I am often asked to review responses to regulatory noncompliance or establishment corrective actions. Many times facilities are wondering why they have repeated occurrences of the “same problem,” or why the regulatory agency is repeatedly documenting the same findings.
When asked whether the facility has conducted a “root cause analysis,” I am always amazed at how many times the response is, “this was an isolated event.”
For every facility finding, as well as FSIS noncompliances or FDA observations, a root cause analysis should be conducted to ensure the appropriate corrective action is taken and the cause (as best as practical) is eliminated, or chances are there will be a repeated occurrence of the situation.
This is similar to gardening when we pluck the weeds out of the soil but leave the roots—we all know the results. If the roots are still there – the weeds will be right back…
What does this really mean in our facilities?
Let’s use an example to illustrate…
If a facility finds employees are not washing their hands when they re-enter the processing floor as described in the sanitation operating procedures, how do we determine the root cause? The first time this is documented it becomes easy to say that it is an “isolated event.” Or many facilities rush to see “who” it was that failed to comply – rather than “why” there was a failure. Other establishments say it is a “training issue” and “remind the employees to wash their hands”. But, how do we know what the real issue was unless we get to the “root” of the problem and take measures to address it? By understanding the problem and how widespread it is, it’s much easier to develop solutions, both temporary and permanent.
What are the potential causes? To understand this, an “investigation” will need to be conducted. This will include unbiased observations, interviews of personnel in the area, records review around the time of the event, etc.
Training
Are the employees that failed to wash their hands newer employees? Temporary employees?
- Were they trained?
- Was the training adequate?
- Was the training presented in a language the employees understood?
Supervision
- Are the employees long-term employees?
- Was it a “lead” employee that was first observed not washing that may have contributed to others considering the behavior “acceptable?”
Time Factor
Were the employees late going back to the processing floor? If yes, why were they late going back to the processing floor?
- Was there a meeting or other establishment process detaining the employees?
- Are there too many employees for the number of hand washing stations available?
- Have employees received a new message on “getting work done” more quickly that would cause them to “rush”?
Equipment Issues
- Was the water functioning?
- Was there warm water available?
- Was there soap available? Is it different soap then has been available before that may cause some individuals to not want to use the soap?
- Were there paper towels?
- Was equipment or product blocking the sink at the time the employees entered the floor?
- What else has changed or is different in this area?
Once you determine the “why,” you may find that there are several other questions that are generated.
In our example, if we learn through our investigation that the water was not functioning at that time, we would then start to ask the “why” questions on why the water wasn’t functioning.
To put proper corrective and preventive measures in place, we would need to understand the total picture and eliminate the true cause of the problem. Get to the roots – don’t just pluck the weeds…
If we learned that maintenance needed to turn the sink off for a short period to update the faucet, then part of our corrective actions would be to ensure maintenance would do this work after hours. In addition, we would train employees that if the water was turned off for any reason, they should use a different sink to wash prior to entering the processing floor. And finally, we may update our sanitation operating procedures and state what we would do if no water was available and train our employees on this circumstance.
If we had just considered this isolated, or assumed it was a training issue, we may not have identified that maintenance was updating faucets throughout the plant without a plan of action as to when they could and could not turn off specific sinks, even for a short period of time.
By getting to the roots – rather than just plucking the weeds – we should prevent future failures.
However, if there are future failures, it will be important to document the trend and analyze why it may be occurring and why previous actions were not effective.
Don’t be doomed from the onset – pluck the roots the first time; then the weeds won’t grow back!
About “Dr. Doom”
Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service’s (FSIS) Administrator, Dr. Barbara Masters. Dr. Masters is a veterinarian who spent eighteen years with FSIS – the final three years as Acting Administrator and Administrator. During her rise to the Administrator’s position, Dr. Masters served as the Deputy Assistant Administrator for Office of Field Operations. While in these key leadership positions at FSIS, Dr. Masters’ primary focus was on the implementation of science-based policies for the protection of public health. Dr. Masters issued the initial Federal Register Notices for a systematic approach to humane treatment of livestock and poultry.
Dr. Masters was involved in the drafting of the training of inspection personnel on the Hazard analysis and critical control points (HACCP) and Sanitation Standard Operating Procedures (SSOP) regulations. She was the lead of the FSIS HACCP Hotline. In addition, Dr. Masters provided technical review for establishment’s hazard analysis, HACCP plans and supporting documentation. She started her career at FSIS as a public health veterinarian that had responsibilities for ante-mortem inspection, sanitation inspection and all post-mortem inspection responsibilities. She has a good understanding of what happens at the in-plant location, because she has spent many of long days working there.
