Bridging the Quality Control Gap: How Six Sigma Can Increase Plant Food Safety and Profitability
In order for food safety professionals to preserve a value-perceived position in industry, we have to understand the business. We also must be able to make and support business decisions; however, we must always be the ethical and legal conscience of the organization when food safety is being encroached upon to deliver business results—that is our credo as food safety professionals. It seems like this principle should be understood by now, but when managing complicated processes within expansive supply chains under extreme pressure to exceed cost reduction targets we must continue to remind our peers and executive teams that food safety is a mandatory prerequisite to the business model. Why? Because of all business deliverables it is the most noticeable when it is absent.
Consider this: If your organization doesn’t deliver on the short-term key performance indicator (KPI) of order fill rates, your products may be temporarily replaced by a competitor’s at a big box retailer. A consumer who prefers the product might not be able to purchase it for a period of time and may switch to another brand. If product deleritous to public health reaches the same shelves, the entire brand could now become defunct. Obviously, the smallest error or omission can yield significant long-term damaging effects to a business—seven-figure recalls are common and costs can escalate rapidly when dealing with a big box retailer or national food service establishment. We must continuously reaffirm to ourselves that safe food products are viewed as an entitlement by our consumers and customers, not another pricey convenience feature. Just because a can of green beans can be purchased from a mega-grocer for $0.59, when the leading national brand is $1.06, consumers do not anticipate that the inexpensive product is marginally safe in comparison.
Most of us do realize that the hazards and business pressures that organizations face on a daily basis are in a constant state of flux. Simply looking at what constitutes a hazard to public health is an interesting exercise: Less than a decade ago most manufacturers and foodservice establishments wouldn’t have foreseen that the process of removing undeclared residues of the “Big 8” allergens from their supply chains would become such a monumental task. The regulatory and public health reasons for getting “clean” have fostered the development of entirely new product lines of inexpensive rapid test kits (with levels of detection in the low part per million range), and specialty consulting firms and a number of diligent organizations are now entirely dedicated to conducting allergen-specific scientific research.
As part of our duties, we must learn to recognize evolutionary forces as they are emerging so that we are not later buried by them. A company pursuing the path of the dinosaur, either failing to evolve or forcefully adapt, will find over time that its resources and assets will become the fuel utilized by its better-positioned adversaries. By learning practices that are commonplace in other industries a proactive corporation can identify methods to more readily adapt and preserve its business position (i.e., brand equity, share, margin and corporate identity), while still managing to protect public health. Our execution strategies must continually evolve as the vast body of knowledge we are responsible for mastering is constantly reshaped. So, what are we doing as food safety professionals to proactively prepare our organizations?
The Hazard Analysis and Critical Control Points (HACCP) program is the current paradigm for achieving food safety deliverables, and the emphasis that we in the food safety community have placed upon this systematic approach is well deserved. By utilizing a uniform HACCP approach we have effectively identified and mitigated food safety hazards across the globe. Historically speaking, the eager consumer base we service is now in a golden era of food safety entitlement, though many outside of the food industry do not recognize the extent of this achievement. Unfortunately, many of us have not realized that by failing to diversify our approach to food safety we have settled into a suboptimal position for the business. However, by spanning self-imposed industry boundaries that confine us to examinations of processes internal to our own food production/service operations, we can instill a new paradigm that positions us to drive results that exceed those currently possible via use of HACCP alone.
Through integration and mastery of ancillary philosophies and toolsets from Six Sigma, total productive maintenance (TPM) and Lean Manufacturing, our mission to deliver products that are inherently safe and wholesome will become much easier. Further, when applied properly, we can simultaneously drive breakthrough results in operational excellence for our respective organizations. When referring to results as “breakthrough,” I do not mean a marginal tenth of a percent improvement in cost of goods sold (COGS). More appropriately, we are referring to results such as: 1) a 3-5% reduction in COGS; 2) delivering undiscovered manufacturing capacity by increasing overall equipment effectiveness (OEE) by 15-20%; and 3) measurably increasing product/process safety parameters by a full order of magnitude—that’s truly breakthrough.
Making Tasty Bites the HACCP Way
Most manufacturers are operating under HACCP although the food safety management system is only mandated currently for use in meat, poultry, seafood and juice operations. In order to understand how we can better augment HACCP with ancillary toolsets that may help keep us ever-adaptive, we must first examine a typical program in operation that we’ll call the Tasty Bites Corp.
Production and large foodservice organizations within the mid- to upper evolutionary tier are usually governed by well-detailed HACCP plans and formal specifications for existing products. Tasty Bites Corp. is no exception. There is an accompaniment of policies, procedures and work instructions readily available to personnel accountable for the day-to-day management of the HACCP plan within these operations. The documentation is developed and maintained as part of the documented quality system (DQS). Trained operators, or even dedicated inspectors, perform the documented monitoring and verification functions in compliance with the written plan. Corrective actions are understood and in place for any product/process that does not conform. Likewise, containment practices are well developed for ensuring products and ingredients identified as nonconforming do not leave the immediate control of the facility. Qualified reviewers and auditors are in place for plan verification and pre-shipment record review. As a final measure, a highly detailed systems audit schedule is maintained by the quality organization to provide evidence of the overall health of the system.
Tasty Bite Corp.’s HACCP plan is updated at least annually, unless a significant change has occurred, such as the introduction of a new product, new ingredient, new supplier, new process or other significant event (i.e., a documented CCP exceedance). The operation may take on further investment to gauge the health of their program by employing the services of a qualified third party auditor to observe operations, over time. The operation will then use the auditor’s findings for continuous improvement and/or further verification of the functionality and appropriateness of their system.
