Food and Drug Safety: Prevention Better Than Cure (For Sure) - Part 1

Food production and distribution is a serious and strategic business, and I am not aware of anyone in my surroundings that takes it lightly; food can not only delight us, but can also make us quite sick and indisposed. While my inner circles (pets included) have luckily not been casualties of recent salmonella, E.coli, and whatnot outbreaks from tainted chilly peppers, tomatoes, spinach, pet food, or most recently peanut butter, the 2008 year-end holidays were not much fun for my family.

Namely, the "G.I. bug" that our 18-month-old likely got in her playgroup spread so quickly and violently to anyone who was in contact with her (including the broader family members that stopped by to just traditionally exchange holiday gifts). Sure, viral gastroenteritis might likely have had nothing to do with what we ate at the time, but the feeling of being listless and other unpleasant (and unspeakable) G.I. bug symptoms were quite similar to those that food poisoning outbreaks can “treat” us to.

Food processing and distribution are not be the only market with burning product safety issues, since similar issues can also apply to the drug and pharmaceuticals sector or consumer packaged goods (CPGs); remember lead-tainted toys or antifreeze-laced toothpaste coming from China? Still, we all seem to be the most sensitive about food-related breaking news, possibly due to the likelihood of those hitting home (perhaps even in a willful way by bio-terrorists).

Thus, some food processing market experts have lately been frustrated by companies’ focus on location and lot control, serial number tracking, and traceability as the panaceas to solve product safety issues.

While important, these critical capabilities still help mostly with minimizing the damage (i.e., during product recalls), but the damage to customers and company’s brand has unfortunately already taken place, leaving many folks seriously ill (if not even fatally affected).

Track-and-trace After the Fact: Good But Insufficient

On the other hand, while I agree that detecting the problem before "the horse leaves the barn" would be a great use of IT tools, my IT experience still only involves location and lot tracking (while the product is in the hands of the manufacturer) and traceability (once the goods go to the customer). The goal has typically been the immediacy of problem identification and minimizing the extent of a product recall.

Sure, random sampling of ingredients is usually performed by labs and quality control (QC) departments, but they can only report an “accept” or “reject” status. To also be fair, Hazard Analysis and Critical Control Points (HACCP) is a systematic preventive approach to food safety and pharmaceutical safety that addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection. Still, like lot control and traceability, HACCP is only a piece of a much broader product safety issue.

Proactive Product Safety

Some of the market experts within leading enterprise resource planning (ERP) vendors have thus started to develop a broader strategy to proactively protect food safety. The higher the risk (e.g., from non-processed “bag & ship” leafy green vegetables, seafood, meats, fruit and vegetables, dairy products, etc.), the greater the need for a proactive strategy.

Ultimately, this proactive approach could become part of an overarching governance, risk, and compliance (GRC) strategy (and message). Namely, companies can either choose to be reactive and support regulations and tracking as an imposed requirement or take a more proactive stance as part of a more comprehensive corporate social responsibility (CSR) message.

In other words, providing nutrition labeling and track-and-trace capability is one thing, whereas adding food education and balanced eating with more "green" or "organic" products is a whole different level that goes beyond simply compliance reporting. Implementing a comprehensive food safety management program both on the internal production side and overall supply chain side is one thing, whereas educating consumers is a CSR message.

Certainly, phrases like "organic or real food" and "farm-to-table" may sound like elitist jargon tossed around at upscale restaurants, and completely out of touch with the folks than cannot afford even a $0.99 burger (or such junk food) these days. But the country's top chefs, several of whom traveled to Washington, DC for President Obama's recent inauguration, hope that Obama's apparent flair for good and healthy food will encourage people to expand their horizons when it comes to what they eat.

These chefs tout locally grown, environmentally friendly and - most importantly - nutritious food. They urge diners, even those who may never be able to afford to eat at their extravagant restaurants, to grow their own vegetables, shop at farmers' markets, and pay attention to where their food comes from.

