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Development of a Premarket Approval in China - Coursework Example

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The paper "Development of a Premarket Approval in China" is an engrossing example of coursework on finance and accounting. China Airlines (CAL) whose company slogan is Journey with a caring smile is the flag carrier of the Republic of China, on the other hand, Air China is the national airline of the People's Republic of China…
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Table of Contents. Chapter 1 Internship Company Introduction. 1.1 China Airline Introduction. 1.2 China Airline Techniques Introduction. Chapter 2 Reason and Impetus of PMA Parts Utilization in China Airline 2.1 Price and supply advantage  2.2 Adding bargaining weapon in business affairs  2.3 Impulse force for OEM After-Sales Service Improvement  Chapter 3 PMA Part Introduction  3.1 The Define of PMA Parts  3.2 PMA Parts Origination  3.3 PMA Parts Authority Administration  3.4 PMA Part Is Not a “Bogus” Part  3.5 What Parts are Excluding In PMA Parts?  3.6 The Growth of PMA Parts 3.6.1 FAA-PMA Parts Growth  3.6.2 CAAC-PMA growth Chapter 4 Airworthiness Regulation of PMA Parts 4.1 FAA PMA Regulations  4.2 CAAC -PMA regulation  4.2.1 CCAR part 21  4.2.2 AC-20-01 4.2.3 AC-121-55R1  4.3 EASA Policy ... Chapter 5 PMA parts management in china airline. 5.1 The Evolution of PMA Parts Utilization in Air China(for example) 5.1.1 Preliminary Stage  5.1.2 The Second Stage 5.1.3The newest Stage 5.2 The PMA Parts Evaluation and Management in Air China  5.2.1 Authoritative Responsibility Department for PMA Management 5.2.2 The PMA Parts Categories in Air China  5.2.3 Air China policy for FAA-PMA 5.2.4 Requirement of Accepting a PMA parts 5.2.5 The evaluation items . 5.2.6 Evaluating person qualification 5.2.7 The evaluation process 5.2.8 The related records The PMA parts management in Air China 5.2.9 Storage requirement. 5.3 Example of Evaluation Process of a Major Engine PMA parts Chapter 6 Conclusions and Suggestions 6.1 Conclusion  6.2 improvement and suggestion Introduction The research is focussed on the utilization of PMA by china airlines. China Airline Introduction China Airlines (CAL) whose company slogan is Journey with a caring smile is the flag carrier of the Republic of China, on the other hand, Air China, is the national airline of People's Republic of China. The Airline which was founded in December 16, 1959,  has its headquarters in Taiwan Taoyuan International Airport in Dayuan Township is partially owned by the Republic of China through the China Aviation Development Foundation. The airline flies to ninety eight destinations in twenty nine in Europe, Asia, Oceania and North America. The Hong Kong route generates the highest profit for the airline, whose Registered Capital is NT$ 46,316,223,510, furthermore the company has several other subsidiaries such as CAL-Dynasty International, Inc, Hwa Hsia Company Ltd, Abacus Distribution Systems Taiwan Ltd and Taiwan Airport Services (Samoa) Co. Ltd among others. The company was listed on the Taiwan Stock Exchange in the year 1993. The long term objective of the airline is to be a full member of SkyTeam alliance, however the airline has been facing stiff competition from EVA Air. China Airlines has a total of sixty seven aircraft, including forty eight Passenger Jets and nineteen freighters, with the average age of the aircraft being 8.2 years as of March, 2011. The distribution of the aircraft, classified as per aircraft type, owned by the airline are thirteen Boeing 747-400, six Airbus 340-300, nineteen Airbus 330-300, ten Boeing 737-800 and nineteen 747-400F. The company has bagged a number of Awards such as being awarded “CG6005 Corporate Governance System Evaluation Certification” on June 29, 2010, becoming the first airline in Taiwan to be awarded by the Taiwan Corporate Governance Association. In the year 2006-2010, the airline has been rated A, by the Securities and Futures Institute in terms of Information Disclosure Evaluation System. The airline has had a number of challenges in terms of accidents and incidents. All the 19 crew members and 206 passengers died on 25 May 2002, when a Boeing 747-200B belonging to the airline , broke up in mid-air while travelling from Chiang Kai-shek International Airport in Taiwan to Hong Kong International Airport in Hong Kong. Moreover, the airline has in the past faced challenges politically instigated, due to the difference between People's Republic of China and the Republic of China commonly referred to as Taiwan. China Airline Techniques Introduction. Chapter Two Reason and Impetus of PMA Parts Utilization in China Airline There are several reasons which have made PMA to be the most suitable alternatives, implemented and utilised by Airlines globally. Several researches have argued on the reason and the impetus of PMA parts utilization in airlines. Some of the reasons include the price and supply advantage , the Impulse force for OEM After-Sales Service Improvement , bargaining power , often feature improved availability and lead-times, PMA parts engineering is FAA-approved to assure airworthiness, Parts Manufacturer Approval manufacturers have the independent prospects to correct and improve flaws, substantially reduced costs and FAA approval ensure conformity to approved design and quality in production systems. Arguably PMA parts have the potential of performing better than OEM parts due to useful modifications made and improvements with the price being lower. These factors influence China Airlines. 