✅The Audit Survival Guide
A method monitoring check takes only a few minutes to perform. Missing it for two weeks could potentially impact hundreds of reported results. Why?
Method monitoring provides evidence that the alternative method is performing as intended; without it, confidence in reported results may be affected. Cannot prove the method was in control for thoe weeks.
A technician prints an old version of a laboratory log sheet and continues using it after a revised version has been issued.
Use of an obsolete/uncontrolled document. Accurate data recorded on an uncontrolled form is still a compliance finding.
After cleaning a spill, a technician continues testing with the same contaminated gloves because the task is almost complete.
Failure to change contaminated PPE.
Everything about the test appears correct. The result is accurate. The product meets specification. The only problem is there is no documentation proving it.
From an auditor's perspective, the activity cannot be verified because it was not documented. ("If it isn't documented, it didn't happen.")
The Vitamin C result passed specification but is outside the control limits for trueness.
Retest and evaluation needed. A passing product result does not override a failed trueness control.
During an audit, investigators discover that oven Total Solids results were generated and reported, but the required 89 inspections were never created in SAP to confirm specification compliance.
Failure to perform required SAP verification (SPV) before lab release.
A coworker verbally explains a process that differs from the SOP, saying, "This is how I have always done it."
Failure to follow the approved procedure.
A Vitamin C sample result is within specification, but the duplicate analyses exceed the method's allowable CVr limit.
Retest. The result does not meet method acceptance criteria and must be evaluated according to procedure
During a lab inspection, 70% IPA is stored directly beside the hydrogen peroxide refills in a flammable storage cabinet. What should be reviewed before approving this storage arrangement?
Chemical compatibility and SDS storage requirements.
A technician leaves the laboratory wearing their lab coat to retrieve supplies from another area and then returns directly to testing activities.
Potential cross-contamination due to improper lab coat use.
During SPV, a verifier notices a transcription error. What should happen next?
The error must be corrected and documented according to procedure before proceeding.
A BPV composite total solid result is in spec from the FT-NIR at 28.6%. The oven reference method result is 28.40%, which fails specification. A technician wants to release the result because the FT-NIR "is in spec."
Retest! The discrepancy must be investigated before laboratory release.
During record review, the NQAC report (raw data) cannot be located to support a reported result. What NGLP crime has been committed?
Failure to retain original records
While performing a procedure, a technician accidentally splashes pre-prepared sodium hydroxide solution onto their glove. They continue working because there is no immediate discomfort.
Failure to respond appropriately to a potential corrosive chemical exposure. Refer to SDS
An orange laboratory-designated dustpan is missing from the lab. A technician borrows one from another area to clean up a product spill and then returns it.
Potential cross-contamination due to non-dedicated tools used in the laboratory.
An auditor finds a procedure in use that does not match the version in Cority. Name the compliance concern.
Failure to follow the controlled document process.
Why is retesting only one pack from a composite sample a risk when the procedure requires B/M/M/E packs?
Because a single pack may not be representative of the entire composite, and the required retest design was intended to evaluate all portions of the original sample set.
A technician discovers an error but decides not to document it because the final result passed. What NGLP principle was violated?
All errors and deviations must be documented.
A technician is preparing Erythrosin Dye Solution, which requires 70% IPA. They find an unlabeled bottle containing a clear liquid in the reagent preparation area. Assuming it is 70% IPA, they use it without verifying the contents or checking the SDS.
Failure to verify chemical identity before use. Unlabeled Chemical!
An incubator located outside the laboratory in a production environment misses several scheduled MSS cleanings. If an auditor asks what risk this creates, the concern is not that contamination definitely occurred, but that _________.
There is no documented evidence that contamination prevention controls were effectively maintained.