The CAPA processes should be well defined to support an effective and efficient project management process. When working with CAPA, corrective actions are defined as actions set in motion to eliminate a nonconformity or other unwanted situations which have already occurred, and preventive actions as actions set in motion to eliminate potential nonconformities or unwanted situations.
CAPA is a mandatory part of the Quality Management System (QMS) for any pharmaceutical or medical device manufacturer, who reporting any Regulatory Authority.
The CAPA process plays an important role in the quality management system of any company. It helps to identify, evaluate, prioritize and manage nonconformities or problems related to products or processes to prevent them from recurring.
- Nonconformity is nothing but the non-fulfillment of a specified requirement.
- A correction is when you fix the thing that went wrong ( the non-conformity) or to contain the problem.
- For Example, Reworking, repair or replacement are corrections.
Corrective Action- Action to eliminate the cause of a detected nonconformity
A corrective action (CA) deals with a nonconformity that has occurred i.e. the corrective action is performed on detected non-conformity. The objective of CA is to prevent a recurrence For Example: Installing the filter after an incidence of filter choking. Corrective action is a reaction that can be made along with the correction.Preventive Action - Action to eliminate a cause of a potential nonconformity
Preventive action determines and eliminates the cause of potential non-conformities to prevent occurrence. The objective of PA is to prevent its occurrence. For Example: Installing an alarm to warn you when your process is drifting out of the acceptance range. Preventive action is proactive.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.CAPA is the abbreviation for corrective and preventive actions. The term refers to the improvements to an organization's processes to mitigate undesirable situations like product nonconformities and is typically used in connection with quality assurance.
CAPA can provide a structure for organizations to follow to find the cause of a problem, solve it, and identify ways to prevent the problem from occurring in the future. Thus, organizations correct the issue and prevent it going forward.
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.
Corrective Action (CA) vs Preventive Action (PA)
Corrective action is a kind of extension of the Root Cause Analysis (RCA) approach. Step 1 of CA is to identify the root cause of the issue following a report of a nonconformity. Step 2 is to eliminate the root cause to prevent the nonconformity from recurring.Preventive action is when you identify and remove potential sources of nonconformities before an undesirable situation has the chance to occur.
PA follows a similar design to the lessons learned/read-across approach. It emphasises the sharing of information across the organisation so that problems can be taken care of efficiently.
The purpose of an efficient CAPA process
CAPA is designed to ensure quality and continuous improvement, which is especially important in the pharmaceutical and medical device industry since / because lack of process can have fatal consequences.CAPA is one of the most essential regulatory areas for both the Regulatory Authority and ISO in pharmaceutical quality systems and for industries producing medical devices.
The CAPA system is always a part of the regulatory compliance audit and around 30-50 percent of non conformances cited quoted by the Regulatory Authority are due to inadequate implementation of CAPA.
However, an efficient CAPA process can also help create value for the company, as it is effective in uncovering and solving quality problems. Solving the wrong problem or having recurring quality problems can be expensive for a company. An efficient CAPA is a comprehensive procedure that collects and monitors information about existing and potential quality problems and allows for analysis and investigation of issues to identify root causes, and initiate actions to fix the problem.
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.There are certain situations, that when they occur, can trigger a CAPA.
Non conformances 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.
- 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 an instance, If the manufacturer receives a complaint on the About the product that it is not turning on after power supply, It should trigger a CAPA.
- 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.
Regulatory Guideline
CAPA is most commonly used in highly regulated industries and is a mandatory part of a QMS for any pharmaceutical or medical device manufacturer reporting to the Regulatory Authority or who is compliant with ISO:13485 Medical Devices as well as European Pharmaceutical GMP and IATF. Procedures for corrective actions are also mandatory in the QMS for the majority of ISO management systems.Here is a list of some well-known guidelines and standards in the pharmaceutical and medical device industries that mention requirements for Corrective and Preventive Actions (CAPA). These documents provide guidance on implementing CAPA processes to address and prevent quality issues:
Pharmaceutical Industry:
- ICH Q9: Quality Risk Management: The International Council for Harmonisation (ICH) guideline Q9 discusses the principles and processes of quality risk management, which include the identification and management of risks that can lead to the need for CAPA.
- FDA 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals: The U.S. FDA's Code of Federal Regulations (CFR) Title 21, Part 211, includes requirements for CAPA systems in pharmaceutical manufacturing to address deviations, discrepancies, and non-conformances.
- EU GMP Annex 15: Qualification and Validation: This European Union (EU) Good Manufacturing Practice (GMP) guideline includes requirements for CAPA in the context of qualification and validation activities.
- PIC/S PI 011-3: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments: This document provides guidance on data integrity and emphasizes the need for CAPA when data discrepancies are identified.
- ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes: ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry and includes specific requirements for CAPA processes.
- FDA 21 CFR Part 820: Quality System Regulation: The U.S. FDA's Quality System Regulation for medical devices (Title 21, Part 820) includes comprehensive requirements for CAPA to address and prevent non-conformities.
- ISO 14971: Medical devices - Application of risk management to medical devices: ISO 14971 provides guidance on risk management for medical devices, including the identification and management of risks that may require CAPA actions.
- EU MDR and IVDR: The European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) include requirements for CAPA as part of the post-market surveillance and vigilance processes.
- FDA Guidance Document - "Medical Device Quality Systems Manual: This FDA guidance document provides insights into quality system regulations and emphasizes CAPA requirements in medical device manufacturing.
