The last check before test results reach a client is the approval stage. Where test results are formally reported on a certificate of analysis, approval is authenticated by signature. So, what does that signature mean? And what should Lab Managers review before they sign the dotted line?In this blog, we describe 4 key areas Lab Managers should review.
When you are testing product to specification, it is imperative to check that the results are within limits. In addition to this, you will want to check that the correct specification is applied to the test results by referencing client or product files. Where you have a LIMS system that readily stores this information, checking results against specification can be quick and easy – especially if your LIMS is validated. Some laboratories also like to monitor warning limits which may help identify results which may be out of trend and require further investigation before reporting the final results to the client.
When results are outside specification, an investigation would be triggered to effectively identify the root cause of the failure. When reviewing the test results, it is good practice to review the investigation documentation. This may include an analysis of previous test data and failures to identify patterns. You will want to ensure that the investigation has been thoroughly conducted, appropriate corrective actions have been raised, and that the investigation has been satisfactorily closed. If you have a LIMS system, you may have the functionality to flag samples that have investigations and link your quality documentation for organised data storage and retrieval.
Audit trails are an important part of the sample analysis process. If you are working in a regulated industry such as pharma, the audit trail requires review before approval and reporting of test results. The audit trail details who did what and when, and if any changes were made outside the routine process, a reason for these changes should also be detailed in the audit trail. For laboratories who operate a LIMS system, the audit trail will be easily retrievable for review as most actions of the sample analysis process will be electronically documented with the system. Reviewing the audit trail before approval of results allows the Lab Manager to check for anomalies or abuse of access to the system to ensure data integrity is maintained.
It is so important to ensure that errors have not been made in the reporting of test results. In quality control, product is tested to ensure that it is safe and effective for consumers to use, and if errors such as transcription or typographical errors are reported, this poses a risk to the release of non-compliant product to the market. Therefore, when reviewing the test results, it is important to ensure that the results have been accurately recorded and transcribed onto the report, and that in comparison with the specification, you are reporting reliable test data to your client. Additional information that appears on the certificate should also be checked for accuracy such as batch number, specification reference numbers and supplementary batch information.