2.1 Price and supply advantage  The price of PMA parts has been argued to provide cost advantage of between 30 percent and 50 percent to Airlines. Globally, on average maintenance represent 10 percent of the airlines' expenditures annually, of which 35 to 40 percent of the maintenance expenditure was for parts. The highest expenditures are Engines and components which account for more than seventy five percent of the total parts expenditure. The prices of parts supplied to China Airlines by Original manufacturer (OEM) of the equipment, are significantly higher in comparison to PMA due to several reasons. Parts costs substantially impact on China Airlines financial performance, this costs have been increasing over time globally, as captured by the ATA. Whereas OEM spend a lot of money in Research and Development, however PMA manufacturers utilize Reverse Engineering. Considering that the PMA manufacturers utilise reverse engineering process to derive a proposed replacement to original parts, without solely relying on dimensional comparison, results to parts with the same attributes to the original part, without compromising on quality, but at a cheaper cost. Instead of spending handsomely in research and development, PMA manufacturers utilize a host of reverse engineering techniques such as sample size, dimensional tolerances, materials and weight and mass properties. Concerning sample sizing, PMA manufacturers take several samples of new, unused parts from approved and traceable sources, and utilising several samples, the PMA manufacturers are able to accurately characterize the essential features of a design. These include importance features such as fabrication processes, material properties, tolerances and nominal dimensions. Potential sources of variability is captured by using parts from different sources at different times. The testing is also less costly since it involves highlighting equivalency between a new original and the derived PMA part. The utilization of PMA parts as a result of affordability in pricing by China Airlines is supported by varied reasons. China Airlines is able to source for PMA parts cheaply since in some instances, the PMA holder is also the actual supplier to the Original Equipment Manufacturer. There are instances where the OEM do not produce parts by contract certified manufacturers to produce the parts on their behalf, the parts are then sold to the airlines. Since the OEM has to make profit, there is a difference between the price offered by the manufacturer and the OEM price, China airlines therefore benefits by purchasing directly from the manufacturer at a reduced costs, than buying from the OEM, which in this case plays a facilitative role not the production. Another price advantage fostering the utilization of PMA by China Airlines is the fact that PMA parts are designed, tested and approved some time after the OEM parts have been manufactured. This enables the PMA manufacturers to utilize new manufacturing methodologies and best practice manufacturing techniques such as 6-sigma process improvements, Cellular manufacturing, computerized SPC (statistical process control), CNC computerized milling and turning equipment., state of the art compressor blade cell, CBN 5-axis grinding and 5S's housekeeping practices. Cumulatively, these practices and technologies enhance production while reducing production expenses. Since the technologies were initially not available to OEM’s , PMA parts with the same quality as OEM’s tend to be cheaper. In addition, the business model utilized by several OEM manufacturers contributes to the differences in pricing between the OEM and the PMA. Some manufacturers adopt a model of selling the engines to airlines and prices less than the market value expected to achieve profits from the aftermarket parts. Therefore, the parts are sold by the OEM at prices higher than their actual market value, on the other hand PMA parts are sold commercially reasonable price, hence being a suitable alternative for the China Airlines. Moreover, without investing in establishing the tolerances, PMA manufacturers utilize Dimensional Tolerances. In this case, the PMA part conforms to the minimum and maximum dimensions derived from the sampled approved parts as well as deriving the variations from accepted engineering practices. From the materials perspective, several documentations and tests from the supplier or PAH define the material composition of a part, in most cases, PMA part materials are comparable to the