Laboratory Audits and Oversight
AQA maintains a staff of Department of Energy Consolidated Audit Program (DOECAP) certified auditors, including a certified lead auditor. Our audit
personnel also include a certified NELAC Lead Assessor and a Department of Defense Environmental Laboratory Accreditation Program (DoD ELAP) Lead
Auditor. AQA's chemists are experienced in all aspects of laboratory operations and are well qualified to conduct all of the audits and assessments discussed below.
Audits of analytical chemistry laboratories are formal processes for evaluating compliance with contract specifications, regulatory requirements, and
industry-standard practices. Quality system audits cover a laboratory’s quality assurance practices and are generally performed using commonly accepted
guidelines such as those given in ISO 17025 and NELAC Chapter 5. Supplier quality audits specifically target laboratory practices as they relate to the
technical specifications of the client’s statement of work and the applicable analytical methods. AQA often combines quality system and supplier quality
audits into a single visit to the laboratory site.
If data defensibility is of particular concern to a client, AQA will also perform data package assessments during visits to the laboratory site. Data
package assessments are a formal process for evaluating laboratory performance, including compliance with quality control, quality assurance, record keeping,
and data reporting requirements, as reflected in actual practice for particular laboratory deliverables.
When client resources or the scope of services is limited, AQA can also perform desk audits that are specifically tailored to the client’s particular
needs or concerns without actually visiting the laboratory.
AQA often oversees or mediates in the corrective action process on our clients' behalf. This can become necessary following an audit, when an issue
is particularly complex or crucially important to a client's program, or when the initial response from a laboratory does not adequately address the client's
concerns. We apply the expertise of our auditors and subject matter experts to ensure the efficacy of corrective actions and track those corrective actions
to closure. AQA verifies corrective action implementation as part of an audit program or by a variety of other means.
In the course of data validation, AQA routinely requests corrective action for missing or erroneous information associated with individual data packages.
Corrective action requests will be issued either directly to the laboratory or to the client, depending upon client protocols, by the AQA project manager.
All data package corrective action requests, including the laboratory's response times, are documented in our data validation tracking systems.
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