Quality, Compliance and Management System

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2 Quality, Compliance and Management System Facilitators Jean-Luc Boutillier Director, Quality & Risk Management, IATA Edmond Bohland Deputy Head, Policy and Planning, EASA Dr. Eric Janssen Director General, European Organization for Quality (EOQ) Gregory Kirkland FAA Flight Standards National Field Office (AFS-900), Assistant Manager Milt Krivokuca Former Chairman of American Society for Quality (ASQ) Stephen Creamer Director, Air Navigation Bureau, ICAO 2

3 Edmond Bohland Deputy Head, Policy and Planning, EASA 3

4 Quality, Compliance and Management System Edmund Bohland Deputy Head Policy and Planning TE.GEN

5 Management Systems in EU Regulations 22/04/2015 change via "view" > "header and footer" 5

6 Management Systems in EU Regulations Harmonized Organization requirements have been introduced with the Implementing Rules on flight crew licensing and air operations. The standards are to be followed in other areas allowing for an integrated approach. This is particularly relevant to operators who also hold a CAMO approval (continuing airworthiness management organization) The rule provides the framework for a management system supporting an effective (safety) management system by containing a means for monitoring compliance, estimating risks and aiming at continuous improvement. Insofar the regulation prescribes a function to monitor compliance of the operator with the relevant requirements. The compliance monitoring shall include a feedback system of findings to the accountable manger to ensure effective implementation of corrective actions. 22/04/2015 change via "view" > "header and footer" 6

7 Management Systems in EU Regulations Compliance Monitoring Function 22/04/2015 change via "view" > "header and footer" 7

8 Management Systems in EU Regulations 22/04/2015 change via "view" > "header and footer" 8

9 Management Systems in EU Regulations Extension to MRO organisations is under review with the intention to minimise changes in existing regulations and therefore the impact on organisations, The introduction of Management System requirements into new domains will be based on a careful gap analysis between existing requirements and the ICAO Annex 19 framework The implementation of the Policy needs to ensure proportionality by ensuring an approach tailored to the different actors in the aviation system. Systematic consideration of Best practice and Industry Standards i.e. IAQG developing the 9110 Standard for QMS Requirements for Aviation Maintenance Organizations. Referenced in papers during the recent ICAO HLSC 22/04/2015 change via "view" > "header and footer" 9

10 Integrated Management Systems Multiple facets need to be considered for the integration of management systems with those required by other legislative or regulatory requirements such as occupational health and safety, security, environment and QMS. It may also include the integration of non-regulated systems such as finance and human resources. 22/04/2015 change via "view" > "header and footer" 10

11 Integrated Management Systems Considerations: identification of accountabilities and responsibilities. The organization has documented how the management systems are functionally linked and identified how the systems interface with each other and with the integrated management system. Evidence exists that the organization dedicates the necessary priorities and resources for the integrated management system and for each of the interacting management systems. The organization clearly identifies and documents how it will address multiple inputs from and to the interacting management systems. The organization assesses the effectiveness of its integrated management systems and modifies the system as a result of changes and lessons learned, as appropriate. The organization possesses processes/tools to allow the Authority to oversee the management system in their area of responsibility. 22/04/2015 change via "view" > "header and footer" 11

12 Harmonisation To ensure proportionality and flexibility, the management system requirements at Implementing Rule level should be limited to key principles. Non-essential implementation provisions should be included as Acceptable Means of Compliance (AMCs) and the development and acceptance of Industry Standards and Best Practices should be encouraged to support Management System implementation 22/04/2015 change via "view" > "header and footer" 12

13 Harmonisation Risks still exist even in the most compliant systems. Moreover, in reality, it is impossible to develop rules for every possible situation A performance based environment (rules) is the way forward to ensure that the management system deploys its full potential: The organization should be allowed flexibility to implement specific means for mitigation of risks Continued compliance to prescriptive rules remains a success factor in a PBE to meet the targets 22/04/2015 change via "view" > "header and footer" 13

14 Enablers for effective management system Leadership (actions speak louder than words) Integration into day-to-day business; senior management commitment is crucial Understanding that we are all in this together with common goals and ideals System approach (identifying, understanding and managing interrelated processes as a system Organization culture covering the full range Flexible culture Just culture Learning culture Informed culture Reporting culture 22/04/2015 change via "view" > "header and footer" 14

