Tag Archives: CAPA

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. 

Technical Writing Workshop Focuses on Key Skills Needed for Writing Up Non-Conformances and CAPAs

By Food Safety Tech Staff
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Technical writing is not as simple as it sounds—especially as it relates to writing non-conformances and CAPAs. Innovative Publishing is offering a Technical Writing Virtual Workshop that takes place over two two-hour sessions on March 3 and 10. The event is being hosted by Food Safety Tech’s sister publication, MedTech Intelligence, but the content is applicable to the food industry as well.

The course will be instructed by world-class, international quality and regulatory consultant Mark Proulx, president of MLB Consulting Services. Proulx has more than 25 years of direct manufacturing, auditing, and FDA experience and is a certified quality auditor and Six Sigma Black Belt.

The workshop was developed for the following industry professionals:

  • Engineers responsible for writing up investigations and reports
  • Tech writers who must communicate the results of testing in reports, write up papers, produce arguments for or against an issue
  • Middle-level managers who are attempting to make arguments or show results
  • Laboratory staff who document results and write reports
  • Technicians who must write up test protocols, non-conformance reports, corrective actions, reports to upper management, etc.
  • Quality Assurance/Quality Control and Regulatory Compliance people who must document clearly the purpose of investigations and produce final reports that clearly state actions to be performed or the results of testing

Learn more about this special Technical Writing Virtual Workshop now! Register by February 11 for a special discount.

Audit

Best Practices for ISO 17025 Accreditation: Preparing for Your Food Laboratory Audit (Part II)

By Joy Dell’Aringa
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Audit

In Part I of this article, we explored the considerations a laboratory should initially evaluate when pursuing accreditation, as well as guidance from leading industry experts on how to prepare for an ISO 17025 audit. Here we will review what comes after the on-site assessment and provide practical user-based advice for preparing a response, common areas of non-conformance, and future changes to the ISO 17025 Standard.

The Response

Once the assessor has completed the audit, they will typically hold a closing meeting on-site where they present their findings, also referred to as deficiencies or non-conformances. For each finding they will document a specific reference to the standard as evidence and provide opportunity for questions and discussion. Most assessors will be open and conversational during this final portion of the assessment; laboratories are well suited to take advantage of this time. Some assessors will even brainstorm possible responses and corrective actions while onsite; this is valuable insight for the laboratories quality team and can help them get a jump on the response.

Depending on the accrediting body, the laboratory will have a certain amount of time to respond to the findings, usually 30–60 days. The anatomy of a well-assembled response will include a full corrective action report, complete with root cause analysis. Often, the assessor will also request supporting documents and records to show the effectiveness of a corrective action. Most laboratories will have forms to help guide users through the corrective action and root cause process. It is important to have a systematic approach to ensure your corrective action is thorough and balanced.

Determining root cause is a critical part of this exercise. Erin Crowley, CSO of Q Laboratories shares their approach. “We use a variety of root cause analysis techniques, but have found for our operation the principle of the ‘5 Why’s’ is very effective,” she says. “Don’t simply answer the singular deficiency. Accrediting bodies will want to know that you have addressed all variables that might be associated with a finding. For example, if a specific incubator was out of range on a specific date, don’t just indicate that someone fixed it and move on. Assess how they addressed the issue, any impact on data, what they did to react to it, and how they are putting systems in place to prevent it from happening in the future on any other incubator. You have to show the full process.”

Implementing procedures as an outcome of a corrective action can also bring challenges to an operation. As a national multi-site reference lab, Eurofins Quality Manager Peter Dragasakis must work with other departments and locations to deploy new or changed systems for compliance. “Sometimes the most challenging part of the entire audit process is coordinating internal stakeholders across other departments such as IT or complimentary analytical departments,” he says. “Coordinating a response in a timely manner takes full organizational cooperation and support.” Communication throughout the quality and operational arms of an organization is critical to a successful response. Often, accrediting bodies and laboratories may shuttle a response back and forth a few times before everyone is satisfied with the outcome.

