Organizing for preventive and corrective actions

17.8 Organizing for preventive and corrective actions

Proper performance of these CAPA activities depends on the existence of a permanent core organizational unit as well as many ad hoc team partici-

preventive action pants. This nucleus, generally known as the Corrective Action Board (CAB)

committee, although it may have other titles in different organizations, pro- motes 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.

Members of the SQA unit, top-level professionals and development and maintenance department managers are the natural candidates for member- ship in a CAB committee.

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.

Most members of the CAPA ad hoc team are department members, experi- enced in the subject matter. In cases where localized knowledge is

Summary 361 Summ

(1) Explain the difference between defect correction and corrective and preventive actions.

ar

Defect correction is a limited activity directed toward immediate solution of the

defects detected in a project or a software system. ■

Corrective and preventive actions are wider in scope; they are meant to initiate and guide performance of organization-wide actions that will eliminate the causes of known or potential faults.

(2) List the main types of internal sources for CAPA processes.

There are four main information source types that support and feed CAPA processes: ■

Software development process ■

Software maintenance ■

SQA infrastructure procedures ■

Software quality management procedures.

(3) List and explain the main approaches for introduction of CAPA.

Five approaches are commonly used: ■

Updating relevant procedures. ■

Changing software development or maintenance practices and updating work instructions.

Changing current to more effective software development tools that are less prone to faults.

Improving reporting methods by revising task content and reporting frequencies. This approach is meant to achieve earlier detection of faults and thus reduce damages.

■ Initiating training, retraining and updating of staff.

(4) Explain the main CAPA follow-up tasks.

Three main follow-up tasks necessary for successful CAPA processes are: ■

Follow-up of the flow of development and maintenance CA records enables feedback regarding cases of no reporting or low-quality reporting.

Implementation follow-up determines whether a CAPA has been performed as required.

Outcomes follow-up ascertains the degree to which a CAPA has achieved the expected results.

(5) List the participants in the CAPA process and their contribution to its successful implementation.

members of targeted ad hoc CAPA teams, promoting implementation and following up the process. The ad hoc CAPA team’s task is to analyze information about a given

17 topic in addition to developing solutions and a CAPA process. The team members

C are expected to implement the CAPA and use CAB-provided assistance, if needed. orrective and

Most members of ad hoc CAPA teams are department staff members experienced in the subject matter.

Selected bibliography preventive action

1. ISO (1997) ISO 9000-3:1997(E), Quality Management and Quality Assurance Standards – Part 3: Guidelines for the Application of ISO 9001:1994 to the Development, Supply, Installation and Maintenance of Computer Software, 2nd

edn, International Organization for Standardization (ISO), Geneva. 2. ISO/IEC (2001) “ISO 9000-3:2001 Software and System Engineering – Guidelines for the Application of ISO 9001:2000 to Software, Final draft”, International Organization for Standardization (ISO), Geneva, unpublished draft, December 2001.

3. Paulk, M. C., Weber, C. V., Curtis, B. and Chrissis, M. B. (1995) The Capability Maturity Model: Guidelines for Improving the Software Process, Addison-

Wesley, Reading, MA.