152 

14 CFR Ch. I (1–1–14 Edition) 

§ 21.138 

(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. 

(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. 

§ 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 

VerDate Mar<15>2010 

10:12 Mar 18, 2014

Jkt 232046

PO 00000

Frm 00162

Fmt 8010

Sfmt 8002

Y:\SGML\232046.XXX

232046

pmangrum on DSK3VPTVN1PROD with CFR