US FDA Issues Model Accreditation Standards for Third Party Certification Bodies and Fee Structure under FSMA
SAFEGUARDS | Food NO. 195/16
On December 7, 2016, the United States Food and Drug Administration (US FDA) published their third-party certification body accreditation for food safety: model accreditation standards , which is guidance for the industry and their own staff. On December 14, they finalized the fee structure .
The major sections of this guidance are:
- Legal authority and responsibility
- Capacity and competency (of the audit body and agents)
- Conflicts of interest
- Quality assurance
- Record keeping
- Requirements of the regulatory report
Legal Authority and Responsibility
The third-party certification body must be able to demonstrate to the accreditation body and/or the US FDA their capability to perform the required activities listed in the third-party certification program regulation. They must have the authority to review records, grant the US FDA access to relevant records, conduct unannounced onsite audits, and suspend or withdraw certification of facilities that fail to comply with the requirements. If sampling and testing is necessary during the audit a laboratory accredited to ISO/IEC 17025:2005 or similar must be used. If a serious risk to public health is found during an audit the third-party certification body must have the ability to notify the US FDA of this issue.
Capacity and Competence
The third-party certification body must have adequate numbers of trained employees, or other agents, to perform audits, manage auditors, equipment to perform the audits, quality assurance and other support personnel and effectively communicate with foreign facilities that require the audit. The US FDA has established the education or experience of an entry level auditor and a lead auditor, the specific attributes and code of conduct needed, training for auditors and managers and evaluation and monitoring processes to ensure that auditors are competent. This includes ongoing monitoring of auditors, annual performance evaluation at minimum and witnessing an auditor performing an audit at least once every two years.
Conflicts of Interest
The certification body must have a written program to protect against conflicts of interest. The program must promote independence, objectivity and impartiality. An audit agent must not perform both the consultative and the regulatory audit within a 13 month period, unless there is insufficient access to accredited third party certification bodies in the country or region of the facility. The certification body must have a website with an up to date list of the facilities certified, scope of certification and duration.
The certification body must have a written quality assurance program to monitor and evaluate the performance of all personnel involved in auditing and certification activities. The certification body must have the ability to perform self assessment, quickly implement effective corrective actions, establish and maintain corrective actions and prepare reports of the assessments. Annual reviews of the system must include areas for improvement, implementation of appropriate corrective actions, effectiveness of corrective actions, as well as the evaluation of personnel in regards to conflict of interest and resources that may be needed.
Records are to be kept for a minimum of four years. They must include consultative audit documents, requests for regulatory audits, regulatory audits documents (including laboratory tests), notifications of audit agent to the certification body of a condition of serious risk to the public health, and from the certification body to the US FDA of a serious risk to the public health, any certifications, self assessments, facility monitoring, corrective actions and others as required. Additionally, records kept must include a written program to protect against conflict of interest and documentation related to competency.
Regulatory Audit Report
The report will include the facility location, US FDA registration and establishment identifier, date and scope, processes and foods observed, name and personnel of the responsible parties at the facility. It must also include any adverse health related deficiencies noted, corrective action plan unless correct on site and verified by the auditor, any sampling and testing and whether the facility has made any significant changes to its building, equipment, operation, processes or products in the two years before the audit was performed.
The US FDA finalized the fee structure for this program, which will become effective January 13, 2017 and will remain in effect until September 30, 2017. There are fees associated with accreditation body application, renewal and annual fees, as well as annual fees for certification bodies directly accredited by the FDA, and certification bodies accredited by recognized accreditation bodies. In FY 2017, the only fee that will be collected by FDA is the initial application fee for accreditation bodies seeking recognition.
What Does This Mean For The Food Industry?
The US FDA has previously supplied the framework for, and now has supplied the details of, the requirements of a certification body to perform a third-party audit, as required by the Voluntary Qualified Import Program (VQIP). This will allow certification bodies to apply to approved accreditation bodies in order to obtain approval to perform food safety audits and issue facility certifications to eligible foreign entities. These approved certification bodies can then perform third party audits at foreign facilities.
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