BALANCING COMPLIANCE, RISK, AND PERFORMANCE HOW TO ... · Optimizing Your FSQM System for Better Results There are a few ways you can optimize your company’s FSQM system to achieve

BALANCING COMPLIANCE, RISK, AND PERFORMANCE HOW TO OPTIMIZE YOUR FOOD SAFETY AND QUALITY SYSTEMS

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Balancing Compliance, Risk, and Performance: How to Optimize Your Food Safety and Quality Systems

For food and beverage companies, managing compliance is an integral component of everyday

operations. In addition to complying with regulatory, audit, and customer requirements, organizations

must also protect themselves from product recalls and foodborne illness outbreaks. For quality

assurance (QA) teams, keeping up with these requirements can be challenging in itself. Moving

beyond basic compliance to actually improve operations and proactively mitigate risks for optimized

performance is thus even more demanding.

There are many complexities associated with balancing compliance, risk, and performance. Yet, the

elements of this trifecta are all connected: Once QA professionals are able to effectively manage food

safety and quality compliance and risks, performance will improve as a result.

Throughout this guide, we’ll cover simple yet effective strategies for optimizing food safety and quality

systems for improved operational performance. Key focus areas include:

check Establishing effective foundations for Food Safety and Quality Management (FSQM) systems

check Assuring regulatory compliance and audit standards

check Best practices for mitigating risks

check Optimizing FSQM systems for results

check Effective management of FSQM systems

We’ll begin by taking a look at the requirements and main challenges of FSQM systems.



Effective Foundations for FSQM SystemsFood and beverage companies must have a strong foundation in place for addressing both the quality

and safety of their products. To achieve optimal effectiveness, FSQM systems should encompass the

following four elements:

1. Prerequisite programs, including sanitation, maintenance, allergen control, etc.

2. HACCP plans to identify proper critical control points, or Food Safety Plans which identify

preventive controls

3. Quality Standard Operating Procedures (SOPs) to ensure the quality of products

4. Critical Quality Points (CQPs), which can be identified by performing quality risk assessments

Beyond supporting these elements, FSQM systems must also meet regulatory, audit, and customer

requirements, all while protecting the company from product recalls and foodborne illness outbreaks.

Companies must therefore have strong QA teams with effective training to satisfy these demands on an

ongoing basis.

Oftentimes, the QA departments in food and beverage companies are short-staffed which leaves

management personnel to repeatedly put out fires. Instead of progressing to a level where they can

effectively mitigate risks and optimize the performance of their FSQM systems, these professionals must

dedicate their time and effort to simply managing compliance.

Ultimately, QA management starts with strong leadership: When QA teams are backed by strong

commitment and sponsorship, they can fulfill their roles more effectively. Senior management must

view food safety as a necessary component of doing business, ensuring coverage for multiple shifts and

promoting a positive food safety culture with QA and operations working cooperatively.



Additionally, training for competency is crucial to FSQM system efficacy. QA personnel, food safety

teams, and operations managers should all have thorough training to understand not just what needs

to be done to support food safety and quality efforts, but also why it must be done. Training programs

should be provided to ensure competency at both managerial and technician levels.

Challenges to Managing FSQM Systems

There are numerous challenges in effectively managing FSQM systems. Here are some of the most

noteworthy obstacles companies face:

check Inadequate sponsorship from senior management or operations

Some companies may benefit from a short training program to help senior management

understand the risks businesses can face in terms of product recalls. By gaining a deeper

understanding of what could go wrong in the industry, senior management teams may become

more likely to provide the resources needed to help QA teams grow and develop. This can also

aid in developing strategies to address issues with inadequate staffing and turnover for QA

departments.

check Customer specifications and complaints Managing customer specifications continues to be one of the most significant challenges QA

teams face. The key to alleviating these challenges is to ensure realistic specifications are being

set in the first place. Make sure the requirements are achievable given your company’s resources

and processing facilities.

check Audit management Most companies have a significant number of procedures which must be controlled within

the facility and within records. Given the vast number of records generated on a daily basis,

companies can benefit by implementing an electronic system for managing records, thereby

aiding in audit readiness. Overall, this can help to support management of regulatory, audit, and

customer compliance.



