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Crazy Richard’s Peanut Butter Co. P.O. Box 715 Dublin, OH 43017 Phone: (614) 889-4824 PB Pumped Project Portfolio Grace Ashton, Justin Bashein, Steven Miller, Caitlin Stryker

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Page 1: P.O. Box 715 Dublin, OH 43017 Phone: (614) 889-4824 · razy Richard’s Peanut utter o. P.O. Box 715 Dublin, OH 43017 Phone: (614) 889-4824 PB Pumped Project Portfolio Grace Ashton,

Crazy Richard’s Peanut Butter Co.

P.O. Box 715

Dublin, OH 43017

Phone: (614) 889-4824

PB Pumped Project Portfolio

Grace Ashton, Justin Bashein, Steven Miller, Caitlin Stryker

Page 2: P.O. Box 715 Dublin, OH 43017 Phone: (614) 889-4824 · razy Richard’s Peanut utter o. P.O. Box 715 Dublin, OH 43017 Phone: (614) 889-4824 PB Pumped Project Portfolio Grace Ashton,

Thank You We would like to take this opportunity to thank Crazy Richards Co for allowing us the

opportunity to work so closely with them. We really enjoyed working on this project and learned a great deal in the process. Thank you!!

Executive Summary

Included in this portfolio are all pertinent documents pertaining to the protein enriched peanut butter, or PB Pumped, project including consumer reports, specifications, and a HACCP plan.

This product will require little change to your current process, should be inexpensive to product, and is comparable to the original creamy formula and very acceptable. However, some attention should be given to certain marketing aspects for this product regarding education and

how to describe the enrichment of this product.

Changes Made to the Peanut Butter Changes were made to improve the nutritional status of Crazy Richard’s Peanut Butter. To

boost the nutrient content we added brown powder which increased the protein content and created a complete protein.

Consumer Sensory Results

Two natural peanut butter samples (Crazy Richard’s Creamy Peanut Butter and PB Pumped) were compared in a consumer home-use test from March 22nd to March 28th, 2016. Three natural peanut butter samples (Crazy Richard’s Creamy, PB Pumped, and Adams) were then compared in a focus group at the Brigham Young University Sensory Laboratory on March 29th, 2016 to determine comparative acceptability of samples among consumers of natural peanut butter. The home use test revealed that for OVERALL ACCEPTABILITY, FLAVOR, SATIETY, APPEARANCE, ENERGY LEVEL BEFORE EATING, and ENERGY LEVEL AFTER EATING, PB Pumped and Crazy Richard’s Creamy were not significantly different from each other except for MOUTHFEEL, which was ranked significantly lower for PB Pumped. The focus group clarified this observation, showing that the panelists across the board felt that Crazy Richard’s Creamy had a more pleasing and less astringent mouthfeel than PB Pumped. Panelists in the focus group (especially Mothers and Millennials) felt that the proposed cost was too high for PB Pumped. These consumers could not justify purchasing PB Pumped over another less expensive peanut butter because they perceived that the extra protein was not worth the additional cost, despite the convenience of the product. However, most panelists in both tests revealed that Crazy Richard’s Creamy was as well liked as PB Pumped in OVERALL ACCEPTABILITY and most were positive towards the potential health benefits of a complete, high protein peanut butter.

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Table of Contents

Product Brief …………………………..…………………………………………………………..1

Consumer Testing Report …………..……………………………………………………….6

Formula Page ……….…………………………………….……………………………………..37

Nutrition Label ……….…………………………………….…………………………………..38

Cost Analysis ……………………………………………………………………………………..39

Specifications ………...………..………………….……………………………………………40

Stability Test Protocol ...…….…………………….…………..……………………………43

Plant Trial Plan ...…….…………………………………………...……………………………45

HACCP Plan ...…….………………………..………………………………………….…………47

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Product Development Brief

1. General: Objective: Create a more complete amino acid profile peanut butter product. Launch Date: TBD

Milestone Timing: (See attached General and Detailed Timelines)

Positioning: People looking for a healthy snack alternative, including athletes and mothers. Target market: National Health Food Markets

2. Product Guidelines: Proposed Product Name: TBD

Physical/Sensory Attributes: Smooth, spreadable, high-protein

Suggested Flavor Varieties: Peanut, Thai, Mexican Salsa, African curry Specific Ingredient Limitations or Requirements: Grain protein powder, natural, non-gmo, no trans fat, no cholesterol, no salt/sugar added. Minimal number of ingredients. Desired Preparation/Consumption Details: Spread or dipping

