Keeping Fasteners Safe

Standard parts – particularly fasteners – continue to be a topic that is being discussed by regulators on both sides of the Atlantic.  We’ve had private conversations with both FAA and EASA executives on this issue.

The Issue

In 2013, EASA published a Safety Information Bulletin (SIB) entitled “Defective Standard Hardware – MS21042, NAS1291 and LN9338 Self-Locking Nuts, and NAS626 Bolts.”  This European SIB highlighted defects in certain self-locking nuts, and certain bolts.  In each case, the fasteners were standard parts.  EASA recommended that those who use these fasteners should visually inspect them for surface irregularities, such as gouges or cracks, before use.  EASA also recommended testing 1% of each lot received as a means of identifying non-conformities.

In 2014, the FAA published a follow-on document (Standard Hardware, AN, MS and NAS Fasteners, FAA SAIB HQ-14-16 (April 28, 2014)) that expanded on the EASA SIB.  Further investigation had shown that the non-conformities were attributed to hydrogen embrittlement and other other latent manufacturing defects.  Although this information was not published, industry rumor suggested that the hydrogen embrittlement was the product of inadequate heat treating.

The FAA has described the defects in these fasteners as “emblematic of potential flaws in other standard hardware.”  In conversations with both FAA and EASA executives on this issue, the root cause opinions appear to be uniform – when many military specification standards were retired by the U.S military, they were then republished by civil standards organizations for continued use in civil aircraft (e.g. AIA publishes the National Aerospace Standards).  After that time, the Department of Defense no longer provided oversight to these standards.  The civil standards organizations do not certify, monitor compliance or perform surveillance of parts produced to these standards (nor of their manufacturers). The responsibility for compliance with these standards and specifications lies with their respective manufacturers – and nearly all of the time, these manufacturers are doing the right thing – they are ensuring that their standard parts meet the requirements of the applicable standards.  But events have shown that a tiny sliver of bad actors can cause unwanted problems, and some people in the government feel that this lack of oversight has left an opportunity for improper manufacturing.

How can we address this lack of oversight economically?  By considering other forms of oversight and assurance.

There is a solution.

Many fastener distributors are accredited to the ASA-100 standard.  The ASA-100 standard includes a requirement that fastener distributors perform visual inspection on fasteners, and maintain batch/lot segregation of fasteners.  This requirement establishes a second set of eyes to help ensure that fasteners are not subject to obvious flaws.

Thus, buying standard parts from ASA-100 accredited distributors helps to ensure the integrity of the fasteners that you are receiving.

The FAA and EASA are both continuing to look at this issue.

We recently met with EASA and proposed that their regulatory structure already is developing a framework for embracing a solution.  EASA published Opinion 2013-12 which included a recommendation for the updating of EASA 145.A.42.  The new language would include enhanced requirements for acceptance of components:

The organisation shall establish procedures for the acceptance of components, standard parts and materials for installation to ensure that components, standard parts and materials are in satisfactory condition and meet the applicable requirements of point (a).

In the proposed GM3 145.A.42(b)(1) that would accompany this regulatory change, Part 145 organizations would be permitted to rely on “other-party” surveillance of suppliers.  This would include reliance on the surveillance performed under the AC 00-56 program and under the ASA-100 program.  The proposed GM is published in the EASA Comment Response Document (CRD).

In light of the fact that ASA-100 already includes fastener surveillance, EASA could use this upcoming promulgation as a tool to better enhance standard fastener oversight by endorsing fastener surveillance as a required element for inclusion in the GM.  By using the distribution community as a second set of eyes, EASA and the FAA would have an inexpensive mechanism for helping to catch problems in cases where fasteners are not properly produced to the expected standards.

Distributor accreditation has been successful in addressing unapproved parts issues, by creating a knowledgeable group with appropriate quality management systems that are designed to identify those sorts of problems.  This model has already been successfully expanded to fastener issues within the ASA-100 community.  This model can also be further expanded to make use of the entire distributor accreditation community as a second set of eyes, watching for fastener issues.

