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Maintenance Management

QUALITY QM/QA/QS

Part 5

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Quality Management Quality Assurance Quality system


ISO 9000 EN 9100 EFQM TQM

Quality History

Major change of focus:


From external quality to internal quality From product/service improvement to process improvement From second-party certification to third-party certification

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Quality History
Year
1959 1963 1971

QualityStandard
MIL-Q-9858(USA) Quality management program MIL-Q9858(USA) rev. A

1978 1979 1980 1987

ANSI N 45.2(USA) QualityAssuranceprogramRequirementsforNuclear Facilities CSA Z 299.1 QualityAssuranceProgramRequirement BS 5750 commercialqualitymanagementstandard

TQM
ISO9001/2/3,QualitySystem(obsolete)

Quality History
Year 1994 1997
1997 1999 2000 2001 2003 2008

Quality Standard
First revision of ISO 9001 (soft revision) AS9000 AS9100-1997 EN9100-1999 ISO 9001-2000 QualitymanagementSystemRequirements EN9100-2001 EN9100-2003 ISO 9001-2008 QualitymanagementSystemRequirements

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Quality History
Quality Control Quality Assurance Quality Management

(Detection)
BS 5750 1979-1987

(Prevention)
ISO 9001/2/3 1987-2000

(Direction)

ISO 9001 2000/2008

Quality History

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Quality History

AS9000:1997

Inputs

AS9000:1997
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Standard Creation 1998(QS)


Americas Standard AS9000
European Standard

ISO 9001 1994


World Aerospace Quality Standard ; AS/EN/JIS Q 9100

prEN 9000-1

AS9100

ISO TC 20 WG11

EN 9100
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ISO 9001 / EN 9100 timeline

2000

2001

2002

2003

DEC. 2003

ISO 9001:1994 ISO 9001:2000

9100 : 1999

9100 : 2001

9100:2003 ?

9100A:2001 will include both ISO 9001:1994 and ISO 9001:2000 models until December 2003
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EN9100
EN9100-1999 = ISO 9001-1994 + 83 additional requirement. EN9100-2001= ISO 9001-2000 +80 additional requirement +18 note List of EN 9100 standard 1. 9101 :Checklist 2. 9110 Repair Station Quality System 3. 9120 Distributor Quality System 4.

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Other ISO related standards


ISO 9000:2005 : Quality management systems Fundamentals and vocabulary ISO 9001:2000 : Quality management systems Requirement. (obsolete) ISO 19011 : Guidelines for quality and/or environmental management systems auditing. ISO 9004 :Quality management systems Guidelines for performance improvements.

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ISO
The term ISO stands for the International Organization for Standardization. You would reasonably assume that it ought to be IOS, but it isn't. Apparently, the term ISO was chosen (instead of IOS), because ISO in Greek means equal, and ISO wanted to convey the idea of equality - the idea that they develop standards to place organizations on an equal footing.

ISO 9001:2008 Principle


Principle 1: Customer focus Principle 2: Leadership Principle 3: Involvement of people Principle 4: Process approach Principle 5: System approach to management Principle 6: Continual improvement Principle 7: Factual approach to decision making Principle 8: Mutually beneficial supplier relationships

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Element of Quality management


1. Organizational Structure 2. Responsibilities 3. Methods 4. Processes 5. Resources 6. Customer Satisfaction 7. Continuous Improvement

Which one have better Quality?

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What is Quality?
Degree to which a set of inherent characteristics fulfils requirements. The assurance of Regulatory compliance (aviation)
Quality is defined by the customer
(internal/external) expectations.

Good quality process meet or exceed

Which one have better Quality?

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What is Quality Assurance ?


Independent activity of providing the evidence needed to establish confidence, among all concerned, that the quality function is effectively being performed. A system that oversees compliance with a set standards. A tool for continuous improvement. A management control tool.

PDCA CYCLE

The PDCA cycle is an established, logical, method that can be used to improve a process.

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PDCA CYCLE
(P) planning (what to do and how to do it), (D) executing the plan (do what was planned), (C) checking the results (did things happened according to plan) and (A) act to improve the process (how to improve next time) The PDCA cycle can be applied within an individual process, or across a group of processes

PDCA CYCLE

The PDCA cycle is an established, logical, method that can be used to improve a process.

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Quality Management Proccess Model


Continual improvement of the quality management system

Customers

Management Responsibility

Customers

Resource management

Measurement, analysis and improvement

Satisfaction

Input

Output
Product Realisation Product

Requirements

Definition
Management System The collective body of managers and other associated managerial elements that provide for direction, oversight and control of an organisation Quality The degree to which a system consistently meets specified requirements, satisfies stated needs, or produces desired outcomes.

