A poorly written CAPA report can result in a warning letter from the FDA, no matter how well the CAPA sub-system was executed. Similarly, International Organization for Standardization – ISO also requires Corrective and Preventive action reports during their routine audits. It may issue non-conformance if a company fails to provide properly written CAPA reports.

The auditors review the CAPA reports in knowing the organization’s ability to understand non-conformance and whether the organization has taken enough measures to correct and prevent the non-conformance.

In this article, you will learn about the importance of CAPA report and how to write an effective report that conforms to the regulatory requirements. It also includes an example CAPA report to help you prepare your own.

But first, let’s cover the basics:

• What Is a Corrective and Preventive Action (CAPA) Report
• When Is Corrective and Preventive Action (CAPA) Report Required?
• How Do You Write a Corrective and Preventive Action (CAPA) Report?
• Corrective and Preventive Action (CAPA) Report Example
• CAPA Report Form Template [Free Download]
• Digitize and Automate CAPA Reporting Processes

What Is a Corrective and Preventive Action (CAPA) Report

A CAPA report is documented evidence that a CAPA system has been successfully implemented.

It summarizes the entire CAPA activity, with detailed identification and description of non-conformance. It also includes the corresponding Corrective and Preventive measures for that particular non-conformance.

A CAPA report and CAPA form are essentially the same things. When personnel fills the CAPA form with the relevant data and subsequent approval by authorized personnel, the CAPA form’s status changes to the CAPA report.

A well-written CAPA report demonstrates that the organization has an effective quality system in place. The quality system is well equipped with the necessary tools, personnel expertise, and resources, which helps identify problems. It also implements corrective and preventive actions to tackle the quality problems.

If, for example, a lack of training is identified as Preventive Action, the report contains information about the training contents, trainer, training participants, and training evaluation plan for the trainees.

Regulatory bodies have no compulsion to include corrective and preventive action in the same report. Instead, it leaves the decision to the organization.

Some organizations include Corrective and Preventive in one report, often called Corrective and Preventive Action (CAPA) reports. Meanwhile, others have Corrective and Preventive in a separate report, called Corrective Action Report (CAR) and Preventive Action Report (PAR).

More and more life science companies are utilizing software solutions, including the CAPA software to generate the CAPA reports. Learn how the SimplerQMS CAPA management software module can automate your CAPA reporting processes.

When Is Corrective and Preventive Action (CAPA) Report Required?

Not every event requires a CAPA report. Instead, it depends on the problem’s severity. The quality department should evaluate the problem’s impact in terms of risk severity in a Risk Assessment stage to determine whether corrective and preventive actions are required or not.

Assessing the risk severity also enables the quality department to determine the risk impact, resource allocation, investigation level required and evaluate corrective and preventive actions.

How Do You Write a Corrective and Preventive Action (CAPA) Report?

As mentioned above, the CAPA report is the CAPA form’s filled version.

Each field represents a synchronized activity and must be filled properly.

Following are some common steps to fill the CAPA form, which then takes the status of the CAPA report.

CAPA Initiation

As mentioned before, not every quality issue requires a CAPA, so accurately determining the CAPA’s Initiation is very crucial. The quality department initiates the CAPA activity by assigning and filling out a CAPA form.

Different organizations can create their CAPA forms, and their creation depends on several factors.

Common data fields necessary to the CAPA form include:

• Problem Description
• Source of problem
• Date, time, and location of quality problem detected
• Personnel / department
• Is the CAPA related to process or product

For example, the quality department receives the complaint of expiry date misprinting. In this case, the quality department will first decide whether it requires a CAPA or not?

Free Resource: Corrective and Preventive Action (CAPA) Form Template

CAPA Team

The quality department forms a team to conduct a CAPA investigation. The team should include experts from all the relevant departments. They must be informed and briefed about their responsibilities and roles.

For example, for a wrong expiry date printing problem, possible departmental representatives can include Production, Quality, and Engineering.

In an eQMS System assign responsibilities for CAPA tasks or actions to specific employees on your team. This means that one employee handles the Root Cause Analysis and another person is responsible for the Verification. Learn how the CAPA management software module by SimplerQMS can help you work more efficiently with your CAPA process.

Root Cause Analysis

Root Cause Analysis is critical in determining preventive action selection. The potential causes can be identified without classifying them into different categories in this stage.

For example, what were the causes of wrong printing on the packs? Was the operator aware of malfunctioning? Was the operator capable enough to operate the printing equipment? Were the quality personnel deployed on the floor present at the time of the problem?

Risk Assessment

In this step, the problem severity is determined and how it impacts the organization and customers.

Corrective and Preventive Actions

The corrective actions are immediately required to solve the problems in the process. It makes sure that the process returns to normal working parameters. Corrective actions are often implemented before the Root Cause Analysis stage. 

Preventive actions are implemented to prevent the problem recurrence and promote continuous improvement – the primary purpose of the CAPA system.

Planning

The planning for implementing corrective and preventive actions is performed. It involves assigning roles and responsibilities, due dates, and allocating resources.

Verification and Documentation

After identifying the corrective and preventive actions, these are once again evaluated for process improvement. It also monitors the effectiveness of corrective and preventive measures.

Closing

The CAPA form is filled along with the activity after satisfactory results of Corrective and Preventive Actions.

At this stage, the form takes the status of the report. The CAPA report is verified and approved with relevant personnel with their signatures.

Corrective and Preventive Action (CAPA) Report Example

Let’s give an example of a CAPA report.

Description of an Issue

The organization failed to produce batch production records, including manufacturing, processing, and packing information.

Scope

The CAPA is related to the process.

Root Cause Analysis

The organization used a manufacturing checklist without instructions, not recording proper manufacturing information.

Risk Assessment

The nature of this problem is critical, and it can seriously impact the product.

It lacks essential manufacturing data such as batch ingredients, mixing time, and temperature. It also lacks critical data to investigate batch failures.

Immediate Correction

Since this is a critical issue, the quality department immediately stops product manufacturing.

The quality department with the production department points out all the relevant data parameters required in manufacturing. It also takes guidelines from regulatory regulations and personnel expertise.

Corrective Action/Preventive Action

A joint team is created consisting of the Quality and Production department.

The team consults different regulatory guidelines such as cGMP (Current Good Manufacturing Practice) and uses personnel expertise to identify missing manufacturing information.

In addition, the formed team:

• Reviews the current documentation practices
• Updates all documentation related to all products
• Revises SOPs in line with cGMP requirements
• Sets out the deadlines for the implementation of the proposed action plan

Verification of Corrective/Preventive Action

After the due date for Corrective and Preventive Action implementation has passed, the CAPA team again reviews the documentation. 

It is considered complete if the revised documentation includes each manufacturing step information. The CAPA form is completed with all the relevant approvals and signatures.

In an eQMS, all of the relevant approvals can be routed through an automated workflow and electronic Part 11 Compliant signatures can be captured. See how electronic signatures and automated workflows work in SimplerQMS.

CAPA Report Form Template [Free Download]

Manufacturers often find it challenging to prepare their CAPA form according to regulatory requirements. These regulatory bodies require a comprehensive form that addresses every non-conformity in a pharmaceutical, medical device, or any other life science company.

