ANNEX 5 -QUALITY OVERSIGHT 1. INTRODUCTION 2. SCOPE

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1 DSS/Support to CAA-NSA A5-1 Guidelines for NSAs for the Development of the ANSP Oversight Process 5-Quality Oversight ANNEX 5 -QUALITY OVERSIGHT 1. INTRODUCTION ANSP s quality oversight is a fundamental function to improve the overall ANSP s performance in a proactive manner. This is one of the responsibilities of the State authorities. It allows verifying compliance on one side, and even more important to identify improvements towards a dynamic efficient and transparent quality function able to anticipate and mitigate associated risks to ATM. The objective of this process is to show the steps required for the National Supervisory Authority to determine what needs to be designed, developed, implemented and monitored in an ANSP organisation to assure quality of product and service delivery in the context of regulatory oversight and market (customer) needs. Therefore, this oversight also partly covers the ANSP s organisational issues, in particular those related to strategic business and annual plans development. The NSA inspection programme itself should cover issues linked to the national legislation in place. It should not run in isolation but as an integral part of the State broader inspection programme for the ANSP. Training, accreditation and designation of quality auditors are key aspects of the ANSP s quality oversight. The quality oversight depends on relevant skills and training of auditors. 2. SCOPE The scope of this process is the oversight of ANSP s quality management status at national level. FAB and network (Network Manager NM) dimensions are not fully addressed within the scope of this document. Quality Management (QM) contributes to the systematic and consistent delivery of an organisation s products and services. Quality Management permits an organisation to know if it is doing well or badly in its defined market and to be proactive in refining its performance to better meet its user s needs. Sustainability of the business of providing air traffic services is the contribution of a quality management system. Quality management processes feed the strategic business process. The scope of a Quality Management System (QMS) is the total organisation required for the delivery of its services or products. It is important that suppliers to the ANSPs are adequately identified; the interfaces with the business documented and the measures taken to monitor their performance elaborated to allow a common understanding of what is and is not acceptable. This defines the organisational scope to be overseen. It is also necessary to provide a list of all the products and services provided, and the geographical places where these transactions take place, and the organisation s system interdependencies. A quality management system (QMS) is an enabler for the provider of Air Traffic Management products or services to: 1. understand and meet customer and legal requirements, 2. consider the processes required to meet those needs in terms of added value, 3. obtain the required results of product and service delivery through process performance and process effectiveness, and 4. improve processes using an objective measurement of performance focusing on the needs of the business. For ANSPs there are several sources of requirements to assure the safe provision of air traffic services: 1. International Civil Aviation Organisation (ICAO) provisions, 2. National legislation (e.g. aviation (certification), data protection and health and safety at work), 3. International Standards Organisation (ISO) 9001 Quality management systems Requirements, and 4. the European Commission Implementing Regulation of 17 October /2011 laying down common requirements for the provision of air navigation services and amending Regulations (EC) 482/2008 and (EU) 691/2010. An ANSP is liable to conform to each set of requirements. Typically these requirements are mutually compatible, but compatibility should be scrutinised to ensure compliance can be achieved. Oversight of ATS provision may be organised by ICAO, the State Regulator or the European Aviation Safety Agency. An audit of a Quality Management system may be organised by an ISO 9001 certifying body or the European Aviation Safety Agency. Requirements for each of those areas are mentioned in Appendix 1. This appendix represents check lists of auditing process of an ANSP. It is subject to regular or ad hoc updates depending on new EC regulations, national legislation or internal CAA-NSA or ministerial decisions. Edition 1.0 December 2013

