Corrective and Preventive Actions (CAPA) - Revision history

S175074 at 16:10, 21 June 2021

2021-06-21T16:10:24Z

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	~~''Written by Mathilde Kremmer Broberg''~~
	=Abstract=		=Abstract=
	Corrective and Preventive Actions (CAPA) are processes designed to improve quality and handle nonconformity as well as other undesirable situations. 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.<ref name="CAPAFDA">Rodríguez-Pérez, José American Society for Quality 2011, CAPA for the FDA Regulated Industry</ref> CAPA is a mandatory part of the Quality Management System (QMS) for any pharmaceutical or medical device manufacturer reporting to the U.S. Food and Drug Administration (FDA). CAPA is also an integrated part of ISO:13485 and Good Manufacturing Practice (GMP) for medical products. The FDA defines the purpose of a CAPA procedure as: collecting and analyzing information, identifying and investigating product and quality problems, and taking appropriate and effective corrective and/or preventive action to prevent their recurrence.<ref name="FDA">FDA website Corrective and Preventive Actions (CAPA). Link: https://www.fda.gov/corrective-and-preventive-actions-capa#page3.</ref> There are not a regulatory defined framework for the CAPA process only different requirements.		Corrective and Preventive Actions (CAPA) are processes designed to improve quality and handle nonconformity as well as other undesirable situations. 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.<ref name="CAPAFDA">Rodríguez-Pérez, José American Society for Quality 2011, CAPA for the FDA Regulated Industry</ref> CAPA is a mandatory part of the Quality Management System (QMS) for any pharmaceutical or medical device manufacturer reporting to the U.S. Food and Drug Administration (FDA). CAPA is also an integrated part of ISO:13485 and Good Manufacturing Practice (GMP) for medical products. The FDA defines the purpose of a CAPA procedure as: collecting and analyzing information, identifying and investigating product and quality problems, and taking appropriate and effective corrective and/or preventive action to prevent their recurrence.<ref name="FDA">FDA website Corrective and Preventive Actions (CAPA). Link: https://www.fda.gov/corrective-and-preventive-actions-capa#page3.</ref> There are not a regulatory defined framework for the CAPA process only different requirements.

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2021-02-28T22:05:25Z

Step 6: Implementation

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	===Step 6: Implementation===		===Step 6: Implementation===
	In this step we implement the action plan. Documentation of each of the determined actions is important to ensure all actions are completed~~. The documentation should be attached to a final report of the CAPA action~~. When a plan has been completed, all activities should be verified by a party independent of the individual who has completed the task.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref> A frequent problem observed by the FDA 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.<ref name="CAPAFDA">Rodríguez-Pérez, José American Society for Quality 2011, CAPA for the FDA Regulated Industry</ref>		In this step we 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.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref> A frequent problem observed by the FDA 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.<ref name="CAPAFDA">Rodríguez-Pérez, José American Society for Quality 2011, CAPA for the FDA Regulated Industry</ref>