materials for the original part. However, PMA manufacturers may opt for alternative alternate materials and processes, of course with approval and destructive testing of the material properties, composition of each material in the part, special testing on processes, the form of material, as well as material properties. The cumulative cost benefits arising from the cheaper production of the part due to reverse engineering, is then transferred to airlines such as China Airline. The supply advantage of PMA results from the PMA manufacturers supplying several components to several airlines globally. In Europe and Asia, The use of PMA parts is progressively advancing with organized structure with main third-party MRO providers giving confidence airlines to switch to PMA parts. PMA parts are supplied by several manufacturers, with more than 2000 registered PMA manufacturers in the United States. China Airline, is therefore not limited to procuring any part from a specific supplier, but can purchase from different supplies, unlike OEM parts where it has to purchase from the Original manufacturers alone. Moreover, China Airline, are assured of availability, since most PMA manufacturers have several FAA PMA approvals, therefore ensuring the availability of the desired part. In addition, OEM suppliers have several demands to meet,, yet in most cases, it is one company supplying a specific part to several airlines in the world worl. On the other hand, PMA suppliers are several and are not limited to manufacturing only a specific part. China airlines operates aircraft from different suppliers, notably Boeing and Airbus. The Airline can purchase parts from the PMA manufacturer, regardless of whether the parts are for Airbus or Boeing. This contrasts with OEM parts where China Airlines has to order specifically parts for the Boeing Aircraft from Boeing and parts for the Airbus aircraft from Airbus. The benefit of supply is also highlighted by the specialization of PMA manufacturers on the parts they have been licensed to deal with hence ensuring continuity and availability. Moreover, when the aircraft manufacturers discontinue the production of a specific aircraft, the PMA ensures that China Airlines still do have the parts of those aircraft, when there is need to replace. This ensures that the airline is assured of continued working of the aircraft even if the production of the specified series is discontinued. Considering that as new models evolve the Original Equipment Manufacturers may become less interested in supporting old models which makes the availability of spares and parts of such models to be scarce. PMA therefore serves to bridge the gap, created by the scarcity. 2.2 Adding bargaining weapon in business affairs  China Airline operates in a dynamic field, with several factors which impact on the performance and profitability of the company can be affected by several factors. China airline is the national carrier of the Republic of China, therefore factors which are internal and external to the airline such as political situation, weather changes and inter country relationship impact immensely on the airline. Moreover, the aircraft are expensive with human life always at stake; therefore a slight mistake is usually costly with diverse repercussions. Profitability and performance can hardly be accurately predicted, therefore any weapon that can be used to enhance the business performance of China Airlines, plays an important role. PMA has been such a weapon. The utilization of PMA parts by China Airlines serves as a bargaining weapon when it comes to reducing operating challenges and expenses. When the OEM manufacturers are the sole providers of the parts, they can dictate all the factors such as price, quality and supply duration according to their wish. However, the presence of a PMA alternative for the airlines, enables China Airlines to have a bargaining power, since they can shift between the OEM and PMA manufacturers, depending on the favourable terms such as after sales service. Whereas for several years, OEM’s have opposed PMA, market forces and dynamics have dictated otherwise. OEM manufacturers such as GE have shifted the tide, after purchasing a new subsidiary that holds PMAs and Pratt & Whitney applying for PMAs on parts for CFM-56 engines. Chapter 3 PMA Part Introduction  The dynamisms of technology and pricing in the Air transport industry has resulted to the development of Parts Manufacturer Approval (PMA) , which is an  is an authorization to manufacturers of aircraft parts granted by the United States Federal Aviation Administration (FAA) . Due to economic reasons, several airline operators aspire to source aircraft parts from approved sources, apart from the OEM without compromising quality of the parts and safety of operation. The FAA system of granting approval allows the holder of PMA to manufacture and supply aircraft parts to Original Equipment Manufacturers, Aircraft operators and repair agencies as an alternative of OEM manufactured parts. The use of PMA parts does not impinge