Factors for Food Safety Management

This an example to illustrate the application of food safety management of a fictional product. The recipe, the product and the factory are, therefore, of my invention.

HACCP Plan for “Creamy Linguine with Prawns and Almonds”

Fig 1. Creamy Linguine with Prawns and Almonds

Scope

The manufacture of chilled ready-to-eat precooked meals, which must be consumed hot, including products relating to special needs requirements for the following brand:

• “Costiera Pasta” branded products

Term of reference: The HACCP plan for Linguine pasta meals products is designed to cover all the relevant hazards (microbiological, physical, chemical and allergenic) that may cause foodborne illness or intolerance reactions. This HACCP plan will cover all processes for linguine pasta meals products from raw materials intake into the premises to chilled storage of finished products before dispatch.

HACCP Team

S. Pepe: Food Safety Manager (HACCP team leader)

A. Flour: Production Manager

I. Amaranth: Engineering Supervisor

B. Barley: Production Supervisor

F. Tortillas: Technical Consultant

The professionals listed here, form a heterogeneous group with different abilities and have been selected and trained with the aim of providing the group with a broad and complete vision of the process.

Each of them has the knowledge and the experience to make coherent decisions about food safety.

They fully understand:

• the HACCP principles
• the food products and their ingredients
• the equipment and how it works
• the production process
• the packaging systems
• the manufacturing and handling environments

and the likely hazards associated with all the related aspects and the appropriate control mechanisms.

Product description

The “Creamy Linguine with Prawns and Almonds” is a ready-to-eat meal manufactured from fresh (linguine, reduced-fat crème fraîche), frozen (prawns) and dried (almonds, garlic clove, lemon zest, parsley and Italian herbs) raw materials.

Allergens (prawns and almonds) are used on site but they are strictly controlled, through prerequisite programmes that include instructions and legal requirement:

• on handling
• on cleaning and sanitation
• on segregation
• on labelling

All our ingredients are sourced through approved suppliers globally.

All prepared meals are cooked to pasteurisation temperature, then blast chilled, and stored and distributed chilled.

The shelf life is determined by prescribed storage and usage conditions. It is verified during production trials and it is confirmed by microbiological tests.

The packaging in use is always fit-for-purpose food-grade and all packaging carries:

• full ingredient list
• nutritional information
• allergen information
• heating and storage instructions
• shelf life information

Identify Intended Use

• The product is not intended for the general population due to the presence of allergens (prawns and almonds).
• All allergens are stated on the pack and every single pack is carrying the relevant warning.
• The product cannot be consumed cold and must be reheated as per instructions
• The product must be held under refrigerated storage prior to use

Consumer misuse:

• Consumed after the manufacturer’s recommended shelf life (“expire by” date) has expired.
• Not reheated properly or at the right temperature
• Consumed if not stored correctly.

Prerequisite Programme (PRPs)

We follow a set of steps (GMPs and SOPs) designed to control the operational condition in our food establishment and with the aim to promote environmental condition to produce safe food.

Potable water, cooling water, steam, and ice, is available in sufficient quantities, at suitable pressures and temperature, to meet the needs of the operation.

Water Source:

• The water and the plumbing system in to facility provides a safe supply for the water needs
• We got documentation that identify the source of the water and we conduct annual water quality test, for microbiological activity and for chlorine levels. We keep records of the result of such test

• We take all the necessary steps to prevent contamination from potential cross-connections and backflow.
• The backflow prevention devices are inspected and tested routinely. Record is kept.
• Connections without backflow prevention devices are inspected and tested routinely. Record is kept

All food contact surfaces (including equipment, piping and utensils) are designed, fabricated and maintained in a way that is easy to clean and they withstand regular usage. All equipment has smooth seams and is made of impervious materials (such as stainless steel or plastic). Every corroded or worn parts in promptly removed and replaced.

Cleaning and sanitizing for all food contact surfaces is done with appropriate detergents at the proper concentration and water at the appropriate temperature. We kept record of written documentation of cleaning, sanitizing, and maintenance procedures.

Frequencies for cleaning and sanitizing include:

• Before use
• After processing interruptions
• At product changeover
• After use
• As necessary

We monitor:

• The condition and construction of contact surfaces
• The condition of gloves, outer garments, and utensils
• Preventative maintenance programs and all repairs
• Cleanliness and sanitation of food contact surfaces
• Type and concentration of cleaning chemicals and sanitizers
• Employee training and hygiene practices

Almost every procedure must be monitored daily, while few may be monitored less frequently (such as preventative maintenance and training).

