High Sierra Chemicals

Production Operations Sanitarian 2023

Introduction
Sanitation is the most important activity of a food plant. It is my hope that this short guide will provide the necessary essentials for the core of a solid sanitation program.

The USDA’s HACCP regulation puts sanitation--cleaning and sanitizing—in its proper perspective:
“Sanitation maintains or restores a state of cleanliness and promotes hygiene for prevention of foodborne illness.”
It is an essential prerequisite program for food safety. The Preventive Controls Regulation for Human Food found in 21 CFR Part 117 further underscores the importance of this element. Preventive controls are defined as:
“…those risk-based, reasonably appropriate procedures, practices and processes that a person knowledgeable about the safe manufacturing, processing, packing or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing or holding at the time of the analysis.”

Preventive Controls
(3) Sanitation controls. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards. Sanitation controls must include, as appropriate to the facility and the food, procedures, practices, and processes for the:
(i) Cleanliness of food‐contact surfaces, including food‐contact surfaces of utensils and equipment.
(ii) Prevention of allergen cross‐contact and cross‐contamination from insanitary objects and from personnel to food, food packaging material, and other food‐contact surfaces and from raw product to processed product.
Reference: FDA FSMA Title 21 of the Code of Federal Regulation Part 117—Current Good Manufacturing Practice, Hazard Analysis, and Risk‐based Preventive Controls for Human Food.

The basic elements of a sanitation program are:

• Risk Analysis
• PCQI Training of Sanitation Preventive Controls
• Environmental Hazards
• Food Contact Equipment Cleaning
• Zones

·         Sanitation Principles and Food Handling Practices Training
·         Manufacturing Controls and Essential Operations
·         Hygienic Practices Communicable Diseases/Injuries

• Traffic Control/Controlled Access
• Premises and Outside Surroundings

·         Buildings and Facilities
·         Waste
·         Flow-Through Pattern

• Housekeeping
• Commercial Food Sanitation
• RCCAPA
• Storage
• Reference

Risk Analysis:
A risk analysis should be conducted prior to commencing any sanitation program. The elements and principles of HACCP should be used in the following order:

• Preparation for Work
  • Operational Issues
  • Maintenance Requirements
• Training
  • Basic
  • Long Term
  • Tailgate
  • Special Areas:
    • Unique cleaning requirements; robust or highly calibrated equipment
• Tools
  • Serviceability
  • Tool sanitation
  • Tool use and application
• Chemical Compounds
  • Proper dilutions
  • Titration
• Hygienic Zoning
  • Migration
  • Allergenic Areas
• 7 Steps of Cleaning
• Special Circumstances
  • Older areas
  • Receiving and high traffic areas
  • Cleaning of related employee areas
• Order of Work
• Evaluation Procedures
  • ATP
  • Environmental Testing
  • Visual Inspection
• Equipment
  • Critical Points Inspection
• Critical Control Points

PCQI Training of Sanitation Preventive Controls
(It is important to include PCQI guidance on sanitation. JA)
When carrying out your risk assessment, think of sanitation in three main parts to highlight hazards which need to be assessed for preventive controls:

1. Environmental Sanitation
2. Food Contact Equipment Cleaning
3. Zones

Environmental Hazards
If you are producing ready-to-eat product (product will not go through another heat treatment or micro reduction process), you need to think about the risk of pathogenic bacteria from the environment. The main pathogen that is considered here is Listeria monocytogenes, as it likes wet environments and can survive and grow in chilled environments.

Typical environmental hazards from Listeria mono. are things like:

• Dripping condensation over open product, food packaging, ingredients, work in progress materials or food contact equipment. Consider this in areas where there are high levels of steam or where condensation occurs where hot and cold air/materials meet.
• Listeria is commonly found in drains – at floor level of in equipment drains (such as liquid filling equipment).
• If Listeria mono. is in the drains, you can understand why it may be present on the floor.

If your risk assessment deems any of the above hazards to be significant for your product, then sanitation preventive controls should be put in place – in the form of cleaning procedures. This cleaning will also need to be verified, most likely through routine microbiological swabbing.
(Note:  Make sure that high pressure cleaning equipment (such as jet washers) are not used for cleaning – as this will just vaporize the pathogen and spread it around. JA)

Food Contact Equipment Cleaning
Cleaning of food contact equipment is essential to ensure that:

• Ready-to-eat food is not contaminated from cross-contamination from raw food
• Food is not contaminated from cross-contact from allergens
• Food is not contaminated from a build-up from high-risk foods

