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Quality and Auditing

1) Aviation organizations must establish and maintain a quality management system to ensure compliance with international standards and legislation, which is important for flight safety. 2) Quality management system audits are conducted by aviation organizations to monitor compliance with regulations and identify weaknesses in the system. The audit process has two stages - the audit and the corrective action phase. 3) This document provides flowcharts that outline the audit process and corrective action phase for a flight training organization. These flowcharts are intended to provide basic guidance for aviation organizations on managing audits and corrective actions.

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0% found this document useful (0 votes)
276 views6 pages

Quality and Auditing

1) Aviation organizations must establish and maintain a quality management system to ensure compliance with international standards and legislation, which is important for flight safety. 2) Quality management system audits are conducted by aviation organizations to monitor compliance with regulations and identify weaknesses in the system. The audit process has two stages - the audit and the corrective action phase. 3) This document provides flowcharts that outline the audit process and corrective action phase for a flight training organization. These flowcharts are intended to provide basic guidance for aviation organizations on managing audits and corrective actions.

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Vunganai
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Int'l Journal of Computing, Communications & Instrumentation Engg. (IJCCIE) Vol.

4, Issue 1 (2017) ISSN 2349-1469 EISSN 2349-1477

Quality Management and Audit Process in


Aviation Organizations
Ebru YAZGAN

 organizations must carried out their operation and training


Abstract—All areas in the aviation industry such as activities in accordance with all applicable international
maintenance, airport, pilot and maintenance training compliance standarts to ensure flight safety and airworthy aeroplanes. In
with national and/or international legislation is extremely important. other words, in aviation organizations the quality
Operation and training activities in aviation must perform within the management system permits the entity to monitor compliance
framework of similar arrangements all around the world. In other
with national/international regulations and all other standards
words, aviation organizations cannot perform their operations and
trainings except aviation legislation defined with international law.
which introduced by aviation authorities in order to ensure
Therefore organizations should ensure the establishment and the continuation of flight and ground safety operations and
functioning of quality management system to monitor compliance to the continuing airworthiness of aircraft.
the requirements of aviation legislation. Requirements regarding the Aviation organizations should monitor comply with
quality system are given in many aviation legislation. Quality regulatory requirements by doing following:
management system audits are conducted to ensure compliance with  to establish and maint quality management system
legislation and investigate the weaknesses of the system in aviation  to provide feedback system to the Accountable
organizations. In this study, it will be explained that how method Manager
related to auditing and audit management process in aviation
organizations should be followed. However, in this study, flowchart
 to constitute a quality assurance programme
of quality system audits is developed in flight training organization.  to identify all quality and operation producers in
The audit process is split into two separate stages. The audit and manuals.
the corrective action phase. Correction action is taken in response to Quality assurance is the means of quality management
an audit finding in audit management. Besides, in this study, focused on providing confidence that quality requirements
flowchart of corrective action phase is developed in flight training will be fulfilled [2]. Quality assurance includes the
organization. It is aimed that these flowcharts about audits and application of quality systems, in the form of written
corrective action are the basic guidance for aviation organisations. procedures,coupled with specific (and necessary) quality
control checks, all designd to ensure that products and/or
Index Terms— Quality Management, Aviation, Audit Process, services meet defined specifications and satisfy customer
Flowchart, Flight Training Organization. expectations [1].
Annual quality assurance programs are created by the
I. INTRODUCTION Quality Management Department in order to systematically
perform quality audits. The Quality System is required to
A. Quality Management
make progress in the following topics:
Quality is primarily a competitive tool. In the 21 st century  Leadership of management
tehre is no doubt that organizations that understand and make  Creating policies and strategies
use of the fundemantel principles of quality and quality  Determination of operational processes
management can gain tremendous competitive advantage and
 Implementation of regulatory requirements
grow a profitable business. Quality management is the means
 Creating and monitoring organisational structure
by which an organisation ensures that it‟s products and/or
 Determination of establishment, development and
services meet company,customer and regulatory
management responsibilities of quality
requirements. It is combination of resources, responsibilities
management system
and actions that together ensure that specified requirements
 Controlling of all documents including manuals,
are met. It is combination of systematic approaches to doing
reports and records
he work, together with specific checks to ensure that the work
has been undertaken correctly [1].  Creating quality management system programme
Aircraft maintenance, airport, air traffic controller, pilot  Providing and analyzing required financial,
and maintenance training compliance with national and/or material and human resources
international legislation is extremely important. Aviation  Measuring customer satisfaction (for intenal and
external )
 Providing feedbacks to the senior management
Ebru YAZGAN is with Faculty of Aeronautics and Astronautics, Anadolu  Creating required documents
University, Iki Eylul Campus, 26470, Turkey