At SimplerQMS, we have prepared a free CAPA report form template that could solve the problems of life science professionals. This form identifies, addresses, and prevents the occurrence of non-conformances.

You can download a free copy of a CAPA form template that will help you create a CAPA report and ensure regulatory compliance.

Digitize and Automate CAPA Reporting Processes

Manual paper-based systems pose various problems such as conflicting data, version miss-match, de-centralized data collection, communication gaps, which could deteriorate the CAPA process.

SimplerQMS provides an integrated quality management system software solution for life sciences with a built-in CAPA management software module that digitizes and automates your CAPA process. It automatically notifies the concerned person when they are assigned tasks to them.

The system allows you to easily record non-nonconformances, automate data input and follow-ups until the CAPA is marked closed. After closing, it initiates automatic approvals with the required electronic signatures.

Final Thoughts

CAPA report is the crux of the CAPA sub-system, and the regulatory bodies rely on the CAPA report to judge the company’s CAPA implementation and its effectiveness.

Regulatory bodies have no compulsions to use software solutions, but paper-based systems are proving a daunting option nowadays. They can end up more efforts with little output.

CAPA management software such as SimplerQMS is an excellent option to keep your pace with the increased competition, advanced regulatory requirements, and increased production costs.

If you would like to learn more about how SimplerQMS can help you streamline your CAPA process, we recommend you book a demo and talk to our experts.

The post Corrective and Preventive Action (CAPA) Report appeared first on SimplerQMS.

A poorly written or implemented CAPA procedure can lead to failed corrective and preventive actions, increased product recalls, non-conformances, and even legal action.

This article provides an overview of what a CAPA procedure should include, as well as some useful tips for writing good procedures.

But first, let’s cover some of the fundamentals:

• What Is a Corrective and Preventive Action (CAPA) Procedure?
• Why Is a Good Corrective and Preventive Action (CAPA) Procedure Important?
• What Should CAPA Procedure Include?
• Tips to Writing a Good CAPA Procedure
• CAPA Management Software Solution

What Is a Corrective and Preventive Action Procedure?

CAPA procedures are the step-by-step guidelines for implementing corrective and preventive action (CAPA) in an organization.

It documents procedures for a better understanding of various quality problems, how they are corrected, and what measures an organization has implemented to prevent their recurrences.

For example, CAPA procedures can include input methods for inputting quality problems in a CAPA system. It might include customer complaints, non-conformances, audit findings, or other quality events.

Why Is a Good Corrective and Preventive Action Procedure Important?

The importance of an effective corrective and preventive action (CAPA) procedure can be related to two important factors – customer satisfaction and regulatory compliance.

Customer Satisfaction

Effective CAPA procedures are essential drivers for producing quality products. Customers nowadays can easily track a product’s authenticity and validity to protect themselves from a low-quality product.

Regulatory bodies also identify those products and manufacturers that do not conform to their regulatory requirements. 

For example, the FDA regularly issues warning letters and 483 observations for general public information. These include each manufacturer’s non-conformity and relevant FDA action.

When looking at these inspection observations, one of the most common reasons for 483 observations and warning letters is: Procedures for Corrective and Preventive Action have not been [adequately] established.

Every product is intended for meeting customers’ requirements. If it fails to meet the customer’s expectations, all efforts, standardization, and investments made can go into vain.

For example, an effective CAPA procedure will facilitate customer satisfaction by including customer complaints when planning preventive actions. The complaint will be actual feedback compared to analysis performed on the manufacturing plant.

Customer satisfaction helps the manufacturer retain its market share and compete with its competitors.

CAPA procedure can facilitate the manufacturers by understanding customer requirements, offering cost-effective products, and solving their problems.

Regulatory Compliance

Customers worldwide trust those manufacturers that are accredited with reputed regulatory bodies. Their accreditation gives customers trust that the product is safe to use and helps solve their problems.

The two most important bodies that define CAPA procedures’ requirements are the FDA and the ISO.

U.S. Food and Drug Administration (FDA)

The FDA’s Quality System Regulations, 21 CFR 820.100 defines the requirement for a CAPA sub-system. In it, CAPA procedures are defined as:

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

The procedures shall include requirements for:

• Analyzing processes
• Investigating the cause of nonconformities
• Identifying the action(s) needed to correct and prevent a recurrence
• Verifying or validating the corrective and preventive action
• Implementing and recording changes in methods and procedures
• Information related to quality problems or nonconforming products is disseminated to those directly responsible
• Submitting relevant information for management review

The FDA also requires the manufacturer to document all the procedures and results. The FDA inspector inspects the documentation to check for compliance fulfillment.

International Organization for Standardization (ISO)

The International Organization for Standardization – ISO also has guidelines for CAPA procedures.

The latest version of these guidelines is published in 2016, so it is called ISO 13485:2016.

The ISO 13485:2016 has published its requirements for CAPA procedures in two separate clauses, i.e., 8.5.2 for Corrective Actions and 8.5.3 for Preventive actions.

As defined in clause 8.5.2 for Corrective Action, the organization shall document procedures to define:

• Non-Conformities
• Cause of non-conformities
• Need to prevent a recurrence
• Planning and documenting
• Corrective actions do not affect the product quality
• Reviewing the effectiveness of corrective action

As defined in clause 8.5.3 for Preventive Action, the organization shall document procedures to define:

• Potential non-conformities and their causes
• Evaluating need for preventive actions
• Planning and documenting
• Preventive actions do not affect the product quality
• Reviewing the effectiveness of preventive action

If you already have a medical device or drug product(s) on the market, SimplerQMS postmarket automated workflows can help you streamline various quality processes such as CAPAs, customer complaints, non-conformances, audit findings, and more – all in one place. Explore our CAPA management capabilities and learn more about how you can automate your CAPA processes.

What Should CAPA Procedure Include?

The CAPA procedure is the initial document that the inspectors and auditors review before the entire CAPA sub-system.

If they find any non-conformity, and in the case of the FDA inspections, the medical device and/or drug manufacturer can receive an FDA 483 observation.

For this reason, the organization should prepare CAPA procedures with due care.

Typically CAPA procedure includes the following sections.

1. Overview of General Procedure

This section provides basic information about the CAPA standard operating procedure (SOP) document.

Generally, it is divided into:

• Scope: What quality processes or departments will this document serve?
• Purpose: What is the basic idea or theme behind producing this document?
• Involved function: The responsible personnel or department for executing the processes, and in many cases, it includes the Quality department.
• References: Detail of external references used in preparing this document.

2. Definitions

This section includes the organization’s understanding of different terms and methodologies. It describes how the organization interprets the associated technical terms.

Examples of such terms include “immediate correction,” “nonconforming product,” and “quality audit.”

3. CAPA Flow

CAPA flow is the written guide that indicates how the CAPA advances through its stages.

It starts with the input that triggers the CAPA. It describes the input types concerned personnel to disseminate the information. It then proceeds towards the issue handler, which initiates the CAPA with the correct document number. After CAPA is completed, it is reviewed and approved by the relevant departmental heads.