15 Thank You

16 Dr. Eric Janssen Director General, European Organization for Quality (EOQ) 16

17 Recognition of Competence European Organization for Quality Dr. Eric Janssens Director General IATA, Los Angeles, April 2015 Dr. Eric Janssens 17 17

18 European Organization for Quality EOQ information Key messages of the workshop: Awareness about existing requirements and systems Q and Compliance (Management system integration) Need for coordination and harmonization of Standards and Best Practices Promotion of Q culture (transparency and improvements) Recognition of Competence, EOQ Future involvements IATA, Los Angeles, April 2015 Dr. Eric Janssens 18

19 European Organization for Quality Vision: Europe s leading promoter of Quality Mission: Improve European society through the promotion of Quality in its broadest sense IATA, Los Angeles, April 2015 Dr. Eric Janssens 19

20 European Organization for Quality The European Organization for Quality, EOQ, is an autonomous, non-profit association under Belgian law. EOQ was established in 1956 and its present effective membership is comprised of 32 national European quality organizations EOQ Congress in Athens, June 11th and 12th, 2015, 20 IATA, Los Angeles, April 2015 Dr. Eric Janssens

21 Awareness about existing requirements and systems Representation with its members as stakeholder in activities with EOQ Competence and Certification Schemes at Standardization: ISO, Casco, CEN International Personnel Certification Association Accreditation: European Cooperation for Accreditation (EA) and International Accreditation Forum (IAF) IATA, Los Angeles, April 2015 Dr. Eric Janssens 21

22 Awareness about existing requirements and systems Covering Quality, Environmental, Health & Safety, Risk and Energy Management Covering different sectors of the industry: Industrial Healthcare Service Food. IATA, Los Angeles, April 2015 Dr. Eric Janssens 22

23 Quality & Compliance (Management system integration) Historical evolution towards integrated MS Integrated Approach required because SOFTWARE is the future with new function abilities and SERVICES SERVICES in a Global world Compliance: different types and mainly seen as a legal factor IATA, Los Angeles, April 2015 Dr. Eric Janssens 23

24 Harmonization of Standards Recognition of Competence Based on Competence Schemes and Personnel Certification Schemes based on ISO for ISO 9001, 14000, OHSAS, 31000, 26000, Registration and issuing of EOQ Professional Competence Passport. EOQ recognises the competence of managers to fulfil industry & business requirements IATA, Los Angeles, April 2015 Dr. Eric Janssens 24

25 Coordination of Best Practice Recognition of Competence Best practice based on Quality and Safety also found at EOQ members (as an example): Hospitals Nuclear plants Food supplies Exchange of information at conferences and awards offered by Quality Organizations Tools are internationally different IATA, Los Angeles, April 2015 Dr. Eric Janssens 25

26 Need for harmonization of Standards and Best Practices Improve Quality methods: this project began with a desire of EOQ to standardize training in Lean Six Sigma methods throughout Europe. In Europe there is no model available like 6 Sigma (USA) or TQM (Japan). The project team will develop a generic model and then engage the broader global quality community to reach consensus for a final model and to develop a data base of case studies that demonstrate how to apply the method IATA, Los Angeles, April 2015 Dr. Eric Janssens 26

27 Future of Q Management improve quality methods! IATA, Los Angeles, April 2015 Dr. Eric Janssens 27

28 Promotion of Quality Culture New EOQ Project Brand Management Model is based on Quality Directives demonstrating excellent customer orientation and consciousness generated by legal regulations, national and international standards, quality models and company good practice processes. How: Generic Model with Quality directives based on local assessment and checklists developed for different market segments. Why: Brand label showing customer consciousness, brand marketing of implementation of worldwide accepted regulations. IATA, Los Angeles, April 2015 Dr. Eric Janssens 28

29 Thank you for your kind attention! Keep informed: IATA, Los Angeles, April 2015 Dr. Eric Janssens

30 Gregory Kirkland FAA Flight Standards National Field Office (AFS-900), Assistant Manager 30

31 Safety Assurance System Risk Based Decision Making and the Systems Approach Presented By: Greg Kirkland Federal Aviation Administration Flight Standards National Field Office Date: April 13, 2015 FAA Safety Assurance System Federal Aviation Administration 31

