The Definitive When and How to Process a Corrective Action

Part 2 of the Corrective Action Series

Background

The Corrective Action process is the central part of the Continual Improvement process in a QHSE (Quality, Health, Safety and Environment) Management System. It is important that a strict protocol be followed for each corrective action that is conducted by the organization. The protocol will have a big impact on the eventual success of the Corrective Action program, including collection of data in a uniform manner

Initiation

The decision to initiate the corrective action process should be made by the appropriate personnel who have the authority and experience within an organization, based on the level of risk, that the issue at hand presents to the organization’s QMS.  As most quality professionals know, many circumstances can trigger the corrective action process to be initiated, including:

• A safety event is detected that affects the organization’s product or personal
• The product and its function are interrupted
• Production operations are interrupted
• Repetitive problems are detected by inspection/observation, or similar issues across many activities/processes
• Special process(es) create a difficulty in detecting the NC
• By customer request pertaining to NC product
• Overall QMS weakness of detection

Problem is detected

Once a problem has been identified by way of inspection, customer complaints, or audit results, it should be captured using non-conformity reports (NCRs) or corrective action reports (CARs) in order to identify what the problem is, who/what is affected and what impact the problem poses to the QMS or a designated department/process, or product.

Section 10.2.1 of ISO 9001 lays forth the requirements for the occurrence of a nonconformity and include actions to prevent a similar nonconformity or problems from recurring/ occurring. The analysis and evaluation of nonconformities should be an exercise in determining the causes of the NC issue and understanding what steps are necessary to eliminate the issue and taking actions to prevent re-occurrence.  This is not an action where blame is seeking to be laid but an exercise in good judgment and sound evaluation of the evidence gathered.

More detail on Nonconformance management is covered in ISO 9001:8.7, and a separate article at QIA. Dealing with nonconformances can include correction, which must not be confused for Corrective Actions. See article Part1 on Corrective Actions.

Initiating the Corrective action process

What is a corrective action?

A corrective action can be described as an action implemented to address the root-cause or causes of an undesirable condition, situation, nonconformity, or failure; as well as, an action taken to prevent recurrence.

As part of the corrective action process you must identify all the causes (root-cause and contributing causes) that have or may have generated an undesirable condition, situation, nonconformity, or failure.

After the problem has been detected, an organization needs to begin the operation of corrective action.  This usually ensues by delegating and designating individuals who are experienced in the corrective action process to undertake the task.

In most organizations, small and large alike, the corrective action process is a team effort.  A small organization may only have a single person in quality (manager) while larger organizations may employ multiple personnel in multiple departments who are charged with quality assurance, control and inspections. Either way, it is important to engage persons familiar with a process operation (i.e. machinists, engineers, etc.).  These are the people performing the jobs within the organization and may be best people to identify the actual cause of a problem and be influential in the determining the solution. It should be noted that having too many participants may hinder the operation in that multiple persons may become a hindrance to the corrective action process and be less efficient.

Containment, Evaluation and Analysis

The following is a stream-lined view of the corrective action process.

1.   Contain the problem

• The idea is to isolate/quarantine the problem/nonconforming product so as to preclude the nonconforming product from unintended use, such as shipping it, or moving it forward in the manufacturing process.
• actions for dealing with the nonconforming product could include scrap, rework, repair, etc. These actions are not corrective actions. The best word for them is Dispositioning a NC.
• Where necessary, provide an emergency response action to protect your customer and the operations of the organization (to stop the problem getting worse)
• Sometimes a single interim containment action may not be enough. You may need to implement more than one to fully protect your customer and/or your own processes.
• Evaluate and analyze facts – not opinions. At this point, the idea is to determine if the Nonconformance needs to be escalated to a Corrective Action. See related article (Part 1). The best way to do this is via a Risk Assessment. If the risk is high, then a Corrective Action is warranted. Remember, a Corrective Action will end up upgrading process(es). It takes time, effort, money. If so, continue with the next steps:

2.   Investigate the Problem

• • Form a team. People to consider when forming team:
    • those that have to respond to the problem
    • those responsible for areas, equipment, processes and personnel
    • those immediately involved with the problem
    • include any relevant expert in the type of problem, if available
  • Define the problem carefully and accurately. Consider the following two problem statements:
    • We don’t have enough service reps during peak hours
    • Our customers are waiting on hold for an average of 5-7 minutes
    • Consider that the second statement is the real problem, not the first one. Which statement you go with can influence the investigation.
    • Record this definition
  • Cause Analysis
    • There are many methods for cause analysis, the two most popular are the “Five Why” method, and the “Cause and Effect” method.
    • The Five Why method is the simplest, most intuitive and quick method. It consists of asking why the problem happened, and continue forward with why the first cause happened, etc., until the root cause is determined.
    • The Cause and Effect Analysis is best done with the Fish-Bone Diagram, where the bones of the fish help visually list the various causes and sub-causes.
    • Remember that in real life, there seldom is one root cause. Most of the time, there are Direct, Contributing, and Root causes that need to be identified.
    • Record this analysis
    • Read our article on Cause Analysis

3.    Solution Generation

• The thing to remember is that the solution must seek to either eliminate the root cause and other causes or minimize their effect. There must be a clear reason why the formulators of the solution think that the solution will do so.
• Also remember that the solution must change/ upgrade the process(es). It must be focused on the process, not the product. Remember the definition of a product: “product is the result of a process”
• The solution should be documented the same way as how you document a process improvement project.

4.   Solution Implementation

• Implement the solution per the improvement project plan, and keep records

5.   Verification of Effectiveness

• Verify that the solution was implemented as planned
• Verify that the causes were eliminated, or their effects minimized as planned
• This verification can be done on the basis of tests, such as subsequent inspection results. Sometimes is may be admissible to use expert judgement that the solution is deemed effective, in case it takes a long time to verify the actual results.
• Keep records

6.   Validation of Effectiveness

• In the case of significant corrective actions, or those that take a long time to evaluate, or those that a customer requires, you may have to schedule a validation in house at a later date when there is enough data, or at a customer or any other interested party.
• Keep records

7.   Record Keeping

• • Corrective Actions are a significant activity, and adequate/ pertinent records must be kept
  • The point of having records is to gather data which can be analyzed to garner information that will help the organization stay on their Continual Improvement strategy and goals.
  • The data analysis and the entire process of corrective actions can be automated. Read our article on Automated Corrective Actions.
  • Data and information on the NC should be collected and evaluated based on the facts regarding the NC. Opinion as to cause or responsibility should be restrained, and only factual observations should considered and documented.

In summary, the Corrective Action process is essential for identifying and addressing nonconformities within a QHSE management system. By following a structured approach to root cause analysis, solution implementation, and verification, organizations can effectively prevent recurring issues and improve overall quality. Implementing a QMS software with a CAPA (Corrective and Preventive Action) management system can streamline this process, ensuring efficient tracking, documentation, and analysis of corrective actions. This contributes to continual improvement, operational efficiency, and a stronger commitment to quality and safety across the organization.