Why 21 CFR Parts 111 & 117 audits take longer than they should

Most food safety audits don’t run long because the regulations are complex. They run long because audits are designed around documents rather than risk.

Dietary supplement and food manufacturers operating under 21 CFR Part 111 (Current Good Manufacturing Practices (cGMPs) for Dietary Supplements) and 21 CFR Part 117 (cGMPs for Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF)) usually understand the requirements well. Policies are written. Procedures exist. Training is conducted. Records are maintained.

Yet internal audits often feel cumbersome:

• Preparation takes days

• Evidence is requested repeatedly

• Findings reappear year after year

• Operations are disrupted with little lasting improvement to show for it

In most cases, this isn’t a compliance failure. It’s an audit design problem.

An improved audit design can help 21 CFR Parts 111 & 117 audits run more smoothly. Stock photo by Vecteezy

Where dietary supplement and food manufacturer audits commonly go wrong

Across food and supplement operations, the same patterns show up again and again.

Requirements are audited in isolation
Policies, procedures, training, and records are reviewed as separate topics, even when they describe the same control. This fragments understanding and multiplies effort.

Documentation and practice are mixed too early
Auditors jump back and forth between SOPs, records, interviews, and floor observations without a clear sequence. This increases audit time and cognitive overload.

Evidence is re-collected instead of reused
Training records, sanitation logs, and preventive control documentation are often requested multiple times under slightly different questions.

Findings lack continuity
Observations from previous years aren’t immediately visible when reviewing the same requirement this year, making repeat issues harder to recognize and address.

None of these issues are caused by 21 CFR Parts 111 or 117 themselves. They are just signs that you should rethink your audit design strategy.

What efficient audits do differently

Teams that run smoother, more effective audits tend to design them around how controls actually function, not how regulations are written.

They separate intent from execution
Audits begin by confirming that policies, procedures, and responsibilities exist and are appropriate. Only then do auditors verify how those controls are implemented on the floor.

They design questions around evidence, not answers
Questions are structured to naturally produce verifiable evidence—documents, records, observations, or interviews—rather than simple yes/no responses that require follow-up.

They reuse evidence intentionally
Training programs, sanitation records, and preventive control logs are reviewed once and referenced across applicable requirements, rather than being re-examined in multiple sections.

They track findings by requirement, not by audit event
This makes repeat issues visible immediately and supports meaningful trend analysis.

They focus audit depth on risk relevance
Not every requirement carries the same operational risk every year. Time is allocated accordingly.

An efficient audit will lead to actual improvement

When audits are designed this way, teams usually see tangible improvements:

• Shorter audit cycles

• Fewer repeat observations

• Clearer inputs for management review

• Less disruption to daily operations

More importantly, audits begin contributing to actual improvement, not just compliance confirmation.

21 CFR Parts 111 and 117 do not require exhaustive audits. They require clear thinking about risk, controls, and evidence.

When audits are designed with that perspective, efficiency follows naturally.

— Read how GapCross can help streamline your 21 CFR Part 111 & 117 audits. Contact us to learn more.