32 Transforming FAA Oversight FAA Oversight End state-evolve to more collaboration with industry and verification that certificate holders manage safety Safety Assurance System (SAS) Standard method for performing risk-based surveillance and data collection to verify that FAA and certificate holder s risk controls are effective FAA s Safety Management System (SMS) Structured approach for the FAA to identify and address hazards in the civil aviation industry Risk Based Decision Makin (RBDM) Data informed approach to make risk-based decisions, proactively address emerging safety risks Quality Management System (QMS) Means to assure procedures are in place, products/services meet stakeholder oversight requirements, continual improvement of FAA processes FAA Safety Assurance System Federal Aviation Administration 32

33 Safety and Quality Quality Management Systems are mainly mission oriented (serve the customer). Safety Management Systems(SMS) maintain focus on safety controlling risks. FAA prefers, to describe our primary role as a safety regulator. FAA Safety Assurance System Federal Aviation Administration 33

34 The FAA Oversight Journey FAA Safety Assurance System Federal Aviation Administration 34

35 SAS Incorporates System Safety System Safety The application of special technical and managerial skills in a systematic, forward looking manner to identify and control hazards throughout the life cycle of a project, program, or activity" (Roland & Moriarty, 1990) FAA Safety Assurance System Federal Aviation Administration 35

36 System Safety Incorporates Safety Attributes: First Generation of Safety Management Procedures Controls Process Measurement Management Responsibility Management Authority Interfaces FAA Safety Assurance System Federal Aviation Administration 36

37 Risk Based Decision Making Determining acceptability of risks in the NAS Developing risk controls Risk Based Resource Targeting (RBRT) Evaluating effectiveness of FAA and Product/Service Provider risk controls. Design Performance FAA Safety Assurance System Federal Aviation Administration 37

38 Compliance and Risk Management Regulations are specifications for risk control. Product and service providers apply the rules in a manner that controls the intended risks effective compliance. They must also control risks outside of the rules that are unique to their operations. FAA Safety Assurance System Federal Aviation Administration 38

39 Regulations vs Controlling Harm Things that are illegal Things that cause harm Attributed to Dr. Malcolm Sparrow FAA Safety Assurance System Federal Aviation Administration 39

40 SAS Transforms FAA Oversight Evolving the FAA s interface with certificate holders from testing, inspecting, and certifying individual programs/functions to comprehensive approval and periodic audits of the safety management programs Verify the certificate holder complies with FAA regulations and their procedures Verify the certificate holder has an effective process for identifying hazards that affect their operations and mitigating the associated risk. FAA plans surveillance and targets resources based on risk FAA Safety Assurance System Federal Aviation Administration 40

41 Oversight Vision Have a single system for all of FAA Flight Standards to use, for everything related to oversight Share processes, tools, and data with industry Utilize advanced analysis capabilities to assist with identifying risk and targeting resources Use Risk Based Decision Making (RBDM) Refine the skillset of the workforce FAA Safety Assurance System Federal Aviation Administration 41

42 SAS Development SASO Phase I Research and development SASO Phase II Alpha SASO Phase II Beta SASO Phase III Apply System Safety Principles for 14 CFR parts 121, 135, and 145 Part 5 Rule (SMS for 121 Certificate Holders) Complete Oversight Transformation (other CFR parts) Formalize FAA SMS (Internal - multiple lines of business under Aviation Safety (AVS) = 1 SMS) Consolidate Automated Business Systems Maintenance FAA Safety Assurance System Federal Aviation Administration 42

43 Oversight Approach Incremental changes System safety approach, assessing things from a system perspective, drilling down to programs or functions in that system, based on risk Assessing certificate holder s compliance with the FAA risk controls (regulations, etc.), and compliance with their own risk controls (policies, procedures) Assessing how effective the certificate holder is at managing safety FAA Safety Assurance System Federal Aviation Administration 43

44 SAS Business Process Overview In Phase IIA, we use one oversight model for the certification and surveillance of 14 CFR parts 121, 135, and Modules in the Oversight Model - Scoping and Scaling for Customized Tools - Risk Management Process FAA Safety Assurance System Federal Aviation Administration 44

