Quality Assurance / Quality Control Procedures

Kalassay's Quality Control Procedures are integral to every process of our operations.
These procedures are laid down in our laboratory quality systems and are integrated into our Laboratory Information Management System (LIMS).
These procedures have been based on the requirements of ISO17025 and Kalassay is currently pursuing accreditation to this standard.

Our laboratories use a barcoding system, which is integrated with our LIMS.
The barcode allows our laboratory management to track each sample, through every stage of the analytical process.
It also eliminates a number of possible errors and provides a digital audit trail, should one be neccesary.

Our Quality Control and Quality Assurance procedures apply to every stage, of every sample analysis we perform, at every laboratory we manage.
Quality is not an option, it's an integral part of everything we do.

Sample Preparation

Sample preparation is critical to accurate and reproducible analyses.

To check on Sample Preparation performance, every 50th sample prepared, is analysed. A sub-sample from the pulverised retain is particle-sized and compared to our standard specification of 90% passing a 75 micron test screen. The percentage passing 75 microns is recorded and optionally reported with the other assays, or provided as part of our quality reporting procedure in graphic form.

Analysis

The complexity of modern analytical methods require an equally sophisticated quality management regime. Each analytical method has its own set of performance parameters and Q.A. / Q.C. procedures.

Some of the Q.A. / Q.C. procedures employed are:-

• Duplicate and Blank samples are automatically inserted in each batch of samples, in every job that are processed through our laboratories.
  
• Standards are automatically inserted in each batch of samples, in every job that are processed through our laboratories.
  
• Standards are selected where possible, to suit the element suite required, the expected range of element concentrations, and the expected matrix of the samples. The standards used include commercially available standards, internationally-recognised Certified Reference Materials (CRMs) and sometimes a standard produced internally by us to match a clients particular sample matrix (only after careful evaluation and analytical validation, including submission to other refernce agencies).
  
• Where possible, standards are rotated within a job to cover low, medium and high range values for the elements being analysed. In-house standard preparation and analytical data collection and interpretation is co-ordinated by the Quality Control Officer/ Lab Manager, and Chief Chemist
  
• All result monitoring (both samples and standards) is handled by the Laboratory Information Management System under the control of the Laboratory Manager. Data is automatically collected and this QC history for each job processed, forms the basis of graphical and statistical reporting to the client.
• The reporting of all Q.C. / Q.A. data is included in the prices quoted.

Action Outcomes

Standards and any random duplicate results outside the accepted range or variance, prompt staff to instigate a series of check procedures including:

• Examination of raw data and any processing calculations.
  
• Closer scrutiny of all other standards, duplicates and repeats within the job.
  
• Scrutiny of values obtained for other elements in that standard or sample in that job.
  
• Re-analysis of all solutions for the element in question.
  
• Checking and re-calibration of all equipment, and all chemicals, used during the analytical process.
  

This process may require additional steps to be taken, such as additional re-assays within the batch containing the variant analysis. This investigative work (which is done at no extra cost) may involve a delay in reporting results, however our focus is to report the best quality data to you.

In all cases, it is our company policy to report all data if no direct flaw is discovered in the analytical procedure leading to a variance greater than the normally acceptable level.

If you require further information on our quality control systems, or the accuracy and precision of our analytical services, please contact your nearest Kalassay laboratory manager.