Quality Management System Manual. CAD Order

Transcription

1 Quality Management System Manual CAD Order

2 BAHAMAS CIVIL AVIATION DEPARTMENT ORDER Effective Date: November 29, 2013 SUBJ: Aeronautical Information Service (AIS) Quality Management System Manual (QMS) 1. Purpose of This Order. ICAO Annex 15 (Aeronautical Information Service), Chapter 1 implies the necessity for a QMS when it states that Corrupt or erroneous aeronautical information/data can potentially affect the safety of air navigation. Aeronautical information distributed by means of AIPs (Aeronautical Information Publication) including charts and by NOTAM, PIBs (Pre-flight Information Bulletins), AICs (Aeronautical Information Circulars) and other products and services provided by an AIS, have an inherent and essential need to fulfill specific requirements in order to serve its intended purpose and meet the needs of users. The basic characteristics of aeronautical information are those of adequacy, availability and timeliness. The degree to which these and other characteristics fulfill requirements is referred to as "quality". In addition to specifying the quality requirements for aeronautical data, ICAO Annex 15 requires States to introduce a quality system to implement quality management at each of the function stages of originating (or collecting), collating or assembling, editing, formatting, storing, publishing and distributing of aeronautical information. This directive requires the AIS department at the Civil Aviation Department (CAD) to develop and implement a Quality Management System in compliance with ICAO Annex 15 (Aeronautical Information Service) ICAO Document 8126 (Aeronautical Information Services Manual), and CAD Manual (Aeronautical Information Service Manual). Distribution: CAD, ATS, CNS, AFIS, AIS Initiated By: CAD ATS

3 11/29/ Audience. This order applies to Bahamas Civil Aviation Department (CAD) Air Navigation Service (ANS) employees and in specific Aeronautical Information Service (AIS) personnel. 3. Where Can I Find This Order? You can find this order in the appropriate CAD Offices. 4. Responsibilities. Each AIS employee and select CAD personnel must become familiar with the contents of this Order and understand their own important role in the AIS quality process. Employees should recognize that through participation in this program they are helping to improve their own performance, the performance of their coworkers, and the overall quality of its products and services. 5. General Principles and Concepts Quality Management System (QMS) Activities QMS Activities generally include the following: a. Establishment of a quality policy and quality objectives; b. Quality planning; c. Quality control; d. Quality assurance; and e. Quality improvement Cost of Quality The cost of quality, as a measure of quality, is the ultimate test to evaluate the effectiveness of every quality initiative. It consists of four major components, as follows: a. Internal failure costs; Costs associated with defects or non-conformance found before the customer receives the product or service, for example, correcting wrongly encoded aeronautical information when captured by automatic checking procedures. 3

4 11/29/2013 b. External failure costs; Costs associated with defects or non-conformance found after the customer receives the product or service, for example, investigating complaints from a pilot for the late issuance of aeronautical information and loss of goodwill. c. Appraisal costs; Costs incurred to determine the degree of conformance to quality requirements, for example, procedures and resources to enable the verification of aeronautical information, and monitoring of the transit time of the IAIP (Integrated Aeronautical Information Package) d. Prevention costs; Costs incurred to keep failure or non-conformance and appraisal costs to a minimum, for example, training staff in quality practices and procedures. The advancement in approach from inspection, quality control and quality assurance to quality management reduces the quality cost Quality Management Principles (QMP) The following are eight principles of quality management that will be used by senior management at CAD as a framework to guide the Bahamas towards improved performance. These principles are as follows: a. Customer focus; Organisations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer requirements. CAD management shall document customer requirements and monitor the quality of services as perceived by the customers. The means to achieve this may include the conduct of regular customer satisfaction surveys, liaison meetings with representatives of the customers and visits to the operation facilities of the customers. All customer feedback and complaints should be formally recorded and followed up without delay. Details of action taken and recommendations for improvement should be documented. It is also important to give a formal response to the customer before the feedback or complaint is considered "closed". b. Leadership; Leaders establish unity of purpose and direction of the organisation. They should create and maintain the internal environment in which people can become fully involved in achieving the organisation's objectives. The implementation of a QMS will hardly be successful if there is lack of commitment from senior management. As such, it is critical that senior management has a sound appreciation and understanding of all facets of quality management and, in particular, issues pertaining to quality assurance. This understanding 4