Assess the equipment that is being used and the product that is being produced, to ensure that any relevant hazards are included in your risk assessment.  Where the risk is significant, then sanitation preventive controls will be required.
Even when the risk assessment defines that sanitation controls are required, the FDA have stated that the cleaning applied, does not have to be validated by law.  Which means, you don’t have to prove that the cleaning method that you apply controls the hazard that you’ve identified.
The FDA have also stated that verification of clean only needs to be (as a minimum) a visual check.
(Note: However, in my opinion you need to think of what would happen if things were to go wrong.  If someone was to get sick because of a product that you’d produced and you had to stand up in court – if you had not validated your clean, and only checked it visually – would this be sufficient as your due diligence? My recommendation would be to validate and then also verify the clean through an analytical method, even if it’s only routinely rather than for every clean. JA)
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Zones
In order to control cross-contamination and cross-contact, personnel, product and equipment should be segregated.  Therefore, the FSPCA provide guidance on zoning. They suggest that zones should be segregated as follows:

• Non-manufacturing areas: e.g., maintenance shops, offices, employee areas and waste disposal
• Transition areas: e.g., entry rooms and locker rooms that enter basic GMP areas
• Basic GMP areas: raw, receiving and storage
• Primary pathogen control area (CONTROLLED ACCESS): e.g., cooked, pasteurized or ready-to-eat products exposed to the environment
• Sensitive/ high hygiene area (RESTRICTED ACCESS): e.g., products for sensitive populations such as infants

(Note: I agree that zones are essential for controlling contamination, however I do find it odd that zones have been highlighted as a preventive control.  To me, this should be a facility-wide GMP – as you would carry out the assessment of your facility, work out what the zones should be and then apply it.  Once it’s done – it doesn’t need ‘verifying’ routinely like a typical preventive control.  The only verification that could be done would be through auditing. JA)

Sanitation Principles and Food Handling Practices Training:
Personnel training should instill and nurture an understanding of the processing steps and technologies for each product manufactured or handled and where potential problems exist and create a keen desire to satisfy and guard the consumers' interests. Key points in any program are:
·         7 Step SSOP instructions for all equipment and operations
·         Titration of sanitation chemicals upon arrival
·         Effective use of suppliers for technical assistance

Manufacturing Controls and Essential Operations:
Production personnel must be trained in the critical elements of the operations for which they are responsible, in the importance of these operations, monitoring these operations, and in action to be taken when these operations are not controlled. Certain industries have developed certification programs for operators of essential heat-processing equipment (e.g., X-ray machine or dryer operators). If such programs don't exist for a given processing segment, it is important that specific training programs be developed for such personnel.

Hygienic Practices Communicable Diseases/Injuries:
Persons known to be suffering from or known to be carriers of a disease likely to be transmitted through food, must be restricted from any food-handling area. Likewise, persons afflicted with infected wounds, skin infections, sores, etc., must also be restricted from these areas. Any persons with open cuts or wounds should not handle food unless the injury is completely protected by a secure, waterproof covering. Hand-washing Facilities with hot water for handwashing must be provided and must be convenient to food handling areas. All personnel involved in food handling must thoroughly wash hands with soap under warm-running, potable water. Hands must also be washed after handling contaminated materials and after using toilet facilities. Where required, employees must use disinfectant hand dips. Personal Cleanliness and Conduct Personal cleanliness must be maintained while involved in food handling operations:
• Sanitary protective clothing, hair covering, and footwear must be worn and maintained in a clean, sanitary manner.
• Gloves, if worn, must be clean and sanitary.
• All food-handling personnel must remove objects (i.e., watches, jewelry) from their person which may fall into or contaminate the food product.
• Tobacco, gum, and food are not permitted in food-handling areas.

Traffic Control/Controlled Access:
Personnel and visitor access to specific food product handling areas must be restricted. Personnel involved in raw product handling (e.g., farm truck drivers, etc.) must not be allowed in processing or finished product areas. Foot baths and hand dips, where required, must be properly maintained and used. Color coding of clothing, maintenance and other equipment should be used to clearly identify raw vs. processed product operations.

Premises and Outside Surroundings:
Outside surroundings should be evaluated for sources of contamination such as vermin, bird harborage areas, drainage problems, odor problems, debris, refuse, and pollution-smoke, dust, other contaminants. Appropriate steps must be taken to contain and control any potential sources of contamination.

Buildings and Facilities:
The two most important overall elements of any food-processing and handling facility is that it should be cleanable, and so designed and constructed that it prevents entrance or harborage of pests or other sources of contamination. Unfortunately, many existing facilities do not readily meet these essential elements and adjustments to the sanitation program must be implemented.

