Corrective and preventive action
Encyclopedia
Corrective action and preventive action (CAPA, also called corrective action / preventive action) are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice
(GMP). It focuses on the systematic investigation of the root causes of non-conformities in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).
Corrective actions are implemented in response to customer complaints, undesired levels of internal nonconformity, nonconformities identified during an internal audit
or adverse or unstable trends in product and process monitoring such as would be identified by SPC
. Preventive actions are implemented in response to the identification of potential sources of non-conformity.
To ensure that corrective and preventive actions are effective, the systematic investigation of the root causes of failure is pivotal. CAPA is part of the overall quality management system
(QMS).
A common misconception is that the purpose of preventive action is to avert the occurrence of a similar potential problem. This process is all part of corrective action, because it is a process of determining such similarities that should take place in the event of a discrepancy.
Preventive action is any proactive methodology used to determine potential discrepancies before they occur and to ensure that they do not happen (thereby including, for example, preventive maintenance, management review or other common forms of risk aversion). Corrective and preventive actions both include investigation, action, review, and further action if so required. It can be seen that both fit into the PDCA
(plan-do-check-act) philosophy as determined by the Deming-Shewhart cycle.
Investigations to root cause may conclude that no corrective or preventive actions are required, and additionally may suggest simple corrections to a problem with no identified systemic root cause. When multiple investigations end in no corrective action, a new problem statement with expanded scope may be generated, and a more thorough investigation to root cause performed.
Implementation of Corrective & preventive actions is the path towards improvement & effectiveness of Quality Management system. Corrective actions is nothing but the action/s based on the problem identification. The problem or a non-conformance can be identified internally through staff suggestions, management reviews, document reviews or internal audits. Customer complaints / suggestions, customer rejections, non-conformities raised in customer / third party audits & recommendations by the auditors are the external sources which lead to find the ROOT CAUSE of the problem.
Corrective action is a reaction to any of the cause/non-conformance mentioned above & can be divided in two phases of action:
1) Identification of root cause: for this purpose TQM tools such as fish-bone or cause & effects analysis can be practiced. Your CAPA would be appropriate & effective if & only if you have identified the root cause of problem.
2) Taking necessary actions: in order to address the root cause take necessary immediate action/s. The effectiveness of the corrective action taken has to be verified periodically through a systematic approach of PDCA
(Plan - Do - Check - Act) cycle.
Preventive action is prediction of problem & trying to avoid the occurrence (fail safe) through self initiated action/s & analysis related with your processes / products. This can be initiated with the help of active participation of staff members / workers through improvement teams, improvement meetings, management review, customer feedback & deciding own goals quantized in terms of business growth, reducing rejections, utilizing the equipments effectively etc.
In some cases a combination of such actions may be necessary to fully correct the problem.
Good Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
(GMP). It focuses on the systematic investigation of the root causes of non-conformities in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).
Corrective actions are implemented in response to customer complaints, undesired levels of internal nonconformity, nonconformities identified during an internal audit
Internal audit
Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organization's operations. It helps an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk...
or adverse or unstable trends in product and process monitoring such as would be identified by SPC
SPC
SPC may refer to any of the following:in business and law,* Segregated portfolio company, a specialised form of offshore company* Special purpose company or Special purpose vehicle, a subsidiary usually created solely for isolating a financial risk, or for Financial Reporting reasons* Strategic...
. Preventive actions are implemented in response to the identification of potential sources of non-conformity.
To ensure that corrective and preventive actions are effective, the systematic investigation of the root causes of failure is pivotal. CAPA is part of the overall quality management system
Quality management system
A quality management system can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management.-Elements of a Quality Management System:# Organizational structure# Responsibilities# Methods...
(QMS).
Concepts
- Clearly identified sources of data which identify problems that will be investigated.
- Root cause analysisRoot cause analysisRoot cause analysis is a class of problem solving methods aimed at identifying the root causes of problems or events.Root Cause Analysis is any structured approach to identifying the factors that resulted in the nature, the magnitude, the location, and the timing of the harmful outcomes of one...
to identify the cause of a discrepancy or deviation and suggest corrective actions to potentially prevent recurrence of a similar problem, or preventive action to ensure that discrepancies do not occur. - Remedial corrections of a problem which is identified.
A common misconception is that the purpose of preventive action is to avert the occurrence of a similar potential problem. This process is all part of corrective action, because it is a process of determining such similarities that should take place in the event of a discrepancy.
Preventive action is any proactive methodology used to determine potential discrepancies before they occur and to ensure that they do not happen (thereby including, for example, preventive maintenance, management review or other common forms of risk aversion). Corrective and preventive actions both include investigation, action, review, and further action if so required. It can be seen that both fit into the PDCA
PDCA
PDCA is an iterative four-step management method used in business for the control and continuous improvement of processes and products...
(plan-do-check-act) philosophy as determined by the Deming-Shewhart cycle.
Investigations to root cause may conclude that no corrective or preventive actions are required, and additionally may suggest simple corrections to a problem with no identified systemic root cause. When multiple investigations end in no corrective action, a new problem statement with expanded scope may be generated, and a more thorough investigation to root cause performed.
Implementation of Corrective & preventive actions is the path towards improvement & effectiveness of Quality Management system. Corrective actions is nothing but the action/s based on the problem identification. The problem or a non-conformance can be identified internally through staff suggestions, management reviews, document reviews or internal audits. Customer complaints / suggestions, customer rejections, non-conformities raised in customer / third party audits & recommendations by the auditors are the external sources which lead to find the ROOT CAUSE of the problem.
Corrective action is a reaction to any of the cause/non-conformance mentioned above & can be divided in two phases of action:
1) Identification of root cause: for this purpose TQM tools such as fish-bone or cause & effects analysis can be practiced. Your CAPA would be appropriate & effective if & only if you have identified the root cause of problem.
2) Taking necessary actions: in order to address the root cause take necessary immediate action/s. The effectiveness of the corrective action taken has to be verified periodically through a systematic approach of PDCA
PDCA
PDCA is an iterative four-step management method used in business for the control and continuous improvement of processes and products...
(Plan - Do - Check - Act) cycle.
Preventive action is prediction of problem & trying to avoid the occurrence (fail safe) through self initiated action/s & analysis related with your processes / products. This can be initiated with the help of active participation of staff members / workers through improvement teams, improvement meetings, management review, customer feedback & deciding own goals quantized in terms of business growth, reducing rejections, utilizing the equipments effectively etc.
Examples of corrective actions
- Error Proofing (Poka yoke)
- Visible or Audible Alarms
- Process Redesign
- Product Redesign
- TrainingTrainingThe term training refers to the acquisition of knowledge, skills, and competencies as a result of the teaching of vocational or practical skills and knowledge that relate to specific useful competencies. It forms the core of apprenticeships and provides the backbone of content at institutes of...
or enhancement/ modification of existing training programmes - Improvements to maintenancePreventive maintenancePreventive maintenance has the following meanings:#The care and servicing by personnel for the purpose of maintaining equipment and facilities in satisfactory operating condition by providing for systematic inspection, detection, and correction of incipient failures either before they occur or...
schedules - Improvements to material handling or storage
In some cases a combination of such actions may be necessary to fully correct the problem.
External links
- Good Manufacturing Practices for Pharmaceutical Ingredients (ICH)
- Quality Systems Approach to Pharmaceutical CGMP Regulations (FDA)
- Current Pharmaceutical links (FDA)
- Good Automated Manufacturing Practice (GAMP)
- http://qmrs.com/work/services/4%20GDPs%20new.htm
- Quality management system –Medical Devices – Guidance on corrective action and preventive action and related QMS processes