COVID-19 has caused us to change the way we do business in every industry and performing laboratory audits is no exception. The challenge has been to perform quality laboratory accreditation audits in a world of social distancing and ever-changing travel restrictions.
Laboratories are accredited by Accrediting Bodies (ABs). The ABs may be state regulators, International Standard Organizations, or other agencies. Laboratories are accredited using various criteria such as The NELAC Institute (TNI) Standard, the Association of Official Agricultural Chemists (AOAC) criteria for Microbiological and Chemical Analyses of Food and Pharmaceuticals, and/or the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 Standard. These criteria require laboratories to have biennial accreditation audits in order to maintain accreditation. In addition, United States Environmental Protection Agency (EPA) Regions require laboratories performing drinking water testing to have audits every three years.
Prior to the COVID-19 pandemic, the standard practice was for these audits to be performed on site. The on-site audit typically includes an in-brief meeting, audit of laboratory quality and management systems, audit of scope by test/technology, and debrief meeting. While on site, the auditor interviews staff and views laboratory working areas including equipment used to run analyses. A report with observations and findings is provided to the laboratory and AB after the audit is complete.
Due to safety concerns, social distancing requirements, and travel restrictions, on-site audits are not always feasible. To address this quandary, some ABs have approved remote audits, which are now being performed. Remote audits are an effective way to ensure the safety of laboratory employees and auditors from COVID-19 concerns, while ensuring that laboratories comply with the TNI Standard, ISO/IEC 17025 AB, and EPA regulations.
Remote audits must be pre-approved by the AB prior to being scheduled by the laboratory and auditor(s). Items considered by the ABs for approving remote audits include the following: type of audit (renewal, initial, scope addition); number of previous findings and severity of the findings; and whether the laboratory has sufficient internet bandwidth, cameras, and microphones. Once approval is received by the AB, the auditor can move forward with the remote audit.
Prior to the remote audit, the auditor will perform an equipment test with the laboratory. The purpose of this test is to ensure that the laboratory has the proper equipment (phone, tablet, and/or computer with camera and microphones) for the remote audit to be performed smoothly. Headphones with a microphone and a document camera are useful, but not required. Labs must also scan and send data packages to the auditor at least a week prior to the remote audit so that it can be reviewed by the auditor ahead of time. The auditor will request specific data packages from the lab prior to the due date so that the lab has time to compile and scan the data packages and transmit them to the auditor. Due to the size of data packages, an easy-to-use, secure file upload portal is recommended for transmitting the packages in lieu of email.
A remote audit is very similar to an in-person, on-site audit. The laboratory tasks and operations are streamed via mobile devices so that the auditor can observe laboratory operations such as plating of micro samples, chemical separations, sample receipt, etc. Auditors typically schedule shorter amounts of time in front of the computer screen (not the 8 hours per day that is typical of on-site audits) and data review is done offline (between online sessions). Remote audits do not have any travel costs associated with them, but may include more hours to do the virtual audit (screen time) and data review compared to an on-site audit.
Remote audits have been successful for laboratories with both small and large scopes; one- to three- person labs or labs with more than 200 people; small facilities and large facilities or facilities with multiple buildings; and with one auditor or multiple auditors working simultaneously.
Here are some lessons learned over the course of performing remote audits to help the process go smoothly:
- Auditors need more time for data review. It is preferable for much of this review to be done prior to the start of the remote audit.
- An easy-to-use, secure site to upload the requested data packages, standard operating procedures (SOPs), Quality Assurance Manual, etc. works best for all involved.
- It is imperative to have data at least a week before and that large data packages are bookmarked.
- Scheduling back-to-back audits is really tough on auditors.
- The platform used for the remote audit must be secure and allow all users to share their screens and utilize the camera and microphones. The auditor must be able to see and hear what is going on in the laboratory during the audit.
- Everyone involved must have patience; even the “best internet speeds” fail sometimes and you must allow time to log back in to the platform if needed.
- It is necessary to go back and forth via screen share to see what the auditor and auditee are looking at and discussing with regards to data, documents, etc.
- Prior to the audit, the auditor must identify who they will talk to at the lab and when because, during COVID, not all staff work all the time or staff have staggered schedules.
- People do not have to see each other’s face the entire time. It’s ok to turn off the camera and just use voice or screen sharing for data.
- Take “bio breaks” as often as needed by auditor and laboratory staff.
- Laboratories are noisy. Hoods, grinding, and equipment make a lot of background noise. Noise-canceling headphones with a microphone make the process much easier when the analyst is showing the auditor the testing. Once the auditor has seen the equipment and testing, the analyst can move to a quieter room (office, conference room) so that the auditor can continue the interview with less background noise.
- Using a document camera allows log books to be shown without having to scan the document. These cameras are only about $100 and are cheaper than scanning multiple log books for the auditor to view.
Some benefits of remote audits are:
- Once labs are proficient at remote audits and if they have data online, then they can expand data reviewers to people who are off site, thus increasing the hiring population for well-trained experienced people.
- The time that would have been spent on travel can be spent on review of data or more in-depth interviews.
- If other managers or observers such as regulators want to be present, they can do so without travel costs.
- It is costly to bring multiple technology experts on an on-site audit due to the travel. Now, the expert can be involved in one or two hours as needed and not have to travel.
There has been some concern that laboratories can conceal information or equipment during a remote audit. Asking people to demonstrate testing prevents this from occurring. In addition, more data review actually allows the auditor to find data issues that may not have been found with less data review on site.
There is still a need for on-site audits. Remote audits provide a very useful and cost-effective tool for performing audits while ensuring safety and social distancing during challenging times. Remote audits should not replace on-site audits in the future. They should be included as a useful tool in the auditor’s toolbox.