ThirdParty Certification Body Accreditation for Food Safety Audits

Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards: Guidance for Industry and FDA Staff https: //www. fda. gov/downloads/food/guidanceregulation/guidancedocum entsregulatoryinformation/ucm 455331. pdf December, 2016

FSMA Final Rule on Accredited Third-Party Certification https: //www. fda. gov/food/guidanceregulation/fsma/ucm 361903. htm June, 2017

Accredited Third-Party Certification Rule • Rule on was finalized in November 2015 • Establishes a program for the accreditation of thirdparties to conduct food safety audits and issue certifications of foreign entities • Rule will help FDA to ensure the competence and independence of the third parties participating in the program

Two Key Definitions • Recognized Accreditation Body Could be a foreign government/agency or a private thirdparty • Third-Party Certification Body (Auditor) This body is an accredited auditor. It could be a foreign government/agency, a third-party entity or an individual.

Four Key Features of the Rule 1. Scope 2. Requirements for Recognized Accreditation Bodies 3. Requirements for Third-Party Certification Bodies (Auditors) 4. Related FDA Actions

1. Scope of the Rule The Rule identifies procedures and requirements for accreditation bodies seeking recognition by the FDA, including: • • • Legal Authority Competency Capacity Conflict-of-Interest Safeguards Quality Assurance Record Procedures

Scope of the Rule, con’t. The FDA may directly accredit third-party certification bodies (auditors) if there is no recognized accreditation body within two years of establishing the program (estimated June, 2019) Both types of bodies may use ISO/IEC* documentation to meet program requirements FDA will monitor bodies’ performance and has the authority to revoke accreditation *ISO – International Organization for Standardization *IEC – International Electrotechnical Commission

2. Requirements for Recognized Accreditation Bodies Could be a foreign government/agency or a private thirdparty Assess third-party certification bodies (auditors) for accreditation and monitor subsequent performance Assess and correct problems in their own performance Submit reports/notification to FDA and maintain records of activities

3. Requirements for Third-Party Certification Bodies (Auditors) Could be government, a private entity or an individual Auditors must perform unannounced facility audits and notify FDA of threats to public health If the auditor has agents, ensure that the agents are competent and objective Verify the effectiveness of corrective actions Maintain records and provide those to the FDA

Two Types of Audits May be Performed by Third-Party Certification Bodies • Consultative Audit - Conducted in preparation for a regulatory audit and is for internal use. This is not a basis for certification • Regulatory Audit (Inspection) - Can be the basis for certification • Note – In both types of audits, auditors examine compliance with applicable federal food safety rules

Auditing Capacity of Third-Party Certification Bodies The size of the body may vary from single person to a multi-national organization. The size of the job may also vary in this way. The body must have adequate resources, e. g. employees, agents, financial, etc. to examine farms and facilities for compliance Auditors should have the knowledge and skills to issue valid and reliable certification

The Auditor’s Resources Must Include: • • A documented organizational structure Support staff if needed Support for training Equipment for conducting audits Support for sampling and laboratory analyses Capability for maintaining records appropriately Resources for effective communication

Auditing Competency of Third-Party Certification Bodies The individual auditor, the auditing firm, employees, agents, and others with auditing responsibility, must have the knowledge, skills and experience to evaluate a farm facility for regulatory compliance There should be a means of verifying, through written or oral testing, that the responsible persons meet this requirement

Recommended Prerequisites for Auditors Entry Level Auditors • BS or higher degree in a food-related or relevant discipline • At least 30 semester hours of course work plus appropriate experience or additional education • Demonstration of knowledge and experience to perform the required tasks

Recommended Prerequisites for Auditors Lead Auditors • At least 5 years experience in food or associated industry, including 2 years work in quality assurance or food safety functions • Manufacturing, retail, inspection, enforcement, or the equivalent • Other formal qualifications (e. g. advanced degree) may substitute for 3 years work experience

Auditors Personal Attributes and Code of Conduct • • • High Ethical Standards Objectivity Reasoning Skills Interpersonal Skills Analytical Skills Communication Skills Diligence Adaptability Tenacity Intuition Observational Skills

Training of Auditors and Managers • Training in the FDA’s Food Safety Requirements Auditors, managers, employees, etc. must understand properly apply FDA’s food safety requirements Technical training may vary depending on processes and products being audited • Continuing Professional Development Regular training or joint audits with a qualified trainer

Ensuring Competency of Auditors • Evaluation Criteria Documented process for performing initial and ongoing evaluations of auditors skills, knowledge and abilities, to include witness audits • Monitoring Documented process for ongoing monitoring • Frequency of Evaluation Evaluate auditor performance at least annually and do a witness audits at least once every two years

Conflicts of Interest There must be a written program for ensuring that there is not a conflict of interest Good practice to identify officers, personnel, agents, committee members, lines of authority, relationships to other business, etc. in an organizational chart

Records There should be written procedures to establish, control and retain records, including but not limited to the following: 1. 2. 3. 4. Consultative audit documents Requests for regulatory audits Regulatory audit documents Notifications from an agent to an auditor related to health risks 5. Notifications to FDA related to health risks

Records, con’t. 6. Any food or facility certification 7. Any challenge to a regulatory audit decision 8. Any monitoring that is conducted 9. Self assessments and corrective actions 10. Significant changes to an auditing or certification program

Requirements for Regulatory Audit Reports These reports must be submitted to the FDA within 45 days of completion of an audit Refer to the Guidance (page 16) for details on the content of the reports

Exemptions • Certain alcoholic beverages • Certain meat, poultry and eggs subject to USDA

How Do I Apply? https: //www. access. fda. gov/ You must create an account and log in before you can access the Third-Party Certification site

You are not required to have a FDA certified auditor or auditing system You may work with an existing third-party auditing company or entity Auditing information and examples of the auditing forms are available free on-line USDA Harmonized GAP Global. GAP Primus Labs many others

Questions?