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HACCP History Research
Sabal Food Safety Consulting's Blog / May 11th, 2014
HACCP History Research / Background of HACCP
We have always heard that the Hazard Analysis and Critical Control Points (HACCP) system came to life when Pillsbury and NASA joined efforts in developing a system to produce the food the astronauts will consume when traveling outside the earth.
The FAO’s HACCP Training states: “The HACCP concept was pioneered in the 1960s by the Pillsbury Company, the United States Army and the United States National Aeronautics and Space Administration (NASA) as a collaborative development for the production of safe foods for the United States space programme. NASA wanted a "zero defects" programme to guarantee the safety of the foods that astronauts would consume in space. Pillsbury therefore introduced and adopted HACCP as the system that could provide the greatest safety while reducing dependence on end-product inspection and testing.”
I learned about the use of the “Failure Mode, Effects and, Criticality Analysis” (FMECA) as a systematic method to analyze the design of something from concept to realization, mass production during a class at the university. This system is extremely similar to HACCP so I started researching for more information about the origins of the HACCP System and the similarities between HACCP and FMECA.
The oldest reference I have found so far for the application of FMECA is: “FMECA was originally developed in the 1940s by the U.S military, which published MIL–P–1629 in 1949. By the early 1960s, contractors for the U.S. National Aeronautics and Space Administration (NASA) were using variations of FMECA under a variety of names. In 1966 NASA released its FMECA procedure for use on the Apollo program. FMECA was subsequently used on other NASA programs including Viking, Voyager, Magellan, and Galileo. Possibly because MIL–P–1629 was replaced by MIL–STD–1629 (SHIPS) in 1974, development of FMECA is sometimes incorrectly attributed to NASA.”
In my search for MIL-P-1629, I found this standard was “cancelled” by the U.S. Department of Defense (See the image below). It was replaced by MIL-STD-1629 (SHIPS) on November 1st, 1974 and, the current version, MIL-STD-1629-A, was adopted on November 24th, 1980.
The FMECA analysis procedure typically consists of the following logical steps:
• Define the system
• Define ground rules and assumptions in order to help drive the design
• Construct system block diagrams
• Identify failure modes (piece part level or functional)
• Analyze failure effects/causes
• Feed results back into design process
• Classify the failure effects by severity
• Perform criticality calculations
• Rank failure mode criticality
• Determine critical items
• Feed results back into design process
• Identify the means of failure detection, isolation and compensation
• Perform maintainability analysis
• Document the analysis, summarize uncorrectable design areas, identify special controls necessary to reduce failure risk
• Make recommendations
• Follow up on corrective action implementation/effectiveness
As you can see, it is a systematic procedure or process and, very similar in concept to the steps of a HACCP System.
In a copy of the U.S Military Standard MIL-STD-1629-A I have, I pulled some of the definitions of a FMECA system with the intention of highlight their similarity with the HACCP System terms and/or concepts:
• Corrective action: a documented design, process, procedure or materials change implemented and validated to correct the cause of failure or design deficiency.
• Criticality: a relative measure of the consequences of a failure mode and its frequency of occurrences.
• Criticality Analysis: a procedure by which each potential failure is ranked according to the combined influence of severity and probability of occurrence.
• Severity: the consequence of a failure mode. Severity considers the worst potential consequences of a failure, determined by the degree of injury, property damage, or system damage that could ultimately occur.
The classification of the severity in the MIL-STD-1629-A is consistent with MIL-STD-882 and defined as follows:
• Category I – Catastrophic – A failure which may cause death or weapon system loss (i.e., aircraft, tank, missile, ship, etc.)
• Category II – Critical – A failure which may cause severe injury, major property damage, or major system damage which will result in a mission loss.
• Category III – Marginal – A failure which may cause minor injury, minor property damage, or minor system damage which will result in delay or loss of availability or mission degradation.
• Category IV – Minor – A failure not serious enough to cause injury, property damage, or system damage, but which will result in unscheduled maintenance or repair.
The classification of the “Probability of Occurrence Levels” in MIL-STD-1629-A is defined as:
• Level A – Frequent. A high probability of occurrence during the item operating time interval. High probability may be defined as a single failure mode probability greater than 0.20 of the overall probability of failure during the item operating time interval.
• Level B – Reasonably probable. A moderate probability of occurrence during the item operating time interval. Probable may be defined as a single failure mode probability of occurrence which is more than 0.10 but less than 0.20 of the overall probability of failure during the item operating time interval.
• Level C – Occasional. A occasional probability of occurrence during the item operating time interval. Occasional probability may be defined as a single failure mode probability of occurrence which is more than 0.01 but less than 0.10 of the overall probability of failure during the item operating time interval.
• Level D – Remote. An unlikely probability of occurrence during the item operating time interval. Remote probability may be defined as a single failure mode probability of occurrence which is more than 0.001 but less than 0.01 of the overall probability of failure during the item operating time interval.
• Level E – Extremely unlikely. A failure whose probability of occurrence is essentially zero during the item operating time interval. Extremely unlikely may be defined as a single failure mode probability of occurrence which is less than 0.001 of the overall probability of failure during the item operating time interval.
The classifications and ratings of severity and likelihood above are quite similar in concept with the risk matrix we use for determining the risks of the food safety hazards when using the HACCP System.
“Section 4.5 FMECA Report” of the MIL-STD-1629-A states: “The results of the FMEA and other related analyses SHALL be documented in a report that identifies the level of analysis, summarizes the results, documents the data sources and techniques used in performing the analysis and includes the system definition narrative, resultant analysis data, and worksheets.” This is similar to a HACCP System’s documentation.
“Section 4.5.2.2 Single failure points list” of the MIL-STD-1629-A states: “A separate list of all single failure points SHALL be provided. The information described above shall be provided in the summary for each single failure point listed such that it is possible to identify directly the FMEA entry and its related drawings and schematics. The criticality classification for each single failure point SHALL be included in the listing.” This is similar to a HACCP Plan form.
Evidence that NASA was using FMECA can be observed in a two page “Preferred Reliability Practices” document “Practice No. PD-AP-1307” titled “FAILURE MODES, EFFECTS AND CRITICALITY ANALYSIS (FMECA)”. This document states something that is very important, not only for the implementation of FMECA, but for HACCP: “The FMECA has been recognized as such an approach and, if implemented rigorously, will provide the necessary visibility.”
After reading the information provided above about FMECA and MIL-STD-1629-A, anyone will agree that the concepts used by FMECA were the basis for the development of the HACCP System.
A copy of a “Block Diagram” and a “Criticality Matrix” were added below as to show more evidence of the similarity of FMECA and HACCP Systems.
This is an example of a “Block Diagram” as required by MIL-STD-1629-A. Is the same concept and use of the flow diagram of the production of a food product.
This is a “Criticality Matrix” under MIL-STD-1629-A. Even though a graph is used to represent “criticality”, the data used to build this graph can be used to construct a matrix like the one used in HACCP to analyze the risks of the food safety hazards.
As a conclusion and in my opinion, there is sufficient evidence indicating that the U.S Army FMECA was the background concept for the implementation of the HACCP System in food processing facilities.
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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.
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.
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?