Using a QMS software solution with built-in CAPA management workflows like SimplerQMS you can automate document routing, notifications, escalation, and approval of CAPAs and all their related documentation with FDA 21 CFR Part 11 compliant electronic signatures.

There can be three outcomes of CAPA:

• CAPA is not effective and I will issue a new CAPA: in this case, a new CAPA is issued
• CAPA is not effective: it results in the re-opening of CAPA
• CAPA verified and can be closed: when CAPA activity is successful, the CAPA is closed and marked as “CAPA verified and can be closed”.

4. CAPA Form

CAPA form is an approved format in which the CAPA process is documented.

The quality department is responsible for preparing, reviewing, and approving the CAPA forms throughout the organization.

Commonly, the CAPA form includes the following section:

• Input: The issue triggering CAPA
• Scope: Either the issue is related to the product or process
• Root Cause / Investigation: Investigation of problem to prevent a recurrence
• Risk Assessment
• Immediate Correction: corrective actions to resolve the issue
• Corrective/ Preventive Action: remedial actions to prevent recurrence of the problem
• Verification: To measure the effectiveness of proposed preventive and corrective actions.

When the CAPA form is completed and approved, its status changes to the CAPA report.

Recommended Reading: Corrective Action and Preventive Action (CAPA) Form

5. Management Review

It includes information about the CAPA process for management to review.

This is necessary because the organization’s management is responsible for assuring product quality and preventing problems.

Tips to Writing a Good CAPA Procedure

As mentioned above, the CAPA procedures are the initial document that inspectors and auditors review. They aim to inspect whether organizations have addressed the requirements of quality system regulations.

An effective CAPA procedure results in a satisfactory CAPA sub-system.

The CAPA procedure must cater problems of an individual organization. It must address real challenges and problems and provide a scientific approach to solve quality problems.

Here are some tips that might help when writing the CAPA procedure.

1. Design CAPA Form Before Writing CAPA Procedure

The CAPA form must be designed before writing CAPA procedures because it helps to understand the purpose and scope of the CAPA.

If it is the first time you are preparing for CAPA inspections or want to improve your CAPA procedures, feel free to download our free CAPA form template.

2. Keep Procedures Centralized

CAPA procedures must be implemented centrally through a centralized system, and individual departments must not initiate their own.

A centralized QMS software solution like SimplerQMS allows you to keep a single CAPA procedure for all departments.

3. Take Into Consideration the Opinion of Subject Matter Experts

Subject matter experts of relevant departments must be consulted to understand their process flows.

For example, engineering personnel must be involved when devising CAPA procedures for maintenance workshops.

4. Ensure the Procedure is Approved and Reviewed by the Quality Department

Because current good manufacturing practice (cGMP) authorizes and makes the quality department responsible for implementing the quality system in an organization.

It is the responsibility of a quality department to represent the organization during regulatory inspections. So, for this reason, the quality department must approve the final CAPA procedure draft.

5. Ensure CAPA Form and Procedure Work in Sync

CAPA form must not contradict the CAPA procedure. Instead, the CAPA form must be a realistic representation of the CAPA procedure outlined initially.

For example, if the CAPA procedure involves the Department Representative in the Risk Assessment stage, the CAPA form must include an appropriate section to have their findings or inputs recorded.

CAPA Management Software Solution

To this day, many life science organizations are reluctant to use software tools. The only reason for using the paper-based system is that their personnel is used to using paper-based systems.

The paper-based systems are prone to problems such as:

• Data and record duplication
• Chasing signatures
• Decentralized records
• Version mismatch between the original and department’s control copy
• Failure to follow up on critical problems

CAPA software solution such as SimplerQMS is an effective way to prevent such problems. It automates data collection, routing, and follow-up activities related to CAPAs.

For example, it ensures that every data point has been inserted in its correct field. The software’s automated process will not allow the user to move forward if any field is left blank.

It provides a centralized repository for all documentation in your organization, without keeping a hard copy of required documents in individual departments.

For example, keeping a hard copy of the Job Description (JD) is not necessary for your function or department. Instead, a computer with network connectivity is enough to view the relevant JD in the SimplerQMS.

Final Thoughts

Every pharmaceutical and medical device manufacturer and other life science organization must prepare CAPA procedures, that comply with relevant regulatory requirements.

The regulatory bodies, review the CAPA procedure before turning towards the CAPA sub-system.

QMS software with robust CAPA management capabilities such as SimplerQMS is an excellent way to streamline your various CAPA requirements. These software solutions benefit your organization in producing quality products, customer satisfaction, and fulfilling regulatory requirements.

If you are interested in automating and improving the traceability of your CAPA we recommend you book a personalized product demo and talk to our experts.

The post Corrective and Preventive Action (CAPA) Procedure appeared first on SimplerQMS.

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.

But first, let’s cover some of the fundamentals:

• What Is CAPA?
• What Should Trigger CAPA?
• The Importance of CAPA in the Medical Device Industry
• CAPA Regulatory Requirements
• 5 Tips for Effective CAPA Management
• Streamlining CAPA Management Processes

What Is CAPA?

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

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.

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

What Should Trigger CAPA?

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

It is typically triggered by one of the following systems.

Non-Conformances

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

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.

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

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

Customer Complaints

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

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

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.

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

Recommended Reading: Medical Device Complaint Handling Processes

Internal and External Audits

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

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

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

The Importance of CAPA in the Medical Device Industry

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).

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.

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.

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.

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.

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.

Other reasons for establishing CAPA are as follows.

Regulatory Compliance

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.

Efficiency

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

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

Product Quality

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

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.

Cost Savings

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.

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

Corporate Branding

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

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

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.

CAPA Regulatory Requirements

FDA 21 CFR 820.100

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

It states in part that:

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

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

• The need to investigate the causes of non-conformances
• Identification of the actions that an organization needs for correcting and preventing recurrences
• 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

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 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.

5 Tips for Effective CAPA Management

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

1. Create a Process

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.

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

2. Document All Non-conformities and Feedback

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).

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

3. Use QMS Software

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.

4. Conduct a Thorough Investigation of the Root Cause

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.

5. Keep Data Centralized

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

This will help you:

• Monitoring the efficacy of actions taken
• Determine the start and closure dates
• Identify inputs from relevant departments

All this is made possible by implementing QMS software.

Streamlining CAPA Management Processes

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

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.

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.

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

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

Final Thoughts

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.

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!

The post What Is CAPA in the Medical Device Industry? appeared first on SimplerQMS.

The CAPA process plays an important role in the quality management system of any pharmaceutical company. It helps to identify, evaluate, prioritize and manage nonconformities or problems related to products or processes to prevent them from recurring.

This article aims at providing readers with information on what CAPA is all about and how they can successfully implement an effective CAPA system in a pharmaceutical organization.

Here’s what we will discuss:

• What Is CAPA?
• What Should Trigger CAPA?
• The Importance of a CAPA Process in the Pharmaceutical Industry
• CAPA Requirement
• Steps of CAPA Process
• Common Challenges With CAPA
• Tips for Effective CAPA Implementation
• Digitizing CAPA Management Processes

What is CAPA?