	===Step 7: Follow-up===		===Step 7: Follow-up===

S175074: /* Step 5: Action plan */

2021-02-28T22:04:43Z

Step 5: Action plan

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	One corrective action should be defined for each root cause. Actions such as: evaluate, analyse or assess are not adequate.[1] The degree of corrective and preventive actions taken to eliminate or minimize actual or potential non-conformities must be appropriate to the magnitude of the problem and proportional with the risks identified.<ref name="Review">Abhishek, Raj. 2016 A review on corrective action and preventive action (CAPA) Deputy R&D Manager, Quest Pharmaceuticals Pvt. Ltd, Chhata Pipara, Bara, Birgunj, Nepal. Link: https://academicjournals.org/journal/AJPP/article-full-text-pdf/4EF704756791</ref> It is necessary to validate that the proposed corrective and/or preventive actions will achieve the desired results<ref name="CAPAFDA">Rodríguez-Pérez, José American Society for Quality 2011, CAPA for the FDA Regulated Industry</ref>. To review the action plan. the team should ask whether or not the proposed CAPA will address the associated root cause and if the CAPA plan provides sufficient detail of required actions, responsibilities, and realistic timescales.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref>		One corrective action should be defined for each root cause. Actions such as: evaluate, analyse or assess are not adequate.[1] The degree of corrective and preventive actions taken to eliminate or minimize actual or potential non-conformities must be appropriate to the magnitude of the problem and proportional with the risks identified.<ref name="Review">Abhishek, Raj. 2016 A review on corrective action and preventive action (CAPA) Deputy R&D Manager, Quest Pharmaceuticals Pvt. Ltd, Chhata Pipara, Bara, Birgunj, Nepal. Link: https://academicjournals.org/journal/AJPP/article-full-text-pdf/4EF704756791</ref> It is necessary to validate that the proposed corrective and/or preventive actions will achieve the desired results<ref name="CAPAFDA">Rodríguez-Pérez, José American Society for Quality 2011, CAPA for the FDA Regulated Industry</ref>. To review the action plan, the team should ask whether or not the proposed CAPA will address the associated root cause and if the CAPA plan provides sufficient detail of required actions, responsibilities, and realistic timescales.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref>

	===Step 6: Implementation===		===Step 6: Implementation===

S175074: /* Step 5: Action plan */

2021-02-28T22:03:55Z

Step 5: Action plan

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	One corrective action should be defined for each root cause. Actions such as: evaluate, analyse or assess are not adequate.[1] The degree of corrective and preventive actions taken to eliminate or minimize actual or potential non-conformities must be appropriate to the magnitude of the problem and ~~commensurate~~ with the risks ~~encountered~~.<ref name="Review">Abhishek, Raj. 2016 A review on corrective action and preventive action (CAPA) Deputy R&D Manager, Quest Pharmaceuticals Pvt. Ltd, Chhata Pipara, Bara, Birgunj, Nepal. Link: https://academicjournals.org/journal/AJPP/article-full-text-pdf/4EF704756791</ref> It is necessary to validate that the proposed corrective and/or preventive actions will achieve the desired results<ref name="CAPAFDA">Rodríguez-Pérez, José American Society for Quality 2011, CAPA for the FDA Regulated Industry</ref>. To review the action plan. the team should ask whether or not the proposed CAPA will address the associated root cause and if the CAPA plan provides sufficient detail of required actions, responsibilities, and realistic timescales.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref>		One corrective action should be defined for each root cause. Actions such as: evaluate, analyse or assess are not adequate.[1] The degree of corrective and preventive actions taken to eliminate or minimize actual or potential non-conformities must be appropriate to the magnitude of the problem and proportional with the risks identified.<ref name="Review">Abhishek, Raj. 2016 A review on corrective action and preventive action (CAPA) Deputy R&D Manager, Quest Pharmaceuticals Pvt. Ltd, Chhata Pipara, Bara, Birgunj, Nepal. Link: https://academicjournals.org/journal/AJPP/article-full-text-pdf/4EF704756791</ref> It is necessary to validate that the proposed corrective and/or preventive actions will achieve the desired results<ref name="CAPAFDA">Rodríguez-Pérez, José American Society for Quality 2011, CAPA for the FDA Regulated Industry</ref>. To review the action plan. the team should ask whether or not the proposed CAPA will address the associated root cause and if the CAPA plan provides sufficient detail of required actions, responsibilities, and realistic timescales.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref>

	===Step 6: Implementation===		===Step 6: Implementation===

S175074: /* Step 5: Action plan */

2021-02-28T22:01:45Z

Step 5: Action plan

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	===Step 5: Action plan===		===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.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref> 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. An example of a CAPA action plan can be seen in table 3.		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.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref> 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. An example of a CAPA action plan can be seen in table 3.
	{\| class="wikitable" style="margin: auto;"		{\| class="wikitable" style="margin: auto;"
	\|+'''Table 3:''' corrective/preventive action plan <ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref>		\|+'''Table 3:''' corrective/preventive action plan <ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref>

