Today, EASA issued an updated agenda for the 2013 EASA / FAA International Aviation Safety Conference. The Conference is the annual meeting among EASA, FAA, TCCA and other regulators to discuss new paradigms in regulatory oversight. This meeting directly impacts the aviation industry, which is the subject of this regulatory oversight!
The updated agenda provides better guidance on what to expect from the 2013 meeting.
Sessions that will be interesting to member of the PMA manufacturing community will include:
MARPA will be there and will be reporting on the new directions proposed by the regulators.
We have written recently on this blog about the important SMS/Part 21 Aviation Rulemaking Committee (ARC) and corresponding Working Groups in which representatives of MARPA are now participating. The result of this ARC promises to affect each and every manufacturer of PMA in some way or another. MARPA will therefore be there every step of the way, working to ensure that the interests of PMA community are protected. But in order to ensure that we guard our members’ interests, we will need your assistance and feedback! We are therefore asking MARPA members to tracks and share with us the cost of regulatory compliance.
The Regulatory Flexibility Act requires agencies to attempt to fit the burdens of a proposed regulation to the scale of businesses. This recognizes the fact that the same regulatory burden that may simply be the cost of doing business to a large multinational corporation may be crippling to a small company. Recognizing the extreme importance of scalability in the promulgation of the new Part 21, one of the four Working Groups is dedicated solely to undertaking a Cost-Benefit Analysis of the proposed regulatory changes.
This is where MARPA member feedback will be of extreme importance. The Cost-Benefit Analysis Working Group needs data to better understand what the current cost of compliance to small business actually is. This will function as a baseline from which to determine the benefits and costs of the proposals generated by the other three Working Groups. As the Working Groups craft the new regulations they will turn to industry to obtain data demonstrating the effects of the proposed changes.
It is vital that MARPA members participate in providing data to the Working Groups as the new proposals are developed and those assumptions tested against hard data. Hidden costs of compliance with regulations, under-estimations of costs, and over-estimations of benefits have the potential to result in an overly burdensome regulation. The participation of MARPA members in providing data to the ARC Working Groups will go a long way toward shaping an effective regulation while minimizing the burden on small businesses.
Input from members helps MARPA to more effectively advocate for policy changes that benefit the PMA community. Responses to requests for information such as this—or for data regarding the Streamlined PMA Process—helps MARPA to focus its resources to optimize benefit to the membership.
MARPA looks forward to the participation of its members in shaping the future of Part 21. Although the Working Groups have not yet begun to approach industry with requests for data, MARPA would like to get started early. If your company tracks the cost of regulatory compliance, whether in dollars, personnel, man-hours, paperwork, or any other metric, we want to hear from you. Your confidentiality is important to us, so MARPA will only report data in the aggregate; no individual data will be released and no company names will be revealed. You can send this data to MARPA Associate Counsel Ryan Aggergaard at email@example.com. Please also send Ryan an email if you have any questions or would like to start tracking compliance costs.
The FAA has released draft guidance on major repair and alteration data approval, and is seeking public comment.
The guidance is meant for FAA employees/designees and is intended to provide them with assistance in the data approval process. Nonetheless, this is very important guidance for the private sector because it will likely have the effect of limiting major repair and alteration data approval only to the scope of this particular guidance.
It is important for repair stations and air carriers to review this data to ensure that it accurately describes the categories of data that must be approved, and that it provides a reasonable mechanism for approval of that data. It is equally important for PMA manufacturers to review the data, because it may affect their Instructions for Continued Airworthiness, as well as approval of repair and alteration data that is developed to respond to continued operational safety (COS) issues.
The draft guidance can be found online here: http://www.faa.gov/aircraft/draft_docs/media/8300.X.pdf.
Comments are due to the FAA by June 12, 2013 and should be emailed to firstname.lastname@example.org.
Please send copies of your comments to MARPA so that we can be sure that our comments reflect your concerns.
The SMS/Part 21 Aviation Rulemaking Committee (ARC) opened a three day meeting this morning in Rosslyn, Virginia. The meeting expands the scope of the ARC to include four working groups that will develop the new rules for certification and approval of aviation products and articles. MARPA staff attended the live meeting and MARPA members participated by dial-in teleconference. This project will definitely affect every MARPA member and could be the most important rulemaking activity affecting the PMA community in over 60 years!
