A food facility that has to write a food safety plan under FDA's preventive controls rule needs a preventive controls qualified individual, a PCQI, to prepare it or oversee it. The PCQI also oversees validating the controls, reviewing records and reanalyzing the plan. To be one, a person completes training at least equivalent to FDA's recognized standardized curriculum, or is qualified by job experience that taught the same. The PCQI doesn't have to be an employee: a consultant can do it. Training is recorded with its date, type and who took it. In the example below, a Kansas wholesale bakery that has outgrown the very small business line sorts out its PCQI.
The short version
- Facilities that need a full food safety plan need a PCQI to prepare or oversee it.
- Qualified facilities that attest instead don't need one.
- Qualify by training equivalent to FDA's recognized curriculum, or by job experience.
- A PCQI can be an outside consultant.
- The PCQI oversees the plan, validation, records review and reanalysis.
- Record training: date, type and who was trained.
- TaroStack keeps the records the PCQI reviews: batches, checklists and lots. More below.
What the PCQI does or oversees
| Task | Where in the rule |
|---|---|
| Preparing the food safety plan | 117.126(a)(2) |
| Validating the preventive controls, and justifying a validation after the first 90 days | 117.160 |
| Deciding validation isn't required | 117.160(c)(5) |
| Reviewing records, and justifying a review later than 7 working days | 117.165(a)(4) |
| Reanalyzing the plan, and justifying more than 90 days for it | 117.170 |
Whether a facility needs a plan at all starts with the qualified facility test, in qualified facility attestation, and what the plan covers in what is a food safety plan.
The rules
| Rule | Where |
|---|---|
| The tasks | One or more PCQIs must do or oversee the plan, validation, records review and reanalysis (21 CFR 117.180(a)) |
| Who qualifies | Training at least equivalent to an FDA-recognized standardized curriculum, or equivalent job experience; may be but need not be an employee (117.180(c)(1)) |
| Records | Training documented with the date, the type of training and the people trained (117.180(d)) |
| Who needs a plan | Facilities that aren't qualified facilities, under the definitions in 21 CFR 117.3 |
This is general information, not legal advice.
An example: a bakery past the line
Flint Hills Bakery, the made-up wholesale bakery in Topeka, Kansas, I use in these examples, passed the very small business line when a grocery chain's orders took its sales past $1.2 million. Its plan for the PCQI:
| Task | Who | How often |
|---|---|---|
| Prepare the food safety plan | The owner, after a preventive controls course | Once, then on change |
| Validate the bake step | The owner | Within the first 90 days of production |
| Review monitoring and corrective action records | The owner | Within 7 working days |
| Reanalyze the plan | The owner, with a consultant | Every 3 years, or on a change |
| Back-up PCQI | The production manager, by experience, documented | When the owner is away |
The owner took a preventive controls course built on the recognized curriculum and filed the certificate with the training records. The production manager, who ran a food safety plan at a larger bakery for six years, is documented as qualified by experience. The bakery's plan itself is in bakery haccp plan.
Get the checker
Download the PCQI task tracker. One sheet: each task the PCQI does or oversees, how often in days, and when it was last done; the next due date and whether it's overdue fill in. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
A tracker reminds; it doesn't hold the records. The PCQI's review means reading this week's bake logs, checklists and corrective actions, and those have to be somewhere they can be found.
How TaroStack does it
TaroStack keeps the records a PCQI reviews: each batch, its checklist, its lots.
Batches with checklists. Each batch can carry a custom checklist, like the bake temperature, recorded on the batch by whoever made it.
Lots on everything. Ingredients are received by lot and each batch records which lots it used, so a review can follow any batch back.
Recalls. One report shows which batches went to which customers.
| The job | Notebook | In TaroStack |
|---|---|---|
| This week's bake records | Clipboards | Checklists on each batch |
| Which flour went into a batch | Not recorded | Lots on the batch |
| Who got a batch | Invoices | One recall report |
Batches, checklists, lots and recalls are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.