Plan for Change Now - It's Going to Happen
It has been said that the only constant in life is change. Over my years as an environmental consultant, I have seen a lot of change, but I have also noticed that the way one deals with change will greatly affect the outcome. This is particularly evident and notable in the case of laboratories that experience changes.
On the positive side, laboratories have been generally good with planning and executing the big changes, such as location moves, the addition of a new analytical technique (think of addition of per- and polyfluoroalkyl substances [PFAS]), or adding a new facility. The laboratory lays out a plan for development and implementation for those types of major organizational changes, which is known as Management of Change (MOC). Often a laboratory will have written procedures for the execution of these changes, either an event-specific or general policy document (e.g., run method validation study, etc.).
However, smaller, or unexpected changes can wreak havoc on laboratory operations. Personnel changes are a prime example. Valuable staff members may leave the department for a promotion, or may leave the company for a higher-paying position, or possibly even the very rare case of a lottery win. Personnel loss has become very common for laboratories in the recent years. On several occasions as an Auditor, I have personally observed the effects that personnel changes have had, resulting in areas of laboratory operations being overlooked and quality systems breaking down from the lack of MOC procedures.
Why is the case of a staff member moving on such a problem? Filling the position and training new hires takes time and resources, and there are procedures for that process, but the situation can be disruptive and stressful for the existing staff. And recently, these situations have been occurring more frequently due to current economic conditions, laboratory clients asking for lower prices, and staff members/prospective employees looking for higher wages. The situation can be especially problematic when the person leaving has been performing specific routine quality assurance/quality control tasks, like calibration checks for balances or pipettes, refrigerator temperature verifications, checking rotation speeds on toxicity characteristic leaching procedure (TCLP) tumblers, sending weights out for calibration, and reviewing storage blank results, to name a few. These tasks can slip through the cracks and not be picked up by another employee when the previously responsible staff member leaves. Quite often, the activities are not reassigned because management staff is not fully aware of every task the former employee had performed. Tasks like these being dropped creates a breakdown in the quality system and is an MOC failure.
MOC procedures for personnel changes are important, but are seldomly included in a laboratory’s quality system. Since there are many different types of positions within a laboratory, a general approach to managing personnel change is needed. Here are a couple of ideas to consider when developing personnel-related MOC guidelines.
A reactionary approach is to confirm the activities performed by the person during the exit interview (yes, the exit interview is important) to ensure that all their activities are known and will be covered when they leave. This process provides flexibility to address many different areas of the laboratory operation. A supervisor setting up a check list for use during personnel exit interviews would be very useful.
A proactive approach, which is highly beneficial, is to have a primary person and a back-up person assigned to each activity. Smaller facilities may want to cross-train personnel to ensure that procedures and analyses are always covered. Using a back‑up personnel system and/or cross-training staff takes time and effort to keep everyone current; however, this also allows for vacations and sick days to occur without disruption in service to clients. The benefits make these strategies worthwhile.
Change is constant. Management of those changes is needed. Does the laboratory you use have solid MOC procedures in place? If they do not, changes within the laboratory could result in quality issues, and no one wants that. An audit of the facility can reveal missing quality elements, including MOC failures. If you would like to have the laboratories you utilize audited, please contact Environmental Standards.