45 SAS Module 1 - Configuration FAA and CH can edit and update details in the Configuration Module. SAS automation: Communicates with other systems to send and receive some of the configuration data Generates the Operating Profile Who they are, where they operate, approvals and limitations of certificate Identifies DCTs applicable based on the nature and scope of operation Includes messaging and document management system FAA Safety Assurance System Federal Aviation Administration 45

46 SAS Module 2 Planning Principal Inspector completes the Certificate Holder Assessment Tool (CHAT) to identify risks System automatically schedules high-level system performance assessments based on operating profile Principal Inspector develops a riskbased surveillance plan FAA Safety Assurance System Federal Aviation Administration 46

47 SAS Module 3 - Resource Management Management assigns resources based on risk Management identifies if/why resources are not available FAA Safety Assurance System Federal Aviation Administration 47

48 SAS Module 4 Data Collection Inspectors Perform Surveillance Data collection observe and record Data reporting enter details into database Data review second set of eyes completes quality check FAA Safety Assurance System Federal Aviation Administration 48

49 SAS Module 5 Analysis, Assessment and Action Analyze data Determine if there is enough data Decide if there are data review issues Make an assessment Decide if action is required Determine if acceptance/approval is required FAA Safety Assurance System Federal Aviation Administration 49

50 External Portal A web-based application that allows certificate applicants, existing certificate holders to interact with their local FAA office Optional for existing certificate holders but mandatory for new certificate applicants Only data pertaining to your organization is available to you Submit certification documents, communicate with FAA Inspectors, upload and manage documents, request program changes, update information FAA Safety Assurance System Federal Aviation Administration 50

51 Oversight Vision Have a single system for all of FAA Flight Standards to use, for everything related to oversight Share processes, tools, and data with industry Utilize advanced analysis capabilities to assist with identifying risk and targeting resources Use Risk Based Decision Making (RBDM) Refine the skillset of the workforce FAA Safety Assurance System Federal Aviation Administration 51

52 FAA SMS The FAA SMS will help integrate processes across the FAA to ensure safety risk is managed in all areas of the aerospace system within the FAA s purview FAA SMS Airports Aviation Safety Commercial Space Transportation Air Traffic Knowledge and information sharing FAA Safety Assurance System Federal Aviation Administration 52

53 Questions? FAA Safety Assurance System Federal Aviation Administration 53

54 Milt Krivokuca Former Chairman of American Society for Quality (ASQ) 54

55 PERFORMANCE BASED SAFETY A P P L Y I N G Q U A L I T Y M A N A G E M E N T

56 MILTON KRIVOKUCA DBA, CMQ/OE, CQE, SSBB APRIL 1 3,

57 STANDARDS DEVELOPMENT Goals and objectives industry related Establish performance levels (product or service) Verify and validate requirements Assure compliance through audits Taking performance to the next level -

58

59 A SYSTEM TRADITIONAL MANUFACTURING SENSE

60 A SYSTEM IN THE PERSPECTIVE OF ORGANIZATIONAL EXCELLENCE

61 APPLICATION OF QUALITY MANAGEMENT SYSTEMS Provides a structured process for assuring the implementation of legislation Methodical approach to achieve compliance with the legislation The sustainability of the implementation Providing opportunities to benefit from the legislation Deming Baldrige

62 PSYCHOLOGY Which is management s perspective?

63 TIMING IS IN PLACE TO MOVE ORGANIZATIONAL PERFORMANCE TO THE NEXT LEVEL Quality Management Systems - Can accomplish this task!!!

64 Stephen Creamer Director, Air Navigation Bureau, ICAO 64

65 Workshop 6 Quality, Compliance and Management System Stephen Creamer Director, Air Navigation Bureau IATA OPS Conference 2015, Los Angeles USA 14 April 2015

66 QMS SMS Integration at ICAO There are requirements on QMS in Annex 3, 6, 8 and 15 However, there are currently no SARPs on the integration of QMS and SMS 14 April

67 QMS SMS Integration at ICAO ICAO has published guidance material on the integration of QMS to SMS Doc 9859 (chapter 5.4.2) provides a description of QMS and SMS QMS: QMS is generally defined as the organizational structure and associated accountabilities, resources, processes and procedures necessary to establish and promote a system of continuous quality assurance and improvement while delivering a product or service. QMS is an existing aviation regulatory requirement for most service providers including production approval (Annex 8), maintenance organizations (Annex 6, Part I) and meteorological and aeronautical data service providers (Annexes 3 and 15, respectively) 14 April

