Food Safety Data Documentation For Legal Case Requirements

Whitepaper

TASA ID: 1926

BACKGROUND

The food and pharmaceutical industries are both highly regulated. They produce products that people ingest, and digest into their body, which doesn't provide any room for error. The additional risk inherent to the food industry is that food products have a short shelf life and are perishable. Food product manufacturing is complex, highly mechanized, internationally traded, and largely unknown to most citizens. Unfortunately, litigation attorneys don't understand food processing more than the average person - except for state and federal food code laws and regulations. As a result, this white paper has been written to pull the curtains back and provide attorneys insight into the reams of information available for use in litigation cases. Some of the information is case ready, and other data must be mined to fit the overall case strategy.

LEGAL CASE STRATEGY

As a food and beverage expert witness, I always recommend that attorneys construct a case strategy that delineates the types of data required to support the strategy. I use the term "strategate©" to define the data mining process for identifying information that supports the case strategy. Strategate© sessions between an expert witness and attorneys also identify the data types, data formats, and data owners within a food and beverage manufacturing company. The goal of the Strategate© process is to provide general answers to who, what, when, where, and why questions. Following this structured process reduces expert witness case cost, generates case efficiency, and builds case clarity and integrity.

FOOD SAFETY DATA CATEGORIES

Numerous types of food safety data exist within a food processing plant's walls. The most familiar and researched information category is 'regulatory compliance data' (RCD). RCD data is available at local, state, federal, and international levels. This information results from governmental legislative actions, and at times results from prior case law. Legislative food safety information generally falls into two categories - mislabeling and adulteration. Food adulteration results from microbial, ingredient, and foreign material contamination. The more trendy adulteration cases may result from contamination with allergens, gluten, and GMO (Genetically Modified Organisms) ingredients. Most mislabeling issues result from pure ignorance of federal regulations. Other available data is HACCP or Hazard Analysis Critical Control Point, equipment performance (metal detectors, etc.), and product process performance (maintenance repair and equipment downtime).

The initial task of an expert witness is to determine the compliance or noncompliance with regulatory laws and regulations to answer the simple question - Did the food processing company manufacture their product in compliance with local, state, federal, and international country of origin (COOL) laws? Examples of this type of data are 'Standards of Identity' (SOI), USDA or FDA grader and inspector requirements, and compositional analysis. Furthermore, the 2011 Food Safety and Modernization Act gives the federal government wide discretion at closing a food processing plant if it feels public safety is at risk, or a food company cannot immediate provide supporting information to keep a plant open.

FOOD SAFETY DATA FORMATS AND DATABASES

For the sake of simplicity, food safety case data is available in the following databases: 1) Microsoft Word or Excel documents (also called 'flat files'), temperature recorders, relational databases (multi-dimensional relational databases that are the opposite of flat files), data marts or data warehouses, cloud storage (that replace data warehouses), and short-memory databases on specific working machines on a food production line. Some of the equipment database locations are found on the equipment control panels called Human Machine Interfaces (HMI). Other production data is called 'Time Series Data' because continuous production data is collected and stored on a temporary basis - such as weight data. Database formats can range from manual to electronic.

DATA MINING and REPORT GENERATION

Once an expert witness and his/her attorney agree on the food safety data required by the case strategy, know what specific data they are looking for, know where the data is located and how to access it, the next task is to begin the 'Data Mining' process. Data mining represents data collection that supports the case solution building, and comparing data to other events - often called relational data, stored in relational databases. The case information or data is summarized in 'reports' that can represent handwritten notebooks, typed documents, Excel spreadsheets, and electronic PC graphics created by SAP Crystal Report software (or similar brands). Full reports or partial reports can then be included in deposition testimony and/or declarations, or other court documents.

DATA COLLECTION THAT FITS THE CRIME

Now that we understand where the data is located in a food processing plant, what kind of data is available by different topics, who controls or holds security of data in different departments, when it is collected as well as the frequency of collection, we can fit the data to the crime. But before we do that, the crime (or food safety violation) must be clearly defined. Typical data includes food safety standard practices as well as broken data collection processes, quality assurance and quality control data, food processing data such as time and temperature heating logs, bar code and case code data, and other business intelligence (BI).

We've already discussed data mining in detail since it represents a growing capability in the information technology world. But even more important is the individual interview process of people with access to case relevant data, as well as those who store, secure, and report the data. Food safety case development is dependent on old-fashioned one-on-one interviews - a process that has worked for decades.

Since the data must fit the crime, let's review a few examples. If a foreign metal object is found in meat purchased at a local farmer's market or grocery store, the metal detection data needs to be retrieved. If the object is glass, then an alternative approach must be taken since glass can pass undetected though an X-ray machine.  A second scenario is microbial contamination such as Clostridium perfringens or E. coli organisms. In these cases, the expert witness needs to collect technical information like food temperature during processing, pH, acidity, and water activity. This information is foundational in determining if a growth environment existed. And third, an investigator must never be shy about using external, independent laboratories to test case samples - but remember, the output data must fit the crime and investigative strategy or it is wasted time and money.

DATA DEPOSITION

Once the expert witness has collected the data and formatted it into reports, attorneys or expert witnesses may conclude that they have not gained access to all the available data. To insure that hard-to-access data is available for review, further case deposition may be required. To do that, the expert witness and attorneys need to question the data 'Keepers-of-the-keys.' The deposition questions should be used to fill 'information gaps' in completing your case strategic report. This information now needs to be continuously compared to existing regulatory standards. Another way to describe this is case data benchmarking.