Because in our product is present high-risk food (prawns and almonds) we made the Prevention of Cross Contamination our biggest aim. Contaminants such as bacteria are unable to move from one place to another on their own, therefore cross contamination occurs when food, water, air, people, or equipment carry these contaminants from one location to another.

We aim to identify and avoid the factors that can contribute to cross contamination such:

• Poor hygiene
• Employee mistakes (non-compliance with GMPs, employee traffic patterns)
• Poor food handling practices
• Failure to separate raw and cooked products, common equipment, and equipment
• Inadequate cleaning and sanitizing (utilizing color-coded brushes and cleaning equipment)
• Poor plant design (especially important because dealing with allergens, no cross connections between raw and pasteurized product in piping or flow)

We consider imperative that in addition to clean food processing equipment, the facilities associated with production is cleaned, well stocked, and properly maintained.

There are hand washing facilities at each location where GMPs require their use. The condition and cleanliness of facilities are monitored daily.

The facilities are equipped with soap, water at the appropriate temperature, disposal towel and hand dryers, and waste disposal bins.

All the employees have been properly trained in appropriate hand wash technique.

They are used for hand washing only, not for cleaning equipment or utensils.

The toilet facilities are readily accessible with self-closing doors to protect from airborne contamination.

They are all in good sanitary condition and are always supplied with paper products, soap, and warm water.

All ingredients, packaging materials, food contact surfaces, and finished product are protected from various microbiological, chemical, and physical contaminants including water (condensate, splashing from floor, walls, and ceilings, leaks), chemical hazards (fuels, non-food grad lubricants, cleaning and sanitizing compounds, and pesticides), physical hazards (glass, metal, plastic, dirt, rust, and pests), additives (vitamins).

All the finished product labels contain the identification lot number to make a possible recall of the product itself, easier.

Procedures are set in place to monitor any possible contamination of food or food contact surfaces according to GMPs and SOPs.

Toxic compound, such as cleaning, sanitizing chemical and pesticides, are properly labelled, used, and stored away from food, food contact surfaces, and packaging materials to avoid contamination. They are stored in a secured area with limited access.

We use original container with label intact and visible (on the label is present the name of compound or solution in the container, the name and address of manufacturer, the instructions for proper use, the potential hazards and cautions). We use them according to the manufacturer’s instructions and a MSDS (Material Safety Data Sheets) is used for proper handling. We dispose unused compounds according to the manufacturer’s guidelines.

We also have in place a policy that exclude or restrict employees who show or who have been diagnosed with an illness or a wound that could be a source of microbial contamination. All our employees adhere to the Illness and Injury Notification Policy and the supervisors observe the employees for signs of illness and exposed wounds. The employees undergo documented GMP training upon initial hiring and on an annual basis.

Pests (rodents, birds, and insects) are excluded from all areas and approved procedures are followed to prevent or eliminate infestation without contaminating foods or food processing equipment.

As for the distribution of our products, only trucks equipped with cold storage are used, so as not to interrupt the cold chain.

Trucks and cold stored undergo regular maintenance and checks that are recorded and kept on site.

List product’s categories and ingredients

Product category: Seafood Pasta (includes: linguine pasta, prawns, dairy, nuts, herbs, spices).

Workshop Location: Costiera Amalfitana, Italia

Table 1- Product’s List

Pasta	Seafood	Diary	Spices	Nuts
      Linguine	      Prawns	      Butter       Reduced-fat crème fraîce	      Garlic glove       Lemon zest       Parsley       Italian herbs	      Almonds

1. The linguine pasta to be cooked, drained and cooled.
2. The prawns to be cooked with garlic and butter, then the reduced-fat crème fraîce to be added, everything to be transferred into containers for mixing to decant.
3. Linguine, prawns, almonds, and crème to be blend together.
4. Spices and herbs to be added.
5. Mix to be divided into portions (two serves each) and to be covered with the film lid.
6. The finished product to be labelled and covered with outer case packaging.
7. To be refrigerated and stored accordingly.

Table 2-Flow Diagram: Overview

Table 3- Flow Diagram: Cooking and Cooling Activities

Note: Those Flow Diagram must be strictly followed!

On-site Confirmation of Flow Diagram

At this point the flow diagram must be checked to verify that it is correct and accurate in the analysis of all the steps involved and must be approved.

We employ an expert outside the team who is not familiar with this process so that he can have an objective approach and can more easily identify a neglected step.

