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From: Food Quality & Safety magazine, December/January 2006

Critical Violations

From critical violations to corrective actions via root cause analysis

by Jeffrey Lewis

“Eat at Your Own Risk,” a series aired by CBS Chicago last September, indicated that the City of Chicago found 15 percent of popular restaurants and over two dozen franchises faced critical violations. These violations are based on state defined specifications and the predetermined corrective actions.

On the surface it seems that the corrective actions solve critical violation problems. Critical violations reoccur, primarily because the practiced model of corrective actions does not prevent the likely repeat of the critical violation on another occasion. The accepted practice is that the corrective action “fixes” the violation to return to service or operating parameters. What is needed is a method on how to correct the violation, so that there is little likelihood of a re-occurrence.

HAACP provides the basis for monitoring the parameters for managing hazards at critical points. The concept of a corrective action is also embedded in the HACCP format, and seemingly, because of the “fix” tradition of the “corrective action” for violations, there is no strategy for re-occurrence prevention. Thus the same violation re-occurs over and over. An example of the practice is demonstrated by the laws of Sonoma County – Health Services#, which lists over 40 explanations of critical violations with appropriate corrective actions. This is against the background of the California Uniform Retail Food Facilities Law. The violation / corrective action demonstrated does little to impact on maintaining the prescribed conditions.

New Thinking

Corrective actions are meant to avoid reoccurrence of the violation. This thinking is found in the quality management systems known as plan, do, check and act (PDCA) and is the foundation of ISO 9001:2000. Essentially PDCA through corrective action drives continual improvement. The concept is intended to reduce non conformances, as time progresses.

Continual Improvement is facilitated by having an understanding of the root cause of the violation and making the correction at the root cause. It is usual to investigate this by asking the question why, successively until the cause is found. Generally by the time the 5th why is reached the answer is found.

So let us explore the Sonoma County violations, using the root cause methodology:

  • Why is the refrigerated storage inadequate?
    Possible answer: The refrigeration gas was not being monitored
  • Why was it not being monitored?
    Possible answer: There was no schedule
  • Why was there no schedule?
    Possible answer: There was no maintenance program
  • Why there was no maintenance program?
    Possible answer: None was put in place

Therefore, the root cause of the violation is lack of maintenance, and the corrective action is to implement a maintenance program to include a weekly and monthly check of refrigerated parameters.

This methodology, if adhered to, is likely to maintain the correct temperatures and prevent reoccurrence of the violation. The corrective action is nothing more than the scientific specifications to be maintained to avoid the hazard. It makes sense to have a corrective action based on the root cause, rather than identify the correction of the violation as the scientific specifications. The corrective action as shown by the county does not provide the opportunity to avoid the violation over time. The root cause analysis, however, does.

Although one of the seven elements of HACCP is the corrective action, it is likely that its intent is to utilize the root cause methodology. Compliance can only be served by continual improvement. If the continual improvement methodology is not implemented, organizations will continue to be in the violations / fix (corrective action) cycle. The “fix” is not a corrective action as defined within quality management systems.

The Continual Improvement Concept

The real root cause of the issue leads to a meaningful corrective action. Also, apart from the receiving department and as a critical control point, all other critical control points per process types are likely to have equipment to execute the respective process. This means that the following features should be available to establish the means to correct the critical violations via an improvement strategy: Preventive/monitoring procedures by way of checklists, “lock out/tag out,” to deal with any electrical related issues on equipment.

Against this background a tool is needed to deliver the control for managing these different aspects of food safety management. Moreover, according to the PDCA, the corrective action is likely to drive improvement through new or improved related procedures to achieve the following effectively:

  • Reduction of unexpected critical violations based on internal QC;
  • Cost Reductions by way of continual improvements on the reduction of product dispositions;
  • Reduction of out of compliance issues (‘violations’), when checked by the regulatory authorities;
  • Moves the Food Safety exercise from inspection focus to continual improvement management.

Achieving the described level of effectiveness means an integrated workflow, which can be effectively introduced through technology. The objective and configuration of the software should be the application of an appropriate format, to wean organizations off the violation/ fix cycle

On Site Management

The question is; how to facilitate the management of these issues in a simple control format for operators in non-technical work situations. In fast and mega food chains, the challenge is ensuring that the employees stay focused on the food safety parameters to move from critical violations/fix cycle to continual improvement. Generally, regional managers inspect by geography the areas under their control of franchisees or in the case of supermarkets, corrective action records based on the Sonoma format is uploaded to corporate.

What if it was possible via a single handheld—without an on-site desktop computer—to control and maintain the prescribed parameters of the Sonoma corrective action or HACCP scientific data. This means that the problems experienced by the fast foods corporations at the beginning of this article, may be eliminated.

Critical violations can be eliminated because the handheld software provides the following management control:

  • Identifies who is responsible for executing the handheld preventive and monitoring checklists to avoid the violation;
  • Specifies a time for execution and more importantly a bar code trigger, to ensure that the right information is applicable at the Critical Control Point (CCP);
  • Supports the QC function as electronic records provide evidence of execution;
  • Allows access on the handheld to only trained personnel;
  • Informs management when checklists are incomplete or there are readings in the violation zone.

There is strict control on the activities to ensure that there is compliance to the food safety parameters. A corrective action is triggered on the handheld when the parameters are not met. The root cause analysis is meant to provide greater control via an improved checklists or frequency management to avoid critical violation reoccurrence. Seemingly then, the corrective action with root cause drives improvements.

Lending the characteristics of quality management systems per corrective action / root cause, together with the convenience of control at the point of application by the handheld, will enable the elimination of critical violations.


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Jeffrey Lewis is the founder of Safety In Your Hand. Reach him at



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