Recent blog posts

Bridging Checks Introduction

Why would we want to carry out a Bridging Check?

Typically because we have recently acquired a “new to our organisation” aircraft and it is on a different maintenance schedule.

A bridging check is normally required to address tasks which have either not been done by the previous operator (maybe they are not applicable for a particular operator) or alternatively the tasks may have been done at different intervals when directly compared with your existing Maintenance Programme or Schedule.

A ‘bridging check’ is not in itself a maintenance package; rather it is the result of a detailed analysis of the pre and post transfer tasks to identify any differences which need to be addressed during the transfer bridging check.

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Sofema Aviation Services www.sassofia.com and SofemaOnline www.sofemaonline.com

Offering Regulatory Compliant Training for FAA Repair Stations In Classroom & Online

Concerning FAA -EASA Bilateral Agreement

The FAA notes that some part 145 repair stations have European Aviation Safety Agency (EASA) certifications. EASA part 145 contains licensing and training requirements for Approved Maintenance Organizations (AMO) that perform maintenance on articles of those operators under the regulatory control of European Union (EU) Member States.

These EASA part 145 requirements can affect FAA part 145-approved repair stations that also have EASA approvals; since EASA requires maintenance human factors training as part of the Bilateral Aviation Safety Agreement (BASA) and Maintenance Implementation Procedures (MIP) with the United States.

The FAA training program may include the requirements of other civil aviation authorities as long as the part 145 requirements are also met.

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It is not uncommon for the operator to require the CAMO to maintain the reliability program to essentially demonstrate the minimum compliance of the regulatory requirements. Missing the opportunity to foster a genuine desire to engage with a serious investigate process related to the understanding of negative trends and take efficient corrective measures.

Possibly a major reason for this behaviour is related to a lack of understanding by the operator regarding the philosophical reasons related to the effective implementation of a fully active statistical process control. Unfortunately, the focus is on “living and surviving from day to day” solving problems without spending sufficient time on dealing with the underlying causes.

The benefit of a fully integrated Reliability program is that it does not over react to single events rather the focus moves to trends and system related problems.

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Complete your repair station training with SofemaOnline.com

SofemaOnline (SOL) – Virtual Aviation Academy - The “Go To” site for online training

SOL is supported by European Aviation Institute (EAI) an EASA Part 147 approved Maintenance Training Organization (MTO) with Certificate of Approval No RO.147.0003.

Our trainings are designed to be effective and to help you reach the correct level of understanding in the comfort of your own home or office.

FAA 14 CFR Part 145 Detailed Initial Training has been developed for Quality Managers, Technicians, Mechanics, and Repairmen who are either currently involved in a repair station or intend in the future to establish a 14 CFR Part 145 repair station.

Tagged in: CFR FAA Part 145 SOL
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Considering the Fundamental EASA QA/ QC Relationship

The Quality Manager (Compliance Manager) is responsible for the independent assessment of compliance – not to loose sight that this process is additional and should be considered as a Safety Net rather than a primary method of ensuring compliance.

The Continuing Airworthiness Manager (CAM) is responsible for the QC Activities related to the compliances which are validated during the ACAM process.

Building on this understanding means that an effective oversight of an effective process will focus on the physical management, delivery and maintenance of competence within the system of control.

The Regulatory Point of View

Tagged in: ACAM KREs QA QC QMS
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What does the FAA Say about Limit of Validity?

The limit of validity (LOV) represents an operational limit based on fatigue test evidence that supports the maintenance program. The FAA defines the LOV as “the period of time (in flight cycles, flight hours, or both) up to which it has been demonstrated by test evidence, analysis and, if available, service experience and teardown inspections, that widespread fatigue damage will not occur in the airplane structure.” It is further defined as the point in the structural life of an airplane at which there is significantly increased risk of uncertainties in structural performance and probable development of WFD.

Once the airworthiness limitations containing the LOV are approved by the FAA, an airplane may not operate beyond the LOV.

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Posted by on in Regulatory

Whilst the Operators CAMO is responsible for the delivery of an effective and viable maintenance planning process, it is the EASA part 145 Aircraft Maintenance Organisation (AMO) which has the responsibility to perform the maintenance in accordance with the work package.

EASA AMP Obligations

EASA requires Operator Reviews of Validity and Effectiveness of the AMP  - EASA Annex I – Part M - Subpart C - M.A. 302 Aircraft Maintenance Programme - (g) … The aircraft maintenance programme shall be subject to periodic reviews and amended accordingly when necessary. These reviews shall ensure that the programme continues to be valid in light of the operating experience.

