Food Safety Management System Plan

The Food Safety Management System (FSMS) plan is standards established to control and direct aspects of food safety. There are many international food safety management systems like ISO 22000, HACCP, FSSC 22000, etc. However, all these are voluntary certifications. In India, the Food Business Operators (FBOs) must prepare the FSMS plan since it is required during applying for a new FSSAI licence or FSSAI licence renewal.

The Food Safety and Standards (FSS) Act, 2006 defines a food safety management system as the adoption of good hygienic practices, hazard analysis and critical control points, good manufacturing practices, and such other practices as specified by regulation.

Documents Covered Under FSMS

The Food Safety Management System (FSMS) covers the following documents as per the FSSAI regulations and rules:

• FSMS Plan

The FSMS plan is an important document that defines the steps in operation, the identified or applicable hazards, controlling measures of the hazard or threat, critical limits, methods for monitoring critical threats, corrective actions, responsibility and record-keeping. 

The FBOs must develop a separate FSMS plan for each production location and each type of manufactured product. However, the FBOs can group products in a single FSMS plan when the food safety controls and hazards are the same for all products in the group.

• FSMS Flowchart

The FSMS flowchart is a flowchart representation of the food business’s process. The FSMS flowchart helps to understand the flow and process of the activities. Thus it is essential to make the flowchart. The flowchart is prepared as per the steps followed by the food business operation.

• Inspection Checklist

An authorised person checks the inspection points and marks his/her observations using the FSMS inspection checklist. The FBOs take correction actions based on the observations in the checklist in their FSMS plan.

• FSMS Affidavit

The FBOs must submit an FSMS affidavit on a non-judicial stamp paper while applying for an FSSAI licence. The FSMS affidavit states that the food business has a food safety plan to ensure the standards and safety of food as per the food safety Act are met. However, the FSMS affidavit is replaced with an FSSAI undertaking through self-declaration on plain paper.

Requirement for FSMS Plan

The FSS Act provides that all food businesses should have an FSMS plan. The FSMS plan is required even when a food business has a food safety certification from ISO or HACCP. However, preparing an FSMS plan would be easy for those food businesses having an ISO, HACCP or FSSC certification as many areas overlap. Further, the requirement for an FSMS plan is not dependent on the size or type of business. Hence, all food businesses should prepare an FSMS plan.

Sample of FSMS Plan

Below is a sample of the FSMS plan that an FBO needs to prepare:

Below is a sample of a filled FSMS plan for a biscuit manufacturing unit:

More samples of FSMS plans, flowcharts and inspection checklists for different food businesses can be found here.

Preparation of FSMS Plan

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

• Develop a flow diagram

The FBOs should start with developing a flow diagram providing a simple, clear description of the steps involved in processing the food business. 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 process that the food business performs.

• 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 potential product-related hazard should be recorded in column 2 of the hazard analysis worksheet.
• They should next determine whether the potential-related hazard is significant.
• The identified significant hazard should be recorded 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 the minimum or maximum value of a parameter 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 to be used when the monitoring indicates that a critical limit has not been met for a significant 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.

Disclaimer: The materials provided herein are solely for information purposes. No attorney-client relationship is created when you access or use the site or the materials. The information presented on this site does not constitute legal or professional advice and should not be relied upon for such purposes or used as a substitute for legal advice from an attorney licensed in your state.