Pre-Audit Documentation Review
Before scheduling a facility audit, request and review the manufacturer’s quality manual, organizational chart, current certifications, and a recent internal audit summary if available, since this documentation review often reveals whether an on-site audit is warranted or whether initial concerns are significant enough to eliminate a candidate before investing further time. A manufacturer’s quality manual should clearly describe its approach to raw material qualification, in-process controls, and deviation management.
Buyers should also review the manufacturer’s regulatory inspection history where publicly available, such as FDA inspection classification databases, as part of this pre-audit stage, since this information is often accessible without needing to request it directly from the manufacturer.
Facility and Equipment Assessment
An on-site or virtual facility audit should assess whether the physical infrastructure matches what has been described in documentation, including production equipment scale and condition, segregation between different product grades or clients where relevant, and general facility cleanliness and organization. Observing the facility in operation, rather than only during a prepared tour, provides more reliable information about day-to-day practices.
For buyers unable to travel for an in-person audit, many manufacturers now offer live virtual facility tours conducted by video call, which, while not a full substitute for an in-person audit, can provide meaningful additional verification beyond documentation review alone.
Quality System Deep Dive
Beyond confirming that certifications exist, an effective audit examines how the quality system actually functions: how deviations and out-of-specification results are investigated and documented, how corrective and preventive actions are tracked to closure, and how change control is managed when the manufacturer modifies its process. Asking to review a redacted example of a past deviation investigation, if the manufacturer is willing to share one, often reveals more about quality system maturity than any other single request.
The training records and qualification of key personnel, particularly quality assurance and production staff, are also worth reviewing, since a well-designed quality system depends on consistent execution by trained personnel to function as intended.
Documenting and Closing Out the Audit
A formal audit report, documenting findings, any observations requiring follow-up, and an overall qualification determination, should be produced regardless of audit outcome, both to support internal decision-making and to create a record for future reference or regulatory inspection. Any significant observations should be tracked to resolution before finalizing the supplier relationship, with a defined timeline for the manufacturer to address them.
For ongoing supply relationships, periodic re-audit, typically every one to three years depending on risk classification, should be scheduled from the outset rather than treating the initial audit as a one-time event, since manufacturer quality systems and practices can change over time.