Tag Archives: root cause analysis

Prasant Prusty and Arundhathy Shabu

Effective Root Cause Analysis for CAPA Management

By Arundhathy Shabu, Prasant Prusty
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Prasant Prusty and Arundhathy Shabu

Businesses often overlook the power of well-executed, competent complaint-handling systems in boosting business growth. Data from ABa Quality Monitoring Ltd revealed nearly 70% of customers are more likely to stick with a company if their complaints are resolved, and this figure jumps to an impressive 95% if complaints are addressed immediately.

Every company faces distinct operational challenges that can result in missed deadlines, product holds, supply chain disruptions and customer complaints. Each of which can impact the quality of the enterprise’s product or service.

This is why the ability to conduct a comprehensive root cause analysis (RCA) to identify the origin of concerns and formulate and execute remedial processes, such as corrective and preventive actions (CAPA), is essential for food companies. Root cause analyses reduce the risk of future nonconformances and complaints and help streamline business operations and protect your bottom line.

An Overview of CAPA and Root Cause Analysis

Corrective and Preventive Action, or CAPA, is a methodical system used across industries to identify, rectify and avert issues, errors or noncompliance in processes, products or systems. Corrective actions fix existing problems, while preventive actions stop their recurrence.

Root Cause Analysis (RCA) encompasses various problem-solving methodologies, permitting teams to identify the fundamental reasons behind issues. It goes beyond just detecting the main problem to determine contributing factors, implement corrective and preventive measures, and foster continuous improvement in business processes.

Conducting a Root Cause Analysis

A CAPA management system’s success hinges on the RCA strategy’s efficiency. Whether businesses are facing a manufacturing defect, a customer complaint, a safety incident or any other problem, conducting an RCA is instrumental in identifying the underlying reasons and implementing effective solutions. Rather than relying on a one-size-fits-all approach, RCA should comprise a highly adaptable toolkit of techniques, and methods. Here are the basic steps for performing a root cause analysis:

Step 1: Understand the Issue

Initiate the process by clearly defining the problem or incident that must be examined. Ensure that the problem statement is specific, measurable and well-documented, enabling a precise understanding of what needs investigation.

Step 2: Collect Information

Aggregate all available data related to the issue, which may include incident reports, witness statements, photographs, process documentation and any other pertinent information. The more data you collect, the better your grasp of the problem.

Step 3: Identify Root Causes

Recognize the immediate or proximate factors that directly contributed to the problem. These are the most visible elements that directly played a role in the incident. Beyond these immediate causes are the contributing factors, often systemic, which may have indirectly influenced the problem. Thoroughly investigate and unearth the foundational reasons behind the issue using appropriate RCA techniques or methods.

Step 4: Develop Corrective and Preventive Actions

Once the root causes are uncovered, brainstorm and assess suitable corrective and preventive actions. Prioritize these solutions based on their practicality, impact and cost-effectiveness, and put the chosen solutions into effect.

Step 5: Establish a Coordinated Plan

Be sure to establish a plan for carrying out the corrective and preventive actions. This plan should include details about the required resources, the assignment of responsible individuals for task execution and an evaluation of the potential risks associated with these corrective measures.

Step 6: Monitor and Verify

Continuously monitor the situation to ensure that the problem does not reoccur. This may involve ongoing training, regular audits or process improvements.

Methods for Root Cause Analysis

Each root cause analysis method offers a unique approach to uncovering the root cause of a problem, providing a systematized way to investigate and address issues. Following are root cause analysis techniques that are adaptable for standalone or combined use, determined by the issue’s intricacy and the particular objectives of the RCA.

  • The 5 Whys: This technique involves asking “why” multiple times to dig deeper into a problem. Repeatedly questioning the cause behind a situation helps uncover the underlying issues. The goals is to identify the fundamental reason and avoid assumptions.
  • Fishbone Diagram: This visual tool organizes potential causes of a problem into categories, such as people, processes, equipment, environment and materials. It’s great for exploring multiple factors contributing to an issue.
Fishbone RCA diagram
Example of a fishbone diagram with sample categories to consider, and sample causes.
  • FMEA (Failure Modes and Effects Analysis): This method evaluates potential failure modes and their impacts before they occur. It helps in identifying failure points and assessing the existing controls to address these issues.
  • DMAIC (Define, Measure, Analyze, Improve, Control): A data-driven improvement cycle, dividing the problem-solving process into five steps: defining the problem, collecting data, analyzing root causes, putting solutions into action and establishing controls for sustained improvement.
  • Pareto Analysis: Based on the Pareto Principle, it suggests that a significant portion of issues (80%) can be linked to fewer causes (20%). This tool helps prioritize efforts and resources for problem-solving by focusing on the vital few causes.
  • FTA (Fault Tree Analysis): This deductive method works backward from an undesirable event, using graphical representations to analyze relationships between various events and their causes. It uses boolean logic to determine root causes.