S175074: /* Step 4: Analysis */

2021-02-28T22:01:31Z

Step 4: Analysis

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	[[File:CAPAxx.PNG\|800px\|thumb\|centre\|Figure 2: The 5xwhys<ref name="5xwhys">Serrat, Olivier, 2017, The Five Whys Technique, Knowledge Solutions.</ref> & fishbone diagram<ref name="KS">Jensen, Torben Jul 2005 Kvalitetsstyring og måleteknik (quality management and measurement technology).</ref>.]]		[[File:CAPAxx.PNG\|800px\|thumb\|centre\|Figure 2: The 5xwhys<ref name="5xwhys">Serrat, Olivier, 2017, The Five Whys Technique, Knowledge Solutions.</ref> & fishbone diagram<ref name="KS">Jensen, Torben Jul 2005 Kvalitetsstyring og måleteknik (quality management and measurement technology).</ref>.]]
	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.<ref name="5xwhys">Serrat, Olivier, 2017, The Five Whys Technique, Knowledge Solutions.</ref> The 5xwhy approach can quickly be adapted and applied to most problems. There are three fundamental elements to effectively using the 5xwhy: 1) a clear statement; 2) honesty and the competencies for answering the questions; 3) determination to find the problem.<ref name="5xwhys">Serrat, Olivier, 2017, The Five Whys Technique, Knowledge Solutions.</ref>		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.<ref name="5xwhys">Serrat, Olivier, 2017, The Five Whys Technique, Knowledge Solutions.</ref> The 5xwhy approach can quickly be adapted and applied to most problems. There are three fundamental elements to effectively using the 5xwhy: 1) a clear statement; 2) honesty and the competencies for answering the questions; 3) determination to find the problem.<ref name="5xwhys">Serrat, Olivier, 2017, The Five Whys Technique, Knowledge Solutions.</ref>
	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.<ref name="Root">Okes, Duke 2009. Root Cause Analysis – The core of Problem Solving and Corrective Action. ASQ Quality Press.</ref> Here the investigation team can brainstorm contributing factors to the problem within each category. Human factors should not be identified as a root cause, rather as a symptom of an underlying problem. In many pharmaceutical processes determining the actual cause of a problem can be a very demanding exercise. This is often due to a significant number of interactive issues.<ref name="Bio">Smart, Nigel J. 2013 Lean biomanufacturing Creating value through innovative bioprocessing approaches. Woodhead Publishing Series in Biomedicine: Number 37, Chapter 2</ref>		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.<ref name="Root">Okes, Duke 2009. Root Cause Analysis – The core of Problem Solving and Corrective Action. ASQ Quality Press.</ref> Here the investigation team can brainstorm contributing factors to the problem within each category. Human factors should not be identified as a root cause, rather as a symptom of an underlying problem.

