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Validation and Verification, what do they mean?

                                                                                                                Sabal Food Safety Consulting's Blog / April 6th, 2014
 
 
Imagine you are going to develop a hand washing procedure for a company that manufactures a ready to eat (RTE) product. This procedure will contain details, not only about the step-by-step to be followed, but the soap and sanitizer and their concentration, any tool required, frequency of the procedure and, all the requirements of a properly developed procedure. The procedure MUST be "valid" before implementing it!.
 
In order for the hand washing procedure to be "valid", it needs to be effective, meaning, it must remove pathogens from the hands of the person that performs it every time a person washes their hands following this procedure. How you prove the procedure is effective? Select several persons working with the product. Swab their hands and test for the pathogen of concern; this procedure must be performed several times and all the results must be analyzed and compared to the “critical limit” that is acceptable by regulation or guidance document(s). If the results of the tests show consistently that there are no pathogens present on the hands, this represents the “scientific evidence” that this is a "valid" procedure.
 
Then, you need to determine what is the right frequency to repeat the above validated procedure. Using the same scenario, you will test for pathogens, for example, every thirty (30) minutes after the initial hand washing. Once you collect and analyze those results, you will be able to determine when (amount of time) the concentration of pathogens reach the “critical limit”. Now, you have “scientific evidence” to validate the frequency of the procedure.
 
Until this point in time, what you have done is the initial validation of a procedure. The procedure can be approved and used to taught the employees during formal training.
 
This is when verification kicks in. You need to demonstrate that those that were trained on following the validated procedure are doing it "precisely" as it is described in the procedure. Trained individuals must also follow the frequency established in the procedure. In summary, you need to verify that, the procedure is being followed exactly as it was developed and, at the right frequency. Normally, this is accomplished by monitoring those two parts, 1) the procedure itself and, 2) the frequency. Random swabbing of hands and analyzing the results will be considered proof of performing the procedure properly and, somehow, there should be a way to verify all trainees are washing their hands at the right frequency. You must check the procedure and its frequency are verified.
 
As you can see, by using the above scenario, if you start with a hand washing procedure that is NOT valid, you can still verify that people is following that procedure exactly as it was written and at the stated frequency but, the hands will be contaminated. Here are a couple more “validation” questions: what about if someone decides to change the soap described in the procedure or its concentration? Will you have a “valid” procedure?
 
Validation and verification are very confusing terms. For those procedures where a scientific tests can be performed, it is not that difficult to define them. However, how can you validate a Customer Complaints Program when you cannot test for pathogens? My advice is to keep the focus on the “hazard(s)” that are the objective of the procedure to be validated and, making sure your procedure really “prevents, eliminates or reduces” the hazard(s) to an acceptable limit.
 
Sabal Food Safety Consulting has helped many companies by providing guidance on how to validate and verify processes and procedures. Feel free to contact us for your validation and verification needs.

Nutrition Label - Proposed Changes

                                                                                                                                                                           Sabal Food Safety Consulting's Blog / March 1st, 2014

Source: FDA's web site

 

Explanation of the proposed changes to the nutrition label in food products.

FDA wants to update the look and content of the Nutrition Facts Label to better help consumers make informed food choices and follow healthy dietary practices. The proposed changes include: a) a refreshed design, b) an updated "serving sizes" and "new package labeling requirements" and, c) the listing of "added sugars" and other changes based on nutrition science.

The FDA's web page states "A lot has changed in the American diet since the Nutrition Facts label was introduced in 1993 to provide important nutritional information on food packages. People are eating larger serving sizes. Rates of obesity, heart disease and stroke remain high. More is known about the relationship between nutrients and the risk of chronic diseases."

Summary of proposed changes:

  • A greater emphasis—with larger and bolder type—on calories.
  • Added sugars would be included on the label.
  • Calories from fat would no longer be listed. Total, saturated and trans fat will still be required.
  • The number of servings per package would also be more prominent. "Amount Per Serving" would now have the actual serving size listed, such as "Amount per cup".
  • Updating serving size requirements. By law, serving sizes must be based on what people actually eat, not on what they "should" be eating.
  • Update Daily Values for various nutrients and the %DV would be shifted to the left of the label.
  • If present, the amounts of potassium and Vitamin D would be required on the label and, no longer require the labeling of Vitamins A and C.

