Third Party Audit in FSSAI

FSSAI Role Function and Initiative – is the most important topic as per FSSAI Exam 2021 syllabus. in this post, I am providing “A General Understanding of FSSAI Role, Functions and Initiatives” detailed Notes and this is the Next chapter –Third-Party Audit.

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Third Party Audit [FSSAI] Mindmap

Definition of Food Safety Third Party Audit

The inspection and surveillance of FBOs from time to time for sustainable compliance of Food Safety rules and regulations and to ensure the safety of food is called Food Safety Audit.

The Recognised Private agencies by FSSAI is called Third Party Audit Agencies and the person who audits any FBO is called Food Safety Auditor.

Food businesses are classified into different types for different types of Auditing. This classification is based on – food type, customer use, nature of the activity of the businesses, the volume of the business, and processing methods.

Objectives of Food Safety Third Party Audit

The objectives of Food Safety Third Party Audit is to –

• strengthen food safety surveillance system
• reduce the regulatory Food Safety Inspections conducted by Central/State Licensing authorities.
• encourage Self Compliance.
• Develop a self-sustaining ecosystem for ensuring compliance of FBOs.
• Reduce the gap between regulator led enforcement and field level non-compliance.

Criteria for recognition of Audit Organisations/Agencies:

• they should be a legal entity in India
• they should have valid accreditation.
• The accreditation body is a member of IAF (international accreditation Forum) and signatory to IAF Multilateral Recognition Arrangements.
• Should have a minimum of 3 qualified auditors.
• It is desirable to have indemnity insurance.

Qualifications prescribed for the Food Safety Auditors of the Auditing Agency:

• Bachelor’s degree in Food/Dairy/Fisheries/Oil Technology or biotechnology or Agricultural/Veterinary Sciences or Bio-Chemistry or Microbiology or Chemistry from a recognized university.
• accredited Lead Auditor course in FSMS recognized by IRCA/or anybody specified by Food Authority.
• Knowledge of FSS Act, Rules and Regulations.
• Sector Specific knowledge.
• any other additional requirement/mandatory training.

Criteria for approval and recognition of Auditing Agency:

• Auditing Agencies applies for recognition along with Fees
• Applications reviewed by FSSAI
• Applications placed before the screening committee
• Assessed by screening committee on the basis of Qualifications/Experience and if necessary through interview/exams etc. – either Approved or Reject
• Certificate of provisional recognition issued and list of recognized auditors of the agency published on FSSAI website with validity and scope of the audit.
• FBO chooses the auditor as per their business requirement.

Duties of Auditors in Food Safety Third Party Audit:

They should –

• conduct a food safety audit of the Food Business Operator.
• check compliance with the provisions of the various regulations made under the act.
• conduct a pre-commissioning inspection of newly established food business units, as directed by the Food Authority;
• keep all commercial-in-confidence material confidential, which includes process and product formulation information, food safety program information and audit outcomes.
• forward the audit report to the food authority within 15 days of the conduct of the food safety audit.
• carry out necessary follow-up action, including further audit, to check whether any corrective action was taken to remove any deficiency of such a food safety program identified in an audit.
• maintain confidentiality during food safety audits.
• any other related assignment which the Food Authority may specify from time to time.

Audit Examination-

• audit examination shall cover the collection of objective evidence and documenting audit observations.
• Evidence can be collected through interviews, examination of documentation and observation of activities. 
• Where the deficiencies or non-conformances are detected, they shall be documented clearly and concisely and shall point 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 Food Safety Standards Regulations as applicable other than those which may require specific sampling and laboratory analysis of the products. 
• The auditing agency shall check relevant documents related to laboratory reports maintained by the Food Business Operator as part of compliance with various regulations made under the Act.

Audit Report-

• The auditor shall report the findings of the audit to the food business after the completion of the audit, wherein the food business shall be given an opportunity to discuss the findings and provide further information or clarification to the auditor, if necessary.
• The auditing agency shall submit the audit report in the format specified by the Food Authority to the Food Business Operator immediately after completion of the audit and also to the Central or State Licensing Authority within fifteen days.
• the audit report shall clearly bring out the finding or non-conformities. The non-conformities of the audit may be classified into two categories, namely, – 1. Major Non-Conformity and 2. Minor Non-Conformity.
• Major Non-Conformity: when there is a serious failure in the food safety management system of the food business operator, which may result in adverse health consequences possibly even fatal, the auditor shall report such findings to the central or state licensing authority within twenty-four hrs. the central or state licensing authority after ascertaining the seriousness of the situation shall take regulatory action against the concerned food business operator.

Enforcement in Food Safety Third Party Audit

While standards help to set the benchmarks that need to be met, it is imperative to have robust institutional frameworks and systems to ensure compliance with the standards and regulations. A comprehensive compliance system includes surveillance and inspections for both domestic and imported food products. This is called enforcement under FSSAI. Under enforcement, the important points are –

• The primary onus of ensuring compliance rests with the States and UTs.
• State/UT governments have appointed commissioners of Food Safety, notified Adjudicating Officers, Designated Officers and Food Safety Officers for their respective jurisdictions to perform various functions mandated under the Act.
• Additional Food Safety Commissioners have been notified for Railways, Airports and Ports along with Designated Officers for Airports and Ports.
• Appellate Tribunal is established in 25 States/UTs.
• All FBOs in India are required to be licensed or registered under the provisions of the FSS Act 2006. FSSAI has created an online system for Food Licensing and Registration (FLRS) and all States and UTs (except Nagaland) are issuing Food Licenses/Registrations through online mode.
• A large-scale IT platform for Food Safety Compliance through Regular Inspections and Sampling (FoSCoRIS) is being put in place.
• FoSCoRIS is a web-based real-time inspection platform for Food Safety Officers (FSOs). Used via hand-held device like mobile phones and Tablets.
• it uses instant geo-tagging, time stamping, real time data collection and multi-levels of verification. The system uses a nation-wide IT platform to bring together all key stakeholders, namely the food businesses, food safety officers (FSOs), designated officers (Dos), State food safety commissioners (FSCs) so that such inspections and sampling is done by maintaining a high level of integrity of the process and the process itself is effectively monitored at various levels.

Imports

A key mandate of the Food Safety and Standards Authority of India (FSSAI) is to regulate the import of food and ensure that it is safe and wholesome for human consumption. Section 25 of the Food Safety and Standards Act, 2006 provides that all food imports should follow the standards laid down by the Food Authority so that unsafe or sub-standard food is not imported. Accordingly, a separate regulation on imports i.e. The Food Safety and Standards (Import) Regulations 2017 were notified on 9^th March 2017. This provided a single reference regulation for food imports.

As per section 25 of the FSS Act, 2006,

1. No person shall import into India
   • Any unsafe or misbranded or sub-standard food or food containing extraneous matter.
   • Any article of food for the import of which a license is required under any act or rules or regulations, except in accordance with the conditions of the license; and
   • Any article of food in contravention of any other provision of this act or of any rule or regulation made thereunder or any other act.
2. The central government shall, while prohibiting, restricting or otherwise regulating import of article of food under the Foreign Trade (Development and Regulation) Act, 1992, follow the standards laid down by the Food Authority under the provisions of this act and the Rules and regulations made thereunder.

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