on the airworthiness of the aircraft since PMA parts are indistinguishable in design specifications, quality and in some cases in part number to that of original manufacturer. PMA parts are identified OEM’s part number with additional digits which are either prefix or suffix to distinguish it from OEM part number have traceability. The PMA parts are only manufactured under approval and they meet the drawing and material specifications. The PMA components range from simple nuts rivets and bolts to fuel pump gears, feather seals, air foils and shims as well as more complex parts like landing gear, actuating arms, Engine Components, Accessory , Propeller Parts, Gearbox Bearings and Gears, engine parts like compressor blades, hydraulic, turbine veins, pneumatic, and electromechanical, avionics, interior parts. Since the PMA manufacturers do not spend on research and development, PMA parts are relatively less expensive compared with OEM parts. PMA approvals are issued subject to several conditions. FAA has to review and evaluate the production quality system to ascertain that exists a system to guarantee that each part that is produced meets the FAA-approved design. Furthermore, FAA has to review the design of the part to guarantee that the part is safe and meets the requirements of the FAA regulations. PMA Parts Origination  PMA parts originate from approved PMA holders. China Airlines sources the parts from the PMA manufacturers in the United States. The PMA parts origination depends on the aircraft owned by an Airline. There are several approved PMA holders who act as the origins of PMA parts including Zevco Inc 22982 Alcalde Dr Ste 101 Laguna Hills CA 92653 United States, Zantop International Airlines Inc, 4/Flight Industries Inc, AAR Aircraft Services, Yokohama Aerospace America Inc, Yesteryear Aviation Inc, Aaxico Technical Services, Able Engineering & Component Services, WE Aerotech Services Inc, Weatherly Aviation Company Inc, Valcor Engineering Corp, Valtec Aircraft Supply One, Ventura Aerospace Inc, Vibration Isolation Products, Vision Air Services, LLC, Ultra Electronics Flightline Systems, ABS Partnership, Universal Avionics Systems Corporation, Tanis Aircraft Services, Thales Communications Inc,  TIA Division of the Richards Corporation, Saf-Air Products, Schatz Bearing Corporation, Seaman Products of California, Simmonds Precision, BF Goodrich Motion Control Div, Rainbow International, Raytheon Systems Company, Sargent Aerospace, Quality Aircraft Acrylics , Pacific Aircraft Modification Inc, Parker Hannifin Corp, Pemco World Air Services, Oregon Aircraft Design and Offshore Helicopter Support Services Inc There are several other approved PMA manufactures such as NAASCO Northeast Corp Brookhaven Airport, BAE Systems, Nordam Group Inc, Ballistic Recovery Systems Inc, Northrop Grumman Systems Corporation, Calcor Space Facility Inc, Carlisle interconnect Technologies, Machining Programming Manufacturing Inc , McClain International Inc, Meggitt Aircraft Braking Systems Corporation, D & A Manufacturing Inc, L-3 Communications Avionics Systems, Linear Mold and Engineering, Davis Aircraft Products Co Inc, Foster Airdata Systems Inc , Dynatech Aerospace Inc, Delta Engineering Corp, Ejay Filtration Inc, Flightways Manufacturing Inc,  Electro-Mech Components Inc, Acme Aerospace Inc, F Atlee Dodge Aircraft Services, Filtrona Extrusion Inc, G & D Aero Products Inc, Gator Aerial Enterprises, K-Jack Aero Industries LLC, Kelly Aerospace Energy Systems LLC, Keystone Helicopter Corporation, General Machine - Diecron Inc, Hamilton Aviation Inc, Hamilton Standard Commercial, Jay-Dee Aircraft Supply Co Inc, Jormac Aerospace Inc, Hartzell Engine Technologies LLC a division of Tailwind Technologies Inc, Heli-Support Inc, Honeywell International, Elmwood Sensors Inc, IMO Industries Inc, Advanced Engineered Prod Inc, Infinity Aerospace Manufacturing, Aerospace Component Manufacturing & Engineering and Advanced Metal Components Inc However considering the Aircraft owned by China Airlines Boeing 747-400, Airbus 340-300, Airbus 330-300, Boeing 737-800 and 19 Boeing 747-400F, the PMA originators vary. The Airline can source the parts Boeing 747-400 Series from different suppliers, such as the Ring and mating from Aviation Component Solutions, AerFilm LHR from Schneller LLC, reading light and exit light from Honeywell International Inc Honeywell Aerospace, PIN and ROD from Spirit Aero Systems Inc, Fuse Pin, ame Plate - Shock Strut, Body, Nose and Wing Gear, washers, nuts, sleeves and Door Assy from Aerotech Engineering Inc,. The origin of Link, Connecting is Turbine Kinetics Inc, Subsidiary of HEICO Corp, Bearings from RBC Aircraft Products Inc, and Cylinders from Amsafe Aviation. Moreover, the airline can source for Boeing 747-400 from other PMA holders such as balls from Skytronics Inc, Lavatory Module and wing panel from Jamco America Inc. The PMA parts for the Airbus 340-300 originate from various suppliers such as PTI Technologies Inc supplying Filter Element, Retainer Guide from Jet Parts Engineering Inc,. PMA