5 11/29/2013 and appreciation should be obtained through appropriate training and experience. It must also be remembered that leadership can be found at all levels within an organisation and identifying this quality may be of great benefit in establishing a quality culture within a specific section of an organisation or throughout the organisation as a whole. The leadership of CAD Bahamas is committed to a quality management program for AIS. c. Involvement of people; People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation's benefit. Staff must be suitably qualified and competent in their jobs, as the quality of their work directly affects the quality of service. This can be achieved through the provision of appropriate training and evaluation. Quality awareness training should also be provided to all relevant staff to heighten responsibility, accountability and quality consciousness, that is, to assist in building a quality-focused culture. With the implementation of the QMS, staff needs to take on additional responsibilities such as the day-to-day consistency checks as part of the data for product quality assurance and control processes. CAD management is committed to a training and evaluation program that enhances quality awareness and implementation. d. Process approach; A desired result is achieved more efficiently when activities and related resources are managed as a process. A process is a set of interrelated or interacting activities that transform inputs into outputs. A QMS can be thought of as a single large process that uses many inputs to generate many outputs. In turn, this large process is made up of many smaller processes. All activities and resources related to AIM, including operational and administrative, have to be managed as processes. e. System approach to management; Identifying, understanding and managing interrelated processes as a system contributes to the organisation's effectiveness and efficiency in achieving its objectives. AIS has taken the first step by documenting the operational and administrative processes for service provision. These processes should be reviewed and any differences between ICAO Document 8126 or CAD Order requirements and existing processes identified. Quality system procedures should then be developed for these differences and applied so that the processes to achieve the best results can be aligned and integrated. f. Continual improvement; Continual improvement of the organisation's overall performance should be a permanent objective of the organisation. Specifically, the effectiveness and 5

6 11/29/2013 suitability of the QMS have to be evaluated and areas for improvement identified and rectified. Management reviews have to be conducted regularly using the data collected from the monitoring and measurement process to identify areas for further improvement. Channels may need to be established to allow all staff in the organisation to make suggestions on ways to improve the service. CAD management is committed to improving the service of the organisation to its customers, with the overall guiding principle being safety. g. Factual approach to decision-making; Effective decisions are based on the analysis of data and information. Among other things, an AIS automation system should be developed to ensure the accuracy of each of the information elements. Other performance statistics or indicators, such as timeliness and conformance to the specification, user satisfaction survey results and supplier performance records should also be collected in the data and analysis process. h. Mutually beneficial supplier relationships; An organisation and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. Suppliers should be evaluated and selected on the basis of their ability to meet purchase order requirements and on their past performance General Requirements for Implementation of a Quality System The general requirements for the implementation of a QMS are to: a. Identify the processes needed for the QMS; b. Determine the sequence and interaction of these processes; c. Determine criteria and methods required to ensure the effective operation and control of these processes; d. Ensure the availability of information necessary to support the operation and monitoring of these processes; and e. Measure, monitor and analyse these processes, and implement action necessary to achieve planned results and continual improvement. 6

7 11/29/ QMS Development and Implementation Requirements 6-1. QMS Development and Implementation CAD Bahamas shall utilize the plan and template located in Appendices B and D of this document to plan, design and implement its Quality Management system Evaluation, Monitoring, and Identification of Processes Activities that receive inputs and convert them to outputs can be considered to be a process. In many cases, an output from one process will form the input to the next process; for example, data is received from an aerodrome operator, entered into the AIM database, and when combined with other data, is provided as an output for charting or a document. a. CAD Bahamas shall identify and manage the numerous linked processes in its AIS organisation. Systematic identification and management of these many processes and the interactions between these processes that are used within an AIM are often referred to as a process approach. b. As a part of the identification process required above, CAD shall develop a system to acquire and measure customer satisfaction of its AIS products. This approach shall include involving their customers in the development of the quality system. c. CAD Bahamas shall monitor the effectiveness of its procedures and products through the audit processes contained in CAD Order (ATS-Safety Audits Order). 6-3 Management Requirements a. The CAD Director shall issue a quality policy in writing that is available and understood by all personnel that includes the following; 1). A statement of a commitment to quality; 2). What the quality objectives of the organisation are; and 3). How the objectives relate to customer s expectations. 4). A definition of quality and what it means to the Bahamas is communicated, understood and implemented throughout the organisation; and 5). Is reviewed for continuing suitability. 7

8 11/29/2013 b. The CAD Management Team will actively participate and take responsibility for development and implementation of a QMS in the Bahamas as follows: 1). The definition and implementation of quality policy; 2). Communicating the quality policy within the organisation, including the importance of meeting customer, regulatory and legal requirements; 3). Setting objectives, strategies and targets derived from the policy; 4). Create position descriptions that describe the role, responsibilities and authorities for all staff; 5). Ensure that resources for all QMS activities are adequate; 6). Appoint and support a management representative from the executive level; and 7). Schedule regular reviews of the effectiveness of the system. c. Meeting customer and regulatory requirements is the primary business of any service organisation. To ensure that these requirements are met, and that customer confidence is maintained, The CAD and AIS Management Team pledges to provide a clear understanding and defined specifications in the form of user requirements. d. The step that follows the publication of the quality policy is the setting of objectives, strategies and targets that will show how the organisation expects to implement the quality policy. The CAD Management Team is committed to providing the input and guidance necessary to set and measure objectives. e. Planning enables an organisation to exercise control over routine business and changes to ensure that the QMS is effective during the routine activities and after the change. The CAD Management Team shall provide the guidance, resources and feedback necessary to facilitate the planning process. f. A quality system requires responsibilities and authorities for all staff members to be defined and communicated. This means that everyone in the organisation knows what they are responsible for, what the level of their authority is and what the reporting arrangements are. As part of the QMS development process CAD shall publish job descriptions and an organisational chart detailing how AIS fits into the ANS organisation in the Bahamas. 8

