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Federal Aviation Administration, DOT
§ 21.137
§ 21.133
Application.
Each applicant must apply for a pro-
duction certificate in a form and man-
ner prescribed by the FAA.
§ 21.135
Organization.
(a) Each applicant for or holder of a
production certificate must provide the
FAA with a document—
(1) Describing how its organization
will ensure compliance with the provi-
sions of this subpart;
(2) Describing assigned responsibil-
ities, delegated authorities, and the
functional relationship of those respon-
sible for quality to management and
other organizational components; and
(3) Identifying an accountable man-
ager.
(b) The accountable manager speci-
fied in paragraph (a) of this section
must be responsible within the appli-
cant’s or production approval holder’s
organization for, and have authority
over, all production operations con-
ducted under this part. The account-
able manager must confirm that the
procedures described in the quality
manual required by § 21.138 are in place
and that the production approval hold-
er satisfies the requirements of the ap-
plicable regulations of subchapter C,
Aircraft. The accountable manager
must serve as the primary contact with
the FAA.
[Doc. No. FAA–2013–0933, Amdt. 21–98, 80 FR
59031, Oct. 1, 2015]
§ 21.137
Quality system.
Each applicant for or holder of a pro-
duction certificate must establish and
describe in writing a quality system
that ensures that each product and ar-
ticle conforms to its approved design
and is in a condition for safe operation.
This quality system must include:
(a)
Design data control. Procedures for
controlling design data and subsequent
changes to ensure that only current,
correct, and approved data is used.
(b)
Document control. Procedures for
controlling quality system documents
and data and subsequent changes to en-
sure that only current, correct, and ap-
proved documents and data are used.
(c)
Supplier control. Procedures that—
(1) Ensure that each supplier-pro-
vided product, article, or service con-
forms to the production approval hold-
er’s requirements; and
(2) Establish a supplier-reporting
process for products, articles, or serv-
ices that have been released from or
provided by the supplier and subse-
quently found not to conform to the
production approval holder’s require-
ments.
(d)
Manufacturing process control. Pro-
cedures for controlling manufacturing
processes to ensure that each product
and article conforms to its approved
design.
(e)
Inspecting and testing. Procedures
for inspections and tests used to ensure
that each product and article conforms
to its approved design. These proce-
dures must include the following, as
applicable:
(1) A flight test of each aircraft pro-
duced unless that aircraft will be ex-
ported as an unassembled aircraft.
(2) A functional test of each aircraft
engine and each propeller produced.
(f)
Inspection, measuring, and test
equipment control. Procedures to ensure
calibration and control of all inspec-
tion, measuring, and test equipment
used in determining conformity of each
product and article to its approved de-
sign. Each calibration standard must
be traceable to a standard acceptable
to the FAA.
(g)
Inspection and test status. Proce-
dures for documenting the inspection
and test status of products and articles
supplied or manufactured to the ap-
proved design.
(h)
Nonconforming product and article
control. (1) Procedures to ensure that
only products or articles that conform
to their approved design are installed
on a type-certificated product. These
procedures must provide for the identi-
fication, documentation, evaluation,
segregation, and disposition of noncon-
forming products and articles. Only au-
thorized individuals may make disposi-
tion determinations.
(2) Procedures to ensure that dis-
carded articles are rendered unusable.
(i)
Corrective and preventive actions.
Procedures for implementing correc-
tive and preventive actions to elimi-
nate the causes of an actual or poten-
tial nonconformity to the approved de-
sign or noncompliance with the ap-
proved quality system.
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14 CFR Ch. I (1–1–24 Edition)
§ 21.138
(j)
Handling and storage. Procedures
to prevent damage and deterioration of
each product and article during han-
dling, storage, preservation, and pack-
aging.
(k)
Control of quality records. Proce-
dures for identifying, storing, pro-
tecting, retrieving, and retaining qual-
ity records. A production approval
holder must retain these records for at
least 5 years for the products and arti-
cles manufactured under the approval
and at least 10 years for critical compo-
nents identified under § 45.15(c) of this
chapter.
(l)
Internal audits. Procedures for
planning, conducting, and documenting
internal audits to ensure compliance
with the approved quality system. The
procedures must include reporting re-
sults of internal audits to the manager
responsible for implementing correc-
tive and preventive actions.
(m)
In-service feedback. Procedures for
receiving and processing feedback on
in-service failures, malfunctions, and
defects. These procedures must include
a process for assisting the design ap-
proval holder to—
(1) Address any in-service problem in-
volving design changes; and
(2) Determine if any changes to the
Instructions for Continued Airworthi-
ness are necessary.
(n)
Quality escapes. Procedures for
identifying, analyzing, and initiating
appropriate corrective action for prod-
ucts or articles that have been released
from the quality system and that do
not conform to the applicable design
data or quality system requirements.
(o)
Issuing authorized release docu-
ments. Procedures for issuing author-
ized release documents for aircraft en-
gines, propellers, and articles if the
production approval holder intends to
issue those documents. These proce-
dures must provide for the selection,
appointment, training, management,
and removal of individuals authorized
by the production approval holder to
issue authorized release documents.
Authorized release documents may be
issued for new aircraft engines, propel-
lers, and articles manufactured by the
production approval holder; and for
used aircraft engines, propellers, and
articles when rebuilt, or altered, in ac-
cordance with § 43.3(j) of this chapter.
When a production approval holder
issues an authorized release document
for the purpose of export, the produc-
tion approval holder must comply with
the procedures applicable to the export
of new and used aircraft engines, pro-
pellers, and articles specified in § 21.331
and the responsibilities of exporters
specified in § 21.335.
[Docket No. FAA–2006–25877, Amdt. 21–92, 74
FR 53387, Oct. 16, 2009, as amended by Doc.
No. FAA–2013–0933, Amdt. 21–98, 80 FR 59031,
Oct. 1, 2015; Amdt. 21–98A, 80 FR 59031, Dec.
17, 2015]
§ 21.138
Quality manual.
Each applicant for or holder of a pro-
duction certificate must provide a
manual describing its quality system
to the FAA for approval. The manual
must be in the English language and
retrievable in a form acceptable to the
FAA.
§ 21.139
Location of or change to man-
ufacturing facilities.
(a) An applicant may obtain a pro-
duction certificate for manufacturing
facilities located outside of the United
States if the FAA finds no undue bur-
den in administering the applicable re-
quirements of Title 49 U.S.C. and this
subchapter.
(b) The production certificate holder
must obtain FAA approval before mak-
ing any changes to the location of any
of its manufacturing facilities.
(c) The production certificate holder
must immediately notify the FAA, in
writing, of any change to the manufac-
turing facilities that may affect the in-
spection, conformity, or airworthiness
of its product or article.
§ 21.140
Inspections and tests.
Each applicant for or holder of a pro-
duction certificate must allow the FAA
to inspect its quality system, facilities,
technical data, and any manufactured
products or articles and witness any
tests, including any inspections or
tests at a supplier facility, necessary
to determine compliance with this sub-
chapter.
§ 21.141
Issuance.
The FAA issues a production certifi-
cate after finding that the applicant
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