CAPA stands for Corrective Action and Preventive Action, a system for analyzing, correcting, and preventing issues. It outlines procedures to solve the issue, it also analyzes the cause of the problem to prevent its recurrence.

For example, Corrective Action and Preventive Action (CAPA) can investigate the misprinting problem in a pharmaceutical manufacturing environment. The CAPA initially proposes corrective actions to solve the misprinting problem and then investigates the cause to prevent recurrence in the future.

What Should Trigger CAPA?

Not every deviation or nonconformance requires a CAPA.

An unnecessary CAPA can result in additional costs, processes slowdowns, and inefficient usage of the organization’s resources. It also becomes difficult for the team to follow up, resulting in an uncompleted pile of CAPA’s.

Conversely, uncompleted CAPA’s can be a serious compliance problem.

There are certain situations, that when they occur, can trigger a CAPA.

Nonconformances or Deviations

Non-conformance or deviation is the failure to fulfill the associated requirements and can occur both in products and processes. Non-conformance can also result due to an inability to meet the requirements of a customer. It can be identified during the manufacturing process or if a defective product is returned to the manufacturer.

For example, manufacturing requires a specific temperature for carrying out a specific process. However, quality personnel detects the temperature deviation and find out that this deviation is occurring for a very long time. This problem is a non-conformity and triggers a CAPA.

Recommended Reading:

• What Is Non-Conformance And How to Minimize It
• Guide to Deviation Management Process

Customer Complaints

Customer complaints help identify product deficiencies after it is released to the market.

The communication mode can be written, oral, or electronic. The defect can indicate a product’s inability to fulfill its desired effectiveness, quality, results, or performance.

Every manufacturer must maintain a complaint handling system for receiving, reviewing, and evaluating complaints. The manufacturer is also responsible for processing the complaints promptly, documenting complaint reviews and investigations as well as sharing information across relevant departments and regulatory bodies.

For instance, if a pharmaceutical manufacturer receives a complaint of an empty pocket in a tablet blister pack, it should trigger a CAPA.

Audit Findings

The main objective of the pharmaceutical audits is to inspect whether the existing quality system is in line with the established quality system requirements.

There are two types of audits – internal and external audits.

An internal audit is performed by a team of the same manufacturing organization. However, they must be from another department and should not be interested in the department being audited.

On the other hand, external regulatory and standardization organizations perform external audits.

For example, if during an audit, particles are found in injectables filling operation, it will result in non-conformance. Since this is a serious issue, it would require a CAPA.

Using an efficient CAPA management software like SimpleQMS you can quickly initiate forms from various deviations, non-conformances, customer complaints, audit findings, and other issues.

The Importance of a CAPA Process in the Pharmaceutical Industry

CAPA is a resource-intensive activity, and as we discuss, in some cases it can be considered unnecessary.

However, a properly established CAPA process can be an excellent tool for achieving an organization’s quality goals in the following manner.

Regulatory Compliance

CAPA is a compliance requirement for different regulatory agencies,such as the FDA. For example, if during the FDA inspection an auditor finds any cGMP violations, the accredited manufacturers should implement appropriate Corrective Actions and Preventive Actions (CAPA’s). The FDA issues the warning letter if the pharma manufacturer fails to execute necessary Corrective Actions and Preventive Actions (CAPA’s).

Proper CAPA process in a pharmaceutical’s maintenance department can help to keep their maintenance strategies, process flow, and documentation procedures according to guidelines of standardization bodies.

Successful Audits

cGMP violations in pharma manufacturing are not uncommon and can occur due to reasons such as Human Negligence and Environmental factors. During their audit and inspection, Regulatory bodies pay special attention to the organization’s approach towards mitigating risks and improving quality throughout the entire product life cycle. One of many ways is the implementation of a proper CAPA system.

Executing the Corrective Actions and Preventive Actions (CAPA’s) on time helps keep the organization audit-ready. The CAPA must be appropriately carried out, documented, maintained, and produced at the time of audits and inspections.

Cost Savings

One of the main advantages of CAPA is cost-saving, resulting in efficient output with optimum quality.

It also creates reliability in their processes, systems, and products, which could result in increased revenue for a pharmaceutical manufacturer.

In the beginning, it might be costly to establish a CAPA process, but as time advances and the process itself improves, it eliminates the recurring problem and results in improved process performance with minimum downtime and reduced failures.

Overall Efficiency

CAPA increases the efficiency of the processes and systems, as an effective CAPA reduces overall operational costs. The cost-saving can then help promote innovation and improvement in the product.

Improved efficiency can also increase market share by offering cost-effective, quality products to compete with the competitors.

One effective way of improving cost and efficiency is using a digital CAPA management software solution. With SimplerQMS CAPA software, personnel is more focused on executing the process rather than planning, following up, and preparing for audits and inspections.

Improved Product Quality

CAPA is a process improvement system that increases product quality. It includes identifying and investigating product problems and obliging manufacturers to prevent their recurrence. It also enables the manufacturer to study the implemented action plan’s effects and monitor the effectiveness of proposed corrective and preventive actions.

If these activities are carried out regularly, it significantly increases the product quality and lowers product failure.

CAPA Requirements

Let’s look at some of the regulatory requirements regarding CAPA.

ICH Q10 Pharmaceutical Quality System

ICH Q10 is harmonized model for pharma manufacturers to implement a Quality System. It is based on existing models such as cGMP and does not create an alternate model regarding quality requirements. The ICH Q10 considers CAPA as one of four Pharmaceutical Quality System elements.

The ICH Q10 pharmaceutical quality system guidelines require manufacturers to implement a CAPA system for handling complaints, product rejections, nonconformances, and recalls.

The FDA cGMP requirements can be summarized below:

• CAPA procedures must be well-defined and documented
• Appropriate sources of product and quality problems must be identified
• Product and quality information that may show unfavorable trends should be identified
• It is important to verify that the data received by the CAPA system are complete, accurate, and timely
• You must verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems
• Failure investigation procedures must be followed
• Appropriate actions should be taken for significant product and quality problems identification from data sources
• Corrective and preventive actions should be effective and verified or validated before implementation
• You must verify that corrective and preventive actions for product and quality problems are implemented and documented
• Information regarding nonconforming product and quality problems and corrective and preventive actions must be properly disseminated, including dissemination for management review

ISO 9000:2015

The ISO is a standardization body that develops standards, including the Quality Management System (QMS). The QMS focuses on product quality, and the CAPA is a module within a comprehensive QMS.

According to ISO 9000:2015, the pharmaceutical manufacturer is responsible for taking action and controlling the nonconformities. It also requires the manufacturer to eliminate the cause of the nonconformity by:

• Reviewing and analyzing the nonconformity;
• Determining the causes of the nonconformity;
• Determining if similar nonconformities exist, or could potentially occur;

Similar to the FDA requirements, the manufacturer is responsible for implementing corrective actions, reviewing the effectiveness of disciplinary action, analyzing risks and opportunities, and any change for process improvement.

Moreover, the manufacturer should always retain documented evidence of non-conformities and corrective actions.