parts for Airbus 330-300 is sourced from different sources. The Vane-Pump originates from Jet Parts Engineering Inc, Installation Kit Assembly from Am-Safe Inc, cushions from Franklin Products Inc and cylinder from Amsafe Aviation. The origin of PMA parts for the Boeing 737-800 varies, such as reading light , light assy and bezel Assy sourced from Honeywell International Inc Honeywell Aerospace, Gasket originates from Aerotech Engineering Inc, Seal, tube assy, erosion shield, support assy, plunger – proximity sensor and frame assy from Spirit AeroSystems Inc. Actuators are sourced from ITT Enidine Inc, Filter Element from PTI Technologies Inc, Tube, Swaged, Cap-Toggle Switch, Washer - Seal, Spring-Pin Retainer, Cap-Toggle Switch, Fuse Pin, Bushing- Pivot bolt, Fuse Pin, Windshield, scuff plate assy , spring, link fitting, hinge-idler and shim from Aerotech Engineering Inc . Other parts such as Aft Inboard Track Assembly originate from Able Aerospace, emergency light assy , lens assy from Honeywell International Inc Honeywell Aerospace. Seal, Slide Valve originates from Aviation Component Solutions, base assembly, Indicator Light Assembly and Knob from Korry Electronics Co. The cylinders for the Boeing 737-800 originates from Amsafe Aviation, the Point Level (Waste) Sensor from AMETEK Aerospace, Transducer, Pressure Oxygen and Assembly, Regulator Transducer & Coupling Crew Oxygen System from AVOX Systems Inc (formerly Scott Aviation). BAE Systems Controls Inc supply attendant control panel while Hot Short Protector is supplied by Simmonds Precision Products Inc, d/b/a Fuel and Utility Systems. Cable Assembly, Cabin Interconnect, Circular, Plus System is offered by Astronics, Advanced Electronic Systems, Carbon Filament Reinforced Aluminum Pressure Vessel 300 cu. in. Volume Model T37A is offered by Aethra Aviation Technologies, the Race Assy-Outer FWD, Trunnion Bearing, M.L.G is sourced from Alliance Aerospace Engineering LLC while the lens originate from Bruce Aerospace Incorporated. The origin for PMA pars for the Boeing 747-400F tends to be similar to the origin for parts for the Boeing 747-400. Bolts, Insert Assy, cylinders, beams and angle are sourced from Aerotech Engineering Inc,. Spirit AeroSystems Inc supply hinge fitting, eyebolt, rub strip, wear plate and panel assy upper. The link, connecting by Turbine Kinetics Inc, Subsidiary of HEICO Corp,. Bearing from Amsafe Aviation, and fittings from AmSafe Bridport. The origin for the PMA parts utilised by the Airline therefore varies depending on the specific part and the aircraft. 3.3 PMA Parts Authority Administration  The administration of the PMA parts is carried on by the FAA through Aircraft Certification Office (ACO) and manufacturing inspection district office (MIDO) , and the PMA manufacturer, . Whereas there are a number of exceptions, It is generally prohibited to modify or manufacture aircraft parts without a PMA license. However parts manufactured under technical standard order authorization and those manufactured to government or industry standards are accepted from the requirement. FAA ensures that manufacturers producing replacement or modification parts for sale, to be installed on a type-certificated product to get a PMA. The administration of PMA is done through application which is usually a two step process. The applicant has a role to play, where the foremost requirement is the manufacturer-applicant to exhibit and assure FAA that it has a design of a part which meets meet the requirements of the FAA's safety regulations and standards and must be safe. The demonstration is done through utilizing a licensing agreement with another approved manufacturer who has already obtained approval of the design in question. To show that the parts the applicant is making are similar in terms of airworthiness characteristics, the applicant may use comparative analysis to compare the part made with already approved parts. Moreover, the applicant may use qualitative analysis to prove that part directly meets the FAA's safety standards through test and computation. The applicants can also utilize various modern techniques. The second phase involves the applicants seeking FAA production approval which is concerned with the manufacturing quality assurance system. This is only issued, subject to FAA being satisfied that the manufacturing quality assurance system used by the applicant does not allow parts to leave the system until the manufactured parts have been ascertained to to meet the requirements of the approved design. The applicants have other roles in the PMA administration such as setting installation eligibility, offering the Instructions for Continued Airworthiness (ICA) for the PMA part or product as and when needed, setting and maintain a FIS to subscribe to the requirements of 14 CFR, offer and draft a PSCP if required, report service difficulties, ascertain and make sure that the manufactured part performs its intended function. In addition, the applicant is required to provide a plan for Continued Operational Safety (COS) and as well