Maintenance Management 5

Maintenance Management
QUALITY QM/QA/QS
Part 5
MaintenancemanagementBym.shahbazi5/17/2011
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
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
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
Quality History
AS9000:1997
Inputs
AS9000:1997
10
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.
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
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?
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
21
Process flowchart
TQM
22
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?
26
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 ?
27
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.
63
AuditOverview
Whyisitimportant?
Management uses the results of audits to make decisions about which aspects of the organizations operations need attention.
64
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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
65
Audits
66
33
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
69
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
71
QUESTION
Whatisthedifferencebetweeninspectionand audit?
72
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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.
73
product
Accept
INSPECTION
Reject
system
Goals
Audit
process product Systematically
74
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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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Maintenance Management

Quality Management Quality Assurance Quality system

Major change of focus:

1978 1979 1980 1987

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

ISO 9001 2000/2008

Standard Creation 1998(QS)

ISO 9001 1994

ISO 9001 / EN 9100 timeline

ISO 9001:1994 ISO 9001:2000

Other ISO related standards

ISO 9001:2008 Principle

Element of Quality management

Which one have better Quality?

Good quality process meet or exceed

Which one have better Quality?

What is Quality Assurance ?

Quality Management Proccess Model

Measurement, analysis and improvement

Quality System & Quality Assurance

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

Process and procedure

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

How? When Why? Where? Who? What?

Customers and Suppliers

MOE structure and contents

Operation Manual structure and contents

Quality Manual contents

Simple Quality structure

Quality Quality manager manager Continued airworthiness Manager

QA CAMO Compliance Auditor

QA Operation Compliance Auditor

What is the difference between Quality System and Quality assurance?

What is the difference between QA and QC ?

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

Key Auditing Activities

Key Auditing Activities

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

7. Follow-up and close out .

skills Personal attribute

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

AS9100(C), issued in January 2009

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