什么是医疗器械行业中的 CAPA

CAPA consists of a specific set of actions that an organization must complete to resolve and eliminate recurring non-conformance. CAPAs are commonly used when medical devices are non-conforming.

CAPA 由一系列特定的行动组成，组织必须完成这些行动以解决和消除反复出现的不符合情况。当医疗设备不符合规定时，通常会使用 CAPA。

Let us say that your medical devices company is manufacturing lifesaving Class III medical devices, including cochlear implants, which is your most marketed product. Out of the blue, you start getting complaints that a new batch of cochlear implants is malfunctioning.

假设你的医疗设备公司正在生产救生级别的三类医疗设备，包括人工耳蜗植入器，这是你们最畅销的产品。突然间，你开始收到关于一批新的人工耳蜗植入器出现故障的投诉。

Your end-users and the regulatory agencies in the countries where you market these devices demand that the problem be meticulously investigated to ensure that it will not occur again.

Your company will immediately initiate a CAPA. 你们的最终用户和你们在销售这些设备的国家的监管机构要求对这个问题进行详细调查，以确保不会再次发生。

你的公司将立即启动 CAPA。

In this article, we will explain what CAPA is and how to implement a successful CAPA management system for organizations operating in the medical device industry.

在本文中，我们将解释什么是 CAPA，以及如何为在医疗设备行业运营的组织实施成功的 CAPA 管理系统。

What Is CAPA? 什么是 CAPA？

CAPA is the acronym for Corrective Action and Preventive Action (CAPA).

CAPA 是纠正措施和预防措施（CAPA）的首字母缩写。

It is a system that all medical devices companies need to have in place to identify all quality-related issues, investigate the root cause, and implement corrective actions and preventive actions to ensure that such problems do not arise again.

这是一个所有医疗设备公司都需要建立的系统，用于识别所有与质量相关的问题，调查根本原因，并实施纠正措施和预防措施，以确保此类问题不再发生。

Consider the malfunctioning cochlear implant. You will trigger a CAPA to ensure that the problem is both sorted out and will not arise again.

考虑到功能失常的人工耳蜗植入物。您将触发 CAPA 以确保问题得到解决，并且不会再次出现。

What Should Trigger CAPA? 什么应该触发 CAPA？

We now know that CAPA is not a warning system, but rather a system that will address a quality issue.

我们现在知道 CAPA 不是一个警告系统，而是一个解决质量问题的系统。

It is typically triggered by one of the following systems.

通常情况下，它是由以下系统之一触发的。

Non-Conformances 不符合规定

A non-conformance results when there is something wrong with a product, service, or process.

当产品、服务或流程出现问题时，就会出现不符合规定的情况。

For example, the result does not match your initial expectations. On inspection, you find that silicone to be used for ureteral stents is not of the required quality. This is a non-conformance that needs to be addressed.

例如，结果与您最初的期望不符。经检查，您发现用于输尿管支架的硅胶不符合要求的质量。这是一个需要解决的不符合规定的情况。

When there are repeated non-conformances, you will also trigger a CAPA.

当有重复的不符合规定时，您也会触发 CAPA。

Recommended Reading: What Is Non-Conformance and How to Minimize It

推荐阅读：什么是不符合规定以及如何将其最小化

Customer Complaints 客户投诉

When a product is released to the market, consumer complaints assist in identifying any problems.

当产品发布到市场上时，消费者投诉有助于发现任何问题。

For example, your product has been shipped to different markets. Now, you start getting complaints from your customers.

例如，您的产品已经运往不同的市场。现在，您开始收到来自客户的投诉。

Let us say that the packaging material used for your medical devices is not top-notch, and customers from different markets have started complaining. It is not a one-off complaint, but a series of complaints that need to be looked into urgently.

假设您的医疗设备的包装材料不是一流的，来自不同市场的客户已经开始投诉。这不是一个偶发的投诉，而是一系列需要紧急调查的投诉。

This has greater repercussions for your company, so you will trigger a CAPA.

这对您的公司有更大的影响，因此您将触发 CAPA。

Recommended Reading: Medical Device Complaint Handling Processes

推荐阅读：医疗器械投诉处理流程

Internal and External Audits 内部和外部审计

The audits conducted by your company, either internal or external, are a crucial source for triggering CAPA.

