Corrective and Preventive Actions CAPA

The relationship between the main subsystems and other minor systems is illustrated schematically in Figure 12.4. This places management at the core of the quality system, with the other systems arranged as major and minor satellites that revolve around it. This perspective provides the basis for the Quality System Inspection Technique (QSIT), which the FDA uses for auditing medical device facilities. This is based on a top-down approach, which starts with management controls and then looks at three other key subsystems of Design Controls, Corrective and Preventative Actions (CAPA) and Production and Process Controls. The belief is that by focussing on just these four subsystems, you will actually touch on all the other subsystems and obtain a sufficiently satisfactory overview of the state of compliance of the facility. 

Corrective and Preventative Action (CAPA) This is a regulatory concept that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. This model separates CAPA into three separate concepts ... 

Corrective and preventive action (CAPA) is the term commonly used to describe the subsystem of a comprehensive quality system that deals with the systematic investigation, understanding, and response to quality issues including nonconformities. A corrective or preventive action may be initiated based on review and analysis of quality data from a variety of sources including adverse experiences, product complaints, quality audits, FDA inspections, third-party inspections, nonconforming materials reports, process control information, trend analyses, and other sources. 

Manufacturing Deviation Trends and Corrective and Preventative Actions (CAPA)... 

The firm failed to establish and maintain procedures for implementing corrective and preventive action (CAPA), as evidenced by some events not included, long delays in entry of events, no assurance that affected products were quarantined, lack of central log for all CAPAs, and no tracking or trending reports to management. 

For medical devices, inspectors expect to see a process improvement program in place encompassing all activities within the supply chain, including the systems that support it. Activities that would provide evidence that such a program is in place include the implementation of documented processes such as Corrective and Preventative Action (CAPA), self-inspection, and internal audits." Organizations should ensure that where an SOP has been put in place to initiate a process improvement activity, the SOP is adhered to. For example, if a quality audit SOP states that all areas shall be subject to audit at least once every 2 years, then inspectors will expect to see evidence that this has been the case. Failure to do so is likely to result in a citation similar to that issued to Krieger Medical, Inc. ... 

The Quality Management department is expected to carry out regular target-performance comparisons of specifications and requirements, document the evaluations, and provide management with information on the results. For all possible discrepancies from the desired state, for example, complaints, results out of specification (OOS), changes, deviations, and audit results (internal and external audits), the appendant information are collected centrally and processed by means of the Corrective And Preventive Action (CAPA) system. These monitoring and control functions are performed by the staff of quality management. 

All SOPs on the topics "change control" (Change Control), "deviations", "results out of specification" (OOS), "corrective and preventive actions" (CAPA), as well as "training" are updated, valid and trained. 

Subsequently, system control was introduced, through defining preconditions for the prime processes, such as well-trained personnel, adequate premises and equipment. Continuous improvement was going to be supported by, among others. Root Case Analyses and Systems for Corrective and Preventive Actions (CAPA). The need was recognised of structured decisions based on (Quality Risk Management (see Chap. 21). 

Sec. 820.100 Corrective and preventative action - Implement Corrective Action, Preventative Action (CAPA) procedures, incorporating root cause investigation... 

A corrective action is initiated to correct the cause of an identified nonconformity and to prevent it or similar problems from reoccurring. It may include initial and follow-up actions (e.g., conducted after root cause analysis). Current quality system models and the cGMP regulations emphasize corrective actions and require that actions be documented. Under current quality system models, preventive actions include actions taken in response to quality data to address the cause of potential nonconformities to prevent their occurrence. An effective CAPA system therefore includes both reactive and proactive components. The effectiveness of corrective and preventive actions should be evaluated using objective criteria when possible and the evaluation documented. 

A firm s CAPA system and processes should be designed to analyze and respond to quality issues in a systematic way that is commensurate with the risk. The system should provide for the verification or validation of corrective and preventive actions to assure their effectiveness and to assure that actions do not adversely affect the finished product. The system should also assure that pertinent CAPA information is appropriately disseminated throughout the organization as necessary to assure the effective operation of the quality system and for management review. 

There is no formal system to ensure that corrective and preventative measures resulting from OOS investigations are carried out. There is no written procedure assigning specific roles and responsibilities to designated personnel. There was no documented evidence that the CAPA (Corrective and Preventative Actions) was actually implemented. 

When corrective and preventative actions are consistently minimalist and not concise, the results will eventually be reflected in product quality and in the firm s compliance status. Additionally, many problem, can arise when corrective and preventative actions are installed and presumed to be absolute without a short-and long-term assessment of the action. It is important not to assume that the CAPA installed today is necessarily the best practice or solution over the long haul. A long-term review of the CAPA will be the best indicator of its long-term viability. 

Deviation from a stability protocol can occur throughout the study. There are two forms of deviations planned and unplanned. Once a deviation occurs, an investigation must be conducted. Corrective actions and preventive actions (CAPA) may also be necessary to avoid recurrence. The impact of the deviation on the study must also be assessed and documented. 

In concert with the FDA s QSR, the international device community embraced a similar international standard known as ISO 13485 2003. This version of the standard, and the more current version ISO 13485 2012, like the QSR, put the emphasis on design controls. In both systems, the management of the company is held responsible for reviewing products and ensuring they are made according to a sound quality system. Despite international efforts to harmonize these standards and make their implementation as straightforward as possible, medical device manufacturers continue to recall products due to malfunctions and defects. But because of the system known as CAPA (Corrective and Preventative Actions) most medical devices are clean, safe and perform as intended. 

All process deviations whether planned or unplanned, together with errors and out of specification results should be recorded with a controlled form or electronically onto a database system. Whether a paper system or an electronic system this needs to facilitate the management of the investigation stage, including root cause analysis where necessary, corrective and preventative actions and close out, as well as the data being available for trending (CAPA-system). This is an important part of any Pharmaceutical Quality System, see Sect. 35.6.15. 

The way in which Root Cause Analysis (RCA) and a Corrective and preventive action system (CAPA) can be used to improve quality is given by the statement from GMP Chap. 1 Pharmaceutical quality system ... 

For the structured over-all analysis of deviations the Corrective And Preventive Action system (CAPA system) can be used. This system means to document, analyse, solve, and if possible prevent all problems and deviatiOTis. It uses data from other quaUty assurance systems, such as complaints, deviations, recalls, out of trend (OOT) and out of specifications (OOS) data, notices from internal and external audits. By combining aU these data in mie system, a better overview of confounding factors is obtained, which enables an organisation to address problems structurally and prevent recurrence. 

The chamber has malfunctioned and has been repaired. The Corrective Action/Preventative Action (CAPA) might result in a limited requalification. 

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