Risk AssessmentsTHE 5 W’s

What is a risk assessment?´ Define risk

´ Risk is an estimate of the chance of a hazard being present and the chance of it causing harm.

´ Define hazard

´ Hazard is a biological, chemical, including allergenic, physical or radiological substance that has the potential to harm.

´ Risk assessment (or hazard analysis per 117.300), is the scientific evaluation of known or reasonably foreseeable hazard and the severity of illness and probability of occurrence.

´ Risk assessments can be very complicated and take a lot of time, but they help you learn so much about your process

Where are risk assessments needed for FSMA

´ Food Safety Plans ´ Both human and animal food´ Must be conducted for each type of food manufactured, processed, packed

or held at your facility to determine if there are hazards requiring a preventive control.´Processing Steps´Ingredients - part of your supply chain program

´ FSVP´ Ingredients – must be conducted for each type of food that imported´ Suppliers – their performance relevant to food safety

´ Wording is aligned between the three rules and ask for the same types of assessment of risk through the hazard analysis.

5 W’s and a H to Completing a Risk Assessment

WHATWHERE

WHY

WHEN WHO

HOW

The What

´ Flow chart of the process´Define the steps in your processes ´Outline what food safety steps are taken at each step

´Process controls, Allergen controls, Sanitation controls or Supply Chain controls

´Walk the flow chart with the members of your food safety team ´Ensure all the inputs and outputs are correct

Flow charts are your process in pictures. Flow charts can be done in so many ways, this is an example of a simple flow chart

Receive Non-Meat

Ingredients 2

Receive Meat Raw

Materials

IngredientStorage

9Grinding

13

Raw Storage/ Staging

7

Injection/Maceration

11

Curing Solution

Prepared12

Mixing15

ChillingCCP 2

23

Demolding24

Receive Returned Product & Rework

5

Massage/ Tumbler

17

Stuffing18

Cooking CCP 1

22

Storage25

Storage14

ReceivePre-Blended

Meat 3

Receive Processing Packaging Materials

6A

Dry Storage Packaging Materials

16

Stuffed log Storage

20

Depalletize26

Debagging27

Slicing28

Packaging32

Metal Detection

33

Boxing34

Palletizing35

Shipping36

Receive Cooked

Product -Finished Product Dock

1

Dumping10

Ends and Pieces

Collection 29

Bagging 30

Boxing 34

Receive Finished Product

Packaging Materials

6B

Metal Detection

33

Metal Detection

33

Meat Raw Material Shipping

8A

Emulsification 17A

Raw Rework Stripping

19

Rework21

Ship Rework

21A

Flow charts can be colorful and very visually descriptive

Stay consistent in how you use shapes and colors in your flow chart

The What

´Create a List of Ingredients´Bulk, Bagged, Frozen, Liquid, Refrigerated, etc.´Ingredients could be used in more than one risk assessment

depending on use in the facility´List the ingredients used at each step of your process

´Risk is assessed based on point in the process and the nature of use

´This list includes processing aids ´Don’t forget packaging materials

´Risk is often minimal, but important to consider

The Where & How´ Where are ingredients added in the process

´ Could there be multiple points for the same ingredient in a food safety plan or could be in multiple food safety plans

´ Risk determinization can be tricky when added at multiple points´ How are ingredients added

´ Manually or automatically – does that change the risk´ Resources to help assess and determine the risk

´ Scientific studies´ Research journals´ White papers´ Industry publications´ https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM

517402.pdf

Why

´ Ask yourself ´Why are these the risks associated with the ingredient or

processing step´Why do we control them in this manner

´Which programs are in place to ensure the risk of the hazard is minimized or reduced

´Ensure these programs are documented and accurately reflect your plant practices

´Keep asking why until you have found the proper control

The Who

´ Who is responsible for all the risk assessment´Quality – risk assessment, defined hazards, assess risk,

determine preventive controls´Purchasing – approve suppliers, correct ingredient ´Manufacturing – procedures and process controls´Sanitation – cleaning procedures´Warehouse – storage and rotation

The When

´ Risk assessment is a living document´ Re-assess when

´A new ingredient is added´An ingredient is used in a new manner´Process steps change – either added or removed´Processing parameters change

How to bring it together

´ No correct format ´ Suggest using excel spreadsheet format

´ Severity and Likelihood (Probability) ´ Determine a consistent way to define for both process and ingredients

