§21.135 - Organization.

  1. Does the new rule §21.135 apply to TSO authorization grantees?   No. Section 21.135 applies to applicants for and holders of a production certificate. However, the same requirement for TSOA Holders exist in §21.605.
  2. The new regulation requires a description of the organization. How do I describe it?   The rule requires a document describing how the organization will ensure compliance with the provisions of this subpart. This can be done as a narrative and may include flow-charts. The FAA recognizes the varying business models and organizational structures of different businesses. The intent of this requirement is to obtain a commitment from top management to establish a quality system that complies with this part and ensures that each product and article conforms to its approved design and is in a condition for safe operation and to continually improve that quality system.

§21.137 - Quality system.

  1. Can a Production Approval Holder (PAH) address any of the 14 elements of the quality system as non-applicable (N/A) in their quality manual?   The PAH can list the element within their quality manual as "not applicable." The FAA will then determine whether or not this element is truly not applicable to the PAH and approve or disapprove the submittal.
    A possible example of a quality system element being not applicable could be a PAH for software not requiring a calibration system.
  2. The preamble states the quality system is scalable.  What does this mean?   Each applicant for or holder of a production approval must establish and describe, in writing, a quality system that ensures that each product and article conforms to its approved design and is in a condition for safe operation.  The quality system must address the 14 elements listed in §21.137.  Examples of Scalability of Quality System under �21.137 (PDF), by system element to large and small companies.
  3. Can a PAH implement quality system procedures described in §21.137 before the 18-month compliance date?   Yes. The FAA encourages PAHs to take a proactive approach in implementing these procedures when they can. The PAH should follow current processes with their Manufacturing Inspection District Office (MIDO) for making changes to their quality system prior to the 18-month compliance date.
    The new procedure(s) will also need to be described in the quality manual submitted to the FAA in accordance with the new §§21.138, 21.308, and 21.608.  These procedures will be validated at the next certificate management activity that takes place after the 18-month compliance date.
  4. Can my quality system be evaluated for compliance prior to the 18-month compliance date?   No.  The quality system will be evaluated for compliance by the FAA during certificate management activity after the compliance date of the rule.

§21.138 - Quality manual.

  1. If I submit a quality manual within the required time and the MIDO does not approve the manual by the compliance date, can I continue to produce parts?   Yes.  To be in compliance with the rule, the PAH must have submitted their manual describing their quality system to the FAA for approval in accordance with §§21.138, 21.308, and 21.608 by the compliance date.
    Although the FAA has not approved the manual by the compliance date, PAHs must operate to their new/revised quality manual and comply with the new part 21 rule.
  2. If a PAH previously submitted data describing their quality control system or fabrication inspection system (via a quality manual or other document), will a new/revised manual need to be submitted to the FAA?   Yes.  To be compliant with the new part 21 rule, all PAHs must submit a manual that describes the quality systems required by §§21.137, 21.307, and 21.607.
    Some PAHs may already have manuals that describes the requirements in §§21.137, 21.307, and 21.607 and will simply need to be submit those manuals to the FAA for approval.
  3. Clarify that the MIDO�s should not approve quality manuals until after the 18 months release to the Federal Register. They can have the manuals in their possession, but cannot actually issue the approval until after 18 months.   MIDOs may approve quality manuals, which are written for the purpose of meeting the requirements of the new part 21 rule, prior to the 18 month compliance date. The approval letter, issued by the MIDO to the PAH, will have an effective date no earlier than 4/16/2011.

§21.139 - Location of or change to manufacturing facilities.

  1. Do you plan to provide guidance on how the FAA should formally respond to the notification of a facility�s relocation?   No.  The current relocation guidance in FAA Order 8120.2 remains adequate.
  2. a.  Will the order address the mandatory notification process that is required prior to a "Location of or change to manufacturing facilities"?   No.  The current relocation guidance in FAA Order 8120.2 remains adequate.
    b.  Is it a formal letter from the applicant? And FAA?   Policy will require formal written notification from the PAH.
    c.  Does an email notification suffice?   No.  However, the FAA will accept an email with a copy of the formal written notification attached to an email.
  3. Request that there be a definition, standardization and clarification of "Immediate Notification."   Request is noted. Requests for changes to directives should be submitted via a Directive Feedback Information, FAA Form 1320-19.

§21.145 - Privileges.

  1. May a 145 Repair Station utilize its existing quality system for the PMA quality system and if so may they reference the existing Repair Station Quality Manual when developing the approved PMA quality manual?   No. The quality system requirements for your Repair Station are not the same as those required by part 21 for a PMA. However, you may use your Repair Station quality system and manual as a basis for your PMA quality system and quality manual. The hybrid system would need to account for all the requirements necessary to meet both sets of regulations. As a consequence of having both quality systems in one manual and the manual becoming approved data by the FAA, your PI for the PMA would evaluate, perform certificate management, and possibly take enforcement action on all aspects of your quality system as documented in your approved quality manual.
    While it is indeed possible for you to document both sets of quality system requirements within a single quality manual, it is not recommended.

§21.146 - Responsibility of holder.

  1. a.  If we approve the manual, do we have to approve changes to the manual?   Yes.  Sections 21.146, 21.316, and 21.616 all require the PAHs to "maintain the quality system in compliance with the data and procedures approved for the PC, PMA, or TSO," respectively. Therefore, changes to the quality manual would need to be approved.
    b. & c.  Is this done before or after the company implements the changes?  Does this include lower level documents as well?   How the changes are approved will be up to the FAA managing office and the PAH. For example, the FAA and the PAH may agree that for minor changes, the PAH would notify the FAA and integrate them into the quality manual. When a significant number of minor changes have been added to the manual, it would then be sent to the FAA for approval.
  2. a.  My FAA Principal Inspector states that because 14 CFR section 21.161 is still in effect, we still have to post copies of our Production Certificate at the main entrance of each of our manufacturing facilities. Is it intended that §21.161 will be deleted in future publications? Do we have to comply with it in the meantime?   Yes.  Your production certificate must be displayed at the main facility in accordance with §21.161 until April 16, 2011 when that section of the rule becomes §21.146(g).
    b.  If we don't have to post at each facility, is it expected that each facility will retain a copy or is it only required at the main facility?   After April 16, 2011, §21.146(g) requires production certificates to be retained and made available to the FAA upon request.
  3. Section 21.146 requires the PAH to work to an approved system. What happens if the PAH submits the manual to the FAA but it is not approved by April 16, 2011?   No.  Section 21.146(b) requires the PC holder to "maintain the quality system in compliance with the data and procedures approved for the production certificate." If the PAH has submitted their quality manual and has not received an approval by the FAA by April 16, 2011, they are still responsible to have a system, and be operating to the system, which meets all the requirements of the rule in effect on that date.
    If the FAA has not approved the quality manual then they will not take enforcement action against a PAH for a violation of §21.139 or §21.146(b).

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