In this post, I’m going to introduce a helpful strategy for importers manufacturing in China or elsewhere to reduce quality risks and improve processes that may cause the problems: corrective actions and preventive actions or CAPA. This is also sometimes called a creative action and preventive action plan, too. You’ll learn what CAPA is, its background, how the process works, and the best time to apply these actions.
What is CAPA?
Let’s start by answering the question: “What is CAPA?”
CAPA is a systemic risk-reduction and process-improvement strategy that can be used in manufacturing and most other fields, too. Fundamentally, it is a process that drives an organization to find and fix problems that either might or have occurred and continue to manage the actions put in place. In the case of manufacturing, these would commonly be quality issues with a product that cause customer dissatisfaction, safety issues, and reliability problems such as breakdowns.
CAPA stands for corrective actions and preventive actions plan and it’s a particular approach that is usually applied to the post-production phase of a product. It bears a lot of relation to processes like root cause analysis, corrective action plan, preventive action plan and mistake proofing that all focus on finding and eliminating issues once and for all.
CAPA has a long-standing history of applications in the automotive industry and beyond and is most applicable to the quality issues that occur in manufacturing, production, and even post-production.
CAPA is not necessarily used as a risk assessment process, but actually has a lot to do with how you improve product quality before, during, and after production, rather than a process like mistake-proofing, for example, which has a narrower focus just on how workers use tools and the processes they follow on the production line.
When it comes to roles and responsibilities, the quality director is often responsible for overall CAPA implementation within an organization.
How the Corrective Actions and Preventive Actions process works
When considering the Corrective Actions and Preventive Actions process, typically you have an organization producing a product which, according to the process, meets all of its requirements (such as passing quality inspections, etc) and is ready to ship to the customer. However, once you have shipped the product for some reason you end up having field failures resulting in unhappy customers and complaints.
If there are excessive customer complaints typically the quality director and manager of an organization will take immediate action to respond. They’ll try to understand what the issues are and when they realize that the problem is severe and it’s not just one or two relatively mild issues happening they typically open up a CAPA process.
Each particular issue or failure mode in the field will be assigned a CAPA number for identification and tracking purposes and then it goes through a process very similar to the 8D Problem Solving Process. You have to go through a corrective action process and then follow up with the preventive action process, so it’s really the two processes one after another.
The CAPA process, based on the ISO 9001:2015: Quality Management Systems standard, is as follows (with a focus on product quality):
1. Define the problem. Describe the problem in detail. what is it, how does it happen, why, etc. Is it actually perceived or happening? What is the outcome and how may it be solved?
2. Define the scope. Is it a large issue that occurs all of the time or only occaisonally? Is it on most products or only a few?
3. Put in place a Corrective Action. Devise and put in place a short-term fix to stop the problem while finding the root cause and coming up with a preventive action.
4. Identify the root cause of the problem. Finding the underlying cause and not just the perceived problem is the goal of this. You may select whichever root cause analysis methods suit you.
5. Devise the Preventive Action. The preventive action must focus on eliminating the root cause and the plan will include its steps. Its cost and ROI must also be considered.
6. Implement the Preventive Action. Implement the preventive action. Examples might include redesigning a troublesome aspect of the product and then validating the new version once again, rewriting work instructions to solve a production issue, putting in place mistake proofiing measures on the production line to stop a mistake that causes defects, and more.
7. Follow up to be sure that the CAPA has been effective. After some time, followup on the product and see if the same issues have reoccurred, if not the actions are working.
The entire CAPA process and whatever has been learned needs to be documented and all stakeholders must be made aware of the changes and their effects.
So, if you receive customer complaints about a product, once the CAPA process begins your engineers investigate samples of the faulty units to examine them and troubleshoot the issue/s. If there’s definitely a problem that can be fixed immediately per unit that is a ‘corrective action,’ but then a better solution needs to be found to put a stop to this issue occurring at its source, perhaps the product design or manufacturing process, which is when you apply the ‘preventive action.’ In some cases, you might have to go back and check the design FMEA that was done to find out if any of these issues you’re seeing now were even discussed or seen during the product development and if any action was taken at that time. The beauty of the Corrective Actions and Preventive Actions process is that it brings in other previous actions such as earlier corrective actions, the risk assessment that was done, troubleshooting done for a particular failure of that same type, etc, and this can help influence the lasting preventive action put in place to finally fix the issue.
For example, maybe part of a product’s display is not functioning properly and you realize that a quick software update temporarily fixes it for a week or so, so you immediately apply the software update to all users as a corrective action. Now the clock is ticking, so the preventive action is to overhaul the entire software and test and troubleshoot it to see if the display issue is fixed once and for all. If so, the new update can be actioned and, as long as customers don’t complain about the issue again and the devices appear to be functioning correctly now, you can consider the CAPA to have been a success in this case.
Who is in a CAPA meeting?
You need to have a team assigned for the CAPA process, and the CAPA expert will typically be a quality engineer who has design experience and is very familiar with that product, its functionality, and customer use case scenarios. They will also have a basic understanding of how the product was designed and manufactured. When it comes to deep issues where it requires either a manufacturing or design expert’s involvement, this individual knows who to contact within the organization and will set up a meeting to involve them in the process and harness their knowledge and experience. This is where they actually discuss corrective actions, root cause analysis, risk assessment, risk management, earlier dFMEA, and then a preventive action plan.
They can put a poka-yoke system in place so that the issue doesn’t reoccur because they know that they can’t afford to let issues like this creep into a follow-up of the product, maybe a V2.0, as these are often based on the current version. A scenario that the CAPA expert doesn’t want is to have several CAPAs in progress at the same time for different versions of a product that stemmed from that one initial version that had the issue that wasn’t solved. Engaging the main design manager, design engineer, manufacturing engineer, etc, who are typically extremely busy people to meet regularly in meetings for different CAPAs would be unrealistic and almost doomed to fall behind and result in unresolved problems.
How long does a CAPA process last?
Typically the initial part of the CAPA process with corrective actions needs to be done within seven days after initiation. Speed may very well be of the essence because manufacturers are often contractually obliged in their manufacturing agreement to solve issue/s (with a temporary fix that the customer agrees on) with products within a certain time period, typically 7 days, that they have produced, otherwise they will bear financial penalties. Products that fail in the field have a knock-on effect on the customer because they are losing customers and brand recognition every day, so penalties like this redress the balance somewhat.
Then there is a second time period that is also usually agreed by both parties in the manufacturing agreement of somewhere between one to three months for the manufacturer to resolve the issue/s completely with preventive actions otherwise there will be other penalties, too.
What if a product failure returns after CAPA?
Unfortunately, I have seen some situations where a particular failure returned in a ‘Second or Third Return’ and this happens for two reasons:
- The corrective action was good but the preventive action plan was not successfully done or was done in a hurry so the product actually broke down and the failure repeated itself.
- The manufacturer really did not know how to fix the issue, so they didn’t do any preventive action at all and so after the corrective action’s effects, which lasted for only two or three months, dissipated, all of a sudden the failure showed itself again.
Why avoiding CAPA is good for business
The poor implementation of Corrective Actions and Preventive Actions that you just read about happens quite a lot and it is one of the ways that companies lose huge amounts of money. So it’s for this reason that businesses should be focused on preventing the need for a CAPA process in the first place by paying attention to certain ways to reduce risks and performing helpful activities during the entire product development and manufacturing process, such as:
- Following a comprehensive NPI process
- Performing a dFMEA
- Testing and qualifying the product design
- Making sure that product designs are mature before working with a manufacturer
- Doing reliability testing
- Implementing pilot runs before mass production
If you do a great job of risk-reduction, testing, and validation during the product design and development process, hopefully, there won’t be a need for CAPA once products are in end-users’ hands.
CAPAs tend only to be implemented on big failures where either you’ll have to activate a recall of the product, you have a large number of product returns, or you have a lot of complaints from customers that could result in terrible reviews and reputational damage. CAPA should be implemented on a product when the failure is actually impacting the functionality and performance of the product to a point where customer dissatisfaction is imminent, so it’s more of an emergency action acting as the last line of defense when trying to bring the product into reliability and, to be honest, most companies will have to pull the product from shelves, shut down production, and will settle with the customer and work on bringing an improved V2.0 of the product to market as soon as possible.
Is it always the manufacturer’s fault if CAPA is required?
If the manufacturer has not been involved with developing the product and the issue comes from product design it’s not the manufacturer’s fault, but if it’s an assembly problem or an issue caused by a deficient process in the factory then it probably is. It all depends on what the failure was.
For example, if the manufacturer created the original design, sourced the parts, and is mass producing the product for you and a key part fails, there is a good chance that they have failed to qualify component suppliers and so they would be at fault because at the end of the day the product they’re designing, building, and providing to their customers is their product. The customers aren’t interested in where an individual part came from, they simply expect the product to work as promised by the manufacturer that they employed to develop and produce it.
Conclusion
What makes the Corrective Actions and Preventive Actions process both important and difficult is that the person or persons who are responsible for implementing it really need to be at a senior level and highly experienced in quality and reliability testing, manufacturing, and even product design. Then when there’s a discussion in the group the designer and engineers all need to understand each other and their comments need to be brought together into a successful implementation process. Unfortunately, I have seen in many situations that teams are overloaded and lack resources and they hire a new person to implement CAPA. This is a huge mistake because this new person is unlikely to know the product well enough and may just be an organizer rather than a positive contributor to the whole process leading to risks that the actions don’t ‘stick’ successfully.
Reducing the risk of poor quality is really important. If you’re manufacturing your product now and are concerned about its quality, let us know and we’ll try to offer you some advice on how to proceed.
