Why Do Many Food Manufacturers Fail ISO 22000 at Their First Audit?

Why Do Many Food Manufacturers Fail ISO 22000 at Their First Audit?

For many food manufacturers, ISO 22000 certification seems straightforward—until the first audit arrives.
In reality, a significant number of companies fail or receive major nonconformities during their initial ISO 22000 audit.

So why does this happen?

Most failures are not caused by technical complexity, but by misunderstanding how ISO 22000 actually works.


What “Failing” an ISO 22000 Audit Really Means

Failing does not always mean rejection. It often includes:

  • Major nonconformities raised

  • Inability to proceed to Stage 2 audit

  • Extended corrective action periods

  • Delayed certification timeline

These outcomes increase:

  • Cost

  • Stress

  • Operational disruption


Top Reasons Food Manufacturers Fail ISO 22000 at the First Audit

1️⃣ Treating ISO 22000 as Documentation Only

Common issues:

  • Documents prepared purely for audit

  • Procedures not followed on the shop floor

  • Staff unaware of documented controls

Auditors typically find:

  • “Paper systems” with no implementation

  • Inconsistent practices between shifts


2️⃣ Weak Hazard Analysis & Risk Assessment

Frequent audit findings include:

  • Generic hazard analysis copied from templates

  • Hazards not linked to actual processes

  • Incomplete evaluation of biological, chemical, and physical risks

ISO 22000 requires:

  • Process-specific hazard identification

  • Justified risk evaluation

  • Clear linkage to control measures


3️⃣ Incorrect Use of CCP, OPRP, and PRP

Many companies struggle with:

  • Over-designating CCPs

  • Misclassifying OPRPs

  • Poor justification for control categorization

Auditors often ask:

  • Why is this a CCP?

  • What happens if this control fails?

If answers are unclear, major nonconformities are likely.


4️⃣ Poor Prerequisite Program (PRP) Implementation

Common PRP failures include:

  • Inadequate cleaning and sanitation records

  • Weak pest control monitoring

  • Poor maintenance and calibration control

  • Inconsistent personal hygiene practices

PRPs form the foundation of ISO 22000—if they fail, the system collapses.


5️⃣ Lack of Staff Competence and Awareness

Typical audit observations:

  • Operators unaware of food safety hazards

  • Supervisors unclear about control measures

  • HACCP team members unable to explain decisions

ISO 22000 requires:

  • Competency-based training

  • Ongoing awareness—not one-time courses


6️⃣ Management Not Actively Involved

Auditors often detect:

  • Management review done only on paper

  • Food safety objectives not monitored

  • Top management absent during key discussions

ISO 22000 demands:

  • Leadership commitment

  • Decision-making involvement

  • Resource allocation

Without management support, audits usually fail.


7️⃣ Poor Control of Nonconformities & Corrective Actions

Many companies:

  • Fix problems temporarily

  • Fail to identify root causes

  • Repeat the same issues during audits

Auditors look for:

  • Root cause analysis

  • Effective corrective actions

  • Preventive thinking


8️⃣ Inadequate Traceability & Recall Readiness

Common findings include:

  • Traceability exercises not tested

  • Incomplete supplier or batch records

  • Recall procedures not verified

ISO 22000 expects:

  • End-to-end traceability

  • Tested and documented recall systems


Why First-Time Applicants Are More Likely to Fail

First-time ISO 22000 applicants often:

  • Underestimate audit depth

  • Rely heavily on templates

  • Lack internal food safety maturity

  • Rush implementation timelines

ISO 22000 is:

  • A management system

  • Not a one-time certification project


How Food Manufacturers Can Avoid Failing ISO 22000

Practical Prevention Strategies

  • Conduct a realistic gap assessment

  • Customize hazard analysis to actual processes

  • Strengthen PRPs before HACCP

  • Train staff based on job roles

  • Involve top management early

  • Perform internal audits seriously—not symbolically


ISO 22000 vs HACCP: A Key Misunderstanding

Many failures occur because:

  • HACCP plans exist

  • But system controls are missing

ISO 22000 requires:

  • HACCP plus

  • Management control

  • Performance monitoring

  • Continuous improvement


Final Thought

Most food manufacturers do not fail ISO 22000 because the standard is too hard.
They fail because the system is not truly implemented.

When ISO 22000 is treated as a daily operational tool, first-audit success rates increase significantly.

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