HACCP Auditor

Preliminary Tasks to Develop a HACCP System

1. Assemble and train the HACCP team. 2. Describe the product and its distribution. 3. Describe the intended use of the product and its end user: consumer, patient, vulnerable group, etc. 4. Develop a product or process flow diagram. 5. Verify the flow diagram.

Design Methods to be Considered to Ensure Control over sanitary operational conditions

1. Facility location 2. Building structure (exterior and interior) 3. Ventilation 4. Water system 5. Lighting 6. Waste disposal 7. Personnel facilities (lunchroom, washroom, hand-wash station, locker)

Hazard Condition

A biological, chemical, or physical agent in, or condition of, food with the potential to cause an adverse health effect (injury or illness)

Deviation

A departure from a set of standards or specifications (critical limits)

Develop a Product or Process Flow Diagram

A flow diagram should be developed to evaluate each process step, from receiving of raw materials to the shipping of products. This ensures that significant product safety hazards have not been overlooked or underestimated. The flow diagram should represent all process steps (including all inputs such as water addition and compressed air use and outputs like waste points or rework) under the control of the company and may include steps prior to and after the plant's operations. Typically, the personnel responsible for developing a flow diagram are process experts that are members of the HACCP team. Initially the flow diagram should be very detailed. Each step in the process or movement of product through the manufacturing process should be noted. For simplicity and ease of understanding, process flow diagrams usually are represented in block formation. Both hand-written and computer-generated models are acceptable since the method used often depends on the resources available.

Preventive Maintenance

A proactive method of controlling potential hazards through the systematic inspection, effective monitoring, and controlling of various procedures and protocols. It can be achieved by regular service of equipment and continuous training of personnel involved in HACCP. Considered a prerequisite program in many industry HACCP programs.

Personal Hygiene Program

A program that addresses employee health practices, designed to reduce the risk of microbiological and pathogen contamination to food products.

Chemical & Hazardous Material Control Program

A program that outlines the methods utilized to reduce or eliminate the risk of food contamination from chemicals and hazardous materials.

Sanitation Standard Operating Procedures (SSOPs)

A set of written instructions that outline the who, what, when, why, and how to clean and sanitize food handling equipment. The SSOPs often include methods to utilize when verifying the effectiveness of cleaning activities.

Personnel Training

All personnel must be trained to keep all entrances/access points secured when not in use. They must not prop doors or windows open. They should not let unknown or unauthorized personnel into the facility. Employees should be trained in a proper method to politely confront strangers.

Visitor Control

All visitors and contractors must be restricted to enter the building through the main entrance after being received and documented in some manner. They must be asked to sign in at the front desk and their I.D. should be checked. Visitors and contractors should be provided with some sort of identification such as a color-coded uniform, bump cap, and/or name tag. Visitors and contractors should be accompanied by a company representative at all times.

Allergen Segregation

Allergenic ingredients must be segregated from non-allergenic ingredients to prevent cross contamination. Allergenic finished product must be segregated from non-allergenic finished product. Same goes with the tools and utensils for handling allergen must be segregated from other tools. Proper production scheduling is also important in controlling allergen. Nonallergenic products must be produced before allergenic products. The food plant must also address potential allergens cross contact in rework items and in work-in-progress (WIP) materials.

How often should employees receive training in GLPs

At a minimum, receive introductory training upon hire or assignment to laboratory function and at least annually thereafter for refresher training. Should be trained in proper safety of lab work, chemical/reagent storage, and facility specific procedures such as shelf life studies, micro testing, sampling, and sample (micro) disposal. Must be trained in calibration of all lab equipment, management of reagents.

How often should employees receive training in GMPs

At a minimum, upon hire and at refresher training annually. Must include the minimum requirements as outline in the CFR, which includes personal cleanliness, jewelry, hand washing, hair restraints, clothing/outer garments, personal item storage, medicine usage, and taking any other necessary precautions. There should be a check for comprehension prior to completion of the training - usually quiz or test. All training should be documented.

