For years, EPL Bio Analytical Services has operated in compliance with the Environmental Protection Agency’s Good Laboratory Practice (GLP) standards. Recently, we have gained accreditation to theInternational Organization for Standardization (ISO) General Requirements for the Competence of Testing and Calibration Laboratories (ISO 17025:2005) with additional requirements outlined in the 2010 AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals.What changes did we have to make to meet these requirements, and why should potential customers, including those looking to place GLP work, consider this accreditation when evaluating us as a company?
GLP vs. ISO 17025
Currently in the US, “GLP” is basically a self-certification. A laboratory states that it performed a certain study in compliance with GLP standards and then may be audited after the fact by its customer or the EPA. However, with recent government cutbacks, there are few EPA auditors available to evaluate these studies. Furthermore, each country sets its own GLP standards, which means that a study conducted in compliance with US GLP standards may not meet the requirements to be submitted in Europe. ISO 17025 is an internationally accepted standard that is the same country to country. EPL underwent a rigorous on-site assessment by A2LA (a non-profit company accredited to perform these assessments) to be granted accreditation. To keep our accreditation, we will undergo a biennial on-site assessment with a smaller, off-site review of our procedures in the off years. GLP standards place the emphasis for compliance on an individual study, while ISO 17025 accreditation applies more to processes and methodologies. Whether it is a GLP study of 700 samples or a single sample with no regulatory requirements, our ISO accreditation assures the customer that we have the technical and managerial procedures in place to consistently deliver valid data that will be accepted all over the world.
Because we are a flat company, we were already very focused on improving our processes. We know when a change in efficiency, cost, or turn around time has had an impact because we can see it in the amount of work we get, how quickly we can handle that work, and ultimately in our paychecks! However, ISO 17025 required us to formalize that process. We developed a Corrective and Preventive Action (CAPA) system and database to keep track of our projects. It has really helped us to improve the effectiveness of these projects because it forced us to:
- Perform Root Cause Analysis so that we were treating the cause of the problem rather than the symptoms,
- Break large projects down into smaller, easier-to-tackle action items,
- Make it clear who is responsible for each action item and by when it should be done,
- Keep records of what we did and why we did it that institutional knowledge is not lost when an employee leaves,
- and Monitor changes formally to ensure that the project did what we intended it to do.
This CAPA system is also supported by the rigorous internal auditing we were already doing to comply with GLP standards. Expanded from our Quality Assurance Unit, our Internal Audit Team monitors all methods and processes for adherence, conformance to regulatory/standard requirements, and effectiveness.
When we are continually improving our processes, our customers benefit because we can provide higher and higher quality data in less time at the lowest cost possible!
A Focus on the Customer
ISO 17025 is much more focused on satisfying the customer than the GLP standards. We already work very closely with our customers to ensure that we are meeting their requirements, so many of the ISO requirements were already in place (in fact, it is worrisome to think that there are laboratories out there that do not follow the best business practices outlined in this standard). As with continuous improvement, it was more about formalizing the processes we already had in place. We have begun sending surveys at key points in projects and keeping a log of feedback obtained elsewhere. Any issues or complaints brought up by our customers trigger Corrective Action as described in the system above. Everything we do, from the lab to the office to the boardroom, is for the customer, not for regulatory agencies, and ISO 17025 emphasizes that.
Quality of Results
Although the GLP standards are very specific about how to perform and document a study, they are not as detailed regarding the actual quality of data generated. There are many requirements of ISO 17025 that ensure the quality and consistency of results produced by the lab:
- Training: Initial and ongoing competence must be evaluated prior to authorization of an analyst to begin or continue running a method. Proof of this competence (e.g. results that meet our quality criteria, proficiency testing) is retained in our analysts’ training files
- Method Validation: New methods or significant changes to current methods must meet accuracy and precision criteria prior to use. Other criteria determined by the method or customer may also be taken into account.
- Measurement Uncertainty/Traceability: Measurement uncertainty is the error inherent in any measurement, while traceability is the ability to identify and add up all those errors throughout a method.Because it had not been a requirement of our customers in the past,EPL had to develop a method for estimating the measurement uncertainty for our methods. Also, to provide measurement traceability, we began using only ISO 17025 accredited calibration service providers and reference material producers to support the work on our scope. Our already rigorous equipment calibration, verification, and maintenance schedules also help to ensure our analyses can give the level of measurement uncertainty needed.
Ensuring the Quality of Test Results: Once a method is validated, it is still important to ensure that the individual sample results are accurate and precise:
- Internal QC material: In most analyses a Quality Control sample is evaluated against an internally developed control range to determine set acceptance. This chart also allows us to monitor for biases and stop trends before they start. Internal QC material may also be fortified to determine recovery
- Proficiency Testing: EPL is participating in an increasing number of proficiency testing studies. These studies allow us to compare our results to those of other labs testing the same sample. Proficiency testing is a way to assure the international community that we can get the same number for the same sample as a lab in Japan, Germany, etc.
- Other quality assurance methods: There are many other methods we employ to assure the quality of our results, including analysis of Certified Reference Material, running of check standards, evaluation of reagent blanks, etc.
- Scope of Accreditation: Although our quality management system applies to the entire business,the Scope of Accreditation is the list of the specific methods for which A2LA has accredited EPL. Assessors watched each method in progress or had an analyst walk them through the procedure. They scrutinized equipment maintenance records and reagent supplies. We currently have 27 methods on our Scope of Accreditation, but we will continually to add to it.
Our Commitment to Quality
Besides enrolling in proficiency testing programs and estimating measurement uncertainty, we really didn't have to make any substantial changes in the way that we perform our analyses because we already employ scientific best practices in our work everyday. Changes in processes outside the lab were similarly minor. However,preparing for this accreditation has already made us a better company and it is gratifying to be recognized for the quality we pursue above and beyond the regulations we follow. This external recognition will allow us to serve new areas of the market and should also give our current customers added confidence in the product they receive from us.