	===Step 5: Action plan===		===Step 5: Action plan===

S175074: /* Step 4: Analysis */

2021-02-28T21:59:39Z

Step 4: Analysis

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	===Step 4: Analysis===		===Step 4: Analysis===
	In this step, the investigation procedure is used to determine the root cause of the problem as well as any contributing factors. This is done by collecting all relevant data and investigating all possible causes through a Root Cause Analysis (RCA). An 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.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref> In many pharmaceutical processes determining the actual cause of a problem can be a very demanding exercise. This is often due to a significant number of interacting issues.<ref name="Bio">Smart, Nigel J. 2013 Lean biomanufacturing Creating value through innovative bioprocessing approaches. Woodhead Publishing Series in Biomedicine: Number 37, Chapter 2</ref> Different tools can, therefore, be helpful in supporting this step. The most typical tools include, 5xwhy and the fishbone diagram.		In this step, the investigation procedure is used to determine the root cause of the problem as well as any contributing factors. 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.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref> In many pharmaceutical processes determining the actual cause of a problem can be a very demanding exercise. This is often due to a significant number of interacting issues.<ref name="Bio">Smart, Nigel J. 2013 Lean biomanufacturing Creating value through innovative bioprocessing approaches. Woodhead Publishing Series in Biomedicine: Number 37, Chapter 2</ref> Different tools can, therefore, be helpful in supporting this step. The most typical tools include, 5xwhy and the fishbone diagram.
	[[File:CAPAxx.PNG\|800px\|thumb\|centre\|Figure 2: The 5xwhys<ref name="5xwhys">Serrat, Olivier, 2017, The Five Whys Technique, Knowledge Solutions.</ref> & fishbone diagram<ref name="KS">Jensen, Torben Jul 2005 Kvalitetsstyring og måleteknik (quality management and measurement technology).</ref>.]]		[[File:CAPAxx.PNG\|800px\|thumb\|centre\|Figure 2: The 5xwhys<ref name="5xwhys">Serrat, Olivier, 2017, The Five Whys Technique, Knowledge Solutions.</ref> & fishbone diagram<ref name="KS">Jensen, Torben Jul 2005 Kvalitetsstyring og måleteknik (quality management and measurement technology).</ref>.]]
	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.<ref name="5xwhys">Serrat, Olivier, 2017, The Five Whys Technique, Knowledge Solutions.</ref> The 5xwhy approach can quickly be adapted and applied to most problems. There are three fundamental elements to effectively using the 5xwhy: 1) a clear statement; 2) honesty and the competencies for answering the questions; 3) determination to find the problem.<ref name="5xwhys">Serrat, Olivier, 2017, The Five Whys Technique, Knowledge Solutions.</ref>		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.<ref name="5xwhys">Serrat, Olivier, 2017, The Five Whys Technique, Knowledge Solutions.</ref> The 5xwhy approach can quickly be adapted and applied to most problems. There are three fundamental elements to effectively using the 5xwhy: 1) a clear statement; 2) honesty and the competencies for answering the questions; 3) determination to find the problem.<ref name="5xwhys">Serrat, Olivier, 2017, The Five Whys Technique, Knowledge Solutions.</ref>

S175074: /* Step 3: Investigation */

2021-02-28T21:58:59Z

Step 3: Investigation

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	*Which resources are required (money, time, testing equipment, personnel, etc.)		*Which resources are required (money, time, testing equipment, personnel, etc.)
	*Who is responsible for conducting the investigation		*Who is responsible for conducting the investigation
	*~~which~~ data is collected		*Which data is collected
	*~~instructions~~ for determining the causes of the problem including a timeline.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref><ref name="MasterControl">Simplifying CAPA: Seven Steps to a Comprehensive CAPA Plan 2019 MasterControl. Link: https://www.mastercontrol.com/learning-center/capa-management/simplifying-capa-seven-steps.</ref>		*Instructions for determining the causes of the problem including a timeline.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref><ref name="MasterControl">Simplifying CAPA: Seven Steps to a Comprehensive CAPA Plan 2019 MasterControl. Link: https://www.mastercontrol.com/learning-center/capa-management/simplifying-capa-seven-steps.</ref>

	The procedure requires a review of all circumstances related to the problem and must consider the following: external factors, software, training, design, procedures, personnel, materials and equipment. The level of investigation is determined based on the risk evaluation results or trend analysis results.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine</ref>		The procedure requires a review of all circumstances related to the problem and must consider the following: external factors, software, training, design, procedures, personnel, materials and equipment. The level of investigation is determined based on the risk evaluation results or trend analysis results.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine</ref>