Nutrition/Fortification: Target 10g/svg Protein. Target Shelf-life: 3 months

Proposed Distribution & Display: TBD

Potential Claims & Functional Attributes: High protein, all-natural, non gmo, organic

Net Weight or Volume: 11 oz

Serving Size: 2 Tbsp

Packaging: Jar or single-serve

Proposed Label Graphics: Explosion of grains and peanuts erupting outward towards consumer behind the logo. Regulatory Constraints: Allergens to be aware of for labeling purposes (peanuts). Necessary quality testing for aflatoxin.

3. Process Guidelines: Process Limitations: none.

4. Cost Guidelines: Estimated R&D Budget: $35,798 (see attachments) Raw Material Cost Target: TBD

Variable Manufacturing Costs: TBD

Estimated Manufacturing Volumes: TBD

5. Competitive Information: Benchmark Competitor: N/A

Category Standard Shelf-life: 2-3 months (3-6 months in the refrigerator).

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General Timeline

Product Development Task Time Estimated

Project Initiation 1/4/16 - 1/19/16

Key Prototype Reviews with Client 1/19/16 – 3/7/16

Consumer Test Dates 3/25/2016 - 4/1/2016

Completion Date 4/12/2016

Final Nutrition Panel and Ingredient Declaration Info Available 4/12/2016

Projected Plant Trial Dates May 2016 - July 2016

Projected Production Start-up Date 8/1/2016

Target Launch Date 8/15/2016

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Detailed Timeline

Product Development Task Estimated Date of Completion

Project Initiation 1/4/16

Brainstorm 1/5/16

Develop Protocepts 1/11/16 - 1/19/16

Client Meeting/ Protocept Presentation 1/19/16

Reformulation/ Redirection 1/19/16

Contact Suppliers about Rice Protein 1/20/16

Rice Protein Prototype Evaluation/Formulation 1 1/25/16 - 1/26/16

Prototype Evaluation/ Reformulation 2 Send out samples for evaluation.

2/1/16 - 2/2/16

Prototype Evaluation/ Reformulation 3 ****IF NECESSARY**** (Evaluate with Crazy Richard’s, finalize protein formula)

2/8/16 - 2/9/16

Set Product Specifications, Implement Plant Trial Tests 2/8/16 - 4/12/16

Prototype Evaluation/Reformulation 2/16/16

Final Evaluation/ Reformulation ****IF NECESSARY**** (Evaluate with Crazy Richard’s and finalize protein formula)

2/29/16-2/23/16

Continue Testing 2/29/16 - 3/1/16

Double Check Label, Sensory Questionnaire 3/7/16 - 3/8/16

Consumer Testing For Acceptability and Likeliness to purchase 3/22/16 - 3/29/16

Consumer Testing, Analyze Results 3/29/16

HACCP / Finalize Portfolio 3/28/16 - 4/5/16

Client Presentation 4/12/16

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Finished Product Specification – DRAFT

Crazy Richards Peanut Butter

Issue Date: 28 March 2016

Product: PB Pumped

Product Description: A protein enhanced all natural peanut butter product.

Attribute Test Method Target/Range

Flavor Organoleptic Typical of fresh roasted peanut, no rancid or offset flavor

Aroma Organoleptic Typical of fresh roasted peanuts

Color, L Hunter Colorimeter

49+/-2

Grind, mils Bauer Gauge <12

Fat, % AOAC <55

Protein, g AOAC 35g/100g +/- 1

Aflatoxin AOAC <20 ppb

Standard Plate Count, cfu/g BAM <10,000

Yeast and Mold, cfu/g BAM <100

Coliform, cfu/g BAM <10

E. coli, cfu/10g BAM Negative

Staph aureus, cfu/10g BAM Negative

Salmonella, cfu/10g BAM Negative

Gluten, ppm ELISA <20

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Process Specification – DRAFT

Crazy Richards Peanut Butter

Issue Date: 28 Mar 2016

Product: PB Pumped

Process Stage: Receiving Rice Protein Powder Process Description: Visually inspect product upon arrival to ensure that driver documentation matches supplier CoA. Also ensure that packaging isn’t unnecessarily damaged or wet. Take a representative sample for quality testing. Perform quality tests listed on raw material specification to ensure the ingredient is safe to use in processing.

