CAPA Your Quality System with 6 Steps*
Marci L. Crane
December 31, 2008
An effective quality system may require many integral processes that function together for best results. These processes may include audits, change control procedures, customer complaints management, etc. They may also include CAPA management processes, or in other words, Corrective and Preventative Action procedures.
CAPA (Corrective and Preventative Action)
CAPA, according to an online source, "is a concept within Good Manufacturing Practice (GMP),"1 and can be explained (at least partially) in six steps:
Quality System CAPA Procedure #1: Definition
When a company seeks to implement their CAPA process, they must have a problem that they have identified and defined within their quality system. The definition phase requires clear reporting (i.e. documentation) in regard to how the problem information was gathered or deduced and documentation that explains the problem in detail. There must also be proof that the problem exists.
Quality System CAPA Procedure #2: The Appraisal
Procedure #2—like most of the CAPA procedures—requires some strategic thinking. For example, during the appraisal stage a quality personnel member in charge of a CAPA case will need to determine the impact that the problem is likely to have on the company´s overall quality system. An online presentation states that possible impacts may be related to "costs, function, product quality, safety, reliability, and/or customer satisfaction."2 This determination regarding impact should include risk to customers or to employees and any forms of remedial action that are necessary.
Once impacts and risks are pinpointed, as well as possible, the seriousness of the issue is determined. After years of experience, companies will begin to associate certain risks and/or impacts with varying levels of seriousness. These levels of seriousness will act as guides to those actions which are determined to be necessary for measures involving corrective and preventative actions. It is after the action is taken (immediate action, remedial action, long-term action) may be taken.
Quality System CAPA Procedure #3: Discovery
The discovery phase of the CAPA process is only undertaken if a remedial action has not resolved the issue at hand during phase #2. If however, a long-term action is required then phase #3 will commence.
Phase #3 can be defined as the discovery phase since an investigation will be required. Before the investigation can commence however goals for the CAPA action must be determined. These goals will become important because they will act as the guidelines for whether or not the CAPA action is resolved by phase #6. After the goals have been determined, a strategy should be developed for the CAPA investigation itself. The strategy, according to an online CAPA presentation should include "a set of specific instructions for determining the contributing and root causes of the problem,"3 and should also direct "a comprehensive review of all circumstances related to the problem and must consider:"
Quality System CAPA Procedure #4: Examination
The examination stage is the stage at which the root cause is rooted out if at all possible. This "rooting out" takes place after determining any possible and probable cause of the problem and after data has been collected to support and/or refute these possible causes. Every aspect of data need to be documented during this stage as well as organized. According to the online CAPA presentation, the data that supports the examination phase "may come from a variety of sources: testing results and/or review of records, processes, service information, design controls, operations, and any other information that may lead to a determination of the fundamental cause of the problem."5 This data can then be collected, organized and documented on a readable form.
Quality System CAPA Procedure #5: Action and Implementation
It is during the action and implementation stage that "real-life" progress starts to be taken within a company´s quality system. For example, once a CAPA investigator has determined the root causes of the problem then he or she can start to develop a methodology that will prevent the problem from continuing to occur. This plan must be documented—like all other CAPA stages—and then responsibility for the various aspects and stages of the CAPA action can be assigned. Companies may also want to consider an automated CAPA software solution which will automatically track and store all CAPA related forms and records and will automate routing and collaboration processes across company wide networks as well as ensure accountability from CAPA participants. A CAPA software solution can literally save companies days, months and even years worth of valuable time that can be spent on more valuable endeavors. After this has occurred then the implementation of the plan can occur and the software can keep track of what has happened and who did it! To close the implementation phase, the CAPA investigator should summarize any actions taken during phase #5 and any changes that were made to processes or documentation should be listed within CAPA documentation.
Quality System CAPA Procedure #6: Closure
The closure of the CAPA investigation can occur only after the concluded CAPA actions have been evaluated. The evaluation, according to the online CAPA presentation "must not only verify the successful completion of the identified tasks, but also assess the appropriateness and effectiveness of the actions taken."6 This can be accomplished by answering a series of questions also presented in the online presentation:
If these four questions have been answered successfully then proof of the actions´ success should be documented. Then validation of the action should occur.
Conclusion
After reviewing the phases required during a CAPA investigation it is easy to see the power that a good CAPA process can have on a company´s quality system.
Notes and References
The content in this article is based on the following: http://209.85.173.104/search?q=cache:5FPeCdmqmB0J:www.rmbimedical.com/RegulatoryAffairs/Corrective%2520and%2520Preventive%2520Actions.pps+FDA+root+cause+analysis&hl=en&ct=clnk&cd=4&gl=us
1. http://en.wikipedia.org/wiki/Corrective_and_preventative_action
2-6. http://209.85.173.104/search?q=cache:5FPeCdmqmB0J:www.rmbimedical.com/RegulatoryAffairs/Corrective%2520and%2520Preventive%2520Actions.pps+FDA+root+cause+analysis&hl=en&ct=clnk&cd=4&gl=us
CAPA (Corrective and Preventative Action)
CAPA, according to an online source, "is a concept within Good Manufacturing Practice (GMP),"1 and can be explained (at least partially) in six steps:
Quality System CAPA Procedure #1: Definition
When a company seeks to implement their CAPA process, they must have a problem that they have identified and defined within their quality system. The definition phase requires clear reporting (i.e. documentation) in regard to how the problem information was gathered or deduced and documentation that explains the problem in detail. There must also be proof that the problem exists.
