Aug. 4, 2009 – An FDA shellfish specialist (left) and a New Jersey state inspector look at a map of the waters where the clams in the foreground were harvested. The risks associated with eating raw or partially cooked shellfish are often related to the quality of water from which they are harvested. Specialty food quality control: audits for owners
Photo by The U.S. Food and Drug Administration on Wikimedia Commons, Public domain

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Specialty food quality control: audits for owners

A practical specialty food quality control system for owners: batch-release, shipment, and monthly audits, complaint records, holds, and regulatory follow-up.

What to take away

  • Specialty food quality control has two faces in this tradethe product in the jar, and the service around it. A buyer who receives a perfect product late, in a dented case, with a wrong invoice, experienced poor quality.
  • Check quality with three audits that run on different clocksrelease per batch, shipment per order, and the monthly review of everything the first two and the complaint log turned up.
  • The checklist tells you a step was signed. The audit tells you whether the step worked. They are different questions and the second one catches what the first missed.
  • Every complaint is data, and the ones that never reach you are the expensive ones. Make it easy to complain.

Why an audit and not another checklist

The daily checklist, set out in the SOP checklist for daily operations, asks whether each step was done and signed.

An audit asks whether the result is right: does the fill weight match the label, does the seal hold, did the case arrive on the promised day. A signed step that produced the wrong result is what an audit exists to find. For net quantity, check the declaration against 21 CFR 101.105 and use the applicable package-inspection procedures in NIST Handbook 133; confirm any state weights-and-measures requirements with the relevant state office.

Audit 1: batch release

Before any unit from a batch is sold, one person who did not make the batch checks:

Use these five checks to make the release decision:

  1. Confirm the product, batch ID, production date, approved recipe, and ingredient and packaging lot records match.
  2. Review required in-process records and food-safety control records for missing entries, deviations, and documented corrective actions.
  3. Inspect units from the beginning, middle, and end of the batch for closure or seal, date or lot code, appearance, and other product specifications.
  4. Compare the label with the approved label and batch ingredients, including allergen declarations. Check net quantity with an appropriate scale and the applicable method.
  5. Reconcile finished units, rejects, and samples against the batch record; document unresolved deviations and the hold or release decision.

Batch Release Audit Steps

  • Batch record completesteps, lots, yield, signatures
  • Weigh samplefill weight against label
  • Test sealsinverted, squeezed, container failure
  • Label current, lot legible, allergen match
  • Compare appearance, aroma, taste to retained sample
  • Write release or hold with name and date

Step 4 catches a labeling error at the cheapest possible moment. The U.S. Food and Drug Administration: Questions and Answers Regarding Food Allergens guidance explains the federal allergen-labeling duties for packaged foods.

The release audit compares the label's declaration with the batch record's ingredients. An allergen mismatch is an automatic hold, not an automatic recall; if affected product has already left your control, use the recall and reporting procedure below.

Audit 2: shipment

For a sample of orders each week, and every order to a new buyer, check what the buyer will actually receive:

Shipment Audit Checks

Check

The order
Products, sizes, case counts match
The date
Shipped and delivered on promise
The case
Undamaged, correctly marked, units intact
The dating
Remaining life meets buyer minimum
The temperature
Cold-chain arrives at temperature
The paperwork
Invoice, certificate, sell sheet if new

What right looks like

The order
Shipment record against order
The date
Shipment record against calendar
The case
Photograph before sealing; delivery note
The dating
Lot dates against buyer minimum
The temperature
Data logger or receiving record
The paperwork
Buyer's vendor file

What the record says

The order
The date
The case
The dating
The temperature
The paperwork
CheckWhat right looks likeWhat the record says
The orderProducts, sizes and case counts match the order and the invoiceShipment record against order
The dateShipped on the promised day; delivered within the promised windowShipment record against the calendar
The caseUndamaged, correctly marked, units inside undamagedA photograph before sealing; the carrier's delivery note
The datingRemaining life meets what the buyer requiresLot dates against the buyer's stated minimum
The temperatureCold-chain products arrive at temperatureA data logger or the buyer's receiving record, for cold products
The paperworkInvoice, any certificate the buyer requires, the sell sheet if newThe buyer's vendor file

Ship one case to yourself each quarter and open it as a buyer would. A lid that leaks in transit is a quality failure that never shows up in the kitchen.

