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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:
 | On-site audits, providing a complete
assessment of the QA system |
 | Paper 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:
 | Investigation of particular data sets to
determine if records indicate and support specific conclusions |
 | Paper review of the QA system |
 | Technical assessment of procedures for both
adequacy and effective implementation |
 | On-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:
 | Verification and validation of data including
assessment of supporting documentation |
 | On-site audit of the testing facility to
provide an overview of quality system effectiveness and implementation |
 | Technical 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:
 | Review of manufacturing records to determine compliance
with contractual/regulatory requirements |
 | On-site or paper audit of the quality system
to assess the effectiveness of design and implementation |
 | Review of non-compliance procedures and
records to identify potential manufacturing defects |
 | Vendor 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:
 | Review of QA system documentation (QAPs, SOPs,
work instructions, etc.) to determine completeness, adequacy and
effectiveness |
 | On-site or paper audit of data and records
generated during analysis for traceability and completeness |
 | Detailed 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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