Tech-Enabled Solutions to Optimize RCA Processes

In a world where time-consuming manual tasks can hinder productivity, embracing CAPA management and root cause analysis process technology can drive excellence across your enterprise. By digitalizing CAPA processes, organizations can seamlessly manage the entire lifecycle of complaints, holds and deviations.

Digital systems and software for RCA and CAPA management can enable food companies to centralize and automate the recording and tracking of customer complaints, product holds and deviations from established standards, which will evidently lead to faster response times, improved data analysis and better communication across departments. These digital tools aid in identifying recurring issues for swift remediation while preventing similar problems in the future by facilitating real-time monitoring and reporting.

An ideal CAPA management solution will possess the following digital functionalities to revolutionize the process:

Configurable Record Templates. Customized templates for recording complaints, deviations, holds and CAPA can be created or tailored flexibly, allowing users to accommodate differing data requirements to solve a problem. This helps standardize and streamline the documentation processes involved in RCA and CAPA procedures, as these templates help in the consistent recording of incident details, root causes, corrective actions and preventive measures, simplifying the generation of auditable records. Not to mention, they would play a significant role in reducing data entry errors and saving time, consequently supporting a proficient CAPA management system.

CAPA Workflow Automation. CAPA management tools are designed to facilitate the automation of various stages of CAPA, from incident reporting to the review and approval process. By automating tasks such as routing for reviews, approvals and monitoring deadlines for corrective actions, workflow automation significantly reduces the need for manual intervention, saving time and minimizing the potential for human error within the workflow. As a result, the entire CAPA process becomes less resource-intensive and more refined, ensuring a more seamless journey from identification to resolution.

Investigation & Root Cause Analysis. Digitalization ushers a thorough investigation process by collecting documentary evidence in an organized manner, enabling a quicker and more accurate determination of root causes and leading to more efficient corrective and preventive actions to prevent recurrence.

Integrated systematic RCA models into the digital system expedites the root cause analysis process while amplifying its efficacy. Through continuous data gathering from machinery and processes, advanced analytics platforms identify patterns and anomalies, aiding in pinpointing the root cause of failures or issues. Visualization tools provide clear insights into complex relationships among various factors, aiding in understanding causality and devising adequate solutions.

Collaboration is also substantially improved through digital platforms, allowing multidisciplinary teams to collaborate seamlessly regardless of their locations. These tools help structure the RCA process, ensuring tasks are assigned, progress is monitored, and deadlines are met, thus driving the investigation into a more optimal and exhaustive RCA analysis.

Non-Compliance Management. Well-defined planning and implementation of noncompliance action items become possible through digital tools by assigning corrective and preventive actions to respective stakeholders for prompt rectification, compliance maintenance and future risk mitigation. Furthermore, evaluating and validating the effectiveness of corrective and preventive actions is a critical step in RCA. Ensuring the successful closure of the CAPA process by reviewing and confirming the resolution of nonconformances becomes more efficient with digital solutions.

Notification & Alerts. CAPA management systems can be configured to send timely notifications and alerts to relevant stakeholders and responsible parties involved in the CAPA process. These notifications serve as unique reminders, ensuring that individuals are promptly informed about their tasks and impending deadlines. By doing so, the risk of missed actions or delays is considerably mitigated. This real-time communication not only keeps everyone on track but also supports a more responsive and accountable approach to handling corrective and preventive actions.

Reporting & Trend Analysis. Digital CAPA management tools also empower organizations to generate customized reports and analyze data trends. These serve as a window into the performance of the detection, rectification and thorough review of outliers within CAPA processes, providing invaluable insights for informed decision-making and continuous improvement initiatives.

In essence, the transformative power of digital tools is instigating a monumental shift in technology adoption, heralding a new era in establishing efficacious root cause analysis for successful CAPA management. By harnessing these tools, organizations can unlock avenues for enhanced efficiency, elevated quality standards and fortified regulatory compliance. This paradigm shift is paving a path toward sustained progress, where proactive problem-solving becomes the cornerstone of organizational growth and resilience. 