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Definition
Quality Assurance (QA) The formal and systematic process of auditing and evaluation of management system and operational functions of an operator to ensure: compliance with regulatory and internal requirements; satisfaction of stated operational needs; identification of hazards, undesirable conditions and areas requiring improvement. Equivalent Terms: Internal Evaluation, Safety Assurance

Quality System & Quality Assurance


QA is a system of management activities to ensure that a process, item, or service is of the type and quality needed by the user. QA is just one part of a quality system. A quality system provides the framework for developing quality assurance policy and management controls.

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Definition
Quality Control (QC) The audit, inspection or testing of the output of a process, which may be a product, service or function, to determine an operators compliance with technical, performance and/or quality standards. Quality control activities are typically sponsored by operations, maintenance or security managers, who have the direct responsibility for the safety and security of operations. Equivalent Terms: Product Inspection, Product Audit

Definition
Quality Policy Means the overall intentions and direction of an organisation (operator, AMO, service provider) related to Quality, as approved by those managers that direct and control the organisation (e.g. Accountable Manager). Quality System Standards The criteria developed by the organisation that will provide means to ensure all maintenance and aircraft components reflect the appropriate standards.

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Definition
Quality Systems The total network of administrative and detailed procedures, which is implemented to ensure all operations and maintenance activities satisfy the customer's requirement and the documentation accurately reflects the criteria used to perform the maintenance.

Quality Costs

100 90 80 70 60 50 40 30 20 10 0 1st year 2nd year 3rd year 4th year

failure cost total quality costs prevention costs

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Quality Documentation
INTENT POLICY QUALITY MANUAL MOE,POE,Op, ... PROCEDURES LOCAL/WORK INSTRUCTIONS RECORDS / FORMS PROOF WHAT?

HOW? WHY?

Process and procedure


Process : Is a series of events , stages, or phases that take place over time and have an identifiable result. - It tells you what happens or how it works Procedure : is a set of steps that a person performs to achieve specified outcomes, including decisions that need to be made. - It tells you how to do it.
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Process Management
Process include:
Control Effectiveness

1. Input 2. Output 3. Resource 4. Controls 5. Activities 6. Owner


Recourse Efficiency

Input

process

Output

Procedure
a good procedure must include answer for following question.
Sample procedure content
1. Procedure Title 2. Procedure identification number 3. Version 4. Effective Date 5. Approved By 6. Date Approved 7. Objective 8. Scope 9. Responsibility 10.Reference document 11.acronyms and Definitions 12.abbreviations 13.Description 14.Appendices
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1. 2. 3. 4. 5. 6.

How? When Why? Where? Who? What?

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Customers and Suppliers


Environment (surroundings)

Method People

Input (supplier)

Internal process

Output (customer)

Process approach
Process Approach: is a way of obtaining a desired result, by managing activities and related resources as a process.
The "process approach" is a key element of the ISO 9000 standards. The systematic identification and management of the various processes employed within an organization, and particularly the interactions between such processes, may be referred to as the process approach to management.

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Process relationship

The above diagram shows that an input-output relationship is usually a two-way street. Inputs go one way and outputs go the other way.

Process approach
To adopt the "process approach" an organization should apply the following steps: Identify the processes of the organization, Plan the processes, Implement and measure the processes, Analyse the processes, Improve the processes.

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Process controls

The effectiveness of an individual process may be measured by the conformity of its output or product to customer requirements. Its efficiency may be measured from its use of resources.

Process Management
Process symbols: Start/end Action (activity) link to sub-process Document branch /decision yes No

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Process flowchart

TQM

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TQM

MOE structure and contents


According to Part- 145
PART 0 PART 1 PART 2 PART 2L PART 3 PART 4 PART 5 PART 6 .. General Organisation Management Maintenance Procedures Maintenance Procedures Quality System Procedures Contracted operators Sample of Document operators maintenance procedures

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Operation Manual structure and contents


According to Part- OPS
Part A

General/Basic 0. 1.

3.Quality system
.

Sample

Part B

Airplane operating mater Route & Aerodrome instruction and information Training

Part C

Part D

Quality Manual contents


1. Terminology 2. Quality , Safety and Security Policy 3. Quality S system appointments, and job description. 4. Document control. 5. Audit procedure. 6. Audit Schedule and Progress Tracking. 7. Reporting procedure. 8. Follow up and remedial action procedure. 9. Non-conformity recording and tracking system. 10. Quality training requirement and training syllabus 11. Quality management review meeting

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Simple Quality structure


Accountable manager

Quality Quality manager manager Continued airworthiness Manager

Maintenance Manager

Operations Manager

QA CAMO

QA Maintenance

QA Operation

QA & QC structure
Quality manager

QA CAMO Compliance Auditor

QA Maintenance

QA Operation Compliance Auditor

QC Compliance Auditor

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Question 1

What is the difference between Quality System and Quality assurance?