Quality System CAPA Procedure #2: The Appraisal
Procedure #2—like most of the CAPA procedures—requires some strategic thinking. For example, during the appraisal stage a quality personnel member in charge of a CAPA case will need to determine the impact that the problem is likely to have on the company´s overall quality system. An online presentation states that possible impacts may be related to "costs, function, product quality, safety, reliability, and/or customer satisfaction."2 This determination regarding impact should include risk to customers or to employees and any forms of remedial action that are necessary.
Once impacts and risks are pinpointed, as well as possible, the seriousness of the issue is determined. After years of experience, companies will begin to associate certain risks and/or impacts with varying levels of seriousness. These levels of seriousness will act as guides to those actions which are determined to be necessary for measures involving corrective and preventative actions. It is after the action is taken (immediate action, remedial action, long-term action) may be taken.
Quality System CAPA Procedure #3: Discovery
The discovery phase of the CAPA process is only undertaken if a remedial action has not resolved the issue at hand during phase #2. If however, a long-term action is required then phase #3 will commence.
Phase #3 can be defined as the discovery phase since an investigation will be required. Before the investigation can commence however goals for the CAPA action must be determined. These goals will become important because they will act as the guidelines for whether or not the CAPA action is resolved by phase #6. After the goals have been determined, a strategy should be developed for the CAPA investigation itself. The strategy, according to an online CAPA presentation should include "a set of specific instructions for determining the contributing and root causes of the problem,"3 and should also direct "a comprehensive review of all circumstances related to the problem and must consider:"
- "external factors"
- "software"
- "training"
- "design"
- "procedures"
- "personnel"
- "materials"
- "equipment"4
Quality System CAPA Procedure #4: Examination
The examination stage is the stage at which the root cause is rooted out if at all possible. This "rooting out" takes place after determining any possible and probable cause of the problem and after data has been collected to support and/or refute these possible causes. Every aspect of data need to be documented during this stage as well as organized. According to the online CAPA presentation, the data that supports the examination phase "may come from a variety of sources: testing results and/or review of records, processes, service information, design controls, operations, and any other information that may lead to a determination of the fundamental cause of the problem."5 This data can then be collected, organized and documented on a readable form.
Quality System CAPA Procedure #5: Action and Implementation
It is during the action and implementation stage that "real-life" progress starts to be taken within a company´s quality system. For example, once a CAPA investigator has determined the root causes of the problem then he or she can start to develop a methodology that will prevent the problem from continuing to occur. This plan must be documented—like all other CAPA stages—and then responsibility for the various aspects and stages of the CAPA action can be assigned. Companies may also want to consider an automated CAPA software solution which will automatically track and store all CAPA related forms and records and will automate routing and collaboration processes across company wide networks as well as ensure accountability from CAPA participants. A CAPA software solution can literally save companies days, months and even years worth of valuable time that can be spent on more valuable endeavors. After this has occurred then the implementation of the plan can occur and the software can keep track of what has happened and who did it! To close the implementation phase, the CAPA investigator should summarize any actions taken during phase #5 and any changes that were made to processes or documentation should be listed within CAPA documentation.
Quality System CAPA Procedure #6: Closure
The closure of the CAPA investigation can occur only after the concluded CAPA actions have been evaluated. The evaluation, according to the online CAPA presentation "must not only verify the successful completion of the identified tasks, but also assess the appropriateness and effectiveness of the actions taken."6 This can be accomplished by answering a series of questions also presented in the online presentation:
- "Have all of the objectives been met?"
- "Have all recommended changes been completed and verified?"
- "Has training and appropriate communications been implemented to assure that all relevant employees understand the situation and the changes that have been made?"
- "Has an investigation demonstrated that that the actions taken have not had any additional adverse effect on the product or service?"
If these four questions have been answered successfully then proof of the actions´ success should be documented. Then validation of the action should occur.
Conclusion
After reviewing the phases required during a CAPA investigation it is easy to see the power that a good CAPA process can have on a company´s quality system.
Notes and References
The content in this article is based on the following: http://209.85.173.104/search?q=cache:5FPeCdmqmB0J:www.rmbimedical.com/RegulatoryAffairs/Corrective%2520and%2520Preventive%2520Actions.pps+FDA+root+cause+analysis&hl=en&ct=clnk&cd=4&gl=us
1. http://en.wikipedia.org/wiki/Corrective_and_preventative_action
2-6. http://209.85.173.104/search?q=cache:5FPeCdmqmB0J:www.rmbimedical.com/RegulatoryAffairs/Corrective%2520and%2520Preventive%2520Actions.pps+FDA+root+cause+analysis&hl=en&ct=clnk&cd=4&gl=us