HACCP Plan: How To Create One For Food Manufacturing?

Writing an effective HACCP plan requires following systematic tasks that build upon the seven HACCP principles. This guide walks you through each step of the writing process, from assembling your team to documenting verification procedures, ensuring your plan meets regulatory requirements and protects consumers.

Before You Start Writing: Essential Prerequisites

The first step to creating a HACCP plan is to check your prerequisite programs, as outlined in the FDA's HACCP guidance for seafood and juice processors.  These foundational programs ensure basic sanitary conditions before you begin writing your HACCP plan. Your prerequisite programs should address minimum quality standards regarding sanitary design principles, general food safety and hygiene practices, employee health, proper environmental conditions, and proper employee training.

Without solid prerequisite programs in place, your HACCP plan will be built on shaky ground. These programs control basic food safety hazards and create the foundation for your more specific HACCP controls.

Step 1: Assemble Your HACCP Team

The HACCP system is a team effort, and your HACCP plan is only as strong as your team. Writing an effective HACCP plan starts with assembling the right people who understand your operation inside and out.

Your HACCP team should include representatives from different departments to provide a well-rounded approach:

• Production manager: Understands day-to-day operations and process flow
• Quality assurance specialist: Knows food safety regulations and testing procedures
• Maintenance supervisor: Understands equipment capabilities and limitations
• Operations floor staff: Provides practical insights into actual production practices
• Team leader: Coordinates the group and ensures proper HACCP application

The team should include staff from the operating floor because they add practical insight into the process and help identify any oversights. Including these team members also adds a sense of ownership to the HACCP process, which makes its implementation more likely to be a success.

Step 2: Write Your Product Description

Every team's first task is to write a product description. This section of your HACCP plan should include detailed information about your product's characteristics, ingredients, packaging, shelf life, and intended use.

Your product description should cover:

• Ingredients and formulation: List all ingredients, including potential allergens
• Physical and chemical characteristics: pH, water activity, preservatives used
• Processing methods: Heat treatment, acidification, fermentation, etc.
• Packaging and labeling: Type of packaging, storage requirements, labeling claims
• Shelf life and storage: Expected shelf life under normal storage conditions
• Distribution methods: How the product reaches consumers

Many foods are intended for the general public who purchase them to cook at home. However, if you create a niche product, such as dairy-based baby formula, then you need to identify them specifically.

Step 3: Identify Intended Use and Consumer

Clearly define the product or product category in terms of ingredients, packaging, factors critical to safety, shelf life, chemical, physical and microbiological attributes. This step helps you understand potential risks and appropriate control measures.

Consider these questions when writing this section:

• Who is your target consumer (general public, infants, elderly, immunocompromised)?
• How will consumers use your product (ready-to-eat, requires cooking, etc.)?
• Where will it be consumed (home, restaurants, institutions)?
• What are the foreseeable misuses of your product?

Step 4: Construct Your Process Flow Diagram

A systematic representation of the sequence of steps involved in the production of the final product is constructed. This diagram serves as the roadmap for your entire HACCP plan and must accurately reflect your actual production process.

Your flow diagram should include:

• All process steps: From raw material receipt to finished product shipping
• Decision points: Where different pathways might occur in processing
• Storage points: Where products are held during production
• Rework loops: How returned or reworked products enter the process
• Inputs and outputs: Where materials enter and leave each step

Remember: if your process flow diagram is incorrect, then your HACCP plan will be ineffective. Take the time to verify and get it right the first time.

Step 5: Verify Your Flow Diagram On-Site

Upon completion of the flow diagram, members of the team should visit the process flow to compare the information present on the diagram with what actually happens in practice. This is known as "walking the line"—a step-by-step practice to check that all information regarding materials, practices, and controls have been considered.

During your on-site verification:

• Follow the entire production process from start to finish
• Note any steps missing from your diagram
• Identify potential cross-contamination points
• Document actual temperatures, times, and other process parameters
• Talk to production workers about their daily routines

This verification step is crucial because it ensures your written plan matches reality.