Methods to improve and maintain security of food facilities

Building Design Personnel Training Personnel Identification Visitor Control

Building Design

Buildings should be designed in a way where there is only one access point for nonemployees. All entrances leading into the building must be locked and secured. They should only be accessible by a company's employees. This can be achieved through a card access system. All stairs leading to the roof must be locked and only authorized personnel should be entrusted with the key. The building perimeter can be monitored by surveillance cameras. Any outside equipment or product storage must be secured from intentional contamination as well as covered, sealed, locked, etc

Allergens are considered what type of Hazard?

Chemical

Detailed training on the seven core basic principles and expectations for the HACCP plan

Conduct hazard analysis, determine critical control points (CCPs), establish the critical limits, establish monitoring procedures, establish corrective action procedures, establish verification procedures, and establish record-keeping and documentation procedures. It must be noted that not all of the aforementioned activities are to be performed by all team members; however, it is desirable to have all members "know exactly what HACCP expectations are" and what they are committed to achieving as a team. Each of the above sections must be dealt with in close relation to existing plant manufacturing locations and must be customized for the specific plant location. It is important to note that there may be various different ways that can be used for monitoring and verification to manage frequencies of activity. It depends a lot on the production output, process (whether it is automated or personnel), and calibration frequencies of production equipment. Corrective action plans also vary with nonconformance occurrence frequency and degree of product affected when there is a nonconformance.

Allergen

Considered to be a chemical hazard.

The Intended Use of the Product and Its End User

Consumer-unique groups (infants, elderly, immune compromised) Patient-Dosage restrictions, sterile shelf life, do not re-use) Vulnerable Group

GMPs Elements

Control of physical, chemical, and biological hazards. Often viewed as personal practices

Material Status

Described as the state of a material in relation to other materials. May include "on hold", "available", "testing", or "staged" as examples. The status tell us if it can be used an moved to the next step of the operation.

Why Dust Control Is Important

Dust is a common contaminant in food facilities. Dust can act as a carrier for microorganisms and allergens. Dust from soil can provide a medium for bacteria. Ingredient dust in the environment can result in cross contact with an unknown or unexpected allergen.

Training in Chemical and Hazardous Material Control

Employees should receive training upon hire and then at least annually thereafter. The training should include definitions of what constitutes a chemical or hazardous material, organizations policy on purchasing, approval, storage, inventory, identification, right to know info, and as applicable info on which materials may be used or stored on site. Include check of comprehension.

How often should employees receive training in SSOPs

Employees tasked with the cleaning and sanitation of food contact equipment need to have in-depth training on an initial and ongoing basis because of ever-changing technology and regulatory requirements and the sensitivity of the procedures for both employees and consumers. Should include chemical safety, chemical mixing, and chemical dispensing procedures along with the methods used to test cleaning and sanitizing chemicals for proper concentration. Must be a check for comprehension to assure understanding.

Training HACCP Team

Every member of the team understands their role, while serving as SMB in their area. Detailed Training on the Seven Core Basic Principles and Expectations for HACCP plan Good Documentation Practices Training Hazard analysis performed by HACCP coordinator in compliance with current regulatory guidelines Training on the Job Auditing toward HACCP maintenance Plan

Main Building Structure

Facility must be constructed to prevent leakage and entry of external contaminants. Inside there should be segregated areas for high-risk and low risk products, process flow to prevent cross contact between high and low risk items. No flaking paint, rust, and other loose material that may contaminate products.

Shipping Temperature Controls

For temperature-sensitive products, the shipping area should be temperature controlled. This is to prevent temperature abuse of products during the loading process. The temperature of finished product must be verified prior to shipping. Often, the shipment container must be prechilled to a certain limit before finished products are allowed to be loaded.

The Global Food Safety Initiative (GFSI)

HACCP remains the foundation of food safety and quality management schemes benchmarked by the Global Food Safety Initiative (GFSI). Basically, these food safety and quality management schemes already have well-defined, internationally accepted standards that cover all sectors of a food operation. There is already an HACCP scope that food operators are obliged to follow if they choose to be certified under one of these schemes. Some examples of GFSI benchmarked standards include: BRC Global Standard for Food Safety, SQF Code, FSSC 22000, etc.