您公司进行的审计，无论是内部还是外部，都是触发 CAPA 的重要来源。

For instance, internal audits conducted on a new batch of 5cc syringes have reported that the syringe volume is actually 5.2cc.

例如，对一批新的 5cc 注射器进行的内部审计报告称，注射器容量实际上是 5.2cc。

This is a major non-conformance that will trigger a CAPA.

这是一个重大的不符合，将触发 CAPA。

The Importance of CAPA in the Medical Device Industry 医疗器械行业中 CAPA 的重要性

As a medical devices company, you are mandated by regulations set by the US Food and Drug Administration (FDA) and International Organization for Standardization (ISO).

作为一家医疗器械公司，您受到美国食品药品监督管理局（FDA）和国际标准化组织（ISO）制定的法规的规定。

When a product fails for whatever reason, these regulatory bodies will mandate that you rigorously investigate the reasons under FDA 21 CFR Part 820 and ISO 13485. You will investigate and solve the issues concerning your medical device using corrective and preventive action (CAPA). The main purpose of CAPA is to ensure that the problem does not recur in your company.

无论出于何种原因，当产品出现故障时，这些监管机构将要求您根据 FDA 21 CFR 第 820 部分和 ISO 13485 严格调查原因。您将使用纠正和预防措施（CAPA）来调查和解决与您的医疗器械有关的问题。CAPA 的主要目的是确保该问题不会在您的公司中再次发生。

As a medical devices company that has Class II and Class III products registered with the US Food and Drug Administration (FDA), you will be regularly inspected by them for compliance with 21 CFR Part 820.

作为一家在美国食品药品监督管理局（FDA）注册了 II 类和 III 类产品的医疗器械公司，您将定期接受他们的检查，以确保符合 21 CFR 第 820 部分的规定。

After the inspection, you may receive an FDA 483, also called as ‘Inspectional Observations’ Form or a warning letter. The former (namely the FDA 483) will list all observations that the FDA representative made in your facility that is a likely cause for apprehension. Do note that you have a maximum of 15 days to respond to the FDA 483 in the form of a written response.

检查后，您可能会收到一份 FDA 483，也称为“检查观察”表格或警告信。前者（即 FDA 483）将列出 FDA 代表在您的设施中所做的所有观察，这可能是引起担忧的原因。请注意，您有最多 15 天的时间以书面形式回应 FDA 483。

Your response to the FDA 483 and closure of the issues is crucial. Otherwise, you may be issued an FDA Warning Letter. Remember that warning letters are immediately made public by the FDA by being posted on their website.

您对 FDA 483 的回应和问题的解决至关重要。否则，您可能会收到一封 FDA 警告信。请记住，警告信将立即由 FDA 公开，并在其网站上发布。

In fact, the most common reasons for FDA 483 observations and warning letters are that procedures for corrective and preventive action have not been established or are not adequate in your medical devices company.

实际上，FDA 483 观察和警告信的最常见原因是您的医疗器械公司未建立或不足够的纠正和预防措施。

Other reasons for establishing CAPA are as follows.

建立 CAPA 的其他原因如下。

Regulatory Compliance 合规性

As mentioned previously, CAPAs are part of the overall QMS and are mandated by international regulatory agencies, including FDA 21 CFR 820.100 and ISO 13485. If your company fails to adhere to CAPA, you will be violating international regulatory rules.

如前所述，CAPA 是整体 QMS 的一部分，并由国际监管机构（包括 FDA 21 CFR 820.100 和 ISO 13485）强制执行。如果您的公司不遵守 CAPA，将违反国际监管规定。

Efficiency 效率

Not only is CAPA used for corrective action but also preventive action.

CAPA 不仅用于纠正措施，还用于预防措施。

This means that any likely problems with a medical device will be sorted out increasing the efficiency of your company.

这意味着任何可能出现的医疗设备问题都将得到解决，提高了公司的效率。

Product Quality 产品质量

You ensure that a product’s non-conformance is resolved, and the product’s quality is as good as before.

您确保解决产品的不符合问题，并使产品的质量与以前一样好。

If you look at the example of the malfunctioning cochlear implant, you would have resolved the problems and the product can once again be marketed.