Step 6: Conduct Hazard Analysis (Principle 1)

Effective hazard identification and analysis are critical to food safety, as described by the World Health Organization’s food safety hazard overview. For each step in your verified flow diagram, systematically evaluate potential biological, chemical, and physical hazards.

Biological Hazards

These include pathogenic bacteria, viruses, parasites, and allergens that could contaminate your product. Consider:

• Pathogens naturally present in raw materials
• Pathogens that could be introduced during processing
• Allergen cross-contamination
• Spoilage organisms that create toxins

Chemical Hazards

These encompass cleaning chemicals, pesticides, food additives, and naturally occurring toxins.

• Cleaning and sanitizing chemicals
• Pesticide residues on ingredients
• Food additives used beyond safe levels
• Naturally occurring toxins like mycotoxins

Physical Hazards

Foreign objects that could injure consumers or contaminate products:

• Glass from broken lights or containers
• Metal fragments from equipment
• Plastic pieces from packaging materials
• Personal items from workers

For each identified hazard, evaluate the likelihood of occurrence and potential severity. Only those hazards considered by the HACCP team to present an unacceptable risk are taken forward to the next step.

Step 7: Determine Critical Control Points (Principle 2)

Each step in the process flow diagram should be taken in turn and the relevance of each identified hazard should be considered. A Critical Control Point is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Use the FDA’s CCP decision tree to systematically determine which steps require critical control points in your process:

1. Is there a potential hazard at this step? If not, move to the next step.
2. Is this step specifically designed to eliminate or reduce the hazard? If yes, it's likely a CCP.
3. Could contamination occur or increase to unacceptable levels? Consider likelihood and severity.
4. Will a subsequent step eliminate the hazard? If no subsequent step controls it, this step must be a CCP.

Common examples of CCPs include:

• Cooking temperatures for pathogen destruction
• Metal detection for physical hazard removal
• pH adjustment for pathogen control
• Cold storage temperatures for pathogen control

Step 8: Establish Critical Limits (Principle 3)

Critical limits must be specified and validated for each CCP. These are the measurable criteria that separate safe from unsafe conditions. Critical limits are the values which are set for control measures to ensure the food is safe.

Effective critical limits should be:

• Measurable: Temperature, time, pH, water activity, visual appearance
• Based on science: Supported by research, regulations, or validated studies
• Realistic: Achievable within your operational capabilities
• Specific: Clearly defined without ambiguity

For example, a critical limit for a cooking step might be "internal temperature of 165°F (74°C) for 15 seconds." This is specific, measurable, and based on scientific data for pathogen destruction.

Step 9: Establish Monitoring Procedures (Principle 4)

A system of monitoring needs to be established for the criteria of the critical limits at each CCP. Monitoring is a planned sequence of measurements and observations that determine whether the CCP remains under control.

When writing monitoring procedures, specify:

• What will be monitored: Temperature, pH, time, visual appearance, etc.
• How it will be monitored: Specific instruments, observation methods
• When monitoring occurs: Frequency and timing of measurements
• Who will monitor: Specific job titles or individuals responsible

Your monitoring procedure helps identify trends towards loss of control, which allows you to use corrective actions to avoid deviating from the critical limit.

Step 10: Establish Corrective Actions (Principle 5)

Corrective actions must be determined in the plan and be undertaken when a critical limit is not achieved. These procedures must be written into your HACCP plan before implementation, not developed on the fly when problems occur.

Your corrective action procedures should address:

• Immediate action: Steps to regain control of the CCP
• Product evaluation: Assess the safety of products produced during the deviation
• Product disposition: What happens to potentially unsafe products
• Root cause analysis: Investigate why the deviation occurred
• Preventive measures: Steps to prevent similar deviations

For example, if a cooking temperature falls below the critical limit, your corrective action might include extending the cooking time, checking and recalibrating the thermometer, and evaluating whether the affected product is safe for release.

