Considerations Related to the Acceptance of Chemicals & Consumable Materials within an EASA Approved Organisation

Sofema Aviation Services (SAS) considers the key aspects of ensuring the correct receipt of consumable materials, including chemicals.

Introduction

EASA Form 1 is not applicable to consumable materials, including chemicals; nevertheless, the obligation to ensure the correctness of the material or product is paramount.

Within an EASA environment, ensuring that the release documentation issued by distributors of chemicals and consumables includes a valid CoC, MSDS/SDS, and documentation proving traceability to the OEM is crucial.

Regular audits of the distributor’s quality management system and meticulous document control are essential to maintain compliance and ensure safety in aviation operations.

See the following example of issues and challenges

Problematic titanium was found in Boeing and Airbus jets. The FAA is investigating how it got there (Jun 2024)

• New York (CNN) — Titanium that was distributed with fake documentation has been found in commercial Boeing and Airbus jets. Now, the Federal Aviation Administration, the aircraft manufacturers and supplier Spirit AeroSystems are investigating whether those components pose a safety hazard to the public.
• “Boeing reported a voluntary disclosure to the FAA regarding procurement of material through a distributor who may have falsified or provided incorrect records,” the statement said. “Boeing issued a bulletin outlining ways suppliers should remain alert to the potential of falsified records.”

Certificates of Conformity (CoC) Introduction

In an EASA (European Union Aviation Safety Agency) environment, specific requirements for release documentation in respect of Certificates of Conformity (CoC) issued by distributors of chemicals and consumables are necessary to ensure compliance with regulatory standards. Here’s an outline of the key elements and steps involved:

Certificate of Conformity (CoC):

• The CoC should confirm that the chemical or consumable meets the required specifications and standards.

o???It should include the distributor’s information, product identification, batch/lot number, and reference to relevant specifications or standards.

Traceability to Original Equipment Manufacturer (OEM):

• Distributors must provide traceability back to the OEM or the original producer of the chemical or consumable.

o???This includes maintaining records that identify the OEM and ensure that the product’s history is documented from production to final distribution.

Material Safety Data Sheet (MSDS) / Safety Data Sheet (SDS):

• These documents should be provided and must comply with relevant regulations such as REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) in the EU.

o???They should include information on the chemical properties, handling precautions, and emergency measures.

Notes Concerning REACH

REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is a comprehensive regulatory framework established by the European Union to manage the production and use of chemical substances. Its primary aim is to protect human health and the environment from potential risks posed by chemicals. Under REACH, companies that manufacture or import chemicals in quantities of one tonne or more per year must register these substances with the European Chemicals Agency (ECHA), providing detailed information about their properties, uses, and safe handling. This ensures that companies are fully aware of and manage the risks associated with the chemicals they deal with.

The framework also involves the evaluation of submitted information by ECHA and member states to ensure compliance and assess potential risks. Certain high-risk substances require authorization for use, compelling companies to demonstrate that these risks can be controlled or that their socio-economic benefits justify their use. Additionally, REACH allows for the restriction of hazardous substances to minimize risks to human health and the environment. Overall, REACH aims to enhance the safety, transparency, and innovation within the EU chemicals industry while promoting safer alternatives and reducing animal testing.

Compliance with Regulatory Standards:

• Ensure that the product complies with EASA regulations and any other relevant aviation standards.

o???This may include specific certifications or approvals required for use in aviation.

Distributor’s Quality Assurance:

• Distributors should have a quality management system in place that aligns with EASA requirements, ensuring the consistency and reliability of the products supplied.

Steps to Ensure Compliance:

• Request CoC from Distributor:

o???Always obtain a Certificate of Conformity from the distributor for each batch/lot of chemicals or consumables received.

• Verify Traceability:

o???Confirm that the CoC includes sufficient information to trace the product back to the OEM.

• Request additional documentation from the distributor if the CoC does not adequately demonstrate traceability.
• Review and Maintain MSDS/SDS: Ensure that the latest version of the MSDS/SDS is available and accessible. Check that the safety information is up to date and compliant with current regulations.
• Audit Distributor’s Quality System: Periodically audit the distributor’s quality management system to ensure it meets EASA and any other relevant standards. Verify that the distributor maintains accurate records and can provide traceability documentation upon request.
• Document Control: Maintain a controlled and organized system for storing and retrieving CoCs, MSDS/SDS, and any other relevant documentation. Ensure that documentation is readily available for inspections and audits by regulatory authorities.

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