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Int'l Journal of Computing, Communications & Instrumentation Engg. (IJCCIE) Vol. 4, Issue 1 (2017) ISSN 2349-1469 EISSN 2349-1477

 Performing quality system audits audit results are conveyed to the Accountable Manager, not
 Determination of areas and subjects to be audited necessarily as individual findings bu possibly in the form of a
 Monitoring corrective activities trend analysis identifying significant weaknesses in the
 Evaluation of management quality management system, processes or individual products
 Establishing a record system or services. Also, in many regulations the responsibility for
 Controlling subcontractors (if there is) managing the audit process is identified as a responsibility of
 Training quality management system personnel the Quality Manager [1]. Frame of Audit management is
given Figure 1.
B. Basic Principles of Auditing
An audit is a systematic, independent and documented
process for obtaining audit evidence and evaluating it ACCOUNTABLE QUALITY
objectively to determine the extent to which audit criteria are MANAGER MANAGER
fulfilled [3].
Auditing‟s are not undertaken merely to ensure regulatory
compliance, but to search out weaknesses in the management Corrective The Auditor always has
Action a “client” or customer
system. The auditing process is there to serve the needs of Agreement (senior management)
management, to provide them with feedback on systems
implementation and effectiveness and providing objective
data to assist in decision making. For the audit process to AUDITEES AUDITORS
function effectively it needs to be managed. Audit
management is a key responsibility. We need to ensure that Fig.1 Frame of Audit management [1]
both the audit process and the auditors themselves are aligned It is the responsibility of Audit Management to liaise with
to business needs. Auditing provides the feedback mechanism the client and determine what are the audit needs of the
which tells us how well our systems are functioning and client. It is then possible to programme audits to provide this
where improvements could be made. Today, auditing is information and arrange for suitable audit resources. It must
recognized as an extremely powerful technique that may be be recognised that for certain information auditors with very
used by managers alongside other management techniques to specialist knowledge and experience may be required. Once
ensure adequacy of operations and assist in the achievement the audits have been undertaken and the information provided
of objectives, it has become part of the overall process of to the client, it is then the responsibility of the client to decide
business management [1]. if corrective action is neccessary and by when. They Will
C. The Audit Process either need to liase directly with the audited functions or
request the auditors to undertake this task on their behalf [1].
Although every audit project is unique, the audit process is
In this study, flowchart of quality system audits is
similar for most engagements and normally consists of four
developed in flight training organization. This flowchart and
stages: Planning (sometimes called Survey or Preliminary
detail explanations is given in Appendix 1.
Review), Fieldwork, Audit Report, and Follow-up Review [4].
This quality audits flow chart has been developed by
Audits should be undertaken when there is a need for
taking the opinions of experts in aviation sector and the
information in order to facilitate decision making. In many
experience of the quality department employees in Flight
cases, particularly for internal audits, it is the auditors
Training Organization (FTO). This flow chart to make audits
themselves who decide what should be audited and how
show the procedure to be followed not only for the FTOs but
frequently. This is clearly an inadequate approach, however if
also for all aviation organizations.
management take little or no interest in auditing then it is
inevitable that those who appreciate the need, ora re D. Corrective Action and Remedial Action
enthusiastic about the task will drive the process in the way An aspect of auditing that is not often fully addressed in
that they feel best serves the need of the organisation. The regulations is the need to ensure that “Corrective Action”
end result is an audit system that providesinformation about (action to adress the underlying cause of the problem) is taken
aspects of organisational performance that are of little or no in response to an audit finding.
concern by senior management, whilst important aspects are There are two separate actions that often need to be taken
left un-investigated. There are two seperate sub processes in in response to an audit finding. The first action is the
relation to any auditing activity: immediate fixing of the problem- this is termed “Remedial
1. The audit itself-gathering information for the auditor‟s Action” and is the action that will elimintae/remove the
client problem. However audits often only reveal the „symtom‟ of a
2. The corrective action process-which is driven by the fundemantal process weakness or process breakdown, and it
client and may not even involve the auditor. is necessary to identify what has caused this breakdown and
In regulated aviation organisations the Accountable then by fixing it the process will not break down in the future
Manager is the auditor‟s client and it is noted that many and hence further instances of what has found by the audit
regulations require a feedback mechanism to ensure that the

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Int'l Journal of Computing, Communications & Instrumentation Engg. (IJCCIE) Vol. 4, Issue 1 (2017) ISSN 2349-1469 EISSN 2349-1477

will be avoided [1]. Description of Corrective Action and  Find the cause of the potential problem / non
Remedial Action is given Figure 2. conformance
 Develop a plan to prevent the occurrence
Remedial acton „fixes‟ the problem, but does not correct  Implement the plan
the process weakness  Review the actions taken and the effectiveness in
preventing the problem [7].
In this study, flowchart of Corrective Action and Remedial
Action Phase is developed in flight training organization.
Process weakness results This flowchart and detail explanations is given in Appendix
in audit nonconformity 2.
This the request and tracking of corrective and remedial
action flow chart has been developed by taking the opinions
of experts in aviation sector and the experience of the quality
department employees in Flight Training Organization
(FTO). This flow chart to make the request and tracking
corrective and remedial action show the procedure to be
Coorective action „corrects‟ the process weakness and followed not only for the FTOs but also for all aviation
prevents further failures organizations.

