Sofema Online considers the role of Process Failure Mode and Effects Analysis (PFMEA) in Aviation System Root Cause Analysis.

Introduction

Human and System errors can have quite significant negative outcomes. Process Failure Mode and Effects Analysis (PFMEA) looks at each process step to identify risks and possible errors from many different sources.

The sources most often considered are:

Steve Bentley CEO of Sofema Group (www.sassofia.com www.sofemaonline.com www.aets-sofema.com) considers the common errors that people make when considering Aviation Errors

Lack of Detail of Appreciation Related to the initial assessment of the Event, Issue or Problem

Spending time to analyze the initial problem so that we understand “What” has happened as well as “How” it happened. It is important to perform this analysis before moving onto Root Cause Analysis.

This will not only determine the nature of the problem but will also identify exactly where the problem exists within the system, to understand when it exists. So, it is important to recognize that a well defined Problem Statement drives the entire Root Cause Analysis effort.

SofemaOnline (www.sofemaonline.com) considers SMS RCA Obligations

Introduction

All elements of your business should share the same SMS as well as the same process of engagement, in addition, all elements and processes need to be promoted and educated throughout the organization.

The transition from a traditional SMS to the ICAO Annex 19 “Risk Managed Model”, required many changes throughout the organization process and procedures as well as physical within the workplace.

SofemaOnline takes a deep dive into Root Cause Analysis (RCA)

Introduction - What Do We Mean when we talk about "Root Cause"?

This is the first challenge and typically causes must confusion across the business with some people believing there is always a “single” root cause to a particular issue or problem.

In fact, as we will quickly see there can indeed be multiple root causes associated with a single problem.

The purpose of the Root Cause Analysis is to understand the causal factors that contribute to a particular event.

Reality Check! 

RCA should be conducted at a point where informed conclusions can be made, and realistic action plans formulated. In this way the process has the potential to drive real change in the short, medium and longer term.

SofemaOnline (www.sofemaonline.com) looks at the Root Cause Analysis (RCA) process

Introduction

Is RCA used for negative or positive purposes? In fact, often it is used in connection with negative reviews – means something has gone wrong and we are attempting to get to the bottom of it!

RCA can also be useful as a means to identify and promote positive outcomes and aspects which may not necessarily be a “finding” but which are however identified as an “opportunity” during specific audits.

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.

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

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.

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

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.

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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What do we mean by Root Cause? Often people have a bias to stopping at an event, which itself has enables or causes, however with practice it becomes easier to work through the process and achieve meaningful results.

Let’s take some time to De-Mystifying Root Cause, when we talk about Root Cause we are simply trying to understand why a “something” has happened – what where the fundamental causes and on the journey to discover as many of the contributing factors as we can.

So the focus is on “Why” and “How” a particular event or condition occurred so that we can develop the correct understanding.