Food Safety Plans: Building a Practical Food Safety System

Food Safety Plans

A food safety plan should not be a binder that gets created for an inspector and then sits unopened on a shelf.

It should describe how your food business prevents problems every day.

For many growing food businesses, developing a formal food safety system is also the point where informal habits have to become documented procedures.

Who cleans the mixer?

How is sanitizer concentration checked?

What happens if a refrigerator is too warm?

How are allergens controlled?

Which ingredient lot went into yesterday’s production?

Who decides whether questionable product can be released?

A useful food safety plan answers questions like these before something goes wrong.

Does Every Food Business Need the Same Plan?

No.

Requirements depend on the food, process, facility, business structure, sales activity, and regulatory jurisdiction.

Under FDA’s Preventive Controls for Human Food rule, facilities generally required to register with FDA are subject to preventive-control requirements unless an exemption or modified requirement applies. Covered facilities must have and implement a written food safety plan.

Other businesses may operate under different federal, state, or local requirements.

Determine what applies to your operation rather than copying another company’s plan.

Start With the Product and Process

Describe what you make.

For each product or product family, document things such as intended use, packaging, storage conditions, expected shelf life, and basic processing steps.

Then map the process from beginning to end.

A simple flow might be:

Receiving → Storage → Preparation → Mixing → Cooking → Cooling → Packaging → Labeling → Finished Storage → Distribution

Our existing Otherfoods Kitchen Food Safety Plan template uses this same progression and builds the plan around hazard analysis, GMPs, sanitation, allergens, temperatures, traceability, training, recordkeeping, corrective action and verification.

Conduct a Hazard Analysis

The purpose of hazard analysis is to ask what could reasonably go wrong and whether controls are needed.

FDA’s preventive-controls framework considers biological, chemical and physical hazards, including relevant allergen hazards. If a covered facility’s analysis identifies a hazard requiring a preventive control, written preventive controls must be developed and implemented.

This is a technical part of food safety planning. For products or processes with meaningful safety risks, professional guidance may be appropriate.

Establish Preventive Controls

Controls depend on the hazards associated with the operation.

FDA describes categories including process controls, food-allergen controls, sanitation controls, supply-chain controls where applicable, and other controls needed for identified hazards.

A process control might involve time, temperature, pH or another parameter.

An allergen control might address ingredient segregation, production scheduling, cleaning and label verification.

A sanitation control might specify how a food-contact surface is cleaned, how often, with what chemical, at what concentration, and how the cleaning is verified.

Build Strong GMPs

Good Manufacturing Practices create the operating foundation.

Topics commonly include employee hygiene, handwashing, illness policies, protective clothing or hair restraints where appropriate, facility maintenance, equipment condition, pest control, receiving, storage, cleaning, and employee training.

Under FDA’s CGMP rules, employees involved in manufacturing, processing, packing or holding food must be qualified to perform their assigned duties and receive appropriate food hygiene and food-safety training.

Control Allergens Deliberately

Allergen management is not just about putting the right words on a label.

It starts when ingredients enter the building.

Know which ingredients contain allergens. Store them appropriately. Prevent unintended cross-contact. Establish effective cleaning procedures. Control production sequencing when useful. Most importantly, verify that the correct label goes onto the correct product.

FDA’s preventive-controls rule specifically addresses allergen cross-contact and appropriate allergen labeling.

Establish Sanitation Procedures

“Clean the kitchen” is not a sanitation program.

Document:

What gets cleaned?

How is it cleaned?

Which chemical is used?

At what concentration?

How frequently?

Who is responsible?

How is completion verified?

Your food-safety records should show that sanitation is a repeatable process rather than an informal expectation.

Decide What Happens When Something Goes Wrong

A food safety system needs corrective actions.

Suppose a required temperature is missed.

Don’t wait until that happens to decide what to do.

Your procedure should explain how affected product is controlled, who evaluates it, what corrective action is taken, what gets documented, and how recurrence is prevented.

The Otherfoods template specifically includes documentation of deviations, product disposition, root cause and preventive action.

Maintain Useful Records

Your records prove what happened.

Examples include:

• Production/batch records
• Receiving records
• Temperature logs
• Sanitation records
• Calibration records
• Employee training
• Pest-control records
• Allergen checks
• Corrective actions
• Supplier information
• Traceability records
• Recall records

Do not collect paperwork merely because you think an inspector wants paperwork.

Keep records that demonstrate control of the operation.

Review the Plan

A food-safety plan is not permanent.

Review it when products, ingredients, suppliers, equipment, processes, packaging, or facility conditions change, and perform any periodic review or reanalysis required under the rules that apply to your facility.

Food Safety Plan Checklist

A practical plan may include:

• Facility information
• Product descriptions
• Process-flow diagrams
• Hazard analysis
• GMP programs
• Preventive controls where required
• Sanitation procedures
• Allergen controls
• Temperature/process controls
• Supplier controls where applicable
• Traceability procedures
• Recall procedures
• Employee training
• Monitoring records
• Corrective-action procedures
• Verification procedures
• Plan review/reanalysis
• Supporting forms and logs

FDA also provides a free, optional Food Safety Plan Builder designed to help food facilities develop plans consistent with 21 CFR Part 117. FDA expressly notes that using the tool does not mean FDA has approved the resulting plan or determined that the facility complies with applicable requirements.

Where Production Software Helps

Food-safety programs create records.

The challenge is retrieving them when you need them.

Production software can make it easier to connect recipes, production batches, ingredients, lots, finished products and customers.

DoBetter helps small food producers maintain production and lot information electronically so operational records don’t have to live across disconnected spreadsheets, paper forms and notebooks.

Frequently Asked Questions

Is a HACCP plan the same thing as every food safety plan?
No. Different products and regulatory frameworks can require different approaches. Determine which regulations apply to your particular operation.

Who can prepare an FDA preventive-controls food safety plan?
For covered facilities without an applicable exemption, FDA states that preparation of the required food safety plan must be completed or overseen by one or more Preventive Controls Qualified Individuals.

Can I use FDA’s Food Safety Plan Builder?
Yes. FDA provides it as an optional tool, but use of the tool does not itself establish regulatory compliance.