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The Quality Assurance program is described in a separate Quality Assurance Manual . In 1994 our program evolved to comply with EPA and FDA Good Laboratory Practices (GLP) and FDA Good Manufacturing Practices (GMP). As a result, Quality Assurance (QA) and Quality Control (QC) became separate programs. A Quality Assurance Unit (QAU) was created and is headed by a Quality Assurance Officer (QAO). QC remained the responsibility of the individual analytical groups, and our SOP's were greatly expanded. QC consists of specific steps taken by analysts to measure precision and accuracy, i.e.: the analysis of duplicate and spiked samples, blanks, reference samples, etc. QA is now an independent monitor of the QC program. QA audits are performed by the QAU.Quality Assurance, FDA cGMP

Quality Control

The Quality Control program consists of both internal and external checks on precision and accuracy of analytical results. Below is an outline of the our policies:

  1. Method Blanks are analyzed with each batch of twenty or fewer samples to document lack of laboratory contamination during analysis.
  2. Multilevel calibrations covering the analytical linear range are performed to increase accuracy of results.
  3. Duplicate and spike samples are analyzed every twenty or fewer samples.
  4. Relative Percent Differences (RPD) and Spike Recoveries obtained from the Duplicate and Spike analyses are stored in a QC database, and the standard deviations are computed from past data. Any outliers (95% Confidence Limits) are flagged, the cause determined, and the analysis repeated if necessary.
  5. A Laboratory Control Standard (LCS) of known composition is analyzed to certify the accuracy of the analytical techniques being used. These standards are generally NIST Standard Reference Materials.
  6. Surrogates are spiked into samples to monitor extraction efficiency and the stability of analytical conditions throughout the workday. Records of past analyses determine the range of acceptable surrogate recoveries, any outlying samples are reanalyzed.
  7. We participate in several Proficiency Evaluation testing programs to demonstrate our laboratory's high quality performance
  8. All data and results are reviewed by senior chemists to assure our clients of Reliable Results.
  9. Original hardcopy Analytical Data, i.e.; chromatograms and worksheets, are easily accessible by laboratory personnel.
  10. A full time Quality Assurance Unit performs internal audits.

Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP)

While GLP and cGMP regulations under FDA and EPA refer to specific regulated activities in support of the development of drugs or pesticides, we follow many of the practices as standard procedures and is capable of full compliance for the regulated programs when necessary. Under GLP, QC refers to steps taken by the analysts to insure and monitor precision and accuracy. QA is a completely separate and independent monitor of the study and QC activities. We provide completely separate and independent QC and QA functions according to the GLP regulations. The QAM provides a brief description of both.

Another product of compliance with GLP is an expanded set of Standard Operating Procedures (SOPs). Our SOPs now cover many functions previously included less formally in manuals. New SOPs have been 

 Quality Assurance, FDA cGMP

 

 

 

 

 

 

 

 

 

added dealing with the organization and facilities, metrology, safety, complaint resolution, data management, GLP, and instrument operation maintenance, as well as many more analytical method SOPs.

We are FDA Audited, and cGMP & GLP Compliant

Standard Operating Procedures (SOP)

Routine methods are documented in the WCAS Standard Operating Procedures (SOP) Manual. These SOPs are what 

our chemists follow to assure consistency of procedures from sample to sample. SOPs are revised periodically as needed and a summary of changes as well as the revision dates are documented in the preface to each SOP.

Complaint Resolution

Anytime a serious complaint is received, it is logged for a permanent record, tracked to insure resolution, and brought to the attention of senior managers. A serious complaint is one that questions the validity of our results or any complaint about service from a customer. SOP #190 addresses the 

steps taken to resolve the complaint. In general, the nature of the complaint is documented on a form, given to the President, Lab Director, or Technical Director, assigned to someone for resolution, tracked and discussed during weekly staff meetings, final client comments recorded after resolution, and signed by a second senior manager. A permanent record is kept by the Lab Director.
For more information......

Exova

9240 Santa Fe Springs Rd
Santa Fe Springs, CA 90670

info400@exova.com

562.948.2225 Fax 562.948.5850

Exova

Formerly West Coast Analytical Service (WCAS) and Bodycote Testing Group