Achieving and maintaining accreditation is critical to forensic laboratories. The media is full of examples of what happens when quality work is compromised. Not only can a forensic lab lose accreditation, but innocent people might go to jail or guilty individuals may be released only to offend again.
Accreditation is also tied to federal funding, without which a crime laboratory may not be able to fulfill its responsibilities to the community it serves.
Losing accreditation is a very real risk to forensic labs. In 2019, the Director of DC’s Department of Forensic Sciences resigned when the District’s crime lab lost accreditation following an audit which revealed the lab had wrongly connected cartridge casings from two 2015 killings to the same gun – and then misrepresented the mistake.
ISO 17025, first published in 1999 and most recently updated in 2017, details the general requirements for the competence of testing and calibration laboratories. While some of these requirements, such as the development and enforcement of policies and procedures, are unrelated to software implementation, the right LIMS can be a great asset to assist with ISO 17025:2017 compliance.
Although stand-alone quality-management systems are available, a LIMS that includes comprehensive quality management functionality is a far better solution. Such a system should ideally include support for each of the following:
A LIMS for forensic applications should provide the ability to store documents, such as standard operating procedures and training manuals. This should include the ability to route new documents (or new versions) through a review and approval process. Ideally, stakeholders should be notified — and be able to acknowledge receipt — of the new version.
Since documents are a living entity, they should have an assigned owner. That owner should be notified of upcoming expiration dates to avoid procedural noncompliance.
Purchasing Services and Supplies
The LIMS must also be able to track the details of consumable materials received, including lot numbers and expiration dates. When materials are created in-house, the system should track the lot number of the created material as well as all components. Creating materials in-house should be facilitated by storing recipes in the LIMS.
This capability provides several significant benefits:
- Searching for cases in which specific lot numbers were involved (primary material or component) can be a huge advantage when conducting root cause analyses.
- Providing notification for reordering supplies that run low can prevent delays in testing due to a lack of key testing components.
- Preventing the use of expired materials can mitigate audit findings.
Process improvement is a hallmark of any good laboratory. Internal and external auditing can help a laboratory discover problems before casework is negatively affected.
Your lab should have the ability to:
- track non-conforming work by documenting root cause
- create an approval process for the plan of action.
- schedule and track ongoing monitoring requirements.
The ability to track minor incidents is key because not all incidents are serious enough to generate a Corrective Action Report.
Documenting analyst training programs, courses, and proficiency testing is important for assuring courts and the public of the competency of the people who perform this critical work. Analysts should also be certified on the equipment and processes used in their analyses.
Equipment must be fit for use. This means tracking maintenance activities and any repairs, establishing verification standards, and the ability to take equipment offline when validation or performance checks fail. As with consumables, it’s important to know what samples were analyzed on a given piece of equipment in case a problem is identified.
Reporting and Review
At the conclusion of testing, analysts generate a report of their findings. Your LIMS should provide a flexible reporting structure with as much automation as possible. Sometimes a report may require one level of review while others demand multiple levels. In another example, watermarks on draft versions of reports can help prevent unapproved reports from being released from the laboratory.
For a detailed analysis of how LabVantage can help you meet ISO 17025:2017 requirements, download our free ISO 17025:2017 position paper. In addition, stay tuned for more forensic posts and updates, plus details of when a new off-the-shelf forensics accelerator will be available.