(ref: NPA-2013-01A Explanatory note and regulatory impact assessment/draft cover regulation, NPA-2013-01B Part M, NPA-2013-01C Part 145)
Notice of Proposed Amendment 2013-01
As we had already announced in our blog article “SMS e-learning for Aviation Maintenance Organizations” published on June 6th, 2012, the European Aviation Safety Agency (EASA), has recently released the Notice of Proposed Amendment (NPA) 2013-01, that will result into extensive changes to the contents of both EASA Part M and 145, Acceptable Means of Compliance (AMC) and Guidance Material (GM).
NPA 2013-01 details the proposed changes to the requirements for the embodiment of Safety Management Systems (SMS) in the quality system of Part M and Part 145 approved organizations. We have summarized the proposed changes to EC 2042/2003 annex II EASA Part 145 in this article.
Changes to section A of both Annex I (Part M) and Annex II (Part 145) of EC No 2042/2003, include the consolidation of additional requirements related to hazard identification, risk evaluation, and effective risk mitigation into the excising quality system.
Also included in this proposed change is that Human Factors related items in the requirements are reviewed and complemented, where necessary.
What will change for EASA Part 145 approved maintenance organizations?
Introducing the new “MANAGEMENT SYSTEM” 145.A.65 ‘Safety and quality policy, maintenance procedures and quality system’, will be changed into 145.A.65 ‘Management System’. 145.A.65 ‘Management System’ reproduces all elements of the management system requirements including the organisation requirements and related AMC for air crew and air operations. These changes are supported by a series of Guidance Material specific to the context of maintenance organisations, with particular focus on human factors and safety risk management/fatigue risk management.
The new management system provisions are introduced to ensure maximum flexibility by defining core requirements of the management system at Implementing Rule (IR) level, and including the detailed means to achieve these goals at AMC level. They also allow considering those elements that are already in place today in any Part-145 organisation, in terms of quality system related provisions that deliver the ‘compliance monitoring function’ of the new management system requirements. Most of the provisions related to ‘quality system’ in current Part-145 deal with the monitoring of compliance and related reporting and corrective action processes. As there are multiple types of quality systems defined in different international or national standards, with different meanings and scopes, it is more appropriate to refer to compliance monitoring function when it comes to Part-145. This does not mean that organisations will be required to change designations of their quality system personnel. It is left up to each organisation to decide how to refer to this function. Conversely, at the level of the requirements, no reference to quality system will remain.
No longer “Quality System” The former term ‘quality system’ is not used any longer. It has been replaced by ‘compliance monitoring function’, in order to define a consistent set of management system requirements that would be compatible with a wide range of management system standards. This new management system focusses primarily on the monitoring of compliance, a proper reporting to management, and the need to take effective corrective actions. The first of these elements – the monitoring of compliance.
‘Quality Manager’ will be replaced by ‘Compliance Monitoring Manager’ and an additional manager function will be introduced in EASA Part 145: the ‘Safety Manager’. The Safety Manager is responsible for the development, administration, and maintenance of effective safety management processes as part of the management system in accordance with 145.A.65. For non-complex organizations, the Compliance Monitoring Manager and Safety Manager can be one person, although this is not recommended for the larger, complex organisations.
Human Factors To complement and clarify the new provisions related to safety management introduced with 145.A.65, all AMC and GM dealing with Human Factors (HF) issues have been further enhanced. This has been done in cooperation with the EHFAG and leads, among other changes, to the definition of more specific criteria for the qualification of HF training, and to an amendment to the HF training syllabus in GM 145.A.30(e), as well as to the introduction of new definitions that are directly relevant to HF.
Fatique Risk Management Included in the SMS framework, is Fatique Risk Management. It identifies fatigue related hazards and how to manage the related safety risks within the organization’s SMS system.
A reference to Directive 2003/88/EC, ‘EU Working Time Directive’ will be included in the AMC to 145.A.47 ‘Production Planning’. It is important for all Part-145 organisations to specifically address fatigue as part of their hazard identification and risk management processes. Whenever the organisation chooses not to follow the EU Working Time Directive, it needs to additionally provide a specific and detailed fatigue risk management scheme (FRMS) that must be acceptable to the competent authority.
PART M elements included in Part 145 Relevant EASA Part M requirements applicable to EASA Part 145 activities, will be duplicated in EASA Part 145, if this proposed change is supported by the aviation (maintenance) industry.
WHAT IS THE PROPOSED IMPLEMENTATION PERIOD?
Based on this proposal, whereas competent authorities would need to adapt to the new requirements at the latest one year after the entry into force, organizations would have additional time to show full compliance with the new management system requirements and related amendments.
WHAT CAN WE DO FOR YOUR ORGANIZATION?
Holland Aviation Consultancy & Engineering has an extensive background in EASA Part 145, Human Factors training and also in Safety Management System principles. HACE provides (online) EASA Part 145, Human Factors and SMS awareness training, and can also support MRO organizations, with the preparation and implementing the upcoming SMS requirements and changes to the management/quality system.
We will closely monitor the upcomming changes to the regulations and keep our clients informed with articles on our blog and notifications by newsletters.
Once the changes are accepted and implemented in EASA part M and Part 145, we can assist in the transition of your organization’s quality system into a management system, by performing the required changes to the Maintenance Organization’s Exposition (MOE) contents, facilitating the implementation and provide the required training.
With our background, we can ensure that your organization will fully comply with the new Part 145 management system- and SMS requirements.
For more information on the upcoming changes to EASA Part M and Part 145 or requesting assistance in preparing your organization for the upcoming changes, please contact us by e-mail: email@example.com or post a message at the bottom of this article.