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Depending
upon the importance of the laboratory testing and scientific research performed by a contract laboratory,
your company may have requirements to qualify or audit it's contract
laboratories. Many large companies have internal quality policies requiring the qualification or certification
of laboratory vendors. For some of these companies, qualification
of vendors is part of Laboratory requirements or ceritifications
such as ISO.
If
your company requires laboratory auditing as part of it's qualification or
quality policy, identifying the laboratory auditors and developing a well-defined
laboratory Audit Plan should be some of the first tasks. In selecting laboratory auditors,
ensure that all members of the laboratory audit team are experienced and knowledgeable.
Laboratory Auditors should have the proper education, experience and training in auditing as well
as in the scientific disciplines, technologies, regulations, industry standards, and methods
they will be evaluating. Some aspects that this laboratory Audit Plan could address
are the audit purpose, identification of laboratory auditors, responsibilities, scope, objectives,
requirements, and criteria for the laboratory audit. Once the laboratory audit plan is
in approved, a laboratory audit schedule and laboratory audit checklist could be developed
for each laboratory auditor.
When
arriving for the laboratory audit, it's a good idea to review the laboratory audit plan
and laboratory audit schedule with the contract laboratory. Once the laboratory audit has
been completed, it's important to discuss all laboratory audit deficiencies and areas
of concern with the contract laboratory. Some areas to consider when auditing
contract laboratories are:
| - Evaluate the laboratory's Laboratory history and financial stability. If your company has a laboratory vendor qualification program that requires compliance with certain government agencies such as the FDA, GLP, GMP, DEA, or state governments, ensure that the laboratory is in compliance. If available, review past laboratory inspections reports. |
| - Evaluate the laboratory's accreditations, registrations, licenses, and certifications. Ensure the laboratory accreditations, registrations, licenses and certifications are current and genuine. If you are uncertain, contact the accrediting, registering, licensing, or certifying body. If your company has a laboratory vendor qualification program that requires certain laboratory accreditations, licenses, or such as A2LA, CLIA, ISO, UKAS, or NVLAP, ensure that the laboratory has them. |
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Evaluate whether the laboratory has an active laboratory quality assurance program
in place? Review the laboratory quality manual, laboratory quality policies and laboratory quality procedures. |
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Evaluate whether the laboratory is following all contractual
commitments made with your company ? |
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Evaluate the Laboratory Standard Operating Procedures and assess whether the laboratory is followingthe Laboratory Standard Operating Procedures ? |
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Evaluate the adequacy of the Laboratory Standard Operating Procedures ? Do these meet Laboratory
requirements or your firm's standards? |
| - Evaluate the laboratory's test sample handling procedures? Are the incoming laboratory samples properly identified and stored to prevent laboratory sample mix-ups and to maintain the integrity of the laboratory test samples ? |
| Could deficiencies or lack of organization lead to physical or microbial contamination of laboratory samples or laboratory sample mix-up? |
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Evaluate the laboratory's cleanliness and organization? Could deficiencies or lack of organization lead to physical or microbial contamination of laboratory samples, laboratory sample mix-up or loss of integrity of the laboratory testing samples ? |
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Evaluate the experience and knowledge of the laboratory management and laboratory staff
? Is there on-going laboratory training and continuing education ? |
| -
Evaluate the laboratory's handling of laboratory test samples? Look for routes
of physical and microbial contamination, laboratory sample mix-ups or improper storage of laboratory samples |
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Evaluate the laboratory instrumentation and laboratory equipment ? Is the laboratory instrumentation and laboratory equipment adequately used, qualified,
validated, maintained and calibrated? |
| -
Evaluate the laboratory's performance of laboratory testing? Is the laboratory
properly validating any laboratory testing methods and correctly performing the laboratory testing, analysis, experimentation or research ? |
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Evaluate the laboratory's handling of any out of specification
results ( OOS ) and any laboratory investigations. |
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Review any noted deficienciesfound during the laboratory audit with the laboratory management. |
| -
Evaluate the deficiencies found during the laboratory audit and determine whether the laboratory
is an acceptable vendor. |
| Or outsource other Contract Laboratories to perform other research, testing, experiments, surveys, certifications, analysis, assays, inspections, investigations, engineering, product design, evaluations, imaging, examinations, reverse engineering, sampling, monitoring, or studies in such areas as: |
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