requirements
- Your strategy for integrating individual pieces of equipment into a cohesive production line, including mechanical, electrical and control system integrations
Control Systems
You should also include detailed designs and drawings of the control systems within your production line—parts that enable you to manage, command, direct and regulate the behaviour of the equipment in the assembly line. As part of this, include:
- Detailed schematics and diagrams that illustrate the overall architecture of each control system, including main control units, sensors, actuators, communication networks and interfaces
- Descriptions of control logic, algorithms and any software you plan to use to manage the production line
- Safety and interlock systems (including emergency stop systems, safety relays, interlocks between machines and failsafe mechanisms)
- Diagrams and descriptions of the human-machine interface (HMI) screens, control panels and user interface elements, including how they interact with the wider system, access controls and receive feedback or alarms
Modifications
Finally, illustrate and describe any modifications you’ve made to individual pieces of equipment and their control systems, as well as your reasons behind making these modifications. This should include:
- Illustrations and diagrams that detail the exact modifications made, including before-and-after comparisons where applicable
- Written descriptions of specific modifications made, as well as your rationale behind them and how they enhanced safety, functionality or integration
- The impact that the modifications have made to the production line as a whole (for example, improvements in safety, reliability and ease of maintenance)
- Any potential risks that were introduced by the modifications, and the steps you took to mitigate them
- Documentation that modifications comply with relevant safety standards and regulations
2. Declaration of Conformity
For UKCA marking a production line, you need to include a signed Declaration of Conformity (DoC) for each complete machine that makes up the line.
Each DoC serves as a formal declaration that that equipment has met all requirements and safety directives applicable to your equipment. And it generally should include:
- Equipment, type, batch or serial number
- Full name and address of the manufacturer
- Name and address of the person authorised to compile the technical file
- A statement that you accept full responsibility
- Means of identifying the equipment
- A statement that the equipment conforms with the relevant legislation
- References to any designated standards, where applicable
- Reference to the approved body that carried out any conformity assessment activity, where applicable
- Your name and signature
- Place and date of declaration
- Supplementary information, if applicable
3. Declaration of Incorporation
If your production line is subject to the Supply of Machinery (Safety) Regulations, any partially completed machines that can’t function independently and have been incorporated into the line require a signed Declaration of Incorporation (DoI).
Each DoI serves as a formal declaration that each partially completed machine complies with the Supply of Machinery (Safety) Regulations. It generally should include:
- Business name and full address of the manufacturer’s details
- Name and address of the person authorised to compile relevant technical documentation
- Product description and identification
- A declaration of the health and safety requirements met
- An undertaking to transmit information to national authorities if required
- A statement that the equipment will not be used until the final machinery it’s been incorporated into has been declared to conform
- Date and place of declaration
Learn more about the requirements for your DoI via the government website here.
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