HACCP EXAM 1

HACCP USDA plan

Meat poultry

fish/ fish products (catfish)

egg products

SSOP

sanitation standard operating procedure

SOP

standard operating procedure

GMP

good manufacturing practice

HACCP FDA plan

seafood

juice

preventative Control plan

all other foods regulated by FDA

preventative

USDA

preventive

FDA

HACCP

hazard, analysis, critical, control point

PCQI

preventative controls qualified individual

7 principles of HACCP

• Conduct hazard analysis

• Determine the critical control points required to control the identified hazards

• Establish critical limits that must be met at each identified ccp 

• Establish a system to monitor control of the ccps

• Establish corrective actions to be taken when there is deviation identified by monitoring a given ccp 

• Establish verification process

• Establish record keeping and documentation process

required in food safety plan

hazard analysis, preventative controls, procedures for monitoring, corrective action verification, recall plan

HACCP def

Systematic, science-based process control system for food safety that serves as the basic structure of a preventative system for the production of food products that are safe to consume 

objectives of haccp

make product as safe as possible

be able to prove that the product was processed safely

haccp is designed to

identify hazards

establish controls

monitor controls

haccp orgin

1959 developed by pilsbury, us army, and nasa

adapted modes of failure concept developed by Natick for production of food

spring 1971

Connecticut woman found glass in baby food— Pillsbury farina

— lead to implementing procedures that bauman helped with when he worked at NASA and championed HACCP for industry

1971

haccp first presented to the public at national conference on food protection

3 principles haccp first consisted of

1. identification and assessment of hazards

2. determination of ccps

3. establish monitoring systems

1972

haccp used to train FDA inspectors for canned, acidified and low acid foods

1985

national academy of sciences provided strong endorsment of haccp

1988

national advisory committee on microbial criteria for foods meetings encouraged adoption of haccp

1989

NACMCF 1st major HACCP document

-7 HACCP principles and systematic approach

1992

NACMCF updated 1989 HACCP document

-Included new risk assessment procedure

-Modifications to ease of use

1997

NACMCF revised HACCP document

benefits of haccp to companies

• provides best available framework to assure that food products are safe for consumers

• cost of producing unsafe food is too high for any company to bear

• applying the principles of process control ot its operations, a company can minimize costs associated with product failure of all types

key benefits of haccp

1. Better understanding of food hazards associated with

products and processes

2. Designation of CCPs that prevent, eliminate or reduce

identified hazards to an acceptable level

3. Records documenting that controls are applied at CCPs

and corrective actions are taken when deviations occur

4. Increased accountability for implementing prescribed

food safety operations

5. Improved level of customer satisfaction and confidence

6. Reduction in quantity of discarded product

food safety preventative controls alliance (FSPCA)

broad based public private alliance of industry, academia and goverment stakeholders, established in late 2011 by FDA

FSPCA vision

be an internationally recognized trusted source for training programs and outreach for the prevention-oreinted standards for the food safety modernization act

FSPCA mission

assist the human and animal food industry and related entities in building food safety capacity through education, training and outreach wuth an emphasis on small and medium sized businesses

risk based preventive controls

system that identifies food safety hazards within the food process and designated appropriate controls to minimize the risk of those hazards

haccp to preventive controls

HACCP focuses primarily on controlling hazards associated with the process through implementing controls at Critical Control Points, or CCPs.

Preventive Controls expands on the concept to include a focus on significant hazards associated with the process such as:

‒ Allergens (cross-contact and mislabeling),

‒ Sanitation (processing equipment and environment), and

‒ Supply-Chain (raw materials and other ingredients).

need for preventive controls approach

allergen control

sanitation control

supply chain control

food modernization act (FSMA)

signed into law in 2011 with the aim of ensuring a safer food supply with a focus on prevention

food safety plan

A set of written documents that is based on food safety principles; incorporates a hazard analysis; and as determined from that analysis, appropriate preventive controls; procedures for monitoring, corrective actions and verification; and a recall plan

food safety system

the outcome of implementing the food safety plan and its supporting elements

contents of a food safety plan

hazard analysis

preventive controls

procedures for monitoring, corrective action, and verification

recall plan

food safety plan organizational sections

backround info, hazard analysis, preventive controls, recall plan

background information

information to organize the plan

preliminary steps in developing a food safety plan

not required by regulation

hazard analysis

drives decision making for identifying hazards that require a preventive control which must be included in the food safety plan

recall plan

required when a hazard requiring a preventive control is identified

written procedures and assignment of responsibility to assure affected product is removed from commerce