Training on the Job

Hands-on experience in discussing concerns and issues within the HACCP team will actually be a great source of training for the complete team. It should be appreciated of the fact that everyone thinks differently, and this is very critical for success of HACCP team. Different controls and processing activities must be discussed in detail so there are criteria identified for continuous improvements within the organization. The team must evolve with new ideas, management of risks, and think of innovative/different ways to avoid hazards in their products. It is necessary to challenge each other to best gain company interests and ultimately build the confidence level in customers.

Codex Alimentarious

Harmonizes the standards for HACCP, allows one source for globally acceptable methods in establishing, implementing, and maintaining HACCP systems. Established by WHO and FAO to harmonize international food standards, guidelines, and codes of practice to protect the health of consumers.

Why Humidity Control is Important

High humidity in a plant environment can result in issues such as mold and condensation. This creates an unsanitary production environment where the production of safe and consistent quality product is not likely, or even not possible.

Material Identification

Identifying all materials in the plant in some unique way so they can easily be found and traced

Elements of a Chemical and Hazardous Materials Program

Include elements such as approval, purchasing, storage, usage, inventory controls, and consolidation of such materials.

Allergen Sanitation

It is not always feasible to control allergen through production scheduling. Cleaning and sanitation is crucial in preventing allergen cross contamination. Thorough sanitation can remove any allergen residue from a surface (equipment, tools, environment). Even with thorough cleaning, sanitation effectiveness must be verified prior to ensure proper sanitation is completed.

Allergen Identification

It is not always possible to completely prevent the use of allergenic ingredients. When allergenic ingredients are used, food business operators must ensure they are properly identified. To make allergenic ingredients stand out for easy identification, color-coded labels that identify the type of allergens in the ingredients can be used. in addition to ingredients, utensils and tools for handling allergens also must be identified. This can be done through color coding. Allergens present in a finished product must be properly declared on label to warn consumers with allergies.

Allergen Training

Last but certainly not least, proper awareness training for employee is important to control allergens. Employee must be made aware of allergens that are present in the facility and the risks they pose to operators and consumers. They must also be taught the proper methods to control allergens and prevent allergen cross contamination.

Facility Location

Must be located away form potential sources of contaminants such as garbage dumps and waste water treatment centers.

Training in Personal Hygiene Programs

Must receive training upon hire, and should receive annual refresher training. Training should include internal company policies, proper hand washing practices, uniform requirements, glove usage, the management of cuts, scrapes, boils and other wounds, as well as reporting illnesses that may be communicable. Check for comprehension using oral interviews or open discussions should be undertaken.

Personal Hygiene Programs

Often serve as a stand alone program but at times may be combined with a GMP or GAP program. Typically include hand washing, which should address the type of soap used, water temperature, maximum time limits that it takes for the water to reach temperature, and the posting of "Wash Hands" signs.

"event chain diagram"

One way to define the scope of an HACCP system. Each component of the chain diagram should be analyzed on its impact to the safety of the finished product.

Risk Management

Potential hazards identified in the HACCP system must be determined based on risk. Other than that, the monitoring and verification activities must be based on risk assessment. The likelihood and severity of a potential risk or hazard must be carefully determined. The frequency and the coverage of the monitoring and verification activities must be assessed to ensure those activities are sufficient to ensure the identified hazards will not exceed the critical limits. Other than the HACCP flow itself, this also applies to activities that are covered by HACCP scope. Risk assessment on activities covered by HACCP scope such as sanitation and preventive maintenance is important to ensure sufficient controls are in place to govern hazards that are not controlled in the HACCP flow.

Good Laboratory Practices (GLPs)

Practices or procedures used to define the rules and criteria for a quality or food safety system concerned with the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, and reported. Serve as prerequisite program for HACCP in the food, pharmaceutical, cosmetic, and medical device industry.

Good Agricultural Practices (GAPs)

Practices related to the primary production of foods, usually through farming. They address the practices on farms that define the elements for the development of best practice of production while incorporating integrated crop management, integrated pest management, and hygienic practices in an agricultural setting.

Good Manufacturing Practices (GMP)

Practices utilized in a food manufacturing environment and are designed to ensure that food products are consistently produced to meet regulatory requirements and customer specifications.

