Quality and Auditing
Quality and Auditing
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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
https://doi.org/10.15242/IJCCIE.IAE1216204 91
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.
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Int'l Journal of Computing, Communications & Instrumentation Engg. (IJCCIE) Vol. 4, Issue 1 (2017) ISSN 2349-1469 EISSN 2349-1477
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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.
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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
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