PCQI

preventive controls qualified individual

• successfully complete training in the development and application of risk based preventive controls or be otherwise qualified through job experience

one or more PCQI must do or oversee the following

Preparation of the Food Safety Plan

Validation of the preventive controls

Review of records

Reanalysis of the Food Safety Plan

national academy of sciences (NAS)

received congressional charter 1863

designated as an official advisor to federal government on science and technology matters

centers for disease control and prevention (CDC)

responsible for characterizing risk factors and prevention strategies for diseases that impact public health

codex alimentarius (CODEX)

sponsored by the food and agriculture organization (FAO) and world health organization of the united nations

• facilitate international trade by establishing uniform food standards

national advisory committee on microbial criteria for foods (NACMCF)

expert scientific advisory panel to the secretaries of agriculture, commerce, defense, and health and human services

provides scientific advice to federal food safety agencies for use in the development of an integrated national food safety system approach from farm to final consumption to assure the safety of domestic, imported and exported foods

FDA seafood HACCP regulation

importers and processors must comply

FDA seafood HACCP regulation does not apply to

harvest or transport of fish or fishery products

practices intended solely to prepare a fish for holding on a harvest vessel

the operation of a retail establishment

4 components in USDA rule

1. develop and implement written sanitation standard operating procedures

2. regular microbial testing required for slaughter establishments to verify the adequacy of a plants process controls for the prevention and removal of fecal contamination and associated bacteria

3. all slaughter plants and plants producing raw ground products must meet pathogen reduction performance standards for salmonella

4. develop and implement HACCP programs

large plants

> 500 employees —> Haccp jan 1998

small plants

10-500 employees —> Haccp jan 1999

very small plants

<10 employees or <2.5 millions in sales —> Haccp jan 2000

how are pc and haccp simmilar/ differnt

HACCP created by regulation, not federal statute

Under FDA, HACCP only applies to seafood and juice

PC applies to all FDA food facilities except those already under mandatory HACCP (although there are exemptions)

preventive controls for human food steps

1. Hazard Analysis

2. Risk-based Preventative Controls

3. Monitoring of Effectiveness

4. Corrective Actions

5. Verification

6. Recordkeeping and Documentation

7. Requirement to Reanalyze/Recall plan

model food code

set of uniform federal recommendations, a major part of which is the use of HACCP in retail food systems, to local, state, and federal agencies that inspect retail level food operations

juice products

proposed april 1998

haccp for juice/ labeling for juice

• from death of child in colorado

warning statement required effective sept 1998 for apple juice/ cider

juice haccp effective dates- jan 2002

exception of juice haccp

retail producers of juices

egg initatives

shell egg carton safe handling instructions

eggs required to be placed under refrigeration upon delivery at retail establishments

global food safety initaitive (GFSI)

collaboration between some of the worlds leading food safety experts from retailer, manufacturer, and food service companies, and service providers associated with the food supply chain

safe quality food initiative

SQF

administered by FMI, recognized by GFSI

provides independent certification that a suppliers food safety and management meets international and domestic food safety requirements

international organization for standardization

ISO

non-government network of 162 countries, coordinated in Geneva Switzerland

specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption

common GMP violations

pest control

sanitary operations

manufacturing processing

personnel practices

equipment

prerequisite programs

procedures, including current good manufacturing practices (CGMPs) that provide the basic environmental and operating conditions necessary to support the food safety plan

food safety system

the outcome of implementing the food safety plan and its supporting elements

prerequisite programs

• provide basic environmental and operating conditions necessary for production of safe, wholesome food

• should be well documented with written standard operating procedures (SOP’s)

• should e revised and reviewed as needed

• can include objectives other than food safety

CGMP

Provides the minimum regulatory standards for conditions and practice that must be met within food operations

