§ 280.1123 - Assessment report.  


Latest version.
  • (a) The Registrar may adopt reporting procedures that suit its needs but, as a minimum, these procedures shall ensure that:

    (1) A meeting takes place between the audit team and the fastener manufacturer's management prior to leaving the premises, at which the audit team provides a written or oral indication regarding the conformity of the quality assurance system, as employed in particular Facility, with the particular registration requirements and provides an opportunity for the fastener manufacturer to ask questions about the findings and their basis;

    (2) The audit team provides the Registrar with a report of its findings as to the conformity of the quality assurance system, as employed in the particular Facility, with all of the registration requirements;

    (3) A report on the outcome of the assessment is promptly brought to the fastener manufacturer's attention by the Registrar, identifying any nonconformity to be discharged in order to comply with all of the registration requirements;

    (4) The Registrar shall invite the fastener manufacturer to comment on the report and to describe the specific actions taken, or planned to be taken within a defined time, to remedy any nonconformity with the registration requirements identified during the assessment of its quality assurance system, as employed in the particular Facility, and shall inform the fastener manufacturer of the need for full or partial reassessment of its quality assurance system or whether a written declaration to be confirmed during surveillance will be considered adequate;

    (5) The report shall contain as a minimum:

    (i) The date(s) of the audit(s);

    (ii) The name(s) of the person(s) responsible for the report;

    (iii) The names and addresses of the Facility audited;

    (iv) The assessed scope of registration or reference thereto, including reference to the standard(s) applied;

    (v) Comments on the conformity of the quality assurance system, as employed in the particular Facility, with the registration requirements, with a clear statement of nonconformity and, where applicable, any useful comparison with the results of previous assessments of the quality assurance system, as employed in that particular Facility; and

    (vi) An explanation of any differences from the information presented to the body at the closing meeting.

    (b) If the final report authorized by the Registrar differs from the report referred to in paragraphs (a)(3) and (5) of this section, it shall be submitted to the fastener manufacturer with an explanation of any differences from the previous report. The report shall take into consideration:

    (1) The qualification, experience, and authority of the staff encountered.

    (2) The adequacy of the internal organization and procedures adopted by the applicant body to give confidence in the quality assurance system, as employed in the particular Facility; and

    (3) The actions taken to correct identified nonconformities including, where applicable, those identified at previous assessments.