2 DSS/Support to CAA-NSA A5-2 Guidelines for NSAs for the Development of the ANSP Oversight Process 5-Quality Oversight 3. REGULATORY FRAMEWORK The European regulatory framework (SES I/SES II) The initial SES package came into force in In the light of the SES, a specific regulatory framework for air navigation service (ANS) has been developing in the European Union since 2004 (e.g., Regulation (EC). 550/2004 as amended later and Regulation (EC). 1035/2011 on common requirements). The service provision regulation (EC). 550/2004 establishes common requirements for the safe and efficient provision of ANS in the Community where quality is one of requirements. The regulation includes a common system for the certification and designation of air navigation service providers. This enables the definition of their governing rules and obligations. In particular, the Implementing Regulation (IR) 1035/2011 I paragraph 3.2. states that: 3.2. Quality management system Air navigation service providers shall have in place a quality management system which covers all air navigation services that they provide, according to the following principles. The quality management system shall: 1. define the quality policy in such a way as to meet the needs of different users as closely as possible; 2. set up a quality assurance programme that contains procedures designed to verify that all operations are being conducted in accordance with applicable requirements, standards and procedures; 3. provide evidence of the functioning of the quality management system by means of manuals and monitoring documents; 4. appoint management representatives to monitor compliance with, and adequacy of, procedures to ensure safe and efficient operational practices; 5. perform reviews of the quality management system in place and take remedial actions, as appropriate. An EN ISO 9001 certificate, issued by an appropriately accredited organisation, covering the air navigation services of the provider shall be considered as a sufficient means of compliance. The air navigation service provider shall accept the disclosure of the documentation related to the certification to the competent authority upon the latter s request. Air navigation service providers may integrate safety, security and quality management systems into their total management system. ANSP s quality auditors must be familiar with regulations in place or under development, as well as with on activities in the field at national, regional and global level. Although quality is not explicitly mentioned in the SESII package (EC 691/2010, it is a fundamental enabler for the realisation of the SES. Also, the para of I related to ANSP (ATS, CNS, AIS, MET) operations manuals is subject to the quality domain. According to this paragraph: 3.3. Operations manuals Air navigation service providers shall provide and keep up-to-date operations manuals relating to the provision of their services for the use and guidance of operations personnel. They shall ensure that: 1. operations manuals contain the instructions and information required by the operations personnel to perform their duties; 2. relevant parts of the operations manuals are accessible to the personnel concerned; 3. the operations personnel are expeditiously informed of amendments to the operations manual applying to their duties as well as of their entry into force. The national regulatory framework The related to the domain national legislation should be part of this oversight, certainly in an agreement and close co-operation with the State authorities charged to audits and inspections. The oversight scope should include the above mentioned areas. Therefore, NSA staff must acquire competence and related skills. Edition 1.0 December 2013

3 DSS/Support to CAA-NSA A5-3 Guidelines for NSAs for the Development of the ANSP Oversight Process 5-Quality Oversight 4. PROCESS FOR THE QUALITY OVERSIGHT OF AN ANSP The steps to be followed by the NSA for the ANSP s QMS continuing oversight are the same as in the generic oversight process. Some further consideration should be particularly taken into account, as follows: 1. Determine the nature of the system for the oversight activity, stand alone or integrated. 2. Identify if there is another body conducting a similar activity for the purposes of certification, legal compliance etc. 3. Establish which parts of the organisation need to be overseen directly and which parts of oversight can be provided by a qualified third party, independent supplier e.g. ISO 9001 assessor, ICAO Universal Safety Oversight Process. 4. In the case of joint use civilian and military entities, a combined view of the service provision needs should be established and a lead auditor agreed. Military standards preceded ISO 9001 standards, so the essence will be the same or similar, but the language may vary and cause uncertainty if not addressed in advance of quality management activities. 5. Assemble the documentary evidence of a performing quality management system for those parts to be directly assessed by the NSA including stakeholder feedback on the products and services provided. 6. Assess that the documents accurately describe what is needed and what is done. Establish consistency between the need and the act. 7. Assess that what is done is correctly described in the supporting documentation (on site inspection). 8. Create a list of non conformities to the business need and the stated intent of the process and supporting activities. 9. Compile the set of non conformities from the different independent sources. 10. Propose the list of actions to close non conformities in a way that reinforces the process contribution to the business need, taking account of short, medium and long term effects and any potentially competing needs e.g safety. 11. Establish the risks to the business of not closing the non conformity. 12. Prioritise the list of actions and plan their effective implementation, ensuring the desired outcome through performance monitoring. The process of quality assurance induces organisational change; as such the changes need to be understood from the point of product or service delivery to the point of strategic vision and intent. The process of auditing a quality management system must be documented and managed as with all the activities contributing to the business of air traffic service provision. Document Management standards apply equally to the quality assurance activity as to all parts of the organisation. The Quality management review of the ANSP (ATS, CNS, AIS and MET) according to SES Regulation (CR/ I/3.2 should cover the following documents: 1. Quality policy and quality objectives document; 2. Description of QMS organisational structure (Quality manager, staff, reporting lines, job descriptions, competencies, etc.); 3. Quality manual; 4. Documented quality Assurance system and its programme; 5. Quality records; 6. Description of processes Generic compliance lists are provided in Appendix 1. This list comes from the IR 1035/2011, Common Requirements and in particular from I/para 3.2 and 3.3 related to the ANSP QMS. Edition 1.0 December 2013

