Corrective and preventive action

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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. [1]

Contents

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.[ citation needed ]

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. [2] CAPA is a concept within good manufacturing practice (GMP), Hazard Analysis and Critical Control Points/Hazard Analysis and Risk-based Preventive Controls (HACCP/HARPC) and numerous ISO business standards. It focuses on the systematic investigation of the root causes of identified problems or identified risks 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, as well as adverse or unstable trends in product and process monitoring such as would be identified by statistical process control (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

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.

The PDCA cycle PDCA Cycle.svg
The PDCA cycle

Preventive action is any proactive method 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 (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 or other methods, e.g. an Ishikawa diagram.

Correction is the action to eliminate a detected nonconformity or nonconformance. [4]

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's code FDA 21 CFR 820.100 [5] medical device companies need to establish a CAPA process [6] 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. [7] 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. [8]

A corrective action can also be a field correction, an action taken to correct problems with non-conforming products. [9] An example is the pharmaceutical company Avanos Medical, which in 2022 conducted a voluntary field correction after reports of 60 injuries and 23 patient deaths related to misplaced nasogastric feeding tubes while using their CORTRAK* 2 Enteral Access System. [10]

The voluntary field correction led Avanos Medical to recall the product. The FDA identified it as a Class I recall, the most severe type of recall. [11]

Examples of corrective actions

In some cases, a combination of such actions may be necessary to fully correct the problem.

See also

Related Research Articles

A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction. It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both and deals with quality and sustainability and their integration.

The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) which help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. The ISO refers to the set of standards as a "family", bringing together the standard for quality management systems and a set of "supporting standards", and their presentation as a family facilitates their integrated application within an organisation. ISO 9000 deals with the fundamentals and vocabulary of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. A companion document, ISO/TS 9002, provides guidelines for the application of ISO 9001. ISO 9004 gives guidance on achieving sustained organizational success.

<span class="mw-page-title-main">Hazard analysis and critical control points</span> Systematic preventive approach to food safety

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 measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.

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, accident analysis (e.g., in aviation, rail transport, or nuclear plants), medical diagnosis, the healthcare industry (e.g., for epidemiology), etc. Root cause analysis is a form of inductive inference (first create a theory, or root, based on empirical evidence, or causes) and deductive inference (test the theory, i.e., the underlying causal mechanisms, with empirical data).

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 more specification-conforming products with less waste scrap. SPC can be applied to any process where the "conforming product" output can be measured. Key tools used in SPC include run charts, control charts, a focus on continuous improvement, and the design of experiments. An example of a process where SPC is applied is manufacturing lines.

<span class="mw-page-title-main">Good manufacturing practice</span> Manufacturing quality standards

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, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use.

<span class="mw-page-title-main">PDCA</span> Iterative design and management method used in business

PDCA or plan–do–check–act 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 circle/cycle. Another version of this PDCA cycle is OPDCA. The added "O" stands for observation or as some versions say: "Observe the current condition." This emphasis on observation and current condition has currency with the literature on lean manufacturing and the Toyota Production System. The PDCA cycle, with Ishikawa's changes, can be traced back to S. Mizuno of the Tokyo Institute of Technology in 1959.

Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control, and quality improvement. Quality management is focused both on product and service quality and the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines quality. It is a written or unwritten commitment to a known or unknown consumer in the market. Quality can be defined as how well the product performs its intended function.

Reliability engineering is a sub-discipline of systems engineering that emphasizes the ability of equipment to function without failure. Reliability is defined as the probability that a product, system, or service will perform its intended function adequately for a specified period of time, OR will operate in a defined environment without failure. Reliability is closely related to availability, which is typically described as the ability of a component or system to function at a specified moment or interval of time.

Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization's quality management system and is a key element in the ISO quality system standard, ISO 9001.

ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.

