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Quality Management Systems Aviation Industry - Maintenance

Dr Ali AL-Zubaidi FCQI CQP

Integrated Management Systems Associates (IMSA)

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Evolution of Concept of Quality

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Evolution of Quality Management Systems & Supporting Standards

1979: BS 5750 (Quality Control)

1987: ISO 9001 (enhanced Quality Control)

1994: ISO 9001 (Quality Assurance)

2000: ISO 9000 Family (Quality Management System (incorporating Process Approach & Continual Improvement)

2008: ISO 9000 Family (Quality Management System (re-enforced)

2015: ISO 9000 Family (Quality Management System (incorporating Risk Management)

BAEKSA/QCDP/Module No.1/Functional Competency Element No. 1/February 2017 4

Quality Management

Quality Management 17

Quality Improvement

Quality Planning

Quality Policy & Objectives

Quality Assurance

Quality Control

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Management PrinciplesCurrent (7)

Customer focus

Leadership

Engagement of people

Process approach

Improvement

Evidence-based decision making

Relationship management

Old (8)

Customer focus

Leadership

Involvement of people

Process approach System approach to management (now incorporated in the process approach)

Continual improvement

Factual approach to decision making

Mutually beneficial supplier relationships

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BAEKSA/QCDP/Module No.2/Functional Competency Element No. 5/February 2017 6

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Quality Management System Standard Structure

BAEKSA/QCDP/Module No.2/Functional Competency Element No. 5/February 2017 7

1. Improvement

2. Leadership

3. Support

4. Operation

5. Performance Evaluation

6. Planning

ISO 9001:2015 Provisions34

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Quality Management System Standard Structure

Leadership (5)

Improvement (10)

Support (7) & Operation (8)

Planning (6) Performance Evaluation (9)

Plan Do

CheckAct

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▪ Less prescriptive, but with greater focus on achieving conforming products and services

▪ More user friendly for service providers and knowledge-based organisations

▪ Greater leadership engagement ▪ More structured planning for setting objectives ▪ Management review is aligned to organisational results ▪ Opportunity for more flexible documented information ▪ Addresses organisational risks and opportunities in a structured

manner ▪ Addresses supply chain management more effectively ▪ Provide opportunity to establish an integrated management system

that addresses other elements such as environment, health & safety, business continuity, etc.

Quality Management Systems Standards Summary Features

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Annex SL

ISO 9001 (QMS)

AS 9100 AS 911O AS 912O AS 9115

Quality Management Systems Standards – Aviation, Space & Defence

Industries

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▪ AS 9100: Quality management systems - Requirements for aviation, space and defence organisations

▪ AS 9110: Quality management systems - Requirements for aviation maintenance organisations

▪ AS 9120: Quality management systems - Requirements for aviation, space and defence distributors

▪ AS 9115: Quality management systems - Requirements for aviation, space and defence organisations - deliverable software

Quality Management Systems Standards – Aviation, Space & Defence Industries

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System Set of interrelated or interacting elements

(processes)

Management System Set of interrelated or interacting elements of an

organisation to establish policies and objectives and processes to achieve those objectives

Quality Management System Part of management system with regard to quality

Quality Management Systems

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BAEKSA/QCDP/Module No.1/Functional Competency Element No. 2/February 2017 13

Management Systems (MS)

Management Systems vs. Management Standards

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NOT ONLY

MS ≠ Standards MS = Standards+++++

Standards are Generic while

MS is Specific

Standards (Requirements & Guidelines)

Stakeholders Requirements

(Needs & Expectations)

Statutory & Legal

Requirements

Specific Business

Requirements

Management Systems

(MS)

Management Systems vs. Management Standards

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Quality Management System

▪ A quality management system is dynamic enveloping over time through concept of continual improvement.

▪ Every organisation has quality management activities, however, these need to be planned and managed in a systemic way.

▪ Developing a quality management system enables organisation to focus on activities that really add value to the organisation and its stakeholders.

▪ Such a system provides framework for planning, executing, monitoring and improving performance activities within organisation.

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▪Comprises activities by which the organisation identifies its objectives and determines the processes and resources required to achieve desired results. ▪Manages processes and their interactions, together with resources required to provide value and realize results for relevant interested parties (stakeholders). ▪Enables top management to optimize the use of resources considering the long and short term consequences of their decisions. ▪Provides the means to identify actions to address intended and unintended consequences providing products and services.

Quality Management Systems (QMS)

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✓ Deliver customer (stakeholders) satisfaction

✓ Deliver safe products and operations

✓ Deliver business assurance

✓ Enable continual improve through lessons learned

★ It is not simply about obtaining certification

★ Do you agree?