The supervisor has the purpose of taking into consideration whether the representation of the process is accurate and current and if in practice all the steps are carried out as designed at the time of the creation of the Flow Diagram, during all the different work shifts and with different staff, at different times of the year and therefore in different production conditions.

We keep the records that the diagram was confirmed as correct and the record of when the check took place.

We also keep the old out-of-date diagrams.

Potential Hazard food-related

Amongst foods, seafood is the most perishable of all. It is harvested and processed in a wide array of circumstances, often in remote, under-equipped and unsanitary conditions. Therefore prawns, whether wild-caught or cultured, is subjected to a wide range of safety hazards. This has prompted the importing countries to tighten quality requirements, revising food sanitation laws and hygienic standards, which often results in import restrictions and embargoes. This leads to one conclusion: it is very important that a HACCP-Plan is in place.

Hazard Analysis

Good Receipt

Hazards:

• Physical Hazard: Foreign material from damage packaging (glass, wood, metal, and plastic)
• Biological Hazard: Presence of pathogenic micro-organism in prawns (Salmonella, Shigella, E. coli, Vibrio Cholerae, V. parahaemolyticus, V. vulnificus, Listeria monocytogenes…). Growth of microorganisms due to Temperature abuse of refrigerated goods in transit
• Chemical Hazards: Veterinary residues (Hormones, growth regulators, antibiotics such as chloramphenicol, nitro-furan and its metabolites and permitted antibiotics which residue is not over MRL). Pesticide residue (Herbicides, fungicides, insecticides…)
• Allergenic Hazards: (prawns and almonds)

Control Measures:

• Good intake prerequisite
• Rejection of damaged goods
• Cooking at later step

Codex Decision Tree:

Q1=Y, Q2=N, Q2a=N, Q3=Y, Q4=Y

CCP? =NO

Justification for decision:

• Unlikely to cause harm to the consumer
• Separate full ingredient hazard analysis to be performed
• Allergens managed by strict prerequisite programmes and labelling, which rely on knowledge of all allergens in materials supplied as per specifications and allergenic ingredient list. (Any substitution of ingredients could endanger existing control measures)

Ingredient Storage

Hazards:

• Biological Hazard: Possible growth of pathogenic micro-organism. Multiplication of moulds (pasta), multiplication of E. coli01571, salmonella, listeria monocytogenes (prawns and fresh crème fraîche).
• Physical Hazard: Presence of foreign objects, pests.

Control Measures:

• Rapid transfer, managed with prerequisite programmes.
• Store off the floor.
• Rejection of material outside of specified limits-target <5C (fridge)
• Product only kept until their “best before” date, with visual checks for moulds prior to use.
• Hand washing routine.
• SOPs (training, cleaning and equipment procedure) in place.
• Pest control procedure in place.
• Ingredients kept in sealed packaging.
• Maintenance daily checks standards.

Codex Decision Tree:

Q1=Y, Q2=N, Q2a=N, Q3=Y, Q4=Y

CCP? =NO

Justification:

• Unlikely to cause harm to the consumer.

 Packaging Material Storage

Hazards:

• Microbiological: Contamination with unspecified bacteria.
• Physical: Foreign object from storage area (droppings, dust, hair…)

Control Measures:

• Deep cleaning of storage area.
• Pest control procedure covered by PRPs
• Store off the floor.
• Daily checks as part of SOPs.
• Keep ingredients in sealed packaging.
• Dispose of damaged packaging.

Justification:

• Temperature control and stock rotation as part of PRPs.
• Unlikely to harm consumers.

Decant/Unwrap, Batch-weight, Preparation activities

Hazards:

• Microbiological (multiplication and/or contamination of Salmonella and Campylobacted)
• Physical: Parts of prawn’s exoskeleton and parts of almond’s husk may be present and not removed during preparation. Other foreign objects from handlers (nails, hair, jewellery).
• Chemical: Residues from cleaning activities.

Control Measures:

• Careful opening packaging and immediate disposal of it.
• SOPs in place.
• PRPs of hygiene in place.
• Staff trained as per PRPs.

Codex Decision Tree:

• Q1=Y, Q2=N, Q2a=N, Q3=Y, Q4=Y

CCP? =NO

Justification:

• Allergens managed by strict PRPs (dedicated containers, segregated storage area, labelling).
• Food waste products will be controlled later by x-ray detection.
• Unlikely to harm consumers.

Module 6

Cooking Linguine

Hazard:

• Survival of pathogenic micro-organism (fungi and moulds) due to inadequate heat processing.