68 Focus of the Two Systems QMS is focused on consistent delivery of products and services that meet relevant specifications SMS is focused on safety performance Both systems: Must be planned and managed Depend upon measurement and monitoring of performance indicators Involve all organizational functions related to the delivery of aviation products and services Strive for continuous improvement 14 April

69 Relationship of QMS and SMS QMS SMS Quality Quality assurance Quality control Quality culture Compliance with requirements Prescriptive Standards and specification Reactive Proactive Safety Safety assurance Hazard identification and risk control Safety culture Acceptable level of safety performance Performance-based Organizational and human factors Proactive Predictive 14 April

70 The Way Forward Industry nowadays is moving towards an integrated and system-wide risk management approach that is not compartmentalized in Safety, Security, Quality, Finance, etc. but overarching. Development of potential SARPs on QMS and SMS integration and system wide implementation would be dealt with through the Safety Management Panel. IATA to bring industry best practices to the table through SMP representation. 14 April

71

72 Management Systems in EU Regulations Harmonised Organisation requirements have been introduced with the Implementing Rules on flight crew licensing and air operations. The standards are to be followed in other areas allowing for an integrated approach. This is particularly relevant to operators who also hold a CAMO approval (continuing airworthiness management organisation) The rule provides the framework for a management system supporting an effective (safety) management system by containing a means for monitoring compliance, estimating risks and aiming at continuous improvement. Insofar the regulation prescribes a function to monitor compliance of the operator with the relevant requirements. The compliance monitoring shall include a feedback system of findings to the accountable manger to ensure effective implementation of corrective actions.

73 Management Systems in EU Regulations Compliance Monitoring Function

74 Management Systems in EU Regulations

75 Management Systems in EU Regulations Extension to MRO organisations is under review with the intention to minimise changes in existing regulations and therefore the impact on organisations, the introduction of Management System requirements into new domains will be based on a careful gap analysis between existing requirements and the ICAO Annex 19 framework The implementation of the Policy needs to ensure proportionality by ensuring an approach tailored to the different actors in the aviation system. Systematic consideration of Best practice and Industry Standards i.e. IAQG developing the 9110 Standard for QMS Requirements for Aviation Maintenance Organizations. Referenced in papers during the recent ICAO HLSC

76 Integrated Management Systems Multiple facets need to be considered for the integration of management systems with those required by other legislative or regulatory requirements such as occupational health and safety, security, environment and QMS. It may also include the integration of non-regulated systems such as finance and human resources.

77 Considerations: Integrated Management Systems identification of accountabilities and responsibilities. The organisation has documented how the management systems are functionally linked and identified how the systems interface with each other and with the integrated management system. Evidence exists that the organisation dedicates the necessary priorities and resources for the integrated management system and for each of the interacting management systems. The organisation clearly identifies and documents how it will address multiple inputs from and to the interacting management systems. The organisation assesses the effectiveness of its integrated management systems and modifies the system as a result of changes and lessons learned, as appropriate. The organisation possesses processes/tools to allow the Authority to oversee the management system in their area of responsibility.

78 Harmonisation To ensure proportionality and flexibility, the management system requirements at Implementing Rule level should be limited to key principles. Non-essential implementation provisions should be included as Acceptable Means of Compliance (AMCs) and the development and acceptance of Industry Standards and Best Practices should be encouraged to support Management System implementation

79 Harmonisation Risks still exist even in the most compliant systems. Moreover, in reality, it is impossible to develop rules for every possible situation A performance based environment (rules) is the way forward to ensure that the management system deploys its full potential: The organisation should be allowed flexibility to implement specific means for mitigation of risks Continued compliance to prescriptive rules remains a success factor in a PBE to meet the targets

80 Enablers for effective management system Leadership (actions speak louder than words) Integration into day-to-day business; senior management commitment is crucial Understanding that we are all in this together with common goals and ideals System approach (identifying, understanding and managing interrelated processes as a system Organization culture covering the full range Flexible culture Just culture Learning culture Informed culture Reporting culture

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