Version Public - Nebraska

Public Version

EXAMPLE FOOD SAFETY PLAN DRY EXTRUDED DOG AND CAT FOOD

Owner, operator, or agent in charge: Arnold Zipfel, General Manager, ABC Pet Food 6/2/2016.

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Example Food Safety Plan

sion This manual was created to assist participants in the Food Safety Preventive Controls Alliance's r Preventive Controls for Animal Food course in an attempt to reinforce learning.

All examples are hypothetical. Application of preventive controls requires in-depth knowledge of actual

e operating conditions, thus information in the curriculum and in this example plan may not be directly

applicable to a specific operation. Assistance from a Preventive Controls Qualified Individual is necessary

V to ensure compliance with FDA regulations. Public1stEdition,June 2016

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Table of Contents

1. Background Information ....................................................................................................................... 4 Food Safety Team Members ..................................................................................................................... 4 Facility Overview ....................................................................................................................................... 4 Flow Diagram ............................................................................................................................................ 5

2. Hazard Analysis and Preventive Controls Determination..................................................................... 6 3. Preventive Controls and Management Components ........................................................................... 7

Supporting SOPs........................................................................................................................................ 9 4. Recall Plan ............................................................................................................................................... 10

n Notification of the public ........................................................................................................................ 15

Notification of customers ....................................................................................................................... 19

io Effectiveness Checks ............................................................................................................................... 19

Appropriate disposal of recalled animal food......................................................................................... 20

s 5. Implementation Records ........................................................................................................................ 21 r Supporting Forms.................................................................................................................................... 22 Public Ve Locations of Records ............................................................................................................................... 23

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1. Background Information

Example Food Safety Plan

Food Safety Team Members

Name

Position

I.R. Charge*

Plant manager

F.S. Leader

Production supervisor

I.M. Quality

Quality supervisor

I.M. Fixer

Maintenance supervisor

*Preventive Controls Qualified Individual. Attended FSPCA Course for Animal Food June 2016. Completion certificate is in personnel file.

n Facility Overview io ? Facility Description: The facility was built in the 1980s and runs one shift, 5 days per week. s ? Product Description: Complete and balanced food for all life stages of dogs and cats. Dry r extruded kibble is packaged in differing bagged net weights. e ? Intended Use: Fed as a complete ration to dogs or cats at all life stages. Fed as is, directly

from the bag and stored in a cool, dry environment.

Public V Hazard Evaluation Rubric

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Example Food Safety Plan

Flow Diagram

Receiving for Ingredients and Materials

Bulk / Liquid Storage

Meat Storage

Bagged Ingredient Storage

Packaging Material Storage (Bags)

Inspection / Hammer mill / weigh up

Screens / Magnets

Waste Reclaim

Inspection / Weigh-Up

Conditioner Extruder Dryer Coater

Cooler

Storage Bins / Magnets

lic Surge Hopper

b Palletizing

Bundler

Pu Pallet Stickers (License Plates)

Inspection / Weigh-Up Screens / Magnets

n Coloring / Fats / Oils rsio Palatants VeFines

Bags

Scale

Bagger

Bag Codes Applied

Metal Detection

Heat Seal or Sew Bags

Warehouse Storage

Shipping

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2. Hazard Analysis and Preventive Controls Determination

*Note that these sections are abridged; typical may likely require multiple pages. Additional justification may be necessary to attached, particularly for when it is determined that hazards do not require a preventive control (i.e. historical data to support

thiamine levels in incoming vitamin premix are in accordance with the COA is appropriate to include).

Public Version

Table 1. Hazard Analysis

Identification

(1)

(2)

List Ingredients and

Steps/Equipment within the

Process Flow

Identify Known or Reasonably Foreseeable

Hazards

B

Salmonella spp.

Ingredients

C Thiamine deficiency

Foreign material : P metal, plastic, bone,

glass, wood

B

Salmonella spp.

