EASA has issued a Notice of Proposed Amendment (NPA) that would establish new SMS regulations for repair stations and manufacturers.
This NPA proposes to apply safety management systems (SMS) to production and design organizations approved under Subparts G and J of Part 21. It introduces elements of SMS into the regulations, but also makes a number of other changes in each, as well.
European manufacturing changes are important to the US manufacturing community because of the long history of harmonization and cooperation between Europe and the United States.
- Future analogous changes in the United States’ rules could be justified using harmonization as a rationale for the implementation.
- Europe might refuse to accept US aircraft products or parts on safety grounds if the US does not implement comparable safety regulations.
- EASA 145 organizations, which must have procedures for the acceptance of components to ensure they are in satisfactory condition and meet applicable requirements, could refuse to accept parts produced by US manufacturers without SMS systems
Thus, US manufacturers should examine these changes carefully to help predict what sort of standards might be applied to US manufacturing in the future.
The proposed manufacturer SMS rules are published in section B of the NPA (there is a section C that applies to repair stations).
Changes include an expansion of mandatory reporting system to require collection, investigation and analysis of all voluntary reports, in addition to mandatory reports. It would expand the system to include requirements for reporting and managing internal errors and other hazards that do not fall under the traditional failures, malfunctions, defects and adverse effects occurrences that have been reported in the past. While it is clearly meant well, this change could have the unintended effect of inhibiting voluntary reports, because of the new collection, investigation and analysis burden associated with these voluntary reports.
The new regulation would also impose on the production approval holder a duplicative collection, investigation, analysis and reporting obligation (currently the burden belongs to the design approval holder).
The reports made to the competent authority will also need to safeguard the identity of the reporter, which could inhibit subsequent investigation by the competent authority.
The new regulations will feature expanded record-keeping requirements and also a requirement for arrangements (like contractual requirements) that make all “partners, supplier and subcontractors” open to competent authority investigations. This could mean that US suppliers to Airbus, for example would need to permit EASA investigators free access to audit or investigate at any time.
This is not a complete list of all of the proposed changes – it is worthwhile for anyone in the aviation industry to review these changes carefully as they may have wide-ranging effects. There are also draft Acceptable Means of Compliance (AMC) and Guidance Material (GM) in the NPA, as well.
The public is permitted to submit comments using the automated Comment-Response Tool (CRT). The deadline for comments on this NPA is July 17, 2019.