Sanitary Facilities and Controls

• Adequate potable water supply

• Proper plumbing

• Adequate floor drainage

• Proper sewage disposal

• Adequate, accessible, sanitary toilet facilities

• Convenient handwashing and hand sanitizing facilities

• Proper trash and waste disposal

storage and transportation of food must be under condition that protect against

microbial growth

allergn cross contact

contamination of the food with hazards

deteroration of the food and the container

defect action level

a level of non hazardous naturally occurring, unavoidable defect at which fda may regard a food product “adulterated” and subject to enforcement action

why facilites need to clean and sanitize

risk of pathogen and spoilage organism

pests

alergen concerns

quality concerns

wet cleaning

removes food residue with water and chemicals

match cleaning chemical and method to surface and soil

dry cleaning

removed food residue with mechanical action

ensure method is the best fit for surface or equipment

wet cleaning sanitation process

preclean, prerinse, washing, post rinse, inspect, sanitize

wet cleaning methods

manual- hand cleaning

foams/ gels

mechanical

transient microorganisms

introduced via raw materials, personnel, packaging materials

removed through normal cleaning and sanitizing

resident microorganisms

become established in the environment

may persist for long periods

facility hygienic zoning and GMPs- documented assesment of the facility considering

infrastructure

Personnel practices

Traffic flow including people, equipment, and materials

Crossover areas

Pressurized air, airflow

Compressed air, if used in direct product contact

Drainage systems

Adjacent and support areas

environmental monitoring

verify the effectiveness of sanitation programs

verify that hygienic zoning is working

adverse event

a situation known to be associated with increased potential for environmental contamination

example- roof leak, floor drain back up

environmental monitoring records

track and trend environmental data

collect and record data to provide actionable information

preliminary HACCP steps

assemble HACCP team

describe the food and its distribution

describe the intended use and consumers of the food

develop a flow diagram that describes the process

verify the flow diagram

assemble the HACCP team

responsible the planning, developing and implementing the HACCP plan

describe the food and its distribution HACCP

identify products the plan will encompass

• general description of food, ingredients, processing

• describe nature of the product

• method of storage and distribution

• where product will be sold

• self life packaging

9 process categories for USDA HACCP plans

• slaughter

• raw product, non intact

• raw product, intact

• thermally processed commercially sterile

• not heat treated, shelf stable

• heat treated, shelf stable

• fully cooked, not shelf stable

• heat treated, not fully cooked

• product with secondary inhibitor, not shelf stable

describe the intended use and consumers of the food HACCP

describe properties that will influence the safety of the product- pH, water activity

ready to eat, heat and serve, how to prepare

general public, infants etc

develop a flow diagram that describes the process HACCP

provide a clear, simple outline of steps in process

verify flow diagram HACCP

HACCP team should inspect operation to verify accuracy and completeness of diagram , onsite inspection

USDA pre HACCP steps

1.Bring together your HACCP resources

2. Describe the product and its method of distribution

3. Develop a complete list of ingredients and raw

materials used in the product

4. Develop a process flow diagram

5. Meet the regulatory requirements for SSOP

1- conduct a hazard analysis

process of collecting and evaluating info on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan

2- identify critical control points

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

the haccp team evaluated the potential hazards that are reasonably likey to cause illness or injury in the absence of their control to determine if they are ccps

3- establish critical limits

a max or min value to which a biolocal, chemical, or physical parameter must be controlled at a ccp to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard

the haccp team sets critical limits to distinguish between safe and unsafe operating conditions at each ccp

4- establish monitoring procedures

to conduct a planned sequence of observation or measurements to assess weather a ccp is under control and to produce an accurate record for future use in verification

5- establish corrective actions

procedures followed when a deviation occurs

deviation- failure to meet critical limit

• to prevent foods which may be hazardous from reaching consumers

6- establish verification procedures

those activites other than monitoring that determine the validity of the haccp plan that the system is operating according to the plan

7- establish record keeping and documentation procedures

the haccp team sets up a record keeping program which provides written documentation that the haccp plan is being carried out as described in the written plan

HACCP plan

written document which is based upon the principles of HACCP and which delineates the procedures to be followed

food safety team responsibilities

developers, documents, maintains and reviews the food safety plan

oversees implementation of the food safety plan

ensures pensonnel are trained to carry out their responsibilities

preliminary task for food safety plan

assemble food safety team

describe product and its distribution

describe the intended use and consumers of the food

develop a flow diagram and describe the process

verify the flow diagram

Preliminary Task #1:

Assemble the Food Safety Team

Management commitment to resources: Supports realistic and executable plan

Team approach: Reduces risk of missing key food safety considerations, Encourages ownership of the plan

Individuals with different specialties and experiences

“Preventive Controls Qualified Individual”