4 DSS/Support to CAA-NSA A5-4 Guidelines for NSAs for the Development of the ANSP Oversight Process 5-Quality Oversight 5. AUDIT/INSPECTION PROGRAMME When developing an ANSP s QMS audit/inspection programme, apart from the basic and trivial elements, the following ones should be considered: 1. The ATM QMS inspection plan must be an integral part of the overall national programme, since it is a component of the overall audit concept; 2. A single authority must be responsible for oversight programme. NSA s role or links to other authorities responsible in the field must be clarified; 3. Develop the plan for quality management oversight activities involving the required participants in the plan. 4. Ensure the plan makes timely and best use of other planned oversight and audit activities. Where possible the activity should be conducted without conflicting with other similar activities. Every effort should be made to prevent conflicting findings and to resolve any conflicting findings pragmatically. 5. Agree on generic steps of the process on: Threat and risk assessment: what are the quality threats to the ATM system; Audit/inspection annual plan, coordination, preparations; Verification of compliance/desk-top, previsit activities; Oversight of compliance on-site, on-site inspection; Resulting actions: audit reports, oversight record archive, resolution of nonconformities, follow up and conclusion of oversight, conclusions of conformities and non conformities, monitoring continuing compliance and improvement. 6. Policy setting: basic principles for ATM quality which forms the basis for associated developments. 7. The audit/inspections plan must be developed on annual basis; must be done in coordination with the organisations to be audited. It should include: schedules; pre-visit questionnaires and check lists; pending actions resulting from last inspections; on-site audit check lists and; co-ordination details. Edition 1.0 December 2013

5 DSS/Support to CAA-NSA A5/App 1-1 Guidelines for NSAs for the Development of the ANSP Oversight Process 5-Quality Oversight APPENDIX 1: COMPLIANCE CKECK LISTS OF THE ANSP QUALITY OVERSIGHT PROCESS. Edition 1.0 December 2013

6 How to Assess the 3. SAFETY AND QUALITY I 3 ANSP MANAGEMENT I 3 2 ANSP 3.2. Quality management system I ANSP Air navigation service providers shall have in place a quality management system which covers all air navigation services that they provide, according to the following principles. 1. The ANSP shall have a quality management system (QMS) in place that shall cover all air navigation services provided. The following at least should be in place: 1. A quality policy text well communicated in the organisation; 2. Quality assurance programme and associated procedures; 3. Quality management system documents and records; 4. Management representative confirmation; 5. Records from management reviews; 6. Internal quality audits and provision of relevant reports. Scenario 1: Check the availability, the scope and validity of the EN ISO 9001 Certificate Scenario 2: NSA could check evidence by 1. conducting a desk audit (on/off site) 2. conducting an on-site audit 3. issuing its own NSA questionnaire 4. contracting a third-party for auditing 5. checking internal quality audits by ANSP & provision of audit reports I ANSP The quality management system shall: Page: 1/7

