Reanalysis—A Critical Component of Verification

A Hazard Analysis and Critical Control Points (HACCP)-based program is not a document that is simply written and forgotten. Changes occur over time, whether those are related to the facility, the process, or the ingredients. In addition, collective knowledge about science and technology improves; for example, the survivability of a given pathogen under certain processing conditions or the effects of climate change (drought) on increased incidence of mycotoxin hazards in raw agricultural commodities. Due to these factors, a company's Food Safety Plan/HACCP Plan ("the plan") must adapt to reflect these ongoing changes and any new information. This is where reanalysis comes in. Reanalysis is a critical component of the verification principle where the plan is reviewed to ensure that it is accurate and applicable, and that it reflects change and improved understanding. Reanalysis activities also incorporate the review of records to identify trends.

When the time comes to reanalyze the plan, this process needs to be more than a "rubber-stamping" of the current plan; it needs to be a chance to truly confirm that the plan is working and is sufficient to control the identified hazards. Within this process, it must be ensured that all required documentation is present including validation support and process records. It is reaffirmed that all hazards have been identified, that appropriate controls are in place for these identified hazards, and that these controls are performing as intended.

One issue is that, too often, the reanalysis process is not considered until the last minute, when it is time to conduct that activity due to a regulatory deadline or third-party audit requirement. Reanalysis should occur at a frequency that ensures the plan is being followed continuously. For the reanalysis process to be most effective, it should be part of an ongoing process of gathering information from internal sources, as well as external sources. One should not wait passively for that stated time to pass to review the plan, but instead look for signs and trends that indicate when a review is needed.

Internally, it is recommended to look at all changes to raw materials, process, and product, as well as indicators that something may be going awry. Externally, it is recommended to look at information involving suppliers, other companies processing the same or similar products, and the broader industry. It is important to follow developments in science that address the ingredients and processes used and the advances in understanding of the associated hazards. If this ongoing activity becomes part of a normal review regiment, then the reanalysis process will be more fruitful, occurring when it needs to rather than coming about as just a "check-off" item to meet regulatory or third-party audit time requirements.

Reanalysis is One Component of Verification

Verification, a key principle within the HACCP-based program, is the application of methods, procedures, tests, and other evaluations, in addition to monitoring, that determine: 1) the validity of the plan, and 2) that the system is operating according to the plan. Think of verification as an umbrella with three key components underneath the umbrella:

Verification of implementation and effectiveness—e.g., review of monitoring, corrective action, and verification records; calibration of process monitoring equipment; and product testing
Validation, the component of verification focused on collecting and evaluating scientific and technical information to determine if the Critical Control Point (CCP) or Process Preventive Control can effectively control the identified hazard when the plan has been properly implemented
Reanalysis of the Food Safety Plan.

The activities involved with the first verification component occur frequently, such as ensuring daily compliance of process controls (e.g., calibration, record review, and product testing). This ensures that the plan is working as it was designed. The second component, validation, establishes the scientific basis for the CCP or Process Preventive Control in the plan utilizing scientific principles and data, expert opinion, or challenge studies and is typically conducted before the Food Safety Plan is implemented and whenever changes occur that would impact the efficacy of the process control. The third component, reanalysis of the Food Safety Plan, is the review of the overall plan for compliance. This not only ensures the plan is being implemented properly, but also gives the chance to review whether the elements of the plan are correct. Reanalysis, by definition, is "a verification procedure to assure that the Food Safety Plan remains valid and the food safety system is operating according to the plan."¹

When is reanalysis started? At a minimum, a plan should be reviewed at a set frequency selected by the company, but often is determined by regulatory or third-party audit requirements. Since regulatory requirements for reanalysis can be one to three years, it is advisable that more frequent reanalysis be conducted. Certain situations should also trigger a reanalysis:

A significant change in the process or other activities conducted within the facility that impact the control of the hazard or increase the likelihood of a new hazard
Changes in raw materials or suppliers
Adverse findings obtained in monitoring or verification activities
New information about potential hazards associated with the food
Changes in downstream supply chain practices—distribution, further processing, or sales
New consumer practices
If the plan or a control is found to be ineffective.