Waste:
Facilities designed to prevent contamination should provide for the sanitary storage of waste and inedible material prior to their removal from plant or surroundings. Waste containers are to be clearly identified. General Protection from contamination In general, the facilities and various non-product contact surfaces and equipment must be evaluated to assess potential for food-product contamination. Shielding from overhead contamination should be provided as deemed necessary. Examples include shielding over food product fillers or clamshells, shielding from refrigeration unit drip in coolers.

Flow-Through Pattern
A well-designed food-processing or -handling facility is constructed to minimize traffic to prevent contamination. It is desirable to have a product flow-through that physically and operationally separates raw product functions from processing functions and finished product functions in order to avoid cross-contamination. Boiler and engineering rooms must always be separated from food-processing and handling areas. Sanitary Facilities Washrooms, Lunchrooms, Change Rooms Self-closing doors must be provided for all washroom facilities. Washrooms, lunchrooms, and change rooms must be separate from-and not directly entered from-food-processing and handling areas. Such facilities are to be properly ventilated and maintained. Hand Washing Facilities Sufficient numbers of handwashing sinks, with automatic hot and cold potable water, soap, sanitary hand drying supplies or devices, must be provided in washrooms. A sufficiency of suitably located handwashing sinks are also necessary in food processing and handling. Hand-washing sinks should be separate from sinks used for equipment cleaning and other operations.

Housekeeping:
All food-processing and handling rooms and other rooms must be maintained in a clean, sanitary manner. A major source of plant contamination is from employee restrooms, break areas, custodial personnel and equipment. All custodial brushes and equipment must be in good repair as well as being clean and sanitary. A sanitation program for custodial tools is required.  These tools along with sanitation tools also require a mandatory replacement date.

Pest Control:
An adequate pest control program is necessary for sanitary operation of a food-processing or -handling facility. Effectiveness of the pest-control program should be verified on a regular frequency. All GFSI food safety schemes outline effective programs.  The elements are:

• Contract
• Service outline
• SDS and Label references
• Training
• Operator license
• Insurance binder
• Sighting log
• Pesticide application log
• Map

Success Benchmarks and KPI’s:
Environmental Savings KPI: Paper use, energy consumption, quantity of paper sheets used for data capture, training, printed reports, manuals, etc. Efficiency increases and waste decreases have a positive impact on carbon footprint.
Cost Savings KPI: Document Management, PM/AM, Defects, scrape/waste, staff reallocation from administration to more productive roles. Paper & Document Management costs are dramatically reduced. Reduction of waste, unplanned downtime.
Time Savings & Productivity Enhancements KPI: Time to close, Time to first review, Throughput, yield, defects, abnormalities. Completing data capture more efficiently. Automatic and real-time notifications vs physically transporting documents. Digital data storage vs filing cabinets. Automated spreadsheets and reports vs manually rekeying data. Automated form requirements vs manually clarifying mistakes and omissions. Photo capture vs verbal descriptions. Real-time messaging vs in person discussions. Real-time visibility of all data and KPIs throughout the site, including open tasks and assignments. Automated project alerts vs tracking down technicians to get an update. Easy signature capture for approvals. Easy regulatory compliance.
KPI: Document Management, PM/AM, Defects, scrape/waste, Staff reallocation from administration to more productive roles. Paper & Document Management costs are dramatically reduced. Reduction of waste, unplanned downtime.
Employee Engagement KPI: Suggestions, Safety Observations, Training, engagement surveys. Staff can access tools and resources that enable meaningful participation in operational excellence Staff are empowered to be accountable for the team’s success. Stress-free compliance and success. Enhanced moral and culture. Increased engagement as staff witness real impact and change.

Commercial Food Sanitation:
Commercial Food Sanitation (CFS) is the most robust approach to what I believe is “Operational Sanitation”. It combines all the critical components of Production and Operations Management into one program.  The analysis that comes from a CFS audit is critical to employing the concepts in this guide and operations to form a single well-functioning unit.  GFSI food safety schemes need to recognize this platform and employ its concepts into their audits.

RCCAPA:
Root Cause, Corrective Action and Preventative Action (RCCAPA) is an effective way to correct issues as they occur.  The process should be conducted after audit findings, internal reviews and crisis events. 

• Root Cause (RC) is most effective when employing the “5 Why” process,
• Corrective Actions (CA) are only effective if the “5 Why” process is done correctly,
• Preventative Actions (PA) verify if the RC and CA process is robust,
• Records are to be changed along with training to ensure the entire process is a closed loop.

Storage:
Storage facilities must be large enough that there is space to store equipment properly, inventory chemicals and other critical supplies and conduct training.