Quality Applications
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Quality Assurance:
The development and documentation of a comprehensive quality assurance plan is essential for any testing laboratory. Each laboratory will tailor the plan to meet their own unique circumstances, but must include basic elements such as quality control, personnel training, testing criteria, document control, and proficiency testing. Without a well planned and implemented quality assurance plan, no laboratory will be in a position to support and defend their results. The reliability of data is directly related to the maturity and effectiveness of the generator's quality systems.

LCV can assess the effectiveness of an organization's quality assurance system through use of techniques such as:

bulletOn-site audits, providing a complete assessment of the QA system
bulletPaper audits to assess implementation of specific elements of the QA plan through review of documentation and records associated with particular data sets

 

Forensic evidence:
Unfortunately, there are many recent incidences highlighting the need for attorneys to question the validity of forensic evidence. The O.J. Simpson trial, the Guy Paul Morin case, Fred Zain, and the San Francisco crime laboratory technician fraud are a few examples that easily come to mind. Robert Stevenson1 said that any attorney who does not review forensic evidence is derelict in his or her responsibility to the client.
Even if your data comes from an accredited or certified laboratory, an independent assessment of the underlying quality systems should be performed. Do not believe that accreditation or certification means reliable data and no mistakes.

LCV's experience in the field can be utilized to assess the defensibility of Forensic evidence in the following ways:

bulletInvestigation of particular data sets to determine if records indicate and support specific conclusions
bulletPaper review of the QA system
bulletTechnical assessment of procedures for both adequacy and effective implementation
bulletOn-site audits of facilities to provide an overall evaluation of the quality system and procedure implementation

 

Environmental data:
The laboratory says that no PCBs are present in your sample;  can you rely on this result? Does it mean that no PCBs were there, or that the laboratory could not detect what was there? Without verifying and validating the data, this is impossible to determine. Reviewing the laboratory's records and documentation will provide you with the information needed to make an informed determination regarding the data's reliability and accuracy. Whether you are concerned with VOCs, metals, SVOC, chromatography, mass spectrometry, or any type of analytical data, an investigation into how the data was generated is essential.

LCV can appraise environmental results by:

bulletVerification and validation of data including assessment of supporting documentation
bulletOn-site audit of the testing facility to provide an overview of quality system effectiveness and implementation
bulletTechnical assessment of measuring and test equipment (M&TE), e.g. analytical instrument calibration and maintenance, calibration of support equipment, and suitability of standards and reference materials

 

Manufactured products:
It is possible to verify, through review of manufacturing records, if a product was produced in accordance with internal, external, or regulatory requirements. An audit of manufacturing records can provide valuable information about product quality and how the manufacturer's quality system is working.
Firestone's recent troubles have highlighted just how vital robust and fully implemented quality assurance and quality control systems are to producing acceptable products.

LCV can assist in the manufacturing sector by:

bulletReview of manufacturing records to determine compliance with contractual/regulatory requirements
bulletOn-site or paper audit of the quality system to assess the effectiveness of design and implementation
bulletReview of non-compliance procedures and records to identify potential manufacturing defects
bulletVendor quality audits to qualify potential materials suppliers

 

Analytical data:
Any type of data, whether from a paint factory, dairy, drug manufacturing facility, or contact lens manufacturer, should be generated in accordance with regulatory, GMPs, GLPs, ISO or other requirements. These requirements will flow down directly into the organization's policies, procedures, and practices; these will be defined in a Quality Assurance Plan (QAP), Standard Operating Procedures (SOPs), Work Instructions  and other similar documents (specific names of these documents will vary between organizations but their purpose and function will not). These documents will define what analytical protocols should be followed and what records should be generated during execution of the analytical/manufacturing process. 
Complete records and documentation (QAP, SOPs, runlogs, calibration records etc.), available from the data generator, will enable a knowledgeable reviewer to reconstruct the manufacturing/analytical process for the sample(s) of concern. Data that cannot be supported by the required records and documentation are always open to question. 

LCV's extensive laboratory experience can be applied to the assessment of analytical data and an evaluation of the laboratory's ability to produce data of the required quality:

bulletReview of QA system documentation (QAPs, SOPs, work instructions, etc.) to determine completeness, adequacy and effectiveness
bulletOn-site or paper audit of data and records generated during analysis for traceability and completeness
bulletDetailed review of specific elements of the QA system, e.g. calibration system or document control system

References:
1. "Crisis in forensic science: Fallout in the courts and society", Robert Stevenson, American Environmental Laboratory, volume 10, number 2.

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