Why This Assessment Exists

Audits and inspections rarely fail because of unexpected issues.
They fail because of known gaps that were never reviewed objectively.

Section 1: Food Safety Management System (QMS/FSMS)

1. 1.Is your food safety system fully implemented and actively maintained, not just documented?
2. Are management review meetings conducted at defined intervals with recorded decisions and follow-up actions?
3. Are internal audits completed on schedule, covering all applicable scopes?
4. Are corrective actions tracked to closure with verified effectiveness?
5. Are food safety responsibilities clearly assigned and understood at all levels?

Section 2: Validation & Verification

1. Are all critical processes formally validated against defined acceptance criteria?
2. Is validation data current and reflective of actual operating conditions?
3. Are worst-case conditions considered and documented?
4. Are processes revalidated after changes to equipment, formulation, suppliers, or volume?
5. Is verification data reviewed and trended rather than filed?

Section 3: Temperature Mapping & Environmental Control

1. Has temperature mapping been conducted for all critical areas?
2. Were sensor locations selected based on risk rather than convenience?
3. Are seasonal or operational variations considered?
4. Is mapping repeated or reviewed following changes or time gaps?
5. Can the mapping rationale be clearly defended to an auditor?

Section 4: Calibration & Monitoring

1. Are all critical instruments identified and assigned calibration frequencies?
2. Are calibration standards traceable to recognized references?
3. Are instruments used strictly within validated ranges?
4. Are out-of-tolerance events investigated for product impact?
5. Are expired or failed instruments effectively controlled?

Section 5: SOPs & Operational Alignment

1. Do written procedures reflect actual day-to-day practices?
2. Are operators trained and assessed against current SOPs?
3. Are deviations documented and addressed consistently?
4. Can staff explain why procedures exist?
5. Are SOPs reviewed and updated on a defined schedule?

Section 6: Change Control & Risk Management

1. Is there a formal change control process in place?
2. Are food safety impacts assessed before changes occur?
3. Are validations updated after changes?
4. Are temporary changes documented and closed?
5. Can historical change control be demonstrated?

Section 7: Supplier & Input Control

1. Are suppliers approved based on risk and documented criteria?
2. Are supplier audits or verifications current?
3. Are specifications defined for critical inputs?
4. Are supplier deviations tracked and escalated?
5. Is supplier performance periodically reviewed?

Section 8: Audit & Inspection Preparedness

1. Are previous audit findings fully closed and verified?
2. Are staff trained on auditor and inspector interaction?
3. Are records readily accessible without last-minute searching?
4. Can management explain system decisions clearly?
5. Is there a defined process for responding to findings?

Scoring & Interpretation

0–5 gaps: Generally audit-ready, with targeted improvements recommended.

6–15 gaps: Moderate risk. Gaps are likely to attract auditor attention.

16+ gaps: High risk. Findings are probable without corrective action.

What This Assessment Does Not Replace

List:

• A formal audit
• Regulatory inspections
• On-site validation or temperature mapping

This assessment is intended to identify where to act before pressure exists.

Next Step

If this assessment identified gaps, a remote or on-site Audit Readiness / Validation Gap Review can help prioritize actions and reduce audit risk.