´ Re-assess when ´ A new ingredient is added´ An ingredient is used in a new manner´ Process steps change – either added or removed´ Processing parameters change

Ingredient Risk Assessment Examples

Ingredient Name

Ingredient Identificat

ion

Products for Which

the Ingredient is

Used Ha

zard

Typ

e

Potential Hazard)

Reason why the hazard is known

to occur or reasonably

foreseeable for the food or

facility

Prerequisite programs and other control

measures in place at the facility that reduce likelihood that the potential hazard will occur

Severity of the potential

hazard if it were to occur

Likelihood that the potential

hazard will occur with the Prerequisite in place but no

preventive controls

Preventive Control(s) required

to significantly minimize or prevent the

hazard)

Likelihood that the hazard will occur with the

preventive control(s) in

place

At w

hat s

tep

(s) i

s a

Prev

entiv

e C

ontro

l a

pp

lied

for t

he

signi

fica

nt h

aza

rd?

Frosted Corn Flake 127Cereal

POST-COOK

B Vegetative pathogens i.e. Salmonella

Raw grains have been associated with pathogens None Life threatening Possible based on

history of food or facility Yes Supply Chain Controls Practically impossible No Cooking

C Mycotoxins i.e. aflatoxin, vomitoxin, fumoisin

Aflatoxin, vomitoxin and fumonisn have been

identified in corn productsSupplier Approval Program Temporary impairment

self resolving Unlikely to occur No NA NA No NA

CExcessive levels of

pesticide residue or the use of unapproved

pesticides

Pesticides may be used in the growing of certain

grains and seedsSupplier Approval Program Temporary impairment

self resolving Unlikely to occur No NA NA No NA

C Gluten This ingredient could contains gluten

Allergen Control ProgramSanitation Control Program

Temporary impairment requiring medical

treatmentUnlikely to occur No NA NA No NA

P Foreign materialForeign material could be in this ingredient from the

suppliers

Supplier Approval ProgramForeign Material Control Program

Temporary impairment requiring medical

treatmentUnlikely to occur No NA NA No NA

Ingredient Supplier Country of Origin

Known or reasonably foreseeable

hazards

Reason for known or reasonably foreseeable hazard

Hazard SeverityHigh - H

Medium - MLow - L

Is Hazard a significant hazard?

Justify your decision for the previous column

Pea Protein XXX China

B Salmonella

Hazard Analysis and Risk-Based Preventive Controls for Human

Food: Draft Guidance for Industry states Salmonella could be

potential risk in ingredients like pea protein

M No Supplier is providing lot based testing for Salmonella on a COA.

C Pesticide Residue

Pesticides can be used in the growing of peas and other

vegetablesL No

Supplier provided documentation that peas are grown in the United

States and Canada and comply with the country requirements for

pesticides testing

C Heavy Metals Peas are a legume and can absorb heavy metals from the soil L No

Supplier provided documentation that peas used to manufacture the pea protein in China are grown in

the United States and Canada

P None N/A N/A N/A N/A

Detailed Risk Assessment

Simpler but same outcome for FSVP

FSVP Supplier Evaluation Assessment

Overall Supplier Risk Rating

<10 = low risk, <20 = medium risk, >20 = high risk

SupplierLocation (Country)

Management Commitment 3rd party Audit

COA Compliance

Food Safety Plan/HACCP

Plan

Environmental Monitoring

Chemical, Allergen,

Radiological Risk Control

Physical Risk Control News & Media

FDA Warning Letters & Recalls

Import Refusals

(past three years)

Total Risk Score

ZZZ Colombia 0 0 0 0 0 0 0 0 0

YYY China 0 0 0 0 0 1 0 0 0 0 1

XXX Thailand 0 0 0 0 0 0 0 0 0

0

Criteria:Management Commitment

0

1

2

3rd Party Audit0 - GFSI certified with acceptable supplier approval score1 - GFSI certified with unacceptable score for supplier approval2 - 3rd party food safety audit only

- Supplier has a fully engaged management staff, collaborative and have strong food safety vision, relationship established and transparent and open with information sharing- Supplier has an engaged management staff, but could use improvement, willing to make changes, partial relationship established, limited transparency/openness of information sharing- Minimal to no engagement from the management staff, limited food safety vision and willingness to make changes, no relationship established, no transparency

DISCUSSION & QUESTIONS