HACCP Plans (21 CFR Part 117)
The HACCP add-on lets you build, maintain, and export food safety plans that meet the requirements of 21 CFR Part 117 (FSMA Preventive Controls for Human Food). When active, a HACCP item appears in the left navigation.
Who needs this
Any food business subject to FSMA Preventive Controls — essentially any registered food facility not covered by an exemption — must have a written food safety plan that includes a hazard analysis and, where required, Critical Control Points (CCPs) with defined critical limits and monitoring procedures.
HACCP Plans
A HACCP plan ties together:
- Facility information — the name and address of the facility where this process runs
- Product and process description — what you're making and the overall production flow
- HACCP team — the names, titles, and roles of team members responsible for the plan
- Hazard Analysis — a table of every potential hazard at each process step (biological, chemical, physical, radiological), whether it's significant, and the justification
- Critical Control Points (CCPs) — for each significant hazard, the critical limits, monitoring procedure and frequency, corrective action, verification method, and record-keeping approach
- Approval — the name and title of the person who reviewed and approved the plan, with the approval date
Creating a plan
- Go to HACCP in the left navigation.
- Click New Plan.
- Enter a plan name (e.g. "Ready-to-Eat Hot Sauce — Bottling Line A").
- Optionally link the plan to a recipe — this pre-populates the product description and connects monitoring logs to production runs for that recipe.
- Fill in the Details tab: facility info, product description, process description, and HACCP team members.
Prefer a guided walk-through? New Plan opens Iris, who asks the questions in order (see Building a plan with Iris below). Create by hand opens the form described above.
Plan statuses
| Status | Meaning |
|---|---|
| Draft | Being built — not yet approved |
| Active | Approved and in use for production |
| Archived | Superseded by a newer version |
Approving a plan
Click Approve on any draft plan. Enter the name and title of the approving authority. The plan moves to Active status with the approval date recorded.
Duplicating a plan
Use Duplicate to create an editable copy of an existing plan (including all hazard analyses and CCPs). The copy starts in Draft status. This is the recommended workflow when issuing a new version — duplicate, revise, approve, then archive the old version.
Exporting
Click Export PDF on any plan to download a complete, formatted HACCP plan document suitable for regulatory review, third-party audits, or internal records.
Building a plan with Iris
Iris walks you through a plan in the order the HACCP method goes, so you end up with a complete plan that is ready to approve. Use it for your first plan, or whenever you'd like the method laid out step by step. If you already know the method and just want to type, use Create by hand (or open an existing plan) and work on the plan page instead. Both write the same plan; you can switch at any time.
Open HACCP and choose New Plan. You can stop at any point: the plan waits for you, and everything you've saved is already on it.
What Iris will and won't do
- She asks; you write. Iris never writes a hazard, a critical limit, a justification or a corrective action for you. Every box starts empty.
- Examples are examples. Beside some fields you'll see example wording (for instance, common hazards when cooking or cooling). It is only there to jog your memory. It is never inserted into your plan, and nothing is copied for you.
- Suggestions need your yes. The only text Iris ever adds is the one sentence from the decision questions in Act 4, and only when you tap Accept this result. You can decide differently, and then your decision is saved on its own and your justification is left alone.
- Food safety is yours. The content of the plan, and whether it is adequate for your product and process, are your responsibility, not Iraca's. Approving a plan says you have read it and stand behind it.
The five acts
1. The plan. Start a new plan (name, an optional recipe, and your facility's name and address, filled in from your business profile and editable), or copy a plan you already have if this is a second product (see below). Then name your HACCP team (at least one person) and describe the product in your own words: what it is, ingredients, packaging, shelf life, storage, who eats it and any vulnerable groups. A recipe only supplies its name; Iraca's recipes have no process steps.
2. The process. List each step your product goes through, in order, from receiving to shipping. You can reorder steps, and the common steps are offered as buttons you tap to add. Renaming a step carries through to the hazards written under it. Removing a step that has hazards asks you to confirm, and a step with a critical control point can't be removed until that control point is.
3. Hazards. Take your steps one at a time and write the biological, chemical and physical hazards at each, with whether each is significant, your justification, and the preventive measure. If a step truly has none, tick No hazards at this step. Iris won't treat a step as done until you've done one or the other.
4. Control points. For each hazard you called significant, Iris asks the four standard decision-tree questions. The result is a suggestion: nothing is saved to the hazard unless you tap Accept this result, and you can make your own call without the questions. For each hazard that needs a control point, write the critical limits (a name, a minimum and/or a maximum, and a unit), how you monitor, how often, the corrective action, the verification and the records. A preview then shows what your team will be asked each time they log a reading against that control point.
