29 Corrective and Preventive Actions (CAPA)

Systematic activities that implement organization-wide improvements of effectiveness and operational efficiency fall under the heading of Corrective and Preventive actions (CAPA). By promoting continuous improvement of effectiveness and efficiency, the CAPA process has become one of the main tools used to achieve the performance oriented objective of SQA. In corrective actions, a regularly applied feedback process that includes Collection of information on quality non-conformities, identification and analysis of sources of irregularities. Development and assimilation of improved practices and procedures, together with control of their implementation and measurement of their outcomes. In preventive actions a regularly applied feedback process that includes the collection of information on potential quality problems and analysis of departures from quality standards, development and assimilation of improved practices and procedures together with control of their implementation and measurement of their outcomes.

 

Successful operation of a CAPA process includes the following activities:

  • Information collection
  • Analysis of information
  • Development of solutions and improved methods
  • Implementation of improved methods
  • Follow-up.

The process is regularly fed by the flow of information from a variety of sources. In order to estimate the success of the process, a closed feedback loop is applied to control the flow of information, implementation of the resulting changes in practices and procedures together with measurement of the outcomes.

Fig 1: The corrective and preventive action process

 

The variety of information sources, internal and external, that serve the CAPA process is quite remarkable. Following this internal/external dichotomy, the four main internal sources of information are the (1) Software development process, (2) Software maintenance, (3) SQA infrastructure and (4) Software quality management procedures. The initiation of inquiries into major project failures is almost instinctive. The conclusions reached by these inquiries affect a project’s immediate environment; in many cases they also contribute to improved practices and procedures through the application of CAPA.

 

Regular operation of the CAPA process is expected to create a massive flow of documents related to a wide range of information. Analysis involves: Screening the information and identifying potential improvements: Documents received from the various sources of information are reviewed by professionals in order to identify potential opportunities for CAPA. Analysis of potential improvements: Efforts are directed to determine: – Expected types and levels of damage resulting from the identified fault. – Causes for faults. Typical causes are non-compliance with work instructions and procedures, insufficient technical knowledge, extreme time and/or budget pressures due to unrealistic estimates, and lack of experience with new development tools. Generating feedback on the content and regularity of information received from the designated information sources.

 

In the phase of development of solutions, solutions to identified causes of recurrent software systems faults are required to:

  • Eliminate recurrence of the types of faults detected

  • Contribute to improved efficiency by enabling higher productivity and shorter schedules.
  • Changes in practices, including updating of relevant work instructions (if any exist).
  • Shifting to a development tool that is more effective and less prone to the detected faults.
  • Improvement of reporting methods, including changes in report content, frequency of reporting and reporting tasks.
  • Initiatives for training, retraining or updating staff. This direction is taken only in cases when the same training deficiencies are found in several teams.

Implementation of CAPA solutions relies on proper instructions and often training but most of all on the cooperation of the relevant units and individuals. Successful implementation requires that targeted staff members be convinced of the appropriateness of the proposed solution. Three main follow-up tasks are necessary for the proper functioning of a CAPA process in any organization:

  • Follow-up of the flow of development and maintenance CAPA records
  • Follow-up of implementation
  • Follow-up of outcomes

Follow-up of the flow of development and maintenance CAPA records from the various sources of information which enables feedback that reveals cases of no reporting as well as low-quality reporting, where important details are missing or inaccurate. Conducted mainly through analysis of long-term activity information, which generates feedback to the CAPA information sources. This activity is intended to indicate whether the designated actions – training activities, replacement of development tools, procedural changes (after approval) have been performed in practice. Adequate feedback is delivered to the bodies responsible for implementation of the corrective and preventive actions. Follow-up of the improved methods’ actual outcomes enables assessment of the degree to which corrective or preventive actions have achieved the expected results. Feedback on the outcomes is delivered to the improved methods’ developers. In cases of low performance, formulation of a revised or new corrective action is needed.

 

Proper performance of these CAPA activities depends on the existence of a permanent core organizational unit generally known as Corrective Action Board (CAB). Members of the SQA unit, top-level professionals and development and maintenance department managers are the natural candidates for membership in a CAB committee. The various tasks of Corrective Action Board (CAB) includes:

  • Collecting CAPA records from the various sources Screening the collected information
  • Nominating entire adhoc CAPA teams to attend to given subjects, or heading some of the teams Promoting implementation of CAPA in units, projects, etc.

Proper performance of these CAPA activities depends on the existence of a permanent core organizational unit as well as many ad hoc team participants. This nucleus, generally known as the Corrective Action Board (CAB) committee, although it may have other titles in different organizations, promotes the CAPA cause within the organization. Its tasks include:

  • Collecting CAPA records from the various sources Screening the collected information
  • Nominating entire ad hoc CAPA teams to attend to given subjects, or heading some of the teams Promoting implementation of CAPA in units, projects, etc.
  • Following up information collection, data analysis, progress made by ad hoc teams and implementation as well as outcomes of improved CAPA methods.

A complementary group of potential participants, taken from regular staff, join CAPA efforts as members of ad hoc CAPA teams. They regularly focus on:

  • Analysis of the information related to the team’s topic
  • Initiation of additional observations and inquiries
  • Identification of the causes for the faults
  • Development of solutions and the relevant corrective and preventive actions
  • Preparation of proposed implementation revisions

Summary

 

CAPA are activities that are not intended to deal with immediate correction of detected defects, but to eliminate the causes of those defects throughout software development departments. The main types of internal sources for CAPA process, the main approaches for introduction of CAPA and the main CAPA follow–up tasks have been discussed. The participants in the CAPA process and their contributions to its successful implementation were also explained in detail.