Verification or Validation of Sanitation Controls: What Should We Do?
This year at the IAFP annual meeting on July 11 in Tampa Florida, our VP of Food Safety & Quality Assurance Evan Rosen gave a presentation on sanitation controls to help attendees ensure their procedures are acceptable for food safety and for FSMA requirements. Because of Evan’s unique history of auditing food facilities and his current work at PacMoore leading the quality department in regards to our food contract manufacturing offerings of dry blending, extrusion, spray drying, consumer packaging, and re-packaging, he understands the requirements, needs and struggles on both sides. IAFP graciously provided us with the video of Evan’s presentation, so we’re pleased to be able to share it with you on our blog! We hope you learn something new about sanitation controls from the video below. Evan’s slide content is also provided on this page below the video.
Presentation Outline
Why are we so confused?
- Verification and validation are terms often used interchangeably, but are not synonyms
- Customers, regulatory and GFSI-based standards have differing expectations
FSMA vs. GFSI Certification
- FDA – FSMA sanitation controls require verification but not validation
- GFSI-based certification standards require BOTH validation AND verification
How do we comply?
- Combine the most stringent requirements among customer, certification and regulatory
- Use guidance documents (usda.gov, fda.gov)
- Evolve, not devolve!
Validation
- Will the SSOP work?
- Can it be replicated?
- Will it achieve its intended purpose?
Clean in Place (CIP) Validation Parameters
- Time
- Temperature
- Flow rate
- Pressure
- Conductivity
- Pump/valve sequencing
- Chemicals
Allergen Cleaning Validation Parameters
- Protein-specific lateral flow/ELISA testing of hard-to-reach food contact surfaces
- Non-protein testing (e.g. sulfites – rinse water)
- DON’T rely solely on finished product testing due to dilution factor
- ATP is verification, NOT validation
Verification
- Did we do what we said we will do?
- Was the SSOP followed as prescribed?
Verification Parameters
- Visual inspection
- APT testing – challenge!
- Protein testing (can be verification in addition to validation, but expensive)
- Avoid conflicts of interest
- Do records reflect actual outcomes?
CIP Spray Ball Verification
- Ensure:
- Correct position
- Shape/type
- Full coverage
- Inspect/remove
- No foreign material
- No damage
Preventive Control Verification
- 21 CFR § 117.165 (Human)
- 21 CFR § 507.49 (Animal)
- Ensure records are:
- Complete
- Accurate
- Verified by PCQI or via PCQI oversight
- Within 7 calendar days
- Exceptions documented
Supporting Records
- Not just monitoring!
- Documented vertical demonstration of sanitation preventive control integrity
- Calibration and accuracy checks
- Training
- Corrections and corrective actions
- Supporting validation studies
Breaches, Deviations, Nonconformities
- Missing outcomes
- Falsification
- Out of specification
- Out of context
- Program failures
- Failure at multiple levels
Nonconformity Examples
- No correction or corrective action
- Cross-connections
- Temperature/time
- Wrong concentration
- Wrong chemical
- Misuse of utensils
- Improper storage/cross-contamination
Correction vs. Corrective Action
- Correction is a short-term fix to mitigate immediate risk; does NOT address root cause
- Corrective action addresses root cause to prevent recurrence
- Corrections for sanitation preventive controls are sometimes accepted in lieu of corrective action, except when tied to recurrence
Corrective Action Examples
- Revised SSOP or utensil
- Training
- Combination of revision and training
- Change chemicals
- Change equipment
- Recurring corrective action may require review and revalidation of SSOP