Process Stage: Receiving Peanuts

Process Description: Visually inspect product upon arrival to ensure that driver documentation matches supplier CoA. Also ensure that packaging isn’t unnecessarily damaged or wet. Take a representative sample for quality testing. Perform quality tests listed on raw material specification to ensure the ingredient is safe to use in processing.

Process Stage: Shelling and Sorting

Process Description: Raw peanuts are crushed through rollers and then sorted by a gravity separator. Different sized sieves are used to remove shells. After sorting they are visually inspected to insure no shells remain in the peanuts.

Process Stage: Roasting

Process Description: Peanuts travel by conveyor through commercial roaster. Roaster is set to 800 degrees Fahrenheit ± 10 degrees to achieve flavor and color indicative to peanut butter. (or standard roast conditions for Crazy Richard’s)

Process Stage: Mixing and Grinding

Process Description: The peanuts are transferred to the grinder and ground to a coarse paste state. The appropriate amount of rice protein powder is weighed and added according to formulation and batch size. Peanut butter and protein are then ground and mixed for 20 minutes or until desired consistency is achieved. The peanut butter is then deposited into foil pack pouches from a hopper, and are then loaded into boxes. Each box passes through a metal detector before being loaded into larger boxes. Finished product specifications are tested from representative

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Formula Page

W16003013A Consumer test code: 829

Ingredient Supplier Product Name Product Number

% Weight (g)

Natural Peanut Butter

Crazy Richard’s Crazy Richard’s Peanut Butter

N/A 92

Brown Rice Protein Axiom Foods Inc.

Organic Oryzatein® Silk 90

4080 8

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Nutrition Label

Formula: W16003018A (Pb Pumped)

Ingredients: Peanuts, Organic Brown Rice Protein. Contains Peanut

Ingredient Declaration Percentage Breakdown

Ingredient % Total Formula

Peanuts (Natural Peanut Butter) 92

Organic Brown Rice Protein 8

Effect of Brown Rice Protein Powder on Health Claims compared to normal Crazy Richard’s Peanut Butter:

“High in Protein” is available as a claim. o CFR 101.54(b): The terms “high,” “rich in,” or

“excellent source of” may be used on the label and in the labeling of foods, except meal products as defined in §101.13(l) and main dish products as defined in §101.13(m), provided that the food contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed.

o CFR 101.9(c)(7)(iii): For the purpose of labeling with a percent of the Daily Reference Value (DRV) or RDI, a value of 50 grams of protein shall be the DRV for adults and children 4 or more years of age, and the RDI for protein for children less than 4 years of age, infants, pregnant women, and lactating women shall be 16 grams, 14 grams, 60 grams, and 65 grams, respectively.

o This product has 22% of the DRV for protein since it contains 11 grams of the 50 grams.

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Cost Analysis Raw Materials Crazy Richard’s Peanut Butter: $3.25/lb Rice Protein: $15/lb Packaging Packages for final product (32g tube): $0.057/tube Total Cost for Raw Materials g

ingred

g ingre

d

g ingre

d

g ingred Ingred

Price**

Ingred

Price

Fin Prod

Fin Prod

Ingredient

Supplier & Code*

% Total

Formula

Per Batch

Per KG

prod

Per lb prod

Per serving $/lb $/Kg $/lb $/SKU

Natural Peanut Butter

Crazy Richard'

s

92.00% 29.44 920.00

417.30

29.44 $3.25 $7.16 $2.9900

$1.6875

Organic Brown

Rice Protein

Axiom Foods

Inc

8.00% 2.56 80.00 36.29 2.56 $15.00

$33.07

$1.2000

$0.6773

If the finished product is packaged in single serving 32g pouch, 1 lb. of finished product would approximately equal about 14 pouches. Assuming that 1 lb.of finished product is equal to 453.592 grams of finished product. Considering the estimated cost above, a package of 8 single serving size pouches would cost approximately $1.709 to produce. *Cost is likely overestimated because raw material costs are based on minimum volume consumer prices.

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Raw Specification – Crazy Richards Peanut Butter (Creamy)

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Raw Specification – Organic Brown Rice Protein

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Proposed Stability Test Protocol

• General Overview

The product to be tested is a protein-boosted natural peanut butter. The peanut butter will be ground before the addition of the rice protein powder is initiated. The final product will be mixed using an industrial mixer at the Crazy Richard’s facility

The peanut butter will be packaged in a 1.15 oz (32 g) foil squeeze pouch (the same kind of pouch as the PB Burst product).