Why do we need a quality management systems?

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Management Leadership & Role▪Determining critical (core & supporting) processes and their interactions. ▪Determining & evaluating of risks associated with processes and interactions ▪Ensure effective strategic, system and operational planning. ▪Provision of adequate resources (human & infrastructure). ▪Ensure competency of human resources and capability of infrastructure. ▪Implementing appropriate control measures. ▪Monitoring of processes performance. ▪Effective internal and external communication. ▪Performing planned reviews to ensure effective performance of implemented quality management system.

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Management Systems Key Elements

Context of Organisation

Stakeholders Needs

Process Management

Risk Management

Continual Improvement Management

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Process Set of interrelated or interacting activities that use

inputs to deliver an intended result ▪Processes are planned & managed under

controlled conditions for effectiveness & efficiency ▪Outputs from processes could be inputs to

other processes & vise-versa ▪Some processes (special) have outputs which

cannot be readily or economically verified

Process Management67

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Process Management

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Implementation considerations ▪ Use a risk-driven approach throughout your organisational

processes ▪ Identify and prioritize what the risks are in your organisation

(it depends on context: product or process complexity, organizational complexity) ✓ what is acceptable? ✓ what is unacceptable?

▪ Plan actions to address the risks ✓ how can I avoid, eliminate or mitigate risks?

▪ Implement the plan; take action ▪ Check the effectiveness of the action; does it work? ▪ Learn from experience; improve

Risk-based Thinking82

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Process Risk Profile

Process Controls

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Plan, implement, and control processes needed to assure product safety, as appropriate to organisation. These processes can include: ✓hazard identification, including reactive and proactive methods; ✓analysis, assessment, and control of safety risks associated with identified hazards; ✓identification and management of changes that may impact product safety; ✓assessment of the effectiveness of safety management processes; ✓provision of training on product safety responsibilities to relevant personnel; ✓communication of product safety information, including safety-critical information, safety events, and changes to safety procedures, as applicable; ✓reporting of safety events to the customer, authorities, and type certificate holder in accordance with customer and regulatory requirements.

Product Safety131

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• Addresses need to determine and manage the knowledge maintained by the organisation to ensure effective operation of its processes. ︎︎︎ ︎︎︎

• Organisational knowledge requires protection as it: ➢Safeguard organisation from loss of knowledge, through

staff turnover and failure to capture and share information ➢Encourage organisation to acquire knowledge, through

learning from experience, mentoring & benchmarking ▪ Capturing of knowledge from lessons learned and introducing

relevant change ▪ Identification of experts able to transfer knowledge, on job

training, tutorial sessions ▪ Implement succession planning activities

Organisational Knowledge98

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Plan, implement, and control processes, appropriate to the organisation and the product, for the prevention of counterfeit or suspect counterfeit part use and their inclusion in product(s) delivered to the customer.

Plan, implement, and control a process appropriate to the organisation and its scope of work that identifies and prevents the use of unapproved and suspected unapproved parts.

Counterfeit Parts134

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Establish, implement, and maintain a process that ensures approved parts: a. properly identified, as appropriate for product or to which they are to be

fitted; b. acceptable for installation on product or article, in accordance with applicable

requirements from competent authority or the customer; c. if used, are in a satisfactory condition and that their airworthiness is

ascertained, in particular applicable airworthiness directives have been accomplished;

d. if life limited, do not exceed those limits and that all related documented information is available;

e. if removed from an aircraft involved in an accident or incident, are processed per a specific work order including all inspections and repairs deemed necessary to ensure parts are airworthy prior to installation;

f. if dismantled, have been managed by an organisation that: ✴holds the required approvals; ✴complies with applicable requirements related to environmental impact; ✴is able to manage the necessary documented information.

Counterfeit Parts134

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Persons doing work under the organisation’s control are aware of: a. quality policy & relevant quality objectives; c. their contribution to the effectiveness of the quality management

system, including the benefits of improved performance; d. implications of not conforming with quality management system

requirements; e. relevant quality management system documented

information and changes thereto; f. their contribution to product or service conformity; g. their contribution to product safety; h. importance of ethical behaviour; i. safety policy and safety objectives related to the product; j. Human factors and their potential consequences on

maintenance activities.

Awareness144

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• Standard now refers to only “documented information”, covering all types of documentation, i.e no mention of “documents”, “documented procedures” or “records”.

• These types of documentation can still be used but it is the decision of the organisation.

• Organisation is responsible for determining what documented information needs to be maintained (documented procedure) and retained (records) and period of time for which it is to be retained and media to be used for its retention

Documented Information103

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