9 11/29/2013 g. Internal communications is all about keeping everybody in the team informed about what is going on and to keep abreast of the processes, changes and outcomes. This includes the good news and the bad news Resource Requirements a. The term resource applies to personnel, facilities and equipment. A successful QMS requires adequate resources of all types to be effective. The resources allocated must be at a level to: 1). Implement and improve the processes of the QMS; and 2). Address customer satisfaction. b. The human resources committed to the QMS must: 1). Be competent on the basis of applicable education, training, skills and experience. 2). Staffing numbers must be adequate to support the AIS organisation and the QMS process. 3). CAD Management will promote the correct level of technical proficiency of personnel within the AIS. 4). CAD Management will ensure that the AIS has an appropriate and recognized status in the ANS organisation of the Bahamas. 5). CAD will assess on a regular basis the competence of personnel required by the organisation to check, edit and publish aeronautical information. These procedures should include the levels of training, qualification and experience necessary to achieve expeditious publication of information. (The provisions of CAD Order Performance Management can be used for this purpose.) 6-5. Product Development and Delivery a. During the planning of the processes to bring a product to completion, CAD AIS shall consider the following: 1). Objectives for the product, project or contract; 2). The need to establish processes and documentation, and provide resources and facilities specific to the product; 3). Verification and validation activities, and the criteria for acceptability; and 9

10 11/29/2013 4). The records that are necessary to provide confidence of conformity of the processes and resulting product. b. All planning information shall be documented. c. Customer product requirements shall be considered as follows: 1). Product requirements specified by the customer, including the requirements for availability, delivery and support; 2). Product requirements not specified by the customer but necessary for intended or specified use; and 3). The obligations related to product, including regulatory and legal requirements. d. As part of the QMS development/implementation process CAD shall review all customer requirements. This review must be conducted prior to the commitment to supply a product to the customer, e.g. submission of a tender, acceptance of a contract or order, and to ensure that: 1). Product requirements are defined; 2). Where the customer provides no documented statement of requirement, the customer requirements are confirmed before acceptance; 3). Contract or order requirements differing from those previously expressed (e.g. in a tender or quotation) are resolved; and 4). The organisation has the ability to meet defined requirements. e. The results of the review and subsequent follow up actions must be recorded and form part of the quality records. f. When product requirements are changed, the CAD AIS office must ensure that any associated documentation, procedures, processes, etc., are also amended to reflect the changes, and that the staff are kept aware of the changed requirements. g. A customer communications plan is vital to success. The CAD AIS plan must include information about: 1). Product information; 2). Enquiries, contracts or order handling, including amendments; and 3). Customer feedback, including customer complaints. 10

11 11/29/2013 h. When a customer orders a new product or service, an understanding of the requirements of the order is critical. All parts of the customer's order or contract need to be reviewed to ensure commitments can be met. Often problems can arise because of a misunderstanding about what was ordered. This makes good communications with the customer an essential part of good business and is essential to resolve any misunderstandings. 1). Where electronic media are involved, two options shall be applied: either save permanently on disk or print out the details. 2). When an order is received by telephone, the order shall be recorded in writing and read back to the customer. 3). At the time the order is received, AIS needs to determine if there are any design requirements in the order and whether commitment to the customer can be met. i. Information relating to product requirements must be defined and documented, and include: 1). Functional and performance requirements; 2). Applicable regulatory and legal requirements; 3). Applicable information derived from previous similar designs; and 4). Any other requirements essential for design and/or development. 5). New product information must be reviewed for adequacy and any incomplete, ambiguous or conflicting requirements resolved. j. Verification of results compared to requirements; the design plan for new products at CAD AIS shall identify the verification method to be used, including who is to carry it out, how it is to be performed and what records are to be kept. There are many ways to verify the design, such as: 1). Performing alternative calculations; 2). Comparing the new design with a similar proven design (if available); 3). Undertaking tests and demonstrations, e.g. flight validations; and 4). Reviewing the design stage documents before release. k. Validation is the process of checking that the final product and/or service will be capable of meeting, or does meet, the customer's needs in use. This may include marketing trials or 11