But before this “organic pie in the sky” becomes a reality, let’s see what some pundits within ERP providers have in mind when it comes to being proactive about food safety. Whenever there is a serious discussion about the food industry, one cannot avoid Olin Thompson, VP of Industry Strategy at Lawson Software and former contributor to TEC’s newsletter (e.g., see TEC’s previous article entitled “Food Safety, Government Regulations, and Brand Protection”). Lately, Olin has been talking about his (and Lawson’s) holistic approach as the "Four Ps" ("4Ps") of Food Safety (along the lines of well-known 4Ps of the Marketing Theory).

"Four Ps" of Food Safety

The first “P” is “Prevent” or take steps to avoid a problem, since the best defense is good offense. Olin considers this as the most important of the four Ps, whereby sanitation, QC, and HACCP are some utilized practices. The idea is to build a quality fence around your business, with top management’s genuine commitment to food safety. To that end, your business system should provide the following capabilities:

The second “P” stands for “Prepare” or build the ability to react to a problem if and when it happens. Good preparation presumes that you will have an incident and prepares you to respond via integration of food safety data with operations and automated data collection (ADC), storage, and analysis of food safety data. To that end, your business system should provide lot track-and-trace and location management capabilities.

Next comes “Prove,” to both yourselves and other concerned parties, that you are preventing problems and you are prepared to react if you have one. In other words, you have to be able to prove to all concerned parties that your product recall system will respond when it is needed (whether due to problems of an internal nature or coming from customers and regulators). This can be achieved by frequently testing the system, whereby the business system should be able to conduct mock recalls.

Finally, the last P is “Proactively respond” (OK, Olin acknowledges that it requires a little stretch here to get another “P”). Namely, if a problem is uncovered, one must be aggressive in addressing the recall and other needs, since holding back usually makes it worse. All incidents must be taken seriously and the company must respond quickly and completely.  Over-response is often less expensive in terms of dollars and negative PR than under-response.

While management commitment to a proactive response is critical, the company’s business system should also provide rapid recall support. In other words, to meet the four-hour response requirement set forth in the Bioterrorism Act of 2002, the system must provide the actionable information in minutes rather than hours.

Which Enterprise Applications Can Cater to the 4Ps of Product Safety?

The critical part in the 4Ps-enabling applications landscape would be a Process Manufacturing ERP system like Lawson M3 [evaluate this product]. These systems are typically the most important for tracing and establishing the quality fence. Namely, ERP systems process inventory transactions that can come from the entire value chain. Process manufacturing ERP systems often have the laboratory software applications as well, while the procurement module can handle specifications, vendor certifications, and vendor rating.

Interestingly, Olin doesn’t consider product lifecycle management (PLM) systems to be critical with regards to product safety. Still, he at least acknowledges PLM systems’ help with creating quality specifications and matching approved ingredients to geographic markets (e.g., can this ingredient be in a product that is going to be sold in Japan?).

Supply chain event management (SCEM) tools are certainly critical for visibility and action reasons, albeit they can overlap with the inventory management modules of ERP systems. These visibility and workflow-based tools help only if they have lot tracking capabilities, perhaps bolstered with radio frequency identification (RFID) sensors and accompanying applications.

To that end, recently launched Lawson M3 Trace Engine is a standalone solution that combines repository, SCEM, data cleansing and integration, and workflow capabilities for food safety in extended supply chains. The product was described in great detail in my previous two-part blog series.

Manufacturing execution systems (MES) are important since HACCP capabilities are often found within them, but typically a MES is lot-blind and thus has to be interfaced to an ERP counterpart.  Likewise, a laboratory information management system (LIMS) or quality management system (QMS) is a critical part of the quality fence for handling testing rules, analysis of results, vendor ratings, lab instructions, etc.

But as a standalone solution LIMS/QMS is usually not linked to a recall system. Most recall systems are part of ERP, which again demands some involved integration or interfacing.

Part II of this blog series will introduce another process industries expert and his proactive product compliance strategy. Your views, comments, opinions, experiences, etc. about the abovementioned food safety issues are welcome in the meantime.
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