Quality Assurance Program (QA Program)

The QA Program that is implemented in the laboratory ensures our clients that they will receive reliable and legally justifiable data in a timely fashion. Our staff is dedicated in meeting these requirements.

Our quality policies and practices, which are applied consistently across the entire organization, are continuously evaluated against regulatory bodies, both nationally and internationally, and client standards. We endeavor to maintain our high quality of standards while constantly striving to improve operations through the spirit of innovation and new technology.

Our quality system, an integral component of our QA program, is the application of key quality systems such as:

• Regular scheduled internal audits of documentation practices, analyst training, safety systems and other critical activities.
• Multi-tiered review of all data and reports that includes verification of accuracy (QC), management review for scientific integrity, and QA review to confirm corporate and regulatory compliance

All these elements of our Quality System are clearly documented in our Quality Assurance Manual and are utilized by all our employees. Standard Operating Procedures for all tests and measuring activities are developed in accordance with guidelines set forth in our Quality Assurance Manual.

The laboratory obtained accreditation in accordance to ISO 17025 from SANAS (South African National Accreditation System) in May 2009. The schedule of the laboratory is available from the SANAS website: http://www.sanas.co.za/ or as PDF document. The SANAS accreditation number for the laboratory is: T0410

Survey

As required by our quality assurance program and ISO 17025 accreditation we constantly evaluate the service rendered by the laboratory.

Please complete the annual survey as this will aid us in our commitment of continuous improvement and help us to serve you better.

Proficiency Testing (PT)

Participation in a proficiency testing scheme (PT) is used by the management of the laboratory as one of the tools to evaluate the performance of the laboratory against pre-established criteria by means of inter-laboratory comparisons.   It is also a requirement of accreditation to ISO/IEC 17025 that the laboratory takes part in a PT scheme, if a suitable scheme exists.  Together with the use of validated methods and internal quality control, proficiency testing is an essential element of laboratory quality assurance.

The analysis of external quality check samples as part of the laboratory’s routine procedures provides objective standards for the laboratory to perform against and permits us to compare our analytical results with those from other laboratories. In summary, PT is a way of checking the accuracy of results.

The laboratory routinely participates in the FAPAS proficiency testing scheme hosted by FERA, the Food and Environment Research Agency, an Executive agency of the UK government Department for Environment, Food and Rural Affairs (Defra).

FAPAS PT favours the use of z-scores because the standard deviation is based on a fit-for-purpose criterion, i.e. it is a prescribed ‘standard deviation for proficiency’, then the significance or the performance assessment is immediately apparent, no matter what the concentration or identity of the analyte, the nature of the test material or the physical principle underlying the analytical measurement. By assessing a participant’s performance by way of a z-score, both the trueness and the precision of the result is addressed.

How to interpret z-scores:

The guiding principle of scoring in FAPAS PT is fitness-for-purpose.  This means that the standard of accuracy required is based on an uncertainty that is independently determined to be appropriate for the analysis in question.  Performance in a FAPAS PT, therefore, is considered fit-for-purpose if a z-score lies within the range ±2. It follows that an exactly-conforming participant’s z-sores will fall outside this range with a probability of 1 in 20. Occasional scores in the range 2<|z|<3 may therefore be of no importance. Such z-scores require consideration and appropriate action, in the context of the other scores obtained by that laboratory. However, the probability of a conforming participant’s z-score falling outside |z| > 3 is less than about of 1 in 300. Given this rarity, such scores therefore represent results that are probably not fit-for-purpose and are used to trigger action and remedial action.