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Answer
QA is just one part of a quality system. A quality system provides the framework for developing quality assurance, Policy, and management controls.

Question 2

What is the difference between QA and QC ?

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Answer
The difference is that QA is process oriented and QC is product oriented. Testing is one example of a QC activity, but there are others such as inspections Quality Assurance: A set of activities designed to ensure that the development and/or maintenance process is adequate to ensure a system will meet its objectives. Quality Control: A set of activities designed to evaluate a developed work product. Testing: The process of executing a system with the intent of finding defects.

Answer
QA: A set of activities designed to ensure that the development and/or maintenance process is adequate to ensure a system will meet its objectives. QC: A set of activities designed to evaluate a developed work product. Testing: The process of executing a system with the intent of finding defects.

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Safety Management
Safety Management System (SMS) A systematic approach to managing safety within an organisation, including the necessary organisational structures, accountabilities, policies and procedures.

Safety Management
Safety Management System (SMS) ( cont.) As a minimum, an SMS: identifies safety hazards; ensures that remedial action necessary to maintain an acceptable level of safety is implemented; provides for continuous monitoring and regular assessment of the safety level achieved; and aims to make continuous improvement to the overall level of safety.

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Safety Management
Safety (Operational) A condition in which the risk of injury or damage occurring during operations is limited to an acceptable level. Safety Assurance The component of a safety management system that comprises processes for: safety performance monitoring and measurement; the management of change; continual improvement of the SMS

Safety Management
Safety Risk Management The component of a safety management system that comprises: hazard identification processes; risk assessment and mitigation processes.

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Security Management
Security Management System (SEMS) The documented system of an Operator based on threat assessment to ensure security operations consistently fulfill all requirements mandated in the national civil aviation security programme of the State of the Operator in the most efficient and cost effective manner considering the operational environment of the airline. Integrated Management System the.

Security Management
Integrated Management System (IMS) the.

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AuditOverview

Whatisanaudit?
It is a process of systematically and objectively determining whether an organizations financial or operational goals are being met. Auditing is an important function within an organization.

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AuditOverview

Whyisitimportant?
Management uses the results of audits to make decisions about which aspects of the organizations operations need attention.

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Type of Audit
First Party audit: (Internal Audit) Audit carried out by organization on their own systems. Second Party Audit: (External Audit) Audit carried out by organization on their suppliers , contractors or service providers. Third Party audit : (Certification Audit) Audit performed by an independent body usually for certification purposes Note: Audit performed by Authority some times called Third Party audit and sometimes called Authority audit
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Audits

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What is criteria?

Criteria

Company/O.P/M. O/T.C Requirement


conformance

Regulatory Requirement
compliance 67

What is criteria?
Audit criteria: means a set of regulation ,policies, procedures or requirements used as a reference (Reference Document)

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Key Auditing Activities


1. 2. 3. 4. 5. 6. 7. Initiation Preparation Reviewing Observation and gathering of audit evidence Analysis Reporting Follow-up and close out
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Key Auditing Activities


1. Initiation 2. Preparation 3. Reviewing
(define audit scope & objectives) (audit planning and preparation including audit plan and checklist development) (implies examining the management system documents ) (auditing the management system ) (finding reconciliation ) (reporting the results of the audit )

4. Observation and gathering of audit evidence. 5. Analysis.

6. Reporting.

7. Follow-up and close out .


(conducting audit follow-up and close out of findings ) 70

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Auditor Development
Knowledge
and

skills Personal attribute

Education

Training

Experience

through written or oral examination, evaluation panel or other acceptable means.

Demonstration

Competent Auditor
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QUESTION
Whatisthedifferencebetweeninspectionand audit?

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Inspection: conformity evaluation by observation and judgment accompanied as appropriate by measurements, testing gauging. Audit: It is a process of systematically and objectively determining whether an organizations financial or operational goals are being met.

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product

Accept

INSPECTION
Reject
system

Goals

Audit
process product Systematically

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Any Question?

Any Question?

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9101 - Checksheet Checksheet for 9100 for 9100 9102 - First Article Inspection First Article Inspection 9103 - Management of Key Characteristics Management of Key Characteristics 9110 - Quality System for Aerospace Repair Quality System for Aerospace Repair Stations Stations 9111 - Checksheet Checksheet for 9110 for 9110 9120 - Quality System for Quality System for Pass PassThrough Through Distributors Distributors 9121 - Checksheet Checksheet for 9120

AS9100(C), issued in January 2009


Incorporation of

ISO 9001:2008 changes Expansion of the scope to include aviation, space and defense, as well as land- and sea-based systems for defense applications Ensure alignment with IAQG strategy for on-time, onquality delivery performance (OTOQD) Adopt new requirements based on stakeholder needs, and Improve existing requirements where stakeholders identified a need for clarification, including when a documented procedure is required.

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