GxP Lifeline
CAPA and Root Cause Analysis in the Food Industry
Can you find the root cause for the chaos in this kitchen? Unless you identify the root cause of a problem, you cannot resolve it.
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 (RCA)? 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 can help represent the resulting CA or PA plan to other areas of the organization and help facilitate buy-in, consensus, and execution of the plan
The CAPA 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:
- Identify the problem: Before you can solve the problem, you must identify it plainly and clearly.
- Evaluate /Review: How big is the problem? What are the implications? What is the severity of the consequences?
- Investigate: Make a plan to research the problem.
- 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
- The Action Plan: Narrow the list of possible causes.
- Implement: Execute the action plan
- 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.
Reprinted with author's permission.
Dr. Bob Strong is Industry Leader for Food Safety at SAI Global Assurance Services, and a driving force behind food safety operations in the areas of Good Manufacturing Practice (GMP), Good Agricultural Practice (GAP) and supplier assurance programs, including SAFE, SQF and BRC. Dr. Strong consults on food safety for a number of the leading hospitality and manufacturing chains both within and outside the U.S. Dr. Strong has more than 39 years of experience in the food industry, while working for national and international companies in quality assurance, product development and auditing. He is an oft-requested seminar speaker in the areas of GMP and HACCP. He earned a Ph.D. and BSC in Chemistry and is an accomplished food safety trainer for numerous food safety manager certification courses including Serv Safe and Experior. In addition, he is a GMP/HACCP instructor, a Lead Auditor trainer, and is also certified to consult on the Global Food Safety Initiative by SQF and by BRC, and is certified in 19 product categories.
