Factory audit and training

Several certification schemes assess the factory as well as the product: an initial audit of the production site before the certificate issues, and periodic surveillance afterwards to keep it valid. An audit is the item that most often turns a project measured in weeks into one measured in months, and unlike testing it cannot be accelerated by paying more — the constraint is auditor availability and the site’s own readiness. We identify whether a scheme requires one, prepare the site and its records against what the auditor will look for, attend, and train the people who have to answer.

Which schemes audit the site, and why it matters early

Product certification and site certification are different things and several schemes require both. Certificate schemes under the Eurasian Economic Union technical regulations include production-site assessment for the higher schemes. The Emirates Quality Mark and the Saudi Quality Mark are both product marks backed by a factory audit and ongoing surveillance. Halal certification audits the plant as a matter of course, because the scope is the process. Management-system certification is entirely an audit.

The reason to know this in week one rather than month three is scheduling. An audit needs the site ready, an auditor available and, for a foreign site, travel arranged. Where the scheme requires it and the project plan does not, the launch date is already wrong and nobody has noticed.

What an auditor is actually checking

Less about the equipment than manufacturers expect, and much more about whether the process described on paper is the process running on the floor. The recurring question in every scheme is the same: show me the record. Incoming material inspection against a specification. Calibration of the instruments that verify the product. Traceability from a finished unit back to its batch of components. Control of nonconforming product — what happened to the units that failed, and can you show it.

Change control is the second theme, and the one most often weak. A supplier substituted for a component that affects conformity, without an assessment of whether it still conforms, is a finding in every scheme that looks for it. So is a production change that the technical file does not reflect.

The third is the people. Auditors ask operators to describe the procedure they are following, and a site where the documented procedure and the described procedure differ has a real gap rather than a paperwork one. This is where training earns its cost — not in teaching the standard, but in making sure the people on the line can explain what they do and why.

Preparation, and the difference between a finding and a delay

Most first audits produce findings. What decides the schedule is whether they are minor findings closed with a corrective action plan, or major ones that require a follow-up visit — and the difference is usually preparation rather than capability. A site with the right records in the right place and staff who can find them typically closes on paper. A site where the records exist but nobody can produce them in the room gets a second visit.

The preparation is unglamorous: assemble the records the scheme names, check the calibration status of everything that matters, walk the traceability of one finished unit end to end, and rehearse the questions. Doing that once before the auditor arrives is the difference between a certificate this quarter and a certificate next quarter.

Training is the other half. Where a site is being audited for the first time, or against a scheme it has not met before, the useful training is specific to the scheme and to the roles that will be in the room, rather than a general course on the standard.

When a site audit applies

The rows with no audit are not the rows with no obligation. A self-declared route replaces the scheduled audit with unannounced market surveillance, which asks the same questions of the same records with less notice.