Steps of CAPA Process

Let’s go through the seven steps of a CAPA implementation process.

Identification

Problem identification is the first step and plays a vital role in the success of the ongoing CAPA process. It includes identifying all the product and quality problems that require corrective actions. It also provides identification of sources used to classify issues such as complaints, returned product records, quality audits, installation reports, lawsuits, and non-conforming products.

Evaluation

In this stage, the problem is evaluated for further decision-making.

The problem is analyzed to determine its nature and whether it requires a CAPA or not? It also considers its impact on other processes and its effect on the output.

It also analyzes the severity of the problem.

For example, suppose a lack of safety is identified on the machine during an audit. In that case, it can be evaluated for different severity levels and how it impacts the machine operation and operator safety.

Investigation

In this step, the problem is investigated for further planning.

The typical investigation includes objectives, i.e., deliverables, Procedures delivering the intent of the action, and Personnel for conducting the investigation. The root cause should be documented for better understanding and implementation.

For example, a team leader’s responsibilities can include authorization to use departmental resources and interviewing the concerned personnel to fully understand the problem.

Analysis

This step identifies and establishes the root cause of the problem by investigating the available data. The required information must be accurately depicted and preserved to reflect the actual cause of the problem.

Action Plan

This step’s success depends on the success of the preceding steps.

It is a series of steps required to implement corrective and preventive actions.

For example, it might include employee training if the CAPA team concludes that the cause of the problem was the inability of the personnel to use the system.

Implementation

It is about how the action plan is implemented, devised in the previous stage.

It includes detailed information about the action plan, desired outcomes, settings, steps, and observation. The final action plan must be thoroughly documented for record purposes.

For example, if the training plan is the action plan, implementation of the training could include devising training contents, arranging training resources, instructor, and so on.

Follow Up

After the team executes the CAPA activity, they must follow up.

It helps to measure the effectiveness of the Corrective and Preventive actions and improves the remedial measures.

After this stage, the CAPA activity is finally concluded with a detailed CAPA report.

For example, the training plan is the suggested solution. In that case, follow-up could include assessing the participant’s capabilities, whether more training is required or not, and marking participants as pass or fail.

Using QMS software with a built-in training management software solution you can assure efficient, well-documented, and compliant training management. With SimplerQMS, you can ensure that all employees receive the correct training based on their functional roles. Automatic notifications and reminders ensure that everyone is kept up to date with new trainable procedures, instructions, documents, and videos.

Common Challenges With CAPA

Many pharmaceutical manufacturers face challenges when implementing Corrective Actions and Preventive Actions (CAPA’s).

Because every manufacturer wants to focus on production, and during production, cGMP violations are not uncommon. These violations demand Corrective and Preventive Actions, thus most manufacturers found CAPA one of the primary compliance pain points.

In-Efficient Root Cause Analysis

The CAPA is all about Root Cause Analysis (RCA) to investigate and pinpoint the problem cause. If it does not process in the right direction, the entire CAPA will have inefficient solutions and wastage of resources. It could result in corrective actions that address the same event repeatedly.

There are many reasons for an inefficient Root Cause Analysis (RCA), for example:

• The inability of the CAPA team to identify, and categorize the problem
• Lack of a tool for CAPA processing like CAPA management software
• Not giving importance to RCA and instead of treating it as a compliance requirement

Manual CAPA Processing

Most pharma manufacturers still use manual paper/spreadsheet-based systems to process their CAPA’s. This creates challenges for pharma manufacturers to maintain consistency and comply with the regulatory requirements regarding a CAPA system.

Without a dedicated document control solution, pharma manufacturers can face de-centralized documents, manual chasing for signatures, overlapping responsibilities, and most importantly, missing due dates in implementing CAPA.

This can also result in overused CAPA or underused CAPA. This means initiating CAPA for the issues that do not require CAPA while missing the critical conformities requiring corrective and preventive actions.

Lack of Adequate Documentation

Quality compliance requires the pharmaceutical manufacturers to document all the processes correctly, and the same is the case with CAPA’s.

Every step, process, and outcome should be reported.

The documentation format should be pre-approved before the execution of the CAPA activity. The regulatory bodies during an audit and inspection purposefully check the documentation for consistent CAPA activity.

Tips for Effective CAPA Implementation

Effectively implementing CAPA is necessary to create practical corrective and preventive actions. Otherwise, it can result in a wastage of resources.

Some tips for effective CAPA implementation are mentioned below.

Approved Process

The CAPA activity should be carried out as per the approved process. The approval must be taken from all the stakeholders, such as the Quality department, production, and maintenance department. After approval, the document must be controlled, and a copy to be retained in all the concerned departments.

This is often called a CAPA procedure.

Additionally, there must also be a CAPA form. The CAPA form is an approved format, which helps initiate a CAPA for process improvements.

Typical CAPA form includes:

• Detailed problem description
• Root Cause associated with the problem
• Corrective actions proposed to solve the problem
• Preventive actions proposed to prevent recurring
• Approval and Signatures from the concerned department, and personnel involved in the CAPA process

Keep Data Centralized

Secure data storage, access controls are key to any process, and timely data availability is vital to the success of any CAPA activity.

Therefore, it is recommended to consider implementing a document control software system like SimplerQMS that stores the data in centralized and secure cloud storage and makes it readily available at any time, from anywhere.

Document Non-Conformities and Feedback

Recording all non-conformities and feedback helps CAPA keep on track, in line with main objectives. Because, during CAPA, there can be many input variables which can be sometimes relevant, and sometimes not. Recording all the information makes it possible to analyze during the decision-making step.

For example, the information required during the identification stage should be thoroughly filled, including problems and their sources.

Risk-Based Approach

It is recommended to execute CAPA by utilizing a risk-based approach. The risk-based approach allows assessing risks associated with non-conformity under observation. The outcome of the CAPA is treated as a risk, with its appropriate severity level.

For example, if a department fails to show a control copy of the Job Description for any of its personnel, this shortcoming can be categorized as Low, Medium, or High risk, according to the acceptance criteria.

Simple Problem Definition

Problem definition or presentation should be simple, aimed at ordinary personnel with basic process understanding.

This helps to quickly and easily understand the problem without confusion. Simple problem definition leads to effective and accurate solutions, resulting in better process improvement and quality.

Digitizing CAPA Management Processes

Manual, paper-based documentation processes have several drawbacks, including a lack of visibility, incomplete documents, missing signatures, and so on.

Modern eQMS solution with powerful CAPA management capabilities like SimplerQMS allows you to digitize and automate a bulk of routine CAPA processes in a pharmaceutical organization. Such as document routing, notifications, task reminders, escalation, and approvals. This allows you to accelerate issue resolution and ensure regulatory compliance.

SimplerQMS integrates the CAPA system with the core quality management system (QMS) providing you enterprise-wide visibility.

Furthermore, you can use pre-configured forms to quickly initiate forms from nonconformances, customer complaints, audit findings, and more. With visibility into all quality processes, you can analyze data identify patterns, and address areas of concern before they become a reality.

Final Thoughts

Pharmaceutical companies are required to maintain a quality management system that ensures the safety, efficacy, and quality of products. It is therefore important for pharmaceutical organizations to implement CAPA systems in their operations.