Dorenda Baker is the Director of the FAA Aircraft Certification Service. Ultimately, the ARC reports to her. Baker explained that the FAA is committed to taking the ARC’s recommendations and moving forward with those recommendations to craft a rule that meets our ICAO SARP obligations (SMS or Safety Management Systems). She stressed that we need to take into consideration how this rule will apply to both large and small companies. It needs to achieve safety goals for everyone.
Some of the points that Baker raised included these:
MARPA has been centrally involved in drafting the working group charters in order to ensure that the ARC recommendations will support the next generation of safety management. Baker’s commitment to protecting the interest of both small companies and large companies is encouraging; but the details will be important to the PMA community and there is plenty of opportunity to see a rule that does not work well. With this in mind, this could be one of the most important projects that MARPA has ever worked-on for the future of the PMA community. MARPA will remain at the heart of this process in order to ensure that the interests of the PMA community are protected.
The FAA has released a new draft Advisory Circular that is intended to describe acceptable statistical methods for developing substantiating data for comparative test and analysis compliance findings to support FAA approval of turbine engine and APU parts produced under a PMA, TC, STC, repair or alteration. The guidance is intended to help generate substantiating data to support compliance with the airworthiness requirements of 14 C.F.R. 21.303 as well as parts 33, 43 and TSO C77.
Several members have brought this AC to our attention and expressed their concerns about the details of this guidance. We welcome specific comments from members about problems and/or ways to improve this document. Based on member comments we have received so far, the proposed guidance appears likely to discourage applications to produce replacement parts. One reason for this is the large suggested sample size, and associated high costs, necessary to satisfy the proposed statistical analysis metrics.
The proposed AC discusses statistical principles and methods in an effort to explain appropriate approaches of determining proper sample sizes and population specimens for the purpose of showing equivalency and discrepancies between sample populations of parts.
The AC primarily attempts to address two separate problems: (1) the use of statistical tests designed to show difference rather than equivalency and (2) the use of small sample sizes.
The guidance observes that applicants frequently submit data based on a simple t-test, which is designed to determine difference, rather than equivalency. This is a problem because failure to show a statistically significant difference is not the same as demonstrating the equivalence between an approved part and a replacement part. The guidance states that a methodology for demonstrating equivalency must instead be used.
The guidance also explains the procedure for determining the sample sizes of approved and replacement parts necessary to demonstrate equivalency. This test for determining sample size yields a large sample-size requirement, based on the needs of the statistical test for equivalency as well as the importance of accounting for lot-to-lot variance.
The practical effect of compliance with the suggested sample size would appear to make the cost of conducting the required testing incredibly cost-prohibitive. MARPA seeks comments from its members to determine whether compliance with the sample sizes indicated by the suggested procedure are economically feasible.
The FAA appears to acknowledge the burden of the sample sizes indicated by the formula by including in the proposed guidance a section titled “Practical alternative for sample size requirements.” The section offers alternative suggestions to using the statistically derived sample sizes and methods for analyzing small samples.
The proposed AC also appears to take an unrealistic view of the nature of part procurement when procuring approved parts for the purpose of comparison. The guidance repeatedly emphasizes the importance of drawing sample parts from different lots to account for variance. Determining the source lots of a series of approved parts seems to be an unrealistic burden without substantial compliance from the manufacturer.
It is important that the engine PMA community examine this guidance to determine whether it offers any benefit to safety and whether compliance would even be practicable.
You can find this proposed AC, Statistical Analysis Considerations for Comparative Test and Analysis Based Compliance Findings for Turbine Engine, at http://www.faa.gov/aircraft/draft_docs/media/AC_33-X.doc.
Comments are due to the FAA by July 11, 2013. Comments can be emailed to Marc Bouthillier at Marc.Bouthillier@faa.gov or faxed to (781) 238-7199. We would appreciate copies of your comments, so we can make sure that MARPA‘s own comments supports the industry’s comments and needs.
The FAA has announced that it is assigning two new tasks to the Aviation Rulemaking Advisory Committee (ARAC).