Regulatory and Audit ComplianceAchieving compliance is the most basic operating requirement for food and beverage companies,

which also makes it among the most critical elements to a company’s success. When it comes to audit

compliance, there are some ongoing challenges organizations must overcome:

check Changing standards

GFSI-certified companies face changes in standards once every three years at a minimum, but

many schemes are updated more frequently. SQF and BRC are two popular schemes which are

updated regularly.

check Multiple audits

Many companies are audited by customers frequently, to the point at which audit management

may actually become a full-time job. For organizations that undergo 25 audits or more annually,

employing a full-time QA staff member simply to manage audits is often necessary.

check Unannounced audits

To ensure success for unannounced audits, companies should aim to be audit-ready every day.

We’ll discuss audit-readiness tips to help companies maintain ongoing preparedness in the

following section.

check Code requirements vs. guideline expectations

Because there is variability among auditors, it is important for QA teams to ensure the actual

code requirements – not simply guideline expectations – are being enforced.

check Time management To prevent audits from becoming too time-intensive, companies must do their part in facilitating

a streamlined, efficient process.

Audit Compliance Readiness Tips

Companies can make their auditing processes more effective by adopting internal audit processes. By

checking various processes throughout the year, you will be able to minimize nonconformities when it

comes time for real audits. Additionally, verifying and validating prerequisite program verifications can

also help to reduce audit non-conformances.

Prior to audits, it is essential to perform a preparation inspection. QA teams should always be fully

aware of what is taking place inside their facilities and should therefore never be surprised by a non-

conformance. Instead, any non-conformance should simply be an issue of which management was

already aware but was unable to fully address prior to the audit.

Additionally, having an audit management strategy in place can facilitate efficient, well-run audits. Your

strategy should define which types of products you will be making on the day of the audit, as well as

the representatives from QA and operations who will participate in the audit. You should also hold



advance team inspections to quickly correct any issues ahead of the auditor as needed. Finally, be sure

to demonstrate manager commitment and involvement during audits by having personnel from QA and

operations going through facility inspections.

Regulatory Compliance

Like preparing for audits, ensuring regulatory compliance presents a unique set of challenges, including:

check Understanding new regulations

For companies under FSMA, understanding new regulatory requirements has been a learning

process. As the most significant reform of food safety law in decades, FSMA calls for many

changes which must be implemented effectively for ongoing compliance.

check Inspector interpretations

From one inspector to the next, interpretations of regulatory compliance can vary. It can

therefore become difficult for companies to meet the expectations of each individual inspector.

check Rogue inspectors and retaliatory actions In companies that have many inspectors visiting their facilities, it’s possible to encounter a rogue

inspector who may attempt to take retaliatory actions when inspection results are challenged.

The following section will review best practices for navigating these circumstances effectively.

check Developing responses to enforcement actions Companies must find ways to properly manage USDA NRs or FDA 483s as needed.

Regulatory Compliance Tips

First and foremost, personnel should complete proper training to develop a complete understanding

of applicable regulations. Additionally, in the event of a violation, be sure to ask which specific

regulation was violated and how. In some instances, it may be appropriate for your company to appeal

certain violations. However, keep in mind that it is best to appeal only the records that appear to be

unwarranted, not every single violation.

During inspections, present only the information required. Maintain professionalism and courtesy

without volunteering any additional information. Likewise, ensure that the inspection is controlled to the

identified scope. Respond to identified issues only with the corrective action taken and the supporting

documentation.



Best Practices to Mitigate RisksTo move beyond basic compliance, food and beverage companies must mitigate risks in three major

areas: product recalls, regulatory non-compliance, and pathogen contamination/foodborne illnesses.

The most effective strategy for doing so is adopting an enterprise risk management process. This

allows companies to take a proactive look at food safety management. The advantage of enterprise risk

management is that it presents a comprehensive overview of high, moderate, and low risks – without any

audit scores or regulatory non-conformances that will be shared publicly.