Operators are able to strongly influence the success of a continuous development of scheduled maintenance program data but providing a virtuous circle of feedback to the Type Certificate Holder (TCH), A continuous review of TCH and Original Equipment Manufacturer (OEM) service bulletins, reliability data, service letters, airworthiness directives provides source material for optimisations.

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Maintenance Planning Document (MPD) – The MPD is essentially generic across a particular fleet, is issued by the aircraft manufacturer and applies to many aircraft, it is not customized and several (hundreds of) tasks are dependent for example on the aircraft modification status and its serial number.

It cannot under any circumstances be considered as a final list of tasks for a given tail number.

Aircraft Modification Status – The applicability of multiple tasks may be affected by the aircraft modification status. (The MPD may list a task as “pre mod” or “post mod”.)

To correct set the tasks we must know the mod status of the aircraft in order to know which tasks are applicable and should be carried out.

Also, the aircraft may have custom modifications embodied, which often come with their own maintenance tasks. (Via Supplemental Type Certificate (STC) controlled by Part 21 Subpart J Design organisations)

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When a maintenance program is developed, it includes tasks that satisfy the criteria for both applicability and effectiveness.

The applicability of a task is determined by the characteristics of the component or equipment to be maintained.

The effectiveness is stated in terms of the consequences that the task is designed to prevent. The basics types of tasks that are performed by maintenance personnel are each applicable under a unique set of conditions.

Tasks may be directed at preventing functional failures or preventing a failure event consisting of the sequential occurrence of two or more independent failures which may have consequences that would not be produced by any of the failures occurring separately.

Maintenance Program task types include:

(1) Inspections of an item to find and correct any potential failures;

(2) Rework/remanufacture/overhaul of an item at or before some specified time or age limit;

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Compliance Auditing brings with it the daily challenge of ensuring that the organisation remains at all times fully compliant with both internal and external obligations.

The Audit Management, Control and Oversight system should ensure that the established safety and quality procedures are fully complied with.

In addition :

a)     To plan and deliver audits

b)     To review findings

c)     To perform root cause analysis and develop additional actions where necessary (under the specific control or guidance of the business area owner of post holder)

In an effective Quality Management System QMS monitoring is a continuous process. It is essential to ensure robust and continuous oversight of all internal processes, and procedures.

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Let’s consider the difference between Assessment & Audit

Assessment

The evaluation process used to measure the performance or effectiveness of a system and its elements.

Our goal is to perform an assessment of the auditing process follow up to determine both the cost effectiveness and overall value to the business.

Audit

An EASA Audit is a systematic and independent examination to determine whether quality activities comply with external regulatory requirements and internal organisational specifications and whether these specifications are implemented effectively.

A primary indicator of a poor or failing system is repeat findings or findings which should be addressed at a lower level – for example the Competent Authority should not identify problems which are normally expected to be found within the internal Quality Assurance System audit process.

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The ability to successfully identify and address the root cause is not a given and like many activities benefits from improved knowledge experience and development of individual competence.

Typically it is only by monitoring over time that we are able to confirm that the mitigation's which have been developed as a result of analysed root cause have done the job. However we can draw a conclusion based on our understanding of the analysis and actions which have taken place to assess if we have confidence in the steps which have been taken.

Any shortfall in expectation could for example cause the finding to be re-opened for additional analysis.

Some of the reasons that the true root cause has been miss identified are considered here :

a) Root Cause Analysis (RCA) based on assumptions rather than on objective evidence. It is essential to ensure that all data is accurately classified and clearly understood in relation to the observed facts.

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Please consider that just because a product meets for example compliance with ISO 9001-2015 objectives does not automatically mean it is safe. (Just as not having an accident can be taken as meaning that we will not have an accident in the future.)

In reality the key aspect becomes our ability to measure risk and exposure. Quality systems audits consider gaps related to compliance with both external regulations and internal organisational process and procedures.

Quality Assurance and Risk Assessment

The first point to make is that the term “risk” subjective whereas the role of an EASA regulatory driven audit is to assess compliance with a standard not an opinion so this creates a challenge.

So when a discrepancy is identified it creates a number of questions

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Why should we wish to measure the performance of our Compliance Audit Process?

Essentially for 2 reasons

1/ The first is that we have an organisational obligation to ensure both regulatory and organisation compliance and of course there is a cost for this – so the question becomes is the organisation receiving value for money?

2/ The second is because there is a cost associated lets call it a return on investment – if we invest more will we return more- without a measure we will not be able to understand this.

The Internal Audit function was predominantly existing as a mandatory process to ensure and demonstrate compliance is also able to focus on improving business performance and add value by supporting strategic business objectives.