Step 11: Establish Verification Procedures (Principle 6)

It is important to undertake activities, tests, and reviews to periodically ensure the HACCP plan is effective. Verification consists of methods, procedures, and tests used to determine if the HACCP system is working as intended.

Verification activities include:

• Equipment calibration: Ensuring monitoring instruments are accurate
• Record review: Checking that monitoring and corrective actions are properly documented
• System validation: Confirming that your HACCP plan actually prevents the identified hazards
• Internal audits: Regular assessments of HACCP system effectiveness

The initial validation step can be in the form of internal audits, but verification should be ongoing throughout the life of your HACCP plan.

Step 12: Establish Record-Keeping and Documentation (Principle 7)

All activities associated with the management and operation of the HACCP plan must be maintained in records. Your HACCP plan must specify what records will be kept and how they will be maintained.

Essential HACCP records include:

• The HACCP plan itself: Including hazard analysis and CCP determination
• Monitoring records: Documentation of CCP monitoring activities
• Corrective action records: Details of deviations and actions taken
• Verification records: Results of calibration, validation, and audit activities
• Training records: Evidence that personnel are properly trained

Records should be signed and dated by the person responsible and maintained for a period that exceeds the shelf life of the product.

Implementation: Bringing Your HACCP Plan to Life

Writing the HACCP plan is only the beginning. Upon completion of the plan, it is best practice to develop a timeline for the initial implementation. The implementation process involves the continual application of corrective action procedures, monitoring, and record-keeping.

Key implementation steps include:

• Staff training: Ensure all personnel understand their roles in the HACCP system
• Pilot testing: Test your procedures on a small scale before full implementation
• Monitoring system setup: Install and calibrate all monitoring equipment
• Record system establishment: Set up documentation and record-keeping systems

Maintaining Your HACCP Plan

The plan must be reassessed at least annually and whenever changes occur that could affect the hazard analysis or alter the HACCP plan. Your written plan is a living document that should evolve with your operation.

Regular review and updates should occur when:

• New products are introduced
• Process changes are made
• Equipment is modified or replaced
• New hazards are identified
• Regulatory requirements change

Companies like Epicurean Butter have found that regular plan reviews help them stay ahead of potential issues and continuously improve their food safety performance.

Common Mistakes When Writing HACCP Plans

Avoid these frequent pitfalls when writing your HACCP plan:

• Inadequate hazard analysis:  Failing to consider all potential biological, chemical, and physical hazards at each process step.
• Incorrect CCP determination: Identifying too many or too few critical control points, or confusing CCPs with operational prerequisites.
• Vague critical limits: Setting limits that are not specific, measurable, or scientifically justified.
• Insufficient monitoring procedures: Not specifying who, what, when, and how for monitoring activities.
• Generic corrective actions: Using one-size-fits-all corrective actions instead of specific procedures for each CCP.
• Poor documentation: Failing to specify record-keeping requirements or maintaining inadequate records.

Conclusion: Your Roadmap to Effective HACCP Plan Writing

Writing an effective HACCP plan requires systematic attention to detail and thorough understanding of your food production process. By following the twelve-step approach outlined in this guide, you can create a HACCP plan that not only meets regulatory requirements but also provides practical protection for consumers and your business.

Remember that writing a HACCP plan is an iterative process. Your first draft won't be perfect, and that's okay. The key is to start with solid fundamentals, verify your plan against actual operations, and continuously improve based on experience and feedback.

The time and effort invested in properly writing your HACCP plan will pay dividends in reduced risk, improved compliance, and enhanced confidence in your food safety systems. Whether you choose traditional documentation methods or modern digital platforms, the principles remain the same: systematic hazard analysis, appropriate control measures, and thorough documentation.

Your written HACCP plan becomes the foundation for all food safety activities in your facility. Take the time to write it well, and it will serve as your roadmap to consistent food safety success.

Once your plan is complete, the next step is to pursue HACCP certification to demonstrate compliance, build customer trust, and meet industry requirements.