12 11/29/2013 operational testing. It is also acceptable for the customer to perform the validation and to provide feedback of the results to the designer. All CAD AIS products shall be validated before being put into service. l. Design and/or development changes must be identified, documented and controlled. The results of the review of changes and subsequent follow up actions must be documented. m. Changes occurring due to the customer, market, design review, verification or validation activities must be recorded, reviewed and approved. The extent to which the design needs to be modified as a result of the changes needs to be considered. n. CAD AIS needs to establish what the internal requirements are and document them. In AIS, identification and traceability are specified requirements. An effective identification and traceability system will make it much easier to replace the poor quality service and initiate steps to avoid recurrence, such as retraining or a review of process operations. Records that provide the traceability (including the change requirements) should be retained as part of the quality records. The method(s) the CAD AIS adopt(s) as being most suited to its business shall be described (e.g. in its work instructions), so that everybody knows how it works. o. Control of measuring and monitoring devices; When necessary, the CAD AIS must identify the measurements to be made and the measuring and monitoring devices required to assure conformity of products to specified requirements. Measuring and monitoring devices must be used when appropriate and controlled to ensure that measurement capability is consistent with the measurement requirements. When applicable, measuring and monitoring devices must: 1). Be calibrated and adjusted periodically, or prior to use, against devices traceable to international or national standards; where no such standards exist, the basis used for calibration must be recorded; 2). Be safeguarded from adjustments that would invalidate the calibration; 3). Be protected from damage and deterioration during handling, maintenance and storage; 4). Have the results of their calibration recorded; and 5). Have the validity of previous results re-assessed if they are subsequently found to be out of calibration, and corrective action taken. 12

13 11/29/2013 p. Measurement and monitoring of products; CAD AIS must measure and monitor the characteristics of the product to verify that requirements for the product are met, and must be carried out at appropriate stages of the product realization process. Evidence of conformity with the acceptance criteria must be documented, and records must indicate the authority responsible for release of product. Product release and service delivery must not proceed until all the specified activities have been satisfactorily completed, unless otherwise approved by the customer. q. Checking things are right; CAD AIS must establish how products will be checked and monitored. Some examples of measurement and monitoring include: 1). Measuring dimensions; 2). Proof-reading publications; and 3). Reviewing products to make sure they comply with what was requested. r. CAD AIS shall decide what its measurement and monitoring requirements are and how they are to be carried out. s. The measurement and monitoring to be carried out may be listed in a number of ways, such as: 1). A quality plan; 2). A sampling plan; 3). An inspection and test plan; 4). A procedure; 5). An instruction; and 6). The customer's order. t. CAD AIS shall establish a consistent method of recording that the measurement and monitoring has been carried out. CAD AIS shall establish a system for keeping the necessary testing and inspection records or have other means of showing that the inspections have taken place. 13

14 11/29/2013 u. CAD AIS must ensure that products that do not conform to requirements are identified and controlled to prevent unintended use or delivery. These activities shall be defined in a documented procedure. v. AIS shall decide, and record, who has the authority to say a job is finished and the product and/or service can be delivered. w. The final approval phase shall include checking the finished product and/or service, and that all the inspections and tests that ought to have been done, have in fact been done, and that if any paperwork is to go with the product and/or service, that it has been prepared and is satisfactory Control of the Non-Conformity of Products and Services a. CAD AIS shall ensure that products that do not conform to requirements are identified and controlled to prevent unintended use or delivery. These activities shall be defined in a documented procedure. Non-conforming products must be corrected and subject to reverification after correction to demonstrate conformity. When non-conforming products are detected after delivery or use has started, the organisation shall take appropriate action regarding the consequences of the non-conformity. b. Analysis of data; CAD AIS shall collect and analyse appropriate data to determine the suitability and effectiveness of the product quality management system and to identify improvements that can be made. In this regard, the AIS must analyse data to provide information on: 1). Customer satisfaction and/or dissatisfaction; 2). Conformance to customer requirements; 3). Characteristics of processes, product and their trends; and 4). Suppliers. c. As a result of the measuring and monitoring activities, AIS shall use collected data to identify any trends. d. CAD AIS shall develop a plan for the continual improvement of the product/service quality management system. Some processes to be included could be the use of the quality policy, 14