determine part criticality through evaluating the impacts of PMA part failure on the subsequent higher assembly and associated product. Administration of PMA is also done by the Aircraft Certification Office (ACO). The role of ACO in the administration of PMA includes coordinating and participating in developing a PSCP as required, investigating service challenges, witnessing or delegate various functions, reviewing of Continued Operational Safety plans, Coordinating with aircraft evaluation group (AEG) for ICA review as required, ensuring compliance with agency procedures, programs, regulations and standards on issuing design approval for alternate and modification parts. The ACO also informs the applicant of design approval and forwards the application documentations and evidences to the MIDO after design approval. In the PMA management, the MIDO office plays an important role of processing PMA applications based on license agreements and STCs, accepting Fabrication Inspection Systems, issuing of PMA supplements after design approval and Fabrication Inspection System validation, ensure conformity to the approved design, investigating service difficulties, issuing the FAA-PMA production approval letter. The MIDO also investigates and submits enforcement reports when non-PMA holders and PMA holders fail to comply with 14 CFR, and conducts surveillance at the PMA holder’s and supplier’s premises. PMA Part Is Not a “Bogus” Part  There is perception among some airlines that PMA Part Is Not a “Bogus” Part. However, it is imperative to realize that the production of PMA parts is approved by the FAA after a rigorous process on ensuring that the final product conforms to quality and safety requirements. The engineering of PMA parts is therefore FAA-approved to assure airworthiness. In addition, PMA production quality system must be FAA-approved; this ensures conformity to approved design. Moreover, the quality of PMA is fostered by the fact that PMA manufacturers have self-sufficient opportunities to correct and progress from flaws 3.5 Parts excluded In PMA Parts The excluded parts are those parts which are not regulated since they do fail to within the scope of the regulation. Federal Aviation Administration, which is an operating mode of the United States Department of Transportation have defined parts production regulations which distinctively apply only to parts manufactured for type-certificated products. The PMA requirement therefore excludes parts made for non-aviation utilization, in addition this therefore excludes parts made specifically for utilization on non-type-certificated experimental aircraft. Furthermore, Part 21 of the manufacturing rules of the Federal Aviation Administration’s regulations allows acceptance of foreign produced parts in agreement with the conditions of a mutual agreement between the country of export and the United States. Aircraft parts produced in a different country, other than the United States under a foreign authority may be deemed acceptable for use in the United States even though the parts may not have been produced in accordance with the terms of the PMA rule based on other rules under Part 21. The main requirement in this case is the part to meet the requirements of the bilateral airworthiness safety agreement (BASA). Parts manufactured with foreign production approval with agreement with the U.S meeting the BASA are therefore acceptable in the U.S, but are excluded from the PMA. The Growth of PMA Parts PMA parts have experienced substantial growth in the recent past, having initially received low acceptance among the airlines, and opposition by the OEM. In the last first years, a paradigm shift has transpired where a significant increase in interest in PMA Parts are witnessed globally. At present, PMA parts are produced for a great percentage of ATA chapter on the aircraft. In the year 2007, the previously PMA shy airlines embraced PMA with Aftermarket parts manufacturer Heico with its subsidiary Seal Dynamics clinching a deal to sale FAA-approved PMA replacement parts to British Airways. This gave the PMA’s the impetuous to move ahead in gaining acceptance. 3.6.1 FAA-PMA Parts Growth  PMA regulations were created in 1955 to offer a means of approval for airworthy modification & replacement, initially as a response for replacement parts for no longer manufactured Military Surplus Aircraft that were being operated as Civil Aircraft. The Federal Aviation Administration (FAA) started granting Parts Manufacturer Approval (PMA) for third-party manufacturers in the 1950’s, this approval allowed the PMA manufacturers to produce replacement parts for aircraft. In the 1990’s, the though economic times made airlines to keenly look for any cost saving measurers. PMA parts proved to be such measure, coupled with the increasing prices of OEM’s hence the increase in interest in PMA’s. FAA then engaged in an "Enhanced Enforcement" program that was aimed at enlightening the Air Transport industry concerning the need for approval, consequently several aircraft parts were