 

The HACCP Team


What is the HACCP Team

Basically, anyone looking to implement a HACCP Program must first go through the five preliminary steps. For this discussion, we are going to talk about the HACCP Team.

The first step is to assemble a HACCP Team. The HACCP Team must be integrated by people that are knowledgeable of the process(es) performed and the product(s) manufactured. All members of the Team must be trained in the HACCP method, specially the HACCP Team Leader or HACCP Coordinator.

But why all members must understand the HACCP method?

When someone takes a training on HACCP, the basic information on how the HACCP method works and the definitions of hazards and risk are explained. The definition of a "Critical Control Point" (CCP), critical limit, what is a deviation?, corrective actions, verification and validation must be fully understood by the team members.

What happen when I'm auditing? I verify that the HACCP Coordinator/HACCP Team Leader has formal training and, that this training was examinable to determine basic understanding of the methodology. What is the expectative for the other team members? They must understand the HACCP method too! how can they cooperate in the development of the HACCP Program if they don't understand what is a hazard analysis, what is a hazard and which are its risks? All members of the HACCP Team must fully understand the basic concepts of the HACCP method!

Who else must have an understanding of the HACCP method? Monitors of CCPs and anyone responsible for verification of any area of the HACCP Program. What is your opinion about an employee that is a monitor of a CCP and does not know what is a deviation, does not know what is the critical limit or which are the parameters that are monitored and why?

Training on HACCP and verification of understanding of the training is of critical importance for the proper implementation of a HACCP Program.

What is your experience in assembling the HACCP Team?

 

System Effectiveness

Why food companies are implementing "food safety systems"? No matter if that system is a HACCP program, a GFSI program or any other "food safety" scheme, the purpose is the same: "prevent, reduce or eliminate" food safety hazards. 
 
The only way that you can really accomplish this is by fully understanding the process on how to develop and implement the food safety scheme of your choice. 
 
The main factor, the most critical point to accomplish in the implementation of a food safety system, is to have evidence that the system is effective, that the controls in place (...and you can call them control measures or preventive controls, procedures or, any other name...) are actually preventing, reducing or eliminating identified hazards. Otherwise, you'll have a lot of documents and records with no relevant meaning. 
 
So, how do you accomplish your goal of developing and implementing an effective food safety system? For sure, it is not by just going to a HACCP class and/or taking a training specific for the standard you decided to implement. I'm a certified Adult Train-The-Trainer, a trainer for Seafood HACCP Alliance, a trainer for the International HACCP Alliance and SQF. I can say that, in most cases, my students leave the training room with a very good understanding of hazards and risks and control measures and critical limits, just to mention a few terms used during the trainings. Does that mean they know all the requirements of the Law, that they will be able to identify all hazards and determine which are significant and which are not, that they can develop the documentation with details of the goals of the procedures, responsible individuals (...and their training requirements), that they are capable of designing all records required to provide evidence that whatever is important in that procedure is being recorded and, how to validate and verify each procedure? 
 
You not only need to have a very strong background in HACCP methodology but, good understanding of the hazards associated with each ingredient, with the process, with people, etc. This knowledge is not gained by attending a training! It is gained by continuous education and years of practice. For example, the Codex Alimentarius states: "A qualified individual (with proper scientific background) must analyse the measurements to interpret correctly the data collected." In the Food Safety Modernization Act (FSMA) in the US, a "qualified individual would be required to prepare the food safety plan, develop the hazard analysis, validate the preventive controls, review records and conduct a reanalysis of the food safety plan (or oversee these activities)."
 
If someone is looking to develop and implement a food safety system, it is wise to have someone with the necessary "qualifications" to guide the process and mostly, to help in the training of the employees and mostly those that will have food safety responsibilities.

Surveillance for Foodborne Disease Outbreaks

During 1998–2008, CDC received reports of 13,405 foodborne disease outbreaks, which resulted in 273,120 reported cases of illness, 9,109 hospitalizations, and 200 deaths.

Read more...

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