Jeff Chilton

What Food Manufacturers Can Learn from the Baby Formula Recall

By Jeff Chilton
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Jeff Chilton

Months after the most high-profile product recalls in U.S. history, grocery stores are replenishing their supplies of baby formula. While the news remains fresh in everyone’s memory, food manufacturers have an opportunity to reflect on the mistakes that brought about this tragic event.

Abbott Nutrition, which produces about one-fourth of the nation’s infant formula, will be associated with this year’s baby formula shortage for years because it failed on so many levels to keep products safe at its plant in Sturgis, Michigan.

Many of the factors behind this crisis could have been easily avoided or at least quickly corrected. Instead, it took a whistleblower to alert the FDA, citing falsified records, releasing of untested products, sanitation problems, information hidden from auditors, failure to take corrective actions, and traceability issues.

In addition to near irreparable damage to its brand, Abbott Nutrition and members of its executive team are facing regulatory actions, criminal prosecution, and lawsuits.

The formula recall offers an opportunity for food manufacturers to learn from Abbott’s mistakes and to prepare for intensified scrutiny from federal regulators. Let’s dive into some of the most important lessons learned from the Abbott baby formula recall.

Empower Employees
Your frontline employees are your best defense for maintaining food and workplace safety. Make sure they know they won’t face retaliation for reporting incidents. In Abbott’s case, the whistleblower talked about retaliation against employees for reporting food safety concerns. And some employees were afraid they might lose their jobs if they raised concerns.

Take Corrective Actions
A failure to take effective corrective action was a big issue across the board for Abbott and something that all companies find difficult to do. Unfortunately, in the food industry, it’s much more common to put a band-aid on a symptom than conduct a root cause analysis to identify a problem. Fix the root problem as soon as you discover it so you’re not fighting the same fire day after day.

Ensure Record-Keeping Integrity
This seems obvious, but many food manufacturers still don’t have a formalized process to maintain proper record-keeping practices. This process should be documented and shared when necessary with auditors, and there should always be a zero-tolerance policy to prevent falsified records.

Provide Audit Transparency
During the Abbott investigation and audits, there was a lack of transparency and a willingness to withhold information. This can be a fine line to walk. When your workers’ and customers’ health and safety are on the line, it’s critical to be as forthcoming as possible. When preparing for audits, there is the temptation to answer questions only when asked and to avoid volunteering additional information. However, this mentality can mask problems that will eventually come to light.

Establish Proper Sanitation Practices
Many food manufacturers fail to maintain, validate, and consistently implement proper sanitation procedures. Sanitation jobs can be challenging. They involve cold and wet processing environments and are usually worked during third shifts. Most companies struggle with an excessively high employee turnover in these positions. And with few workers on hand, they strive to prepare for the next shift in just a few hours. Maintaining sanitation procedures is a big challenge for many companies, but critical to delivering safe food products.

Validate Environmental Monitoring
Food manufacturers should have environmental monitoring programs in place where they test equipment and the processing environment for various pathogens. From food contact surfaces to areas inside the processing room—including floors, walls, and drains—to outside processing areas like break rooms and common hallways, it is imperative to identify the correct sites to sample, ensure adequate sampling frequency, and act when necessary based on the results.

Establish Traceability

Food manufacturers need to be able to trace all raw materials, packaging materials, processing aids, and anything else that goes into their finished product, as well as their shipping processes and destinations. Most companies have a good idea of where products are shipped, but they’re not as adept at tracing the raw materials and processing aids that come into their manufacturing facilities. That was one of the issues cited with Abbott Nutrition, and it’s a problem in the food industry.

Ensure Redundancy and Sustainability in the Supply Chain

Our country relies too much on just a few manufacturers to supply critical food supplies in too many areas. In the case of Abbott Nutrition, one major factory shutdown sent shockwaves through the industry and panicked consumers. Food manufacturers must have backup plans and processes in place in case of recalls, fires, tornados, floods, sabotage, or any other issue that might bring their operations to a halt.

These are some of the most prominent lessons we can all learn from Abbott’s missteps around their baby formula recall. The food industry must do as much as possible to ensure a safe and sustainable food supply. This means evaluating food safety and quality assurance systems to identify potential risks and reassessing programs to create a stronger food safety quality assurance system.