To conduct an enterprise risk assessment, companies must evaluate all major areas of their food safety

and quality systems, then go through checklists for each to identify potential risks. The results will then

allow you to focus on the areas that need the most attention, encouraging you to be proactive and not

reactive.

Some of the areas you might assess could include:

check Supply chain

check Supplier risks

check Raw material risks

check Crisis management

check Product recalls

check Audit management

check Traceability

check Regulatory

check Allergens

check Complaints

check Sanitation

check Microbial control

Keep in mind that risk assessments should be tailored to each specific facility according to its unique

processes and products.

Swab-A-Thon Challenge

With the FDA’s increasing focus on controlling Listeria monocytogenes, many companies have begun

to implement “swab-a-thon” challenges. Instead of waiting to undergo an FDA inspection, companies

are performing thorough self-assessments, collecting swabs in every zone of their facilities. Swabbed

areas may include areas outside of food processing areas as well as food contact surfaces. The FDA has

performed more than 500 broad assessment PC inspections and 140 full preventive control assessments

to date. Thus, companies that perform assessments independently can be better prepared for taking any

corrective actions as needed to proactively improve environmental control programs.



Optimizing Your FSQM System for Better ResultsThere are a few ways you can optimize your company’s FSQM system to achieve better results. Food

safety controls can be assured by following your HACCP or Food Safety Plan. Perform thorough, annual

reassessments to verify and validate the effectiveness of your food safety system.

In terms of quality assurance, you can establish

a Quality Process Control System based on

implementing a similar framework to that of HACCP

methodology. Use the existing product descriptions

and flow charts, completing a Quality Risk Analysis

to assess threats and identify Critical Quality Points

(CQPs). When CQPs have been established, you

can then identify operating limits, monitoring,

corrective action, verification, and record keeping

procedures. Note that this approach is similar to

the SQF Food Quality Plan but is focused on CQPs

for performance correlated with specifications.

Additionally, this process does not have to be

implemented only in SQF facilities; its benefits can

be realized by companies with or without GFSI

certification.

One bakery facility, for instance, was able to significantly

improve its performance by reassessing and refining its

food quality plan. The company was losing product based

on quality defects, including the wrong sizes, colors, and

shapes. By reassessing the food quality plan and revisiting

customer specifications, the company was able to identify

critical quality points and found ways to more effectively

control them. As a result, it substantially increased its

product yield and decreased its waste. Formal process

control can benefit any facility facing similar quality-

related issues.



Tips for Optimizing Your FSQM System

As with achieving compliance, optimizing your facility’s

quality assurance efforts starts with realistic product

specifications – both internally and from the customer. The

specifications should serve as a foundation for identifying

critical quality points in a documented quality process

control plan. From there, your facility should be able to

execute according to plan and achieve product consistency.

To further optimize FSQM, consider adopting an automated

system for record keeping. A centralized repository can

be used to document quality process control plans, along

with the records that are generated each day. In doing so,

you will be able to analyze key metrics over an ongoing

basis. We’ll review some key metrics for food and beverage

companies in the next section.

Optimizing your FSQM system yields a number of beneficial outcomes. Reduced out-of-specification

product on hold, increased product yields from less rework, reduced need for CAPAs and RCAs, and

reduced time and labor required for recordkeeping are just a few of the major advantages companies

experience by streamlining their FSQM system. In the final section, we’ll discuss best practices for

managing the FSQM system to help you maximize these results.



Managing the FSQM System EffectivelyTo promote ongoing improvement in performance, set objectives for your FSQM system with measurable

metrics and specific goals. While it is recommended for companies to set monthly measurable objectives

to assess performance, some may prefer to operate on a quarterly basis. At the very least, be sure to

repeat the process once per year.

Analyze the results and trends in performance to identify continuous improvement opportunities for

the FSQM system. Oftentimes, companies use paper-based systems to monitor food safety and quality

outcomes, but after records are generated, they are filed away. It is critical to revisit data on a regular

basis to identify areas needing improvement and implement processes to better support FSQM efficacy.

This can be supported through automated systems which electronically capture data, making trending

and reporting simple and effective.



