ROOT CAUSE ANALYSIS
We believe that you feel at least a small discomfort every time any kind of nonconformity arises. All procedures are followed, quality control does its part, and final inspection shows no deviations from specifications. Then a problem occurs. We completely understand your confusion at that moment, but let’s consider nonconformities as an opportunity for improvement rather than a potential problem. Here, we will present a brief guide for proper management of nonconformities, i.e., conducting risk analysis and defining corrections and corrective actions.
WHAT IS A NONCONFORMITY?
Different standards have different definitions of nonconformity, but in the simplest terms, a nonconformity is a deviation from a requirement or failure to meet a requirement.
Different standards require attention to terminology because, for example:
1.ISO standards: “Nonconformity is the failure to meet one or more requirements.”
2.IFS Food offers a completely different approach: In the IFS group of standards, there are deviations and nonconformities, which might seem similar but have significant differences:
– Deviation: “Nonconformity with a requirement, without affecting food safety related to products and processes.”
– Nonconformity: “Major nonconformities and D evaluations of KO requirements. Nonconformity can be given in cases of:
- Violation of laws,
- Food safety issues,
- Internal dysfunctions, and
- Customer issues.”
So what actually constitutes nonconformities in a management system?
Typically, nonconformities are linked to complaints or internal/external audits. Nonconformities can arise from these sources but also from:
- Customer complaints,
- Supplier complaints,
- Results from internal/external audits,
- Process records,
- Process performance reports,
- Quality goal achievement reports,
- Customer satisfaction reports,
- Monitoring reports of CP/CCP (including any deviations from critical limits defined by the CCP plan),
- Updates to the management system,
- Records from HACCP system verification and/or product safety management system reviews, etc.
What should a company do when a nonconformity occurs?
In the case of a nonconformity, whether it arises from the production process, internal or external audits, or complaints, the company must conduct a root cause analysis to determine appropriate measures to eliminate the nonconformity and its cause. Before explaining the entire process, let’s clarify the difference between eliminating a nonconformity and addressing its root cause.
Do you know the difference between correction and corrective action? Or, do you know what a corrective measure is compared to a preventive measure? It can be confusing when different standards use different terminologies for the same concept. Therefore, it is advisable to follow the terminology of the standard you apply in your company. For example:
a) BRC standard:
- Corrective action: Action to remove the detected nonconformity or nonconforming product.
- Preventive action: Action to eliminate the root cause of the detected nonconformity and prevent recurrence.
b) IFS standard:
– Correction: Action to eliminate the detected deviation and/or nonconformity.
– Corrective action: Action to eliminate the cause of the detected deviation and/or nonconformity.
Now let’s explain the procedure for addressing nonconformities:
ELIMINATING NONCONFORMITIES AND IMPLEMENTING CORRECTIVE ACTIONS
When any type of nonconformity arises, it must be eliminated. What if it reappears? To ensure the same nonconformity does not reoccur, follow the procedure described below. Clearly, if the same nonconformity appears again, the procedure was not adequately implemented: you probably addressed only the nonconformity but not its cause.
Nonconformity: When a nonconformity occurs, the company’s responsible personnel assess the nonconformity and then its root cause to implement corrective and/or preventive measures to eliminate the nonconformity and its cause.
Root cause analysis: How do we identify the root cause of a nonconformity? Through a simple set of questions: why?
-Why is the cookie overbaked? Because the oven temperature was inadequate.
-Why was the oven temperature inadequate? Because of a deviation in the thermostat’s operation.
-Why was there a deviation in the thermostat’s operation? Because it was not inspected preventively.
-Why was it not inspected preventively? Because these inspections were not included in the plan.
-Why were these inspections not included in the plan? An oversight by the FSMS team members.
Corrections and corrective actions: Aha, we did not expect to reach this data! What would be a correction (or corrective measure) and what would be a corrective action (or preventive measure) here? Certainly, updating the preventive maintenance plan with thermostat checks and then retraining the FSMS team regarding standard requirements.
Effectiveness checking: What if we completed the entire process but the nonconformity reappears? We repaired the floor damage, but the floor is damaged again after a month? That’s why effectiveness checks exist, where we evaluate after a certain period whether the same nonconformity recurs. Perhaps we correctly followed the procedure at that time but did not identify the real cause. For example, we had floor damage and identified a large load being transported during one pass. What did we do: we prescribed the load limit for a single vehicle pass. So why did the floor get damaged again? We probably did not consider the possibility that the floor was inadequate: either the material from which the floor was made was inappropriate, or the subfloor was not properly prepared, or there was moisture, etc.
Therefore, in the case of a recurring nonconformity, there is no reason to worry; simply repeat the entire process. Nonconformities should not be viewed as problems but as opportunities for improvement.
If you want to learn more about all types of nonconformities or need ideas on how to resolve them, contact our Agency!