EASA Takes Another Step Toward Formal Recognition of Accreditation

Europe has taken the next step towards formal recognition of the distributor accreditation program.

On December 10th, the European Aviation Safety Agency (EASA) issued its Comment Response Document (CRD) for “Control of suppliers of components and materials used in maintenance.”  This CRD contains the comments received on the Notice of Proposed Amendment (NPA) for the Supplier Control rule.

This changes would require EASA 145 organizations to have a method for assuring the satisfactory condition of the aircraft parts that they receive, and would recommend receiving inspection and supplier control as methods to achieve that end.  Related guidance explains that reliance on accredited distributors (explicitly including ASA-100 accredited distributors) would be a satisfactory way to meet the supplier control element.  A complete discussion of the proposal can be found in an earlier blog post on the NPA.

This is not yet law in Europe.  The next step will be for the European Commission to issue an amendment that features the regulatory changes, and then EASA would issue a Decision that adopts the changes to the advisory/guidance materials.

ASA Continues to Work with EASA on Distributor Issues

In November, ASA will meet again with EASA to discuss the proposed Supplier Control rule for Part 145 maintenance organizations.

Under the proposed rule, Part 145 maintenance organizations would be required to take steps to ensure the airworthiness of the parts that they receive.  This is already a part of the EASA guidance, and is merely being made more explicit in the rules.

The real change under the proposed rule is expanded guidance about methods for effective quality assurance.  The guidance recommendations are focused on two elements that should come as no surprise to anyone in the aviation parts industry: (1) effective receiving inspection, and (2) robust supplier control.

The proposed rule recognizes that the industry has developed a very effective mechanism for aftermarket supplier control, and it endorses this effective mechanism.  It explains that although a Part 145 maintenance organization can perform its own supplier auditing, reliance on certain industry-accepted third party auditing mechanisms has become standard in the industry.  Based on nearly twenty years of success, the proposed rule recognizes that AC 00-56, and the standards that it endorses, represents a sound method for ensuring that effective quality controls are exercised in the aircraft parts distribution chain.

In addition to recognizing reliance on AC 00-56 as an effective tool to support supplier quality assurance, the proposed guidance also lays out the elements of an effective distributor quality system (the proposed rule includes an analysis in the appendices to show that ASA-100 already meets the new European requirements).

This European effort helps to validate the notion that companies that voluntarily adopted AC 00-56 (and ASA-100) compliant systems were doing the right thing.

When ASA meets with EASA in early November, we will be discussing the industry comments on the proposed rule, and how best to adopt those comments into the final rule.  Any ASA members who has comments on the proposed rule or the related guidance should make sure to get them to ASA before the end of October.

EASA Proposal Would Recognize ASA-100 Accreditated Suppliers

EASA has published a new draft rule for public comment.  This new rule would form the basis of European recognition of distributor accreditation.  Formal European recognition of distributor accreditation is something that ASA has been working on for many years; most recently as a member of the EASA Working Group that helped to craft the rule.

The draft rule is known as NPA 2012-03.  The title of the draft is ‘Control of suppliers of components and material used in maintenance.’

Under the new rule, maintenance organizations, like repair stations, are provided with guidance about acceptable practices for managing sources of supply.  The change is accomplished by a minor change to the EASA rules that apply to maintenance organizations, and a more significant change to the EASA guidance material.  The new rule language requires 145 organizations to “establish procedures for the acceptance of components and material.”  The proposal also includes substantial guidance material to explain what this means, from a practical standpoint. To begin with, the guidance material makes it clear that maintenance organizations can inspect parts to ensure airworthiness, but that reliance on credibility of sources to support the finding of airworthiness is also a piece of the analysis.