It’s also critical to develop a robust food safety culture across the entire company from the top down. Every manufacturer needs to be proactive in maintaining food safety. No company should rely on inspectors or auditors to discover their issues. They must anticipate questions and problems that can occur during audits through robust internal review processes. This not only allows them to pass their audits but also gives them the ability to proactively identify and address issues before they become major violations or national recalls that make headlines.

FDA

FDA Receives Record Turnout As Industry Eager to Discuss New Era of Smarter Food Safety

By Maria Fontanazza
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FDA

Industry from the public and private sector joined for a record turnout during the FDA public meeting yesterday to discuss the agency’s initiative, a new era of smarter food safety. The meeting, which was at maximum capacity for both in-person as well as webcast attendance, began with a call to action from FDA Deputy Commissioner, Office of Food Policy and Response, Frank Yiannas on the importance of all stakeholders in the industry to work together to drive the change. As Yiannas has previously commented, the food industry is in the midst of a revolution. The world is changing faster than ever, and the FDA is challenged with not just creating a safer, more technology-centric and traceable food system, but also getting there faster and more effectively. “I’ve always believed that words we use are important,” he said. As the day’s various discussions would be around the new era of smarter food safety, Yiannas gave the audience a definition to consider: “A new era is a memorable or important date or event, especially one that begins with a new period in our history.”

FDA held breakout sessions centered on areas critical to the initiative:

  • Tech-enabled traceability and outbreak response
  • Smarter tools and approaches for prevention
  • Adapting to new business models and retail modernization
  • Food safety culture

During each session, FDA facilitators asked the audience questions. The following are some key points brought out during the breakouts.

Tech-Enabled Traceability and Outbreak Response

  • FDA should consider all parts of the supply chain when thinking about traceability
  • Take into account considerations for sharing sensitive data along the supply chain
  • Speaking a common language and creating data standards, along with necessary minimum data elements for traceability is critical
  • Better communication related to data sharing as well as more meetings with FDA and stakeholders, especially during outbreaks
  • Show industry the ROI of the data
  • Provide a roadmap or recommendation for companies on where they can begin on their traceability journey
  • Request for unity across government agencies (i.e., FDA, USDA), as it would provide more clarity during an outbreak

Smarter Tools and Approaches for Prevention

  • Trust and transparency are key
  • Safeguards that address privacy concerns and liability
  • Data
    • Data sharing: Concern about retroactive investigations
    • Types of data: With the “treasure trove” of existing data out there, which is the most important and helpful in improving food safety?
  • Environmental assessments and root cause analysis—more dialogue between FDA and industry

Adapting to New Business Models and Retail Food Safety Modernization

  • More need for collaboration
  • Globalization and use of best practices
  • Establishing a common standard to level the playing field
  • Establish best practices for tamper resistance
  • The last mile: Food safety training for food delivery personnel as well as harmonization for last mile delivery
  • More consumer education

Food Safety Culture

  • Emphasis on behavior and humanizing the work: Focusing on what happens within organizations at all levels
  • Clarity and communication are important
  • Leveraging current food safety culture best practices as well as any relevant existing standards (i.e., ISO, Codex)
  • Partnerships are critical, finding the balance between compliance and collaboration

Other Factors FDA Must Consider

The FDA meeting also included panel discussions that drew out the realities FDA must consider in this rapidly changing environment. “These are exciting times and this initiative is recasting our thinking in a whole new light,” said CFSAN Director Susan Mayne, adding, “We need to get ahead of these challenges and not be in reactive mode.”

Consumer awareness and demands for healthy, locally sourced and minimally processed food, for example, are creating increased pressures on food companies and retailers. In addition, the digital savvy and diverse Generation Z (the population born between 1990 and 2010, which will comprise nearly 40% of the U.S. population by 2020) has buying habits and a strong desire for transparency that is shifting how food companies will need to do business, according to Mary Wagner, president of MX Wagner & Associates.

“Trust represents safety, quality and commitment on a much more personal level to our consumers,” said Dirk Herdes, senior vice president at the Nielsen Company, emphasizing the need to communicate with authenticity. “Consumers have never been more informed, but never have been more overwhelmed with information. It’s not data—it’s trust. Trust is the new currency with which we’ll operate.”

FDA and USDA also remain committed to building a stronger relationship between the agencies, said Mindy Brashears, Ph.D., deputy undersecretary for food safety at USDA. “As science moves forward, we have to allow our policies to move forward to keep consumers safe,” she added.