The peanut butter is intended for distribution under ambient conditions The primary modes of failure are:

Oxidative rancidity of the natural peanut oils Textural changes from protein

• Samples

Crazy Richard’s Natural Peanut Butter Crazy Richard’s Protein Boosted Natural Peanut Butter

• Storage Conditions

Control Controls samples will be from product produced on the same day, stored at ambient

warehouse temperatures Average Conditions

Temperature 21°C Relative Humidity 50% Samples stored in the dark

Accelerated/ Worst Case Scenario Temperature 32°F Relative Humidity 85%

• Storage Duration

The “average conditions” test will be real time. The shelf life of natural peanut butter ranges from 2 to 6 months, so testing of this product should be conducted for at least 6 months.

Accelerated testing should be conducted for about 2 months.

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• Sampling Plan

Real time test Samples will be pulled once every two week for the duration of the test

Accelerated/Worst case scenario Samples will be pulled once a week for the duration of the test

Sample unit to be tested will be the finished 1.15 oz (32 g) foil squeeze pouch. Tests to be performed

Sensory vs. control Color Aroma Texture Flavor

Analytical Hexanal test for rancidity Peroxide value test Texture via Brookfield

Number of samples to store Average Conditions

24 samples will be needed, an additional 8 samples will be stored to account for any error = 32 total.

Accelerated/ Worst case scenario 16 samples will be needed, an additional 4 samples will be stored to account for

any error = 20 total. Control

To account for each of the tests 52 samples will be stored, this includes the extra 6 samples.

• Reporting Schedule

Preliminary reports will be issued at 1, 2, and 4 months At 4 months, a semi-final report will be issued At 6 months a final report will be issued

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PB Pumped - Proposed Plant Trial Plan

• Trial dates and times (shifts)

- May 23 – 24, 2016 Continuous shifts (24 hours) - The trial will begin with the start of the grind process around 7am on May 23rd, since there is no change to the processing procedure before this step. • Plant and lines to be used

- Crazy Richard’s Plant, Dublin, OH

- Line #4

• R&D and other outside personnel attending

- BYU R&D: Grace Aston, Justin Bashein, Steven Miller, Caitlin Stryker

- Plant Manager

- Production Manager

- Chris Wernli - David Budge • Objectives: - To determine whether the process of adding protein powder to peanut butter can

be effectively achieved and integrated into the Crazy Richard’s manufacturing setting. Stability and consumer test samples will be taken to compare to the bench-top samples.

• Specify process requirements

Process equipment needed and key process parameters *Crazy Richard’s line number 4 grinder

*Crazy Richard’s line number 4 mixer

*Peanut butter mixed for XX time

*Target moisture of peanut butter XX%, with Aw XX

(See attached flowchart for the key process parameters)

Clearly point out trial-related changes in plant SOPs Once a butter texture has begun to form in the ground nuts, plant workers will be instructed to add XX lbs of protein powder to the grinder to allow the powder to be thoroughly distributed and integrated for every XX lbs of peanut butter. With the exception of adding the rice protein to the peanut butter, the process will be the same. Aw will need to be taken at the times they are typically taken in the process (see flowchart), although R&D staff will also record the data for their own keeping.

Batch size, number of batches, estimated line time *Batch size: 1 tote (~XXlb peanut butter, XXlb protein powder) *Number of batches: 3

*Estimated line time: XX hours grinding, XX hours mixing (Total time: XX hours) Additional plant personnel required

*Representative from Axiom Ingredients Indicate special equipment supplied/ordered by R&D

N/A

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• List of ingredients and packaging

Those to be supplied by plant, incl. quantities ~XX lbs. peanuts

Those supplied/ordered by R&D Axiom Foods’ Oryzatein Silk 90

Quantity: 1 pallet Supplier: Axiom Foods (310-264-2606) Arrival Date: May 5th

Shipped to Crazy Richard’s Plant • Data collection/sample collection requirements

*Protein level of rice protein *Target moisture and Aw of peanut butter

*Texture and flavor

*Protein of final product

(See attached flowchart for the key process parameters)

• Disposition of trial finished product The majority will be used for consumer testing and some will be used for stability testing. These samples should be set aside and held until shipping instructions are received from R&D

