On 12 October 2017, the FSSAI notified the draft Food Safety and Standards (Food Safety Auditing) Regulations, 2017 which have been uploaded for stakeholder consultation. Any objections, suggestions, and comments must receive the FSSAI office by 17 November 2017.
The FSSAI envisages the introduction of third-party auditing through FSSAI recognized Auditing Agencies for those food businesses that find auditing and inspecting an enormous task. While FSSAI lays emphasis on self-compliance, never-the-less there is still a need to monitor compliance which the recognized third-party auditors will carry out. In this way, third-party audits will help to foster growth in the culture of compliance.
Selected food categories, based on their risk classification will be subject to third-party auditing. Such food businesses would be required to get their businesses audited by recognized Auditing Agencies on their own and in a timely manner. Food businesses which are not subject to mandatory auditing can also voluntarily opt for third-party auditing of their businesses. Food Businesses that have satisfactory audits may see a reduction in the frequency of inspections by Central or State licensing authorities. Third parties audits will also in this way reduce the burden on the regulatory inspection and encourage self-compliance.
This draft Food Safety and Standards (Food Safety Auditing) Regulations, 2017 is divided into Parts and Schedule, which have the various forms.
PART – I
This section includes the definition of some terms that will be used in the regulation like accreditation body, application, auditing report, auditing agency, food safety audit, risk and a third party and which have all been clarified here.
PART-II
Recognition of auditing organization or agency
The auditing agency shall
- be registered in India
- hold a valid accreditation ISO/IEC 17020 and ISO/IEC 17021 for the required food categories specified by the Food Authority
- have a minimum of three auditors with minimum qualification requirements as follows:
(i) Bachelor’s degree in Food or Dairy Fisheries or Oil Technology or Biotechnology or Agricultural or Veterinary Sciences or Biochemistry or Microbiology or Chemistry from a recognized university
(ii) Successfully completed Accredited Lead Auditor course in Food Safety Management System recognized by International Register of Certificated Auditors (IRCA) and/or any other body specified by the Food Authority from time to time
(iii) Have knowledge of the Act and the rules and regulations made thereunder
(iv) Have specific knowledge of hygienic and sanitary practices, processing techniques, hazards identification, analysis and control and knowledge of contaminants, allergens, etc.
(v) Any other additional requirement or mandatory training as may be specified by the Food Authority.
- Criteria for recognition may be relaxed by the Food Authority for the reasons to be recorded in writing.
Procedure for recognition
- The auditing agency shall file an application in Form A, enclose documents as given in the annexure of the schedule appended to these regulations and fees
- On scrutiny, if the deficiency is found, then the applicant will be informed within 30 days and applicant must provide information sought within 15 days of receipt of said communication or the application is likely to be rejected without refund of fees.
- FSSAI will constitute a Screening Committee for recognition of the auditing agency
- If the Food Authority is satisfied that the applicant fulfills all the requirements the application shall be placed before the Screening Committee for making recommendations to the Food Authority for its recognition.
Terms and conditions of recognition
- On the recommendation of the Screening Committee, the Food Authority may recognize the auditing agency
- The auditing agency shall be provided with a certificate of recognition in Form ‘B’ of the schedule with a unique identification number
- The certificate of recognition granted under these regulations shall be valid for a period of three years.
- The recognition that has been granted to the auditing agency shall be liable to be suspended or canceled by the Food Authority
Procedure for renewal
- The auditing agency may make an application for renewal of recognition not later than sixty days prior to the date of expiry specified in the certificate of recognition.
- The Food Authority shall consider the application for renewal on the basis that it continues to meet the criteria for recognition specified in the regulations and based on the performance of the auditing agency over the three year period.
- The same shall be placed before the Screening Committee for evaluation and on their recommendation, the Food Authority shall renew the certificate of recognition.
Procedure for cancellation or suspension
The Food Authority may issue a show cause notice to suspend or cancel the recognition of the auditing agency by an order if the Auditing Agency has
- made an application to be declared an insolvent
- failed to carry out any orders issued by the Food Authority;
- committed a fraudulent act
- become incompetent to continue to be accredited food safety auditor as required under these regulations
- failed to provide access to records and furnish necessary information to the Food Authority to conduct the assessment or investigation
- failed to take timely and necessary corrective measures, if any, as directed by the Food Authority
- provided false information with regard to conflict of interest
And also for any reason
- found by the Screening Committee on receipt of complaints and conduct of the auditing agency
- that the Food Authority may specify in this behalf
On receiving show cause notice
- The Auditing Agency shall file a reply to the FSSAI within 15 days of receiving the show cause notice, failing which the Food Authority can decide to suspend or cancel the recognition.
