staying ahead of the audit curve with food industry process audits
TRANSCRIPT
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
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
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Types of Audits
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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
How Process Audits Differ from Quality System Audits
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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
Process Audit Elements
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Inputs Process Steps Outputs Finished
Product
(Materials, Measures and Methods)
(People, Equipment and Environment)
Process Audit Methods
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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
Records Audit By Process Step (Raw Materials)
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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
Records Audit By Process Steps (Processing)
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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
Records Audit By Process Step (Packaging / Shipping)
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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
Document Audit By Process Step (Raw Materials)
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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
Document Audit By Process Step (Processing)
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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
Document Audit By Process Step (Packaging / Shipping)
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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
Other Related Program and Records Audits
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• 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
Process Audit Implications
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• 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
Corrective Actions and Learnings
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Internal Process Audits
Process Audit
Conduct an Internal Process
Audit
Repeat and Verify by
Process / Dept
Implement Corrective
Actions
Identify Non-Conformances
Best Practices to Eliminate Audit Gaps
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Module 2 – System ElementsArea 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 TimelyInternal Audits Implement Corrective Actions For Deficiencies Identified; Complete As ScheduledAllergen Management Assure Proper Storage; Complete Allergen Validation; Assure Effective Sanitation and ChangeoversBusiness Continuity Planning Assure Proper Threats Are identified; Complete Effective Tests; Keep CMT Contact List Current
Module 11 – Facility AuditsArea Best Practices To Eliminate GapsEquipment, 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 DrainsDust, Fly, and Vermin Proofing Prevent Pest Activity; Assure Proper Seals Under and Around Doors and WindowsControl of Foreign Matter Contamination
Use Effective Foreign Material Control Methods; Monitor Devices As Scheduled; Manage Findings
SQF Auditor Perspective
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• 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
Conclusion
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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
Questions?
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