Control Measure:

• Approved cooking methods (water’s T at boiling=100C, time= enough to be cooked “al dente”).

Codex Decision Tree:

Q1=Y, Q2=Y, Q3=Y

CCP? =YES (CPP 1)

Justification:

• Failure to cook to T=100C can result in the survival and growth of bacteria and result in food-borne illness.

Cooking Prawns

Hazard:

• Survival of pathogenic micro-organism (Salmonella, Shigella, E. coli, Vibrio Cholerae, V. parahaemolyticus, V. vulnificus, Listeria monocytogenes) due to inadequate heat processing.
• Cross-contamination from dirty utensils used to handle raw food.

Control Measure:

• Approved cooking methods.

Codex Decision Tree:

Q1=Y, Q2=Y, Q3=Y

CCP? =YES (CPP 2)

Justification:

• Failure to cook to T=100C can result in the survival and growth of bacteria and result in food-borne illness.

Blast Chill

Hazards:

• Microbiological: Multiplication of pathogens if the cooling period is excessive. Contamination from food handler when placing on cooling vessels (Staphylococcus Aureus).
• Physical: Foreign objects from the chiller/food handlers.

Control Measures:

• Rapid blast chilling (cool to 5C in 90 minutes).
• High level of personal hygiene as per PRPs.
• Maintenance, cleaning and staff hygiene and training prerequisite.
• SOPs in place.

Codex Decision Tree:

• Q1=Y, Q2=N, Q3=Y, Q4=N, Q5=N (no further steps to reduce the microbiological hazard)

CCP? =YES (CCP 3)

Combining and mixing components’ meals

Hazards:

• Cross-contamination with allergens into wrong products.
• Cross-contamination with pathogenic microorganism vegetative or spore formers, from environment or utensils.
• Germination and outgrowth of spore-forming pathogens.
• Foreign objects from food handlers, loose or broken pieces of machinery.

Control Measures:

• Immediate through process.
• PRPs and SOPs to follow.
• Labelling carefully.
• Maintenance, cleaning and staff hygiene and training prerequisite SOPs in place.

Codex Decision Tree:

• Q1=Y, Q2=N, Q3=N

CCP? = NO

Justification:

• Process area is held at < 10C; as all components are chilled, limited opportunity for temperature to rise into danger zone.
• Allergens managed by strict PRPs (production scheduling for specific allergens and deep cleaning after these products)
• High standards of hygiene for production environment and utensils.
• Risk of contamination is low due to the PRPs and SOPs in place.

Secondary and tertiary packaging

Hazards:

• Physical: Presence of metal from previous steps, not identified, leading to hazardous metal inclusion in product
• Allergens: Presence of unlabelled allergens if wrong sleeve applied
• Chemical: Residues from cleaning procedures.

Control Measures:

• All products pass through a functioning metal detector.
• Barcode scanning of all products to ensure correct sleeve on product.
• Documented procedure for labelling of products as part of PRPs and legal control.
• All products pass through functioning scanner device.

Codex Decision Tree:

• Q1=Y, Q2=N, Q3=N

CCP? = NO

Justification:

• Unlikely that incorrect shelf life could be applied.
• Scanner will pick up wrong cartons that may be received in mid-stack from printer or that may have become stuck in machine at changeover.

Process Control (Critical control points/Monitoring/Corrective actions)

CCP n.1 Cooking Linguine

Hazards:

• Survival of microorganism, fungi and moulds.

Control Measures:

• Through cooking

Critical Limits:

• Cook at boiling T (100C until cooked).
•  Tolerance +/- 5C.

Monitoring Processes:

• Procedures: Check T
• Frequency: every batch
• Responsibility: Cooker Operator, Quality Assurance Supervisor

Corrective Actions:

• Supervisor is informed.
• Production is halted and the batch is discarded.
• The silos are checked for faults and repaired if necessary
• Responsibility of Quality Assurance Supervisor, Cooker Operator, Engineers.

Records:

• Record taken.
• If corrective action required, it is recorded.

CCP n.2 Cooking Prawns

Hazards:

• Survival of pathogenic microorganism (Salmonella, Shigella, E.coli, Vibrio Cholerae, Listeria…)

Control Measures:

• Through cooking

Critical Limits:

• Cook at boiling T (75C for 30 seconds).
•  Tolerance +/- 5C.