AMC 145.A.42 (a) Acceptance of components

The procedures for acceptance of components should have the objective of ensuring that the supplied components and material are in satisfactory condition and meet the organisation’s requirements. These procedures may be based upon:

1) incoming inspections which include:

  • physical inspection of components and/or material;
  • review of accompanying documentation and data, which should be acceptable in accordance with 145.A.42(e).

2) supplier evaluation and control.

The guidance goes on to explain that an organization may choose to directly evaluate sources (suppliers) or it may rely on a third party to do so.  The guidance material recommends the following standards as typical elements for a supplier’s quality system:

GM 145.A.42 (a) Supplier evaluation and control

1) The following elements may be checked for the evaluation and control of a supplier’s quality system, as appropriate, to ensure that the component and/or material is supplied in satisfactory condition:

a. Availability of appropriate up to date regulations, specifications such as component manufacturer’s data and standards;

b. Standards and procedures for training of personnel and competency assessment;

c. Procedures for shelf-life control;

d. Procedures for handling of electrostatic sensitive devices;

e. Procedure for identifying the source from which components and material were received;

f. Purchasing procedures identifying documentation to accompany components and material for subsequent use by approved Part-145 maintenance organisations;

g. Procedures for incoming inspection of components and materials;

h. Procedures for control of measuring equipment that provide for appropriate storage, usage, and for calibration when such equipment is required;

i. Procedures to ensure appropriate storage conditions for components and materials that are adequate to protect the components and materials from damage and/or deterioration. Such procedures should comply with manufacturers’ recommendations and relevant standards;

j. Procedures for adequate packing and shipping of components and materials to protect them from damage and deterioration, including procedures for proper shipping of dangerous goods. (e.g. ICAO and ATA specifications);

k. Procedure for detecting and reporting of suspected unapproved components;

l. Procedure for handling unsalvageable components in accordance with applicable regulations and standards;

m. Procedures for batch splitting or redistribution of lots and handling of the related documents;

n. Procedure notifying purchasers of any components that have been shipped and have later been identified as not conforming to the applicable technical data or standard;

o. Procedure for recall control to ensure that components and materials shipped can be traced and recalled if necessary; p. Procedure for monitoring the effectiveness of the quality system.

Finally. the new guidance explains that certain standards are known to be acceptable:

2) Suppliers certified to officially recognised standards that have a quality system that includes the elements specified in 1) may be acceptable; such standards include:

a. EN/AS9120 and listed in the OASIS database;

b. ASA-100;

c. EASO 2012;

d. FAA AC 00-56.

The use of such suppliers does not exempt the organisation from its obligations under 145.A.42 to ensure that supplied components and material are in satisfactory condition and meet the applicable criteria of 145.A.42(e).

The appendices to the proposal show correspondence tables that demonstrate the acceptability of each of the above standards.

The last element of the above guidance, explaining that use of accredited suppliers “does not exempt the organisation from its obligations under 145.A.42 to ensure that supplied components and material are in satisfactory condition and meet the applicable criteria of 145.A.42(e),” means that the other regulatory requirements, like documentation requirements, continue to apply regardless of source.

For Americans, it is important to remember that the all maintenance in the European system is performed by Part 145 organizations.  Even air carriers must have 145 certificates in order to maintain their own aircraft.  So a European rule that affects maintenance providers will affect all European purchasers of parts.  It will also affect many U.S. repair stations, because a significant number of U.S. repair stations are EASA 145-accepted, which means that they conform to both U.S. regulations and European regulations.

ASA is pleased that this allows the U.S. and Europe to rely on harmonized standards of distributor accreditation, that recognize popular accreditation standards like ASA-100 and the other standards accepted under FAA AC 00-56.

Comments on the draft rule are due July 12, 2012.  They may be submitted by posting them on the Comment-Response Tool (CRT) available at http://hub.easa.europa.eu/crt/, or by mail to:

Process Support
Rulemaking Directorate
EASA
Postfach 10 12 53
50452 Cologne
Germany

Please send copies of your comments to ASA as well, so we can be sure to reinforce and support our members’ comments.