• Disposition of excess/unused raw materials/packaging

Excess rice protein will be carried back to BYU. There should not be other excess raw materials of concern. Everything else is already used by the plant. • Include formulas and specifications or indicate when available

Formula will be available April 1

Drafts of specifications will be the sent for both the process and the finished product with the added protein • Include pre- and post-trial meeting requests

We would like to meet with the plant manager and possibly Chris Wernli a day before the actual plant trial (May 22) to make sure everyone understands that with the exception of adding the rice protein to the peanut butter, the process will be the same. A post-trial meeting will be conducted on May 25 to discuss the outcome of the trial and determine if the addition of the pea protein is a feasible and desired process for Crazy Richard’s peanut butter.

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PB PUMPED HACCP PLAN

HACCP Team Plant Manager

- Ensures that the QA team is performing proper procedures to produce.

QA Manager

- Verifies daily that quality procedures are being followed.

- Monitors QA and CCP checks

- Received HACCP training

Safety Specialist

- Identifies possible hazards in the facility.

- Received HACCP training.

Production Manager

- Oversees the process related with the CCP’s.

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Product Description Description of Food:

- This peanut butter is a ready-to-eat product that has been enriched with organic brown rice protein powder. It is intended to be eaten directly out of the packaging without needing any additional preparation, but it can be used as an ingredient or consumed with other foods.

Description of Distribution: - Crazy Richard’s Peanut Butter Co. produces this product, which is a family business that

specializes in all-natural, clean-labeled nut butters. This brand’s products are distributed to a variety of grocery stores throughout the US, but they are sold under the Krema label on the West Coast and under the Crazy Richard’s label on the East Coast.

Description of Intended Use/Consumer: - This product is intended to be eaten on the go, either consumed straight from the

pouch or squeezed onto some sort of carrier (cracker, veggies, fruit, etc). This company is targeting athletes, millennials, and moms who are looking to provide convenient, high-quality protein foods and snacks for themselves or their families.

Ingredient Declaration/ List of Raw Materials - PB Pumped: All Natural Creamy Protein-Enriched Peanut Butter

- Peanuts, Organic Brown Rice Protein powder

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Flow Diagram

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Description of Process

RECEIVING: A trained employee visually inspects the raw product before being accepted from the

supplier, looking specifically for water, insect, or pest damage. This employee will also ensure that driver documentation matches the supplier’s Certificate of Analysis. Then a representative sample will be taken for further on-site quality testing, ensuring that specifications have been met.

SHELLING AND SORTING:

Raw peanuts are dumped on to the processing machinery and are first fed into a series of rollers, which crush the outer shells, exposing the nuts. The broken shells are then sorted from the nuts using a gravity separator. A sequence of sieves of various sizes is used to ensure the removal of all shells from the peanuts. A quick visual inspection guarantees that all shells have been removed from the nuts, and that they are ready for the next step

ROASTING: Freshly cracked peanuts then travel through a commercial roaster by conveyer where

they are roasted in an 800-degree Fahrenheit oven in order to achieve the desirable color and flavor.

BLANCHING and COLOR INSPECTION: The roasted peanuts are then blanched in a large kettle. Steam and friction work to

remove the skins form the peanuts. Sieves are again utilized to remove the skins. Now that the skins have been removed, a color inspection is completed to measure the amount of color in the roasted nuts. Samples are taken and analyzed using a Hunter colorimeter to ensure that the correct amount of roasting has been achieved. Under roasted nuts can be cooked again and over roasted nuts are rejected.

GRINDING: The roasted nuts are weighed and then fed into grinder where the coordinating weight

of brown rice powder is then added to meet the formulation ratios. The ingredients are ground and blended for twenty minutes or until the consistency is acceptable. The freshly ground peanut butter is then continuously fed into foil tubes which are sealed with a heat sealer and then are fed into small boxes.

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Description of Process (cont.)

METAL DETECTOR: The small boxes are then fed through a metal detector to determine if extraneous

material is present. If a problem is detected, the problem package is removed from the line for analysis. The technician operating the machine approves the now-cleared line, indicating it is ready to be shipped.

PACKAGING: The small boxes are then placed into larger boxes by hand. A few samples of small boxes

are retained for further QA analysis and to ensure that all specifications have been met. The boxes are then sealed, dated, and ready for distribution.