The comments shared during yesterday’s meeting, along with written and electronic comments (with a deadline of November 20), will be considered as FDA puts together its blueprint document for a new era of smarter food safety. More information about providing comments can be found on the Federal Register page.

CAPA and Root Cause Analysis for the Food Industry

By Dr. Bob Strong
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A thorough and effective CAPA can provide many benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections.

Why do a Root Cause Analysis? Because unless you identify the root cause of a problem, you cannot resolve it. You need to find out what went wrong, how the problem was not detected, or what has changed.

Often times, it may seem that a Correction conceived on the fly solves the nonconformity. However, manufacturing processes—especially in the food industry—can involve a huge number of variables. As a result, problems that arise can involve multiple levels of causal relationships that must be followed in order to locate the true root cause of a nonconformity. This is why performing an RCA is essential; we may think we’re addressing the root cause of a non-conformity with a Correction, but in fact, we are only treating a symptom of a larger (and often more costly) issue.

Without an RCA, it’s anyone’s guess whether a Correction will hold. The nonconformity might be solved, or it might come back—and bring with it other issues related to the root cause.In any case, guessing is not sound strategy for dealing with non-conformities. This is why it is essential for organizations to be disciplined in their approach to investigating non-conformities. Sure, performing an RCA takes time, and nobody wants to waste time on something unnecessary. Nevertheless, organizations should understand that identifying the root cause of a nonconformity early could save a great deal of time and expense in the long run. Of course, you won’t know unless you perform the RCA, so it is always a better practice to invest time into an RCA upfront rather than get exposed to a more serious nonconformity at a later date that could threaten the safety and/or quality of product being produced or handled.

Who should perform the RCA?

Though it may be possible for a single person to perform an RCA, it is always better to have a team of minds working on the problem—people who are familiar with the relevant products, processes, equipment, and challenges of the working environment. A team also brings a greater pool of experience, knowledge, and perspectives, which can be extremely helpful in the investigative process of an RCA. It also makes sense for your RCA team to be comprised of people who canhelp represent the resulting CA or PA plan to other areas of the organization and help facilitate buy-in, consensus, and execution of the plan

CAPA: The process unpacked

A new white paper, published by SAI Global Assurance Services, describes in detail the various steps involved in CAPA. Broadly, these have been described as:

  1. Identify the problem: Before you can solve the problem, you must identify it plainly and clearly.
  2. Evaluate /Review: How big is the problem? What are the implications? What is the severity of the consequences?
  3. Investigate: Make a plan to research the problem.
  4. Analyze: Identify all possible causes using different methodologies such as It is/ It is not analysis, the 5 Why’s Method, and The Fishbone Diagram
  5. The Action Plan: Narrow the list of possible causes.
  6. Implement: Execute the action plan
  7. Review: Verify and assess effectiveness

CAPA benefits

A thorough and effective CAPA provides a lot of benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections, frequency of which will be based on on the robustness of your food safety programs.

This article is an excerpt from a white paper prepared by SAI Global Assurance Services, and has been published in Food Safety Tech with permission. Click here to download the white paper in its entirety.

Ask the Expert : Root Cause Analysis – Responding to Audit Non-Conformances

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A food manufacturer’s food safety program must encourage continual improvement to their existing program in order to be successful and to comply with their food safety standard. And root cause analysis is a great tool for problem solving when a site is found not to be in conformance.

The food industry has been introduced to the concept of third-party certification to help manage and control their food safety programs. Food manufacturers benefit from a food safety quality system that is based on Global Food Safety Initiative (GFSI) principles.

Business People with Puzzle Pieces and Teamwork Concept

A food manufacturer’s food safety program must encourage continual improvement to their existing program in order to be successful. Current GFSI benchmarking initiatives have introduced the concept of implementing root cause analysis as a tool for problem solving when a site is found not to be in conformance with their food safety standard.

A new white paper from CERT ID covers relevant information that can assist food companies understand how to implement their solution, review and evaluate the results, and reflect and act on what was learned. This Q&A with CERT ID’s Michael J. Pearsall, Vice President of Business Development, offers some insights.

Q: These RCA tools are nice but require large amounts of resources to solve problems. Is this really necessary?

