What a remote supplier audit can establish, and what it cannot

Remote supplier audits became routine when travel stopped, and many buyers have kept them because they are quicker to arrange and cheaper to run. A team logs into a video call, the supplier shares its screen, documents are requested and shown, and a camera is carried around the site. At the end there is a report, and often an approval.

That report is worth having, but only if everyone who relies on it understands what kind of evidence sits behind it. A remote audit is a different instrument from an on site audit, with different strengths and real blind spots. This article describes general practice. Whether a remote audit is acceptable for a given supplier, and when an on site visit is expected, depends on your market, your product and your own quality system, so check the current guidance that applies to you.

What can a remote supplier audit establish?

A remote audit is strongest wherever the evidence is a document. In a well run session an auditor can read procedures and see whether they are current, controlled and approved. They can pick batch records at random and follow one batch from receipt of raw materials to release. They can open the deviation log, choose entries and ask to see the investigation, the root cause and the corrective action. They can look at change control, complaints, recalls, supplier qualification files, training records and the most recent internal audits.

This tests something that matters a great deal: whether the quality system exists as a working set of records, and whether the people responsible can find, explain and defend them. A supplier whose quality manager cannot retrieve a deviation from last quarter, or whose batch records cannot be produced on request, has told you something important, whether you are in the room or not.

Interviews still work

Much of auditing is conversation. Asking an operator to describe how they clean a line, or asking the head of quality control what happens when a result is out of specification, works almost as well on a call as in person. Hesitation, contradictions between people and answers read from a script are all visible on a screen.

What can a remote supplier audit not establish?

The limitations of a remote supplier audit come from one fact: the supplier controls what you see. The camera points where the supplier points it, documents arrive when the supplier chooses, and the walk round follows a route the supplier has planned.

• The physical condition of the site. A camera flattens detail. Wear on surfaces, damaged seals, dust in corners, condensation and pest activity are easy to miss and easy to keep out of frame.
• What happens when nobody is presenting. On site, an auditor can stop at an unplanned door, look into a warehouse bay, or watch a shift change. Remotely, almost everything is presented rather than discovered.
• Whether the documents match practice. A record can be complete and still describe work that was done differently, or not at all. Comparing a logbook with the equipment beside it, at the same moment, is far harder through a screen.
• Whether you are seeing the right site. A video tour shows a building. It does not by itself prove that it is the building named on the certificate, or that your material is made there.
• Sensory and environmental cues. Smell, noise, temperature and the feel of a clean area tell an experienced auditor a lot, and none of them travel well.

When is a remote audit a reasonable choice?

Remote audits suit some situations better than others. They are most defensible for a supplier you already know well, with a clean history and an earlier on site audit to compare against, where the purpose is a periodic review rather than a first approval. They are also useful as a first screen before deciding whether a supplier is worth a visit, and as a focused follow up to check that corrective actions from an earlier audit were closed.

They are weakest for a new supplier making a critical or high risk material, for a site with a history of problems, and for any case where the main question is whether the supplier really manufactures what it sells. On that last point, our article on telling a manufacturer from a trading company sets out the checks that do not depend on a video tour.

How do you get more out of a remote audit?

A remote audit is only as good as its preparation. A few habits make a large difference.

• Send a document request in advance, then ask for several further records live, chosen during the session, so they cannot all be prepared beforehand.
• Ask for a live walk round with the camera held by someone you can direct, not a recorded video, and ask to see specific rooms, equipment identification plates and status labels.
• Pick one batch and trace it end to end, from raw material receipt through production, testing and release, checking that dates, equipment numbers and signatures agree.
• Compare what you see with what you already hold: the site address on the GMP certificate, the manufacturing address in the filing, and the details on the certificate of analysis.
• Record clearly in the report which areas were assessed remotely, which could not be assessed, and what would need an on site visit to close.

Comparing documents across sources is often where remote audits find their most useful results. Our article on reading a GMP certificate explains what that document does and does not prove.

What should the audit report say about its own limits?

An honest remote audit report states that it was remote, lists what was examined and how, and names the areas it could not cover. It should not read like an on site report with the word remote added to the title. If the approval rests partly on a remote audit, the supplier file should also say when and how the open points will be checked in person, and the quality agreement should give you the right to do so.

For the wider checks behind choosing a supplier, see our articles on manufacturers and trading companies and quality agreements with API suppliers, and for sourcing and compliance support, our consultancy page.

NJMC Medical Supplies Co., Ltd is a trading and consultancy company in Nanjing, China, supplying medical equipment, medical consumables and active pharmaceutical ingredients to healthcare institutions, sourced from manufacturers in China and India.

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