Common Areas of Non-Conformance: Pro-Tips

While all areas of the standard are important to a conformant operation, there are a few key areas that are frequently the focus of assessments and often bare the most findings.

Measurement Uncertainty. Depending on the laboratories Field of Testing (FOT), Measurement Uncertainty (MU) can be captured in a multitude of ways. The process aims to systematically and quantifiably capture variability in a process. For chemical analysis this is typically well defined and straightforward. For microbiological analysis the approach is more challenging. A2LA’s General Manager, Accreditation Services, Adam Gouker says the reason many labs find themselves deficient in this area is “they don’t consider all of the contributors that impact the measurement, or they don’t know where to begin or what they need to do.” Fortunately, A2LA offers categorical guidance in documents P103a and P103b (for the life sciences laboratories, two of the of many guidance documents aimed at helping laboratories devise systems and protocols for conformance.

Traceability. There are several requirements in the ISO 17025 standard around traceability. In terms of calibration conformance, which accrediting bodies seem to have emphasized in the last few years, Dragasakis offers this tip: “When requesting [calibration] services from a vendor, make sure you’re requesting 17025 accredited service. You must specify this, as several levels of service may be available, and “NIST Traceable” certificates are usually no longer sufficient.” He also advises that calibration certificates be scrutinized for all elements of compliance closely. “Some companies will simply state that it is ‘ISO 17025 compliant’, [and] this does not mean it is necessarily certified. Look for a specific reference to the accrediting body and the accreditation certificate number. Buyer beware, there is often a price difference between the different levels of calibration. Always practice due diligence when evaluating your calibration vendor and their services, and contact the calibration service if you have any questions.”

Validation vs. Verification. One of the more nuanced areas of the standard lies in determining when a test requires validation, verification, or an extension, specifically when there is a modification to a method or a sample type not previously validated by an internationally recognized organization (AOAC, AFNOR, etc.). Certified Laboratories Director Benjamin Howard reminds us, “think of validation and verification as existing on a spectrum. The more you stray away from an existing validation, the more validation work is required by the analyzing laboratory.” For example, analyzing Swiss cheese for Salmonella by a method that has already been validated for soft queso cheese may require only minimal verification or matrix extension. However, a laboratory that is altering a validated incubation time or temperature would require a much more robust and rigid validation process. Howard cautions, “Accredited laboratories must be transparent about modifications, not only on their scope of accreditation but on their reports [or CofA’s] as well. Under FSMA, companies are now accountable to the data that their laboratories generate. If you see a “modification” note on your report, perform due diligence and discuss this with your laboratory. Ensure a proper validation of the modification was performed. “Additionally, the ISO 17025 standard and accrediting bodies do not mandate how a validation or verification should be done. Laboratories should have a standalone SOP that outlines these procedures using scientifically supported justification for their approach.

CAPA / Root Cause. A good corrective action / preventive action (CAPA) and root cause (RC) analysis program is at the heart of every sound quality system. “Corrective and preventive action (CAPA) processes can either add value or steal time away from the organization according the quality of the root cause analysis,” says Vanessa Cook, quality systems manager at Tyson Foods Safety & Laboratory Services. “CAPA might be the single greatest influence on an organization’s ability to continuously improve and adapt to change if diligence is given to this activity.” Investing in resources such as ongoing training in CAPA/RC programs and techniques are key components to ensuring a robust and effective CAPA / RC program.

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8 Food Industry Trends Fueled by FSMA

By Lori Carlson
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FSMA is fostering a surge in technology solutions, analytical tools and training products marketed to the food industry in the name of achieving FSMA compliance. And while many of these products were available pre-FSMA (especially in other industries like the life sciences), FSMA’s momentum has fueled the adaptation of solutions to meet the specific needs of the food industry for achieving and maintaining regulatory compliance. This article is a summary of emerging trends in food safety management by producers, manufacturers, distributors and retailers through the application of technology, educational tools, monitoring and detection systems, and other support mechanisms.

