PROCESS CONTROL | December 2015/January 2016

HACCP Issues and Impacts

By Regina Tihfon, M.Sc.

Hazard Analysis and Critical Control Points (HACCP) was originally developed based on
several key program types. The templates were created for specific industries and food
risks and therefore do not fully address HACCP-level requirements of all food-level risks
in the marketplace. For example:

• AIB is focused on the bakery and confection market.

• Codex Alimentarius Commission looks at general food on a global level.

• The U.S. Department of Agriculture Food Safety and Inspection Service (USDA-
FSIS), International HACCP Alliance and the National Environmental Health
Association focus on meats, protein and dairy.

Much of the development of HACCP programs is based on training for these segments.
Ultimately, foods or industry segments requiring HACCP have followed these
established models, even though they do not always align with food risks or operational
models. As a result, HACCP plan coordinators outside these risk categories [e.g., food
contact packaging, contract food packaging, food ingredients, pet food, service providers
(e.g., transport, warehouse, logistics, uniforms)] have been challenged to make
determinations with limited comparable references.

Unfortunately, facilities like these are often left with ineffective HACCP programs that
are deficient in managing operational risks unique to the company’s product or
processing environment. These may include a lack of risk assessments, minimal
preventive controls and validations or not being scalable to the changing requirements
of the market [i.e., Global Food Safety Initiative (GFSI) continuous improvement,
science-based findings of risks, Food Safety Modernization Act’s (FSMA) Hazard
Analysis and Risk-Based Preventive Controls].

Workable HACCP Solutions

Food companies, including those specializing in food-grade ingredients, food contact
materials and packaging as well as service providers, must develop HACCP programs
using a “clean-sheet” approach rather than follow the established HACCP templates
used for other specific food processor types. This approach should be based on the fit of
their operations (e.g., high-risk protein, low-risk protein, liquid or dry ingredient,
chemical, packaging or logistics) to existing HACCP models and templates and/or the
unique aspects of the operational models and food risks.

Effective and workable approaches to mitigating the above issues should consider
designing and customizing HACCP training to include product and unique process flow.
To best accomplish this, several issues must be addressed, including the following:

• Training needs to be more open to specific and unique industry and operational
needs. It further needs to be “fit for the use” of the related product and process food
safety risk. For example, in packaging with high engineering of product, training needs
to focus on the ultimate process design and capability developed and maintained by
process engineers.

• Content registers must be developed to provide elements and direction for HACCP
program design, development and implementation. HACCP teams should work under
the direction of a competent and advanced HACCP-trained coordinator to design and
establish the content register during development and implementation, in addition to
using the established five-step approach and seven HACCP principles per Codex
Alimentarius. The content register should address risks and control measures that are
unique to operations, finished product and services that impact food safety (e.g., pest
control, service contractors, trainings, comanufacturers).
• The HACCP development process needs to be open and channel aspects of the program
to the risks associated with nontraditional HACCP food applications (see “New HACCP
Applications,”) or service operations.

• In-depth reviews and assessments should be conducted by an appointed HACCP/food

safety team and/or outside expert(s) with emphasis in the following areas:

• Food ingredients, including dry, mill, liquid, whole grains, snack foods, etc.

• Potential pathogens unique to raw materials/ingredients, potentially introduced

from processing conditions and the environment, water activity, allergen control
program, operational product changeover, food contact utensils, maintenance tools,
microbial air quality based on air-handling units, process room air quality and pressure,
critical equipment necessary for safe food production, environmental monitoring
programs, cleaning in-place and cleaning out-of-place, plant construction monitoring
program during operation, preventive maintenance program for critical parts and
aligned equipment, employee traffic, material and product handling, contact packaging
supplier, etc.

• Food contact packaging (i.e., flexible films, lids, paper, converters, rigid plastic,
glass, metal), including source and validation of inks and dyes (domestic or imported),
compressed air quality, type of lubricants (food-grade versus non-food-grade, soy- or
mineral oil-based), physical and chemical properties with reference to ink, migration
and permeability, compatibility and reaction of adhesives/inks under various handling
conditions by consumers such as heat and cold. These could be mitigated through
documented material and ingredient vendor/supplier validation studies or in-house
finished product shelf-life studies.

• Service providers (e.g., transport, logistics, uniforms), including airflow and

circulation during handling and transportation of refrigerated and frozen foods,
approved laundry chemicals, cleaning water temperatures, verification and validation of
cleaning uniforms during storage and transportation, and driver and personnel training
on critical responsibilities that impact food safety.
New HACCP Applications
In recent years—under pressure from specific USDA-FSIS and U.S. Food and Drug
Administration (FDA) regulations as well as industry requirements under GFSI and
customer requirements—HACCP has evolved in expected content and food industry
application.

