Summary
In short
- Record why each hazard was or was not judged significant. The reasoning is the part that is examined and the part most plans omit.
- A CCP is a step at which control is essential and where loss of control would result in an unacceptable risk. Steps that are important but not essential are prerequisite programmes or other preventive controls, not CCPs.
- Too many CCPs is a defect. Monitoring effort spreads thin, deviations become routine, and the discipline that makes a genuine CCP work is diluted.
- Critical limits must be validated, measurable and achievable in practice. A limit derived from a textbook and never tested on the actual process is an assumption.
- The plan must be reassessed at least annually and whenever any change could affect the hazard analysis, which includes ingredients, suppliers, equipment, process and packaging.
- The preliminary steps matter: the flow diagram must be verified on site, because plans are routinely built on a diagram that no longer matches the line.
What it is
What it is
What is a HACCP plan?
A documented system identifying food safety hazards significant enough to require control, determining the critical control points at which they are controlled, and specifying critical limits, monitoring, corrective action, verification and record keeping for each. Codex sets out twelve steps of which the last seven are the HACCP principles.
How does it relate to a FSMA food safety plan?
They overlap substantially and are not identical. The preventive controls framework recognises process, allergen, sanitation and supply chain controls, several of which are not CCPs in the classical sense. A facility subject to the preventive controls rule needs a food safety plan meeting that rule, and a HACCP plan alone may not satisfy it.
When to use it
When to use it, and when not to
This is the plan itself. The records it generates and the programmes it depends on sit separately.
Use it for
- Documenting the hazard analysis, CCP determination, critical limits, monitoring and verification for a product or product group
- Reassessment at least annually and on any change affecting the hazard analysis
- New product, process, ingredient, supplier, equipment or packaging introduction
- Following a deviation, complaint, recall or regulatory finding indicating the analysis was incomplete
- Supporting scheme certification requirements built on HACCP principles
Not for
- Prerequisite programmes, which control the general conditions the plan assumes to be in place
- Monitoring records generated under the plan, which are the evidence of its operation
- Validation studies for critical limits, which are technical work referenced by the plan
- The FSMA food safety plan, where the preventive controls rule applies and requires additional elements
- Product specifications, which the plan references rather than contains
Standards
What it is built against
HACCP is defined by Codex and adopted into regulation and scheme requirements with local variations.
| Clause | Requirement | Where it lands |
|---|---|---|
| Codex CXC 1-1969 | Twelve steps including the seven HACCP principles, with prerequisite programmes as the foundation | Team and preliminaries |
| Codex principle 1 | Conduct a hazard analysis and identify control measures | Hazard analysis |
| Codex principle 2 | Determine the critical control points | CCP details |
| Codex principles 3-5 | Establish validated critical limits, monitoring, and corrective actions | CCP details |
| Codex principles 6-7 | Establish verification procedures and documentation and record keeping | Plan quality |
| 21 CFR 117 Subpart C | Food safety plan with hazard analysis and preventive controls, prepared by a PCQI | Header |
| 9 CFR 417 | HACCP for meat and poultry, including reassessment at least annually | Plan quality |
| SQF Edition 9 cl.2.4 | Food safety plan validated and verified, developed by qualified personnel | Team and preliminaries |
What it does not cover
- Prerequisite programmes, controlling the general conditions the plan assumes.
- Monitoring records, which are the evidence the plan is operating.
- Validation studies establishing that the critical limits control the hazard.
- The FSMA food safety plan, where the preventive controls rule applies and requires additional elements.
- Training records evidencing that those monitoring CCPs are competent to do so.
Filling it in
Filling it in well
Get the preliminaries right, justify every decision, and keep the number of CCPs honest.
Walk the process and confirm the diagram matches, including rework loops, holding steps, sampling points and any bypass route. Plans are routinely built on a diagram drawn when the line was installed, and rework in particular is the step most often missing and most often implicated in problems.
For each hazard at each step: likelihood, severity, and why it is or is not significant. Where a hazard is controlled elsewhere, say where. This is the field auditors examine and the one most frequently absent, and writing it forces the analysis to happen at each step rather than at the interesting ones.
A CCP is a step where control is essential and loss of control would result in an unacceptable risk. Steps that are important but where failure would be caught later, or where a prerequisite programme provides adequate control, are not CCPs. Plans with fifteen CCPs dilute monitoring attention and normalise deviation.
A limit must be measurable at the point of control, achievable by the equipment in use, and validated as sufficient to control the hazard. Limits taken from a code of practice and never tested against the actual product and equipment are assumptions, and they surface as a problem during a deviation rather than during an audit.