The article has touched upon some of the major aspects that need to be considered when designing and implementing a CAPA system. Pharmaceutical organizations must have an effective CAPA process in place, which can help them avoid risks such as product recalls or loss of customer trust.

If you are looking for a powerful eQMS solution with robust CAPA management capabilities, feel free to get in touch with our experts by booking a demo today!

The post What is CAPA in the Pharmaceutical Industry? appeared first on SimplerQMS.

Corrective Actions and Preventive Actions (CAPA’s) can also be used to eliminate causes of other events such as complaints, audit findings, and others.

For such instances, your medical devices company is regulated by the FDA and other international regulatory agencies to maintain Corrective and Preventive Actions (CAPA) procedures and policies. You will initiate the non-conformance issue into the CAPA process by using a CAPA form, which will ensure that it is turned into your organization’s process improvement.

This article educates about the CAPA form and also provides a free downloadable template for a CAPA form.

Let us look at CAPA and the CAPA form in more detail:

• What Are Corrective Action and Preventive Action (CAPA)?
• What Is a Corrective and Preventive Action (CAPA) Form?
• What Does a Corrective and Preventive Action (CAPA) Form Include?
• Best Practices for Creating Effective CAPA Form
• Example of a Filled Corrective and Preventive Actions (CAPA) Form
• Corrective and Preventive Actions (CAPA) Form Template
• Streamline Your CAPA Process With CAPA Management Software

What Are Corrective Action and Preventive Action (CAPA)?

CAPA is a set of actions that your organization (medical devices, biotechnology, pharmaceuticals, food, beverages, etc.) maintains to eradicate all causes of recurring non-conformances and other unexpected situations.

Thus, Corrective and Preventive Actions (CAPA) will provide your organization with a structure to discover the root cause of a problem(s) and to resolve the same.

Let us look at the example mentioned in the introduction section – the malfunctioning implantable pacemaker. With a proper system in place, your company will be able to immediately execute a CAPA process because of the resultant non-conformance.

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

This CAPA process has various steps, each of which needs to be successfully executed and submitted to the CAPA program.

1. Create a CAPA request and submit the same for review
2. The quality manager/quality management review board of your organization will review the request
3. The CAPA request is either accepted or rejected
4. If accepted, the request will be formally initiated as a CAPA
5. Departments, processes, procedures will be finalized as the CAPA resources
6. Identify whether immediate action/corrections are needs
7. All findings are investigated and documented

As you can see, inherently, a thorough CAPA process is necessary to maintain a high level of product quality and safety. That’s why more organizations nowadays implement digital and integrated CAPA software solutions to execute the CAPA process following regulatory requirements. It integrates with the core quality management system and automates processes like routing, notifications, reminders, escalation of activities, and approvals, which results in a more streamlined CAPA management process.

What Is a Corrective and Preventive Action (CAPA) Form?

Once your organization has identified a non-conformance and initiated a CAPA, you will escalate the issue by using a CAPA form. This CAPA form is the mechanism by which your organization will initiate non-conformance issues into the CAPA process.

The CAPA form is a tracking form of all corrective and preventive actions taken for a given non-conformance. It will be initiated as soon as the CAPA request is accepted and converted into a formal CAPA.

Your organization is mandated by international regulatory agencies to maintain a thorough record of all CAPAs. This is proof of your commitment to the continuous improvement of all quality processes, products, and operations.

The CAPA form is crucial to this entire process.

When relevant personnel complete the CAPA form with accurate data and receive authorization, the form’s status changes to the CAPA report.

Let us look at the implantable pacemaker that your medical device company manufactures and markets across the globe. The malfunctioning is a major non-conformance and a CAPA needs to be initiated without fail. Once the CAPA request has been formalized, your quality manager/quality review board will maintain the CAPA form.

What Does a Corrective and Preventive Action (CAPA) Form Include?

Corrective and Preventive Action (CAPA) form template includes four main components of a CAPA form.

Those components are:

1. Description of the problem
2. Root cause analysis and action plan
3. Effectiveness checks
4. Signature and closure date

Let’s look at each one in more detail.

1. Description of the Problem

The CAPA form will have sufficient space for providing a detailed description of the non-conformance. This will also include the name of the person initiating the CAPA, date, and other essential details.

2. Root Cause Analysis and Action Plan

This component of the CAPA form is detailed by the person conducting the analysis. Using an eQMS like SimplerQMS you can assign each action to specific employees who can work asynchronously on these tasks.

Here, the immediate action is taken, methodology, and the root cause analysis that will determine the source of the non-conformance will be mentioned.

Also, think about whether any other factors are contributing to the non-conformance?

Lastly, outline the CAPA plan that after implementation will prevent the particular non-conformance from occurring again.

For instance, you have corrected the non-conformance in one product, but to prevent the problem from occurring somewhere else, you will need to go through preventive action steps. You will take the lessons learned from a particular issue and apply them across the entire organization concerning related situations, processes, or equipment.

3. Effectiveness Checks

How do you determine whether the corrective or preventive actions that you have taken do correct or prevent the problem?

This is possible by using effectiveness checks which will help you determine whether the action taken was correct. Verification and validation are examples of such effectiveness checks.

The actions that you take before the implementation of the remedial process are referred to as verification. On the other hand, validation means the steps you take after the remedial process has been implemented.

Over time, you will have to monitor all quality reports to authenticate the effectiveness of the corrective or preventive actions. This also means that you will have to document the solution to the issue, the person(s) who did the verification or validation, and the date.

4. Signatures and Closure Date

An important component of the CAPA form is the signature of the person(s) who initiated the CAPA process and the person(s) who analyzed the CAPA and executed the solution to the non-conformance.

This is necessary for both responsibility and traceability all through the CAPA process.

Again, these are mandatory guidelines set forth by international regulatory agencies such as the U.S. FDA. At times, regulatory agencies may only review the completed records.

To make this process easier, an eQMS with FDA 21 CFR Part 11 compliant electronic signatures can be used to sign off CAPA’s.

Best Practices for Creating Effective CAPA Form

As an organization dealing with life-saving medical devices, pharmaceuticals, etc., you will be taking utmost care to ensure that non-conformances do not occur. However, non-conformances may happen, in which case a CAPA is required along with a detailed CAPA form.

An effectively filled CAPA form will ensure that all actions are complied with.

Let us look at the 5 best practices for creating effective CAPA forms.

1. Correct Filling of Dates

Ensure that all dates in the CAPA form are correctly filled and actions strictly adhered to. These dates will include the date on which the CAPA was initiated, the target due date, and the date on which the CAPA was closed.

For example, the clear mentioning of the date on which the CAPA was commenced will help calculate the due date and ensure that there is no unwarranted delay in completion.

QMS software like SimplerQMScan help by automatically reminding you about the due date of each CAPA.

2. Cross-Referencing

We know that all CAPAs have a sequentially assigned log number that has to be prominently highlighted on each page. Cross-referencing becomes particularly important if you still have a paper-based system in place. What if one or more sheets of a particular CAPA form go missing?