GAPs

Prerequisite program they serve as a preventive measure to eliminate or greatly reduce hazards such as chemical contamination from fertilizers, fungicides, herbicides, and pesticides while also focusing on sustainability through crop rotation

Importance of Management's Commitment to Prerequisite Programs

Prerequisite programs are the foundation of an HACCP system. They govern the operational conditions within a business. Therefore, it is vital for senior management to show commitment to prerequisite programs to ensure there are good operational conditions to support the HACCP.

Methods to control allergens in a food facility

Prevention Identification Segregations Sanitation Training

HACCP System should cover all activities including but not limited to

Procurement Transportation Distribution Production Maintenance Storage Sanitation Human Resource Management

Environmental Control Programs

Programs include an allergen control program, temperature and humidity monitoring programs, and air monitoring program.

National Advisory Committee on Microbiological Criteria for Foods (NACMCF)

Provides impartial, scientific advice to federal food safety agencies.

Temperature Control Points

Receiving Storage Production Shipping

Monitoring Signs and Results of Humidity

Rust, Condensation Dripping, etc. can indicate if high humidity is a problem to be dealt with

GLPs

Serve as guidelines to ensure that clinical and nonclinical laboratory testing is undertaken in a sanitary and appropriately documented manner, resulting in accurate and repeatable results. Identify responsibilities, safe practices, documentation and record retention, and standard operating procedures for all aspects of the studies being conducted and the condition that a laboratory must maintain.

How often should employees receive training in GAPs

Should occur with employees upon initial hire and at least annually thereafter. Also valuable when the crop to be harvested or handled changes, as field and packing house conditions can change when a product changes.

Production Temperature Control

Some food products need to be prepared in a "cool" environment. The temperature of the room must be controlled and monitored to prevent temperature abuse to products or ingredients. The temperature of the product and ingredients must also be monitored and controlled for food safety. A procedure should be established to limit the amount of time temperature-sensitive ingredients are allowed to be left in a nontemperature-controlled environment.

Methods to Keep Management Apprised of Current and emerging Issues

Standards (subscribe to newsletters/attend conferences) Hazards (be part of HACCP team, review HACCP min in management review) Technologies (subscribe to newsletters/attend conferences) Related Regulations (subscribe to newsletters/attend conferences)

Storage Temperature Control

Storage locations such as coolers and freezers must be temperature controlled. Temperature must be checked routinely and frequently enough to assure there are no unacceptable conditions for products. Temperature can be monitored using a temperature recording chart. Connecting the temperature recorder to an alarm that will notify appropriate personnel when the temperature falls below the set point is also a valuable tool in this prerequisite program

Hazard analysis performed by HACCP coordinator in compliance with current regulatory guidelines

The FDA (or Hazard Analysis Database in Canada) at this time does not have any document specifically addressing varied ingredients/processes used in food manufacturing and their link to physical, chemical, and microbiological hazards. It is imperative for each HACCP team member to understand the different types of hazards that are unacceptable in food products (for example, physical hazards, chemical hazards, and microbiological hazards). During above training, the SME/HACCP coordinator must give examples of hazards that can be added inadvertently to their food products directly related to the specific plant. This helps HACCP team members to understand and implement controls for hazards in discussion.

Assembling HACCP Team

The HACCP team should consist of cross-functional, multidisciplinary members from production, operations, shipping and receiving, quality (both QA and QC), and maintenance. Sanitation designated be included to offer technical insight on process flow, equipment hazards, and chemical hazards in relation to cleaning and microbiological results. These members must belong to all different levels (multidisciplinary) of employees in the company--floor employees, supervisors, and mid-level positions, like coordinators, or departmental leads, managers, etc. It is advisable to keep this number to about five to seven team members only for a mid-sized company (about 150 to 200 employees). However, for smaller companies (less than 100 employees) the team may consist of only four to five members. The HACCP coordinator must lead the HACCP team.

The Product and its Distribution should Include these Details

The Manufactures Name and Address Common Names or Brand Names The Intended Use Method of Storage and Distribution Shelf-life and Traceability Information Packaging Type Technical Information

Allergen Prevention

The best way to control allergens is to prevent them from entering the facility. Food business operators must have a stringent purchasing program. Supplier and ingredients must be evaluated prior to purchase and an allergen declaration must be provided by supplier. Food business operators must also ensure that only approved ingredients are received into the facility.