Fig.2 Description of Corrective Action and Remedial Action II. CONCLUSION


[1]
At the end of the study, improvement of the flowcharts
“Corrective action” means an action to eliminate the cause
about quality audits and corrective, remedial action shall
of a finding of non-conformity with the applicable
guide aviation organizations that have to make quality
requirements in order to prevent recurrence.The competent
management system audits . Since the requirements of
authority shall report to the Agency in due time on the
national or international instructions are excessive, flight
completion of corrective actions and provide evidence thereof
traininig organizations experience too serious difficulties in
[5].
audit period. By using the flowcharts to be improved in this
It is recommended that the audit life cycle is split into two
study by aviation organizations; difficulties of excess and
processes. The audit itself and the corrective action phase.
complex instructions necessary to follow are aimed to be
Auditee management are fully responsible for the
removed and audit periods are aimed to be reduced. This
determination and implementation of appropriate corrective
study may leading for both other departments and
action in a timely manner to ensure that system weaknesses
organizations.
are rectified as soon as practicable. Audit management need
Consequently, flowcharts for the procedures to be followed
to be satisfied that corrective action is taken and effective, this
by has been put forward. While forming the flowcharts, all
should be formally recorded and the audit „closed out‟. This
relevant activities necessary to make quality audits has been
check on the effectiveness of the corrective action is aimed at
investigated and expert opinions has been taken. Thus the
establishing that the root cause of the problem has been
results of this study shall constitute a guide for both flight
addressed and the problem („symptoms‟) found on the initial
training organizations and other aviation organizations.
audit is no longer evident. This will require appropriate audit
With this study is to emphasize the importance of quality
samples to check for the problem previously noted in
management system audits for aviation organizations by
appropriate areas of the organization. It may be useful to
improving flowcharts. Also this study aims to increase the
check the ongoing effectiveness of any corrective actions
situational awareness about quality management system for
again at subsequent audits [1].
aviation organizations.
A corrective action is a reaction to a problem that has
already occurred. The actions initiated are intended to: a) fix
APPENDIX
the problem and b) modify the quality system so that the
process that caused it is monitored to prevent a reoccurrence. Flowchart of quality system audits for flight training
The documentation for a corrective action provides evidence organization is given in Appendix 1.
that the problem was recognized, corrected, and proper Flowchart of Corrective Action and Remedial Action
controls installed to make sure that it does not happen again Phase for flight training organization is given in Appendix 2.
[6].
A Preventive Action is a proactive approach and process
for detecting non-conformances or undesirable situations that
have not yet happened and prevents them before occurring.
The process includes:
 Identify potential problems or non-conformances

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Appendix 1: Quality System Audits Flow Chart


Flow Chart of Quality System Audits Responsible Explanations

Least one week before planned audit date,


Quality an audit document will be written by the
Management quality department to pilotage department.
Department
If a delay demand comes from the pilotage
department, audits/ inspections will delay an
appropriate date.

Before performing audit, auditors should


Pilotage make a briefing among themselves to create
Department an audit plan and discuss among themselves
as an important check on where they should
be prepared to.

When auditors go to the pilotage


department, an auditor should give
Quality information about the content in the opening
Management and meeting. If there is evidence, it must be
Pilotage collected and analyzed.
Departments
After audit, findings are shared with
pilotage department to be confirmed in the
Quality close meeting.
Management
Department Finding or incompliance is the
unsatisfaction of the intended situation
including safety, security and airworthiness.
Quality Findings and incompliances are divided into
Management and two categories: Level 1 and Level 2.
Pilotage Level 1 Findings: Incompliances to
Departments subjects directly affecting safety, security
and airworthiness stated in documents like
Training Manuals and Operation Manual
Level 2 Findings: Subjects available in
documents like Training Manuals and
Quality Operation Manual but not directly affecting
Management safety, security and airworthiness. However,
significant incompliances are reported to the
competent authority by Accountable
Manager within 72 hours.

Pilotage manager is responsible to perform


Quality corrective and remedial actions for
Management elimination of findings and incompliances
Department which found during audit. Also, He/She
should take measures to not happen again.
Quality manager determines the final dates
of corrective actions. Corrective and
Pilotage Remedial Action Form has been prepared
Department by Quality department. Pilotage department
has to make root-cause analyses and
perform corrective and remedial actions and
also fill the form.

