Achieving and maintaining accreditation is critical to forensic laboratories. There are numerous examples in the media of what happens when the quality of work is compromised. A forensic lab could not only lose its certification, but innocent people could be imprisoned, or guilty people may be set free only to commit new offenses.
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Without government financing, a crime laboratory might not be able to carry out its obligations to the community it serves, and accreditation is also linked to funding from that source.
Forensic labs face a high level of scrutiny and must work diligently to maintain quality standards and accreditation. When it was recently discovered that a firearms examiner incorrectly linked cartridge casings from two deaths in 2015 to the same pistol — and then misrepresented the error — the director of the that laboratory resigned.
The most recent revision to ISO 17025, which was initially released in 1999, describes the fundamental standards for the proficiency of testing and calibration laboratories.
Even while some of these standards, including the creation and implementation of policies and procedures, have nothing to do with the adoption of software, the correct LIMS can be a huge help in ensuring compliance with ISO 17025:2017.
A LIMS that has extensive quality management functionality is a much better option than the stand-alone quality-management systems that are currently available. The ideal version of such a system would support each of the following:
Document control
Documents like training manuals and standard operating procedures should be able to be stored by a LIMS for forensic purposes. This must allow for the routing of new documents (or new revisions) through a review and approval procedure. Stakeholders should ideally be informed of the revised version and given the opportunity to acknowledge receipt.
Documents should have a designated owner since they are living entities. To prevent procedural noncompliance, the owner should be made aware of impending expiration dates.
Purchasing services and supplies
Furthermore, the LIMS needs to be capable of tracking information about received consumables, such as lot numbers and expiration dates. Recipes stored in the LIMS make it easier to properly make reagents.The system should keep track of both the lot number of the developed material and its components when materials are produced internally.
This ability offers a number of important advantages.
- Audit results can be mitigated by not using expired materials
- When conducting root cause analysis, looking for instances where specific lot numbers were involved in the primary material or component can be quite helpful
- It is possible to avoid testing delays caused by a lack of essential testing components by giving notice when supplies are running low
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Process improvement
Every good laboratory strives to improve its processes. An auditing laboratory can use internal and external audits to find issues before they have a negative impact on casework.
The lab should be capable of:
- Establishing a procedure for the action plan’s approval
- Planning and keeping track of continuous monitoring needs
- Tracking nonconformance by recording the root cause
Since not every occurrence is serious enough to warrant a Corrective Action Report, the capacity to track smaller instances is essential.
Personnel
Analyst training programs, seminars, and proficiency testing documentation are crucial for demonstrating to courts and the general public the competence of those who carry out this crucial work. Additionally, analysts ought to be certified in the tools and procedures they employ.
Equipment
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The equipment must be effective. This includes keeping track of maintenance tasks and any repairs, setting up standards for verification, and having the option to shut down equipment when validation or performance checks are unsuccessful.
If a problem is identified, it is important to understand what samples were examined on a specific piece of equipment, just like with consumables.
Reporting and review
Analysts produce a report of their results at the end of testing. The LIMS should provide a flexible reporting framework with as much automation as possible. Some reports might only need one level of review, while others might need several.
About LabVantage Solutions
LabVantage Solutions, Inc. is the leading global laboratory informatics provider. Our industry-leading LIMS platform, including ELN, LES, and SDMS, and world-class services are the result of nearly 40 years of experience in laboratory informatics. LabVantage offers a comprehensive portfolio of products and services that enable companies to innovate faster in the R&D cycle, improve manufactured product quality, achieve accurate recordkeeping and data integrity, and comply with regulatory requirements.
LabVantage is a highly configurable, web-based LIMS platform that powers hundreds of laboratories globally, large and small. Built on a platform that is widely recognized as the best in the industry, LabVantage can support hundreds of concurrent users as well as interface with instruments and other enterprise systems. It is the best choice for industries ranging from pharmaceuticals and consumer goods to molecular diagnostics and bio banking. LabVantage domain experts advise customers on best practices and maximize their ROIs by optimizing LIMS implementation with a rapid and successful deployment.
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