A: The effort and resources utilized to solve a problem should reflect the scale of the issue with regard to the impact on the person or organization. The tools that are normally advertised are to be used for complex problems. What about the simple day-to-day problems we all face as managers? A human being solves problems without even realizing it. You have a built in mechanism that you have acquired through life experiences and this device should be called upon first. Develop a personal strategy as to how to approach a problem that starts with observation; defining the issue; prioritization; short term strategy and finally a long term strategy to prevent issues from reoccurring. Complexity of problems change but your strategy should not.

Q: We went through a complex root cause analysis and solved the problem but it keeps reoccurring. It is very frustrating so how do we prevent this?

A: I hate to tell you this but problems are only temporarily solved. Many very intelligent people forget, the most important part of problem solving, developing a strategy to maintain the gains you spent so much of your resources to obtain.

There is an overused Old Testament bible story about David and Goliath. Many think that David killed Goliath with a stone from his sling but this is not true. David had developed a strategy to maintain his gain. David had to immobilize the giant to gain access to him. He solved the problem by hitting him in the head with a stone, but the long term strategy was to grab his sword to cut his head off securing the gains to his problem solving effort. It is necessary to think about how you will maintain the gain once a problem is unraveled.

For more information, click here to download Responding to Audit Non-Conformances: Root Cause Analysis, a complimentary white paper from CERT ID. 

Dr. Bob Strong

How to Perform Root Cause Analysis?

By Sangita Viswanathan
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Dr. Bob Strong

SAI Global logoDr. Strong was speaking in a recent webinar onThe Importance of CAPA and Root Cause Analysis for the Food Industry, in which he discussed CAPA, Root Cause Analysis and the benefits of these quality systems. We present below the comprehensive list of questions as presented by Dr. Strong.

Questions to ask: People

  1. Does the person know what he’s expected to do in this job?
  2. Is he well trained?
  3. How much experience does the person have?
  4. Does the person have the right tools/ equipment needed to do the job?
  5. Is the workload reasonable?
  6. Does the person have adequate supervision and support?
  7. Do physical conditions such as light or temperature affect their work?
  8. Who does the person contact when problems arise?

Questions to ask: Method

  1. How is the process used defined?
  2. Is the process regular reviewed for adequacy?
  3. Is the process used affected by external factors?
  4. Have any changes been made recently in the process?
  5. What adjustments must the operator make during the process?
  6. How does the operator know if the process is operating effectively?
  7. Have other methods or processes been considered?

‘What would you do if things go wrong,’ this could be the most revealing question you can ask your employees that it may identify a real issue, added Dr. Strong.

Questions to ask: Equipment

  1. How old is the equipment or machinery?
  2. Is preventive maintenance performed regularly on it?
  3. Is the machine affected by heat, vibration, or other physical factors?
  4. How does the operator know if the machine is operating correctly?
  5. What adjustments must the operator make during the process?
  6. Have any changes been made recently in the equipment?
  7. How is the equipment cleaned?
  8. What tools are used to clean the equipment?

Questions to ask: Raw materials

  1. What is the source of the raw material?
  2. Has there been a change in suppliers recently?
  3. How is the raw material produced?
  4. How is the safety of the raw material verified?
  5. How old is the raw material?
  6. How is safety assessed prior to your operation?
  7. What is the level of safety and quality?
  8. How is the raw material packaged?
  9. Can temperature, light or humidity affect the material quality?

Questions to ask: Environment

  1. How are environmental conditions monitored?
  2. How are environmental conditions controlled?
  3. How is environmental control measuring equipment calibrated?
  4. Are there changes in conditions at different times of the day?
  5. Does environmental change affect the processes being used?
  6. Does environmental change affect the materials being used?

Questions to ask: Inspection System

  1. How frequently are products inspected?
  2. How is the measuring equipment calibrated?
  3. Are all products measured using the same tools or equipment?
  4. How are inspection results recorded?
  5. Is there a set of procedures and do inspectors follow the same procedures?
  6. Do inspectors know how to use the test equipment? 

Ask your team ‘what would happen if the systems weren’t calibrated? Are they giving you valid results?’ Probably that’s why you are not in compliance, explains Dr. Strong. 

All this take takes time and effort, and Dr. Strong urges management to devote the resources to go around ask these questions and get the answers.

What is your experience with Root Cause Analysis? Have your used such questions? Do you have more to add? Join the discussion by commenting below.

For more information, visit SAI Global’s Food Safety Resource Center, to access this complimentary, ON-Demand webinar.