After Corrective and Remedial Action Form


comes from the pilotage department to
Quality Manager Quality department, if needed auditors
inspect these actions and then sign the
form.Quality department sends these reports
to accountable manager to be approved. If
accountable manager find it necessary,
demands extra activities from the Quality
Quality department.
Management
Department

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Int'l Journal of Computing, Communications & Instrumentation Engg. (IJCCIE) Vol. 4, Issue 1 (2017) ISSN 2349-1469 EISSN 2349-1477

Appendix 2: The Request and Tracking of Corrective and Remedial Action Flow Chart
Flow Chart of Corrective Action and Remedial Action (CARA)
Responsible Explanations
Phase
If there is CARA request from pilotage, the
date and return date must be specified in the
Quality form.
Management If CARA has not been taken by pilotage
Department department, audit result is not closed. It
must be specified in the audit program that
the audit result is close or open Evaluation
results are not closed, expired inspection is
unacceptable. If the audit result is not
closed, the audit cannot be accepted as final.

Quality Manager After audit Quality Manager sign the


CARA form. Then audit report and CARA
form are sent to the Accountable Manager
to examine and sign.

If Level 1 and Level 2 findings (major


errors and incompliances) are detected,
these findings must be reported to the
pilotage department and it is requested that
Accountable necessary corrective and remedial activities
Manager is carried out. If the detected error or
nonconformity directly affects flight safety,
the flight training activities are stopped and
the flight training activities are not resumed
without the necessary corrective and
remedial actions being taken.
Quality
Management If Level 2 findings are detected, the deadline
Department for the elimination of findings is determined
and re-audited at the end of the period.
Additional time is given if necessary. The
period given in Level 2 findings cannot
Pilotage exceed a total of 90 business days.
Department
For elimination of findings which found
during audit, pilotage department manager
is responsible to perform corrective and
remedial actions. Also he/she is responsible
Pilotage to ensure that these findings are not
Department repeated.

Pilotage department has to make root-cause


analyses and perform corrective and
remedial actions. Also CARA Form is filled
and signed by pilotage manager. Quality
department inspects the corrective and
Quality remedial activities, if needed. The Quality
Management Management may check that these activities
Department carried out if deemed necessary.

If pilotage department request extension the


date, extension date may be given by the
Quality Management department. After
Quality CARA form comes from the pilotage
Management department, the auditor who performs the
Department audit signs the form and closes the CARA
The acceptance letter of the CARA to be
performed is prepared by the quality
management department and sent to
pilotage department.

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Int'l Journal of Computing, Communications & Instrumentation Engg. (IJCCIE) Vol. 4, Issue 1 (2017) ISSN 2349-1469 EISSN 2349-1477

ACKNOWLEDGMENT
I thank to Musab AYDIN and Fatih KATIRCIOGLU for
the writing stage. I also thank to Mustafa TOPAL for the
development of flowcharts stage.

REFERENCES
[1] Joint Aviation Authorities (JAA), (2013). Quality management - principles
& practice in an aviation environment.
[2] ISO 9000:2005, Clause 3.2.11.
[3] http://asq.org/public/auditing-qms-p1.pdf.
[4] https://www.auditnet.org/audit-library/the-internal-audit-process-from-a-to-
z-how-it-works
[5] https://www.caa.co.uk/uploadedFiles/CAA/Content/Standard_Content/Co
mmercial_industry/Aircraft/Airworthiness/Seminars/Corporate_aviation_J
une_2016/FWM20160629_09_Root%20Cause%20Analysis.pdf
[6] http://www.rmbimedical.com/RegulatoryAffairs/capa%20guidelines.pdf
[7] http://www.sgs.com/en/news/2014/02/capa-management-in-a-gmp-
environment

Ebru Yazgan was born in 1977 in Eskisehir.


She received her undergraduate degree in the
Department of Mechanical Engineering,
Istanbul Technical University, Istanbul, Turkey
in 1999. She received her Master of Science and
Ph. D. degrees in the Department of Industrial
Engineering, Eskisehir Osmangazi University,
Eskisehir, Turkey in 2005 and 2010,
respectively.
She worked in various factories in Turkey as
product development engineer and process engineer between 1999–2004. She is
now the quality management coordinator and lecturer in Faculty of Aeronautics
and Astronautics at Anadolu University, Eskisehir since 2005. She teaches
Human Factors, Ergonomics, and Cognitive Ergonomics. Among her research
areas are ergonomics, human factors, human error, pilot error and quality. She
has published many papers at various national and international journal and
conferences.

https://doi.org/10.15242/IJCCIE.IAE1216204 95

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