- AAMI TIR57: Principles for medical device security - Risk management: AAMI TIR57 discusses principles for medical device security, including risk management and CAPA in the context of cybersecurity.
Application of Corrective Action and Preventive Action System throughout the Product Lifecycle
- Product Development: Product or process variability is explored. CAPA methodology is useful where corrective actions and preventive actions are incorporated into the iterative design and development process.
- Technology Transfer: CAPA can be used as an effective system for feedback, feed forward and continual improvement.
- Commercial Manufacturing: CAPA should be used and the effectiveness of the actions should be evaluated.
- Product Discontinuation: CAPA should continue after the product is discontinued. The impact on product remaining on the market should be considered as well as other products which might be impacted.
Steps for Effective CAPA Implementation
- should have Excellent communication/presentation skills.
- should have Strong analytical problem solving skills.
- should have Influence management skills; ability to work constructively across all functions of the organization.
- should have Experience in all areas of the CAPA process.
- should have Experience with quality tools and process improvement techniques.
- should have Project management experience.
Step – 1: Identification
The first step of the CAPA process is to identify, describe and document the problem. A nonconformity incident does not necessarily trigger a CAPA. However, it is necessary to evaluate every nonconformance and assess what actions are appropriate. Nonconformance's can be identified from both internal and external sources, including, but not limited to:
- Deviation
- Change Control
- Incidents
- Internal quality audits Observations
- Customer complaints / Product Quality Complaints
- Product Recalls
- Quality Assurance inspections
- Staff observations
- Trending data
- Audit findings
- Regulatory Inspections/Testing, Deviations
- Process Monitoring
- New Amendments to regulatory Guidelines
- Investigations
- Product Quality Reviews
- Risk Assessments
- Management Reviews
- Any Warning Letters or other Regulatory Observations
- Negative GMP Trends and other sources of Quality data
- What: Explain what happened or what you want to happen
- When: When did the problem occur/was discovered?
- Where: Where was the problem found? (process, region, department, etc.)
- Who: Who is affected by the problem?
- How much: How much of a process, product, batch, etc. is affected?
Step – 2: Evaluation
Here evaluate the problem to determine why it’s of concern,
and the impact and risk associated with the problem. And evaluate the possible
impact on costs, function, product quality, safety, reliability, customer
satisfaction, etc.
Step – 3: Investigation
In this step you should measure the gravity of the problem. You should determine the scope and boundary of the problem. An understanding of immediate actions is prepared. The following questions are helpful to understand what immediate steps are taken and why.
- What actions are taken immediately to fix the problem? (to record briefly the actions taken and by whom?)
- How long did it take to fix the problems? (to determine incident lost time)
- Has this happened before? (to identify history or trend on similar incidents)
- What actions were taken before? (to record any changes made previously)
- Which area of the processing line has been impacted?
- Are immediate actions sufficient to fix the issue?
Step – 4: Analysis
In this step, the investigation procedure is used to
determine the root cause of the problem. This is done by collecting all
relevant data and investigating all possible causes through a Root Cause
Analysis (RCA). A RCA is a systematic approach to finding the underlying (main)
cause of a problem. When a root cause is properly managed, the problem doesn’t
recur. The most typical tools include, 5xwhy and the fishbone diagram. 5xwhy is
a simple and very popular tool for RCA.
To find the root cause, one has to ask what caused the
problem, and question the answer five times.
The 5x why approach can quickly be adapted and applied to
most problems. There are three fundamental elements to effectively using the
5xwhy:
- a clear statement;
- honesty and the competencies for answering the questions;
- determination to find the problem.
The second method is the fishbone diagram (also known as the
Cause and Effect Diagram),which can be used by itself or together with the
5xwhy.
The fishbone diagram is used to identify different elements
that could be the root cause, including sub-elements. The fishbone diagram is
useful if many factors affect the problem.
Step – 5: Action Plan
When the root cause is identified, an action plan needs to
be developed. The action plan determines which actions will be initiated, how,
by whom, when and so on. The documentation of the actions that are initiated is
important in order to have an effective follow-up.
The Examples of actions that can be initiated
include: documentation/forms/instruction
changes; procedural changes; employee training; or new equipment.
A monitoring system or controls also need to be implemented
to prevent the problem from recurring.
Step – 6: Implementation
Once the corrective and preventive action plans are
prepared, implement the action plan. Documentation of each of the determined
actions is important to ensure all actions are completed. When a plan has been
completed, all activities should be verified by a party independent of the
individual who has completed the task. A
frequent problem observed by the Regulatory Authorities is that the corrective
and preventive actions were not implemented. It is therefore important to define clear
responsibility and apply a tracking system to verify the implementation.
Step – 7: Follow-Up
The final stage of corrective and preventive action process
is to periodically follow up the effectiveness of the actions implemented
earlier and prepare a schedule to revisit the corrective and preventions and
check if the plans were not deviated from the target. At stage of Follow up it
should measure the root causes have been eliminated completely from the
process.
Step – 8: CAPA Closure
All actions must be completed and assessed for effectiveness
prior to CAPA closure with required approvals and distribution of all measures
taken.
Measuring the Effectiveness of CAPA
Once the CAPA is complete, a good effectiveness check should
demonstrate that the CAPA did in fact achieve what was intended. It should be
clear:
- who is doing this check,
- what will be checked,
- where will the data/information be recorded and tracked,
- when will the data/information be checked,
- if the data qualitative or quantitative data,
- who will gather the data/information,
- how the data/information gathered will be used to determine the effectiveness,
- if further action is required,
- how will the outcome be communicated to the right people?