15 11/29/2013 objectives, audit results, analysis of data, corrective and preventive action and management review. e. CAD AIS shall take corrective action to eliminate the cause of non-conformities in order to prevent recurrence. The documented procedure for corrective action must define requirements for: 1). Identifying non-conformities (including customer complaints); 2). Determining the causes of non-conformity; 3). Evaluating the need for actions to ensure that non-conformities do not recur; 4). Determining and implementing the corrective action needed; and 5). Reviewing and recording results of corrective action taken. f. Preventive actions taken shall be appropriate to the impact of the potential problems. The documented procedure for preventive action must define requirements for: 1). Identifying potential non-conformities and their causes; 2). Determining and ensuring the implementation of preventive action needed; 3). Recording results of action taken; and 4). Reviewing of preventive action taken. g. Fixing the cause of known problems; there is a difference between carrying out corrective action and fixing non-conformity. Fixing a non-conformity is about correcting the problem, either by reworking, replacing or any of the other activities described in the guidance material. A corrective action is concerned with finding out why the non-conformity occurred and making sure that the problem does not occur again. The need for corrective action could be indicated by a number of factors, some of which could be: 1). Customer complaints; 2). Non-conformances; 3). Rework or repairs; and 4). Audit reports. h. When corrective action is taken, it should be recorded and followed up within a reasonable period to find out whether it has worked. 15

16 11/29/2013 i. Fixing the cause of potential problems; Where a potential problem is identified, a course of action shall be developed and put in place to reduce, or eliminate, the risk of the problem. If preventive action is found to be necessary, it should be recorded and followed up within a reasonable period to find out whether it has worked. j. Customer satisfaction; CAD AIS shall monitor information on customer satisfaction and/or dissatisfaction as one of the measurements of the performance of the QMS. The methodologies for obtaining and using this information include: 1). Telephone calls made periodically, or after delivery of product and/or service; and 2). Questionnaires and surveys. k. Satisfaction as a measure of the system performance; CAD AIS shall use customer satisfaction as a measure of the performance of the QMS. CAD AIS shall produce a practical measure to rate customer satisfaction for use in telephone calls and surveys. m. Internal audits shall be conducted in accordance with CAD Order (Audits and Assessments). CAD AIS shall work with the CAD Safety Manager to identify audit points of the QMS for the audit checklist. 7. QMS Documentation Requirements 7-1. General Documentation of AIS procedures is a vital part of the QMS. Work procedures that are documented do not have to be rewritten (e.g. CAD Order , AIS Procedures Directive) but need to be referred to in the quality manual and controlled. Documents are created and controlled via the hierarchy below: a. Level 1 documentation defines the principles and approaches of CAD AIS to quality-related issues. It consists of the quality manual, the quality policy and objectives of the organisation. b. Level 2 documentation consists of procedures by which CAD AIS has chosen to manage its QMS organisation as follows: 1). Control of documents; 2). Control of records; 16

17 11/29/2013 3). Internal Audit; CAD AIS audit procedures are governed and documented in CAD Order (Audits and Assessments); 4). Control of non-conforming product; 5). Corrective action; and 6). Preventive action. c. Level 3 documentation provides detailed instructions, in the form of work instructions or procedure manuals, which the staff need to follow when carrying out specific operational activities. These procedures are documented in CAD Order (AIS Procedures Manual). d. Level 4 documentation consists of all forms and records that serve as the objective evidence of conformity to requirements and of the effective operation of the QMS QMS Document Requirements CAD QMS documentation shall include the following: 1). Quality policy and objectives; 2). Quality manual; 3). Documented procedures; 4). Work instructions/operational procedures; 5). External documents which include, ICAO Annex 15, Doc 8126, CAD AIP, CAD Order , and CAD Order ; and 6). Forms and records Document Master List CAD AIS shall develop a list of controlled documents which have one master copy. All changes shall be made to the master. Copies are issued from the approved master. The Manager of CAD AIS is the owner of all controlled documents and approves all changes Quality Manual CAD AIS shall develop a quality manual according to the template in Appendix B of this document. The quality manual shall include the following information: 1). The scope of the QMS; 2). The documented procedures or a suitable reference; and 17

18 11/29/2013 3). A description of the sequence and interaction of the processes included in the QMS. 4). The quality policy; 5). The activities of the business; 6). How the documentation works and where people might look to find information about how to do things; 7). A definition of any terms having a unique meaning to your business; and 8). Statements of responsibility and authority Recordkeeping Procedures CAD AIS acknowledges the advantages of having documented procedures for the keeping of quality records. CAD AIS shall develop procedures for quality records as appropriate. The minimum retention period for records would depend on requirements to maintain a "paper trail" for the purposes of audit, inquiries or proof in the event of litigation. Records may be kept longer than the minimum period if there is adequate space. Regardless of whether records are stored in paper form or electronically, a procedure must be created for their disposal and for the storage of records that are kept beyond the minimum retention period. Examples of records include: a. Document records 1). Document change request form 2). Controlled documents master list b. Human resources records 1). Training 2). Education c. Process and product review records 1). Non-conformance reports 2). Management review results 3). Status of corrective actions 4). Requirements and changes to requirements 18

