“CAPA” … this term is used frequently in the Medical, Aerospace and Automotive sectors and is a fundamental principle of a Quality Management System (QMS). As the title of the article shows, CAPA stands for “Corrective Action, Preventive Action”. CAPA consists of actions which stop concerns or nonconformities initially through temporary countermeasures and at a later stage permanently through process and/or design changes. In this article, we will cover CAPA fundamentals, real-world examples and some common missteps that can prevent robust CAPA activities.
CAPA – what does it mean?
Corrective Action – Preventive Action (CAPA) is a systematic approach used by organizations to identify, investigate, and address problems or discrepancies in processes, products, or services.
- Corrective Action (CA) focuses on addressing existing issues, deviations, or non-conformities that have already occurred. It involves investigating the root causes of problems and implementing solutions to prevent their recurrence.
- Preventive Action (PA), on the other hand, aims to proactively identify and eliminate potential sources of problems before they occur. It involves assessing risks, analyzing processes, and implementing measures to prevent future issues.
CAPA – when is it applied?
When a concern or undesirable situation occurs, CAPA is used to stop the problem from reoccurring. In the context of Automotive manufacturing, a concern can be found by the final Customer (vehicle owner), the OEM (vehicle manufacturer) or within the Supply Chain (component manufacturer).
CAPA is applied at all stages of the Product Lifecycle, in terms of APQP, phases 1 to 5.
Below are examples of concerns that arise regularly in the Automotive industry:
1st Example – A product recall where several thousand vehicles have a safety issue such as accelerator pedal sticking (see Toyota, Tesla…).
2nd Example – A customer complaint in warranty where a navigation display screen has an intermittent function (randomly turns off).
3rd Example – An OEM finds a Colour Harmony issue (Door colour mismatch to Door Handle) with their vehicles at a final inspection point before shipment to customers.
4th Example – A supplier has manufactured Headlights which are dimensionally out of specification to the Engineering Drawing.
CAPA Hierarchy
Let’s start with the fundamentals of how this term is defined:
The CAPA Hierarchy helps investigators choose countermeasures which are effective in prevention of the reoccurrence of the original problem.
Elimination
Elimination is the most effective approach to reoccurrence and will prevent deviations, concerns and problems.
Implement Poka-Yoke devices such as design changes to the product or add devices to the process where non-confirming products cannot be progressed to the next manufacturing stage.
Replacement
This category looks at replacing the current process or equipment with more reliable alternatives. Improving the reliability of processes and equipment reduces the probability of issues and non-conformances.
Facilitation
Making the process easier to perform reduces the likelihood of mistakes. This can be achieved through implementing visual aids, colour coding, and left-hand/right-hand part numbers, so concerns become easier to recognise.
Detection
Improving detection capabilities is a fundamental aspect of effective CAPA actions. By improving monitoring systems and introducing more capable sensors in the process, organizations can identify concerns and take corrective action before they lead to major escalation.
Mitigation
The weakest and least effective CAPA Action are mitigation which involves reducing the effects of errors and non-conformities. Mitigation measures typically involve sorting, rework, or temporary solutions.
CAPA and the Eight Disciplines
A common Automotive industry standard practice to structuring CAPA is it use the Eight Disciplines of Problem Solving or better known as 8D. The eight steps are:
CAPA Missteps
CAPA investigations and actions can fall short in terms of effectiveness in resolving a concern. When robustly followed, problems can be quickly identified, contained and countermeasured in a relatively short space of time.
Some common mistakes are shown below:
- Lack of Investigation.
- Lack of Timeliness.
- Lack of adequate trending.
- Root Cause is not identified.
- Root Cause is not Corrected.
- The Symptom is Correct not the Root Cause.
- Lack of Interim Actions.
- Lack of Robust Permanent Actions.
- Verification of Permanent Actions poorly conducted.
- “Operator/Human Error” used as a Root Cause.
Recognizing these common errors in the CAPA process will help prevent biases and poor concern resolution implementation.
CAPA in connection to QMS requirements
CAPA activities are intertwined strongly with ISO 9001:2015 Standard regarding Quality Management System requirements and also with the IATF 16949.
The starting point with requirements is 10.2.1 Reaction to nonconformities which states:
“When a nonconformity occurs, including any arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:
1. take action to control and correct it;
2. deal with the consequences;
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
1. reviewing and analysing the nonconformity;
2. determining the causes of the nonconformity;
3. determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) update risks and opportunities determined during planning, if necessary;
f) make changes to the quality management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.”
Remember according to 10.2.2 to retain documented information of corrective actions as evidence of the nature of the nonconformities, actions taken and the results of corrective actions.
However, in automotive Quality Management System requirements according to IATF 16949:2016 we can associate two very important clauses:
10.2.3 Problem solving
“The organization shall have documented processes for problem solving, which prevent(s) recurrence, including:
a) defined approaches for various types and scale of problems (…);
b) containment, interim actions, and related activities necessary for control of nonconforming outputs (…);
c) root cause analysis, methodology used, analysis, and results;
d) implementation of systemic corrective actions, including consideration of the impact on similar processes and products;
e) verification of the effectiveness of implemented corrective actions;
f) reviewing and where necessary, updating the appropriate documented information (e.g. PFMEA, control plan). (…)”
10.2.6 Customer complaints and field failure test analysis
“The organization shall perform analysis on customer complaints and field failures, including any returned parts, and shall initiate problem solving and corrective action to prevent recurrence. (…)”
Let’s sum up!
The article emphasizes the importance of verifying the effectiveness of implemented actions. Also how document the entire CAPA process for traceability and continuous improvement. It underscores that CAPA should be viewed as an ongoing cycle. Feedback loops are important to incorporate lessons learned into future practices.
We hope the article provides a comprehensive overview of CAPA. We highlighted its significance in ensuring product quality and customer satisfaction within organizations. It serves as a valuable resource for professionals seeking to implement or improve CAPA processes in their respective domains.
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For people who want to know more:
Knowledge must have a solid foundation in order to avoid information noise. Therefore, the article was based on the following literature:
IATF 16949: 2016 Requirements for quality management systems in serial production and the production of spare parts in the automotive industry, 1st edition, 2016
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