Difference Between Regulatory and Voluntary HACCP Programs

The difference between them is that regulatory HACCP programs often have predetermined critical control points (CCPs) and the critical limits are set by regulatory authorities. Some of the prerequisite standards are also determined by regulatory authorities. An example of it is light intensity in a meat processing plant. Production records such as CCP records under a regulatory HACCP program are legal documents.

Quality Management

The foundation of an HACCP plan is based on prerequisite programs. Most activities defined in an HACCP scope are controlled by prerequisite programs. The purpose of a prerequisite program is to control potential hazards that are not covered in the HACCP system. The activities directly and indirectly affect the quality and safety of the food or medical device. An example of this is the sourcing and purchasing of raw materials. The requirement on raw material specifications has a direct impact on the quality and safety of the finished product. Another example is product development. Other than assessing the safety hazards, quality parameters of products during product development should also be assessed. It can be said that HACCP and prerequisite programs play a major role in a quality management system.

Medical Devices

The margin of error in the medical devices industry is very small. Therefore, HACCP scope must thoroughly cover all the components in the business to prevent potential hazards from entering into the HACCP flow. It must be very detailed to ensure there are no uncontrolled hazards. Referencing medical device regulatory standards can ensure that appropriate hazards are identified and critical limits are set to ensure regulatory compliance. Recall data should be researched to establish a history of known hazards when possible.

Verify the Flow Diagram

The process and responsibility for verifying the accuracy of a process flow diagram should be clearly stated in the HACCP quality system procedures. The HACCP team may elect to walk through the entire process to gain consensus as to whether the diagram clearly depicts the process. It is always suggested that the individual verifying the flow diagram not be included in the development of the diagram. Failure to include a step in the process could lead to disastrous consequences. Omission of a processing step could mean the step is not subjected to the required scientific hazard analysis review. Rework has to also be included in the HACCP flow. If rework is not included on the flow diagram but is being carried out, it could be another omission that has serious consequences. Flow diagrams should be signed and dated as to when they were verified and by whom; these are typically revivified annually or when process flow changes.

Receiving Temperature Control

The temperature of refrigerated and frozen incoming ingredients must be monitored. In addition, these materials should be received in a temperature-controlled environment so as to not compromise product safety.

Waste Disposal

There must be a separate and designated area for waste collection and disposal.

Personnel Identification

There should be some sort of identification that can be used to differentiate employees from nonemployees. This should also identify employees from different work areas, thus preventing cross contamination due to traffic flow. The most basic form of this identification is color coding uniforms (cap, smock, hair net).

Lighting

There should be sufficient lighting for production and inspection activities. The light bulbs used in a food plant should be such that if they break, they will not contaminate products.

Washroom, lunchroom, and other personnel facilities

These facilities must be provided and maintained appropriately. These areas must be separated from production areas to prevent cross contamination. There must be adequate hand-washing facilities that are easily accessible to employees.

Auditing toward HACCP maintenance plan

This is a mandatory requirement for a successful team. There may be situations where activities are not performed as per predetermined frequency. At this point of time, everyone must understand the corrective-action plan, as it may be required to troubleshoot. However, it must be ensured at all times that no food safety issue/concern is left pending disposition for unusually long periods of time. This may impact the performance of the whole team and also lead to monetary loss to the company in terms of product loss, customer or client loss, or eventual loss of business. Internal auditing is best trained by "shadowing an experienced auditor;" this is the key to success of HACCP team training. Of course, the HACCP coordinator/CHA/SME is the experienced auditor and every section of the HACCP must be "shadow audited" by all team members to finally sign off as "trained HACCP team members."

Good documentation practices training

This is mandatory and critical for the HACCP team, and each member must accurately follow this diligently. No white outs, no over writing on other's records, sign off if any of errors are made during record writing, etc.

How are SSOPs established?

Through a combination of manufacturer's recommendations, scientific data, process studies, and chemical requirements.

Water System

Water distribution lines must be constructed to ensure there's no cross contamination between potable and nonpotable water. The quality of incoming water must be monitored to ensure it is fit for food production. Hot water must be available for cleaning and other production purposes. Drainage systems must be constructed in a way to prevent backflow. There must be adequate slope to floors to prevent pooling of water.

