BRCGS Consumer Products Issue 4 Section 6 Part 1: Process Control, HARA, Line Clearance and Release

By Robert Low, Director, Lead Auditor & BRCGS Approved Trainer

Section 6 of Issue 4 governs manufacturing itself, and it is dense enough that I am splitting it in two. This first half covers control of operations, including the process hazard and risk assessment at 6.1.1 and line clearance, equipment and equipment maintenance, calibration and control of measuring devices, final product packing, and stock control and product release. The contamination control block at 6.3 gets its own post, because it earns one.

6.1.1: The Process Risk Assessment

At the heart of control of operations sits the requirement for a documented hazard and risk assessment of your manufacturing processes: identify what can go wrong at each step, determine controls, set limits, monitor them and act on deviations. This is HARA thinking, and I have written a full explainer on the HARA methodology that applies here directly: team, verified flow diagrams, honest hazard identification, validated controls. The Issue 4 findings cluster in two places. Flow diagrams that skip rework loops, waste routes and holding steps, so the assessment never even considered the step where the problem lives. And monitoring records that exist for the controls that are easy to record rather than the controls that matter.

Line Clearance and Process Checks

Start-up and changeover line clearance must confirm the line is clear of previous materials, components and documentation before the next run begins, recorded and signed. In mixed-product factories this is one of the highest-value disciplines in the whole standard, because the wrong component in the wrong pack is precisely how consumer product recalls happen. Process checks at start-up, after adjustment and periodically through the run keep the operation inside the manufacturing instruction, and the bill of materials for the batch should be at the line, not in an office.

Equipment, Calibration, Packing and Release

Equipment must be fit for purpose with planned maintenance that does not itself contaminate product, temporary repairs documented and made permanent within a defined timescale, the tape-and-cable-tie economy being an auditor magnet. Measuring devices controlling safety, legality or quality must be identified, calibrated traceably to national standards, protected from unauthorised adjustment, and, the clause with teeth, when a device is found inaccurate, the product measured with it since the last good check must be risk assessed, not just the device fixed. Final packing checks confirm the right product in the right packaging, and product release requires positive authorisation against defined criteria before dispatch, with quarantined stock physically incapable of shipping by accident.

What Changes Under Issue 5

Issue 5, as per the public draft, relocates most of this: the process risk assessment moves into the combined Section 2 as full HARA, equipment maintenance moves to site standards, and process control, elevated to Fundamental, joins a merged product and process control section. The disciplines transfer intact, full detail in the Issue 5 breakdown. Back to the series hub, or on to Section 6 part 2.