Anne Frank said, "What is done cannot be undone, but at least one can keep it from happening again." While the context was quite different, this message can also apply to breakdowns in your food safety programs. Those breakdowns can lead directly to a critical food safety event or can initiate a chain reaction of events leading to the same result. Oftentimes, seemingly benign non-conformances can be the tip of the iceberg, indicating larger risks beneath the surface. The benefit of performing a root cause analysis (RCA) is the detection and mitigation of vulnerabilities before they lead to adverse food safety situations.
Immediate corrections may appear to solve the problem but are essentially reactive, short-term solutions that do not identify the root cause nor the preventive action or actions to fully address the issue. In other words, the corrective action may be treating the symptom but not the illness.
Seemingly unrelated issues can have a common root cause
Any obstacles to effectively implementing preventive controls and/or prerequisite programs can have unexpected repercussions. Below is an example.
An exterior man-door in the shipping and receiving area is observed by the Quality Assurance Manager as being propped open. The door is closed and employees are re-trained on the need to keep doors shut. A few weeks later, that same door is noted as being propped open during an internal GMP audit. Employees are once again instructed not to leave the exterior doors open. For another few weeks, everything is fine and the management team does not notice any exterior doors propped open. Subsequently, a rodent is found in a tincat in a production area. The pest control company is called in, but they don’t have any solid answers to how the rodent entered the building – they also note that pest trends have been rising.
It takes a few more weeks before the Warehouse Manager notices employees are propping that same door open when they take cardboard out to the recycle dumpster. When they are done, they quickly close the door again. In the amount of time it takes for the employees to walk back and forth several times between the building and the recycle dumpster, there is adequate opportunity for pests to enter the facility. The Warehouse Manager discusses this with the warehouse employees and they mention having to punch their security code on the keypad outside the door every time they come back to the building – sometimes the keypad does not respond, meaning they have to punch it in multiple times to get the door to open. Because they were instructed to keep the door shut, but were still frustrated by the recalcitrant keypad, they took matters into their own hands and hid their actions from the Quality Assurance Manager.
Replacing the keypad might be a simple solution, but the larger issue to be addressed here is the poor communication within the company. The effective use of the root cause analysis process can determine why a food safety program broke down, and how to prevent it from happening again.
Is this the tip of the iceberg?
I recall an incident where an employee dropped a maintenance tool into a piece of production equipment. The equipment was badly damaged, the line was shut down, and maintenance was brought in. During the course of repairs, the tool was discovered and traced back to that employee. Not surprisingly, the employee was promptly fired. Problem solved, right? Not exactly. Several incidents, related and unrelated to this issue, occurred with employees not reporting problems with equipment, not following GMPs, showing up late or not at all, etc. Turnover was high. The incident with the maintenance tool was indicative of a much larger problem. The company culture was toxic. Firing the one employee (while probably necessary), did not fix the deeply-rooted cultural issue.
Other situations may not be as dramatic. One observation I have made numerous times is the use of employee-devised temporary repairs on equipment. Often, materials such as cardboard, tape, plastic zip ties, grocery bags, gloves, etc. are used. Management’s response tends to include instructing and re-training employees, filing official warnings in an employee’s HR file, and/or to simply calling Maintenance in to create a permanent fix. More often than not, the true questions as to why the situation occurred remain unanswered.
People problem-solve on the floor for a variety of reasons. Resources may not be readily available. Company goals and/or measures of performance may not include food safety (for example, are based on throughput). Employees may not understand what constitutes a food safety issue. There are other reasons as well, but let’s dive a little deeper into cause and effect.
Why do people do what they do?
Let’s take that example of an employee creating an “innovative” non-food safe temporary fix to a piece of production equipment.
During an internal GMP inspection, the Food Safety & Quality Assurance Manager notes a piece of cardboard used to deflect product from falling off a conveyor belt. It is clear the cardboard has been there for a while – at least since the last GMP inspection a month earlier. The corrective action of repairing the side of the conveyor line is assigned to the Maintenance department. Production employees are trained to communicate with Maintenance when there is a problem and not to create temporary fixes.
This type of situation will happen again – I can almost guarantee it – and in the future may result in product contamination. When analyzing this situation several questions come to mind.
Why did employees (e.g., line workers, supervisors, quality techs, etc.) not notify the appropriate personnel, such as Maintenance? Are employees encouraged and rewarded when they identify issues, notify the appropriate people to resolve them, or even communicate potential solutions, if appropriate? Do employees feel siloed, only performing the tasks they are assigned?
Why did Maintenance personnel not notice the broken equipment? Do they prioritize keeping the line running over addressing food safety related issues? Are they behind on their preventative maintenance schedule or busy with other more pressing tasks? Do they have the time and resources to fix the equipment?
Questions like these look many levels deeper to find the true root cause (or causes) of the issue and help in the development of preventive actions.
What does it take to strengthen your RCA process?
Commitment to performing RCAs must come from senior management. Lack of time is one of the main reasons RCAs are not conducted. Lack of expertise, leadership support, and interdepartmental goal conflicts are other reasons. Providing the necessary human resources, training them on the fundamentals of the process, and setting aside valuable time to conduct RCAs is critical to preventing future breakdowns in a company’s food safety programs.
Once an operation realizes the critical nature of pursuing true root causes to food safety breakdowns, they must build a multi-disciplinary RCA team. By involving multiple departments, there will be a broader knowledge base and differing viewpoints that can result in a more robust analysis. In addition, when a plan to address a non-conformance is developed, team members can return to their respective departments to introduce the resolution, facilitate employee buy-in, and achieve consensus on execution of the plan.
There are several steps to take in order to conduct a root cause analysis:
First, assemble the RCA team and set aside time to discuss the issue.
Identify the observed issue (wait on determining the “why” – that will come later).
Determine the implications and severity of the issue. For example, can this non-conformance lead to other problems or is it indicative of another issue?
Now is the time to pursue the true root cause. This can be done using several different methods, such as 5 Whys, Fishbone, etc. Make sure the method is consistent (used each time an RCA is conducted). The team should brainstorm – no rock should be left unturned.
Once the root cause (or root causes) is identified, the team creates an action plan to address the root cause(s).
The action plan is introduced to employees. If the action plan includes a specific departments or departments, the RCA team department representative needs to be the one driving the execution of the plan, allowing input from involved employees. This can result in employee buy-in, more effective implementation, and prevention of future occurrences. This also fosters the company’s desired food safety culture.
Conducting a root cause analysis is not easy but can protect your operation from costly food safety events
RCAs take time, resources, and a strong knowledge base on the different methodologies and tools available to make the process effective. However, the time and effort spent on a strong RCA process will further engage your employees, foster a strong food safety culture, identify low hanging fruit to support continuous improvement, and help reveal operational food safety gaps.
Contact Jennifer Frankenberg at Kidder Consulting Services for assistance on identifying your operation’s food safety vulnerabilities and putting the most effective solutions in place.