The complaint log

One log, one owner, every complaint from any source: buyer email, shopper message, market comment, return. For each, record date, product, and lot. Then note what was said, what was done, and whether the person was told. Read it weekly.

The lot column turns a complaint into information: three complaints on one lot is a batch problem, three on three lots is a process or packaging problem.

Make complaining easy. A contact on the label that reaches a person, a reply within a day, and a replacement without argument produce complaints you can learn from. Silence produces buyers who stop ordering without saying why.

Audit 3: the monthly review

One hour, with the batch records, the release audits, the shipment audits and the complaint log on the table.

Monthly Review Agenda

  1. Yield by batch, plotted or listed in order
  2. Release holds this month, and why
  3. Shipment audit failures, by cause
  4. Complaints by lot and by type
  5. One change, owner, check date

Use this agenda for the monthly review:

  1. Compare batch yields and recorded results with the batch records and product specifications.
  2. Review release holds, deviations, corrective actions, and whether prior fixes worked.
  3. Look for complaint patterns by product and lot, and decide whether they point to a batch, process, or packaging issue.
  4. Review shipment audit failures, including damage, temperature, delivery, and paperwork problems.
  5. Choose one change, assign an owner, and check it at the next monthly review.

What the audits feed

If the federal preventive-controls rule covers your facility, the U.S. Food and Drug Administration's Preventive Controls for Human Food page explains the written food-safety plan, monitoring, verification, and records requirements in 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. Food facility registration, when required, is governed by section 415 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 1, Subpart H. The release audit is verification in its plainest form. The monthly review is where corrective actions are decided.

Ask FDA whether the preventive-controls rule and facility-registration requirements apply to your operation. For state licensing and inspection, contact your state's Department of Agriculture or health department; jurisdiction varies by state and product. A buyer may review written product specifications, vendor questionnaires, required certifications, and insurance documents, or conduct a GMP audit. Ask which requirements apply: SQF and BRCGS are GFSI-recognized certification programs, while GFSI itself is not an audit scheme.

Keep a written withdrawal and recall procedure that identifies who stops distribution, traces affected lots, accounts for product, and notifies buyers and regulators. If you determine that food is reportable under federal law, the responsible party must submit a report through FDA's Reportable Food Registry. A quality hold alone does not automatically mean a recall or a reportable food.

The audit records are also business records. The Internal Revenue Service: What kind of records should I keep? guidance leaves the system to you, provided it clearly shows income and expenses with the supporting documents. A shipment audit attached to its invoice, and a complaint log entry attached to a credit note, are those documents.

What the audits fail to show

Whether the buyer is happy. An order that passed every check can still be one the buyer dreads receiving because the delivery arrives during their rush hour or the invoice format fights their system. Ask each buyer, twice a year, what would make you easier to deal with. Then do one of the things they say.

Where quality failures come from

Most release holds trace to a station: a cooling step that ran long, a filler drifting, a labeler misaligned. The station list in the equipment and setup guide is where the fix usually lives.

Most shipment failures trace to scheduling: an input that arrived late, a slot that was not there, which is the subject of how to schedule specialty food orders. And the batch day that the release audit checks is the anatomy set out in the operations and workflow guide.

Distance is a quality variable. A buyer three states away receives a case handled more times, at more temperatures, for longer.

When the shipment audit starts failing on damage or temperature for distant buyers only, that shows where the product can be sold well. It belongs in the criteria that the best markets for a specialty food business weighs.

Common questions

Who should do the release audit in a one-person business?

You, on a different day from the batch, with the retained sample in hand and the record in front of you. The separation in time does part of what a second person would do.

How many units should I sample?

Enough to see both ends of the batch and the middle. For a small batch that may be most of it. Ask your process authority or a food-testing laboratory for sampling expectations suited to your product and test. For state requirements, contact your state's Department of Agriculture or health department.

What do I do with a held batch?

Find out why before deciding. A fill-weight miss can be corrected; an allergen mismatch cannot, and the product is not sold. Record the decision and the reason on the batch record.

Should I tell buyers about a hold?

If it affects their order, yes, the same day, with the new date. A buyer told early that a batch was held for quality trusts you more, not less.

How often should the shipment audit run?

Weekly on a sample, and on every first order to a new buyer. A quarterly case shipped to yourself catches what the sample misses.

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