While it is up to you to determine which key metrics to analyze, here are some suggestions to consider:

Recalls Aim for a zero-tolerance goal

Audit Results Strive for passing within the top two scoring tiers

External and Internal Audit Non-conformances Identsified

Assess both the quantity and trends

Customer ComplaintsBased on percentage of targeted improvement over baseline results

Non-conforming ProductNumber of incidents, and based on percentage of targeted improvement over baseline results

CCP Deviation History Number of deviations

USDA NR’s Non-Compliance Records

Quantity and percentage of targeted improvement over baseline results

Vendor Non-conformancesNumber of incidents, trend analysis, and percentage of targeted improvement over baseline results

SSOP ResultsNumber of pre-operational and operational sanitation deficiencies, based on percentage of targeted improvement over baseline results

Microbiological ResultsFinished product testing percentage compliance within specification; food contact surface and environmental testing and compliance with goals

Corrective Action ResultsNumber of incidents and effectiveness evaluation to prevent deficiencies

Note that these are just some of the metrics you can use to gauge the progress of your FSQM system.

The metrics you choose to analyze should align with your company’s long- and short-term goals.

Management reviews of results should be conducted at least once per quarter, with the Food Safety

Team and senior management participating. Consider the inputs of results and necessary outputs for

addressing problem areas and driving continuous improvement.



SummaryThroughout this guide, we’ve reviewed some of the ways food and beverage companies can not only

achieve basic compliance, but actually improve operations by proactively mitigating risks. While the risks

each facility faces will vary according to its product line and other differentiating factors, taking a more

proactive approach to food safety and quality can benefit all companies.

To leave you with some key takeaways, here are a few of the main points that have been discussed:

check Effective FSQM systems begin with a strong foundation. From prerequisite programs to

HACCP or Food Safety Plans and well-staffed, trained QA teams, organizations must have a

stable support system before they can begin to pursue improvement in food safety and quality

outcomes.

check Maintaining regulatory and audit compliance is the most basic day-to-day requirement companies

must satisfy. Compliance can be better supported by ensuring requirements are realistic given

your facility’s capabilities. From there, compliance efforts can be further refined by receiving

training on updated regulations and adopting an audit management strategy.

check Proactively mitigating risks is what helps successful food and beverage companies excel. By

conducting an enterprise risk assessment, companies can thoroughly analyze their FSQM systems

to pinpoint high-risk areas needing attention. These assessments can yield invaluable insights,

which will help you to optimize your FSQM system for better results.

check Optimizing your FSQM system has a number of benefits. It can help you reduce waste, increase

productivity, and ultimately, drive better bottom-line results. You can use technology to derive

key metrics that will help you implement strategies for ongoing performance.

Balancing compliance, risk, and performance is not a simple, one-time task. It requires companies to take

a more proactive approach and perform routine analyses. However, with benefits such as more effective

food safety and quality programs and better overall performance, striking a balance is indeed worth the

pursuit.



About SafetyChainSafetyChain is a Quality Management System (QMS) that helps food and beverage companies improve

productivity, profitability, and compliance with a flexible, user-friendly software platform that captures,

manages, and analyzes real-time operations data. Learn more at https://safetychain.com.

About Alchemy SystemsAlchemy Systems is a global leader of innovative solutions that help food and retail companies engage

with their workforces to drive loss prevention, safety, and productivity improvement programs. Learn

more at www.alchemysystems.com.

About Jeff ChiltonJeff has over 30 years of experience in the food industry, specializing

in food safety, quality assurance, and plant management. Prior to

Alchemy, Jeff spent 18 years as a consultant, helping clients achieve

and sustain GFSI certification under the SQF, BRC, and FSSC 22000

standards and providing USDA and FDA Regulatory Compliance

services for HACCP and Food Safety Plan

Jeff is a certified SQF Auditor, SQF Consultant, Preventive Control

for Human Food Lead Instructor, and International HACCP Alliance

Lead Instructor.

https://safetychain.com

http://www.alchemysystems.com

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BALANCING COMPLIANCE, RISK, AND PERFORMANCE HOW TO ... · Optimizing Your FSQM System for Better Results There are a few ways you can optimize your company’s FSQM system to achieve