7 How to Assess the I a ANSP (a) define the quality policy in such a way as to meet the needs of different users as closely as possible; 1. A quality policy text well communicated in the organisation should be agreed; 2. This quality policy should be agreed via an internal ANSP consultation process with the wide participation of key management and individuals of the organisation; 3. The quality policy defined shall cover the needs of the different stakeholders (customers, employees, suppliers, regulatory authorities). 1. The text of the quality policy should be included in the ANSP QMS manual or handbooks; 2. tes, minutes or other records of various consultation sessions should be filled and archived as a piece of evidence. Verify whether the quality policy has been defined and covers the needs of the different users (clients, employees, suppliers...). I b ANSP (b) set up a quality assurance programme that contains procedures designed to verify that all operations are being conducted in accordance with applicable requirements, standards and procedures; 1. The ANSP should set up a quality assurance programme with relevant procedures in place 2. The quality procedures are used to verify that all operations are being conducted in accordance with applicable requirements, standards and procedures. Quality assurance programme and associated procedures in place Verify whether the quality procedures are used to verify that all operations are being conducted in accordance with applicable requirements, standards and procedures. Page: 2/7

8 How to Assess the I c ANSP (c) provide evidence of the functioning of the quality management system by means of manuals and monitoring documents; Manuals, handbooks and documented monitoring procedures should be in place A clear evidence that the of the quality system is functioning as appropriate should consist of the following: 1. quality management system documents e.g. quality management manual; 2. process procedures, work procedures & Verify whether the quality instructions, management documents have 3. monitoring documents; been implemented and verify 4. internal quality audit examples of quality records documents (schedules, based on the procedure outputs. audit reports, corrective action reports); and 5. quality records; 6. verification whether the quality management documents have been implemented and verify examples of quality records based on the procedure outputs. Page: 3/7

9 How to Assess the I d ANSP (d) appoint management representatives to monitor compliance with, and adequacy of, procedures to ensure safe and efficient operational practices; 1. The ANSP should have formally appointed management representatives responsive to monitor the competence of processes and procedures of the work flow; 2. Organisational structure of the quality management should be also defined with associated terms of reference, working arrangements, job and task descriptions. The organisational documentation or quality manual should clearly state; 1. the role of management representative (e.g. QMS manager) for the quality system who, irrespective of other responsibilities: 2. the responsibility and authority of the management to ensure that the QMS is established, implemented and maintained and reports on the performance of the QMS to top management; 3. an adequate job description to make sure that the person for this role has; 4. relevant working arrangements. Verify whether the organisational documentation or quality manual includes: 1. a role of Management Representative for the quality system who, 2. irrespective of other responsibilities 3. has the responsibility and 4. authority 5. to ensure that the QMS is a. established b. implemented c. maintained d. to report on the performance of the QMS to top management; make sure that the person for this role has an adequate job description I e ANSP (e) perform reviews of the quality management system in place and take remedial actions, as appropriate. 1. ANSP perform surveys, reviews and audits of the quality system; 2. take remedial actions, as appropriate The following records should be in place: 1. records from management reviews on the QMS by top management; 2. records of implementing action items and if are properly traced Verify whether records from management reviews are available and if they include action items if appropriate; if action items have been defined, check whether these action items are traced; Page: 4/7

