Oberoende granskning vad är det? Del-21G seminarium 2015 Jukka Salo Slou
Oberoende vad är det? Självständig, fri, obunden, oavhängig, neutral, suverän, autonom! 2
Circle of Life! CMM AM SM Oberoende granskning Xxx AB KUND Regeln Tillståndet Privilegiet NPH Produktion Produkten
Låt oss se på regelverket 21G 21.A.139 Quality System (b) The quality system shall contain: 2. An independent quality assurance function to monitor compliance with, and adequacy of, the documented procedures of the quality system. This monitoring shall include a feedback system to the person or group of persons referred to in point 21.A.145(c)(2) and ultimately to the manager referred to in point 21.A.145(c)(1) to ensure, as necessary, corrective action. 4
Låt oss se på regelverket 21G GM No. 1 to 21.A.139(b)(2) Quality System Independent quality assurance function The quality assurance function which is part of the organisation is required to be independent from the functions being monitored. This required independence relates to the lines of reporting, authority and access within the organisation and assumes an ability to work without technical reliance on the monitored functions. 5
Låt oss se på regelverket 21G GM No. 2 to 21.A.139(b)(2) Quality System Adequacy of procedures and monitoring function Adequacy of procedures means that the quality system, through the use of the procedures as set forth, is capable of meeting the conformity objectives identified in 21.A.139(a). The quality assurance function to ensure the above should perform planned continuing and systematic evaluations or audits of factors that affect the conformity (and, where required, safe operation) of the products, parts or appliances to the applicable design. This evaluation should include all elements of the quality system in order to demonstrate compliance with Part 21 Subpart G. 6
Låt oss se på regelverket 21G 21.A.139 Quality System (b) The quality system shall contain: 1. as applicable within the scope of approval, control procedures for:.. (xiv) internal quality audits and resulting corrective actions; 7
Låt oss se på regelverket 147 147.A.130(b) The organisation shall establish a quality system including: 1. an independent audit function to monitor training standards, the integrity of knowledge examinations and practical assessments, compliance with and adequacy of the procedures, and 2. a feedback system of audit findings to the person(s) and ultimately to the accountable manager referred to in point 147.A.105(a) to ensure, as necessary, corrective action. 8
Låt oss se på regelverket 147 AMC 147.A.130(b) The independent audit procedure should ensure that all aspects of Part-147 compliance should be checked at least once in every 12 months and may be carried out as one complete single exercise or subdivided over a 12- month period in accordance with a scheduled plan. 5. The independence of the audit system should be established by always ensuring that audits are carried out by personnel not responsible for the function or procedure being checked. 9
Låt oss se på regelverket 147 AMC 147.A.130(b) The independent audit is a process of routine sample checks of all aspect of the training organisation s ability to carry out all training and examinations to the required standards. The management control and follow-up system should not be contracted to outside persons. The principal function is to ensure that all findings resulting from the independent audit are corrected in a timely manner and to enable the accountable manager to remain properly informed of the state of compliance. Apart from rectification of findings, 10
Låt oss se på regelverket 147 AMC 147.A.130(b) the accountable manager should hold routine meetings to check progress on rectification except that in the large training organisation such meetings may be delegated on a day-to-day basis to the quality manager as long as the accountable manager meets at least once per year with the senior staff involved to review the overall performance. 11
Låt oss se på regelverket 147 PART 3 TRAINING SYSTEM QUALITY PROCEDURES 3.1. Audit of training 3.2. Audit of examinations 3.3. Analysis of examination results 3.4. Audit and analysis remedial action 3.5. Accountable manager annual review 3.6. Qualifying the instructors 3.7. Qualifying the examiners and the assessors 3.8. Records of qualified instructors & examiners 12
Låt oss se på regelverket 145 AMC 145.A.65(c)1 The primary objectives of the quality system are to enable the organisation to ensure that it can deliver a safe product and that organisation remains in compliance with the requirements. 2. An essential element of the quality system is the independent audit. 3. The independent audit is an objective process of routine sample checks of all aspects of the organisation s ability to carry out all maintenance to the required standards and includes some product sampling as this is the end result of the maintenance process. It represents an objective overview of the complete maintenance related activities 13
Låt oss se på regelverket 145 AMC 145.A.65(c)2 The accountable manager should hold regular meetings with staff to check progress on rectification except that in the large organisations such meetings may be delegated on a day to day basis to the quality manager subject to the accountable manager meeting at least twice per year with the senior staff involved to review the overall performance and receiving at least a half yearly summary report on findings of non-compliance. 14
Summasumarum Del-21G; Quality system inkluderar procedurer för oberoende granskning (internaudit) Quality system skall auditeras (som en ingående procedur i 21.A.139. Del-147; Quality system inkluderar procedur för oberoende granskning Quality system skall auditera Verksamheten AM skall auditera Quality system Del-145; Quality system inkluderar procedur för oberoende granskning Quality system skall auditera Verksamheten AM skall auditera Quality system 15
Summasumarum 21G Quality system skall auditeras systematiskt och planerat av en oberoende funktion; Extern auditör Oberoende intern auditör Eller AM (förutsätter skrivna procedurer för tillvägagångssätt och dokumentation i POE) 16
AM 21.A.145 Approval requirements (c) with regard to management and staff: 1. a manager has been nominated by the production organisation, and is accountable to the competent authority. His or her responsibility within the organisation shall consist of ensuring that all production is performed to the required standards and that the production organisation is continuously in compliance with the data and procedures identified in the exposition referred to in point 21.A.143; Närvaro Kunskap om produkten Kunskap om regelverket 17
GM 21.A.145(c)(1) Approval Requirements Accountable manager Accountable manager means the manager who is responsible, and has corporate authority for ensuring that all production work is carried out to the required standard. The manager is responsible for ensuring that all necessary resources are available and properly used in order to produce under the production approval in accordance with Part 21 Section A Subpart G. The manager needs to have sufficient knowledge and authority to enable him or her to respond to the competent authority regarding major issues of the production approval and implement necessary improvements. The manager needs to be able to demonstrate that he or she is fully aware of and supports the quality policy and maintains adequate links with the quality manager. 18
AM - SM - Safety Manager/CCM Compliance Monitoring Manager Focus on; Management system including; Monitoring of Compliance, independent auditing Reporting to management Effective corrective actions Follow up CMM (QM) AM Hazard identification Risk assessment Mitigation Effective actions Safety reporting scheme SM FOKUS! 19
AM Närvaro Kunskap om produkten Kunskap om regelverket 20
Tack för er uppmärksamhet! 21