- The Food Authority shall consider the reply filed by the auditing agency and pass such orders as deemed fit under the provision of these regulations within thirty days of the receipt of the reply of the auditing agency.
- The Food Authority may revoke the suspension of recognition upon consideration of the corrective measures taken by the auditing agency under these regulations.
- In case of cancellation, the applicant shall make a fresh application for recognition to the Food Authority after a period of six months from the date of such cancellation.
- The recognition of the auditing agency shall be deemed to be suspended or canceled if its accreditation is suspended or canceled by its accrediting body.
- The auditing agency aggrieved by the order of suspension or cancellation of recognition may file an appeal to the Chairperson of the Food Authority.
PART – III AUDITING PROCEDURE
Audit process
The Food Authority shall, from time to time specify the category or type of food businesses which shall be subject to mandatory food safety auditing, primarily based on their risk classification. The classification of food business shall be done after consideration of the major risk factors like
- food type
- intended customer use
- nature of the activity of the business
- a volume of the business
- method of processing and/or any other factors that the Food Authority may specify in this behalf
Such food businesses shall get their business audited by the recognized auditing agency as per the frequency specified by the Food Authority. Food businesses for which there is no mandatory food safety auditing can get audited by the recognized auditing agency if they so desire.
Those food businesses where food safety audits have been satisfactorily conducted may be subject to less frequent inspections by the Central or the State licensing authorities except for regulatory purpose: Provided that in case of any complaints against the food businesses or when it comes to the knowledge of the
Food Authority that the public health and safety is at risk, the Food Authority shall have the discretion to undertake more frequent inspections.
The audit process involved in assessing the food safety management system of a Food Business Operator shall be based on IS/ISO 19011:2011 (Guidelines for auditing management systems).
Audit examination
- An audit will cover collection of objective evidence and documenting audit observations 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.
Duties of auditors
The auditor shall perform the following duties
- conduct food safety audit of 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 fifteen days of the conduct of food safety audit
- carry out necessary follow-up action, including further audits, to check whether any corrective action was taken to remove any deficiency of such food safety program identified in an audit
- maintain the confidentiality during food safety audit
- any other related assignment which the Food Authority may specify from time to time.
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 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:
- 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 consequence 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.
- Minor non-conformity- When there is a shortcoming in the food safety management system or regulatory contravention of the Food Business Operator, which may not cause any adverse health consequence, the auditor shall set up an appropriate timeframe for its rectification and follow up, so that the non-conformance could be rectified.
Failure by food business operator to rectify the minor non-conformity within the specified timeframe shall be referred to the Central or State Licensing Authorities, as the case may be. The auditor may recommend in writing the reasons for the change in audit frequency of the food business operator to the Central or State Licensing Authority based on the audit.
Conflict of interest
- The auditing agency shall give a declaration in Form ‘C’ of the schedule before accepting food safety audit of a Food Business Operator.
- The recognition of any auditing agency shall be suspended or canceled immediately by the Food Authority on the event of providing false information on conflict of interest.
PART – IV
Audit monitoring
The Food Authority shall monitor the performance of the recognized auditing agency in the following manner
The monitoring mechanism shall include
- review of the audit reports and performance
- on-site assessment of the auditors to ensure their competency of auditing the food safety management systems and the regulatory requirements
- assessment of auditing agency on the basis of a report of the accreditation body and any other mechanism as specified by the Food Authority
Handling disputes
- The Central or the State Licensing Authorities shall be the contact point for Food Business Operator to engage in case of any dispute or disagreement with auditors
- In case of any non-cooperation or resistance to the working of the auditing agencies or auditors by food business operator, the same shall be referred to the Central or the State Licensing authorities for resolution.
Record keeping
- The final conformance report and all other documents related to the audit conducted including the first audit report, actions taken and successive communications on rectification measures shall be preserved by the auditing agencies at least for a period of five years and full confidentiality of the documents shall be maintained.
- Food Business Operator shall maintain all records of audit findings and rectification for a period of five years.
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