Eight Disciplines Methodology (8D) is a method or model developed at Ford Motor Company used to approach and to resolve problems, typically employed by quality engineers or other professionals. Focused on product and process improvement, its purpose is to identify, correct, and eliminate recurring problems. It establishes a permanent corrective action based on statistical analysis of the problem and on the origin of the problem by determining the root causes. Although it originally comprised eight stages, or 'disciplines', it was later augmented by an initial planning stage. 8D follows the logic of the PDCA cycle. The disciplines are:

A preventive action is a change implemented to address a weakness in a management system that is not yet responsible for causing nonconforming product or service.

In business, engineering, and manufacturing, quality – or high quality – has a pragmatic interpretation as the non-inferiority or superiority of something ; it is also defined as being suitable for the intended purpose while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace. Producers might measure the conformance quality, or degree to which the product/service was produced correctly. Support personnel may measure quality in the degree that a product is reliable, maintainable, or sustainable. In such ways, the subjectivity of quality is rendered objective via operational definitions and measured with metrics such as proxy measures.

Clinical quality management systems (CQMS) are systems used in the life sciences sector designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities, tasks, processes, quality events, relationships, audits and training that must be administered and controlled throughout the life of a clinical trial. The premise of a CQMS is to bring together the activities led by two sectors of clinical research, Clinical Quality and Clinical Operations, to facilitate cross-functional activities to improve efficiencies and transparency and to encourage the use of risk mitigation and risk management practices at the clinical study level.

PTC Windchill is a family of Product Lifecycle Management (PLM) software products that is offered by PTC. In 2004, as part of their expansion in the area of collaboration tools, they arranged having "a hosted version of Windchill to small- and medium-sized customers." As of 2011, products from its marketer, PTC, were being used by over 1.1 million users worldwide.

Continued process verification (CPV) is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits. In 2011 the Food and Drug Administration published a report outlining best practices regarding business process validation in the pharmaceutical industry. Continued process verification is outlined in this report as the third stage in Process Validation.

<span class="mw-page-title-main">A3 problem solving</span> Structured problem improvement approach

A3 problem solving is a structured problem-solving and continuous-improvement approach, first employed at Toyota and typically used by lean manufacturing practitioners. It provides a simple and strict procedure that guides problem solving by workers. The approach typically uses a single sheet of ISO A3-size paper, which is the source of its name. More contemporary versions include the Systems-oriented A3

<span class="mw-page-title-main">Hazard analysis and risk-based preventive controls</span> Food safety regulations

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.

Avanos Medical, Inc. is a medical technology company making clinical medical devices. The company consists of two franchises – Pain Management and Chronic Care – that address reducing the use of opioids while helping patients recover faster and preventing infection.

References

  1. ↑ Pruitt, W. Frazier (May 2019). "A Disciplined Approach". Quality Progress. 52 (5): 64. Retrieved 31 October 2019.
  2. ↑ ISO 9000 Quality management system - Fundamentals and vocabulary. ISO. 2005.
  3. ↑ "Taking the First Step with PDCA". 2 February 2009. Retrieved 17 March 2011.
  4. ↑ ISO 9000:2015 (3.12.3)
  5. ↑ "CFR - Code of Federal Regulations Title 21". www.accessdata.fda.gov. Retrieved 2016-05-20.
  6. ↑ "CAPA Process". 2020. Archived from the original on 2022-01-05.
  7. ↑ "Does Your CAPA Process Need a CAPA?". SOLABS. Retrieved 2016-08-29.
  8. ↑ "Guidance for Industry- Q10 Pharmaceutical Quality System" (PDF). www.fda.gov. Retrieved 2016-08-29.
  9. ↑ "Field Correction definition". lawinsider.com. Retrieved 2023-03-09.
  10. ↑ "URGENT: FIELD CORRECTION CORTRAK* 2 Enteral Access System (EAS)" (PDF). static.foxnews.com. Retrieved 2023-03-09.
  11. ↑ "Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm". fda.gov. 16 May 2022. Retrieved 2023-03-09.
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