Want to learn more about FSMA trends and compliance? Attend the 2016 Food Safety Consortium in Schaumburg, IL | December 7–8 | LEARN MOREWhether by the spark of FSMA or because it makes practical sense (and most likely, a bit of both), businesses are integrating their food safety programs with enterprise initiatives and systems for managing compliance and risk to achieve increased visibility and harmonization across the organization.  The most popular trends fueled by FSMA largely reflect technology solutions to achieve this integration.

Subsequently, solutions that support risk assessment, supply chain management, real-time monitoring, corrective action, self-assessment, traceability, and training management are most attractive and lucrative from an ROI perspective. And while it may be hard to find a one-size-fits-all technology solution depending upon the needs of the organization, technology service providers are quickly raising the bar to meet these growing needs as organizations strive to reduce risk and increase compliance. Other top trends at the periphery of technology solutions include the mobilization of food safety personnel and increased availability of on-demand training and detection tools to bring the FSMA movement full circle.

1. Software-as-a-service (SaaS) technology solutions quickly gained a following in the food industry in recent years to achieve an automated food safety and quality management system (FSQMS) solution.

The substantial management components and recordkeeping requirements of the FSMA rules has accelerated the food industry’s need for automated solutions to document program management, queue workflows and distribute notifications for corrective and preventive action (CAPA). Understanding this need, many SaaS providers evolved with FSMA to provide functionality that dovetails with new regulatory requirements.

2. Increased availability of risk and vulnerability assessment tools is of significant importance in meeting many requirements of FSMA’s rules.

The regulatory language of all FSMA rules is steeped in risk analysis to support the prevention of food safety hazards and threats. This creates a demand for user-friendly tools and training courses to help food businesses analyze and update their management systems within the context of these new requirements. Risk and vulnerability assessment tools currently available to the food industry are diverse in functionality and vary in scope and cost.

For example, FDA’s free online tool, FDA-iRISK 2.0, assesses chemical and microbiological hazards in foods through process models, which quantify risk across scenarios and predict the effectiveness of control strategies.  Commercially available food hazard assessment tools based on HACCP/ HARPC principles include Safefood 360° and EtQ, which provide risk assessment modules as a part of their SaaS platform.

Universities, trade associations, and commercial risk management and consulting firms came together to produce two very different food fraud vulnerability tools to support the industry. SSAFE by the University of Wageningen RIKILT, Vrije Universiteit Amsterdam and PricewaterhouseCoopers (PwC) is a free online tool and mobile app, which guides users through a decision tree and assessment questionnaire to determine fraud opportunities, motivators and gaps in existing controls. EMAlert by the Grocery Manufacturers Association (GMA) and Battelle is a subscription-based online tool to assess vulnerability from economically motivated adulterants (EMA’s). Individuals conducting vulnerability assessments are recommended to periodically access food risk databases such as the U.S. Pharmacopeial Convention’s (USP) food fraud database to stay informed of historical and emerging threats to the supply chain.

And in support of FSMA’s Food Defense rule, the FDA developed a free food defense software tool, Food Defense Plan Builder (FDPB), to help food businesses identify vulnerability to intentional adulterants and terrorist attacks on the food supply chain.

3. SaaS platforms, app-friendly assessment tools and FSMA recordkeeping requirements are creating a natural pathway for the increased use of mobile devices and electronic recordkeeping and verification.

From supply chain management to effective traceability to regulatory compliance, efficient document management and on-demand data retrieval is a must have of the modern FSQMS. Food businesses recognize the inherent obstacles of paper-based systems and increasingly trend towards rugged mobile devices and electronic recordkeeping to make better use of personnel resources, technology solutions and data. FSMA is helping leverage this trend two-fold through increased requirements for documentation and verification of food safety management activities and by not requiring electronic records to additionally meet the provisions of 21 CFR part 11 (electronic recordkeeping).

4. An increased demand for more effective, frequent and accessible training must be met across an organization to maintain an adequately trained workforce responsible for implementing FSMA.