S175074: /* Step 3: Investigation */

2021-02-28T21:58:37Z

Step 3: Investigation

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	===Step 3: Investigation===		===Step 3: Investigation===
	Step 3 involved the formulation of a procedure for the investigation (analysis). High-risk investigations will have priority over low-risk situations.<ref name="CAPAFDA">Rodríguez-Pérez, José American Society for Quality 2011, CAPA for the FDA Regulated Industry</ref> The purpose of the procedure is to ensure that nothing is overlooked in the investigation. The procedure should include information about, but not limited to: ~~the~~ objective for the actions~~, which~~ resources are required (money, time, testing equipment, personnel, etc.)~~, who~~ is responsible for conducting the investigation, which data is collected~~, and~~ instructions for determining the causes of the problem including a timeline.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref><ref name="MasterControl">Simplifying CAPA: Seven Steps to a Comprehensive CAPA Plan 2019 MasterControl. Link: https://www.mastercontrol.com/learning-center/capa-management/simplifying-capa-seven-steps.</ref> The procedure requires a review of all circumstances related to the problem and must consider the following:		Step 3 involved the formulation of a procedure for the investigation (analysis). High-risk investigations will have priority over low-risk situations.<ref name="CAPAFDA">Rodríguez-Pérez, José American Society for Quality 2011, CAPA for the FDA Regulated Industry</ref> The purpose of the procedure is to ensure that nothing is overlooked in the investigation. The procedure should include information about, but not limited to:
	*External factors		*The objective for the actions
	*Software		*Which resources are required (money, time, testing equipment, personnel, etc.)
	*Training		*Who is responsible for conducting the investigation
	*Design		*which data is collected
	*Procedures		*instructions for determining the causes of the problem including a timeline.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref><ref name="MasterControl">Simplifying CAPA: Seven Steps to a Comprehensive CAPA Plan 2019 MasterControl. Link: https://www.mastercontrol.com/learning-center/capa-management/simplifying-capa-seven-steps.</ref>
	*Personnel
	*Materials		The procedure requires a review of all circumstances related to the problem and must consider the following: external factors, software, training, design, procedures, personnel, materials and equipment. The level of investigation is determined based on the risk evaluation results or trend analysis results.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine</ref>
	*Equipment
	The level of investigation is determined based on the risk evaluation results or trend analysis results.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine</ref>

	===Step 4: Analysis===		===Step 4: Analysis===

S175074: /* Step 2: Evaluation */

2021-02-28T21:55:51Z

Step 2: Evaluation

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	[[File:CAPA3.PNG\|500px\|thumb\|centre\|Figure 1: The probability/impact matrix.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref>]]		[[File:CAPA3.PNG\|500px\|thumb\|centre\|Figure 1: The probability/impact matrix.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref>]]
	This evaluation is used to decide the priority of the actions as well as the level of investigation. It makes it possible for management to better prioritize complaints, deviations, nonconformances, corrections, and removals.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref> In some cases immediate corrective action is necessary until a thorough investigation has been conducted and permanent solutions can be implemented. The immediate corrective actions can, in some cases, be enough to correct the problem which eliminates the need for step 5 and 6.<ref name="MasterControl">Simplifying CAPA: Seven Steps to a Comprehensive CAPA Plan 2019 MasterControl. Link: https://www.mastercontrol.com/learning-center/capa-management/simplifying-capa-seven-steps.</ref> In other cases, it may be assessed that no action is required. If this is the conclusion, the justification must be documented.		This evaluation is used to decide the priority of the actions as well as the level of investigation. It makes it possible for management to better prioritize complaints, deviations, nonconformances, corrections, and removals.<ref name="9steps">Rodriguez, Jackelyn. CAPA in the Pharmaceutical and Biotech Industries – How to Implement an Effective Nine Step Program 2016, Woodhead publishing series in biomedicine </ref> In some cases immediate corrective action is necessary until a thorough investigation has been conducted and permanent solutions can be implemented. The immediate corrective actions can, in some cases, be enough to correct the problem which eliminates the need for step 5 and 6.<ref name="MasterControl">Simplifying CAPA: Seven Steps to a Comprehensive CAPA Plan 2019 MasterControl. Link: https://www.mastercontrol.com/learning-center/capa-management/simplifying-capa-seven-steps.</ref> In other cases, it may be assessed that no action is required. If this is the conclusion, the justification must be documented.

	[http://apppm.man.dtu.dk/index.php/Impact_and_Probability_in_Risk_Assessment Read more about impact and probability in risk assessment here.]		[http://apppm.man.dtu.dk/index.php/Impact_and_Probability_in_Risk_Assessment Read more about impact and probability in risk assessment here.]