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Harold Ewell


Simply stated, Compliance is the conformance or the adherence to a procedure, specification, audit criteria or a government regulation. Simply stated, very difficult to achieve for an organization. The requirement(s) which you want to be compliant against must be clearly documented and organized, work instructions created for execution, personnel assigned for execution, personnel trained to execute activities, activities and results documented, activities and results audited, analyzed and acted upon for Read More

Quality Assurance Contrasted

Quality Assurance is the plans and procedures implemented in a quality system to assure that the quality criteria for a product will be consistently achieved. Quality Assurance requires the quality criteria to be documented and approved. The manufacturing process must be capable of achieving the product quality criteria. Assurance of both the appropriateness of the methodologies of product compliance activities to meet the requirements and the knowledge of the executors Read More

Food Safety Management System

Food Safety is a management system by which an organization documents and executes preventive actions against potentially critical health hazards associated with food. The need for Food Safety applies to all activities associated with the sourcing, manufacturing or preparation, warehousing, transportation, and packaging of food within the Food Chain. The accurate identification of hazards and the risk assessment of these hazards are the foundation of a Food Safety management system. Read More

Execute Your Strategic Plan from “Out of the Box”

N2N Global Inc.’s Partner Management software solution is a framework of associated platforms for the management of a Supply Chain Quality Program. The associated platforms allow for the development and maintenance of ingredient, packaging and finished goods specifications in context with the supply chain and the execution of manufacturing needs. Partner Management consists of 20 separate platforms to support both food safety and quality compliance. The re-purposing of specifications as Read More

Which Rule Book do I check?

Question – does FSMA covers Canned Seafood Manufacturing – well yes and no – There was a couple of recalls for canned seafood this week — one of which was: The Spot of Garibaldi, Oregon is voluntarily recalling ALL canned salmon and tuna with any codes starting with “OC” because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are Read More

How are you going to approach FSMA Compliance?

As we all know, the devil is in the details. Are you going to create numerous new and complex policies, plans, procedures and check sheets for compliance or are you going to streamline your approach to compliance with added data analysis abilities to constantly improve your programs. As you read through the basic summary of changes relative to Preventive Measures for Human Foods below, think about the number of redundant Read More

Chasing FSMA Compliance: How far should you go

Actually, the answer is quite simple. Until you have assurance that the significant hazard that is likely to occur that you have identified has reasonable evidence of Preventive Control. Simple right? Let’s take a small example of a program that was a PRP before and now probably will become a PC (preventive control), glass and brittle plastic prevention in the facility. Given that many food processing facilities do not have Read More

What is new and interesting with the release of the FDA’s Preventive Controls for Human Foods?

Obviously, it would be very difficult to boil down all the content of the new Food Safety Modernization Act’s Preventive Controls for Human Foods into a few key points. But after having participated in the three webinars that the FDA conducted last week on Preventive Controls for Human and Animals Foods ( the definition of a farm is still quite confusing and will be further defined in the future through Read More

Some thoughts about Listeria

– what I find remarkable is the level of preventive controls documented by the FDA for processing facilities versus retail deli – the requirements are much more detailed for processors. There is not a mandatory requirement for monitoring for pathogens (Listeria) in Retail and the actual level of rigor in sanitation is vastly different. For example, the full disassembly of the slicer for cleaning and even the steaming of the Read More

What are my customers doing with my product?

Many ingredient manufacturers have customers in two markets, the general public and finished goods manufacturers. While the ingredients that are processed may be very similar, the processing could be significantly different in respect to the type of Critical Control Points in the HACCP plan. The important factor in the HACCP plans for both markets is “who is the customer?” It is a very basic question that is asked during the Read More

Win the Food Safety War

Everyone in the Restaurant Industry has a “war” or “did you heard about so and so company” story concerning customer illness that directly resulted in significant reductions in customer traffic or the bankruptcy of a restaurant. The fear generated by a food safety event will last for years with your customers and the “word of mouth” discussions between people will determine where they will eat in the future based upon Read More

Are your specifications a document or a management system?

Great companies have great specifications for their ingredients, packaging materials, work in process materials, and finished goods. Significant resources are engaged to assure that the requirements for the different products are accurate and the instructions are clear to assure a repeatable manufactured product. These specifications must be detailed enough to support a purchasing contract or if there is a legal dispute, can serve as the primary evidence document for what Read More

Shelf Life Management, Does it stop after study is completed?

As part of the product development process, samples of approved products are placed into different storage conditions based upon the requirements of the type of product. These storage conditions may be in a freezer, refrigerator, or at ambient temperature. After reviewing the quality and/or food safety criteria on a monthly basis (may be more frequent for short shelf life products such as produce or refrigerated products), a determination is made Read More

FSMA – Customer Complaints, What do we really know?

We know that everyone is blogging about FSMA — For example “Preventive Measures for Human Foods” has  been discussed in many different forums. I do not think that this regulation really brings anything new to the industry as far as food safety processes are concerned. Basically food companies should have been doing these “incremental” elements before. The interesting thing about this specific regulation is that the food safety program should Read More