Using efficient QMS software with robust CAPA management functionality this problem would be avoided.

With SimplerQMSyou can make cross-references to any other document such as non-conformance, customer complaint, and audit finding. Furthermore, you can make references to products, equipment, suppliers, and more.

3. Authorized Signatories

Each of the sections in the CAPA form will need to be filled and validated by a designated responsible person.

These will include the person initiating the CAPA and the person who will review and sign the completed CAPA form.

4. Root Cause / Investigation

Several root cause analysis tools are available, including fishbone analysis. Your organization will need to choose the best depending on the current non-conformance.

Also, you may use more than one tool for this part of the investigation.

5. Capture All Details

The CAPA form will have to capture all details from the beginning till the CAPA is closed. These details will include the sources for the CAPA, the actions taken, and the verification for the actions taken. The CAPA form is not a succinct description, but rather a comprehensive explanation of why a particular CAPA was created.

One or more designated persons may become unavailable due to unavoidable reasons. So, ensure that each designated person completes all details, such that even in their absence, the CAPA form will speak for itself.

Example of a Filled Corrective and Preventive Actions (CAPA) Form

Let us look at the example of the malfunctioning implantable pacemaker and briefly look at the details to be filled in the appropriate CAPA form fields.

Ok, we are now at the last step of the CAPA for the malfunctioning implantable pacemaker (verification of corrective/preventive actions).

For example, you have found out that a break in the wire insulation has led to the EC failure. Your organization has recalled all the malfunctioning devices and replaced the insulation.

In the last step, namely, verification of the corrective and preventive actions, you will take a relook at the design, specs, and requirements. This will give you the confidence that the replacement of the insulation will work. You will also establish that there aren’t any hidden/unanticipated quality problems. If otherwise, you will have to make supplementary alterations to the process to prevent the problem from reoccurring again.

Keep in mind that these effectiveness checks are required to determine whether the corrective or preventive actions you have taken do correct or prevent the problem from occurring again. Verification and/or validation are examples of an effectiveness check. Verification implies the steps you take before implementing the remedial process, whereas validation indicates the steps you take after the implementation of the remedial process.

Corrective and Preventive Actions (CAPA) Form Template

Our free CAPA form template has all the required fields and is a quick, readymade solution for busy life science professionals who are looking to save time.

All you need is to fill the fields with essential details, signatures, and dates.

Download the CAPA form template and use it to initiate non-conformance issues into the CAPA process.

Streamline Your CAPA Process With CAPA Management Software

Manual, paper-based systems that are used for performing documentation processes have a lot of drawbacks, including validations, signatures, loss of documents, etc.

These problems can be easily resolved with the use of an eQMS solution with powerful CAPA capabilities that digitizes and automates the CAPA process.

With the SimplerQMS CAPA management software solution, you can automate the collection of data, routing, follow-ups, notifications escalation, and approvals. It integrates with other quality system processes throughout the entire product life cycle. This results in a more compliant and streamlined CAPA management process.

Final Thoughts

Your organization will need to maintain Corrective and Preventive Actions (CAPA) protocols and policies in order to ensure compliance with international regulatory agencies’ guidelines.

A very crucial tool during the CAPA process is initiating and maintaining the CAPA form.

Since paper-based manual CAPA forms have lots of drawbacks, eliminate these problems with the use of the SimplerQMS CAPA software solution that digitizes and automates the entire CAPA workflow.

To learn more about CAPA Management Software and see for yourself how SimplerQMS can help your organization streamline your CAPA processes book a free, personalized demo today!

The post Corrective Action and Preventive Action (CAPA) Form appeared first on SimplerQMS.

CAPA’s are typically used in industries like medical devices, pharmaceuticals, biotechnology, food & beverages, biologics, chemical, and others. Therefore, various regulations and standards require an organization to take certain actions to remedy and eliminate unwanted situations.

This article discusses the concept of corrective action and preventive action (CAPA), and the differences between the two. We discuss how it can provide long-lasting support to your company and how digital tools could help manage the CAPA process.

All in all, we will cover:

• What is CAPA?
• What Is the CAPA Process and Why it Is Important?
• Why Implementation of CAPA is Necessary for QMS?
• Corrective Action VS Preventive Action
• Effective CAPA Implementation Tips
• Steps of CAPA for Life Sciences Industry
• Impact of Risk Management on CAPA
• CAPA Management Software

NOTE
This is not a comprehensive guide on corrective action and preventive action (CAPA) for a specific industry like a medical device, pharma, etc., but a simplified overview of CAPA, with an example of various industries. Always follow the standards applicable to you and your company!

What is CAPA?

CAPA or corrective action and preventive action provide a structure for discovering the main cause of problems and resolving those problems. In addition, it verifies the conditions and solutions for future use and then looking for other possible issues and solutions.

Corrective and Preventive Action is a concept inside the Good Manufacturing Practice (GMP) and ISO 13485. CAPA concentrates on the methodical investigation of discrepancies so that their repetition can be avoided.

To guarantee that corrective and preventive actions are operative, the systematic investigation of the failure incidence is essential in recognizing the corrective and preventing actions undertaken.

For instance, a pharmaceutical or medical device company needs to have a system in place that executes corrective actions and prevents action resultant from the examination of non-conformances, product rejections, audits, deviations, governing inspections, and findings, and trends from process performance and product quality monitoring.

To determine the root cause, an organized approach to the investigation process needs to be utilized. The CAPA methodology needs to result in the product as well as process perfection and improved product and process understanding.

What Is the CAPA Process and Why It Is Important?

The CAPA process consists of numerous steps. At the time of the process, each step needs to be executed successfully and submissive to the CAPA program.

It is necessary to ensure that each action taken is documented carefully because proper documentation helps in offering vital data for continuous quality improvement.

In the case of medical devices, CAPA is part of the different areas of the life cycle processes:

• Production & process controls
• Equipment and facility controls
• Material controls
• Records, documents, and change controls
• Design controls

During the CAPA process, the real scope of the problem should be determined along with causes and detection methods.

Why Implementation of CAPA Is Necessary For QMS?

As per FDA 21 CFR 820, ISO 9001:2015, and ISO 13485:2016, execution of corrective and preventive actions is considered as the path towards the enhancement and success of quality management systems.

Note that corrective actions are mainly the actions that are based upon the identification of the problem. Through staff suggestions, document reviews, management reviews, or internal audits, it is easy to identify non-conformance internally.

On the other hand, customer grievances/suggestions, customer refusals, non-conformities raised in customer/third-party audits & recommendations by the auditors are some of the external sources that assist in finding the root cause of the problem.

Corrective Action VS Preventive Action

Corrective action is a reaction to all the causes or non-conformance that are stated above and is divided into two phases of action:

• Identification of root cause – To recognize the root cause, Total Quality Management (TQM) tools like Fishbone or Cause & Effects analysis can be utilized. Note that CAPA is going to be appropriate and effective only if you have effectively recognized the root cause of the problem.
• Taking important actions – Addressing the root cause requires important and quick actions. By using an efficient approach of the PDCA (plan–do–check–act or plan–do–check–adjust) cycle, the effectiveness of the corrective action requires to be proved periodically.

