SRM-QM
Safery Risk Management - Quality Management
Safery Risk Management - Quality Management
Set of flashcards Details
Flashcards | 48 |
---|---|
Language | English |
Category | Technology |
Level | University |
Created / Updated | 19.02.2020 / 23.12.2020 |
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Definition of safety (ICAO Doc 9859):
Is the state in which the risk of harm to persons or property damage is reduced to, and maintained at or below an acceptable level through a continuing process of hazard identification and risk management. (ICAO Doc 9859)
Definition of safety (IS BAO):
Is the state in which the risk of harm or damage is limited to an acceptable level as low as is reasonably practical (International Standard for Business Aviation Operators IS BAO)
Who defines the acceptable level of safety?
Operator
Market
Authorities
A/C Owners / Insurances / Financers
Public Opinion / Media
What is safety management?
The effort to achieve compliance with expectations of a safe system
How are levels of safety defined?
By expectations (of operator, market, authorities etc.)
Define Quality:
Quality determines the condition of something (service, product) not how good it is.
What is the main basis of expectation of quality in aviation?
Safety
How to achieve safety and satisfy expectations?
Application of safety standards
Reducing remaining risks ALARP (as low as reasonably possible)
Definition of Hazard (ICAO SMM 2.13.2)
A condition or an object with the potential to cause death, injuries to
personnel, damage to equipment or structures, loss of material, or the
reduction of the ability to perform a prescribed function.
For aviation safety risk management:
Conditions which could cause or contribute to unsafe operation of
aircraft or aviation safety related equipment, products and services.
Definition Safety Risk (ICAO SMM 2.14):
Safety Risk is the projected likelihood and severity of the consequence or outcome from an existing hazard or situation.
Whats the difference between quality and compliance management?
Quality: compliance with all requirements
Compliance monitoring: compliance with regulatory requirements
What is regulatory compliance?
Regulatory compliance is the satisfaction of just one of the sets of expectations an operation is confronted with: Laws and regulations
State the main duties of management:
Setting the strategy for the organisation:
- Goals
- Actions to achieve goals
- Available resources
Providing organisational structure and Infrastructure:
- Facilities
- Organisational charts
- Description of functions
- Quality requirements
- etc.
Providing/securing resources:
- Financial
- Human
- Etc.
Providing equipment and tools:
- Hardware
- Software
- Maintenance
- Etc.
Providing training and qualifications for staff:
- Initial training
- Recurrent training
- Ensuring continuous qualification
Providing instruction and guidance for staff:
- Standard operation procedures
- Manuals
- Work instructions
Supervision, analysis and adjustment:
- Quality control
- Compliance monitoring
- Ensuring safety of the operation
- Inspections
- Management evaluation / review
Communication:
- Internal
- External
What areas does ORO.GEN.200 cover:
- Operations (dispatch, pax hotel booking)
- Marketing & sales (Trip feasibility, advertising in magazines)
- Human resources (accountants, pilots)
- Maintenance (Maintenance management, office equipment)
- Finances (Maintenance financing, strategic asset financing)
Weshalb sind Regularien in der Luftfahrt so wichtig?
Da sich an der Luftfahrt eigentlich eher wenig Geld verdienen lässt, muss so viel wie möglich reguliert werden. Dadurch werden Firmen gezwungen, gewisse investitionen to machen und können nicht überall so viel sparen wie sie wollen. Zudem sollen Regularien einen ebenen Grund für den Markt schaffen.
Welche drei grundsätzliche Arten von Regelwerken gibt es in der Luftfahrt?
- Laws / Regulations
- Standards (binding)
- Standards (optional)
Nenne Beispiele für Laws / Regulations:
- Regulation (EU) 965/2012 (Air Ops) and related legal material (AMC, GM)
- Regulation (EU) 1321/2014 (Part M, Part 145, Part 147, Part 66, Part T) and related legal material (AMC, GM)
- Regulation (EU) 1178/2011 (Aircrew) and related legal material (AMC, GM)
- Regulation (EU) 2017/373 (ATM/ANS) and related legal material (AMC, GM)
- National Aviation Laws (e.g. LFG 748.0, LFV 748.01)
- Customs Laws
- Security Regulations
- Labour and Work Security Laws
Nenne Beispiele für Standards (binding):
- ICAO Annexes (e.g. Annex 6, OPS)
- ICAO DOCs (e.g. Doc 9859, SMM)
- etc.