EASA Developing New Guidance to Recognize Distributor Accreditation

I have just returned from a meeting in Germany at the EASA Headquarters.  The purpose of the meeting was to discuss European programs for ensuring appropriate oversight of distributors.  This is part of an EASA rulemaking task that we’ve been supporting for much of this year.

In earlier meetings, proposals had been floated that would have created new and onerous obligations, requiring 145 organizations to audit and provide direct oversight to the quality systems of distributors.  This would have affected 145 organizations around the world, because of the significant number of EASA-145-accepted repair stations outside of Europe. One of our goals in this meeting was to redirect the group’s efforts to the acceptance of a program that woul dnot create new auditing obligations that yielded no new benefits.  We raised the point that there are good, existing systems out there (like AC 00-56A).

The group agreed that the proposal was getting too onerous, and so the group developed some new guidance to replace it that will recognize the existing systems used to provide oversight to distributor quality systems.  The new guidance will encourage participation in the existing systems and permit companies that are ‘doing the right things’ to continue operating the way that they operate today.

Under the proposal, there would be a new EASA 145.A.42(a), and the other elements of EASA 145.A.42 would be incremented.  The new section will clarify that EASA-145 organizations and other 145 organizations subject to EASA jurisdiction shall establish procedures for the acceptance of components and material.  EASA feels that existing regulations, like 145.A.65, already imply a requirement for such procedures; this addition merely clarifies the requiremetn for 145 organizations.

The proposal also adds advisory guidance describing common industry methods for ensuring that the distributors from whom a 145 organization purchases will have adequate quality systems in place.

The result would be that AMC 145.A.42 would look like this (note that the new text is in green):

145.A.42 Acceptance of Components (to be proposed)

(a) The organization shall establish procedures for the acceptance of components and material.

(b) All components shall be classified and appropriately segregated into the following
categories:

1. Components which are in a satisfactory condition, released on an EASA Form 1 or equivalent and marked in accordance with Part-21 Subpart Q.

2. Unserviceable components which shall be maintained in accordance with this section.

3. Unsalvageable components which are classified in accordance with 145.A.42(d).

4. Standard parts used on an aircraft, engine, propeller or other aircraft component when specified in the manufacturer’s illustrated parts catalogue and/or the maintenance data.

5. Material both raw and consumable used in the course of maintenance when the organisation is satisfied that the material meets the required specification and has appropriate traceability. All material must be accompanied by documentation clearly relating to the particular material and containing a conformity to specification statement plus both the manufacturing and supplier source.

(c) Prior to installation of a component, the organisation shall ensure that the particular component is eligible to be fitted when different modification and/or airworthiness directive standards may be applicable.

(d) The organisation may fabricate a restricted range of parts to be used in the course of undergoing work within its own facilities provided procedures are identified in the exposition.

(e) Components which have reached their certified life limit or contain a non-repairable defect shall be classified as unsalvageable and shall not be permitted to re-enter the component supply system unless certified life limits have been extended or a repair solution has been approved according to Part-21.

In addition, the new proposal would include advisory and guidance material designed to support and guide the efforts of 145 organizations.  The existing AMCs for 145.A.42 would be renumbered to reflect and be consistent with the renumbering of the regulation.

AMC 145.A.42 (a) (to be proposed)

The procedures for the acceptance of components should have the objective to ensure that the supplied components or material are in satisfactory condition and meet the organization requirements. These procedures may be based upon:

a)    incoming inspections which includes:

1) physical inspection of those components, parts or material that can be satisfactorily inspected on receipt;

2) review of accompanying documentation and data, which should be acceptable in accordance with 145.A.42(b)

b)    supplier evaluation and control

The point of this new guidance is to make it clear that supplier evaluation supports the 145 organization’s receiving inspection elements by providing a greater level of trust in the documentation that accompanies the parts, which in trun permits the 145 organization to comfortably rely on that documentation.