The first ARAC task is to update the regulations to better reflect fly-by-wire technology. The Flight Test Harmonization Working Group will evaluate issues like takeoff and landing performance and flying qualities that may not be adequately addressed by the existing airworthiness requirements and guidance material. This effort is meant to improve the regulatins and also harmonize them with those of our major trading partners. It is possible that the recommendation(s) could address either engine certification requirements, aircraft operational requirements, or both.
The second ARAC is to “Review and assess the standards and advisory material for bird ingestion requirements.” The Bird Ingestion Working Group will evaluate the threat posed by bird ingestion and develop new standards for addressing this concern. It is possible that the recommendation(s) could address either engine certification requirements, aircraft operational requirements, or both.
The FAA staffs these working groups with technical experts drawn from the industry. It is important to make sure that there is a balanced representation of industry interests on each working group to help ensure that the rules proposed are fair to the entire industry. Because the recommendations could affect certification regulations, they could have a direct affect on the PMA community.
If you are interested in being a technical expert on either of these work groups, please contact MARPA and we can proffer your application as a representative of the PMA industry, or feel free to contact the FAA directly (contact information is listed in the Federal Register notices). The deadline for applying to the FAA for working group membership is April 5, 2013.
MARPA has added video to our website!
Now if you look at the “What is a PMA” page on the MARPA website, you will see that we have added a video presentation that explains what PMA parts are all about. This is our first video on our new Youtube page that will become the home to videos about PMA issues.
Please let us know if you have any ideas for video presentations that you’d like to see on MARPA’s Youtube account or on MARPA’s website!
Have you ever wanted to influence the regulations that affect your business? Well, NOW is your best opportunity to do so!
In January, we provided early notice to the PMA community that the FAA would be seeking industry experts to volunteer for working groups that will be rewriting the manufacturing regulations. Now, we are collecting names and submitting them! This is a tremendous opportunity to make sure that the regulations reflect the current state of the art for certification and approval processes.
The Part 21/SMS Aviation Rulemaking Committee (ARC) is undertaking a major project to review Part 21 and (1) to make it consistent with ICAO Standards for Safety Management Systems, (2) add regulations to create a design organization and (3) update the regulation as necessary.
The Part 21/SMS ARC has recently completed charters for four (4) working groups that will be helping to craft the Part 21 language as well as developing a new paradigm for FAA oversight of systems. These worknig groups will report to the ARC, and will be where the real ground work occurs in changing the manufacturing regulations. We are seeking MARPA members who would like to volunteer to be on these committees. The first working group meetings will likely be April 3-5 and working group members will need to support the working group efforts through 2013 (final Reports are due December 10, 2013).
The four working groups are:
(1) Design Organization: This working group will develop regulations for design organizations, similar to the DOA regulation in Europe. Design organizations will have more safety responsibility and accountability, and in turn would receive greater privileges. The goal of this group will be to help the FAA create design organizations that can serve as the backbone for safety management.
(2) Safety Management Systems (SMS): This working group will help to integrate requirements for safety management systems in to the FAA manufacturing regulations. The goal of this group will be to better align the FAA’s regulations with the requirements of SMS.
(3) Oversight: This working group will develop a new model for FAA oversight that will better reflect risk management in an era with shrinking government budgets and expanding industry need for government approval and/or certification. The goal of this group will be to help the FAA create a program to ensure a consistently high level of safety with a dwindling resource pool.
(4) Cost-Benefit Analysis (CBA): This working group will examine the work of the first three working groups and will help develop the data and other tools that the FAA will need to perform a cost-benefit analysis. The work of this group will be critically important to ensuring that the product from the entire ARC makes good safety sense and good economic sense.
This effort could reflect the most significant change in the U.S. aviation manufacturing regulations in over 50 years. The results of this effort will touch all of us. If you think you would like to serve on one of these working groups then please contact us immediately so we can send you more information. We need to submit our recommendations to the ARC by the end of next week, so we need to hear from you by not later than Thursday, March 7.
Over the past few months, I have encountered a number of PMA exporters, and European PMA importers, who have asked for clear guidance on how to distinguish a “critical” PMA parts from a “non-critical” PMA part.
