Process audits are a new approach to evaluating the effectiveness of your SQF System. They involve selecting a finished product lot and then auditing all the specific SQF components related to that lot. With SQFI considering adopting this methodology in SQF Code Edition 8, now is the time to learn about this process and start conducting your own internal process audits. Join this session to learn more about this process to test your system now and be ready for what’s coming soon!

2. Staying Ahead of The Audit Curve
With Process Audits:
What You Should Be Doing Today to
Prepare For Tomorrow
Jeff Chilton, VP of Professional Services

3. Agenda
Types of Audits
Process Audit Information
Process Audit Methods
Process Audit Implications
Corrective Actions and Learnings
Best Practices to Eliminate Audit Gaps
SQF Auditor Perspective
Q&A
3

4. Types of Audits
4
SQF System Audits
• Module 2 Checklist
• Other Applicable
Modules
• Annual Frequency
• Internal System
Audit
• External 3rd Party
Audit
GMP /
Plant Inspections
• GMP Compliance
Inspections
• Facility Inspections
• Typically Monthly
Frequency
Process Audits
• Selection of a
specific finished
product lot
• Audit of all inputs,
processes and
outputs
• Traceability Audit
• Annual Frequency or
more

5. How Process Audits Differ from Quality System Audits
5
QUALITY SYSTEMS AUDITS PROCESS AUDITS (VERTICAL AUDITS)
• Process driven
• Finished product selected
• Processes audited related to the
production that specific product
• Audit all records at each step of the
process
• Audit all documentation at each
step of the process
• Measures performance of the food
safety and quality system
• Checklists driven
• Inputs checked
• Process under control
• Output verified/validated
• Program specific audit
• Programs audited separately
• Measures conformance to clause
requirements

6. Process Audit Elements
6
Inputs
Process
Steps
Outputs
Finished
Product
(Materials, Measures and Methods)
(People, Equipment and Environment)

7. Process Audit Methods
7
1. Select the finished product lot generally produced 1-5 months prior
2. Identify the process flow to manufacture the product
3. Obtain the Product Specifications and Formulation of the product selected
4. Obtain all SQF/production related records for the production of that specific lot
5. Obtain all SQF/program related records for the production of that specific lot
6. Obtain all other program records for that time period of production
7. Audit traceability of the selected lot’s raw and packaging materials, finished
product
8. Audit all information obtained for the product selected
9. Audit current production of the same process

8. Records Audit By Process Step (Raw Materials)
8
Process Flow and Records Lists
• Approved supplier
register and raw
material risk assessment
• Specification Registers
of each raw material
and packaging material
received
• Receiving records and
QC release records
(COA)
• Traceability / lot code
procedures
Receiving
• Storage records
• Temperature records
• Rotation records
• Pest control records
Storage
• Formulation recipe
• Batch sheets with lot
code traceability
Batching

9. Records Audit By Process Steps (Processing)
9
Process Flow and Records Lists
• Process control records
(formula, temperatures,
sampling, etc)
• Traceability records
• Product identification
• Sanitation records
Mixing / Forming
• Oven temperature
records
• Thermometer / probe
calibration records
• Sanitation records
Baking
• Process control records
• Processing aid
traceability records
Cooling

10. Records Audit By Process Step (Packaging / Shipping)
10
Process Flow and Records Lists
• Product sampling,
inspection and analysis
records (packaging,
temperatures, net
weights)
• Metal detection records
• Lot coding / packaging
traceability / product
identification record
• Label approval and
verification records
• Sanitation records
Packaging
• Storage temperature
records
• Sanitation records
• Pest control records
Storage
• Trailer inspection
records
• Shipping records
• Product traceability
records
Shipping

11. Document Audit By Process Step (Raw Materials)
11
Process Flow and Document Lists
• HACCP plan flow
verification and raw
material risk assessment
• Specifications of each
raw material and
packaging material
received
• Receiving procedure and
QC release procedure
(COA)
• Traceability / lot code
procedures
Receiving
• Storage procedure
• Pest control procedure
• Rotation procedure
Storage
• Formulation control
• Document control and
change management
procedures
Batching