Any significant changes to the process require, at a minimum, a review to determine whether these changes have impacted parameters that can affect the safety of the product. If new information is gained about a pathogen—perhaps its ability to survive under conditions similar to those used in the process—or if a supplier is involved in a recall, then this may necessitate a reanalysis. This reanalysis will help determine if these changes (or new information) have impacted our understanding of control detailed in the hazard analysis.

Without any change or new information, the plan can be reviewed at regular time intervals. Industry practice dictates that reanalysis be completed at least yearly. As part of regulatory requirements, there are also regulated timeframes for reanalysis. For the U.S. Food and Drug Administration's (FDA's) Preventive Controls for Human Foods regulation, reanalysis must occur at least every three years [21 CRF 117.170(a)]. FDA's Seafood and Juice HACCP regulations and USDA's HACCP regulation require a yearly reanalysis.

Reanalysis in Response to Change in Ingredient, Process, or Product

It may be difficult to know when a change will be significant enough to impact the safety of the process or product. Therefore, it is best to have a procedure in place to review all changes in terms of their impact on the Food Safety Plan. The organization must be disciplined in following these procedures regardless of whether some initially perceive these changes as small or insignificant. The procedures must require that the changes are reviewed prior to being made.

Looking at this from a flow-of-food perspective, any changes to the ingredients and the suppliers of those ingredients must be addressed. This may involve the use of a new supplier of a given ingredient and/or changes to the ingredient itself, whether that be in the formulation of the ingredient or its processing. It can include a change in the supplier's operation—e.g., the supplier has introduced a novel allergen into its operation. It can also include a change in a supplier's supplier of an ingredient.

Similar changes can occur in one's own facility, including changes to formulation, processing, equipment, packaging, and storage. The addition of novel allergens or allergen combinations can affect production run cycles and sanitation, as well as labeling operations, so this must be carefully reviewed. In addition, the relocation of equipment may impact the ability of the unit to perform correctly—e.g., moving a metal detector from before the product freezing step to after the freezing step may impact the detector's sensitivity and ability to detect metal, due to changes in the composition of the product.

Looking downstream in the flow of food, changes to distribution practices must be evaluated—e.g., storage or downstream processing, where new conditions can expose hazards that had not been viewed as a risk under the previous evaluation. For example, if product had been shipped and kept frozen to the point of processing, but now the product is thawed under refrigeration for a period of several days prior to processing, then the opportunity for pathogen growth may emerge, especially in the case of temperature fluctuations during storage.

Utilizing a mandatory review process for these expected changes can help better identify potential risks before the change is made, and the risk can continue to be evaluated after the change has been made. Without such a review process, the determination of risk is often left to the person or people who are making the change. There are several problems with this. For one, this person may not have the level of knowledge needed, or they may be willing to forgo an in-depth review (i.e., hazard analysis) to expedite the change. In some cases, the person may take it upon themselves to decide that the change is insignificant and that there is no need for further review. For example, the maintenance manager may decide that moving the metal detector after the freezer is an insignificant change, and not realize that the detector would need to be recalibrated for frozen food conditions.

Having changes reviewed by a team, at the very least, ensures that the facility's most qualified individuals have a chance to review them. Involving more than one person in this analysis ensures that more than one point of view will be considered.

internal sources, as well as external sources. One should not wait passively for that stated time to pass to review the plan, but instead look for signs and trends that indicate when a review is needed.

Ongoing Evaluation of the Process and Associated Parameters

Processes can vary over time, often related to equipment wear, new employees, laxation of procedures, etc. Increases in process variability can then result in loss of control and suspect product produced. Therefore, an ongoing, in-depth analysis of process data and other related information must be in place not only to look for potential issues, but also to identify indicators that potential issues may exist.

Recurring adverse findings are a sure sign that something is not right. An adverse finding is not limited to process deviations where a critical limit is not met, although that certainly necessitates reanalysis. Adverse findings include indicators that signal increased process variation, or data trending toward the point of deviation. In these cases, because a deviation has not occurred, the same attention may not be given to the deviation from a critical limit. However, this should not rule out the need for conducting a reanalysis. The goal here is to determine and correct the process before the critical limit is violated.

