# Presentation: 290611

## Role of Prerequisite Programs in Extraneous Material Management

**William H. Sveum Ph.D.**
**Associate Director of Regulatory Affairs**
**Kraft Foods North America**

## Prerequisite Programs

**Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food **
**Prerequisite programs include GMP's, equipment and process flow design, sanitation, maintenance, receiving and storage, and personnel training**
**Prerequisite programs must be developed, implemented, and documented before conducting the hazard analysis and implementing a HACCP plan**

## Foundation of Food Safety Management:Prerequisite Programs

_**General Quality Systems;**_
_**Monitoring Programs; GMP**_
**Use of Approved Suppliers**
**Rework Practices**
**Formulation (e.g., excess restricted **
**   ****ingredient addition)**
**Post Cook Recontamination**
**Product Sequencing**
**Extraneous Detection / Removal Programs**
**Brine Programs (treatment & testing)**

_**Recalls**_
**Hold & Release**
**Recall Procedures**
**Traceability / Code Dating**

_**Specifications**_
**Raw Materials****	****	****Packaging**
**Formulas****	****	****Labeling**
**Manufacturing Procedures**
**Finished Product**

_**Premises**_
**Building Structure & Utility Systems**
**Outside Property**
**Water Quality Program **
**  ****(treatment & testing)**

_**Sanitation**_
**Pest Control**
**Equipment Cleaning**
**Housekeeping**
**Period Cleaning**

_**Receiving / Storage**_
**Raw Material Management**
**Receiving / Storage Distribution**
**Certificate of Analysis (COA)**
**Letters of Guarantee**
**Hold & Release**
**Truck / Carrier Inspection**
**Label Review for Accuracy (e.g., “keep**
**  ****refrigerated”, cooking instructions)**

_**Equipment Performance & Maintenance**_
**Preventative Maintenance**
**Equipment Calibration**
**Compressed Air Filtration**
**Equipment Design**

_**Personnel Training Program**_
**Employee Hygiene**
**Employee Practices**

## The manufacture of safe food requires the use of a HACCP system built on a foundation of well-designed and administered prerequisite programs

**NACMCF**
**Codex**
**CFIA**
**USDA Generic Model**

**Prerequisite Programs**

## Industry Petition to Amend FSIS HACCP Regulations

**National Food Processors Association comments suggested that the degree of risk presented to consumers by the potential hazard dictate the control**
_**NFPA proposed:**_
**[I]f violation of a control limit clearly represents an inappropriate food safety risk that should lead to action against product, then inclusion of the potential hazard within a HACCP program is generally warranted.  However, if non-conformance with a control limit is undesirable, but unlikely to have health implications and therefore unlikely to require action against product, then ... inclusion of such a potential hazard in a HACCP plan is not generally appropriate....  (Comments to Docket No. 00-014R2, filed December 21, 2000 by the National Food Processors Association, page 4).**

## Food Safety System Definitions

- Critical Control Point: (CFR417.1) “A point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.”
- Prerequisite Programs: Represent the sum of programs, practices and procedures which must be applied to design, produce and distribute safe products in a clean, sanitary environment.

## Benefits of Prerequisite Programs

**Focuses food safety management on process control**
**Doesn’t rely on the limited effectiveness of after the fact inspection practices**
**Directs resources to effectively manage scientifically based CCP’s **
**Effective implementation of HACCP requires a sound foundation of PP’s capable of reducing or even eliminating the likelihood that a potential food safety hazard will occur in a process**

## Food Safety Systems

**Control all potential food safety hazards **
**Food safety hazards that are “reasonably likely to occur” must be controlled by a CCP**
**Some hazards are not “food safety hazards reasonably likely to occur” because PP’s are in place**
**Use validated CCP’s supported by developed, implemented, and documented PP’s**
**PP’s must be audited for effectiveness**
**Prerequisite program records associated with the HACCP plan are accessible for review**

## How Kraft Conducts a Hazard Analysis

**Identify every potential food safety hazard for all ingredients, packaging materials, and processing steps**
**Determine potential frequency and severity**
**Prerequisite programs generate information that supports the hazard analysis**
**Use Prerequisite Programs whenever a hazard can be reduced or eliminated through a series of basic control programs**
**GMP’s+ Equipment Checks+Raw Material Inspection+Routine Sanitation+ Metal Detection  **
**Focus CCP’s on critical food safety hazards in a process**

## Hazard Analysis Is Specific for    Each Process

**Extraneous material may be a hazard “reasonably likely to occur” depending   on the process**
**Lack of sufficient ingredient history to support decision process**
**Packaging material may introduce a risk-glass**

## Rationale for classifying extraneous material as  a hazard “not reasonably likely to occur”

**Ingredient history**
**Process history indicates introduction of foreign material large enough to cause injury is not likely to occur at specific steps**
**Effectiveness of GMP’s and PP’s minimizing the likelihood of occurrence **
**Scientific references **

**Hazard Analysis - Extraneous Material**

## Review of Hazard Analysis

**Identify all potential hazards that pose a food safety risk**
**Utilize a series of prerequisite programs to reduce or eliminate the risks these hazards might create**
**HACCP Plans:**
**Use an integrated approach to food safety management**
**Select CCP’s based on science**
**Support CCP’s with Prerequisite Programs**
**Focus  attention and resources on  critical HACCP activities**

## Processes to Control & Eliminate Extraneous Material in Comminuted Cooked Sausage

**Meat Receival**
**Meat Inspection**
**Grinding**
**Rework Handling**
**Batching**
**Corn Syrup Filter**
**Pump Rotors**

**Metal Detector**
**Emulsification**
**Rare Earth Magnet**
**Finished Product Metal Detector**
**Visual Inspection**
**Clean up**

## HACCP PROCESS FLOW  EXTRANEOUS MATERIAL

**RECEIVAL**

**INGREDIENT STORAGE**

**LARGE F.O. INSPECTION**

**METAL DETECTION**

**PP 2**

**PP 3**

**PP 8   PP 9**

**PP 1**

**  ****PP 2      PP 15**

** ****PP 11    PP15**

** ****PP 4   PP 10   PP 15   PP 18**

- 54

**GRIND**

##     Meat Inspection

**Large foreign object inspection by running meat over an inspection belt prior to grinding**
**All trimmings are run through a metal detector set to detect 10.5 mm ferrous/10.0 mm non-ferrous**
**In line metal detector checked for proper function daily**
**Plant Policy : Plant Manager's Standard Instructions **
**Document : Foreign Objects In Raw Materials report, metal detector verification, grinding log**

## Grinding

**Disassemble grinders after each lot, vendor or species change**
**Grinder is inspected for damage or extraneous material behind the plate. Grinder also inspected anytime disassembled and during clean up**
**Grinder plates and knives changed daily and removed from service at signs of excessive wear**
**Plant Policy : Plant Manager's Standard Instruction**
**Document : grinding log, pre-op sheet**

## Finished Product Metal Detector

**In line metal detector checked for proper function at start-up, every 2 hours, & end-of-run**
**All finished product is run through a metal detector set to detect 2.5 mm stainless steel**
**Plant Policy : Plant Manager's Standard Instruction **
**Document : metal detector check sheet**

## Key Takeaways

**Kraft Food’s approach to HACCP Management**
**Use an integrated approach to food safety management**
**Use science to select CCP’s**
**Failure to recognize Prerequisite Programs diverts attention and resources from critical HACCP activities**
**Prerequisite Programs are used whenever a hazard can be reduced or eliminated through basic control programs**
**GMP’s, Equipment Checks, Temperature Controls, Routine Sanitation, Metal Detection **