New Requirements Create Compliance Challenges for California Labs
By on July 20, 2020
Do you work for a water or wastewater testing lab in California? If so, grab your pen and paper because there are changes you need to make note of. Even if you’re not in California, you need to pay attention because this change is likely to affect you in the future.
On May 5, 2020 the State Water Resources Control Board adopted new regulations to revamp the Environmental Laboratory Accreditation Program (ELAP). This new regulation will affect the over 650 laboratories overseen by ELAP, which regulates testing of drinking water, wastewater discharges and hazardous waste clean up sites throughout the state of California.
So, what’s the news?
In a nutshell, your lab is now required to implement a nationally accepted standard called the 2016 NELAC Institute (TNI) Standard. The TNI standard is based on the ISO/IEC 17025 standard and is used to manage all factors that can potentially affect the quality of lab results- like quality of supplies, equipment, and training of laboratory staff.
In the big picture, this is great news because the new standard benefits everyone in California! Right now, however, it’s going to take energy and determination for your lab to learn and pivot to meet this new standard. As you know, managing accreditation is a full-time job.
But don’t panic, the best news of all is that you have three years to implement the system before full compliance is required. A2LA has even put together a 2-page guide on accreditation to the TNI Standard.
So the question becomes, what can you do over the next three years to get your lab TNI certified and how can Qualtrax help?
I reached out to Dr. Tony Francis with SAW Environmental to help answer some of these questions.
There are new quality management system requirements.
According to the standard, your lab will be responsible for developing a quality manual addressing QA/QC items, reviewing it annually, performing internal audits and maintaining lab records.
“Though labs currently need to have a QMS, the requirements were a lot less up until now,” said Dr. Francis.
In module 2, section 4, it specifies that your lab will be responsible for listing personnel and their responsibilities and authorities, the flow of work in the organization and document control.
In terms of document control, you will need to have an organized system showing which documents you have, current revision statuses, effective dates, etc. You will also need to record corrective and preventative actions.
Document control, specifically, it was one of the main areas where findings occur. The main reason being that documents are not up-to-date.
Another area that Dr. Francis says that many findings occur is in distribution.
“A part of document control is, for instance, asking how many copies of the quality manual exist and where are they?”, he said, adding, “When the quality manual gets updated, you will need to retrieve the old manuals and replace them with new ones. That has to be written down and recorded somewhere.”
This will have a huge effect on the way you organize your lab, the procedures you put in place, and the way training for personnel needs to be monitored and represented.
You will be required to run and report one passing proficiency test (PT) per year.
“Under the 2016 TNI Standard, labs are required to pass two rounds of PTs per year. California labs received an exception and only have to do it once per year,” said Dr. Francis.
PTs are great because they are the one outside test that will demonstrate how your whole process is working from sample receiving, to analysis and reporting.
These tests can be burdensome for labs as it can be challenging to report on the process. This is one of the major changes in Module 1 of the standard. Fortunately, Qualtrax has created a best-in-class Proficiency Testing Workflow.
The workflow allows you to schedule and assign PTs, provide instructions, and create a place to store the results. These results are then sent to the Quality Manager to look for non conformances. There are automatic reminders and emails that can be set up to keep the process on time and hold your team accountable. The results are always available as a report when it’s time for an audit.
Lab personnel will need to prove appropriate credentials and training.
Module 2, section 5 is probably the grayest area of all. The standard lays out the credentials required for various positions within the lab. However, these requirements are very vague and many labs are confused on whether or not they qualify.
Dr. Francis shared that California actually came out with their own requirements. The state gives a couple options on how to prove that an employee is qualified for the position.
In the instance of a Technical Manager(previously named Laboratory Director), there are various routes one could take:
A bachelor degree in a science field with a couple years of experience.
A certification for a wastewater treatment plant
Grandfathered in due to time with the lab
Qualtrax has an entire module in our product where you can record and track personnel credentials, resumes, and transcripts. Having these documents on file will be very helpful when it comes time for an audit.
These are only a few highlights of changes required through the 2016 NELAC Institute (TNI) Standard. You can find a full report by visiting the State Water Resources Control Board.
We know that gaining accreditation to new standards can be overwhelming for both established and new labs alike. We would encourage you to reach out to ELAP and your accrediting body as soon as possible in order to get started with this accreditation process.
While you’re at it, let us show you how Qualtrax can support your path to compliance!
Categories: Audits, Compliance Management, Environmental, News, Process Management, Public Health, Quality Managers, Risk, Testing Labs, Uncategorized