10 How to Assess the I ANSP An EN ISO 9001 certificate, issued by an appropriately accredited organisation, covering the air navigation services of the provider shall be considered as a sufficient means of compliance. The air navigation service provider shall accept the disclosure of the documentation related to the certification to the competent authority upon the latter s request. 1. An EN ISO 9001 certificate, issued by an appropriately accredited organisation and covering all air navigations services the ANSP provides is a sufficient means of compliance. 2. Much attention should be paid to the scope of the certifications for they were issued. 1. The Certification (registration) body should have been approved by an Accreditation Body, e.g. refer to the ISO Directory of ISO 9000 Accreditation and Certification Bodies focus on the certification (registration) bodies operating nationally or multi-nationally. 2. The accredited organisation that issued the certificate has the required specific business-sector experience (SIC 9621 and 4581) 3. the scope of the certificate must cover all air navigation services provided by the ANSP. 1. Accredited organisation should have previous experience in air traffic business at least (if not ATM). 2. & 3. Audit report will reveal the scope and depth of the audit. ISO certificates shoud never be taken "as is". I ANSP Air navigation service providers may integrate safety, security and quality management systems into their management system. Independantly how the combination is made particular oversight on ANSP quality should take place. I 3 3 ANSP 3.3. Operations manuals Page: 5/7

11 How to Assess the I ANSP Air navigation service providers shall provide and keep up-to-date operations manuals relating to the provision of their services for the use and guidance of operations personnel. 1. Operations manuals for ATS, CNS, AIS and MET providers shall be in place 2. All formal operations manuals must be regularly or ad hoc updated in line with a procedure in place; 3. up-to-date documented processes on work flow should provide users with adequate guidance; 4. The ANSP should ensure that it has an effectively functioning document control system. The following evidence should be at least acquired: 1. ANSP s document control procedure, together with a list of examples of controlled documents; 2. the documents listed are appropriate for the scope of the ANSP services provided and include the relevant operations manuals; 3. records demonstrating an effectively functioning document control system; e.g. management reviews, quality audit reports and corrective action plans 4. all operations manuals are available and updated; 5. The following should be checked: the date of last review, alignment with ICAO requirements regarding operations manuals in particular regarding Air Traffic Services, the updating and validity of local operations manuals (e.g. TWRs), Scenario 1: Check the availability and scope of a valid EN ISO 9001 Certificate Scenario 2: 1. Check ANSP s document control procedure, together with a list of controlled documents; Verify whether the documents listed are appropriate for the scope of the ANSP services provided and include the relevant operations manuals; 2. Verify records demonstrating an effectively functioning document control system; e.g. management reviews, quality audit reports and corrective action plans I ANSP They shall ensure that: Page: 6/7

12 How to Assess the I a ANSP (a) operations manuals contain the instructions and information required by the operations personnel to perform their duties; 1. Operations manuals contain the appropriate instructions and 2. information required by operations personnel to perform their duty Documents listed are appropriate for the scope of ANSP's services provided and include the relevant operations manuals; Verify whether the operations manuals cover all areas of operations the ANSP provides (AIS(P), ATS(P), MET(P), CNS(P)) and contain the required information needed by the operations personnel.the ANSP should be able to provide evidence of a process that ensures that the documentation is in line with the appropriate ICAO Standards mentioned in the specific ANNEX for each ANSP. I b ANSP (b) relevant parts of the operations manuals are accessible to the personnel concerned; 1. All key operational manuals should be accessible to the personnel concerned; 2. adequate number of hard copies for all manuals must available 1. The operations personnel can access the relevant and current parts of the operations manuals; 2. In each operational position should be a set of applicable up today operations manuals accessible to operational staff. Verify whether the operations personnel can access the relevant and current parts of the operations manuals. Should be covered by the QMS but due to the importance of the operations manuals the NSA may decide to assess this requirement in any case. I c ANSP (c) the operations personnel are expeditiously informed of amendments to the operations manual applying to their duties as well as of their entry into force. 1. Expeditious communication of amendments to the operations manual 2. and their entry into force to the operations personnel 1. Ask the ANSP to explain the Documentation process that assures that the management system operation personnel is informed should cover: about changes to operations 1. the change manuals based on an example management; (e.g. latest change); 2. records demonstrating 2. Verify whether the date when an effectively functioning the changes enter into force is document control specified; system. 3. Verify if the described evidence is available. Page: 7/7