[Code of Federal Regulations]
[Title 49, Volume 2]
[Revised as of October 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 49CFR178.69]

[Page 897-898]
 
                        TITLE 49--TRANSPORTATION
 
   CHAPTER I--PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, 
                      DEPARTMENT OF TRANSPORTATION
 
PART 178_SPECIFICATIONS FOR PACKAGINGS--Table of Contents
 
                 Subpart C_Specifications for Cylinders
 
Sec.  178.69  Responsibilities and requirements for manufacturers of 

UN pressure receptacles.

    (a) Each manufacturer of a UN pressure receptacle marked with 
``USA'' as a country of approval must comply with the requirements in 
this section. The manufacturer must maintain a quality system, obtain an 
approval for each initial pressure receptacle design type, and ensure 
that all production of UN pressure receptacles meets the applicable 
requirements.
    (1) Quality system. The manufacturer of a UN pressure receptacle 
must have

[[Page 898]]

its quality system approved by the Associate Administrator. The quality 
system will initially be assessed through an audit by the Associate 
Administrator or his or her representative to determine whether it meets 
the requirements of this section. The Associate Administrator will 
notify the manufacturer in writing of the results of the audit. The 
notification will contain the conclusions of the audit and any 
corrective action required. The Associate Administrator may perform 
periodic audits to ensure that the manufacturer operates in accordance 
with the quality system. Reports of periodic audits will be provided to 
the manufacturer. The manufacturer must bear the cost of audits.
    (2) Quality system documentation. The manufacturer must be able to 
demonstrate a documented quality system. Management must review the 
adequacy of the quality system to assure that it is effective and 
conforms to the requirements in Sec.  178.70. The quality system records 
must be in English and must include detailed descriptions of the 
following:
    (i) The organizational structure and responsibilities of personnel 
with regard to design and product quality;
    (ii) The design control and design verification techniques, 
processes, and procedures used when designing the pressure receptacles;
    (iii) The relevant procedures for pressure receptacle manufacturing, 
quality control, quality assurance, and process operation instructions;
    (iv) Inspection and testing methodologies, measuring and testing 
equipment, and calibration data;
    (v) The process for meeting customer requirements;
    (vi) The process for document control and document revision;
    (vii) The system for controlling non-conforming material and 
records, including procedures for identification, segregation, and 
disposition;
    (viii) Production, processing and fabrication, including purchased 
components, in-process and final materials; and
    (ix) Training programs for relevant personnel.
    (3) Maintenance of quality system. The manufacturer must maintain 
the quality system as approved by the Associate Administrator. The 
manufacturer shall notify the Associate Administrator of any intended 
changes to the approved quality system prior to making the change. The 
Associate Administrator will evaluate the proposed change to determine 
whether the amended quality system will satisfy the requirements. The 
Associate Administrator will notify the manufacturer of the findings.
    (b) Design type approvals. The manufacturer must have each pressure 
receptacle design type reviewed by an IIA and approved by the Associate 
Administrator in accordance with Sec.  178.70. A cylinder is considered 
to be of a new design, compared with an existing approved design, as 
stated in the applicable ISO design, construction and testing standard.
    (c) Production inspection and certification. The manufacturer must 
ensure that each UN pressure receptacle is inspected and certified in 
accordance with Sec.  178.71.

[71 FR 33885, June 12, 2006]