To keep up with this demand—as well as the training demand imparted by GFSI schemes and fact that a company’s FSQMS is only as good as those who develop and operate it—food businesses are turning to online and blended learning courses to increase training frequency and effectiveness. In Campden BRI’s 2016 Global Food Safety Training Survey, 70% of food processors and manufacturers responded that they received training deficiencies during audits as the result of a lack of refresher training and/or lack of employee understanding.

In an effort to help close this gap and meet new implementation requirements of FSMA, food safety training providers are increasing offerings of eLearning courses, which provide targeted content in shorter duration to meet users’ needs in an interactive (and often multilingual) format. Shorter and more frequent targeted training is proven to increase knowledge retention and job performance. E-Learning training solutions can be found through dedicated training service providers as well as universities, trade associations, regulatory agencies, scheme owners, certification bodies, and other compliance organizations.

Depending upon the training provider, online training may be distributed through a learning management system (LMS) to provide additional training tools, assess training effectiveness and manage the training activities and competencies of all participants.

5. Targeted monitoring and verification activities such as product testing, environmental monitoring or water quality testing are helping to increase the demand for pathogen testing and push the frontier of improved rapid pathogen detection methods.

In a recent Food Safety Tech article, Strategic Consulting, Inc. noted more than a 13% annual increase in pathogen testing by contract food laboratories as determined by a recent industry study conducted by the group. The study additionally identified turn-around-time as the second most important factor for suppliers when choosing a contract lab. Increased access to rapid pathogen testing—and in particular, detection without time-dependent cultural enrichment—are primary needs of food businesses as regulators and customers push for enhanced monitoring and verification via testing mechanisms.

Currently, there are numerous rapid methods based on DNA, immunological or biosensor techniques. These methods can detect foodborne pathogens in relatively short amounts of time ranging from a few minutes to a few hours. But they often require pre-processing strategies to reduce matrix interference or concentrate pathogens to meet the level of detection (LOD) of the assay.1 These strategies increase the overall time of the assay and are largely the next hurdle for improved rapid detection.

6.  Food businesses are experiencing a wave of self-assessment followed by CAPA as organizations work to analyze and update their food safety systems and protocols within the context of applicable FSMA rules.

This trend has the potential to be the most beneficial to the supply chain and consumers as it provides a distinct opportunity for food businesses to reconsider previously overlooked hazards and vulnerabilities and upgrade food safety controls along with the management system. Seeing the FSQMS with fresh eyes—outside of the framework of a familiar standard—can lead to significant improvements in food safety management, product safety and quality, and even operational efficiency.

7.  For many food businesses, heightened regulation has spurned the need for dedicated staff to support compliance efforts.

Many food businesses are subject to multiple rules—some of which require a dedicated individual such as the Preventive Controls Qualified Individual (PCQI) to assume responsibility for the implementation of various provisions. And food businesses are not exempt from the acute need for qualified individuals with a food safety skill set. Across the industry, from service providers to retailers and everyone in between or at the fringe, executives understand that it takes tireless leadership and knowledgeable staff to produce safe food.

8. More than any other trend, communication on FSMA, food safety and related topics is easily the most prevalent exhibiting exponential activity over the past five years.

Whether in support or contention with the proposed (now final) rules, FSMA promulgates constant dialogue about food safety, what it means and how it should be implemented. The constant flurry of communication provides both benefits and deterrents to understanding the new regulations and identifying effective solutions for compliance. This dichotomy creates a significant need for authoritative and easy-to-understand information from consolidated sources within the industry such as trade associations, risk management organizations and food safety schemes. The divide has also helped fuel the need for information hubs like the Global Food Safety Resource (GFSR) that aggregate critical regulatory information, food safety solutions and best practices to reach a global community.

Reference

  1. Wang, Y. and Salazar, J.K. Culture-Independent Rapid Detection Methods for Bacterial Pathogens and Toxins in Food Matrices. Comprehensive Reviews in Food Science and Food Safety. 2016; 15(1): 183-205.

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.

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.