Technical Information

and other food safety factors including, but not limited to: preservatives used, Ph of product, water activity or moisture, potential misuse by consumer (example: consumer eating raw cookie dough), or other known hazards such as stones, stems, or leaves in dry beans, etc. should be included in the description/finished product profile.

Regulatory HACCP Programs

are HACCP programs that are enforced by a regulatory authority such as the FDA or USDA in the United States and CFIA in Canada. These kinds of HACCP programs are only applied to high-risk food commodity such as meat, dairy, seafood, eggs, etc.

Voluntary HACCP Programs

are not regulated or enforced by a regulatory agency. Food operators who are committed to food safety and quality volunteer to set up an HACCP program. Most of the food safety and quality certification programs such as SQF Code and BRC standards are examples of voluntary HACCP programs.

How can Humidity be Controlled

can be controlled through proper ventilation system operation. Areas with potential high humidity must have sufficient ventilation to remove extra moist air from the room. Dehumidifiers are also used but must be maintained in clean and sanitary condition. Humidity can be monitored through a humidity reader.

Dust Control

can be controlled with proper ventilation. Air intakes should be filtered. Frequent sanitation is effective in removing dust from a processing environment. Fans and other air movement devices must be properly located to prevent creating dust and to prevent moving that product dust onto a dissimilar product (allergen cross contact)

System Scope

defines the items that are covered by the HACCP system. It clearly lays out the activities that are controlled by the preventive food safety program (prerequisite programs), and the food operator should be responsible for them. It is important for the Certified HACCP Auditor (CHA) to understand a system scope so a clear audit objective and scope can be defined. The CHA must also know and understand the crucial activities of a food business that may potentially impact the food safety of the finished product.

Temperature Deviations Procedures

deviation procedures must be established to address situations where the temperature of the temperature-controlled areas goes outside the limits. Typically, the temperature of refrigerated areas should be below 4 degrees Celsius (40 F) and frozen areas should be below -18 degrees Celsius (0 F).

Method of Storage and Distribution

must be included to assess the risks associated with transporting or storing the product. Where cool and dry may be acceptable for some products, ambient storage and distribution may be required for others, and frozen or refrigerated may be required for some. When temperature sensitive, the parameters should be included (-10 F for ice cream or 15 F degrees for frozen vegetables).

Importance of Management's Commitment to HACCP

senior managers make most of the critical decisions in a business, and HACCP requires resources that may require senior-level support and approval. Senior management must show that they endorse and are actively involved in decisions regarding the HACCP system. Management must provide sufficient resources including finance and time to drive the success of an HACCP system.

The Product and its Distribution

should be described exactly as it is referred to in the finished goods item list of the company. This may include a shape description, the item number the company uses for ordering purposes, and ingredient descriptions. Labeling information, i.e., allergens, should be in the description of the product. Also included in the description of the product is the intended use, i.e., ready to eat or the necessity for additional processing of the food. The distribution of the product should include optimal temperatures, with ranges, for both shipping and storage of the product. Shelf life may be crucial to the distribution of the product and therefore must be included in the product description. Relevant information used for traceability of identity needs to be included to assist in the case of recall.

Shelf-life and traceability information

should be identified in the product description or "Finished Product Profile" to identify any special coding and the ideal shelf life. Some food products may become hazardous after their recommended shelf life and the ability to recall or trace is a legal requirement.

Packaging Type

should be identified, as it has bearing on the product safety, a brief description such as "Packaged in high clarity polyethylene (PE) bags, seamed, and sealed using heat. Individual packages are then placed in master cases. Packages are available in 12-ounce, 24- ounce, or 5-pound bags" would be ideal.

Common names or brand names

should be used when applicable along with a summarized product description such as: "Meat (beef) filled tortilla with a variety of seasonings, vegetables, and cheeses."

The intended use

should include demographical information if the product is designed and intended for all demographics, children, teenagers, etc. This is important to understand the risks associated with the finished products, as children or the elderly may have a higher risk to certain attributes such as microbiological limits or allergens.

Ventilation

the Facility HVAC must be designed and maintained to ensure clean air is drawn into the food production area and contaminated air is moved to outside. Use of appropriate air filtration.

The manufacturer's name and address

to formally identify where the product was produced. If portions of the product are outsourced, this needs to be included in the description