Nenne Beispiele für Standards (optional):
- ISO
- IOSA (IATA Operational Safety Audit)
- IS BAO (International Standard for Business Aviation Operators)
- EN 9100 (Aerospace Quality Management System design and manufacturing)
- ISO 19001 (Standard for Auditing Quality Management Systems)
- ISO 31000 (Risk Management Standard)
- etc.
What does PDCA stand for:
Also known as the deming cycle:
PDCA is a management model for the continuing improvement of processes and is applicable to all kinds of activities.
PDCA is the basis for all Quality Management Systems.
- Plan : establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies, and identify and address risks and opportunities;
- Identify the problem/task
- Define possible improvements
- Collect relevant data
- Decide between alternatives
- Identify causes for discrepancies
- Do : implement what was planned
- Conduct the activity/test/experiment
- Record results
- Preserve evidence of discrepancies
- Train staff
- Check : monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results;
- Collect evidence of results of the activity
- Evaluate results
- Compare results to planning data
- Identify requirements for changes
- Act : take actions to improve performance, as necessary.
- Evaluate proposals for changes and improvements
- Decide on changes/measures
- Initiate measures (including documentation and evaluation)
- Standardise
- Start new cycle
The four steps of PDCA shall be under the control of one team/person (centralised responsibility, coordinated with other PDCA
Different levels of hierarchy in charge for the process usually hinder success
Coordinated action requires documentation of processes
Wie können Prozesse bleibend verbessert werden?
Durch die umgehende Standardisierung des Prozesses, zum Beispiel mit der Anpassung der Checklisten. Je weniger der Ausführende selber entscheiden muss umso gleichbleibender wird der Prozess bleiben.
What are the "ISO 9000 Seven Quality Management Principles"?
QMP 1: Customer Focus
The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.
QMP 2: Leadership
Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives.
QMP 3: Engagement of people
Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value.
QMP 4: Process approach
Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.
QMP 5: Improvement
Successful organizations have an ongoing focus on improvement. (PDCA-Cycle)
QMP 6: Evidence based decision making
Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.
QMP 7: Relationship management
For sustained success, an organization manages its relationships with interested parties, such as suppliers.
Wie unterscheidet sich die Qualitätprüfung von früher zu der von heute?
Früher wurden Endprodukte auf deren Qualität überprüft. Dies gab nur einen punktuellen Einblick in die Qualität. Darum wechselte man zum überprüfen der Prozesse, um die Qualität zu verbessern.
What is the content of the ISO 9000 regulation?
Quality management
What is the content of the ISO 31000 regulation?
Risk management
Wie unterscheidet sich das Qualitätsmanagement von Dienstleistungen gegenüber Produkten?
Anders als bei Produkten die einem Vergleichsprodukt gegenübergestellt werden können, können Dienstleistungen nur überprüft werden, wenn darüber Aufzeichnungen gemacht wurden.
Daher sind aufzeichnungen über erbrachte Dienstleistungen für QM zwecke sehr wichtig!
Define the term Management System:
Set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives.
A management system can address a single discipline or several disciplines, e.g. quality management, financial management or environmental management.
The management system elements establish the organization’s structure, roles and responsibilities, planning, operation, policies, practices, rules, beliefs, objectives and processes to achieve those objectives.
The scope of a management system can include the whole of the organization, specific and identified functions of the organization, specific and identified sections of the organization, or one or more functions across a group of organizations.
What are the basic elements to be defined for a procedure?
- Purpose
- what shall be the outcome / result?
- Purpose may be stated at the beginning of the documented procedure to
facilitate interpretation if necessary
- Reference
- Legal reference
- Standard (IOSA, IS BAO, ISO etc.)
- Internal reference
- Who (responsible person,delegation)
- Define the person being responsible for the execution of the process
(process owner) - Define the responsible person by function or position
- Define possibilities for delegation of responsibility
- Define the person being responsible for the execution of the process
- When (occasion, trigger)
- Define events upon which the process has to be or can be executed
- Define repetition criteria (if applicable)
- Define under which conditions the process may not be executed
- Define the extent of process owner‘s own discretion on execution
- What (description of action)
- Define the action to execute the process
- Define alternative action (if applicable)
- Define what not to do (if advisable)
- How (modes, criteria, alternatives)
- Define the ways/techniques how to execute the process
- Define alternative ways/techniques (if any)
- Tools
- Define hardware to be used
- Define software to be used
- Sequence of actions
- Define in which order the activity is to be conducted (parallel action or one after the other)
- Define priorities (if any)
- Verification of result
- Define how the result of the process shall be used
- Define the formal feedback pattern for the involved persons
- Define test patterns for the process
- Recording
- Define how the execution of the process is to be recorded
- Define how and to whom the records shall be processed
- Define storage of records
What are some of the Layouts/Styles possible for defining procedures?