New HACCP applications include the following:

• Food-grade chemicals (liquid, dry, gas)
• Source and safety of materials
• Lot traceability
• Allergen and labeling
• Identification, storage and accessibility by authorized personnel
• Chemical process aids
• Approval by FDA and USDA
• Approval by country of origin and/or customer country of origin
• Recommended or allowable amount per specified amount of product
• Shelf life and storage conditions
• Packaging (rigid, plastic, glass, metal, laminated film, aseptic, high-pressure
processing, other)
• Food-grade
• Generally regarded as safe for humans and animals
• Chemical and physical properties
• Transports (trailers), tankers, rail cars, etc.
• Security during transportation of product or materials
• Temperature control and verification records
• Cleaning certification program and records
• Airflow and design for temperature-sensitive products
• Generally recognized as safe (GRAS) ingredients
• Updated status of GRAS under current regulatory and certification
requirements
• Current customer requirements
• Grade and processing risks
• Packaging
 • Delivery/transport
• Intended use

Operational Processes and Food Risks

HACCP training and programs are typically based on products at high risk of biological
contamination, but many other product and operational scenarios now require HACCP.
Companies should compare their operational process and food risks with HACCP model
options. This can be achieved through the following:

• Reviewing and assessing available human and financial resources with accountability
for deliverables

• Developing high-level, risk-based matrix models

• Aligning definitions for likelihood and severity factors with identified potential and
operational risks from biological, physical, chemical, allergen and radiological
perspectives

• Using scientific validations aligned with process and/or product scope

• Conducting documented and scientific in-house verification and validation study

• Further aligning FSMA preventive controls and incorporating them into the various
food operational and risk categories

Supporting Information
When developing HACCP plans and strategies, identifying industry, academic, category,
customer, supplier and established global information can help support plan design,
including Hazard Analysis, preventive controls and risk rating/ranking. This
information can be obtained through research and communication updates relevant to
the food risks of the product or product type being addressed. Some reliable sources
include the following:
• Industry publications

• Product and raw material technical information and food intended-use validation

• FDA listing of approved food and food contact materials

• EU, UK, Canadian and other national regulatory requirements

• Global regulatory positions (food-grade or non-food-grade determinations)

• Industry and university studies on food-grade products and material risk

requirements

• Examination of past outbreaks resulting from non-food contact materials or

exposures (e.g., liners, pallets, transports, incipient aids, process aids, additives)

• Determination of risk severity and experienced likelihood available to substantiate

specific Hazard Analysis

• Dialogue with customers and suppliers related to their determination of risk analysis
for the food-grade product provided

Value-Added Activities
Developing and implementing HACCP programs require a significant investment of
time and effort. Although HACCP continues to evolve, it is up to the individual company
to design and customize HACCP programs to make them effective and workable,
particularly in foods and industry segments outside HACCP’s “standard” risk categories.
There are a number of operational considerations that can help ensure a compliant and
value-added HACCP program:

• Appoint a food safety team with extensive process and product experience, including
R&D, product engineering, process engineering and maintenance

• Conduct effective and customized HACCP team training by a certified lead HACCP
trainer with extensive and varied product process experience, including contact
packaging, milling, snack foods, etc.

• Establish an approved and verifiable supplier and purchasing program

• Conduct in-depth risk assessment and implement mitigation strategies for critical
equipment

• Include and establish critical equipment during the process Hazard Analysis risk
assessment and development

• Achieve compliance to the GFSI scheme of choice as an HACCP plan requirement

• Develop and implement a verifiable change-management program that focuses on

new product and product development

• Develop a robust in-house training program for CCPs and operational prerequisite
monitors and verifiers

With these considerations in mind, expanding HACCP content to meet operational

objectives can be successfully achieved.

Regina Tihfon, M.Sc., is a senior consultant at Kestrel Management with 25 years of experience
in food safety and quality assurance. She trains management and operators in food safety,
HACCP and conformance to specifications and ISO 9001. Regina has an M.Sc. in food science
and technology from Texas Tech University and an Ordinary National Diploma in Food
Technology from Birmingham College of Food (England).
Categories: Management: Risk Assessment; Process Control: Best
Practices; Regulatory: Audits/Certification/GFSI, FDA, FSMA,HACCP, USDA