如果您看看功能失常的人工耳蜗植入物的例子，您将解决了问题，产品可以再次上市。

Cost Savings 成本节约

Let us say that a few customers have complained about their malfunctioning cochlear implant. You have taken these complaints seriously and recalled the necessary batches from the market.

假设有几位客户抱怨他们的人工耳蜗植入物出现故障。您认真对待了这些投诉，并从市场上召回了必要的批次。

In this way, you are not only proving your responsibility to your customers but also avoiding future messy and expensive litigations.

通过这种方式，您不仅向客户证明了您的责任，还避免了未来混乱和昂贵的诉讼。

Corporate Branding 企业品牌

By complying with regulatory requirements, audits, customer complaints, etc., you effectively initiate CAPAs.

通过遵守监管要求、审计、客户投诉等，您有效地启动了 CAPA。

All these will help improve your brand value in the market.

所有这些都将有助于提高您在市场上的品牌价值。

Nowadays, companies are streamlining their CAPA processes by implementing efficient CAPA management software. If you are interested in facilitating your CAPA management activities, explore the SimplerQMS CAPA management software solution. It makes it easy for organizations to manage non-conformances, customer complaints, audit findings, and other quality issues, all in one place.

如今，公司正在通过实施高效的 CAPA 管理软件来简化其 CAPA 流程。如果您有兴趣简化您的 CAPA 管理活动，请了解 SimplerQMS CAPA 管理软件解决方案。它使组织能够在一个地方管理不符合要求、客户投诉、审计结果和其他质量问题。

CAPA Regulatory Requirements 法规中关于 CAPA 的要求

FDA 21 CFR 820.100

As per the US FDA’s requirements, CAPA comes under FDA 21 CFR 820.100.

根据美国 FDA 的要求，CAPA 属于 FDA 21 CFR 820.100。

It states in part that:

部分规定如下：

“(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action.”

“(a) 每个制造商都应建立和维护实施纠正和预防措施的程序。”

A wide range of requirements are listed for corrective and preventive actions (CAPAs), these include:

纠正和预防措施（CAPAs）列出了广泛的要求，包括：

The need to investigate the causes of non-conformances 需要调查不符合要求的原因
Identification of the actions that an organization needs for correcting and preventing recurrences 确定组织需要纠正和预防再次发生的行动
The need to verify and validate the effectiveness of the corrective actions taken and to ensure that there is no adverse effect on the completed product 需要验证和验证所采取的纠正措施的有效性，并确保对成品没有不良影响

ISO 13485:2016

ISO 13485:2016 standard for CAPA falls under section 8.5.2 for corrective action and section 8.5.3 for preventive action.

ISO 13485:2016 标准的 CAPA 属于纠正措施的 8.5.2 节和预防措施的 8.5.3 节。

ISO 13485:2016 states that the organization will verify that the corrective actions taken do not adversely affect the organization’s ability to follow the necessary regulatory requirements or the safety and performance of the medical device.

ISO 13485:2016 规定，组织将验证所采取的纠正措施不会对组织遵循必要的监管要求或医疗器械的安全性和性能产生不利影响。

5 Tips for Effective CAPA Management 5 个有效的 CAPA 管理提示

The top 5 tips for effective CAPA management are mentioned below.

5 个有效的 CAPA 管理的提示如下。

1. Create a Process 创建一个流程

The most important aspect for creating a CAPA process is the CAPA procedure – which includes the inputs (such as complaints and audits), resources that review the CAPA request (either the Quality Manager or the Quality Review Board of your company), acceptance of the CAPA, and so on.

创建 CAPA 流程的最重要方面是 CAPA 程序-其中包括输入（如投诉和审核），审查 CAPA 请求的资源（可以是质量经理或公司的质量审查委员会），接受 CAPA 等等。

You should also remember that for an effective CAPA, a CAPA form must be initiated with all the details filled in.

您还应记住，为了有效的 CAPA，必须启动一个填写了所有细节的 CAPA 表格。

2. Document All Non-conformities and Feedback 记录所有不符合和反馈

Another crucial aspect is that your company should document feedback as well as all non-conformities using a non-conformance report (also called NCR or non-conformity report).

另一个关键方面是，您的公司应该使用不符合报告（也称为 NCR 或不符合报告）记录反馈以及所有不符合。

This is crucial because over-estimating or under-estimating issues to CAPA are unproductive.

