Corrective and preventive action (CAPA or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of
non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or systems to rectify and eliminate recurring non-conformance. Non-conformance is identified after systematic evaluation and analysis of the root cause of the non-conformance. Non-conformance may be a market complaint or customer complaint or failure of machinery or a quality management system, or misinterpretation of written instructions to carry out work. The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of non-conformance. It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation. The
Eight disciplines problem solving method, or 8D framework, can be used as an effective method of structuring a CAPA.
Corrective action: Action taken to eliminate the causes of non-conformities or other undesirable situations, so as to prevent recurrence.
Preventive action: Action taken to prevent the occurrence of such non-conformities, generally as a result of a risk analysis.
In certain markets and industries, CAPA may be required as part of the quality management system, such as the Medical Devices and Pharmaceutical industries in the United States. In this case, failure to adhere to proper CAPA handling is considered a violation of US Federal regulations on good manufacturing practices. As a consequence, a medicine or medical device can be termed as adulterated or substandard if the company has failed to investigate, record and analyze the root cause of a non-conformance, and failed to design and implement an effective CAPA.
CAPA is used to bring about improvements to an organization's processes, and is often undertaken to eliminate causes of non-conformities or other undesirable situations.
CAPA is a concept within
good manufacturing practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceut ...
(GMP),
Hazard Analysis and Critical Control Points
Hazard analysis and critical control points, or HACCP (), is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs mea ...
/
Hazard Analysis and Risk-based Preventive Controls
Hazard analysis and risk-based preventive controls or HARPC is a successor to the Hazard analysis and critical control points (HACCP) food safety system, mandated in the United States by the FDA Food Safety Modernization Act (FSMA) of 2010.
Pre ...
(
HACCP
Hazard analysis and critical control points, or HACCP (), is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs mea ...
/
HARPC) and numerous
ISO
ISO is the most common abbreviation for the International Organization for Standardization.
ISO or Iso may also refer to: Business and finance
* Iso (supermarket), a chain of Danish supermarkets incorporated into the SuperBest chain in 2007
* Iso ...
business standards. It focuses on the systematic investigation of the
root causes of identified problems or identified
risks
In simple terms, risk is the possibility of something bad happening. Risk involves uncertainty about the effects/implications of an activity with respect to something that humans value (such as health, well-being, wealth, property or the environme ...
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, unacceptable levels of product non-conformance, issues identified during an
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 ...
, as well as adverse or unstable trends in product and process monitoring such as would be identified by
statistical process control
Statistical process control (SPC) or statistical quality control (SQC) is the application of statistical methods to monitor and control the quality of a production process. This helps to ensure that the process operates efficiently, producing ...
(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).
Concepts
* Clearly identified sources of data that identify problems to investigate
*
Root cause analysis
In science and engineering, root cause analysis (RCA) is a method of problem solving used for identifying the root causes of faults or problems. It is widely used in IT operations, manufacturing, telecommunications, industrial process control ...
that identifies the cause of a discrepancy or deviation, and suggest corrective actions
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 avoidance). Corrective and preventive actions include stages for investigation, action, review, and further action is required. It can be seen that both fit into the
PDCA
PDCA (plan–do–check–act or plan–do–check–adjust) is an iterative design and management method used in business for the control and continual improvement of processes and products. It is also known as the Shewhart cycle, or the control ...
(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 and preventive actions is the path towards improvement and effectiveness of Quality Management Systems. Corrective actions are nothing but actions based on problem identification. The problem or a non-conformance can be identified internally through staff suggestions, management reviews, document reviews or internal audits. External leads to finding the root cause of the problem can include Customer complaints and suggestions; customer rejections; non-conformities raised in customer or third-party audits; recommendations by auditors.
A root cause is the identification and investigation of the source of the problem where the person(s), system, process, or external factor is identified as the cause of the nonconformity. The root cause analysis can be done via
5 Whys
Five whys (or 5 whys) is an iterative interrogative technique used to explore the cause-and-effect relationships underlying a particular problem. The primary goal of the technique is to determine the root cause of a defect or problem by repeating ...
or other methods, e.g. an
Ishikawa diagram
Ishikawa diagrams (also called fishbone diagrams, herringbone diagrams, cause-and-effect diagrams) are causal diagrams created by Kaoru Ishikawa that show the potential causes of a specific event.
Common uses of the Ishikawa diagram are product ...
.
Correction is the action to eliminate a detected nonconformity or nonconformance.
Preventive action includes the prediction of problems and attempts to avoid such occurrences (fail-safe) through self-initiated actions and analysis related to the processes or products. This can be initiated with the help of active participation by staff members and workers through improvement teams, improvement meetings, opportunities for improvement during internal audits, management review, customer feedback and deciding own goals quantized in terms of business growth, reducing rejections, utilizing the equipment effectively, etc.
Medical devices and FDA compliance
To comply with the United States
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
's code FDA 21 CFR 820.100 medical device companies need to establish a CAPA process
within their QMS. This part of the system may be paper or digital, but it is something that is looked for during an FDA visit. In 2015 there were over 450 issues found with the CAPA systems for medical device companies. To have an FDA-compliant QMS system required the ability to capture, review, approve, control, and retrieve closed-loop processes.
Examples of corrective actions
*Error Proofing
*Visible or Audible Alarms
*Process Redesign
*Product Redesign
* Define and Implement Action Plan
*
Training
Training is teaching, or developing in oneself or others, any skills and knowledge or fitness that relate to specific useful competencies. Training has specific goals of improving one's capability, capacity, productivity and performance. I ...
or enhancement or modification of existing training programs
*Improvements to
maintenance
Maintenance may refer to:
Biological science
* Maintenance of an organism
* Maintenance respiration
Non-technical maintenance
* Alimony, also called ''maintenance'' in British English
* Champerty and maintenance, two related legal doct ...
schedules
*Improvements to material handling or storage
In some cases, a combination of such actions may be necessary to fully correct the problem.
See also
*
Eight disciplines problem solving
*
Good documentation practice
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by ...
*
Good automated manufacturing practice
Good automated manufacturing practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry ...
(GAMP)
References
{{Reflist
External links
Quality Systems Approach to Pharmaceutical CGMP Regulations(FDA)
ISO standards
Pharmaceutical industry
Quality management
Change management
Prevention