The 4.2 Protocol is a unique and efficient method for
assessing the performance of forensic science laboratories.
At a time when international accreditation for forensic testing laboratories was in its infancy, John Collins became only the fourth director in the United States to successfully lead a full-service forensic science organization (DuPage County, Illinois) to its first international accreditation. Six years later, as Director of the Michigan State Police Forensic Science Division (2010 - 2012) - one of the largest forensic science organizations in the U.S., he and his team led MSP's 7 laboratories to their first international accreditation. Collins has inspected several laboratories in the United States and two overseas.
The Forensic Foundations Group designed and developed two trademarked protocols for assessing the management systems of forensic science laboratories more efficiently and inexpensively. At the heart of our approach is our unique application of the ISO/IEC 17025 standard that tailors the assessment more appropriately for forensic science laboratories. ISO/IEC 17025 is not a forensic science standard and must be amplified with supplemental requirements before it can be properly used to evaluate management and technical operations within a forensic science laboratory. But even with supplemental requirements, the ISO/IEC 17025 standard can be applied more effectively when its many requirements are evaluated in a particular sequence. The name of our system is The 4.2 Protocol, for which there are two types. The are explained on the right side of this page.
About the 4.2 Protocol
Our 4.2 Protocol is named after section 4.2 of the ISO/IEC 17025 standard, which requires laboratories to "establish, implement, and maintain a management system appropriate to the scope of its activities." It is common for laboratory administrators to gloss over this simple statement while familiarizing themselves with the standard but, in fact, it is the foundation upon which the entire standard is built. Consequently, it is the management system of a laboratory that predicts how well and how comprehensively a laboratory will conform to all requirements in an international accreditation program. If one was to compare the ISO/IEC 17025 standard to a radio, section 4.2 would be the tuning dial.
Essentially, our assessment protocol begins and ends with the 4.2 requirements and evaluates the performance of the laboratory's management system in governing the entirety of its operations. There are two variations of our protocol:
Preparatory Accreditation Assessment (PAA)
The purpose of this assessment is to evaluate the management system of the laboratory and its conformance to a large number of management and technical requirements. Most of the assessment is done off-site with the cooperation of the laboratory's administration, but a brief onsite visit is generally included. Using this protocol, an assessor will use a specially designed assessment instrument that applies the requirements of the ISO/IEC 17025 standard in a particular sequence. Although technical experts are not used to assess individual units or disciplines (this can be accommodated at the request of the laboratory), our protocol involves leaders from each unit to identify areas requiring increased focus. At the end of the assessment, the laboratory receives a confidential report in which "recommended levels of focus" are identified and numerically rated. This report may describe findings with some specificity, but they are not scored.
Integrated Organizational Assessment (IOA)
The Integrated Organizational Assessment if a very comprehensive review of a forensic science laboratory to evaluate its conformance to the ISO/IEC 17025 standard with the integration of a special Human Resource Management audit. While the Preparatory Accreditation Assessment evaluates the laboratory's conformance to international requirements, the Integrated Organizational Assessment utilizes our own 4.2 Protocol to:
- evaluate conformance with accreditation standards
- evaluate the overall stability of the organization
- rate the effectiveness of the laboratory's human resource management system