Software Testing and

Quality Assurance
Unit 5
Session 3
 Objectives

After completing this session , you will be able to:

 Explain the difference between defect correction and corrective and

preventive actions.

 List the main types of internal sources for CAPA process.

 List and explain the main approaches for introduction of CAPA.

 Explain the main CAPA follow–up tasks.

 List the participants in the CAPA process and their contributions to its
successful implementation.
Corrective and preventive
actions
Corrective and preventive actions – definitions

• Corrective actions:

• A regularly applied feedback process that includes collection of information on quality

non-conformities, identification and analysis of sources of irregularities as well as
development and assimilation of improved practices and procedures, together with
control of their implementation and measurement of their outcomes.

• Preventive actions:

• A regularly applied feedback process that includes collection of information on potential

quality problems, identification 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
The corrective and preventive actions process

• 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.
Figure : The corrective and preventive action process
Information collection
• Internal information sources
• Software development process
■ Software risk management reports
■ Design review reports
■ Inspection reports
■ Walkthrough reports
■ Experts’ opinion reports
■ Test reviews
■ Special reports on development failures and successes
■ Proposals suggested by staff members.
• Software maintenance
■ Customer applications statistics
■ Software change requests initiated by customer applications
■ Software change requests initiated by maintenance staff
■ Special reports on maintenance failures and successes
■ Proposals suggested by staff members.
• SQA infrastructure class of sources
■ Internal quality audit reports
■ External quality audit reports
■ Performance follow-up of trained and certified staff
■ Proposals suggested by staff members.
• Software quality management procedures class of sources
■ Project progress reports
■ Software quality metrics reports
■ Software quality cost reports
■ Proposals of staff members.

• External information sources

■ Customer complaints
■ Customer service statistics
■ Customer-suggested proposals.
Analysis of collected information
• 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
• This stage includes comparison of documents of the same type received from various
units as well as comparison of documents of different types related to the same case.
■ 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.
 Estimates of the extent of organization-wide potential faults of each type.
• This information is needed to estimate the total damage expected and to determine the
priority of each fault case.
■ Generating feedback
• on the content and regularity of information received from the designated information
sources.
Development of solutions and their implementation

• 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.
• Several directions for solutions are commonly taken:
■ Updating relevant procedures. Changes may refer to a spectrum of procedures, from
those related to specific stages of software development or maintenance (e.g., changes in
style of software comments, changes of contract review procedure in clauses dealing with
proposals for small projects) to procedures of a general nature (e.g. changes of employee
recruitment procedures, changes of the maximum and minimum number of participants in
a formal design review).
.
■ 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.
• This direction is expected to improve prospects for identification of software system faults
and their earlier detection, both resulting in substantial reductions in damages.
■ Initiatives for training, retraining or updating staff.
• This direction is taken only in cases when the same training deficiencies are found in
several teams. It is worth noting that:
■ In many cases, the recommended solutions combine several action items, from one or
several directions.
■ Changing and updating of procedures and work instructions need to be discussed and
approved by the bodies assigned to their development and maintenance
• Returning to our example, the “3S” case displays six instances of CAPA:
■ Updating of existing procedure
■ Replacement of development tools of low efficiency and effectiveness by better tool
■ Improvement in the operation of SQA infrastructure tools
Implementation of a CAPA process

• Implementation of CAPA solutions relies on proper instructions and often training but most
of all on the cooperation of the relevant units and individuals.

• Therefore, successful implementation requires that targeted staff members be convinced

of the appropriateness of the proposed solution.

• Without cooperation, the contribution of a CAPA can be undermined

Follow-up of activities
• Three main follow-up tasks are necessary for the proper functioning of a corrective and
preventive action process in any organization:
■ Follow-up of the flow of development and maintenance CAPA records
• from the various sources of information.
• This enables feedback that reveals cases of no reporting as well as low-quality reporting,
where important details are missing or inaccurate.
• This type of follow-up is conducted mainly through analysis of long-term activity
information, which generates feedback to the CAPA information sources.
• ■ Follow-up of implementation. 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 outcomes. Follow-up of the improved methods’ actual outcomes,

• as observed by project teams and organizational units, 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,

a task undertaken by the CAPA team.
Organizing for preventive and corrective actions

• Corrective Action Board (CAB) committee 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

■ Analysis of the CAPA implementation outcomes and CAPA revision if necessary.

Summary

• The difference between defect correction and corrective and preventive Actions.

•The main types of internal sources for CAPA Processes.

•The main approaches for introduction of CAPA.

•The main CAPA follow-up tasks.

•The participants in the CAPA process and their contribution to its successful
Implementation.
Thank You!