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Tuesday, June 5, 2018

How to respond to an improvement notice from FSSAI ?





















Being a food business operator (FBO) in India obtaining FSSAI license is the top priority for establishing & operating food business. As per the licensing process, the designated officer (DO) or his representatives (TOs) are required to review the licensed food premises for compliance verification. In this regard, the review report with nonconformities to standards will form a improvement notice. However, considering the nature of content there is no data published by FSSAI in public domain on this aspects. Hence, this become unprecedented for few FBOs and they often get perplexed in comprehending the content.

Lets see what the act has to say on what is an Improvement notice


What is an Improvement notice?

As per section 32 of FSS Act, clause 1

If the designated officer has reasonable ground for believing that any food business operator has failed to comply with any regulations, he may, by a notice served on that FBO

a. State the grounds for believing that FBO has failed to comply with the regulations
b. Specify the matters which constitute the FBOs failure so to comply
c. Specify the measures which, in the opinion of the said authority, the food business operator must take, in order to secure compliance; and 
d. Require the FBO to take those measures, or measures which are at least equivalent to them, within a reasonable period (not being less than 14 days) as may be specified in the notice 

As it is clearly states, improvement notices depicts the areas for the FBOs to quickly close the non-compliance's (which also involve explanation or clarifications) which were identified during the FSSAI inspection. However,  FBOs panic when they encounter phrases like "stop production immediately" "seizure of raw material" "usage of unsafe ingredients" will trigger panic 

At the same time, it is important for the FBO to adequately respond within the timelines specified by the Authority failing which the results can be detrimental for the business (like suspension of license, show cause notice followed by cancellation of license)

How do food businesses respond to Improvement notices?

As deliberated in the above section, improvement notices has to be addressed carefully by gathering, analyzing data from internal departments, vendors and other stakeholders of the business. Corrective actions post third party (or internal) audits are seen as analogy to improvement notice responses. Below are the critical steps that can be adapted by the parties in articulating the responses 

1. Comprehend the notice: Upon the receipt of notice, the senior management should comprehend the document and understand the risks to the business. Also, they should nominate a competent person to complete the initial draft along with necessary approvals to expedite the closure prior to the deadline. This will enable the management to vet the draft and tweak the content 

2. Assembling a team: The senior management (or its representative) should engage a team comprising of individuals from quality, internal audit, legal & compliance, supply chain, procurement and any other as applicable and relevant to the nonconformities. Also, external consultants (or SMEs) would bring industry experience and aid the internal team for a quick closure of draft

3. Root-cause analysis: Basis the observations, the team should perform a root cause analysis and come with corrective & even preventive action plan considering the risk and impact. Subsequently, the team should prioritize the tasks based on the time take for completion and initiate the corrective action

4. Gathering evidence: Upon completion of the corrective actions, it is important to demonstrate the compliance to the nonconformities observed. Hence, capturing images of these actions would be helpful for the authorities to gain confidence on the FBO. Evidences include registers, destroying raw materials, segregation of raw materials, pest activity, laboratory reports and so on.

5. Collation of responses & final review: its time for collating the explanations, clarifications and evidences to make a final draft with assurance to Authority on the organization commitment to food safety. It is often recommended to get the final draft reviewed by a consultant (who can bring in a neutral view) before dispatch. Obtain the postal acknowledgment receipt upon dispatching the dossiers to FSSAI

6. Course correction: To err is human; therefore being in food business it is important to develop a course correction plan post such incidents. The senior management has to assemble and draw a strategy to mitigate such risks and product the brand equity. Few corrections like training, increased internal audits, random safety testing, supply chain audits etc., are most prevailing practices in the industry

In conclusion, food businesses should shift towards being self-compliant in the light of unscheduled inspections from the Authority. This attitude will keep the FBO prepared of the regulatory audits and help themselves attain a good compliance score. Also, FBOs as a best practice should retain records & documents for at least one year to demonstrate the food safety compliance. Further, it is recommended that food businesses should adapt the inspection checklist introduced by FSSAI for various businesses


Glossary 

FSSAI - Food safety standards authority of India

FBO - Food business operator 

TO - Technical Officer

DO - Designated Officer

For more information please write to smartcomplianz@outlook.com or call us at 040-48560467

(All content provided on this blog is for informational purposes only. The owner of this blog makes no representations as to the accuracy or completeness of any information on this site or found by following any link on this site)


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