[Integrated Quality Systems]

Many companies that implement Good Manufacturing Practices (GMPs) and Prerequisite Programs seek to improve their food safety systems and comply with the standards necessary to obtain certifications. However, it may not be clear which criteria the facility should measure against to obtain real results that reflect the process implementation.

On many occasions, managers at these companies view the implementation of such programs as an expense instead of an investment. They justify the costs as part of standard compliance or say they are a client requirement. Instead, they should be using them to prove how concrete results (such as reducing the amount of rework used, decreasing client complaints, reducing equipment and process downtime, increasing shelf life, and having more educated and consistent personnel) can be achieved.

Several years ago, AIB developed the Integrated Quality System (IQS) Stool (at right), which illustrates how Quality, Food Safety and Prerequisite programs are important to the process. If one of these programs is lacking, then the IQS model is not sustainable.

Measurements and other valuable criteria should be used to compare current plant conditions to the results obtained once Prerequisite and other programs have been implemented. Without charting these results, it can be very difficult to have continuous process improvement.

Statistics allow us to measure current conditions, search for root causes to problems, and evaluate post-implementation results. To achieve such results, steps for improvement should be followed:

Six Steps for Continuous Improvement Problem Solving

1. Identify the project
2. Define the project
3. Diagnose the cause
4. Solve the problem
5. Measure the results/profits
6. Repeat the results/propose new projects

If every project represents a situation that is out of control and has special variations, but can be controlled by one or more Prerequisite Programs, then we can determine how to maintain the process under control. If the information is managed online, we can measure the results in real time.

Prerequisite Programs. Prerequisite Programs are proactive, seeking to avoid the introduction or intensification of biological, chemical, and physical hazards in food at different process steps. This means the conditions under which food is processed are under control.

If a situation occurs where the process goes out of control, it must be detected before the product leaves the plant, and corrective actions must be taken. Corrective actions include immediate steps to control the issue, as well as long-term steps to avoid repetition of the situation. These results should be measured. It’s especially beneficial if you use an economic value to compare the cost of failure versus the cost of preventing the issue in the first place!

Using Prerequisite Programs (along with a HACCP Plan) to educate personnel and formalize the monitoring, verification and validation processes will help reduce the probability that foods will be exposed to hazards. If these activities are documented, you will have the evidence necessary to measure improvement.

• Monitoring: Real-time observations made during the process that allow you to make adjustments and carry out corrective actions before the product leaves the line. These actions will be completed by the person responsible for the line or for the activity to be carried out.

• Verification: Activities, different from monitoring, which ensure that the controls are adequate and have been implemented correctly and that the system is operating according to the plan, thus confirming the validity of the system.

• Validation: The element of verification which focuses on collecting and evaluating scientific and technical information to determine if the system is effective at controlling risks.

Statistical Process Control should rely on real and reliable data for the presentation of acceptable results. This reinforces the Monitoring and Verification concepts, since you can not evaluate correctly if you don’t have precise data.

CONTROLLING PROCESSES. Having a process remain under control means being able to rely on the following factors:

• Common (as opposed to special) variations are present
• Personnel monitoring the process can review the values in graphic form
• Rapid response to alarms when the process does go out of control
• Fiscal connection to make the effect of the monitoring responsibility better understood and the rate of response higher.

Those persons responsible for Verification (such as supervisors or area managers) usually take care of many activities, and don’t always receive or evaluate data that indicates whether the process is under control or if personnel are complying. And, they can’t always easily compare the effectiveness of different employees who do the same job, or compare two or more production lines regarding different aspects of quality and safety.

Statistical Process Control allows for these activities to be carried out in a planned manner, complete with evaluations of tendencies and economic values. These can determine the effectiveness and efficiency of the procedures and guidelines, as well as an employee’s actual actions. This is a way to confirm that employees are not only trained, but that they are educated on the subject as well.

