SRM-QM
Safery Risk Management - Quality Management
Safery Risk Management - Quality Management
Kartei Details
Karten | 48 |
---|---|
Sprache | English |
Kategorie | Technik |
Stufe | Universität |
Erstellt / Aktualisiert | 19.02.2020 / 23.12.2020 |
Weblink |
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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.
What are the components of a compliance monitoring program?
- Schedule of the monitoring program
- Audit procedures including an audit plan
- Audit reporting
- Follow up and corrective action monitoring (wie wird mit Befunden der Audits umgegangen?)
- Recording system
Worin liegt der Unterscheid zwischen Inspektionen und Audits?
Inspektionen betrachten Ergebisse, Audits betrachten Prozesse
Weshalb sind Checklisten für Audits sehr wichtig?
Da Audits sehr umfangreich sein können, helfen Checklisten dabei nichts zu vergessen.
Weiter hat man so gerade Aufzeichnungen zu den durchgeführten Audits welche archiviert werden können.
What are the two types of Audit Findings?
- Non Conformity (not documented):
Manual provisions do not satisfy/reflect applicable regulations/standards
- Non Conformity (not implemented):
Performed activities do not comply with applicable manual provisions and/or regulations/standards
What are some of the main Auditing Methods to collect information?
Interview
Review of documents
Examination of documents
Witnessing of activities
What should an Audit Report contain?
- Checked requirements and items
- Description of findings (non compliances and non conformities)
- Finding = non-conformity
- non-conformity -> non-fulfillment of a requirement
- requirement -> Need or expectation that is stated, generally implied or obligatory.
- non-conformity -> non-fulfillment of a requirement
- Requirement reference
- Observed facts
- Source of the information on facts
- Objective evidence (documents, records, photographs, audio recordings, etc.)
- Finding = non-conformity
- Level of findings
- 1 - safety affected (
- Gegenmassnahmen zwingend nötig
- Operation kann nicht fortgesetzt werden
- 2 - safety may be affected
- Gegenmassnahmen zwingend nötig
- Operation kann fortgesetzt werden
- 3 - observation / recommendation
- Keine zwingenden Gegenmassnahmen nötig
- Keine zwingenden Gegenmassnahmen nötig
- 1 - safety affected (
- Due date (DD) for corrective action plan (CAP)
- To be set taking into consideration the safety impact of the finding
- Consider to use standard DD periods for CAPs
- Due dates for corrective actions
- To be set taking into consideration the safety impact of the finding
- Consider temporary procedure
- Consider available resources
- Allocation of responsibility for corrective action
- Consider responsibility for affected activity
- Consider capability/qualification
Who should the audit report be destributed to?
- Auditee
- Affected Postholder / NP / Manager
- Quality/Compliance Manager
- Accountable Manager
What is the difference between a correction and correction actions?
A correction is the act of eliminating a detected non-conformity.
A corrective action is the action of eliminating the cause of a detected non-conformity.
There are also preventive actions that eliminate potential non-conformities.
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.
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