Audit NC - Lack of Effective Corrective Action Process

[lamorenita_QA]

Hello, I need advice regarding an up coming re-certification audit to ISO 13485:2003 9001:2008. A finding was issued during our surveillance audit 'the corrective action process is not sufficiently effective'. I have concerns that our corrective action plan is not effective. This is the second time our registrar issued this finding. specifically our root cause analysis is and long term corrective/preventive action is weak. would there be a possibility that we may receive a 'major' nonconformity from our registrar?

[Sidney Vianna]

In Reply to Parent Post by lamorenita_QA

would there be a possibility that we may receive a 'major' nonconformity from our registrar?

Yes, it is possible/likely that the CB auditor will escalate the issue to a major nonconformity, for lack of proper corrective action.

This does not mean necessarily that your certificate will be suspended nor revoked, but effective root cause analysis and proper corrective action must be performed. Since you mentioned ISO 13485, this applies to medical devices (and it's supply chain), so we are talking about products that have a degree of criticality, thus the need for a robust QMS. According to the IAF Mandatory Document for the Application of ISO/IEC 17021 in Medical Device Quality Management Systems (ISO 13485) the CB could even perform unannounced/short-notice audits if they believe your corrective action system is (as you self admitted) weak.

PS I moved the post from it's original location to the ISO 13485 forum for better addressing.

[lamorenita_QA]

In Reply to Parent Post by Sidney Vianna

Yes, it is possible/likely that the CB auditor will escalate the issue to a major nonconformity, for lack of proper corrective action.

This does not mean necessarily that your certificate will be suspended nor revoked, but effective root cause analysis and proper corrective action must be performed. Since you mentioned ISO 13485, this applies to medical devices (and it's supply chain), so we are talking about products that have a degree of criticality, thus the need for a robust QMS.

PS I moved the post from it's original location to the ISO 13485 forum for better addressing.

Thx!, I appreciate your feedback response. root cause analysis has been provided to key Mgrs. regarding effective root cause analysis, corrective preventive action. But, the Mgrs responsible for this implementation of training deem this too hard, and time consuming. They are using and approving the CAPA reporting process as a quick fix, which is why repeat nonconformances are occuring. do you have a suggestion for a plan to improve this system?

[Sidney Vianna]

In Reply to Parent Post by lamorenita_QA

do you have a suggestion for a plan to improve this system?

If the organization top management does not see a problem with repeat problems and the subsequent financial drain, including loss of customer satisfaction, it is very hard for you to be able to implement the cultural shift your organization apparently needs.

I always find amusing how the people who complain that the "complex" solutions necessary to prevent fires/crises are too time consuming, always find the time necessary to fight fires/crises that they did not prevent, with the additional aggravation of having upset some customers along the way.

[Ajit Basrur]

In Reply to Parent Post by lamorenita_QA

Thx!, I appreciate your feedback response. root cause analysis has been provided to key Mgrs. regarding effective root cause analysis, corrective preventive action. But, the Mgrs responsible for this implementation of training deem this too hard, and time consuming. They are using and approving the CAPA reporting process as a quick fix, which is why repeat nonconformances are occuring. do you have a suggestion for a plan to improve this system?

You need to have a robust Root Cause Analysis system in place to address CA and PA. This could be also taken as part of the Management Review meeting to get the Management buy-in.