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Audits and Auditors - Facts and Myths


Sabal Food Safety Consulting / August 6th, 2014


There are many articles and opinions in the media about foodborne illness outbreaks, their sources and the value of inspections and audits. Some of them refer to audits and auditors, inspectors and inspections, and their role in the prevention of foodborne illnesses.
Inspections and audits, what is the difference? In general, when “inspecting”, any finding that does not conform to the reference used must be fixed and evidence must be maintained. When “auditing”, any finding that does not conform to the reference used must be fixed, as in an inspection. But then, an investigation must be performed to find the root cause of the problem and, a “preventive action” must be developed, implemented and verified to prevent the cause of the problem to happen again. Evidence must be maintained to prove the fix and the preventive action of the finding were taken and verified. Based on this, to improve the robustness of a food safety program, it is more useful to have audits than inspections.
An audit is a systematic evaluation – comparison – of the requirements of a food safety standard or regulation against a documented program, a food, feed or beverage manufacturer/processor has developed for their own products, to determine the effectiveness of the program. The auditor’s role is to assess the conformance of the facility’s documented food safety program against the reference used (Standard), verify the effectiveness of the implementation and, check for records showing evidence of performance of the procedures according to the documented and validated program.
Fundamentally, there are three types of audits. First, there are internal audits. Internal audits must be performed by qualified individuals within a company or by a consultant. The purpose is the same as any other type of audit, find possible non-conformities against the reference used. 
Then, there are second-party audits. These audits are performed on suppliers as part of their customers’ request. Something particular about these audits is that the reference used could be developed by the customers requiring the audit, by a consultant or, from other sources, like those developed by certification bodies. Depending on the specific needs of the customers, the reference might be restricted to only certain topics of the full spectrum of what is included in an internationally benchmarked (GFSI) food safety audit. The auditors performing this type of audits may receive training on the “intent” of the reference, like those owned by certification bodies, but may not be required in the other cases.
Third-party audits are the third type. These audits are performed using a reference (Standard) that is benchmarked against the Global Food Safety Initiative (GFSI) Guidance Document, covering the topics necessary to comply with the minimum requirements of a food safety standard. The auditors must receive training on the “intent” of the reference (Standard) as well as training on how to perform the audits.
There are a few food safety audits performed for a specific or reduced scope and those will not be considered in this article.
Based on the explanation above, two basic topics will have a significant impact on the final score or grading of any type of audit. First, the reference used, and second, the auditor’s knowledge, expertise (Skills) and qualifications.
The reference used plays a significant role on the scope of the audit and its score or grading. When performing any of the audit types described above, the auditor will utilize the same reference as the one used to develop the food safety program of the company being audited to perform the audit.
The second topic is the knowledge, experience (Skill) and ethics of the auditor. It is possible that an average person, with food safety background, takes auditor training and will understand what is required to perform an audit. Now, does this mean that this person is an auditor? Most probable, the answer is no, as the expertise plays a big role in the performance of an audit; the more you practice the more you understand how to implement the knowledge acquired.
Ethics comes with the auditor, the human being. This is where food safety meets with money. However, when performing a food safety audit, money must not be “within the scope of certification”.
The relevance of an audit will always depend on how complete is the reference used and, on the ability of the auditor to identify “food safety” non-conformities.

What is a system?

Sabal Food Safety Consulting's blog

May 25th, 2014

1. A system is a set of interacting or interdependent components forming an integrated whole or a set of elements (often called 'components') and relationships. Source: Wikipedia
2. An organized, purposeful structure that consists of interrelated and interdependent elements (components, entities, factors, members, parts etc.). These elements continually influence one another (directly or indirectly) to maintain their activity and the existence of the system, in order to achieve the goal of the system. Source: Business Dictionary
Characteristics of a System
1. A system has structure, it contains parts (or components) that are directly or indirectly related to each other
2. A system has behavior, it exhibits processes that fulfill its function or purpose
3. A system has interconnectivity: the parts and processes are connected by structural and/or behavioral relationships
4. A system's structure and behavior may be decomposed via subsystems and sub-processes to elementary parts and process steps
Facts about a System
  • The System belongs to the company! Not to the individuals that develop it…
  • A system is based on documentation! If it is not documented,
    • How can it be used for training? Because, If training depends on the trainer’s knowledge, trainings will always be different…
    • How it can be audited?
    • How it can be verified?
    • How it can be validated?
Developing a System
Start by assembling a “development team”. The team should have a team leader or coordinator responsible for the overall progress
1. Identify the guidance document (standard) with the criteria to follow
2. Read and understand the guidance
3. Start developing documentation to support the requirements of the guidance
Implementation of a System
1. Once the System is documented and evidence of the effectiveness of is procedures (components) is obtained…
2. Written documentation (policies, procedures, work instructions, forms or records) will be used for training or for developing the training content.
This is how the knowledge (Information) in the documentation is transferred to people.
So, what is a Food Safety System?
1. A Food Safety System is based on a Food Safety Standard (SQF, BRC, FSSC 22000, IFS, etc)
2. Food Safety Systems are developed to control food safety hazards from different sources
This is a graphical representation of a Food Safety System


What is a Food Safety System?
  • Food Safety Systems use the ISO structure of a quality system (Management commitment, management reviews, corrective actions, internal audits, etc), plus:
    • Main component: a HACCP Program
      • Which is why having HACCP training is a pre-requisite for anyone developing a Food Safety System
      • Hazards controlled by the HACCP Program:
        • Related to the process
        • Inherent to the ingredients and finished products
    • Supporting components: pre-requisite programs based on GMP’s
      • Hazards controlled by the pre-requisite programs:
      • Related to the internal and external environment (Outside grounds, plant construction and design, lighting, sanitary operations, pest control, etc).
      • Related to the equipment, tools and utensils.
      • Related to the personnel (clothing, jewelry, disease control, visitors, personal cleanliness, etc).

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.

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 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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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.


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