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Monday, 1 August 2016

Ravaging Food Industry Experts Fraud Flying Under the Radar

Many have been taken by copy-paste experts. But no more! With things like new versions of industry audit standards and emerging food regulations, particularly the U.S. Food Safety Modernization Act (FSMA), the Safe Food for Canadians Act and Regulations (SFCA/R) and similar national initiatives elsewhere, you must refuse to be taken by anyone who will simply read back to you what you can already read for yourself and leave you to do all the work.

Many will come promising you a world of solutions but hand you a replica of the globe. You will have a real replica. It may even be golden but useless in terms of solving your real world problems. The proof of the pudding, they say, is . . .

Let’s take a moment to focus on the FSMA requirement for companies to have Preventive Control Qualified Individuals (PCQIs),if you are thinking of enlisting a trainer or consultant, here are some fraud detection tips:
First ask the trainer or consultant if they know how the FSMA final rules relate to the USC-Title 21, the Code of Federal Regulations (CFRs) and the Federal Food, Drug and Cosmetic Act. If they fumble in describing the relationship, do not hire them.
If they demonstrate a good knowledge of the relationship, proceed to ask them how they are going to help you in identifying all of the potential hazards that pertain to your operation and products according to the categories of hazards listed in the stated requirements below:
United States Code, 2006 Edition, Supplement 4, Title 21 - FOOD AND DRUGS


Sec. 350g - Hazard analysis and risk-based preventive controls
   (a)   In general
The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 342 of this title or misbranded under section 343(w) of this title, monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.
   (b)   Hazard analysis
The owner, operator, or agent in charge of a facility shall—
(1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including—
 (A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and
 (B) hazards that occur naturally, or may be unintentionally introduced; and
(2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and
(3) develop a written analysis of the hazards.

If the hazard analysis that they help you to conduct only involves the listing of what has been published elsewhere without considering your unique situations, environment, facilities, operation setup, supply sources, input materials, other incidental materials used, operation practices (including personnel practices and habits), processing steps, products, product delivery format, delivery channels, destinations, customer/consumer profiles, consumer behaviour that can be anticipated, etc., do not hire them.

Preventive Controls:
Secondly, ask them to provide an analysis of a "Preventive Control". See if they are able to accurately differentiate between "preventive controls" and "critical control points" as well as state the relationship between these. If they do not understand that "preventive controls" is the umbrella term that covers both critical control points and system control measures, do not hire them.

The foregoing list is the minimum. It is not exhaustive, depending on your particular operation, location, etc. Your hired trainer or consultant must cover these plus any other considerations that can be identified in your unique case. If they are not able to identify what applies in your operation; if their focus is only on reading the regulations and fumbling with the interpretation, do not hire them.

Also assess how much your prospective consultant or trainer can actually help you regarding the control of radiological hazards, etc. that are now included in the FSMA list of hazards. If they identify CCPs for controlling some of these hazards (for example a CCP for controlling radiological hazards in purchased raw materials), they may not be sufficiently knowledgeable about the relationship between preventive controls and CCPs, the proper application of CCPs, and the current global food trade practices. You should not hire them. 

The food industry needs problem solvers; not opportunists. It needs practical solutions; not the snake oil variety of solutions.

Posted by Felix Amiri
Felix Amiri is currently the chair of GCSE-Food & Health Protection, and a sworn SSQA advocate.

SSQA Supply Partner Risk Assessment Tool Kit

Updated November 29, 2016

Download the free DEMO Copy use the marked buttons to navigate through some of the key features
Unaided, the process of supplier risk assessment can be daunting. The SSQA Supply Partner Risk Assessment Tool Kit at least reduces, if it does not eliminate, the stress. This tool kit is recommended for use right from the initial material source qualification stages. It can be used for materials listed individually or for groupings of materials. The risk assessment process with this kit is described in section 2.4.4 and Appendix 4 of the SSQA Implementation Manual.

Although SSQA fosters an environment where some of the considerations and concerns are not anticipated, companies will find the Supply Partner Assessment Tool Kit to be very helpful.

The Tool Kit consists of a Material Category Risk Chart and Explanation Lists for the various risks (including nature of the material, sources, processing methods, supplier fraud vulnerability history, propensity, opportunities, tendencies, as well as the proximity, immediacy and possibility of food security threats, etc). The kit also has a Supply Partner Overall Risk Chart and an Action Decision Guide. Figures 1 – 5 show the various tools within the kit:

The Excel template has a dropdown field in every risk rating cell of the Supply Partner Risk Chart for selecting the determined risk levels. The database version further automates the master list with provisions for running supply partner performance summaries, for tracking supply partner status (e.g. approved, primary supplier, etc), for material risk categorization, etc. It also has a Document and General Change Management provisions that not only track document and other changes but also ensures any required training is completed.

The SSQA Supply Partner Risk Assessment model can be customized by SSQA facilitators to suit the unique needs of different operations. From simple to complex operations, this Tool Kit is designed for use with justifiable and verifiable conclusions about determined risks. The supplementary categorization of risk levels helps to minimize subjectivity and ensure consistency. Other considerations such as levels of exposure, risk tolerance and action level determiners are further discussed in section 2.4.4 of the SSQA Implementation Manual.

Inquire about the Supply Partner Assessment Took Kit
You may download the free DEMO Copy

Become a Safety, Security and Quality Assurance (SSQA) Facilitator 

Here is a recommended article about supplier verification under the United States FDA-FSMA. Among other things, it states: “. . . supplier verification under FSMA looks very different than it currently looks under voluntary industry programs.” – Full Article
Posted by Felix Amiri
Felix Amiri is currently the chair of GCSE-Food & Health Protection, and a sworn SSQA advocate.