Audit findings
Common audit findings
HACCP findings concentrate on justification, on CCP inflation, and on reassessment.
| Finding | Clause | What fixes it |
|---|---|---|
| Hazard analysis records conclusions without reasoning. | Codex principle 1 | Record likelihood, severity and why each hazard is or is not significant. |
| Flow diagram not verified on site. | Codex step 5 | Walk the process; rework loops and bypass routes are routinely absent from diagrams. |
| Excessive CCPs where prerequisite programmes provide control. | Codex principle 2 | Reserve CCPs for steps where control is essential; inflation dilutes monitoring. |
| Critical limits not validated for the actual process and equipment. | Codex principle 3 | Validate against your product and line; borrowed limits are assumptions. |
| No reassessment despite an ingredient, supplier or equipment change. | 9 CFR 417.4 | Any change affecting the hazard analysis triggers reassessment, not only the annual cycle. |
| Rework not addressed in the hazard analysis. | Codex principle 1 | Rework carries hazards and allergen profile forward; it belongs in the analysis explicitly. |
| Corrective actions not specified in advance for each CCP. | Codex principle 5 | Define before a deviation occurs, including product disposition and the extent boundary. |
| Verification confused with monitoring. | Codex principle 6 | Monitoring operates the control; verification confirms the system works. |
| HACCP plan presented as satisfying the preventive controls rule. | 21 CFR 117 | The rule requires additional elements; a HACCP plan alone may not satisfy it. |
| Team lacking the process knowledge to challenge the analysis. | SQF 2.4 | Include people who run the line; the analysis needs process reality as well as technical knowledge. |
Worked case
Case in point: the step that was not on the diagram
A ready meal producer maintained a HACCP plan with three CCPs, reviewed annually, verified and certified. The flow diagram had been drawn when the line was commissioned and had been carried forward through each review unchanged.
A complaint investigation traced a problem to a holding step that did not appear on the diagram. Trays that failed a weight check were set aside on a rack beside the line and reintroduced at the next changeover, sometimes several hours later. The practice had begun as a temporary arrangement during a busy period two years earlier.
It was not a rogue practice. Supervisors knew the rack was there, the arrangement was efficient, and nobody had raised it against the HACCP plan because the plan described a process that did not include the step.
Definitions
Definitions and key terms
- Critical control point
- A step at which control is essential to prevent or eliminate a hazard or reduce it to an acceptable level.
- Critical limit
- A measurable criterion separating acceptable from unacceptable, validated as sufficient to control the hazard.
- Prerequisite programme
- Basic conditions and activities necessary to maintain a hygienic environment, on which the HACCP plan depends.
- Validation
- Evidence that the control measures are capable of controlling the hazard, performed before implementation and on change.
- Verification
- Confirmation that the plan is being implemented as intended and remains effective, distinct from monitoring.
- Significance decision
- The judgement that a hazard is reasonably likely to occur and severe enough to require control, requiring recorded reasoning.
- Reassessment
- Review of the plan, required at least annually and on any change that could affect the hazard analysis.
- Flow diagram verification
- On-site confirmation that the documented process matches the process as operated, a Codex step in its own right.
FAQ
Frequently asked questions
What is the most common defect in a HACCP plan?+
A hazard analysis that records conclusions without reasoning. Listing hazards and marking significance produces a document that looks complete and cannot answer the question an auditor asks, which is why a particular hazard was judged not significant at a particular step. Recording likelihood, severity and where else the hazard is controlled is what makes the analysis defensible.
Can you have too many CCPs?+
Yes, and it is a defect rather than caution. A CCP requires monitoring, defined critical limits, corrective action, verification and records. Spreading that discipline across fifteen steps where it is genuinely needed at three dilutes attention, normalises deviation and makes the real CCPs harder to protect. Steps controlled adequately by prerequisite programmes are not CCPs.
Does a HACCP plan satisfy FSMA?+
Not necessarily. The preventive controls rule requires a food safety plan with hazard analysis and preventive controls that include process, allergen, sanitation and supply chain controls, several of which are not CCPs in the classical sense, and it must be prepared or overseen by a preventive controls qualified individual. A facility subject to the rule needs a plan meeting it.
How often must the plan be reassessed?+
At least annually, and whenever a change could affect the hazard analysis: a new ingredient, supplier, formulation, process step, item of equipment, packaging or intended use. The change trigger is the one that fails, because changes are made by people who do not think of them as food safety events.
What does flow diagram verification involve?+
Walking the process and confirming the diagram matches what happens, including rework loops, holding steps, sampling points and bypass routes. It is a distinct Codex step and it is frequently performed as a desk review, which confirms the process everyone believes is running rather than the one that is.
The agents
What the agents do with it
The plan is the food safety system's foundation. What fails is the reasoning nobody recorded and the process step that was never on the diagram.
Holds the hazard analysis with reasoning per hazard per step, links CCPs to their monitoring records, and triggers reassessment on change.
Watches ingredient, supplier, equipment and packaging changes for hazard analysis impact, rather than waiting for the annual reassessment.
Confirms that those monitoring CCPs are trained for the specific limit and reaction plan, and retrains when the plan changes.
Connects equipment used at CCPs to calibration and maintenance, since a critical limit is only as good as the instrument measuring it.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Sources
Sources
- Codex Alimentarius CXC 1-1969, General Principles of Food Hygiene including the HACCP system
- 21 CFR Part 117 Subpart C, hazard analysis and risk-based preventive controls, FDA
- 9 CFR Part 417, hazard analysis and critical control point systems, USDA FSIS
- SQF Edition 9 clause 2.4 and BRCGS Food Safety Issue 9 section 2
- ISO 22000:2018, food safety management systems