19 11/29/2013 5). Minutes of meetings 6). Audit reports d. Miscellaneous quality records 1). Files on customers and suppliers 2). Records of resources and goods received 8. Data Assurance Level (DAL) 8-1 Data Assurance Level (DAL) Objectives 1. The DAL objectives shall define the manner in which processes, tools and procedures should be applied at each stage of the aeronautical data chain. The DAL is defined at three levels as follows: 1). DAL 1 for critical data items; 2). DAL 2 for essential data items; and 3). DAL 3 for routine data items. 2. The table below contains an extract of the data interchange section, listing the specific objectives for direct electronic connection. It describes how the objective is associated with each DAL (a dot means that the objective shall be satisfied; a blank means that satisfaction of the objective is at the discretion of CAD AIS). The level of independence required for each DAL is indicated by the black dot and a letter corresponding to the required separation between the primary activity and the validation activity (in this case a D for a person within a separate group or department and an P for a person within the same group or department). Extract of a data interchange section Objective DAL 1 DAL 2 DAL 3 Guide reference Whenever data is transmitted from one user to the next, processes shall be established to protect the data during the transfer. For data transmitted by electronic means, the integrity of the data shall be protected by applying a CRC to the data before transmitting it to the next intended user 19

20 11/29/2013 For data transmitted by paper means, the integrity of the data may be protected by including the associated CRCs. The applied CRCs shall be robust enough to protect the data from corruption over transfer from one user to the next. D P For data received by electronic means, the integrity of the data shall be confirmed by checking the CRC. On receipt of data, it shall be verified that the received data is from an authorized and approved source. The means for determining authorisation of data shall be appropriate to the method of data transfer. Documentation shall be maintained that identifies all the suppliers of data used by the organisation and the approval status of data. Data that cannot be authenticated shall not be used. After receiving data but before use data reasonableness checks shall be performed. P P For data received by means other than electronic and/or where manual entry of the data is required, the entered data shall be checked against the source data. D D If errors are discovered in the received data, the data supplier shall be informed immediately. 9. Distribution. This order is distributed to Aeronautical Information Service and the Aeronautical Flight Information Service. Patrick Rolle Director, Bahamas Civil Aviation Department 20

21 Appendix A Checklist for the Development of a QMS for CAD AIS 1. PROGRAMME INITIATION Item Senior management 1. Commitment by senior management 2. Briefing/seminar/workshop to familiarize senior management with QMS in general and related ISO regulations and guidelines 3. Development of the quality policy 4. Development of the quality objectives 5. Communicate the quality policy and quality objectives to all AIM staff 6. Define the initial roles and responsibilities of the quality manager 7. Appoint a quality manager 8. Arrange for ISO training of the quality manager 2. PLANNING PHASE 2.1 Project implementation team Item Quality manager 1. Define roles and responsibilities of the project implementation team members 2. Create the project implementation team 3. Brief the project implementation team on the goals and purpose of the QMS, the QMS implementation project and the role of ISO 4. Arrange for ISO training of all team members and staff 5. Assign tasks with specific outcomes and deadlines to the team members 2.2 Gap analysis Item 1. Quality manager (with the assistance of the project implementation team) List the functional groups of AIM and its organisational structure. Show how the organisational structure of each functional group relates to the others and how the AIM functional groups relate to functional groups outside AIM. (This may be represented best as a flow chart) 2. List the activities performed within each functional group. 3. List the processes involved in each of the activities listed, the inputs and outputs of each process and the sequences of the processes. Describe where inputs are derived from outputs of previous processes and where outputs are linked to succeeding processes. 21

22 4. List the customer requirements (including standards and regulations) and the requirements of other functional groups in AIM. Link the processes to these requirements. Note processes that serve neither customers nor other AIM functional groups. Note where processes are still needed to meet requirements. Note where processes need to be improved or changed in order to be effective List the procedures used in each of the processes. Note where procedures are undocumented or non-existent. List the roles and responsibilities of each person involved. Note the differences between actual responsibilities and those documented in the job descriptions, as well as the lack of documented responsibilities List the skills and competencies needed to perform the duties and responsibilities described above. Note where tasks are not carried out because of a lack of training. List existing documentation on all of the above. This documentation maybe in many forms, such as flow charts, procedures, checklists, forms, job descriptions, manuals or style guides. 2.3 Completion of planning items and project proposal Item Quality manager (with the assistance of the project implementation team) 1. Determine the deliverables for the QMS project. 2. Develop a schedule of target dates. 3. Draw up a list of resources required. Internal resources External resources Other costs 4. Complete the project proposal for senior management 2.3 Approval of the implementation project Item Senior management 1. Review project proposal with the quality manager. 2. Approve the implementation project as proposed or negotiate changes. 3. Commit the resources necessary to carry out the implementation project as approved. 3. DESIGN PHASE 3.1 Development of procedures and documentation Item 1. Quality manager (with the assistance of the project implementation team) Create document templates for procedures, instructions, forms, checklists, job descriptions and any other documentation to be developed for the QMS. 2. Develop and produce all necessary procedures and documentation. 22