Typically organizations guard and preserve their HACCP documentation as proof that the CCPs were in control throughout the duration of manufacturing, and that the process output was reviewed as acceptable by an accountable member of management. Organizations that assemble products under a regulated HACCP plan are well versed in the requirements for such documentation, and often there is intense governance of the chain of custody and retention of records (often implemented by dedicated personnel). So what then does the typical product of this exercise look like?
Figure 1 shows “Monitoring Form 5: Process Log,” a sheet that could represent any CCP monitoring step form for any process. For pragmatic reasons, let’s say that, in this case, we are monitoring the percentage of an extremely effective antimicrobial ingredient incorporated into a product to inhibit the outgrowth of pathogens throughout its shelf life. Our hypothetical company is manufacturing Tasty Bites, a product that consumers adore and retailers clamor over due to its inventory velocity and attractive gross revenue per unit sold. The corporation’s marketing team loves the product, the sales organization relies upon it to drive the quarterly top-line, and the consumer base remains loyal due to its consistent aesthetic quality and convenience factors.
The monitoring results for CCP #1 are presented here (remember that this is a very important antimicrobial ingredient)—and the repeatable scientific studies conducted by teams of competent food microbiologists have found that if the concentration of the ingredient within this product matrix falls below 3.7 a biological hazard is reasonably likely to occur. On the flip side, if the product were to contain levels greater than 3.85, the regulatory agency governing the product has stated that a small population of consumers will be at risk of having serious adverse reactions. The organization has therefore established that the manufacturing operation will target a value of 3.75 for the antimicrobial content of finished products destined for sale to the general public with corrective action required for any product that possesses levels <3.7 or >3.85. These values represent the critical limits (CLs) within the organization’s HACCP plan.
As part of the monitoring process, the organization removes representative samples of Tasty Bites from the process and subjects them to an at-line rapid chemistry method to determine if the CCP is in control. As samples are pulled throughout the day and tested an auditor performs periodic verification activities to observe whether the monitoring function is performed according to established protocol. Review of the documentation displays that auditors verified and even physically measured a sample in concert with the process monitor. The CCP monitoring log was reviewed for errors by a designated QA representative, and as part of the organization’s positive release procedure, the record is signed off and dated. If a CCP exceedance was documented, a corrective action process would ensue, comprised of the steps outlined at the bottom of the form and the quality group would contain the product until the evidence is further examined.
Now let’s examine process monitoring record summaries collected while producing Tasty Bites. At this point, the monitoring for CCP #1 has been completed, the results verified as legitimate and compared to the CLs by both the auditors and record review personnel. The summary in Table 1 displays that all samples measured in the first shift fall within our established critical control limits, so the organization decides to release the product for distribution and continue making a windfall of profits that drive shareholder value.
In examining the process monitoring record summaries for the next shift of production, observe that sample 7 is above the defined critical limit (Table 2). What has happened to change the outcome? The quality group places the product on hold for further evaluation, but what can the organization do next? The options proposed by various members of management within the organization will vary. The proposals may range from being 100% corollary to the established body of reasonable knowledge to those seemingly grounded in pure mental instability. Either way, the quality cops (QC) have now held the product, quarantined it and may spend their time reinspecting the entire lot of Tasty Bites. Maybe the company can rework the product, and get the antimicrobial content down to an acceptable level. Unfortunately, this will require resources that aren’t available within such a capacity-constrained supply chain. Landfilling the product is an easy disposition for anyone to carry out, but once again, costly for the organization. Maybe the company will choose to potentially frustrate consumers by attempting to reformulate the product because trying to manage such a stringent specification wasn’t a good idea anyway.
Obviously, playing a game of Russian roulette with public health is not a viable option, but the rest of the exercise that we’ve done here is one that occurs on a daily basis within corporations across the globe. Tabular data was evaluated and a binomial decision (good or bad, no inbetween) was generated. Our focus, and those of the process monitors, auditors and records review personnel was to ensure that the documentation was properly completed and to compare each measurement to the established specification to ultimately judge the safety of the product and its ability to meet the regulatory requirement. Typically, corrective action would only be initiated when a measurement were to exceed a critical limit. The tabular data displayed did not appear to be problematic during the first shift of production—after all the Tasty Bites produced were within the defined CLs. The results from the second shift were unacceptable, however, and required immediate corrective action. The second shift folks must be the problem, right? The company may just terminate one employee per hour from that shift until the product is acceptable! While deriving our judgment on the fate of the product we weren’t even focused upon what the process was doing—we missed that picture altogether. That’s the key: the behavior of the process is what requires the majority of our focus, not inspecting the product itself or looking for a scapegoat to serve up to senior management. By doing this we will be more likely to not violate our HACCP plan, and not continuously face the costly exercise previously outlined.
The HACCP system, in this example, seemed extremely reactive and didn’t help drive improvement of the process, the business or, as we will see later, may not even offer a high level of consumer protection. The intent of HACCP, however, is to compel us, as processors, to recognize and focus upon the mitigation of hazards that are inherent to our processes, products, ingredients and packaging materials. Within organizations that lack focus on continuous improvement and process control, HACCP programs become extremely tollgate in nature—the emphasis is on stopping the “bad” at all cost while letting the perceived “good” go through unquestionably. A well-developed HACCP system may be the current best approach for delivering food safety and when implemented properly serves us well. We must augment our HACCP systems and prerequisite programs with continuous improvement systems like Six Sigma, because as of right now, many organizations are producing an unpredictably high level of waste while simultaneously overtaxing finite resources required that could be better utilized for continuous improvement.