Crazy Richard’s Peanut Butter Co. Critical Control Points

CCP #1

Hazard of

Concern

Critical Limits

Monitoring Corrective Actions Verification Records

Maintained

Metal

Detector

Physical: Metal and other foreign material

The small boxes of individual tubes are sent through the Metal Detector.

A trained technician monitors the detection machines for any sign of hazards. Technician will record any problems that may appear. Machine will sound alarm if foreign material is found. Every hour a trained technician will verify that the metal detector is working properly.

If hazard is detected, the package is pulled off the line to be further examined. After hazard is found, additional investigations will be performed to find the source of the contamination and to remove the source to prevent future contamination.

Trained Technician will sign certificate indicating package is clear of hazards.

Hazard Detection Log Certificate of Approval

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Hazard Analysis Summary Table

Process Step

Type of Hazard Reasonable

Likely to Occur?

Basis Measures that could be

applied to gain Acceptable level

Critical Control Point?

Justification

Receiving - Peanuts

Biological: Presence of E. coli O157:H7, Salmonella,Staph. Aureus, aflatoxin

Yes Common organisms related to food borne illnesses in peanuts

Certificate of Analysis required by supplier declaring results from various microbial assays

No

CoA takes care of any issues and

any residual organisms

eradicated in roasting

Chemical: N/A N/A N/A N/A

Physical: foreign material

No

visual inspection for: rodent droppings, insect damage, damage to the box, signs of leakage or spillage, discoloration, or signs of rotting.

Visual inspection by employee.

Receiving – Brown Rice

Protein Powder

Biological: Presence of Salmonella, E. coli, Staph. Aureus, aflatoxin

No

Common organisms related to food borne illnesses in peanuts

Certificate of Analysis required by supplier declaring results from various microbial assays.

No

Chemical: Heavy metals

No

Supplier's COA ensures that food quality ingredients are approved for use

Certificate of Analysis required by supplier

CoA and visual

inspection sufficent

Physical: foreign material

No

visual inspection for: rodent droppings, insect damage, damage to the box, signs of leakage or spillage, discoloration, or signs of rotting.

Visual inspection by employee

Shelling/ Sorting

Biological: N/A N/A N/A N/A

no

Sieves remove

debris, metal detector spots other foreign

material

Chemical: N/A N/A N/A N/A

Physical: Foreign Material

no

Rocks, metal shaving, other foreign material removed by sieves or spotted on metal detector

Visual inspection by employee. CCP #1 Metal Detector

Roasting

Biological: N/A N/A N/A N/A

no

Taken care of by Colorimeter

and visual inspection

Chemical: N/A N/A N/A N/A

Physical: Burnt nuts no

visual inspection for after blanching or by use of Hunter Colorimeter

Hunter Colorimeter

Page 25: P.O. Box 715 Dublin, OH 43017 Phone: (614) 889-4824 · razy Richard’s Peanut utter o. P.O. Box 715 Dublin, OH 43017 Phone: (614) 889-4824 PB Pumped Project Portfolio Grace Ashton,

53

Hazard Analysis Summary Table (Continued)

Process Step

Type of Hazard Reasonable

Likely to Occur?

Basis Measures that could be

applied to gain Acceptable level

Critical Control Point?

Justification

Blanching / Color

Inspection

Biological: N/A N/A N/A N/A

no

Taken care of by

Colorimeter and visual inspection

Chemical: N/A N/A N/A N/A

Physical: Peanut skins or burnt nuts

no

Any remaining skins, burnt, or under roasted nuts will be rejected by color inspection

Hunter Colorimeter

Grinding

Biological: N/A N/A N/A N/A

no

Taken care of by metal detector

Chemical: N/A N/A N/A N/A

Physical: Metal shavings or pieces

yes

Broken machinery can leave metal

parts in product but will be caught by metal detector

CCP #1 Metal Detection

Metal Detector

Biological: N/A N/A N/A N/A

yes- CCP #1

Only efficient

means to control this

hazard

Chemical: N/A N/A N/A N/A

Physical: Foreign material

no

Boxes run through the machine to determine presence of foreign material

CCP #1 Metal Detector

Packaging

Biological: N/A N/A N/A N/A

no

Visual

inspection sufficient

Chemical: N/A N/A N/A N/A

Physical: visual foreign material

no visual inspection for foreign objects and materials

CCP #1 Metal Detection