Preventive action is a prophecy of the problem and a trying method to prevent the occurrence through self-initiated actions and analysis that are related to your products or processes.

Preventive actions can be introduced with the assistance of active participation of staff members/workers through:

• Improvement teams
• Management review
• Enhancement meetings
• Customer reactions

Such an approach not only assures business growth, decreases rejections but also uses the equipment effectively.

Effective CAPA Implementation Tips

To execute the CAPA process effectively from the beginning, you should first address the problems like lack of adequate documentation and lack of adequate actions. The problems should be addressed as early as possible.

Here are some tips that can help you to implement CAPA in a better way:

• By following the guidelines create a CAPA process quickly
• To ensure better control, don’t forget to keep the data centralized
• Make sure to keep your process simple to assure it’s easy to follow
• At the very first stage of a CAPA process, you need to execute risk management

Clearly distinguish the symptoms from causes and have a clear idea about the problem so that you can reach its root cause more easily.

Steps of CAPA for Life sciences Industry

In seven basic steps, execution of a corrective or preventive action that is capable of meeting quality assurance and regulatory documentation requirements is done.

Identification

This is the first step that involves the identification of the problem. It is necessary to define the situation properly and completely as it exists now. This needs to include the source of the information, complete clarification of the problem, and accessible evidence that the problem exists.

A sample form is offered a corrective/preventive action request that can be used to initiate a CAPA action and gather the initial information.

Recommended Reading: Corrective Action and Preventive Action (CAPA) Form

Evaluation

The situation must be evaluated properly to determine the need for action and then the level of action needed. It is necessary to determine the possible impact of the problem and the real risks linked to the company or customers.

A remedial action plan can be used to explain the steps that need to be taken to prevent any kind of additional adverse effects.

Investigation

A written process for doing an investigation into the problem is formed. This kind of written plan ensures that the investigation is complete, and nothing is missed. This procedure mainly includes an objective for the action, investigation strategy, and assignment of accountability and required resources.

A sample investigation form is included that investigates the problem and contains the objectives and instructions that are required for investigating.

Analysis

The investigation process is used for researching the cause of the problem. The main motive of this analysis is to govern the root cause of the problem defined. Along with this, the contributing cause is also recognized.

A problem analysis form is included which helps record the information which is related to the analysis of the issue.

Action Plan

By using the results from the analysis, one of the best methods for correcting the situation and preventing a future occurrence is better determined by the action plan.

You need to know that tasks that are needed to correct a problem and avoid its reappearance is recognized and included in an action plan.

This type of plan includes changes that need to be made and allocates responsibility for the tasks. With this plan, it becomes easy to recognize a person or person who is accountable for completing each task.

Implementation

The correction and preventive action plan created should then be effectively executed. You need to know that all the required tasks that are listed and described in the action plan are introduced, accomplished, and documented.

Follow-Up

In the CAPA process, one of the most essential steps in completing an evaluation of the actions that were taken. This evaluation should validate the successful completion of the recognized tasks and evaluate the suitability and efficiency of the actions taken.

Once the follow-up is done, the CAPA is complete. It needs to be dated and signed by the authorized personnel.

Therefore, CAPA plays a vital role in the quality management system and improves its effectiveness. Apart from this, CAPA methodology also results in the product as well as process enhancements and ensures a better understanding of the product and process.

In pharmaceutical and biopharmaceutical manufacturing, it is often seen that somewhere in the line something could go wrong and have an effect on the quality. When this happens, the quality issue needs to be resolved in an effective and compliant manner.

In case, the issue is small and there is a solution that can be performed directly and appropriately then the quality event can be closed with an effective correction easily. However, if the problem is substantial then it will be escalated into a CAPA.

The CAPA best practices can help in firming clinical research not only for compliance purposes but at the same time aid accelerate time to market.

Recommended Reading

• Corrective and Preventive Action (CAPA) Procedure
• Clinical Quality Management System [Role of an eQMS]

Impact of Risk Management on CAPA

If you are a medical device manufacturer then risk and risk management are synonymous within your daily operations. Medical device manufacturers must bring a device to the market that will not only prove to be functional for a patient but is also safe and effective to use.

In the medical device industry, risk management is a process that is going to stay for a long time. FDA works to ensure that there is stronger risk management in which the manufacturers of the medical device need to have a clear document process for corrective action and preventive action (CAPA).

Proper CAPA processes for corrective action and preventive action (CAPA) is an important step for medical device companies implementing ISO 13485:2016. Therefore, the concept of a risk-based CAPA process has turned out to be foundational for the success of medical device companies.

Recommended Reading: What Is CAPA in the Medical Device Industry?

CAPA Management Software

As you know, for life science organizations, maintaining full compliance with regulatory requirements, those set by ISO and the FDA are critically important to succeeding.

An integrated CAPA software solution can help companies streamline CAPA management processes. Which typically results in enhanced product quality and safety, increased customer satisfaction, and especially, ensure compliance with the regulations, when implemented properly.

With the help of CAPA management software, it is easy to:

• Recognize and initiate a corrective and preventive action process
• Recognize trends
• Conduct or link to a prevailing investigation and root cause analysis
• Describe action plans to modify or improve
• Assure efficacy checks with an organized verification and closure

CAPA software offers risk assessments and notifies you about the possible problems that might take place. This further permits you to changes that are required before an issue takes place.

When the problems occur, the software assists with root cause analysis to know why the issue happened and what steps can be taken to fix the problem effectively.

CAPA software is mainly used by any business that makes use of a quality control system. One of the major uses for CAPA software is by manufacturers who need to ensure that their processed and products successfully meet the regulatory ethics of their industry.

To summarize, here are some benefits of using CAPA management software:

• Recognize product and process problems along with root cause analysis
• Successfully solve product quality & process problems
• Decrease risk and avert quality issues
• Attain valuable insights into quality problems and possible risks
• Sustain regulatory compliance for your business

Various Electronic Quality Management System vendors provide CAPA Management Software System as one of the modules of their overall solution. Although, there is no one size fits all solution that would suit every life science organization.

SimplerQMS offers a ready-to-use eQMS in which you can easily manage corrective action and preventive action (CAPA) processes. Furthermore, it seamlessly integrates with other subsystems and critical processes, including:

• Customer complaints
• Audit Management
• Change Control
• And others

To see our CAPA Management Software in action and learn how SimplerQMS can help your organization achieve better CAPA management processes book a free demo today!

Final Thoughts

The main purpose of CAPA is to determine the reason why quality events like deviations and non-conformances have occurred in the first place and to prevent them from happening in the future.

Corrective action and preventive action (CAPA) is used in various life science regulations and its basics are described in the regulations, standards, and guidelines like ISO 13483:2016, FDA 21 CFR 820, ISO 9001, and Good Manufacturing Practices (GMP).

CAPA processes are present within various quality systems and the data they produce. Integrated CAPA Management software allows life science organizations to streamline all the critical quality processes throughout the entire product life cycle. When implanted properly, this typically results in increased safety and product quality, enhanced customer satisfaction, and above all, ensure compliance with the regulations.

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