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Introduction
Organisations seeking certification or approval, should develop, document, implement, and maintain a Quality (Safety) Management System with appropriate internal quality assurance (QA) procedures.
The QA process complements that of safety assurance, with each having requirements for analysis, documentation, auditing and management reviews to assure that certain performance criteria are met.
While safety assurance specifically monitors the effectiveness of safety risk controls, QA typically focuses on the organisation’s compliance with regulatory requirements.
The complementary relationship between safety assurance and QA allows for the integration of certain supporting processes.
Therefore, a QMS should be seen as an integral part of the application, management and maintenance of a Safety Management System (SMS).
The fundamental objectives of both SMS and QMS may be summarised as:
• Consistency
• Error/threat reduction
This OTAC provides guidance on essential elements of a basic Quality Management System (QMS).
ICAO Reference Documents
ICAO Doc9859 Edition 3 – Safety Management Manual Chapter 2.9, Table 5-1.
ICAO Doc9906 – Quality Assurance Manual for Flight Procedure Design
Definitions
The following key terms and phrases are defined to ensure a standard interpretation and understanding of the QMS and internal QA procedures.
Concern -A concern is a derived conclusion, supported by objective evidence that may become a Finding. A concern may generate a Preventive Action.
Controls – Controls are management and operational techniques, activities, and procedures that monitor the satisfactory performance of the organisation’s operating processes and procedures.
Evidence – Evidence is a documented statement of fact that is based on observations, measurements, or tests that can be verified in a physical way, e.g. copies of documents or parts of documents, images showing the issue, signed file note or statement of circumstances, etc.
Finding – A finding is a conclusion, supported by objective evidence that demonstrates non-compliance with a specific procedure, requirement or standard. A finding will generate a Corrective or Preventive Action.
Inspection – An inspection is the act of observing, measuring, testing, or gauging one or more characteristics of a particular event or action. This is to ensure that correct procedures and requirements are followed during the accomplishment of that event, or action.
Quality Control (QC) – QC are procedures to ensure a manufactured product or service complies to a defined set of quality criteria, or meets the requirements of the client or end-user.
Quality Assurance (QA) – QA ensures a number of products or services meet consistently the specified requirements.
Quality Management System (QMS) – The quality management system is the glue that bonds all the following together:
• The organizational structure
• The procedures
• The processes
• The resources
All needed to implement a successful quality management system.
Root Cause – The root cause is the underlying organisational or technical system cause, or causes, of any finding or concern.
Components of a Quality Management System
The following summarises the main elements needed for a QMS to be developed where required under the Overseas Territories Aviation Requirements (OTARs).
There are many similarities with the content and structure of a safety management system. Wherever possible the systems should be integrated, see OTAC SMS-1 for comparison.
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