12. Document Audit By Process Step (Processing)
12
Process Flow and Document Lists
• Process control
procedures (mixing /
forming procedure,
work inspections)
• Traceability procedure
• Product procedure
• Sanitation procedures
Mixing / forming
• Baking procedure /
specifications
• Temperature validation
records
• Sanitation procedures
Baking
• Sanitation procedure
• Cooling procedure
Cooling

13. Document Audit By Process Step (Packaging / Shipping)
13
Process Flow and Document Lists
• Packaging specification
• Lot coding / packaging
traceability / product
identification procedure
• Metal detector
validation
• Label verification
procedure
• Sanitation procedure
Packaging
• Storage procedure
• Sanitation procedure
• Pest control program
Storage
• Trailer inspection
procedure
• Shipping procedure
• Traceability procedure
Shipping

14. Other Related Program and Records Audits
14
• Sanitation procedures and
records
• Maintenance program and
records
• Calibration program and records
• Pest control program and records
• Allergen control program and
records
• Foreign material control program
and records
• HACCP plan and records
• Food quality plan and records
• Document control program,
records and register
• Internal audit program and
records
• Customer complaint records
• Non-conforming product records

15. Process Audit Implications
15
• Process audits are a more challenging type audit that better
evaluates the performance of your food safety and quality
management systems
• Process audits require the supplier to demonstrate effective
implementation of SQF requirements on all production lots
• Process audits require specific information to be documented and
provided to the auditor
• Process audits allow auditors to connect the dots throughout the
manufacturing process rather than audit independent programs
separately
• Process audits will identify weak links in the process
• Process audits could result in a larger number of non-conformances
identified during the audit

16. Corrective Actions and Learnings
16
Internal Process Audits
Process
Audit
Conduct an
Internal Process
Audit
Repeat and
Verify by
Process / Dept
Implement
Corrective
Actions
Identify Non-
Conformances

17. Best Practices to Eliminate Audit Gaps
17
Module 2 – System Elements
Area Best Practices To Eliminate Gaps
Food Safety Plan
Verify Flow Charts; Identify Correct Hazards; Validate Critical Limits; Perform Monitoring and
Verification
Records Eliminate Write overs; Assure Legibility; Assure All Information Is Complete, Accurate and Timely
Internal Audits Implement Corrective Actions For Deficiencies Identified; Complete As Scheduled
Allergen Management Assure Proper Storage; Complete Allergen Validation; Assure Effective Sanitation and Changeovers
Business Continuity Planning Assure Proper Threats Are identified; Complete Effective Tests; Keep CMT Contact List Current
Module 11 – Facility Audits
Area Best Practices To Eliminate Gaps
Equipment, Utensils and
Protective Clothing
Maintain Conveyor Belts; Eliminate Frayed Plastic On Utensils; Prevent Overhead
Contamination Risk
Walls, Partitions, Doors and
Ceilings
Prevent and Repair Damage; Establish Effective Facility PM Inspection; Prevent Roof Leaks
Floors, Drains, and Waste Traps Prevent Puddling Water; Seal Cracks In Floors; Maintain Sanitary Drains
Dust, Fly, and Vermin Proofing Prevent Pest Activity; Assure Proper Seals Under and Around Doors and Windows
Control of Foreign Matter
Contamination
Use Effective Foreign Material Control Methods; Monitor Devices As Scheduled; Manage
Findings

18. SQF Auditor Perspective
18
• Changes anticipated with SQF Code
Edition 8 Effective July 2016
• Prefer process audit approach
versus a detailed checklist approach
• More effective test of the food
safety and quality management
system
• Identify opportunities for
continuous improvements
• Natural progression of the audit
process

19. Conclusion
19
Learn more about Process Audits
Encourage and challenge suppliers to audit your processes
with this approach
Follow upcoming announcements SQF Code Edition 8
Be prepared for Process Audits before July 2016

20. 20
THANK YOU
Jeff Chilton
jeff.chilton@alchemysystems.com
alchemysystems.com/solutions/professional-services

21. Questions?
21