Monitoring Processes:

• Procedures: Check T
• Frequency: every batch
• Responsibility: Cooker Operator, Quality Assurance Supervisor

Corrective Actions:

• Supervisor is informed.
• Production is halted and the batch is recooked.
• The silos are checked for faults and repaired if necessary.
• Responsibility of Quality Assurance Supervisor, Cooker Operator, Engineers.

Records:

• Record taken.
• If corrective action required, it is recorded.

CCP n.3 Blast Chill

Hazards:

• Multiplication of pathogens.
• Microbiological contamination from other sources including food handling.

Control Measures:

• Rapid blast cooling

Critical Limits:

• Cool to <5C within 90 minutes.
• Tolerance +/- 1C, +/- in 30 minutes.

Monitoring Process:

• The T is taken using a calibrates, disinfected probe.
• The T and the start time of cooling is recorded.
• Frequency: every batch.
• Responsibility: Cooling operative, Quality Assurance Supervisor.

Corrective Actions:

• If the cooling period is exceeded, the chiller operator marks the record chart as “Non-Conforming Product” and informs the Quality Assurance Supervisor.
• The product is quarantined and discarded.
• The reason for the failure of cooling is investigated.
• If necessary the blast chiller is repaired.
• Any additional actions to prevent recurrence are implemented.
• Responsibility: Quality Assurance Supervisor, Chiller Operator, Engineers.

Records:

• Record all temperatures and times on the cooling record sheet.
• If corrective action necessary, it is recorded.

Verification and Validation

Validation: What a company plans to do. It provides evidence to support the HACCP plan and takes place before implementation and after alterations. When a new information comes alive, the validation should be reassessed.

Any change to the HACCP plan should be:

• Fully incorporated into the documentation
• Recorded following the rules for record keeping system
• Make available and accurate the up-to-date information.

Verification: It is the action of checking conformity with the planned actions and objectives. In order to do so, there is a number of assessment activities that need to be done, including auditing (internal or self-assessments, corporate audits, third-party audits) and inspection.

This process should be formalised to include:

• Methods for verification
• Frequency of testing
• Staff responsibility
• Formal evaluation of results

When a HACCP plan is validated is possible to understand if any improvements is required.

The validation of the control measures must ensure that corrective actions taken in the case of process deviations will result in adequate segregation of non-conforming product to ensure that it will not reach the consumer.

Examples of validation and conformity verification

Hazard analysis:

• Validation: the correct people in HACCP team, the flow diagram is suitable for the purpose, the significant hazards are identified.
• Verification: validation is carried out correctly.

Determination of CCPs:

• Validation: All significant hazards are considered during CCP identification. The CCP are at the appropriate stages in the process.
• Verification: validation is carried out correctly.

Specification of CL to assure that the step is under control:

• Validation: The CL control the identified hazards.
• Verification: validation is carried out correctly

Establishment and implementation of systems to monitor control of CCPs:

• Validation: The monitoring system ensure that the control at CCPs is effective. Procedure for the necessary calibration of testing equipment is included.
• Verification: Record of monitoring exist, is periodically review and confirm compliance.

Establishment the corrective actions taken when a CCP is not under control:

• Validation: Corrective actions prevent non-conforming product from reaching the consumer.
• Verification: Corrective actions are recorded and actions taken by designated persons.

Establishment of procedures for verification to conform that the HACCP system is working effectively:

• Validation: Compliance of the HACCP system has been established
• Verification: All verification procedures are carried out.

Establishment documentation concerning all procedures and records appropriate to these principles and their application:

• Validation: Documentation covering the entire HACCP system has been established.
• Verification: Documentation and record keeping covering the all HACCP system is complete, in the correct format, and properly filled out.

Review

The HACCP plan is reviewed every year and update as required.

Before a new product is launched, a new HACCP study will be carried out.

If there is a new process involved or a new raw material is used, a new HACCP study will be carried out.

All new products go through a product safety assessment process before authorization.

Bibliography

• http://myhaccp.food.gov.uk
• http://www.fao.org/3/v9723t/v9723t0e.htm
• https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines
• http://www.foodsafety.company/2016/11/haccp-basic-principles.html
• http://diaryextension.foodscience.cornell.edu
• https://dairyextension.foodscience.cornell.edu/resources/food-safety/food-safety-planhaccp/principles-food-safety-planshaccp/
• ILSI, Report, Validation and Verification of HACCP, NOV. 1999
• Wallace, C.A., Sperber, W.H. and Mortimore, S.E. (2018) Food Safety for the 21^thCentury: Managing HACCP and food safety throughout the global supply chain (2^nd ed.), Wiley:Oxford.