Why Should We Audit?
AUDITING GAS ANALYSIS LABS
Carl Alleman SPL
The data produced by Gas Chromatograph (GC) laboratories is used for many purposes, including product specification, accounting, safety and environmental compliance issues. The accuracy of this data has direct impact on all of these areas. Auditing laboratories responsible for producing this data is prudent business practice. The audit will provide a means of process improvement, through proper identification of deficiencies and a precise plan for corrective action. The level of confidence in analytical results will increase when the appropriate corrective actions are implemented. The amount of financial and legal exposure can be reduced from a properly executed audit program.
When Should We Audit?
Audits should be performed on a scheduled frequency, typically once a year for laboratories, and quarterly or semi-annually for online analyzers. If a discrepancy arises, or there is concern about the accuracy of analytical data, an audit should be performed. If there has been a change in personnel or equipment an audit may be warranted. After corrective action has been taken, an audit may be performed to determine the level of improvement.
What Should We Audit?
Many audits are performance evaluations that can disrupt the routine procedures of the laboratory being audited. That is, the sample container is not remotely similar to sample containers routinely handled by the laboratory. As a result, the day-to-day sample handling process is not followed explicitly. The data is not handled in the same manner as normal workload samples. The laboratory technicians’ daily routine is disrupted. These audit results demonstrate how the lab can perform when required to modify its process to accommodate the audit sample and auditor, but fail to accomplish the real objectives of the audit.
The ideal audit will examine the entire process from receipt of samples to reporting and cylinder cleaning. Not only does the performance need to be evaluated, but also the entire analytical process. Policies and procedures should be scrutinized to confirm contractual compliance and good laboratory practices are in place. Review of documentation such as Standard Operating Procedures (SOP’s), Quality Assurance/Quality Control (QA/QC) manuals, industry standards manuals and maintenance and QA/QC records will give insight into the laboratories commitment to produce accurate data.
