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Corrective Action Preventive Action, otherwise known as CAPA, is an integral part of the Quality Assurance process. CAPA is a process that entails investigating problems, identifying causes, developing possible solutions to problems, and taking corrective action and preventing recurrences of the root causes. While it is crucial to not only identify problems when they occur, the problem is often just a symptom of the real issue and finding out why the symptom occurred in the first place is the basis for implementing CAPA. Source: CAPA | Corrective Action Preventive Action | Quality-One (quality-one.com)
Check out these videos to get a deeper understanding on the CAPA process and examples of correction, corrective actions, and preventative actions.
Watch the following video and answer the questions that appear. (Submit your responses at the end of the video.)
By examining Scenarios A to D (Appendix B), consider why different nonconformity examples could allow the scenario to progress from ‘no initial correction’ to ‘escalate to Phase III for corrective action.’ How might things progress if the scenario involved a shipment in a warehouse that was incorrectly placed in the wrong location?
Basic Example: The documentation requirements in a research design and development procedure were not followed. The missing documentation involves changing to a different supplier of an electronic board. The requirement is to document the supplier name and the supplier number in the research report.
Source: GHTF SG3 – Quality management system –Medical Devices – Guidance on corrective action and preventive action and related QMS processes – 4 November 2010 (imdrf.org)
No correction The decision is made Phase III (see 6.0). Required, continue measurement and monitoring not to take any correction nor escalate the handling of the nonconformity to.
| Nonconformity | The supplier number was not included in the research report. (however, the supplier name is documented). |
| Key Results of Measurement and Analysis | Analysis indicates that the procedure is adequate and well known to the us- ers of the research procedure. Following a review of the issue this appears to be a one time oversight. The intent of the requirement is for convenience only. |
| Conclusion | No initial correction – It is not necessary to update the research report, as the supplier is documented by name, hence traceability is maintained. Do not escalate to Phase III. |
Correction required, The decision is made to Phase III (see 6.0). Continue measurement and monitoring to perform a correction but not to escalate the handling of the nonconformity
| Nonconformity | The supplier name and number was not included in the research report. |
| Key Results of Measurement and Analysis | Analysis indicates that the procedure is adequate and well known to the us- ers of the research procedure. Following a review of the issue this appears to be a one time oversight. The intent of the requirement is to ensure traceability to the supplier and this could be lost if the research report is not updated. |
| Conclusion | Take an initial correction to update the research report with the supplier name and number. Do not escalate to Phase III. |
Phase III (see 6.0) to the appropriate. To perform an However, a to further investigate as a result of the analysis performed in order to determine corrective action.
| Nonconformity | The supplier name and number was not included in the research report. |
| Key Results of Measurement and Analysis | Analysis indicates that the procedure may not be adequate and it is not well know to the users of the research procedure. The issue has been identified in multiple reports. In some cases, traceability to the supplier could be established via other means, and in other cases it could not. |
| Conclusion | Take an initial correction to update the research report with the supplier name and number (in the cases where the supplier could be identified). Escalate to Phase III for corrective action. |
Escalation for The decision is made action. Therefore the further investigation under the improvement phase. that there is not enough information at this time to determine the required investigation is escalated to Phase III.
| Nonconformity | The supplier name and number was not included in the research report. |
| Key Results of Measurement and Analysis | Analysis indicates that the procedure may not be adequate and it is not well know to the users of the research procedure. The issue has been identified in multiple reports. Traceability to the supplier could not be established via other means in any of the cases. |
| Conclusion | No initial correction – The supplier is not known so an initial correction can- not be taken at this time. Escalate to Phase III for corrective action. |
Review these case studies discussed in this link: ISO 9001: Correction vs. corrective action in the QMS (advisera.com) to examine how the company uses correction and corrective action to solve their issue. Which one worked better? What might a preventative action look like?
Your company has recently completed an audit in which they found that there were incidences of nonconformity in the following areas: spoiled product, employee injury, incorrect shipment amount delivered, cluttered workplace, employee not following safety procedure, etc. Choose one (or pick one that you have noticed in your employment) and reflect on what corrective and preventative measures your company could take to rectify the area of concern.