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FSMS Plan Preparation

FSMS Plan and Affidavit

FSMS Plan Preparation

A food safety management system (FSMS) is a set of written procedures which define the range of actions taken by the food business operator to ensure that the food produced is safe to eat, of the required quality, and legally compliant. FSMS Plan or Food Safety Management System (FSMS) plan is a set of standards established to direct and control aspects of food safety. FSMS plan is an essential part of the FSSAI licensing process. It serves as a mandatory annexure to the application for a food license. As per the FSS Act, 2006, every FBO must devise the FSMS plan before applying for the respective food license. In this article, we look at the process for the preparation of an FSMS plan.

Know more about the FSSAI License and Registration

FSMS Plan

As mentioned above, FSMS Plan or Food Safety Management System (FSMS) plan is a set of standards established to direct and control aspects of food safety. There are many international FSMS like HACCP, ISO 22000, FSSC 22000, and many more. However, these are voluntary certifications, and the FSMS, as defined in the Food Safety and Standards Act, 2006, means the adoption of Good Manufacturing Practices, Good Hygienic Practices, Hazard Analysis and Critical Control Points, and other practices as may be specified by regulation. FSMS plan is required during the application for a new FSSAI License or renewal of an FSSAI License

Requirement for FSMS Plan

The Food Safety and Standard Act 2006 require all food businesses to have an FSMS plan. Even if a food business has a Food Safety Certification from HACCP or ISO of FSSC, an FSMS plan is required per the Food Safety and Standards Act. However, for those food businesses with HACCP, ISO, or FSSC certification, preparing an FSMS plan would be easy as many areas overlap.

Further, the requirement for an FSMS plan is also not dependent on the type or size of the business. Hence, all food businesses require an FSMS plan. But, depending on the size and nature of the company, the size and complexity of the FSMS plan would vary.

Attributes of the FSMS Plan

FSMS plan is an essential document that elaborates on the following;

  • Each of the steps in the operation
  • Applicable/identified hazards,
  • Method for curtailing the hazard/threat
  • Critical limit
  • Method for keeping the tab on the critical threat,
  • Corrective action
  • Obligations
  • Record keeping

Documents Covered Under FSMS

All FSMS Programs must have an FSMS plan, a flow chart for the process, and an inspection checklist.

FSMS Plan

FSMS plan is an important document that defines each of the steps in food business operation, the applicable/identified hazards, the method for controlling the hazard/threat, critical limit, a method for monitoring for urgent threats, corrective action, responsibility, and record keeping. A sample FSMS plan is attached below:

FSMS Flowchart

An FSMS flowchart is a flowchart representation of the process undertaken by the food business. It is essential to have an FSMS flowchart to understand the process and flow of the activities.

Inspection Checklist

The final part of an FSMS plan is the FSMS inspection checklist. Using the FSMS inspection checklist, an authorized person periodically checks the inspection points and marks their observation. Based on the FSMS plan, correction actions are taken based on the word in the checklist.

FSMS Affidavit

While obtaining an FSSAI License, food business operators must submit an FSMS Affidavit in Non-Judicial Stamp Paper. The FSMS affidavit stated that the food business has a food safety plan to ensure food safety and standards and undertakes to put an FSMS as per the food safety Act. However, in the interest of improving the ease of doing business, the FSMS affidavit has been replaced by an FSSAI Undertaking by way of Self Declaration on plain paper. Hence, presently the FSSAI accepts only Undertaking by way of Self Declaration. You can quickly create an FSSAI Undertaking by Self Declaration through the IndiaFilings Live Edit feature.

Preparation of FSMS Plan

Following are the steps for the preparation of an FSMS plan:

Develop a flow diagram

The FBOs should develop a flow diagram that provides a simple, straightforward description of the food business processing steps. It should also describe the ingredients associated with the process, and it should flow from receipt to distribution. The flow diagram should cover every step in the food business’s operation.

Set up the hazard analysis worksheet

The FBOs must prepare the hazard analysis worksheet as follows:

  • They should record all the processing steps (from the prepared flow diagram) in column 1 of the hazard analysis worksheet.
  • Next, they should determine whether the product has a potential product-related hazard.
  • The FBO should record the potential product-related hazard in column 2 of the hazard analysis worksheet.
  • They should next determine whether the potential-related hazard is significant.
  • The FBO should record the identified significant hazard in column 3 of the hazard analysis worksheet for each processing step. 
  • There must be at least one Critical Control Point (CCP) for all significant hazards through which the hazard is controlled.
  • The FBOs should also record the identified potential hazard determined as not significant for a processing step.
  • They should record the reason for determining a potential hazard as significant or not significant in column 4.
  • The preventive measures should be recorded in column 5 for each identified significant hazard.
  • When a processing step is determined as a CCP for a significant hazard, it should be recorded in column 6 of the hazard analysis worksheet.

Set up the FSMS plan

After preparing the hazard analysis worksheet, the FBOs must set up the FSMS plan. The first column of the FSMS plan is the operational step column. The FBOs must find the processing steps identified as CCPs in column 6 of the hazard analysis worksheet and record the names of these processing steps in column 1 of the FSMS plan.

Record the hazard

The FBOs must enter the hazards for which the processing steps are identified as CCPs in column 2 of the FSMS plan. Column 2 of the hazard analysis worksheet also contains this information.

Set Control Measure

The FBOs must enter the control measure in column 3 of the FSMS plan for each identified hazard recorded in column 2 of the FSMS plan. The control activities at a CCP can effectively eliminate, prevent or reduce the hazard to an acceptable level.

Set critical limits

The FBOs must enter the critical limits in column 4 of the FSMS plan. They must identify a parameter’s minimum or maximum value for a process that needs to be controlled to prevent or control the hazard.

Establish monitoring procedures 

The FBOs must describe the monitoring procedures that ensure that each identified hazard’s critical limits are consistently met. They should enter the how, what, who, and frequency monitoring information in column 5 of the FSMS plan. 

Establish corrective action procedures

The FBOs must describe the procedures used when the monitoring indicates a critical limit has not been met for a significantly identified hazard. They should enter the described corrective action procedure in column 6 of the FSMS plan.

Establish responsibility

The FBOs should describe a responsible person who ensures that the FSMS plan is adequate to address the hazard and consistently follow up for each identified hazard. They should enter such responsible persons in column 7 of the FSMS plan.

Establish a recordkeeping system

The FBOs should list the records used to document the success or accomplishment of the monitoring procedures for each identified hazard. The records must contain the details of monitoring the CCP and the actual value observations obtained during the monitoring. They should enter the names of the FSMS monitoring records in column 8 of the FSMS plan.

Complete the FSMS plan form

When the FBOs finish the above steps for all significant hazards related to their product, they will have completed the FSMS plan. They need to sign and date the first page of the FSMS plan. The signature should be of the most responsible individual on-site at the processing facility. It signifies that the food business has accepted the FSMS plan for implementation.

Importance of FSMS Declaration

While applying for an FSSAI Licenseapplicants must furnish an FSMS declaration on the company’s letterhead.

Click here to learn more about the FSMS Declaration.