Adverse findings can be related to product testing results that are slightly out of specification. For example, higher-than-normal microbial levels discovered through testing could be indicative of something amiss within the process. If standard bacterial counts begin to climb, what does this say about the process or the process environment? It may not yet indicate that product must be held, but it should not exclude the need for reanalysis. Another example is detection of metal in a product and conducting an immediate investigation of the root cause, instead of waiting for the scheduled reanalysis date.

Consumer complaints is another parameter that should receive regular and careful review. Are trends emerging in the types of complaints received? Is a root cause analysis completed for complaints that may have a more serious nature? Are trends evident within the consumer complaint data?

Ongoing evaluation of these various parameters cannot be happenstance; rather, they must be part of the regular evaluation routine.

External Evaluation for New Information

In addition to evaluating internal data, the evaluation of external information must be part of a routine review. Recalls, outbreaks, and FDA warning letters are a few obvious sources of information that should be reviewed on a regular basis. Additional information sources include reviews of scientific literature, especially concerning similar processes and types of hazards, as well as less scientific sources of information such as social media.

Tracking food safety issues throughout the industry provides information that may have a direct bearing on one's own operation. For example, a recall that was linked to a similar ingredient or process used by one's own company should be a red flag. In this case, one would want to investigate this issue further to understand what implications this may have on their facility.

New information, such as a published article in a scientific journal, regarding similar hazards or control measures may also trigger reanalysis efforts. If a published study finds that a pathogen has increased heat resistance under certain situations, and this pathogen had been identified in a hazard analysis by one's own company, does this information have any bearing on one's control over this pathogen?

New consumer handling or preparation practices may also trigger the need for reanalysis. Consumers are constantly finding new ways to use food products, including ways that were not intended by the manufacturer. These new uses are often perpetuated to wider adoption through social media channels, so that even more consumers are using these novel—and potentially more risky—practices.

A great example is the use of various frozen foods in making smoothie drinks. While the intent of the manufacturer of that frozen food, as detailed in the cooking instructions, was to have that product fully cooked, consumers are adding the frozen food directly to the blender to be consumed without any further processing. What impact does a novel practice have on these products, and how is that reflected in the hazard analysis?

A Reason to Reanalyze Now—Post-COVID Impacts

In the post-COVID-19 environment, there are many compounding factors that impact the need to conduct a reanalysis. While information may not indicate the need to conduct a reanalysis, it may be a good idea to make sure that the operation has a full understanding of current processes and procedures.

High turnover of personnel (whether that be the quality manager or technical staff) may lead to a situation where new personnel are not fully aware of the plan details. Conducting a reanalysis before there is an immediate need to conduct a reanalysis may provide an opportunity for new personnel to gain an understanding of the plan, where the documents are stored, what types of process validation exist, etc.

In this post-COVID-19 environment, the food supply chain has been severely impacted. As a result, many changes may have gone unnoticed. In some cases, regulatory labeling requirements were relaxed. Purchasing managers have been forced to become nimbler in getting supplies to keep plants running and may have utilized alternative sources of materials, or their suppliers may have found alternative suppliers. A reanalysis may provide the opportunity to review changes that could have impacted the supply chain.

The Food Safety Plan/HACCP Plan is a living document. It requires ongoing maintenance to ensure that the plan adapts to change. Reanalysis is the process by which the plan is ensured to remain valid, and the food safety system is ensured to be operating according to the plan. For this process to be most successful, it requires an active review of internal information that includes changes to process and product, as well as data related to process variation, product testing, and consumer complaints. A process for reviewing external information (both scientific and social) must also be in place.

References

Food Safety Preventive Controls Alliance. "Preventive Controls for Human Foods Training Curriculum." V1.2, First Edition, February 2016.

Martin Bucknavage, M.B.A., M.S., is the Senior Food Safety Extension Associate with the Penn State Department of Food Science and a member of Food Safety Preventive Controls Alliance Executive Advisory Board.

Kathy Gombas is a Food Safety Consultant with FSMA Solutions and Chair of the Food Safety Preventive Controls Alliance Executive Advisory Board. Kathy was formerly a Senior Advisor with the U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN).