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A Guide to Medical Device Corrective Action and Preventative Action (CAPA)

As an experienced medical device professional who has worked with dozens of companies, from startups to mega multi-nationals, I’ve had the opportunity to observe, evaluate, and impact how these companies implement effective quality management systems. Time and time again, however, the one process that nearly always presents the most challenges to medical device companies, regardless of shape and size, is CAPA. That’s right, Corrective Action & Preventive Action. And I suspect that your company might also be facing CAPA related challenges; challenges relating to your CAPA process, challenges related to your approach to initiating CAPAs, challenges related to your CAPA closures, challenges related to the effectiveness of your CAPAs.

Yes, there are numerous challenges related to CAPA. This article will explore those challenges. More importantly, this article will provide you with best practices and ways to improve your CAPA process and approach so that you can ultimately ensure the medical devices you design, develop, manufacture, and sell will be as safe and effective as possible for those patients that depend upon them.

The main message that I want you to take home from reading this article is this, a robust and modern approach to CAPA is about shifting from reacting to situations and events to being proactive to address potential areas of concern before they become reality.

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Regulatory Focus on CAPA and Related Processes

You are probably well aware of the fact that the U.S Food and Drug Administration (FDA) inspects medical device companies each and every year. You might have even been a part of an FDA inspection. I also can imagine that you have been through ISO audits. And if you have not been through any of these activities yet, I’m sure these will be part of your life at some point in the medical device industry. FDA inspections and ISO audits are a significant part of the medical device business.

Did you know that, during a FDA inspection, your CAPA process will always be evaluated?  You should also realize that CAPA process scrutiny is not just a FDA inspection thing. Your CAPA process will also always be evaluated during ISO audits.

Year after year, FDA reports data from inspections. And year after year, companies receive FDA 483 inspectional observations for “lack of or inadequate procedures” for CAPA. In fact, every year going back to 2010, the #1 reason companies receive 483s is because of CAPA.

“Procedures for corrective and preventive action have not been [adequately] established.”

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It should also be noted that you will notice a similar trend with respect to FDA issued warning letters. Yes, CAPA is often the #1 quality system citation in warning letters. Table 1 is a table from 2016 FDA quality system data analysis.

CY2016 Top 10 Most Frequent QS WL Citations

WL Citation QS Subsystem CY2016 # of Citations Percentage of all Citations
21 CFR 820.100(a) CAPA 57 10%
21 CFR 820.198(a) CAPA 39 7%
21 CFR 820.90(a) CAPA 30 5%
21 CFR 820.30(g) DES 27 5%
21 CFR 820.75(a) P&PC 25 4%
21 CFR 820.22 MGMT 23


21 CFR 820.72(a) P&PC 22 4%
21 CFR 820.184 DOC 21 4%
P&PC 20 3%
21 CFR 820.30(i) DES 19 3%
Total of All Citations 594

Table 1: Top 10 most frequent QS WL citations (calendar year 2016)


Unfortunately, there is not similar data available ISO 13485 audits. But based on my ISO audit experiences and the hundreds of medical device professionals I have spoken to about this, CAPA is an equally big deal during ISO audits.

The good news is that there are guidances available to help you. For example, the FDA has published “Guide To Inspections of Quality Systems” (often referred to as “QSIT”) where they tell you how they will conduct an inspection. (For the inspection guide on CAPA, refer to this link: There is also a published guidance available from the International Medical Device Regulators Forum (IMDRF) regarding corrective action, preventive action and related QMS processes.

This regulatory emphasis on CAPA all makes sense. Some would argue that CAPA may be the single most important process within your QMS. But, regardless of the ranking, it is critical to realize how many of your QMS processes feed into the CAPA process and how the results of CAPAs impact the health of your overall QMS.

What is CAPA?

It probably makes sense to take a bit of time to discuss what CAPA is before diving too deeply into all the problems. So let’s begin by sharing how the FDA and ISO 13485 define CAPA.

From 21 CFR Part 820.100, Corrective and Preventive Action:

(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;

(2) Investigating the cause of nonconformities relating to product, processes, and the quality system;

(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;

(4) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;

(5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;

(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and

(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

(b) All activities required under this section, and their results, shall be documented.

Further, in the FDA QSIT guide, they state that the purpose of CAPA:

“…is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures. One of the most important quality system elements is the corrective and preventive action subsystem.” (our emphasis)

In ISO 13485:2016, CAPA is addressed in two separate clauses, 8.5.2, Corrective Action, and 8.5.3, Preventive Action:

8.5.2 Corrective action

The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Any necessary corrective actions shall be taken without undue delay. Corrective actions shall be proportionate to the effects of the nonconformities encountered.

The organization shall document a procedure to define requirements for:

a) reviewing nonconformities (including complaints);

b) determining the causes of nonconformities;

c) evaluating the need for action to ensure that nonconformities do not recur;

d) planning and documenting action needed and implementing such action, including, as appropriate, updating documentation;

e) verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;

f) reviewing the effectiveness of corrective action taken.

Records of the results of any investigation and of action taken shall be maintained (see 4.2.5).

8.5.3 Preventive action

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be proportionate to the effects of the potential problems.

The organization shall document a procedure to describe requirements for:

a) determining potential nonconformities and their causes;

b) evaluating the need for action to prevent occurrence of nonconformities;

c) planning and documenting action needed and implementing such action, including, as appropriate,

updating documentation;

d) verifying that the action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;

e) reviewing the effectiveness of the preventive action taken, as appropriate.

Records of the results of any investigations and of action taken shall be maintained (see 4.2.5).

The Problems with CAPA

As I’ve shared so far in this article, you should have a better understanding as to the visibility of your CAPA process and why having a good approach is so important to the health and success of your medical device company. So let me share a few reasons why there are problems with CAPA.

Lack of Cross-Functionality

Generally speaking, CAPA is most often a process that is owned by the quality function within a medical device company. Quality usually holds the keys and makes the determination as to when a CAPA is required. This makes sense since the quality organization is responsible for your company’s QMS implementation and effectiveness.

But, if the quality function unilaterally makes the decisions as to what does and does not become a CAPA, does this make sense? Probably not. Does the quality organization have visibility into all the sources of data and information to make these decisions?
I doubt it.

Nearly every single medical device company I’ve ever worked with and know about is missing a “single source of truth” in order to make informed decisions about when and what to do. So what should you do to address this concern?

Realize that a CAPA is seldom an issue that only impacts the quality function. A CAPA almost always is cross-functional in nature and involves many other groups and functions of your company. Therefore, a recommended best practice is to establish a cross-functional team to review and discuss issues that may be candidates for a CAPA. Such a team is often called a management review board (MRB) and is comprised of representatives from quality, regulatory, operations and engineering.

A MRB should meet frequently, probably at least weekly, and review issues related to customer feedback, complaints, audits, nonconformances, etc. A MRB then assesses each of the issues and makes determinations as to which should be elevated to a CAPA. Further, I recommend that your MRB maintains a list of the open issues, establishes an agenda for their meetings, and documents minutes from the decisions made. The goal of the MRB is to review, assess, evaluate, prevent, correct and control quality issues.

Once a CAPA is issued, you also need to realize a couple of key points. A CAPA is a project that will require resources to address. Once again, this is an area where cross-functionality is absolutely essential. All too often in medical device companies, CAPAs are not treated with equal status and importance as other initiatives, such as new product development.

Reactive Instead of Proactive

The IMDRF has a guidance document on corrective action and preventive action and related QMS processes. Within this guidance, there is a profound statement about CAPA that I want to share with you.

“The acronym “CAPA” will not be used in this [guidance] document because the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action.

“This document will discuss the escalation process from different “reactive” sources which will be corrective in nature and other “proactive” sources which will be preventive in nature. The manufacturer is required to account for both types of data sources whether they are of a corrective or preventive nature.”

I find this profound for a one major reason. This guidance was published in 2010, yet even today medical device companies still seem to focus most of their CAPA efforts on correcting issues rather than

preventing them in the first place. Is this because of the overuse of the acronym “CAPA”? Perhaps. But I suspect that this is more about a mindset or philosophy. We are more inclined to address known problems rather than investing resources to prevent problems from ever happening. To quote one of “Murphy’s Laws:”

“There is never enough time to do it right the first time, but there is always enough time to do it over.”

It is very common for CAPAs to not be taken seriously in an organization. Most view CAPA management as part of the quality department and not applicable to them. CAPAs often take a back seat to other projects and initiatives deemed more important. However, CAPAs are enterprise-wide and impact the entire organization. CAPAs are a primary indicator of the health of your company’s QMS.

Sadly, CAPAs are more often than not reactions to issues that have already occurred. And it’s only after the issues have happened that medical device companies seem to have the time to do it right. This mentality and approach is wrong. This way of doing things causes a significant strain on medical device businesses. Instead, we need to have systems in place to assess and identify issues before they become problems. And we need to dedicate resources to constantly make our medical devices safer and better.

Overuse Versus Underuse

Let me share another systemic problem regarding CAPA that I have observed. Simply stated, a CAPA process is often at one extreme or another. Either CAPA is overused or it is underused. For example, imagine you receive a complaint on one of your medical devices. Or maybe you have a nonconformance. Does this singular event warrant issuing a CAPA investigation? It might, although I’ve seen instances where some companies issue CAPAs in nearly all situations like this. And before long, there are dozens and dozens of CAPAs, in addition to the complaints, nonconformances and other quality events.

This overuse of the CAPA process creates an undue burden on a medical device company. Conventional wisdom might indicate that issuing a CAPA will lead to improving an issue. But, in reality, overuse of CAPA actually results in more significant challenges. When overused, there are too many CAPAs and strains on resources. CAPAs either linger for months and months or are rushed to complete, without properly addressing underlying issues.

The other extreme is underuse of the CAPA process. When this happens, companies do not use CAPA nearly enough. There may be quality events happening, yet these do not result in CAPAs.

Both overuse and underuse of CAPAs are problematic. So, is there a magic number of CAPAs that a company should have open? No, there is not. So many factors influence if and when a CAPA should be issued. Ultimately, CAPA should be reserved as a process to deal with potential systemic issues.

Poor Root Cause Determination

Root cause determination is one of the biggest areas of concern, especially as it relates to CAPA. From my observations, there is very little time spent actually determining a root cause. Rather, the prevailing practice is to more or less restate the problem statement/issue description and capture this as the root cause.

But the problem statement and issue description hardly ever accurately represent the true root cause. To correct or prevent a problem, you have to define the root cause. Otherwise, your efforts are likely to miss the mark. Yes, you may take care of the problem for the short term. But without getting to the root, the issue has a high potential to happen again. And again.

Defining a root cause takes some effort and time. This is not something you can rush and easily slap together. You need to take the necessary steps to properly define root cause. Without doing so, any actions you define within your CAPA are likely to miss the mark. To say this another way, if you do not drill down to properly define the root cause, the issue you are trying to address will likely still be present, despite the actions you take.

There are numerous root cause tools and techniques, if applied properly, will make a huge improvement to your CAPA process. Personally, I’m a big fan of the “5 whys” approach because it is relatively easy to understand and can be quickly implemented. Let me briefly illustrate this technique.

  • Issue: The device breaks during use.
    • Why? The device is being exposed to extreme forces at point of use.
    • Why? The use technique at facility ABC is different than intended.
    • Why? Facility ABC did not receive in-service training.
    • Why? There is no resource assigned to provide training for that facility.
    • Why? No process to confirm that all use facilities require in-service training before products can be sold to a facility.

Note, with “5 whys,” the number of “why” questions is less important than getting to an actionable root cause. Doing so may only take 3 whys, or it could take 10 whys.

Root cause determination can take quite a bit of time and require cross-functional resources, if done correctly. This should not be rushed through in a couple of hours by a single person. But, regardless of the tools you choose, do make sure that you improve your root cause determination. Doing so will help ensure that your CAPAs are more effective in the long run. And ignoring or choosing to continue with status quo on root cause will mean CAPAs for similar issues will crop up over and over and that your efforts will not be effective.

Poor Definition of a CAPA Process

CAPA process definition is a huge issue for medical device companies. If you recall, this issue is the single biggest reason that the FDA has issued hundreds of 483 observations to medical device companies every year since 2010. These instances are usually the result of one of three things:

  1. The defined CAPA process is not being followed;
  2. The defined CAPA process is not compliant; or
  3. A CAPA process has not been defined.
  4. There might be another issue lurking too. And this would be that you have either not utilized your CAPA process appropriately or are over using CAPA and not getting things done. But, regardless of the reason, this is a huge problem. Companies do a very poor job when it comes to effectively managing CAPAs. And yes, the root cause of this usually lies with poor definition of your CAPA process.

Based on the historical data of FDA inspections, I’ll bet that your CAPA process and practices need work. And because of this, I would like to offer a step-by-step description of a CAPA process that will be a step in the right direction.

CAPA Process – Step-by-Step

First and foremost, realize that your CAPA process is best utilized for systemic issues. Again, keep in mind all the items discussed throughout this article. Make sure first and foremost that you are properly leveraging CAPA appropriately.

Then, assuming this is the case, here are some high-level steps to consider for your CAPA process.

  1. Create CAPA request and submit for review. Identify sources of CAPA worthy issue.
  2. Review CAPA request. Determine whether or not issue requires CAPA investigation.
  3. Accept or reject CAPA request.
  4. If accepted, issue and initiate CAPA.
  5. Finalize CAPA sources (i.e. products, processes).
  6. Determine CAPA cross-functional team.
  7. Identify any immediate actions and corrections required.
  8. Investigate and capture findings.
  9. Determine root cause(s).
  10. Specify corrective and/or preventive action plan.
  11. Complete action plan.
  12. Review CAPA for completeness.
  13. Approve CAPA actions.
  14. Specify steps for effectiveness verification.
  15. Verify effectiveness of CAPA.

How CAPA Connects to Other QMS Processes

As noted throughout this article, CAPA is an important process for your medical device company. In fact, the FDA states in their QSIT guide:

“One of the most important quality system elements is the corrective and preventive action subsystem.”

A solid CAPA process is foundational and an indicator of the health of a medical device company.  While a healthy CAPA process is key to a healthy QMS, it is equally important to understand how other QMS processes connect with CAPA. Some of the key QMS processes related to CAPA include:

  • Customer feedback
  • Complaint handling
  • Nonconforming product
  • Production and process controls
  • Supplier management
  • Audits
  • Design controls
  • Management review

Customer Feedback and Complaint Handling

Once a product is launched, one of the first areas that provides an indication for product opportunities and issues is your customer feedback and complaint handling processes. From the FDA’s perspective, complaint handling is a very critical process. How, what and when you receive complaints is important. Why? If a complaint caused an adverse event, this could require a thorough investigation and reporting to the FDA and other regulatory agencies. And even if a complaint is not an adverse event in nature, it still is an indicator of your product’s performance.

Investigating complaints requires a robust process. A robust complaint handling process is very similar in concept to a CAPA process, as described earlier. Define the issue, determine root cause, establish an action plan to address and correct the situation.

Generally speaking, complaints are often times more reactive in nature. To say it another way, a complaint is usually a response to an event that has already happened. You seldom seek out complaints. Instead, you are contacted after an event has occurred. When you learn of the complaint, addressing the immediate issue is corrective in nature.

But here is where understanding the connection between complaint handling and CAPA processes is important. Just because you have a complaint does not mean you automatically need to issue a CAPA. As noted, if your complaint process is robust, it will help ensure the complaint issue is properly addressed. Remember, CAPA is ideal for addressing systemic issues. Monitoring complaints and analyzing the underlying issues is important for determining if you have systemic product issues to address.

Nonconforming Product

When you launch your device into the market, you need to have processes in place to evaluate and ensure that the products conform to established specifications prior to release. In cases where your product does not meet the defined specifications, this means the product is nonconforming.

A solid nonconformance process is a good proactive measure; potential product issues should be identified before the product is shipped. A solid nonconformance process identifies the issue, incorporates root cause determination, and includes action plans to address the situation. Without a solid nonconformance process in place, you are likely setting your company up to receive more product complaints.

If a nonconformance issue happens one time, this is not necessarily CAPA worthy. Remember, CAPA is a process to address systemic issues. Like the complaint example cited above, analyzing nonconformance data is a proactive means to identify whether or not systemic issues are prevalent. If so, then yes, by all means, issue a CAPA to address the issue. Taking this type of approach is being proactive to address situations instead of just reacting to them after the fact.

Production and Process Controls

Every medical device requires production and process controls. Production and process controls include documented steps required to manufacture medical devices. This includes inspection procedures. Production and process controls are provisions you establish to ensure that the device is manufactured according to established specifications that help to ensure that the product is safe.

Yes, production and process controls also apply to software-based medical devices. While I realize software as a medical device (SaMD) products are not “manufactured” per se, you do need to have established processes to ensure specifications are met and inspection criteria is defined. You must ensure that your SaMD is safe.

Technically speaking, product issues identified during the production process should be captured as nonconformances. A nonconformance is the initial means to address issues with product not meeting established specifications. And as noted above, if the nonconformance is systemic in nature, then issuing a CAPA investigation is a best practice.

There could also be issues with the production related processes. If you identify issues with production processes, then you need to determine a course of action. More times than not, you likely can tackle these via your change management process. However, if the issues are more systemic in nature, then consider a more thorough CAPA investigation.

Supplier Management

Supplier management involves qualifying, evaluating and monitoring the performance of your suppliers. If you identify issues with items purchased from suppliers, then the first step is to issue a nonconformance. Again, a nonconformance is a means to document an issue when an item does not meet established specifications. When this happens, you need to determine, within the nonconformance documentation, whether to use as is, rework the supplied part or component, or return it to the supplier.

If this happens one or two times, then managing the issue via nonconformance is probably sufficient. If a supplier has repeated instances of failing to provide items that meet your specifications, then this is systemic. Yes, you guessed it. A CAPA investigation would then be a best practice.

But what type of CAPA? Should this be handled internally by your company only? Maybe. Maybe you did a poor job of establishing the specifications. There might also be times when you need to issue a (supplier corrective action request (SCAR) to your supplier. Issuing a SCAR is elevating the seriousness of the issue both within your company and (hopefully) with your supplier. If you issue a SCAR, you should track the actions related to this within your CAPA process, identifying the type as supplier related.


In the medical device industry, we are subjected to all kinds of audits and inspections: ISO audits, FDA inspections, supplier audits, internal audits and so on. Most of us dread the thought of being audited. Audits are time-consuming and strain resources. Audits uncover issues that, often times, need to be addressed – especially if discovered by a FDA inspector or ISO auditor.

However, from another point of view, audits also represent a great opportunity to discover potential issues before they become problems and to make improvements. Internal audits are comprised of activities to self-assess and self-evaluate your QMS effectiveness. However, too many companies do not take this approach with respect to internal audits. Many companies do internal audits because they have to, a kind of “check box” activity.

But internal audits, done properly, should be more rigorous and challenging than any other ISO audit or FDA inspection. In fact, this should be the goal of your internal audit program. As you conduct internal audits, you may uncover items to address. If these issues are systemic in nature, then these issues are likely candidates for a more thorough CAPA investigation.

Design Controls

Design controls are all about ensuring that you have demonstrated, proven and documented that your medical device is safe, effective, and meets the needs of the end-user. If you have a significant number of product nonconformances and/or product complaints, then I suggest you take action. To say it another way, volume of nonconformances and complaints are a direct reflection of your design controls process. Design controls best practices are the #1 way to reduce product-related quality events.

I’ve already discussed the need to issue CAPA investigations if you have systemic nonconformances and systemic complaints. If this happens to be the case, I highly recommend that you take another look at your design controls practices as well. I highly recommend you consider issuing a CAPA.

Management Review

Management reviews are times when your executive leadership should be evaluating the effectiveness of your quality management system. Management reviews are times to assess the health of your medical device company. Reviewing customer feedback and complaints, nonconforming products, audits and supplier performance are all invaluable inputs to management review. And as noted above, CAPA is one of the most important quality system elements. As such, CAPA effectiveness is the keystone of management review.

CAPA and the QMS Summary

I’ve shared some insights about how QMS processes for customer feedback, complaints, nonconforming products, production and process controls, supplier management, audits, design controls and management reviews interact and relate to CAPA. If these other QMS processes are effective, then congratulations! Your quality system is likely right-sized and effective. If not, then do something about it! Establish an effective CAPA process to address your systemic issues, and get to a state of QMS effectiveness.

Impact of Risk Management on CAPA

Risk management is a process that is very much here to stay in the medical device industry. On the product side of risk, ISO 14971 continues to be the cornerstone of identifying, assessing, evaluating, and controlling risks as a means to ensure medical devices are as safe and effective as possible.

How does CAPA play a role in product risk management? Many CAPAs will impact medical device products in some way, shape or form. Whether addressing a design issue, how the device is used, dealing with specifications or manufacturing processes, CAPA actions need to consider and address risk management. And it’s not enough to just check a box on a CAPA form. Addressing risk requires reviewing documented product risk management to determine if the issues within the CAPA are defined accurately. If not, then update your risk management accordingly.

From a product side of risk management, this interaction with CAPA is so important. Recall that ISO 14971 establishes risk management as a total product lifecycle process. However, many do not truly keep their risk management files up to date and current.

Another risk concept that was formally introduced to the medical device industry with the publication of ISO 13485:2016 is “risk-based QMS.” What does this mean and how does this relate to CAPA? Yes, it’s true that ISO 13485:2016 does make reference to ISO 14971. And from the product side of things, that makes complete sense. The references also infer that a risk management process and framework is well-defined and well-established by ISO 14971 and that this framework is also applicable to your QMS.

Further, I shared earlier how CAPA is largely regarded as one of, if not the, most important quality system elements. From my perspective, the concept of a risk-based CAPA process becomes foundational to the health and success of your medical device company. There are a lot of factors to consider with respect to apply risk concepts to CAPA. Here are a few suggestions.

Risk-based decision making is almost approaching cliche status these days. However, your CAPA process should incorporate the concept of risk-based decision making from the moment you learn of a quality event (such as a complaint or nonconformance). Does the quality event require a formal CAPA investigation? This is an example of risk-based decision making. And I’ve discussed above about when you should consider a CAPA.

Once a CAPA request is submitted, then the decision as to whether or not to proceed with a CAPA should also be a risk-based decision. After a request is accepted as a formal CAPA, then identifying the priority and urgency are also important and should also be risk-based decisions.

Ensuring all products, processes and sources are identified within a CAPA are key risk elements. In other words, when you issue a CAPA, don’t be too myopic; consider if the issue to be addressed is also prevalent with other products and processes. Be holistic. (Taking this approach could actually reduce the volume of CAPAs and provide a path that allows you to shift from being reactive to proactive.)

Drilling down and identifying root cause is also a risk-based approach. If you do a poor job with root cause, then the issue has a likelihood of happening again. Once root cause is determined, then the actions you take are key to controlling, reducing and mitigating risks. The actions you take, however, are directly related to the identified root cause.

Upon completion of actions, you will need to verify the effectiveness of those actions. This verification step is very crucial because this should be when you determine and confirm, with objective evidence, that the CAPA has been addressed successfully.

To say it another way, your entire CAPA process should be entirely risk-based, from the moment a request is made until you have verified the effectiveness of the actions taken.

Shifting to Preventive Action

It’s now time to shift your approach with CAPA. It’s time to reduce your reliance on reacting to situations, events, and issues and to shift to being proactive. Being reactive, or correcting issues, creates unnecessary challenges to your business and strains your invaluable resources. Being reactive is a sort of “victim” mindset. We should not be waiting for things to happen.

Instead you should be seeking ways to improve preventing issues from ever happening in the first place. You should be using your QMS as it was intended: to focus on “true quality” of your QMS processes, and most importantly the medical devices that are intended to improve the quality of life!

Jon Speer is the founder and VP of QA/RA at Greenlight Guru, a software company that produces the only modern quality management software solution exclusively for medical device companies. Device makers in more than 500 cities in 30 countries use Greenlight Guru to get safer products to market faster while pushing beyond compliance to True Quality. Jon is a medical device industry veteran with over 20 years experience having helped dozens of devices get to market over his career in a variety of roles including product development, project management, quality and regulatory. He is a thought leader, speaker and regular contributor at numerous leading industry publications. He is also the host of the #1 most downloaded podcast in the industry, The Global Medical Device Podcast.” Jon can be reached at

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