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 ryan@washingtonaviation.com. Please also send Ryan an email if you have any questions or would like to start tracking compliance costs.
Has your company taken advantage of the FAA’s streamlined process for PMAs on Non-Safety-Sensitive (NSS) parts, yet? If so, MARPA wants to hear from you.
As we have previously posted on this blog, the streamlined process—detailed in FAA Order 8110.119—involves following the MARPA 1100 Standard for PMA applications for NSS parts. The MARPA 1100 standard is available on our website. Applicants who follow the standard (and confirm that they meet the elements of the FAA Order) are entitled to expedited processing of their applications. The FAA has established a goal to turn-around NSS PMA applications that meet the MARPA standard within 30 days.
A 30-day turn-around would provide NSS PMA applicants with an improved ability to make commitments to customers about expected production and delivery times when those times hinge upon PMA issuance. This should also encourage companies to seek PMA for NSS parts.
The process does not alleviate the applicant of their obligation to ensure compliance with all relevant regulations (remember, you must certify compliance as part of your PMA application); but it does provide a standardized format that should make it easier for FAA ACO engineers to review and approve such applications, consistent with the FAA’s commitment to using risk-based tools to assign resources. This is particularly important as budgets for federal agencies continue to be scaled back.
As with any new initiative, there is likely to be growing pains and some resistance to the adoption and implementation of the streamlined process. We have received some reports from various corners about ACOs that were skeptical of, or unwilling to participate with, the streamline process.
In order to assist MARPA members navigating the streamlined PMA process, we are seeking to issue a set of Best Practices to help guide PMA manufacturers through the new procedure. For this we’d like to hear from you regarding your experiences using the streamlined process. What techniques have been helpful? How did you navigate the MOU process? How closely did you work with your ACO? Do you have any suggestions or words of caution for other PMA manufacturers seeking to take advantage of the streamlined process?
MARPA will compile these responses into a Best Practices guide that will be made available exclusively to MARPA members. We look forward to hearing about your experiences and helping the PMA industry benefit from this new process.
Email your responses to Ryan Aggergaard at Ryan@washingtonaviation.com.
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.
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.
Don’t forget that the 2013 MARPA Winter Meeting will be held in Washington, DC on February 12, 2013.
Expected speakers include:
Our topics for discussion will likely include PMA developments, streamlined PMA for non-safety-sensitive (NSS) parts, Instructions for continued airworthiness, air carrier needs, and tax laws and regulations with a particular affect on PMA parts manufacturers. In addition to our speakers, we will be discussing our government affairs program and strategic planning for the Association.
The Winter meeting is an intimate opportunity to work closely with the Association and the Board on topics of special interest to MARPA members.
If you would like to attend the meeting, please RSVP to MARPA at (202) 628-6777. There is no charge for registering for this meeting; and the meeting is open to all MARPA members.
Have you started using the FAA’s streamlined process for PMAs on Non-Safety-Sensitive (NSS) parts, yet?
Found in FAA Order 8110.119, the streamlined process involves following the MARPA 1100 Standard for PMA applications for NSS parts (which is available on our website). Those who follow that standard (and confirm that they meet the elements of the FAA Order) are entitled to expedited processing. The FAA’s goal is to turn-around NSS PMA applications that meet the MARPA standard within 30 days.
A 30-day turn-around would provide NSS PMA applicants with an improved ability to make commitments to customers about expected production and delivery times when those times hinge upon PMA issuance. This should also encourage companies to seek PMA for NSS parts.
The process does not alleviate the applicant of their obligation to ensure compliance with all relevant regulations (remember, you must certify compliance as part of your PMA application); but it does provide a standardized format that should make it easier for FAA ACO engineers to review and approve such applications, consistent with the FAA’s commitment to using risk-base tools to assign resources.
