Internal Audit Risk Scale and Assessment

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

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

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

Internal Audit Risk Scale and Assessment

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Risk Scale

1 Fatality A Common Occurance

SCORE RISK LEVEL Frequency

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

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

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

4 parts: Filler, Downline and Processor

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

12 Utilities, Water & Air 4 D 21 Yearly Yearly

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

Not expected to occur based on robust

Yearly/ Prior to ANY High Acid

4.9 To include non-food grade chemicals,

Daily inspections and validation of food

22 Customer Complaints and Customer Service 4 D 21 Yearly Yearly

24 Specification Compliance 4 D 21 Yearly Yearly

25 Calibration 4 D 21 Yearly Yearly Inspected quarterly

26 Rework 4 D 21 Yearly Yearly

28 Vendor/Contractor Management 5 E 25 Yearly Yearly

Includes Training, Personal Hygiene,

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 Review of document for accuracy, review of

Or as necessary, or upon any changes

Or as necessary, or upon any changes

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