At a recent ASQ Salt Lake Section symposium held at the headquarters of quality management software solutions provider MasterControl in Salt Lake City, food safety expert Jack Hamilton of EAGLE Certification Group shared some best practices for avoiding problems in managing corrective and preventive action (CAPA) systems.
While CAPA issues are relevant to every manufacturing environment, the CAPA approach that Hamilton takes is food safety management-centered, as that is his area of expertise in his position as senior business development manager with EAGLE. His presentation focused on CAPA as it relates to the SQF Code, the preeminent standard of quality for food production. He compared an organization’s CAPA system to a fast car and the superhero Iron Man, saying, “you don’t want to let it get rusty, or it’s useless.”
In the presentation, Hamilton identified the 10 most common CAPA conundrums he’s encountered and offered helpful suggestions for avoiding them and amending inefficient CAPA processes. “To avoid these pitfalls, you must know the difference between corrections and corrective actions,” he said, pointing out that corrections and corrective actions are unequivocally defined as distinct activities in the SQF Code. While corrections are actions taken to eliminate a detected non-conformity, corrective actions are those taken to eliminate the cause of the undesirable situation and thus entail more involved analysis and documentation.
Top 10 CAPA Pitfalls and Remedies
1. Corrections Being Considered Corrective Actions
Hamilton pointed out that simply making corrections while failing to develop a thorough corrective action strategy is the biggest problem organizations have with CAPA management. “Many of the corrective actions submitted on first pass are really just corrections,” he said. “Containment is the first thing you do to stop an issue from happening. Corrective action, however, is an action taken to eliminate the cause of a detected nonconformance.”
To avoid mistaking simple corrections for corrective actions, organizations must get in the habit of completing a root cause analysis (RCA) for any corrective action. “If it seems like you’re going down a rabbit hole with every problem that you have, it’s probably a good idea to take it through your CAPA process,” he said. When doing so, it is essential to define what should go through the root cause process, educate staff on root cause techniques, and implement those techniques. “A good root cause analysis is more than just a paper shuffle,” he said.
2. All Issues Indiscriminately Sent Through CAPA System
Inevitably, time management problems will be pervasive when all events are funneled through the CAPA system, according to Hamilton. With the understanding that CAPA systems can be easily overburdened and are complex to manage, it becomes increasingly difficult to determine what quality events should be pushed through the CAPA process. Hamilton listed several critical events that should be funneled into a full root cause analysis in food safety management environments:
To avoid overload, Hamilton said that nonconforming events must be adequately defined and that organizations need to be specific about what should go through their full CAPA process. He identified three ways to streamline and unburden CAPA processes:
- Food safety and storage issues
- Hazard Analysis Critical Control Points (HACCP) deviations
- Serious customer complaints
- Customer complaint trends
- Failure to meet customer specifications
- Internal audit trends
- Safety prerequisite program (PRP) ineffectiveness issues
- Adequately define those types of non-conformities that need to go through the CAPA process
- Set targets appropriately
- Trend the little items that may lead to larger concerns
3. Lack of Training in Use of Root Cause Analysis Tools
“People just aren’t used to doing root cause analysis,” Hamilton said. “They don’t know what it is because they’re just used to only correcting problems.” In his experience, there are very few organizations that understand RCA tools, and even fewer are trained in the tools’ proper use.
To avoid being plagued by these disconnections, Hamilton pointed out that an organization must first identify the RCA tools that can potentially be used for investigations, and then train staff on how to use the tools successfully. Effective root cause analysis tools that are frequently employed include fishbone (or “Ishikawa”) diagrams, 8D methods, and the “Five Whys” lean tools. “Identify the tools and find which methods work for you,” Hamilton said. He also recommended that it may be worthwhile for some companies to invest in professional training.
4. Preconceived Idea of Root Cause
Organizations often jump to conclusions when things go wrong because they are looking for a quick fix. Hamilton gave an example of a company that assumed a production nonconformance was due to insufficient hand washing practices, so the company instituted new policies that required longer, more thorough hand washing by the production staff. It wasn’t until the problem persisted that the true root cause was determined: there were an insufficient number of washing stations to adequately handle the number of staff members returning from break simultaneously.
Companies often lean on training as a catch-all fix in such instances, which can erroneously assume the problem lies with an individual employee’s accountability. “The key is to try to change the process, not to put the emphasis on the individual,” Hamilton said. “The process should make it easier for them to succeed.”
Like many of the aforementioned pitfalls, these preconception problems can be rectified by implementing the appropriate RCA tools and documenting the process. “Practice makes perfect, so document your investigations,” he said. “The more times you document your process, the better you’re going to get at it.” He also recommended involving a team, rather than putting the entire burden of an investigation on one person (although it is helpful for a single CAPA owner to have ultimate accountability). “The more people involved, the more input you’ve got and the more ideas are going to come to the table,” he said.
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5. Not Involving the Right People
When only one employee is responsible for handling CAPAs, that individual will quickly become overwhelmed and their investigation input will usually turn out be inadequate, compared to the input that could be generated by a team. Hamilton said it’s also problematic to only involve managers because it may result in missing key information from people on the floor who are experiencing the problems firsthand. These oversights can be mitigated by creating cross-functional teams and by assigning CAPAs to the department specifically responsible for the issue at hand. “Get the decision makers involved,” he added. “You definitely want to include somebody who can spend some money when you need to make changes.”