This is an important distinction because under the Bilateral Airworthiness Safety Agreement (BASA) that was signed between the United States and the European Union, there are three types of PMA parts that are accepted in the European Union (for installation on products certified or validated by EASA) without further showing. Those three “acceptable” situations, as described in the BASA Technical Implementation Procedures (TIP) are:
(1) The PMA part is not a “critical component”; or
(2) The PMA part conforms to design data obtained under a licensing agreement from the TC or STC holder according to 14 CFR §21.303; or
(3) The PMA holder is the holder of an EASA STC which incorporates the PMA part.
Thus, non-critical PMA parts are directly acceptable (and they should have text on their export 8130-3 tag that states “This PMA part is not a critical component”). So there is a significant advantage to having a clear understanding of when a PMA part is critical and when it is not critical.
This can be a little confusing if you don’t know where to look. The FAA has used the term “criticality” to define different categories of parts for approval purposes, and to set differnt levels of FAA involvement in the approval process. The distinct use of the term means that we need to look in the right place for the definition of “critical” that applies to our export/import transactions.
For purposes of US exports of PMA parts that are imported into the European Union, the controlling guidance is found in the BASA’s Technical Implementation Procedures for Airworthiness And Environmental Certification (BASA TIP). The definition of critical component for purposes of that document is found in Section 1.6(i) of the BASA TIP:
“Critical Component” means a part identified as critical by the design approval holder during the product type validation process, or otherwise by the exporting authority. Typically, such components include parts for which a replacement time, inspection interval, or related procedure is specified in the Airworthiness Limitations section or certification maintenance requirements of the manufacturer’s maintenance manual or Instructions for Continued Airworthiness.
Don’t fall for the temptation draw a semantic difference between a “critical component” and a “critical part.” The PMA acceptance procedures found in section 2.8.2(a)(1) of the BASA TIP explicitly cross reference the definition in section 1.6(i).
In light of this definition found in the BASA TIP, the question of whether a PMA part is “critical” will be based on the decision of the FAA (the exporting authority) about whether it was critical at the time of approval.
The regulatory guidance for critical parts is found in the marking requirements discussion in section 45.15(c) of the FAA’s regulations. That section makes it clear that an article is “critical” if it has a hard time specified in the Airworthiness Limitations section of the manual (instructions for continued airworthiness), like a life limit, then it is a critical part (or critical component).
Under normal circumstances, there are two methods for specifying such a limit on a PMA part. The first is during the FAA approval process (usually as an airworthiness limitation published in the instructions for continuous airworthiness), when the airworthiness limitation section associated with the part would be approved. The second is by an FAA airworthiness directive issued after initial approval in response to an identified safety issue.
Thus the best source for identifying whether a PMA article is “critical” is the PMA manufacturer, who should be able to tell customers whether there were any such hard times associated with the article as part of the approval process (or review of the PMA manufacturer’s instructions for continuous airworthiness). If the FAA did not establish that the part was critical at the time of approval, and if they did not subsequently issue an airworthiness limit (such as through an airworthiness directive), then the part is not critical.
Last month, we asked members and readers to respond to a series of questions designed to help guide MARPA as to how the regulations are working, how they are not working, and what we can do to make the aviation manufacturing regulations work better to protect safety. Thank you to those of you who sent in emails in response!
The questions and answers were meant to support MARPA’s work as part of the FAA Safety Management Systems (SMS)/Part 21 Aviation Rulemaking Committee (ARC). Jason Dickstein of MARPA and Dennis Piotrowski of BELAC are both representing the PMA community on that ARC.
The ARC is undertaking a major project to review Part 21 to make it consistent with ICAO Standards for Safety Management Systems. The ARC also plans to recommend a number of clean-up and house-keeping changes to Part 21 – some of which have been waiting many years for an opportunity for implementation.
There is still time to answer last issue’s questions and let MARPA know what you think needs to be changed in the regulations; but this month we are giving you early notice of an opportunity to participate more directly in the rulemaking process.
In mid-February, the FAA ARC will publish Terms of Reference describing the work of each of several working groups that will be helping to craft the Part 21 language as well as developing a new paradigm for FAA oversight of systems. At that time, we will be seeking MARPA members who would like to volunteer to be on these committees. The first working group meetings will likely be in early April.
So be on the look-out for a mid February announcement about those working groups—we would like to get PMA representatives on every one of the working groups to make sure that the industry’s interest are protected—and we will be looking for statements of interest so that we can nominate some members.