5. Approve. Read the plan as it will print (the review step has a PDF download, the same document as Export PDF), then either Approve the plan or Keep as a draft. Approving needs the name and title of the approver, and only an owner or admin can approve; it does exactly what Approve does on the plan page. Anyone else can keep the plan as a draft for an owner or admin to approve.
Copying a plan
On the first step, choose copy and search for an existing plan. The copy comes with its hazards and control points, which is the quick way to do a second product or issue a new version. It starts as a draft, and you go through the later acts to change what's different. What comes along is your own earlier work, so read through it: Iraca doesn't judge whether it still fits the new product.
What blocks approval
A plan can always be saved and left as a draft. These items only block approval; the review step lists the ones still open, each with a button back to the right step.
| What it says | How to fix it |
|---|---|
| Name at least one person on the team | Add a name on The team step. |
| List at least one process step | Add your steps on Process steps. |
| Some steps haven't been decided yet | At each undecided step, write its hazards or tick No hazards at this step. |
| Some significant hazards haven't been decided yet | On Which hazards need a control point, answer the questions for each one, or make your own call. |
| A control point has no critical limit yet | On Critical control points, add at least one limit with a minimum or a maximum. |
| A control point has no corrective action yet | Write what you do when a limit is missed. |
Start over
Start over removes the plan this setup made, with its hazards and control points, but only while the plan is still a draft and nothing has been logged against any of its control points. It never removes:
- a plan you already had before you started,
- a plan you copied from (only the new copy can be removed),
- a plan that has been approved,
- a plan with monitoring log entries,
- anything once the setup is finished.
If you're not sure, leave it as a draft: nothing is lost.
Hazard Analysis (Principle 1)
On the Hazard Analysis tab, add one row for each hazard at each process step:
- Process Step — e.g. "Raw Material Receipt", "Cook", "Cool", "Package"
- Hazard Type — Biological, Chemical, Physical, or Radiological
- Description — the specific hazard (e.g. "Salmonella contamination in raw eggs")
- Significant? — whether this hazard requires a CCP. Check this box and add a justification
- Preventive Measure — the control or prerequisite program if not a CCP
Critical Control Points (Principles 2–6)
On the CCPs tab, add a CCP for each significant hazard. Each CCP defines:
- Critical Limits — the measurable boundary that must not be exceeded (stored as key-value pairs, e.g.
{"min_internal_temp_f": 165}) - Monitoring Procedure — how you measure (e.g. "Calibrated thermocouple at thickest part")
- Monitoring Frequency — how often (e.g. "Every batch, at least 3 readings")
- Corrective Action — what to do when a limit is exceeded
- Verification Method — how you confirm the monitoring is working
- Record Keeping — where readings are recorded
Monitoring Log
On the Monitoring Log tab (desktop) or from the HACCP CCP Monitor screen in Fulfillment Mode (tablet/floor), staff record actual measurements against each CCP:
- Select the CCP
- Enter measurements for each critical limit parameter
- Mark the reading as Pass or Fail
- If Fail, record the corrective action taken
Each log entry is timestamped and tied to the logged-in user. If a production run is active, the log is also linked to that run and its lot number for full traceability.
HACCP CCP Monitor (Fulfillment Mode)
For production floor use, open Fulfillment Mode and tap HACCP CCP Monitor. This screen is optimized for tablets and gloved hands:
- Select today's production run from the list of runs started today.
- Select the CCP you are about to monitor (grouped by plan).
- The critical limits are shown as a reference panel.
- Enter your measurements using large numeric inputs.
- Tap Pass or Fail.
- If Fail, enter the corrective action taken in the text field that appears.
- Tap Save Reading.
The screen stays on the same CCP so you can log multiple readings in sequence without navigating back. Tap Back to switch to a different CCP or run.
The HACCP CCP Monitor card in Fulfillment Mode is only visible when the HACCP add-on is active.
Dashboard widget
When the HACCP add-on is active, a HACCP card appears on the main dashboard showing the number of active and draft plans. If you have plans but none are approved, the card shows an alert — production should not run without an approved plan on file.
What this module does not cover (v1)
- Prerequisite Programs (PRPs) — sanitation, pest control, allergen management (these are referenced in hazard analyses but not tracked as structured records)
- Personnel training records — tracked separately; relevant for 21 CFR Part 117 Subpart C
- HACCP record review and verification schedules — planned for a future release