Health inspection readiness and product recall protocol

The visit is not prepared on the day of the visit

The authority reviews premises, processes and documents, and above all the consistency between them. A finding is almost never a surprise: it is the result of months of documentation, or of the lack of it. That is why the work starts earlier, while things can still be corrected without ending up in an official record.

• Document review. Authorisations in force, consistency between the authorised formula, the printed label and the actual product, and the quality records required by Resolution 2674 of 2013.
• Internal walkthrough. With the quality team, covering the points the authority tends to look at first and the ones the company has been putting off.
• Traceability. That the company can reconstruct a batch's path backwards and forwards. It is the evidence that supports any answer given later.
• Protocol for the day. Who receives the officials, who alerts the firm, who accompanies them, what is handed over, how it is recorded and who may sign.
• Short training. Aimed at the people who will actually be on the plant floor that day, not at the whole company.

During and after the inspection

• Attendance at the visit, with control over what is handed over and how it is recorded.
• Review of the inspection record before anyone signs it, and written observations where appropriate: what is written there frames every later discussion.
• An improvement plan with deadlines and owners, drafted so it can be complied with and evidenced, not so it reads well.
• Responses to requirements and defence of the company in any administrative proceeding that follows.
• Handling of health safety measures imposed on product or premises, and the route to have them lifted.

Restaurants, outlets and warehouses

The visit does not always arrive at a plant. Restaurants, dark kitchens, retail outlets and storage warehouses are inspected by the territorial health authority, with its own logic: handling, cold chain, staff training, supplier control and the condition of the premises. The work is fundamentally the same, reviewing beforehand what will be looked at afterwards, but with a different counterpart and different paperwork. We prepare both scenarios and leave the team at the site knowing what to do.

Product recall

A recall is the stress test of the entire quality system. It is decided on incomplete information, under time pressure and with the phone ringing. A written protocol, with named owners and rehearsed at least once, turns an emergency into a procedure.

• Criteria for deciding whether to withdraw, how far down the chain the recall reaches and which batches it covers.
• Who decides, who executes and who speaks: one spokesperson and one message.
• Communication with the authority, with the distribution channels and with the end consumer.
• Reverse logistics: collection, custody, disposal of the product and a record of what was actually recovered.
• Handling of complaints and consumer liability, together with our consumer law practice.
• Closing the episode: root cause, corrective action and a file showing how it was handled.

What the client receives

• A report on the preparatory review, with findings split between what must be fixed now and what can be scheduled.
• The inspection protocol, including a short version that can be consulted on the day.
• The product recall protocol, with owners, timings and record formats.
• Attendance at the inspection and the responses filed with the authority.
• The file evidencing what the company did, which is what has to be shown if the matter escalates.

Typical situations we handle

• The company is opening a new plant or commissioning a line and wants to be ready for the first visit.
• A requirement or an inspection record with findings has arrived and deadlines are running.
• A batch has shown a problem and a decision on withdrawal and its scope is needed within hours.
• An institutional customer or retail chain wants to see the recall protocol before signing the supply contract.