permitted through formal FAA approval mechanisms. The previously Non PMA licensed manufacturers were given a leeway to apply for PMA certification, hence bringing their operations to full compliance with the regulations. This fostered the growth of PMA’s. OEM’s responded by putting information in the their maintenance manuals and directives for uninterrupted airworthiness that was considered to be against PMA. FAA ensured stringent approval procedures and ascertained that PMAs manufacturers were approved. In the year 2008, FAA issued Special Airworthiness Information Bulletin (SAIB) cautioning OEM’s that it is the responsibility of FAA to ascertain if the installation of a PMA part is invalid or wrong, but not for the engine manufacturers. Repair, Alteration and Fabrication Team (RAFT) study was commissioned by the FAA, which concluded that safety concerns between OEM’s and PMA’s was a non issue. In the year 2009, there was significant revision to the U.S. manufacturing regulations published by the FAA. The published rules removed a number of legal distinctions between forms of production approval issued by the FAA. The rules included a cross reference to the 14 C.F.R. § 21.137, which is concerned with defining the components of a quality system for all production approval holders, therefore instead of different body regulating PMA Fabrication Inspection System (FIS), all production approval holders are exposed to the same production quality standards. This harmonization of standards was a plus to the growth of PMA parts as championed by the Modification and Replacement Parts Association (MARPA). 3.6.2 CAAC-PMA growth There exists FAA and CAAC bilateral agreement concerning PMA. The Civil Aviation Administration of China (CAAC) started issuing PMA approvals to Chinese manufacturers from the year 1998. With more than 60 CAAC-PMA holders in China, Civil Aviation Administration of China has approved more than 400 articles. Whereas the uptake of CAAC-PMA was initially slow, CAAC has played a role in enhancing the growth through encouraging the operators and Chinese carriers to utilize PMA and DER repairs. There is alos interest and substantial government support for PMA parts in China. The parts produced by CAAC-PMA are currently the simpler parts of the aircraft since most the 60 CAAC-PMA holders in China have not specialized in manufacturing class II complex parts, most of the CAAC-PMA manufacturers produce class III parts including nuts,bolts and washers which are in most cases sub-components to class II products. Chapter 4 Airworthiness Regulation of PMA Parts 4.1 FAA PMA Regulations  FAA PMA Regulations is more of a process than an occurrence. Federal Aviation Regulations (FAR) requires approval for the replacement and modification parts for putting in a type certificated product. This is defined by the FAA Advisory Circular (AC) No: 20-62D which states that the for PMA parts the FAA-PMA symbol is required. Section 21.303 is concerned with the issuance of FAA-PMA and every PMA part has to be marked with the letters, "FAA-PMA," in conformity with 14 CFR Part 45, section 45.15: FAA Order 8110-42A further addresses part marking stating that it is mandatory for PMA produced parts to be legibly and permanently marked in a way that enables the users to identify that the part is a PMA part, the part number, the manufacturer and the type certificated product(s) on which the PMA may be installed. Critical components must have a serial number or equivalent and a part number or equivalent. In parts based on supplemental type certification (STC), FAA requires that the reference to the STC on the shipping document must be included, just as the installation-eligible type certificated products. Reviewing the FAA engineering approval includes the review of the identifying marks, which form part of the design data, this is imperative to ensure that the location and process of identification does not mortify airworthiness compliance. The numbering of the PMA part should distinguish the part from the specific Type Certificate holder's part number; this is done through TC holder's part number with a suffix or prefix. The FAA-PMA letter highlights the type-approved part number which can be interchanged with the applicant's part. The PMA letter requires and authorizes the PMA holder to mark the parts in conformity with the approved design. Every part is also required to be marked with "FAA-PMA" near the part number to guarantee that compliance will not interfere with airworthiness considerations. The regulations also have it that the holder of TSOA (Technical Standard Order Authorization), Approved Production Inspection System (APIS) or PMA controls the quality and design of a product or part. The Production Certificate (PC) is held by the Production Approval Holder (PAH). In practically impossible parts to mark, FAA requires that a tag that is attached to the part to carry information not marked on the part or the information to be marked on the container for the part. In cases where the PMA is issued through evidence of