Bulk receiving C

None

Foreign material :

P metal, plastic, glass,

wood

B

None

Mixing

C Thiamine deficiency

P

Metal

(3)

Assess Severity of Illness or Injury to Humans or Animals if the Hazard Were to

Occur

Evaluation

(4)

Assess Probability that the Hazard Will

Occur in Absence of Preventive

Controls

(5)

Determine if Hazard

Requires a Preventive

Control (Yes or No)

(6)

Justify the Classification for the Hazard in Step 5

I ? High

A ? High

Yes

FDA Salmonella CPG 690.800

II- Medium II- Medium

C ? Low B - Medium

COA used by known supplier

No

with historical data to confirm

values

Ingredients may include non-

Yes

ferrous metal that may not be

caught by magnet

I ? High

A ? High

Yes

FDA Salmonella CPG 690.800

n/a II- Medium

n/a II- Medium

II- Medium

n/a B - Medium

n/a C ? Low

B - Medium

n/a

n/a

Foreign material, especially

Yes

metal, may enter receiving

grate

n/a

n/a

COA used by known supplier

No

with historical data to confirm

values

Yes

Mixer paddles made of metal

Preventive Control(s)

(7)

(8)

Determine the Appropriate Control for any Hazard Requiring a Preventive Control

Assign a Preventive Controls

Number

Process Control: Extrusion temperature

1

Sanitation control: Post-extruder surface sanitizing

2

n/a

n/a

Process Control: Metal detection in finished pet foods

3

Process Control: Extrusion temperature

1

Sanitation control: Post-extruder surface sanitizing

2

n/a

n/a

Process Control: Metal detection in finished pet foods

3

n/a

n/a

n/a

n/a

Process Control: Metal detection in finished pet foods

3

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Example Food Safety Plan

3. Preventive Controls and Management Components

*Note that these sections are abridged; typical may likely require multiple pages (i.e. Preventive Control #3 is not shown).

Public Version

(1)

Hazard Requiring

a Preventive

Control

Preventive Control(s)

(2)

(3)

(4)

Appropriate

Control for

Hazard

PC

PC

Requiring a Number Category

Preventive

Control

Table 2. Description of Preventive Controls

Management Components

(5)

(6)

(7)

Monitoring (if applicable)

Parameters (if applicable)

What

How Frequency

Who

Corrective Action(s) and/or Correction(s)

(8) Records

Salmonella spp.

Extrusion temperature

1

Process Control

Extruder barrel temperature > 178?F

(instantaneous 106 reduction)

Automatio n system

Extruder records, thermomet

er readings

Continuous with

exception alarms

Shift operator running the automation system

Identify and correct the problem; reduce the

likelihood that the problem will recur; evaluate all affected animal food for safety; prevent affected

animal food from entering commerce as necessary; reanalyze the food safety

plan when appropriate

Extruder records, validation documents,

corrective action records, and training, thermometer accuracy, thermometer

calibration, and verification records

Correction: If residual

material is observed on

the animal food-contact

surface, re-clean and re-

sanitize. If sanitizer is not

at the proper

Visual

concentration, make a new Daily Sanitation

Salmonella spp.

Post-extruder surface sanitizing

2

Sanitation control

Any residual material on post-extruder

surfaces or 200 ppm sanitizer concentration

inspection of

surfaces, sanitizer concentrati

SOP 201.2

Before operations begin and end of daily production

Sanitation team member

solution. Corrective action: Identify and correct the problem; reduce the likelihood that

the problem will recur;

Sheet, corrective action and

correction records, training records, environmental

on

evaluate all affected

monitoring records

animal food for safety;

prevent affected animal

food from entering

commerce as necessary;

reanalyze the food safety

plan when appropriate

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Recall Plan Example PLANT NAME: ADDRESS:

PAGE 8 of 23 ISSUE DATE 08/02/2015 SUPERSEDES 05/29/2015

*Note that these sections are abridged; typical may likely require multiple pages (i.e. Preventive Control #3 is not shown).

Table 3. Description of Verification Activities

Activity

Description of Activity

Extrusion temperature

o IFT Report to FDA: Kinetics of Microbial Inactivation,

2000

o AFIA Salmonella Control Guidelines, 2010

Type of Validation

o Bianchini et al. in 2012.

n Assurance Monitoring and Corrective io Actions/Corrections are Completed as Directed s Type of Verification of r Implementation and Effectiveness

Ve Reanalysis of Food Safety Public Plan

o Internal process data: minimum required temperature = 175.6 F

Post-extruder surface sanitizing o n/a

Monitoring and corrective action records will be reviewed within 7 working days. Instances exceeding 7 days includes justification.

Extrusion temperature o Daily checks to confirm thermometer accuracy o Quarterly calibration of thermometers o Test and hold procedures per SOP 506.3

Post-extruder surface sanitizing o Environmental monitoring per SOP 213.6 o Product testing when necessary per SOP 213.7

Every three years, or as necessary when there are changes to the process, new information becomes available, or it is determined that

any of the preventive controls are ineffective in controlling the hazard.

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