Code of Federal Regulations Title 21. Food and Drugs § 21.1.655 How must an accredited third-party certification body monitor its own performance?

(1) The performance of its officers, employees, or other agents involved in auditing and certification activities, including the performance of audit agents in examining facilities, process(es), and food using the applicable food safety requirements of the FD&C Act and FDA regulations;

(2) The degree of consistency among its officers, employees, or other agents involved in auditing and certification activities, including evaluating whether its audit agents interpreted audit protocols in a consistent manner;

(3) The compliance of the accredited third-party certification body and its officers, employees, and other agents involved in auditing and certification activities, with the conflict of interest requirements of § 1.657;

(4) Actions taken in response to the results of any assessments conducted by FDA or, where applicable, the recognized accreditation body under § 1.621;  and

(5) As requested by FDA, any other aspects of its performance relevant to a determination of whether the accredited third-party certification body is in compliance with this subpart.

(1) Identify any deficiencies in complying with the requirements of this subpart;

(2) Quickly implement corrective action(s) that effectively address the identified deficiencies;  and

(3) Under § 1.658, establish and maintain records of such corrective action(s).

(1) A description of any corrective action(s) taken under paragraph (c) of this section;

(2) A statement disclosing the extent to which the accredited third-party certification body, and its officers, employees, and other agents involved in auditing and certification activities, complied with the conflict of interest requirements in § 1.657;  and

(3) A statement attesting to the extent to which the accredited third-party certification body complied with the applicable requirements of this subpart.