6. Lack of Time to Perform the Process Properly
When quality events occur, time is critical—even more so when analyses and investigations get more complex and drawn out. And they can be further complicated when companies downsize and consequently dump more responsibilities on their quality professionals. “Time is a critical commodity, and root cause analysis is not a fast and simple process,” Hamilton said. He warned of getting trapped in a correction/containment cycle where, once containment is achieved, the corrective action merely becomes part of a to-do list and potentially forgotten.
Hamilton said that someone with authority must commit to allotting the necessary time for staff to conduct investigations adequately. Companies can only alleviate the problems posed by time constraints by getting a commitment from management to get the job done correctly and thoroughly so they don’t end up with a backlog of root cause analyses without corresponding corrective actions. “Help (management) understand the importance of the process and make the case that proper fix will save time and money in the future,” he said. “Then, communicate this message to the entire staff.” He suggested building some type of reward into the CAPA process whenever possible, such as a bonus day off or free lunch.
7. Verification Step Not Completed
Corrective actions must be verifiably effective. The only way to definitively know if a corrective action is effective, according to Hamilton, is to keep an eye on the problem over time and note if any other similar issues have occurred since the actions were implemented. “You may see that nothing has gone wrong after one day, but that might not hold true in a month,” he said.
In Hamilton’s view, internal audits are usually the best way to verify that the implemented corrective actions have been successful. It is also essential to train CAPA teams to collect proof of the corrective action’s effectiveness. “Another option is to have the CAPA team gather evidence to support the action’s implementation,” he said. “Part of the process can be to go out and show that it’s been taken care of.” He added that creating a system of documentation to track each step of the CAPA process is also integral to verification. “At some point, a good CAPA system is going to have a documented procedure,” he said.
8. Failure to Look at Other Areas Where Issues May Occur
When we only focus on fixing the things that are broken, we can often overlook potential preventive actions that can be made on other lines or with other products. Management oversight can lead to an attitude of not wanting to know about potential problems, which creates an environment where there’s always a possibility for similar quality events to occur in other areas. While Hamilton says the SQF Code doesn’t focus on risk-based quality management to the same degree as ISO and other standards, he believes that many problems can be solved or avoided by increasing attention on preventive actions.
The first step to effective preventive actions is to create cross-functional team because it allows different departments to compare quality issues. Preventive action protocols should always include a review of corrective actions and their possible application to other product lines. Comprehensive CAPA forms that potentially help in-house investigators uncover other related problems can ultimately lead to faster resolution times. “Just put on the CAPA form that it’s part of the process to look at other parts of the business to see if they also have that problem,” Hamilton said. “That way you’re not going to overlook issues.”
9. Lack of Management Commitment
While objective evidence of management’s lack of commitment to CAPA efficiency may not be apparent, Hamilton said that it certainly makes it difficult for auditors to do their jobs. “Management does not always see the benefits,” Hamilton said. “They just see costs and lost time.”
Quality professionals looking to remedy these common organizational dysfunctions and educate their management about the importance of CAPA can start by putting a price tag on each issue. In the food safety world, Hamilton said, this is often best done by drawing management’s attention to the actual costs of potential product recalls and asking them a simple question: “What would a product failure in the field do to your product brand and your sales?” Hamilton encouraged event attendees to put a dollar value on the cost savings of their efforts and to keep good records. Tracking customer complaint and satisfaction data can also be monumentally helpful in making the case for CAPA improvements.
10. Incomplete Documentation
Regulatory agencies approach documentation like a strict math teacher grading a homework assignment: if you can’t show your work, then there’s no evidence proving that any corrective action processes were ever executed. “Auditors look for this verification,” Hamilton said.
The simplest path to ensuring documentation compliance is to create a form that includes verifiable, documented steps to completion. At a minimum, this form should include information about the investigation, the root cause analysis, the correction or containment, the corrective action, and verification. Many organizations find it necessary to use a “no-go” CAPA form that prevents the person filling it out from moving on to the next section until the required information has been entered. Hamilton emphasized the importance of accountability for ensuring that documentation is complete. “Designate someone to be over the program,” he recommended. “Despite the importance of the team approach, things are going to get taken care of when one person is held accountable.”
Hamilton said that by applying these CAPA pitfall-avoidance techniques, EAGLE has seen a verifiable reduction in customer complaints, rework, nonconforming product, audit findings, and the overall cost of quality. His only real source of frustration in quality is when people aren’t using their CAPAs as a tool of continuous improvement. He made it clear that when an organization’s CAPA system is a key part of its continuous improvement program, it becomes far easier for it to achieve its quality, compliance, and business goals. “CAPA should be used as a way to improve the way you do business and manufacture things,” he said.
James Jardine is a Marketing Communications Specialist for MasterControl Inc. He has a bachelor’s degree in journalism from the University of Utah and is based in MasterControl’s headquarters in Salt Lake City, Utah.
“Action to eliminate a detected non-conformity. Shall have the same meaning as ‘corrected.’”
“Action to eliminate the cause of a detected non-conformity or other undesirable situation. Corrective action shall include:
a) Determine / document any immediate action required / taken
i. Determine the cause of the problem
ii. Evaluate action needed on the identified cause
iii. Determine if the problem exists elsewhere in the system and implement actions needed
b) Document the results of the action taken
i. Review/verify and document effectiveness of action taken with objective evidence.”