The most interesting part of this guidance is found in the draft Guidance Material (GM).  This GM defines supplier evaluation and control as consisting of audits to check certain elements.  Those elements were drafted to be consistent both with FAA AC 00-56A and also with JAA TGL 46, which was issued by the now-defunct Joint Aviation Authorities to encourage  the use of accredited distributors.

GM 145.A.42 (a) Supplier evaluation and control (to be proposed)

(a)  The following elements may be checked for the evaluation and control of a supplier’s quality system, as appropriate to ensure that the component is in satisfactory condition:

  1. Availability of appropriate up to date regulations, specifications and standards.
  2. Standards and procedures for training of personnel and competency assessment.
  3. Procedures for shelf-life control.
  4. Procedures for handling of electrostatic sensitive devices.
  5. Procedures for identifying the source from which components and material were received.
  6. Purchasing procedures identifying documentation to accompany components for subsequent use by approved Part 145 maintenance organizations.
  7. Procedures for incoming inspection of components and materials.
  8. Procedures for measuring equipment control that provides for appropriate storage, usage and calibration when such equipment is required.
  9. Procedures to ensure appropriate storage conditions for components and materials that are adequate to protect the components and materials from damage and/or deterioration in accordance with manufacturers’ recommendations and relevant standards.
  10. Procedures for adequate packing and shipping of components and materials for grating protection from damage and deterioration, including procedures for proper shipping of dangerous goods. (e.g. ICAO and ATA specifications)
  11. Procedure for detecting and reporting of suspected unapproved components.
  12. Procedure for handling of unsalvageable components in accordance with applicable regulations and standards.
  13. Procedures for batch splitting or redistribution of lots and handling of the related documents.
  14. Procedure to notify purchasers of any components that have been shipped and later been identified to not conform to the applicable technical data or standard.
  15. Procedure for recall control to ensure that components and materials shipped can be traced and recalled if necessary.
  16. Procedure for monitoring the effectiveness of the distributor’s quality system.

(b)  Suppliers certified to officially recognize standards that have a quality system that includes the elements specified in (a) may be acceptable; such standards include:

  1. EN/AS9120 and listed in the OASIS database
  2. ASA-100
  3. EASO 2012
  4. FAA AC00-56

Note that this GM provides a list of elements that one should expect in a distributor’s quality system.  The list of elements is consistent with the list of quality system elements found in AC 00-56A.

The GM also specifies that certain standards (standards for which EASA had data to confirm) are considered to meet the  quality system elements  of the Guidance, and that therefore distributors accredited/certified to those standards would be considered to be acceptable under the guidance.  AC 00-56 was published by the FAA, but the AC 00-56 list has become an international list of companies around the world that have adopted the quality system elements of the Advisory Circular.  By endorsing AC 00-56, the European guidance would permit the continued reliance on the FAA AC 00-56 accreditation list.  This list has become an important tool in the evaluation of potential suppliers.  European recognition permits companies selling to European 145 organizations to continue doing what they are doing if they are doing the ‘right’ thing, and it provides very clear guidance on expectations for distribution companies that have not yet implemented effective quality systems.

The group also felt that an additional GM is necessary – one that clarifies an obligation to specify the documentation required for receipt at the time tat the part is ordered.  One of the motivations for this was data among the 145 organizations in the group suggesting that one of the most significant reasons for rejecting a component in Europe is because the documention was not correct or did not meet the 145.a.42 requirements.  The group felt that there is a lesser likelihood of getting the wrong documentation when the buyer specifies the documentation expectations.  This should help European Part 145 organizations better communicate their regulatory documentation requirements to sellers.

GM to 145.A.42 (b) (to be proposed): The part-145 organization should ensure that when they order components or material they specify the required documentation in accordance with 145.A.42 (b).

The new rule and guidance still have to go through internal EASA coordination and review.  If the draft survives that coordination process, then it is possible that it could be issued to the public for comment in the Spring of 2012.