Blog posts tagged in Quality

How Effective is your Maintenance Error Management System (MEMS)?

The basic MEDA philosophy is based on an understanding that people do not intentionally make errors and that organizational factors play a significant and contributory role.

It is widely recognized that the majority of causal and contributory factors leading to an error can be managed. In addition developing root cause understandings, leads to a wider and more effective mitigation process.

Where do you Stand?

How many of the following questions can you answer?

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How to deliver Performance Audits?

One example concerns a process or concept which is known as Total Quality Management (TQM), if TQM is effectively embedded within the organisation it can play a significant role and serve as a driving force to improve performance.

As with all effective business processes it requires ownership and a timeline to deliver.

If the organisation system process is to be improved, then that system must be understood in terms of all key elements:

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Considering the relationship between Aviation Quality and Aviation Safety, together with the relationship between Quality Assurance Auditing and Safety Assurance Auditing in Aviation

Often it is apparent there is some confusion between the specific functions of the two different undertakings namely a quality assurance management system and that of a safety assurance management system.

So consider that Quality is essentially looking at compliance, and Safety is looking at Risk.
In essence Quality Assurance is determining gaps based on non compliance with either the regulatory requirements or organisational requirements.

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Steve Bentley MD of Sofema Aviation Services www.sassofia.com explains

It is very healthy within the organisation to ensure that the Post Holder is able to deliver Compliance Independently of the QM (CM) - Explain

Consider the Role of the Aviation Quality System within the European Aviation Safety Agency “EASA”

Consider the following role definitions and responsibilities:

- First, that the Accountable Manager is responsible for the Quality System which includes both elements of Quality Control and Quality Assurance;

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Steven Bentley MD of Sofema Aviation Services believes it is time to recognise QAS as a component of our organisations' SMS.

Where Should an EASA Compliant Quality Assurance System “Sit” in relation to the Organisations SMS?

Introduction

Historically (and growing up in the workplace through the 1970’s I can attest to the fact) there was no formal Quality Assurance within European Aviation Operations.

Of course we had Quality Control and the Role of Flight Operations Director and within Maintenance the Role of “Chief Inspector”.

As the Joint Airworthiness Authority’s influence grew the concept of an independent assessment of conformity became the acceptable way of demonstrating compliance.

Tagged in: QA QC Quality Safety SMS
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To deliver effective EASA compliance audits it is necessary to pay attention to a number of key areas which are identified below for discussion purposes.

a) Maintaining Objectivity
b) Sample Size
c) Value of Finding Raised
d) Operator’s Authority on Area of Audit

Maintaining Objectivity

Objectivity requires both perspective and balance on the part of the auditor. We should also pay attention to the fundamental reason we are carrying out the audit.

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An essential element of any system is to be able measure the effectiveness of the various processes which are involved in delivering the overall product.

The Quality System consists of 2 distinct parts:

a) The Quality Control Processes – Embedded in all production areas
b) The Quality Audit Processes – An independent way of assessing point a) above

By measuring the effectiveness of both parts of the company’s quality system (QA & QC) we will be able to provide a detailed status of the strength of the Quality Management System (QMS) as well as to provide a detailed understanding which will facilitate management planning and development.

Step 1 - Organisation & Regulatory Review

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Introduction

The essential purpose of an EASA compliance audit is to support the maintenance of the regulatory approval.

Quality Assurance Compliance Audits are a systematic and independent comparison of the way the system process or objective is met. Using the observations made during this audit, as “objective evidence” a comparison is thus made against the standard, generating non-conformities or corrective actions in the event of any discrepancy.

The audits should be documented with a checklist which shows the details of the audit standard or audit criteria which is being applied to the audit.

Note 1 Quality Assurance Audits are Prescriptive in as much as they are always referenced against a standard – means compliant.

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Management system audit requirements may include reference to documents such as policies, objectives, processes, procedures, instructions, quality plans, which can when combined with an audit scope statement, deliver internal audits which can be either wide-ranging or focused on any aspect of the organization or part thereof and which has the potential to address risk performance.

ISO 19011 considers that there is a risk associated with delivering an audit program which addresses all the requirements of the various standard or the management system are covered within a year.

Why does this method of scheduling create a risk?

Essentially audit programs which are fitted into an annual 12-month calendar program rarely take risk into consideration.

Tagged in: Audit Program Quality Risks
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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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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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There are many misconceptions and misunderstandings regarding Aviation Safety Management Systems (SMS) and Quality Management Systems (QMS).

The following is intended hopefully to clear up this misunderstanding:

QMS and SMS - Offers many common methods and techniques, but provides different outcomes an objectives:

Sufficient competent resources are critical to the success of both the CM system and the SMS. It is also important to realize that essentially the role of both QMS and SMS is to provide a service to the management team to understand both the non-conformities and risks which they face within the business areas.

Tagged in: EASA QMS Quality Safety SMS
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Related to Auditor Experience

If you are new to auditing or you have limited experience then the challenge of performing an audit can be quite daunting. It is not at all unusual to feel like a fish out of water (so to speak).
The best way to approach this is to be professional in our approach – to understand the audit subject and to use the knowledge of the auditee to our advantage.

Tagged in: Audit QA Quality
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Let’s consider the purpose and role of an EASA compliant Audit, and at the same time to consider how it differs from other types of Audit.

What the Audit is?

The Joint Airworthiness Authority (JAA) implemented and EASA continued the role of Quality Assurance (It should be noted that the one of the unique aspects of this role is the need to demonstrate independence from the function or activity).
A Quality Assurance Audit (Now referred to also as a Compliance Audit specifically looks at the organisations process and procedures with too primary objectives).
Firstly to demonstrate compliance with the regulatory requirements and secondly to demonstrate also compliance with the company procedures.

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SofemaOnline is developing a portfolio of online training courses written by professionals with many years of experience.

Here we look at techniques to support an effective Aviation Quality Assurance Audit and the way we ask questions during an audit, to enable us to take the maximum benefit from the responses we receive.

For the most effective outcome the Auditor should remain in control of the process from start to finish. The auditor has (or should have) the full attention of the Auditee and must ensure that you understand the responsibility to obtain the information necessary to make the correct determinations.

So how are we going to ask questions, in such a way that we quickly get to the substance of what we are trying to audit?
Although we ask questions of each other all day long we seldom consider which technique works best and how we may improve our questioning skills.

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Our goal is typically two fold:

1. To reduce our accident and incident rate on a continuous basis so that we see an improvement year on year
2. To identify latent exposures which can adversely impact us, and to develop mitigations before they become a problem

To ensure the best possible oversight, we need to make sure that our reporting processes within both our QMS & SMS are effective, to do this we need to ensure we have good reporting systems and effective data capture.

The Data gathered through internal and external audits together with other information will provide a sound indication for the management as to whether we are achieving our objectives.

Surveys can also provide a significant insight into the actual perception felt by the staff, and measure the effectiveness of the communications processes.

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There can be two reasons to implement a Quality Assurance System. The first is that it is a required mandatory process to ensure compliance with all regulatory and organisational requirements. The second is that we have an opportunity to use the QA process to support the companies objectives to effectively manage the business in the most efficient way.

A commitment to Quality can become intrinsic within the organization whereby Quality becomes the driver rather than allowing Compliance to become the driver – Compliance should be assumed as a given rather than a target.

If a regulatory audit throws up a non compliance then it is also an indication of a Quality Assurance system shortfall as this is where the non compliance should have been identified. To move to a higher level requires the company to develop effective and compliant business processes which are acceptable to the post holders and business area managers and can at the same time be supported by all employees.

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