23 Appendix B Template of a Quality Manual to be used by an AIS organisation The template for a project proposal in this appendix shall be used as the basis for a proposal to CAD senior management to secure approval of the QMS implementation project. It shall also be used as a framework for the development of the QMS in terms of defining scope, assessing the potential benefits, outlining the programme, determining the roles and responsibilities of those involved in the development and implementation of the QMS, and for specifying deliverables, target dates and the resources needed. 23

24 PROJECT PROPOSAL IMPLEMENTATION OF A QMS FOR AERONAUTICAL INFORMATION SERVICES (AIS) Commonwealth of the Bahamas 24

25 1. Introduction ICAO Annex 15 Aeronautical Information Services requires that States introduce a quality system to implement quality management at each function stage performed by the aeronautical information service. Furthermore, it is recommended in Annex 15 that the quality system be in conformity with the International Organisation for Standardization (ISO) 9000 series of quality assurance standards and that it be certified by an approved organisation. 2. Objective This proposal outlines the project to implement a QMS (QMS) within the AIM of (State). The objectives of the project are to comply with the ICAO provisions and add specific objectives. 3. Scope The programme described will implement a QMS for all activities (or specify) performed by all functional groups (or specify) at all locations (or specify) that contribute to AIM. 4. Benefits The implementation and operation of quality measures in the form of a QMS will bring improvements in quality, efficiency and reliability with subsequent enhancements to productivity, safety and service levels. 5. Programme Description The programme tasks can be broken down into following four principal phases: a. Planning of QMS requirements in the AIM functional groups; b. Design of the QMS; c. Deployment and testing of the QMS; and d. Final adjustment and audit for ISO certification. 6. Planning of the QMS The objective of this phase is to establish, in relation to each of the AIM products and services: a. The activities and the organisational relationships; b. The processes involved; c. The requirements; d. The necessary procedures to affect the processes identified and fulfill the requirements; e. The duties and responsibilities and the associated skills and competencies required; and f. The necessary documentation. 7. Design of the QMS In this phase it is necessary to: a. Create new procedures as required and to ensure consistency with existing ones; 25

26 b. Write all documentation; c. Develop training plans; and d. Plan for certification by audit. The key to this phase will be developing and producing the necessary documentation. 8. Deployment and testing of the QMS As the QMS develops, the procedures need to be issued/applied and the system must be implemented in such a manner that the processes can be tested and checked for correct functioning. Discrepancies will be dealt with by corrective action and follow-up action procedures. 9. Final adjustment and internal audit The final phase represents the on-going working QMS which will be operated for a period of time before the internal audit. This provides an opportunity for fine tuning of the QMS elements. The timescale for this adjustment phase may extend beyond the internal audit date in order to accommodate any corrective action issues that may arise from the internal audit. 10. Project Plan The following is a schedule of the programme, showing a proposed total implementation timescale of [number] work days. Document Type Information Planning Content Development Implementation Evaluation and review Revision Work days Target dates Quality manual Quality objectives Requirements Processes Procedures Quality records Instructions Document templates Checklists Forms Job descriptions Training plan Audit plan Total number of work days 26

27 11. Project Implementation Team The following staff members are proposed to form the project implementation team. An assessment of the effort required of each staff member is included. Name Project implementation team Role Quality manager/ Project implementation team leader Skills/department represented Estimated effort required Work days, fulltime/part time, etc. 12. Resources Internal The following is an estimate of the effort required for the specified tasks, the majority of which can be provided internally. Task Process Analysis Procedures Development Documentation Development Documentation Control and other Records QMS Training Internal Auditor Training Internal Effort Estimated Effort (work days) 27

28 External Some external support is recommended to assist with correct interpretation of QMS requirements and to ensure that the project implementation team is kept on track for compliance. External Effort Task Estimated Effort (work days) Cost Interpretation of QMS Requirements QMS Awareness Training Internal Auditor Training Pre-registration Audit Other Support Costs Other support costs Item Purpose Cost Software Document control, text processing, etc. Hardware Upgrading of database, networking, etc. 13. Deliverables The project objective is to establish a QMS that meets the requirements of the ISO 9001 standard. The following are considered to be essential elements of this process: a. Quality manual b. Documented procedures c. Quality records 14. References 1. Annex 4 Aeronautical Charts 2. Annex 11 Air Traffic Services 3. Annex 14 Aerodromes 4. Annex 15 Aeronautical Information Services 5. Doc 8400, PANS-ABC Procedures for Air Navigation Services ICAO Abbreviations and Codes 6. Doc 8126 Aeronautical Information Services Manual 28

29 7. Doc 8697 Aeronautical Chart Manual 8. Doc 9679 World Geodetic System 1984 (WGS-84)Manual 9. Doc xxxx Manual on the Quality Management System for Aeronautical Information Services 10.ISO 9001:2008 QMS Requirements [Include national laws and/or regulations if applicable.] 29