- Organisation Charts
- Shall reflect organisational set up
- Shall visualise command and reporting lines
- Shall include function / position / role
- Each function shall show the name of the role holder and the deputy / deputies
- Vertical List
- Introduce the breakouts with a visual marker, for example a dash, a letter, or a number
- Make sure the list is in the correct order
- Make sure the list is complete
- If the list contains only suggestions or is not complete, identify this by a remark (e.g. «not limiting» or «for guidance only, amend as appropriate»)
- Text
- Pro:
- Allows for very detailed description of activities (conditions, modes, tools, etc.) and responsibilities
- Con:
- Not very user friendly, particularly in a time critical environment
- Not very user friendly, particularly in a time critical environment
- Pro:
- Flow Chart
- Pro:
- Provides good and quick overview of procedures and their position in a process system;
- Allows for colour coding of sub-procedures
- Con:
- Procedures cannot be described very detailed due to limited space for text
- Procedures cannot be described very detailed due to limited space for text
- Pro:
- Table
- Pro:
- Provides good and quick overview of procedures;
- Allows for reasonably detailed description of activities (conditions, modes, tools, etc.);
- Allows for coding of sub-procedures (letters, numbers, colours etc.);
- Provides references to connected processes/procedures
- Can easily be transformed into checklists
- Provides good basis for standardised training
- Con:
- Needs to be structured carefully to achieve user friendliness
- Pro:
Most Operations Manuals Procedures consist of combinations uf multiple styles!
What has to be considered when writing manuals or procedure descriptions? (Human Factors)
General Rule:
It is not important what you want to say with your wording
but
what the addressee understands !
Wording Rules:
- Use short and clear sentences
- Use standard terminology / phraseology
- Use simple syntax
-> Simplified Technical English (ASD-STE100)
Always consider that instructions may have to be understood by non-native speakers even under pressure.
Avoid message redundancies! Say things only once!
If something needs to be said twice or more times: use the same wording for each case.
What are the Elements of a Quality Management System?
- Quality Policy and Standards
- Organisation , Responsibilities and Duties within the Q System
- Feedback and Reporting System
- Quality Assurance Program
- Contractor Monitoring
- Quality Training
- Document and Records Control / Management
What are the functions of an Accountable Manager?
- Has the overall responsibility for the Management System
- Must ensure compliance
- Must ensure sufficient financing
What are the functins of a Quality Manager?
- Establishing, implementing and maintaining the Quality Management System
- Quality reporting to the top management
- Internal promotion of awareness of customer requirements
What has to be considered, regarding an Auditor?
- He/She shall not be responsible for the function, procedure or products being audited
- He/She shall be sufficiently qualified as an auditor
- He/She may be employed or contracted
What is the function of a Postholder / Nominated Person?
- Ensures compliance by
- Supervising staff in carrying out their tasks
- Conducting inspections in his/her field of competence if sufficiently trained in quality management and auditing
- Is ultimately responsible to the Accountable Manager
What are the functions of regular staff?
- Carry out day to day tasks
- Monitor day to day tasks
- Provide feedback to colleagues, superiors, Quality Manager and Safety Manager
- Shall be sufficiently qualified to perform tasks in accordance with applicable requirements
- Must be aware of the rules and procedures relevant to the exercise of their duties
What is quality assurance? (Based on ISO 9001, 9)
Quality Assurance is a part of quality management, focused on providing confidence that quality requirements will be fulfilled.
Was ist der Zweck von quality assurance?
Quality assurance soll die möglichkeit geben, zu erkennenob wir das was in den Manuals beschrieben wird richtig aisgeführt wird und ob das so sinn macht.
Quality assurance activities do not control quality, they establish the extent to which quality will be, is being or has been controlled.
Quality assurance activities are post event activities performed off line and serve to build confidence in results, claims and predictions.
Welches problem mit "customer requirements" besteht?
Der Kunde ist nicht immer ofensichtlich, oft Intern und nicht endnutzer!
Whats the difference between quality control, and quality assurance?
Quality control is an action (ISO 9000,3.3.7: part of quality management focused on fulfilling quality requirements).
Quality assurance is not an action but a result. It results from obtaining reliable information that testifies to the occuracy or validity of an event or product.