SRM-QM

• 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
       
• 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
       
• 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

Most Operations Manuals Procedures consist of combinations uf multiple styles!

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.

• 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

• Has the overall responsibility for the Management System
• Must ensure compliance
• Must ensure sufficient financing

• Establishing, implementing and maintaining the Quality Management System
• Quality reporting to the top management
• Internal promotion of awareness of customer requirements

• 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

• 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

• 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

Quality Assurance is a part of quality management, focused on providing confidence that quality requirements will be fulfilled.

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.

Der Kunde ist nicht immer ofensichtlich, oft Intern und nicht endnutzer!

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.

• 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

Inspektionen betrachten Ergebisse, Audits betrachten Prozesse

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.

• 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

Interview

Review of documents

Examination of documents

Witnessing of activities

• 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.
  • Requirement reference
  • Observed facts
  • Source of the information on facts
  • Objective evidence (documents, records, photographs, audio recordings, etc.)
     
• 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
       
• 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

• Auditee
• Affected Postholder / NP / Manager
• Quality/Compliance Manager
• Accountable Manager

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.

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)

Operator
Market
Authorities
A/C Owners / Insurances / Financers
Public Opinion / Media

The effort to achieve compliance with expectations of a safe system

By expectations (of operator, market, authorities etc.)

Quality determines the condition of something (service, product) not how good it is.

Safety

Application of safety standards

Reducing remaining risks ALARP (as low as reasonably possible)

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.

Safety Risk is the projected likelihood and severity of the consequence or outcome from an existing hazard or situation.

Quality: compliance with all requirements

Compliance monitoring: compliance with regulatory requirements

Regulatory compliance is the satisfaction of just one of the sets of expectations an operation is confronted with: Laws and regulations

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

• 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)

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.

• Laws / Regulations
• Standards (binding)
• Standards (optional)

• 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

• ICAO Annexes (e.g. Annex 6, OPS)
• ICAO DOCs (e.g. Doc 9859, SMM)
• etc.

• 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.

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