PED 2014/68/EU Technical Documentation Checklist: 12 Essential Records Manufacturers Need for CE Marking

1. Product description and identification

Begin by clearly knowing what equipment you have and what it is used for. Note down the manufacturer’s information, the model number, the identification number, and any important design details. The specific details you need may depend on the type of equipment, such as maximum pressure (PS), volume (V), and the highest and lowest temperatures (TS) it can handle, along with the type of fluid it works with. Having accurate information helps determine the correct PED requirements and avoids mixing up different versions of the product.

2. Design drawings and technical specifications

Make sure the drawings are up-to-date and clearly show how the equipment is set up and built. Include general arrangement drawings, detailed component drawings, how parts connect, measurements, and design rules. The documents should match exactly what is being made. Using old or conflicting drawings can lead to unnecessary problems during a technical check.’

3. Design calculations

Keep the calculations that show the equipment meets the required design standards.

Depending on the type of equipment and the design method used, these calculations may cover things like wall thickness, pressure handling, loads, stresses, and other important design factors.

Write down all the assumptions, input values, design rules used, and the results of the calculations so that someone else can understand and follow the evaluation process.

4. Risk assessment and safety analysis

Find the possible dangers that could happen while using the equipment as planned and in situations that might happen. Write down the main safety rules that must be followed and explain how the design and safety features help meet those rules. Make sure the analysis is suitable for the specific equipment and not just a general risk checklist.

5. Applicable standards and compliance mapping

List the technical standards that help ensure conformity, and note which specific standards or parts were used.

If harmonized standards are not used where relevant, explain the technical solutions used to meet the necessary safety requirements.

Make sure to check the latest references published in the Official Journal of the European Union instead of using an outdated list of standards.

6. Material specifications and certificates

Material traceability is important for ensuring the safety of pressure equipment. Keep track of the correct material specifications, purchase records, identification details, and inspection documents. Make sure the material grades and their properties match what was designed for the equipment. When needed, check the material certificates according to EN 10204 and the material-related rules in PED Annex I. The type of certificate needed and the supporting documents depend on the equipment and the conformity assessment process.

7. Welding documentation

When welding is used in structures that carry pressure, check the relevant welding procedure specifications (WPS), welding procedure qualification records (WPQR), and welder qualification records.

PED Annex I includes rules about how to join parts permanently and the skills needed for the workers.

Based on the equipment type and the rules that apply, approval from a qualified third party might be needed. The records must match the real materials, welding methods, and the actual work being done.

8. Non-destructive testing (NDT) records

Make sure to keep the right NDT procedures, test reports, and proof that staff are qualified.

Depending on how the product is made and what needs to be checked, different methods might be used like radiographic testing (RT), ultrasonic testing (UT), magnetic particle testing (MT), or liquid penetrant testing (PT).

Write down what was tested, the standards for approval, the results, and any fixes that need to be done. Not all testing methods are needed for every product.

9. Manufacturing and quality records

Technical documents must show the real equipment that was made. Check the inspection and testing plans, records from manufacturing, where materials came from, how parts were joined, and the quality control results.

Make sure any problems are written down and fixed properly, and that the final product matches the approved technical details.

10. Pressure and final test reports

Gather reports for all necessary pressure tests, final checks, and other required verification steps. Each report must clearly state what equipment or product was tested, the method used, the conditions under which the test was done, the standards it had to meet, and the results obtained.

Make sure that all testing and verification processes are done according to the required rules and procedures for approval.

11. Instructions, safety information and equipment marking

Make sure to prepare the operating instructions and safety information for the equipment.

Check the proper identification and marking requirements, such as the manufacturer’s details, equipment identification, and other important technical information.

If the equipment needs a PED CE marking, confirm that the marking is added only after all the necessary conformity assessment steps have been completed.

12. Conformity assessment and declaration records

Find the right PED conformity assessment module and keep the related proof. Depending on the path, this might involve notified body certificates, examination reports, quality system approvals, or other conformity assessment documents.

The manufacturer needs to create the EU Declaration of Conformity when needed and make sure it refers to the correct equipment.

Under PED, the technical documents and the declaration should usually be kept available to national authorities for 10 years after the equipment is sold on the market, as long as the relevant rules apply.