Blog: Regulatory

ISO 17025 Documentation within a LIMS Solution using Xybion LIMS - Part 2

Part 2 - Corrective and Preventative Actions (CAPA)

29th November 2016

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ISO/IEC 17025:2005 is used by laboratories to develop their management system for quality, administrative and technical operations. This series of articles examines how a well configured LIMS, such as Xybion LIMS, can make a significant contribution to the fulfillment of ISO 17025 requirements in areas over and above the direct management of data related to sampling, testing and reporting. In Part 1 of the series we looked at how Xybion LIMS can help with the management of documents and this article concentrates on the management of corrective and preventative actions (CAPA).

ISO/IEC 17025 specifies the general requirements for the competence of a laboratory to carry out tests and/or calibrations, including sampling. In defining competence, the standard requires that there are procedures for the resolution of complaints from customers or others, control of nonconforming testing and/or calibration work and for the implementation and monitoring of any corrective or preventative actions required. Sections 4.8, 4.9, 4.10, 4.11 and 4.12 of ISO 17025 cover all of these requirements. The Autoscribe Quality Management Suite for Xybion LIMS features a number of discrete modules that are available individually if required, which help with the systematic storage, traceability and integrity of data. The CAPA module is specifically designed to help with the management of corrective and preventative actions.

  • QMS

CAPA for Laboratory Systems

Laboratories need to be accountable for the analytical results that they produce and this leads back to the procedures and process they have in place. ISO 17025 requires them to have policies to deal with customer complaints, with records being kept not only of these complaints but any subsequent investigations and corrective actions. In addition laboratories will need to have policies to deal with any aspect of non-conformance in testing or calibration even if it is not instigated by a customer complaint. Any changes that are necessary as a result of corrective action investigations must be documented as well as implemented. Since an evaluation of the significance of any nonconforming work needs to be made, recording and date stamping of any associated activities will help with this. In addition, ISO 17025 requires that laboratories should continually aim to improve the effectiveness of their management systems and this can be facilitated through audit results, and the analysis of data associated with corrective and preventive actions. Corrective action is, by definition, a reactive response to a problem. Laboratories are also required to have a preventative action policy, to allow the identification of improvements and potential sources of nonconformities. Any preventative action plans that are developed in this way must also be documented and monitored.

  • CAPA

Using Xybion LIMS for CAPA

The CAPA module for Xybion LIMS allows the recording of issues associated with quality control and auditing related to ISO 17025. Issues and actions can be defined and allocated to appropriate staff for implementation with outcomes stored within the system. Audit outcomes, customer comments and feedback can be logged directly into the module to help to drive continual service improvement. Screens can be configured to reflect the specific workflow requirements of a laboratory which can help with reporting on specific concerns for preventative action. The system allows users to:

  • Reduce the cost and operational risk associated with addressing recurring issues
  • Improve operational performance of the laboratory with standardized processes
  • Decrease the mean time to resolution of issues for the benefit of both internal staff and customers
  • Speed up the reporting and auditing of quality control

In the part 3 of this series, we will look at how Xybion LIMS handles Competency requirements. You can catch up with Part 1 of this series and you can call the experts on +44 118 984 0610 to find out how Xybion LIMS could help your lab meet ISO 17025 requirements. A copy of ISO 17025 can be purchased online at: www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-2:v1:en