The tools used to carry out Statistical Process Control allow us to evaluate all types of variables and attributes related to cleanliness, safety, and quality that can exist in the product being processed.

Let’s take a look at an example of how certain variables are affected by a Prerequisite Program. You can use a Scatter Plot (see below) to evaluate the Cleaning and Sanitation Program regarding:

• Shutting down equipment
• Product shelf-life
• Number of accidents on the production line

In another example, you can use a Box Plot to evaluate Production employees who are carrying out the same task in different shifts:

• Heat treatment of a product
• Equipment cleaning
• Equipment maintenance

SPECS VS. PROCESS LIMITS. Many plants operate using food safety, sanitation, and quality specifications without necessarily knowing the limitations of their processes. By using Statistical Process Controls, we can differentiate the process limits versus the specifications in order to ensure that the process is under or within the specifications, which are the real objectives.

For example, let’s look at validating the Sanitation Program in process steps such as cooking, pasteurization, autoclave, washing, etc. Knowing in detail process capabilities and behavior helps us know if we can comply 100 percent of the time with the non-negotiable objectives of sanitation and food safety, or if we should make adjustments to the process to reach this objective.

The process limits do not have anything to do with the specifications with which we need to comply. The question is, how do we measure the process and compare it against the specifications?

VARIABLE CONTROL CHARTS. Using control charts to present process data allows those responsible for monitoring to receive data that has already been processed and is easy to understand. As well as using graphs, it is useful to have formulas that link the true costs of being outside the process limits. This provides a tool to show that corrective actions are taken immediately.

Control charts also will standardize the criteria used by different people on the same task, because reviewing clear and reliable data replaces the need to use a guessing game to determine causes and reactions. To find the real root cause we need to follow the six steps for continuous improvement so that personnel are more effective and efficient.

PROCESS FAILURE costs. In addition to the possibility of having an unsanitary or unsafe product, every situation that presents itself as out of control has increased costs associated with it. These can vary depending on whether the product with the hazard (or failure) was detected inside the plant, or if the detection occurred once the product left the facility.

If the failure is detected while the product is still at the facility, the average costs will increase slightly; however, if the failure is detected once the product has left the facility, the associated costs can be high enough to shut down the company.

Understanding the concept clearly demonstrates what can happen when a process is not completely under control and generates product hazards with a high risk of harming consumers.

In Figure 1.1, we review a traditional visualization of the excess costs of production that a plant might have. In the following figures, we see models of the real production costs.

THE ROOT CAUSE(S). Prerequisite Programs and HACCP Plans are looking for corrective actions that can lead to the true root cause(s) of a failure. This can be achieved by relying on our own knowledge, or by using appropriate tools which will give us the Statistical Process Control.

Analyzing the root cause of a problem or event can help us know if there is one cause or multiple causes, how they are related to each other, and whether or not we can arrive at a true root cause.

Correcting the root causes is more effective than just treating the symptoms; however, in order to do this we need to use a method that is systematic and supported by evidence. The method must be systematic so that we can be consistent when focusing on the true root cause(s) and assure ourselves of doing the job completely. Furthermore, the method must be supported by evidence so that we can measure the successful correction of the problem within an acceptable time frame. We also can be consistent when trying to achieve desired objectives in the long term.

Root Cause Analysis. Root cause analysis tools allow us to prioritize potential failures and focus on the principles or methods that will lead our analysis to discover the true root causes:

• Pareto Chart

• The Five W’s

• Casual Factor Chart and Flow Chart

• Fishbone Diagram

CONCLUSION. Using Statistical Process Control can help us be more proactive in keeping a process under control by using the respective controls for special variables. If we keep in mind the perspective that implementing and maintaining GMPs and Prerequisite Programs can be a very effective tool to achieve a better margin on profitability, instead of just a way to comply with a standard, then we are speaking the language of plant managers and giving the achieved actions a more tangible dimension. AIB

The author works for Food Knowledge in Ecuador, which is closely associated to AIB International through the IQS Alliance.