这是至关重要的，因为对 CAPA 问题的估计过高或过低是无效的。

3. Use QMS Software 使用 QMS 软件

The use of an integrated QMS software solution like SimplerQMS that automates CAPA processes such as routing, notifications, follow-ups, and approvals will help accelerate the resolution of the particular CAPA issue faster.

使用像 SimplerQMS 这样的集成 QMS 软件解决方案，自动化 CAPA 流程，如路由、通知、跟进和批准，将有助于更快地解决特定的 CAPA 问题。

4. Conduct a Thorough Investigation of the Root Cause 对根本原因进行彻底调查

There can be more than one potential cause and determining which cause is more important can be a problem. You can identify the root cause of the problem using systematic analyses such as the 5 Whys and the Fishbone Diagram.

可能有多个潜在原因，确定哪个原因更重要可能是一个问题。您可以使用系统分析方法（如五个为什么和鱼骨图）来确定问题的根本原因。

5. Keep Data Centralized 保持数据集中化

You should have a central point in your company wherein all CAPAs are documented.

您应该在公司中设立一个中心点，记录所有 CAPA。

This will help you:

这将帮助您：

Monitoring the efficacy of actions taken 监测采取的行动的有效性
Determine the start and closure dates 确定开始和结束日期
Identify inputs from relevant departments 识别相关部门的输入

All this is made possible by implementing QMS software.

所有这些都可以通过实施 QMS 软件来实现。

Streamlining CAPA Management Processes 简化 CAPA 管理流程

CAPA management is a critical part of quality management, but it can be tedious and time-consuming.

CAPA 管理是质量管理的关键部分，但它可能是繁琐和耗时的。

To this day, many small to medium organizations use manual, paper-based systems to manage their CAPA processes. This makes it hard to keep track of what actions have been taken, who is responsible for the action items, and when they will be completed. This leads to unnecessary delays in issue resolution which potentially puts your company out of compliance with regulatory bodies.

直到今天，许多中小型组织仍然使用手动、纸质系统来管理他们的 CAPA 流程。这使得很难跟踪已经采取的行动、谁负责行动事项以及何时完成。这导致问题解决的不必要延迟，可能使您的公司不符合监管机构的规定。

SimplerQMS provides QMS software with powerful CAPA management capabilities, designed for medical device manufacturers and other life science organizations. It allows you to automate routine processes, such as the creation of documents, routing, notifications, and others, improve collaboration between teams, reduce manual work, decrease human error and accelerate quality issue resolution.

SimplreQMS 提供具有强大 CAPA 管理功能的 QMS 软件，专为医疗设备制造商和其他生命科学机构设计。它可以帮助您自动化常规流程，如文件创建、路由、通知等，改善团队之间的协作，减少手动工作，降低人为错误，加快质量问题的解决。

All this helps you meet your regulatory obligations as well as promote continuous improvement across your organization.

所有这些都有助于满足您的监管义务，并促进组织的持续改进。

If you need help automating and streamlining the traceability of your CAPA process, we suggest exploring the SimplerQMS CAPA management solution.

如果您需要帮助自动化和简化 CAPA 过程的可追溯性，我们建议您了解简单 QMS 的 CAPA 管理解决方案。

Conclusion 总结

如果您对我们具有强大 CAPA 管理功能的 QMS 软件解决方案感兴趣，我们建议您立即预约演示并与我们的专家交流！

CAPA is important for your medical devices company for international regulatory compliance, cost savings, efficiency, and branding, amongst other reasons.

Rather than continuing with paper-based systems that have many pitfalls, when you opt for efficient CAPA management software such as SimplerQMS, you will have digitized and automated solution, centralized cloud-based data storage, pre-approved CAPA forms, and procedures, all at the click of a mouse button.

与继续使用存在许多问题的纸质系统不同，当您选择高效的 CAPA 管理软件，如 SimplerQMS 时，您将拥有数字化和自动化的解决方案，集中的云存储数据，预先批准的 CAPA 表单和流程，一切都可以通过点击鼠标按钮实现。

If you are interested in learning more about our QMS software solution with robust CAPA management capabilities, we suggest booking a demo today and talking to our experts!

对于国际监管合规、成本节约、效率和品牌等诸多原因，CAPA 对于医疗设备公司至关重要。