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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

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.