Risk Scale

Revised 12/5/2013

SEVERITY FREQUENCY

1 Fatality A Common Occurance

2 Serious Illness B Known to Occur
3 Product Recall C Could Occur (Probable)
4 Customer Complaint D Not Expected to Occur
5 Insignificant E Practically Impossible

A B C D E
1 1 2 4 7 11
2 3 5 8 12 16
3 6 9 13 17 20
4 10 14 18 21 23
5 15 19 22 24 25

SCORE RISK LEVEL Frequency

1-5 High Weekly
6-9 Major Monthly
10 -15 Moderate Quarterly
16 - 19 Minor 2x/ Year
20 - 25 Low 1x/ Year

**Frequencies determined by risk, may be deviated based on historical evidence**

 Audit Risk Analysis 2014 Revised 12/5/2013

Risk Analysis

Frequency
Likeliness of Risk Based on Reason for Deviation of
Audit Severity Occurrence Value Risk Audit Frequency Frequency Comments:
Inspections for this program will be
1 GMP - Employee Practices & Hygiene 4 D 21 Yearly Yearly Large Temporary Workforce performed at a minimum weekly

2 GMP - External Grounds 5 D 24 Yearly 2x Year Maintain Facility

3 GMP - Interior Structure 4 C 18 2x Year 2x Year

4 GMP - Equipment 3 D 17 2x Year 2x Year

BRC states a min. of once per month,
5 Zone 1 Audit (open product) 3 D 17 2x Year Monthly Quality concerns only - not food safety South Warehouse and Processing Rooms

6 Zone 2 Audit (product areas- not open) 4 C 18 2x Year 2x Year Fillers, Downline, Material staging

7 Zone 3 Audit (auxiliary areas) 4 D 21 Yearly Yearly Warehouse, outside perimeter

For GMP purposes, This is a BRC
Sanitary Operations - Product Flow (Rec, fundamental, Frequent new
8 Blend, fill, pack ship) 4 D 21 Yearly 2x Year equipment/HACCP changes

4 parts: Filler, Downline and Processor

Sanitation validation; Master Sanitation
Schedule, CIP Concentrations, Times, and
Temps, Visual Checks. Quarterly inspections
may be a combination of audits and self-
9 Sanitation Program 3 D 17 2x Year 2x Year assessments
Quarterly surverys and review of trend
Based on past history, reports; annual overview audit of entire
10 Pest Management 4 D 21 Yearly Quarterly recommendation of BRC program

11 Warehouse, Shipping and Receiving 4 D 21 Yearly Yearly Include inventory checks

12 Utilities, Water & Air 4 D 21 Yearly Yearly

13 Good Lab Practices - Micro Testing 4 E 23 Yearly Yearly Does not directly affect food safety

14 Maintenance, PMP 3 D 17 2x Year 2x Year

Not expected to occur based on robust

allergen program; Quarterly inspections
may be a combination of audits and self-
15 Allergen Control 2 D 12 Quarterly Quarterly assessments.
 Environmental Monitoring and Product
16 Inspection, Testing & Fill Weights 4 D 21 Yearly Yearly 5.5.1.1

Yearly/ Prior to ANY High Acid

changes which may Includes HACCP Flow Diagram and Flow
17 HACCP Validation and Verification 3 E 20 Yearly affect food safety Charts
Inspections: Zone 1 - Quarterly; Zone 2 - 2x
18 Glass and Brittle Plastic 4 D 21 Yearly Yearly Year; Zone 3 - Yearly

4.9 To include non-food grade chemicals,

MSDS, segregation and storage, training of
19 Chemical and Foreign Material Control 4 D 21 Yearly Yearly personnel, review of GMP audits and G&BP

Daily inspections and validation of food

security programs. Quarterly audits may be
a combination of audits and self-
20 Food Security 1 E 11 Quarterly Quarterly assessments
Control of Non-Conforming Product and
21 Raw Materials 3 D 17 2x Year 2x Year Hold Program

22 Customer Complaints and Customer Service 4 D 21 Yearly Yearly

Raw Material Management and Incoming
23 Material Inspection 3 D 17 2x Year 2x Year

24 Specification Compliance 4 D 21 Yearly Yearly

25 Calibration 4 D 21 Yearly Yearly Inspected quarterly

26 Rework 4 D 21 Yearly Yearly

Mass Balance check required every 6
27 Identity Preserved (Kosher and Organic) 3 D 17 2x Year 2x Year months by BRC

28 Vendor/Contractor Management 5 E 25 Yearly Yearly

Includes Training, Personal Hygiene,

Medical Screening, and Protective Clothing/
Aspects of this program are audited/
29 Personnel 4 D 21 Yearly Yearly reviewed with other programs as well
A Mock Recall will also be performed
30 Traceability and Recall 2 E 16 2x Year 2x Year minimally twice a year

31 Control of Operations 2 E 16 2x Year 2x Year Systems review of Process Control

OTHER BRC FUNDAMENTAL AUDITS

 Or as necessary, or upon any changes
Senior Management Commitment N/A N/A N/A N/A Yearly that affect the scope of the program KPI Review, Objective Action Plan

Or as necessary, or upon any changes Review of document for accuracy, review of

Document Review N/A N/A N/A N/A Yearly that affect the scope of the program records for current revisions

Or as necessary, or upon any changes

Corrective Actions N/A N/A N/A N/A Yearly that affect the scope of the program Review of effectiveness

Or as necessary, or upon any changes

External and Internal Audits Review N/A N/A N/A N/A Yearly that affect the scope of the program Audit close outs, on-time performance