Management communication of the various shortfalls related to the audit findings should be strong and consistent and to be demonstrated to have a contributory impact on a culture of compliance within an organization

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With the exception of EASA Part 21 Subpart J "Design Organisation Approval" which as will be aware is managed directly by EASA the process for all other approvals (Air Carrier – Part 145 / Part M / Part 147 / Part 21 Subpart G POE / ATO) essentially works as follows

Achieving Regulatory Approval (Simplified)

1/ The organisation demonstrates to the Competent Authority (CA) that they satisfy the pre-requisites to be granted the requested approval

Documentation / Facilities / Manpower / Competence / Finance / Oversight

2/ The Accountable Manager of the Approved Organisation signs a statement to confirm his or her responsibility related to ensure sufficient finance is available to maintain full compliance

3/ The Organisation must set up a process (Independent Quality Assurance) to ensure continuous compliance

4/ The CA periodically assess the organisation for continuous compliance and raises findings for any non – compliance (Level 1 or 2 as appropriate)

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Analytical Techniques (RCA Tools)

“Five Whys” Approach

The “five whys” approach. By using this approach, root cause contributors can be identified along with the antecedent events, and potential mitigation or prevention strategies can be suggested on the basis of the answers.

Once the initiating problem is specified, a consecutive series of “why” questions are asked, with each answer becoming the subject of the next question.

Note that with each response, not only does a deeper investigational dive occur, but opportunities for implementing mitigation strategies are highlighted.

Ishikawa Fishbone Diagrams

A fishbone diagram, which is essentially a cause and effect diagram provides for a graphic representation which categorises the potential causes related to a problem in order to identify the root causes.

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The process to understand the causal elements including the various Root Causes is a subjective process – means it can be influenced by personal behaviour. 

It is important for the reason that we should take careful steps to ensure the we have the necessary skill level and competence in the persons or teams who are responsible for the evaluation process. 

Team Composition

Any team which is assembled to consider Root Cause must have the Appropriate skill set and knowledge of Investigative Methodology. Background Knowledge and understanding related to Parts, Materials, Processes & Human Performance as required should be present as required.

Note the importance of ensuring Management Commitment to be successful in any given investigation the lead investigator and team members should be given

management backing to pursue the root cause in the most effective way

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Within our Aviation system both Quality and Safety Management systems have shared common values. To be effective they both have to be planned and managed and provided with appropriate resources. In addition both aim to involve every relevant functional element within the organization and indeed, both processes strive for continuous improvement. 

Root Cause is Root Cause you may correctly say! So how can there be a difference between Quality Management Systems (QMS) Root Cause and Safety Management Systems (SMS) Root Cause.

Lets first consider the Different roles of Quality & Safety.

Quality is looking at Compliance (It has happened!).

Quality systems tend not to consider the role of risk whereas of course this is a fundamental tenant of the SMS system.

The Quality Management System (QMS) remains however the primary means of ensuring that the organization is meeting requirements (Ensuring Regulatory Compliance) and continuously improving its processes.

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www.sassofia.com considers the complexities of Root Cause Analysis (RCA)

To be effective in reducing negative events we need to understand how we can use various analytical techniques to first understand and then to mitigate the actual as well as potential exposure.

The root cause analysis (RCA) method uses a cause and effect approach by asking (For example) multiple "why" questions as an effective way to identify one or more low level elements which contributed in some way to a subsequent failure.

With sufficient information available we are able to develop a number of corrective actions which should directly impact the exposure and which if taken correctly should prevent failure in the future.

Direct cause is defined as “the cause that directly resulted in the occurrence.” This would be like the person who whilst following a standard operating procedure (SOP) makes an “error” which results in an adverse outcome.

So therefore we can say that the person’s error is the direct cause of the problem that occurred.

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A Supplemental Type Certificate (STC) is an FAA  or EASA approved major modification or repair to an existing type certified aircraft, engine or propeller. As it adds to the existing type certificate, it is deemed 'supplemental'. As its name suggests, an STC is a certificate. It defines the product design change, states how the modification affects the existing type design, and lists serial number effectively. It also identifies the certification basis, listing specific regulatory compliance for the design change.

An STC being a supplemental type design approval for a major alteration and specific to a make and model or even a specific serial number as a one “off” STC

The STC Holder – STCH remains ultimately responsible for the certification of the modification.  An STC is a design approval, however it doesn’t allow the holder to produce anything. (typically created by Part 21 /FAR 21 Subpart J Organisation Design Approval Holder (DAH) Design Organisation Approval (DOA)).

Note - The STC, which incorporates by reference the related Type Certificate (TC), approves not only the modification, but how the modification affects the original design.

The application must be made in the form and manner prescribed by the FAA  or EASA.

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