a licensing agreement, the letters FAA-PMA and the PMA part number may be indistinguishable to that on the type certificated part. Using the TC holder's design, by the applicant under a licensing agreement the part number may be similar to that of the TC holder, with the PMA holder's identification symbol and the letters "FAA-PMA," on the part. Parts replacement and modification  Procedures for the evaluation and approval of Parts Manufacturer Approval (PMA) for replacement and modification parts are stated by the FAA Order 8110-42A. These regulations apply to all manufacturing and engineering personnel. STC procedures are used where the PMA application constitutes a major change. Any party manufacturing replacement or modification parts for sale for installation on a type certificated product have to obtain a PMA as stated by 14 CFR Part 21 § 21.303. Part 21 § 21.303(b) states the exceptions. Replacement parts for TSOA articles may also be made through PMA with the condition that the installation eligibility of that product can be shown. The design must however meet the applicable airworthiness standards. The applicant can show compliance through tests and computations or through a type certificate, the part must perform its function without interference to adjacent hardware. The data should have information that conform the requirements of Part 21 § 21.303 (c) and the airworthiness requirements of the FARs from the perspective of the product on which the part is to be installed. The information should include fabrication processes, manufacturing controls, performance, endurance and test requirements as well as assembly techniques to ascertain the airworthiness of the part in conformity with applicable regulations.  The PMA should also provide detailed identification of and information on the part to give demonstration on which products the part may be installed on, detailed understanding of where the part goes, and how the part relates to the next higher assembly. Maintenance instructions for continued airworthiness  Comprehensive set of Instructions for Continued Airworthiness (IFCA) should be prepared by a holder of a design approval in conformity with the airworthiness requirements applicable to the product as per Part 21 § 21.50 (b) of the FAA. This applies to parts whose application was made after Jan. 28, 1981. The furnished data should be comprehensive to enable FAA to establish that the IFCA will continue to be valid for the product with the PMA part installed. The applicant also has to provide analysis, supported by an appropriate test design and results to affirm compliance with the applicable airworthiness standards under test and computation. These analyses have to be supported by in-depth engineering assessment of the impacts on other parts and the product, if the part fails to perform its intended function. In addition, it is the responsibility of the applicant to demonstrate that its design complies with the applicable regulations. PMA applicants are also required to establish and maintain a fabrication inspection system (FIS) to conform with the requirements of Part 21 § 21.303(h), and more specifically Part 21 § 21.303(h)(1)-(9), as well as the provisions for reporting under Part 21 § 21.3. Considering that FAA's focus is safety and accountability, the PMA may only be issued if the applicant has demonstrated on the basis of tests and computations that the part meets each and every appropriate airworthiness requirements. 4.2 CAAC -PMA regulation  The Civil Aviation of China (CAAC) is the body charged with the responsibility of managing the national civil aviation affairs 4.2 CAAC -PMA regulation  4.2.1 CCAR part 21  4.2.2 AC-20-01 4.2.3 AC-121-55R1  4.3 EASA Policy ... Chapter 5 PMA parts management in china airline. 5.1 The Evolution of PMA Parts Utilization in Air China(for example) 5.1.1 Preliminary Stage  5.1.2 The Second Stage 5.1.3The newest Stage 5.2 The PMA Parts Evaluation and Management in Air China  5.2.1 Authoritative Responsibility Department for PMA Management 5.2.2 The PMA Parts Categories in Air China  5.2.3 Air China policy for FAA-PMA 5.2.4 Requirement of Accepting a PMA parts 5.2.5 The evaluation items . 5.2.6 Evaluating person qualification 5.2.7 The evaluation process 5.2.8 The related records The PMA parts management in Air China 5.2.9 Storage requirement. 5.3 Example of Evaluation Process of a Major Engine PMA parts Chapter 6 Conclusions and Suggestions 6.1 Conclusion  6.2 improvement and suggestion Read More
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Development of a Premarket Approval in China Coursework Example | Topics and Well Written Essays - 3500 words. https://studentshare.org/finance-accounting/2077858-study-on-development-of-pma-in-china
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Development of a Premarket Approval in China Coursework Example | Topics and Well Written Essays - 3500 Words. https://studentshare.org/finance-accounting/2077858-study-on-development-of-pma-in-china.
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