Information & Training. | Quality Assurance. Quality Management.
Supplier Corrective and Preventative Action (CAPA).
Problems can arise with suppliers not meeting performance expectations. In such situations it is critical that an efficient, effective Supplier Corrective and Preventative Action process is in place to identify the non-conformance, to address any immediate impacts of the non-conformance, to commence a process to investigate and understand the reason for the non-conformance and to agree appropriate actions to correct and to prevent any repetition.Outsourced operations are an extension of an organization’s Quality System. Defective product or services from suppliers that result in adulterated / misbranded products become the responsibility of the (purchasing) manufacturer by default. For example:
– The name of the final manufacturer / service provide, not the sub-suppliers will be in the mind of the end customer. Hence potential reputation damage.
– Where there is regulatory oversight, the final manufacturer, will need to address regulatory agency concerns.
– Corrections and removals may be required to address a risk to customers or users.
– Recall actions may be necessary to address volatile product remaining on the market.
Supplier Quality Assurance
Audits & Auditing
Etc. …. Etc. …. Etc. …
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Consequences such as the above can have very serious long term impacts, therefore, the corrective and preventative action process must be comprehensive, truly identify root causes and permanently address.
When a non-conformance to requirements arises, appropriate and timely corrective action is required by all parties. The non-conformity must be fully evaluated, a corrective action plan needs to be initiated, detailing the range of tasks and actions to be performed, detailing responsibilities and all performed in accordance with pre-defined and approved documented procedures.
There is a need to work collaboratively with suppliers if they are involved and to provide on-going, timely feedback to the supplier if the supplier is not directly involved in the CAPA investigation.
Pending completion of the Supplier Corrective and Preventative Action (CAPA) process, questions such as the need to implement a “Ship hold” must be asked, do regulators, customers or product distributions need to be informed, should alternative sources of supply be identified, etc..
Information & Training. | Quality Assurance. Quality Management.
- The Principles of Quality Management
- The Quality Manual
- Quality Standards and Specifications
- The Quality Management System
- Revised requirements of ISO 9001: 2015
- Design Quality – Products & Processes
- Good Manufacturing Practice (GMP)
- Documentation
- CAPA – Corrective And Preventative Action
- Calibration Certification
- Change Management and Control
- Quality Management Training
- Product and Process Validation
- Supplier Quality Assurance
- Audits & Auditing
- Ensuring the Quality Management System is Risk based
- Etc. …. Etc. …. Etc. …
- Information & Training presentation >>>