WHO TO DEPOSE

Once we fully understand exactly what information needs to be deposed, a careful determination needs to be made regarding 'whom' to depose. Unfortunately, in the food industry, all case-relevant food safety data does not reside with one person.  In reality, segments of case data are spread throughout multiple departments. A short list of people to depose includes the in-house microbiologist, quality assurance manager, plant manager, quality control manager, food safety coordinator, chief information officer (CIO), CEO, and compliance program team leaders. Examples of compliance programs include risk management teams or incident management teams. A good starting point question is - Who Knew What When?

In food safety cases, there should never be hesitation to depose the CEO or members of the executive team. Ultimately, the CEO is responsible for the commitment to the corporate food safety program. Any food safety program gaps can be quickly exposed by interviewing people at the top and bottom. Remember, you're looking for a pattern of food safety excellence, or neglect, or an incomplete training program. More progressive CEOs are now implementing external independent food safety program audit teams as an additional layer of protection for their company. But don't assume these external teams are foolproof. I have seen glaring information technology gaps in these teams so far.

SCOPE OF 'SUPPLY CHAIN' DATA STRATEGY

The term 'supply chain' is rarely connected to food safety cases, but it should be. After spending 20 years working in restaurants and food manufacturing plants, I found that most visible food problems resulted from a sequence of prior food issues that are visible and invisible. This principle when applied to food processing is called the supply chain. Collecting supply chain strategic data means that the expert witness needs to review the sourcing of individual ingredients from disparate suppliers that are combined to make the finished goods. The finished goods are then routed through various transportation systems and distribution centers before they are delivered to the final consumer purchase destination point. By carefully examining every step of the supply chain process, you improve your chances that the case is placed in the win column.

SAMPLE SECURITY AND INCIDENT INFORMATION REQUIREMENT CHECKLIST

In my expert witness practice, I use the following checklist to begin my assessment of new cases. This checklist has resulted from 25 years of working in food and beverage manufacturing plants, and understanding the hard questions that need to be asked to get the case into the win column:

1. Food Sample Security & Management
2. Sample Incident Specific Information
3. Pre-Incident Information
4. Documented Incident Information
5. Post-Incident Information
6. Incident Location Information
7. People with Incident Knowledge
8. Log Sequence of Events: Product Recall Timeline
9. Data Collection Frequency & Time Sequence
10. Case Specific Federal, State, Local Regulatory Data

In summary, once the contaminated or adultered food sample was identified, was it placed in a secure environment, and what security management protocol was followed to protect the sample's integrity? The sample should be treated as crime scene evidence because the litigation case success hinges on these questions. Second, the expert witness needs to document as much information as possible regarding the sample incident. Just like the crime investigation reality show 48 HOURS, immediate information is the best information. Third, pertinent pre-incident information must be sourced. This represents information that could have affected the outcome of the incident, i.e. temperature abuse of a food ingredient prior to incorporating it into the final product recipe is critical incident information. Fourth, document the incident information into categories: regulatory abuse, temperature abuse, contamination (insect, etc.). Fifth, log any post-incident information. This information quite often results from a second round of interviews; it is like fitting the missing pieces of the puzzle together. Let's PAUSE a second here. One of my biggest challenges for the Expert Witness is the way incident samples are managed or mismanaged.  Clients may collect a sample from the food they ate and send it back to the store or manufacturer without any protection guarantees. They should immediately contact an attorney to determine where to securely "PARK IT." The remaining 5 steps speak for themselves.

TOP 10 CASE BENEFITS FROM A HIGHLY EFFECTIVE DATA STRATEGY

I can identify at least 10 case benefits resulting from a highly effective data strategy:

1.       Case efficiency results from creating and following an efficient strategic plan.

2.       Case efficiency also results from prior identification of data locations and databases

3.       A strategic plan identifies key personnel to interviews - including database stakeholders

4.       A supply chain data strategy insures all data throughout the supply chain scope is reviewed and a comprehensive case risk analysis completed.

5.       A systematic data assessment exposes data gaps between personnel, responsible departments, and regulatory agencies

6.       A structured project analysis plan creates well-defined project milestones and timelines

7.       A clearly delineated case strategy reduces expert witness time - fits a plan

8.       Careful case planning also reduces expert witness cost - because they are more efficient

9.       A well-written case strategy also creates a more effective court presentation

10.   And the attorney is never in the 'investigative dark' because the strategic plan was co-developed with the expert witness

CASE EXAMPLE # 1: E. coli FOOD POISONING

Since each food litigation case has different information requirements, I have included a short information checklist that can be used as a template for food contamination cases. Please remember that this is only a brief starting point.

1. Types of Data Required:
   
   - Product and Plant History
   
   

   - Production Data

   - Store/Consumer Data

   - Product Recall and Destruction Data

   - Safety Program Training

2. Information Locations: Plant & Distribution
3. People with Knowledge/Decision Makers
4. Data Collection Frequency
5. Time Sequence Data
6. Sequence of Events Data: Product Recall Timeline
7. Strategic Approach

SUMMARY

I hope this white paper helps you develop higher quality case strategies and technical arguments in food safety cases. I tried to reach a balance of a holistic overview and provision of critical detailed information. Remember to develop a case strategy before doing anything else - and follow the Strategate© process.

This article discusses issues of general interest and does not give any specific legal or business advice pertaining to any specific circumstances.  Before acting upon any of its information, you should obtain appropriate advice from a lawyer or other qualified professional.

This article may not be duplicated, altered, distributed, saved, incorporated into another document or website, or otherwise modified without the permission of TASA.