Inspecting and auditing food businesses is a humongous task, hence in order to cultivate and foster the growth of compliance culture FSSAI is enabling compliance through Auditing Agencies. While emphasizing on self-compliance by the food businesses, to address the need to monitor such compliance, FSSAI is envisaging introducing Audit of the food companies by FSSAI Recognized Auditing Agencies.

This Food Safety and Standards (Food Safety Auditing) Regulations, 2018 includes the Procedure for recognition of Auditing Agencies, Procedure for Renewal/ Cancellation/Suspension of recognition, Terms and conditions of recognition, auditing procedure, Duties of auditors, Audit reporting and audit monitoring system.

An audit examination shall include collection of objective evidence and recording of audit observations collected or made through interviews, examination of documents and activities.

The deficiencies or non-conformities observed by the auditing agency shall be recorded clearly and concisely, pointing out the regulatory requirements that are being contravened.

During the audit process, the auditing agency shall verify the compliance not only with the food safety measures, but also with the provisions of the Act and the rules and regulation made thereunder, except those which require specific sampling and laboratory analysis of the products and also verify relevant documents relating to laboratory reports maintained by the Food Business Operator.

Duties of Auditor:

The auditor shall perform the following duties, namely, -

i. Conduct food safety audit of Food Business Operator;

ii. Verify the compliance by the Food Business Operator of the provisions of the Act and the rules and regulations made thereunder;

iii. Conduct pre-commissioning inspection of newly established food business unit, as and when directed by the Food Authority;

iv. Maintain confidentiality in respect of commercial-in-confidence materials, which may include process and product formulation information, food safety programme information and audit outcomes;

v. Forward the audit report to the Food Authority within fifteen days of the conduct of food safety audit;

vi. Carry out necessary follow-up action, including further audits, to verify if any corrective action has taken to remove any deficiency of such food safety program identified during the audit;

vii. Maintain confidentiality of food safety audit;

viii. Such other duties as may be directed by the Food Authority.

Roles of auditor after making the audit report:

(1) The auditor shall after the completion of the audit, inform the FBO of the deficiencies or the non-conformities observed during the audit and give an opportunity to provide any further information or clarification required for completion of audit finding and reflect the same in the audit report.

(2) When there is a major non-conformity which is a serious failure in the food safety management system of the FBO and may result in adverse health consequence possibly even fatal, the auditor shall report such findings to the Central Licensing Authority or State Licensing Authority within twenty-four hours.

(3) When there is a minor non-conformity which is shortcoming in the food safety management system or regulatory contravention of the FBO and may not cause any adverse health consequence, the auditor shall set up an appropriate timeframe of not more than 30 days for its rectification and follow up, so that the non-conformance could be rectified.

(4) Failure by FBO to rectify the minor non conformity within the specified timeframe shall be referred to the Central or State Licensing Authorities (The Authority), as the case may be.

(5) The auditing agency shall submit a copy of audit report to the FBO immediately after completion of the audit and forward audit report the authority, as the case may be within fifteen days clearly bringing out the findings or non-conformities or concerns and observations for improvement.

(6) The auditor may recommend in writing the reasons for the change in audit frequency of the FBO to the Authority based on the audit.

The auditing agency shall give a declaration in Form ‘C’ of the schedule before accepting food safety audit of a FBO. The recognition of any auditing agency shall be suspended or cancelled immediately by the Food Authority on the event of providing false information on conflict of interest.