Technical records: How much information is sufficient?

Arlene Fox

in Inside Laboratory Management – AOAC International – November / December 2009 – Page 8.

- Introduction

ISO 17025 and GLP require maintaining adequate technical records. But what needs to be recorded?  Section 4.13.2.1. of  ISO 17025 requires that: “The laboratory shall retain records of original observations, derived data, and sufficient information to establish an audit trail”.

The records is a tool: “to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original”.

- Laboratory sampling receipt

An unique identification label is necessary so that analysis of that sample can be tracked throughout the analytical process.

- Chain of custody

It is important to record a chain of custody from the time a laboratory takes responsibility for a sample until the results are reported to the customer. This is expecially important for GPL ad forensic analyses.

- Sample storage conditions

If the sample is stored at not the proper temperature, the analysis will not be valid. Therefore additional records are required for refrigerator or freezer where the sample is stored before analysis.

- Sample preparation and adopted analytical method

Records should show who performed the analysis, what equipment was used, which method was used.

- Staff training

The training records should show that the analyst is authorized to perform the analysis.

AOAC International Guidelines – ALACC Guidelines says: “Records shall include verification that the effectiveness of the training action has been evaluated”.

“Laboratory Management shall retain records that demonstrate that each individual has the required knowledge, skills, and abilities to adequately perform their assigned tasks”.

- Maintenance and Calibration of instrumentation

Calibration records not only include an account that this step has been performed, but must show that it was performed properly and by an accredited calibration provider or properly trained in-house staff.

- Handling Errors

When original data is corrected, it must never be erased or made illegible. ISO/ IEC 17025:2005 requires that: “it be crossed out with the corrected value entered next to the original and signed or initialed  by the person making the correction”.

- Retaining records

ALAAC Guide Lines says: “Record retention policies shall be consistent  with the customer’s requirements and the requirements of the laboratory”.

FDA  requests that records should be retained until 2 years after FDA approval or 5 years after FDA submissions.

- Conclusions

Maintaining adequate data is important in establishing an audit trail. By reviewing these records, it is possible to recreate what happened in the laboratory.