Concerning Shelf Life and the use of Chemicals within an EASA Part 145 Organisation

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Sofema Online (SOL), www.sofemaonline.com, considers the use of chemicals, particularly when approaching shelf life expiry or when it expires.

Introduction

Under EASA Part 145 regulations, using chemicals beyond their expiry date is not generally permitted.

Here are some key points regarding the storage and usage of chemicals, including Non-Destructive Testing (NDT) penetrant chemicals, in a maintenance organisation approved under EASA Part 145:

  • • Compliance with Manufacturer's Recommendations: The chemical manufacturer provides a specific product shelf life based on stability and effectiveness data.

 - Usage beyond this date may compromise the chemical's performance and safety.

  • • Regulatory Requirements: EASA Part 145 mandates that all materials and products used must be within their specified shelf life unless an extension is authorized by the manufacturer.

 - 145.A.42(a) and 145.A.42(c): These sections of EASA Part 145 outline the general requirements for the storage and use of components and materials, ensuring they are used within their specified shelf life per the manufacturer's instructions.

 - AMC 145.A.42(c) and GM 145.A.42(c): Provide additional guidance on implementing these requirements, emphasizing the importance of adhering to shelf life limitations and the procedures to manage them.

 - In practice, maintenance organisations must have robust procedures to track and manage the shelf life of all materials and components, ensuring compliance with these regulatory requirements.

  • • Authorization and Re-certification: If an expired chemical is to be used, the maintenance organisation must seek re-certification or authorization from the manufacturer.

 - The manufacturer might conduct tests to determine if the chemical meets the necessary standards.

  • • Quality Control Procedures:  Maintenance organisations must have strict quality control procedures.

 - These procedures include ensuring all chemicals are within their shelf life and stored according to the manufacturer's specifications.

  • • Documentation and Records: Proper documentation and records must be maintained for all chemicals, including their shelf life and any extensions granted by the manufacturer.
  • • Storage Conditions: Even if the chemical is within its shelf life, improper storage conditions (e.g., temperature, humidity) can reduce its effectiveness. Organisations must adhere to the manufacturer's storage guidelines.
  • • Risk Assessment: A risk assessment should be conducted before using any chemical beyond its expiry date. The assessment should consider potential impacts on safety, effectiveness, and regulatory compliance.

Specific Steps for NDT Penetrant Chemicals:

  • • Review Manufacturer's Shelf Life and Storage Instructions:
  • • Seek Manufacturer's Extension:

 - If an NDT penetrant chemical is beyond its shelf life, contact the manufacturer to inquire about the possibility of an extension.

 - They may require samples for testing to verify continued efficacy.

Internal Procedures and Approval:

  • • Establish internal procedures for handling expired chemicals. These should include obtaining approval from relevant authorities within the organisation, such as quality assurance or engineering departments.

Conduct Performance Tests:

  • • Perform tests to ensure the chemical still meets the required performance standards. This may include sensitivity tests for penetrants to ensure they still function correctly.

Can the 145 Organisations Quality Manager Grant an Extension, and if so, under what circumstances

While the Quality Manager plays a key role in managing and coordinating the process of extending the shelf life of chemicals, the actual approval must come from the chemical manufacturer. The Quality Manager's responsibility includes ensuring compliance with internal procedures, conducting risk assessments, and maintaining thorough documentation to support the extension request.

  • • Under EASA Part 145 regulations, the Quality Manager of a maintenance organisation does not typically have the authority to grant independent extensions for the use of chemicals beyond their expiry date.
  • • Extending a chemical's shelf life usually requires validation and approval from the manufacturer.

 - The Quality Manager plays a crucial role in ensuring compliance and managing the process of obtaining such extensions.

  • • Here are the key points to consider:

 - The primary route for extending a chemical's shelf life is obtaining approval from the manufacturer.

 - The manufacturer may conduct tests to ensure the chemical meets its specifications and provide an extension if deemed appropriate.

Quality Manager's Role:

The quality manager may coordinate to obtain an extension from the manufacturer. This includes submitting samples for testing and ensuring all documentation and records are updated accordingly.

Internal Procedures:

Maintenance organisations should have internal procedures for handling requests for shelf life extensions. These procedures should involve the Quality Manager but ultimately rely on the manufacturer's decision.

Important Note: In some exceptional circumstances, and where there is a justifiable reason, the Quality Manager might facilitate a temporary extension based on interim measures, such as additional testing and monitoring, while awaiting the manufacturer's formal approval.

  • • Regulatory Compliance: Any extension granted should comply with EASA regulations and be justifiable during audits or inspections.
  • • The Quality Manager must ensure that all regulatory requirements are met and proper records are maintained.

Specific Steps for the Quality Manager When Granting an Extension:

  • Identify the Need:
  • Identify the chemicals approaching or exceeding their expiry date and assess the need for continued use.
  • Reach out to the chemical manufacturer to request an extension. Provide any required samples and documentation.
  • If interim use is necessary, arrange for additional tests to verify the chemical's performance. Document these tests thoroughly.
  • Ensure all documentation, including storage records, test results, and manufacturer correspondence, is up-to-date and readily available for audit purposes.
  • Implement Controls: Implement additional controls and monitoring to ensure the chemical's continued efficacy and safety during the extended period.
  • Report and Review: Regularly review the status of extended chemicals and report any issues or findings to senior management and regulatory bodies as required.

Next Steps

Sofema Aviation Services www.sassofia.com and Sofema Online www.sofemaonline.com provide Classroom, Webinar and Online training in support of Stores & Logistics Roles – please see the website or email [email protected]

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