Woman Following a CAPA Procedure

Corrective and Preventive Action (CAPA) Procedure

by | Feb 7, 2022 | CAPA

Corrective and preventive action (CAPA) procedures are critical to the success of the quality management system (QMS) and CAPA sub-system in any life science organization.

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 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.

CAPA Process Illustration

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

Free CAPA From Template Download

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.

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