30 Appendix C Acronyms AIC ADP AIM AIP AIS ANSP ATM ATS ATSP CAA CRC DAL EUROCAE IAIP IAF ISO KPI NOF PDCA PIB QMS RNAV RNP SARPs SDP SLA SMS Aeronautical Information Circular AIS Data Process Aeronautical Information Management Aeronautical Information Publication Aeronautical Information Service(s) Air Navigation Service Provider Air Traffic Management Air Traffic Services Air Traffic Service Provider Civil Aviation Authority Cyclic Redundancy Check Data Assurance Level European Organisation for Civil Aviation Equipment Integrated Aeronautical Information Package International Accreditation Forum International Organisation for Standardization Key Performance Indicator International NOTAM office Plan-Do-Check-Act Pre-flight Information Bulletin Quality Management System Area Navigation Required Navigation Performance Standards and Recommended Practices Static Data Procedures Service Level Agreement Safety Management System. 30

31 Appendix D QMS Implementation Project 1. Introduction This appendix describes the four basic phases of the AIS QMS implementation project: planning, design, deployment and testing, and registration. It also explains the tasks to be undertaken to complete each phase. 2. Phase 1 Planning 1. Overview; The key task in the planning phase is to review the existing quality system and assess where there is a need to develop and extend existing features of the system. This "gap analysis" reveals where additional procedures and documentation will be needed. This information is then used to estimate the time and resources required for the QMS implementation project. The information on what needs to be developed, along with the estimates of how long it will take and the resources required, is used to develop a project proposal which is presented to senior management for approval. Depending on the size and complexity of the QMS implementation project, the quality manager may require the assistance of a project implementation team. 2. Project implementation team; The project implementation team may be drawn from existing AIS staff, seconded from other areas of the administration or, should financial resources be available, from outside the administration. The team may be composed of a few or many team members. The implementation project may be completed more expeditiously by dividing tasks among a large group of people. On the other hand, the project implementation team should not be so large as to create difficulties in communication and coordination. 3. It is the responsibility of the project manager to define the roles and responsibilities of the project implementation team members. It should be noted that the assignment of duties and responsibilities related to the work of the project implementation team need not imply that team members will continue to perform similar functions with similar responsibilities within the QMS once it has been implemented. 4. If team members are selected internally, they may be chosen from each of the major functional groups of AIS. Depending on the organisation of the AIS, these functional groups may be based on products and services (AIP, AIP Amendments, AIP Supplements, etc.), departments (NOF, pre-/post-flight briefing, etc.) or processes (data entry, verification, data processing, etc.). Gap Analysis 1. Before work can begin on designing the QMS for AIS, the project manager must assess whether, and, if so, where, gaps exist between the current system of procedures and documentation and an effective QMS. This assessment, called a gap analysis, begins with 31

32 evaluating what AIS does, how it is done and what are the supporting procedures and documentation, as follows: a. Organisational perspective; List the functional groups of AIS and its organisational structure. Show how the organisational structure of each functional group relates to the others and how the AIS functional groups relate to functional groups outside AIS (This may be represented best as a flow chart). b. Products and services, and customers; List the products and services provided by AIS. List the customers for the products and services provided. c. Activities; List the activities performed within each functional group and link them to the products and services provided. d. Processes; List the processes involved in each of the activities listed, the inputs and outputs of each process and the sequence of the processes. Describe where inputs are derived from outputs of previous processes and where outputs are linked to succeeding processes. e. Customer requirements; List the customer requirements (including standards and regulations) and the requirements of other functional groups in AIS. Link the processes to these requirements. Note processes that serve neither customers nor other AIS functional groups. Note where processes are still needed to meet requirements. Note where processes need to be improved or changed in order to be effective. f. Procedures; List the procedures used in each of the processes. Note where procedures required to ensure quality are undocumented or non-existent. g. Duties and responsibilities; List the duties and responsibilities of each person involved in processes. Link responsibilities to processes. Note the differences between actual responsibilities and those documented in the job descriptions, as well as the lack of documented responsibilities. h. Skills and competencies; List the skills and competencies needed to perform the duties and responsibilities described above. Note where tasks are not carried out because of a lack of training. i. Infrastructure; List the workspace, hardware, software and equipment required to effectively carry out activities. Note where a lack of infrastructure is adversely affecting activities. j. Documentation; List existing documentation on all of the above. This documentation may be in various formats, such as flow charts, procedures, checklists, records, forms, job descriptions, manuals or style guides. Note any missing documentation related to all of the above. 2. One way to approach the gap analysis task is to have every person in the functional group write down the following details or each of the activities they perform: a. How a job is initiated; b. How the work gets started; c. Who monitors the progress; 32