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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2017]
[CITE: 21CFR1.655]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL

PART 1 -- GENERAL ENFORCEMENT REGULATIONS

Subpart M--Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications

Requirements for Third-Party Certification Bodies That Have Been Accredited Under This Subpart

Sec. 1.655 How must an accredited third-party certification body monitor its own performance?

(a) An accredited third-party certification body must annually, upon FDA request made for cause, or as required under 1.631(f)(1)(i), 1.634(d)(1)(i), or 1.635(c)(1)(i), conduct a self-assessment that includes evaluation of compliance with this subpart, including:

(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.

(b) As a means to assess its performance, the accredited third-party certification body may evaluate the compliance of one or more of eligible entities to which a food or facility certification was issued under this subpart.

(c) Based on the assessments and evaluations conducted under paragraphs (a) and (b) of this section, the accredited third-party certification body must:

(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).

(d) The accredited third-party certification body must prepare a written report of the results of its self-assessment that includes:

(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.

(e) An accredited third-party certification body may use a report, supplemented as necessary, on its conformance to ISO/IEC 17021: 2011 or ISO/IEC 17065: 2012 in meeting the requirements of this section.

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