8D Report for customer complaints (ISO 13485 and FDA QSR)

[perinad]

Hi all,

I do have a question. When doing 8D reports because of customer complaint, as supplier, if I implement corrective actions and not only corrections am I am implcitiy falling into the CAPA process all the time or could I have situations where I drive a corrective actions in the complaint process till they are effective and only escalate certain issues and their related corrective actions to CAPAs and therefore I will have to seperate processes?

Best Regards

Davide

 

[Bev D]

Why wouldn’t you want to follow a Corrective Action process? Essentially, if you are responding to a quality problem (customer complaint or other source) with an investigation to determine cause and implementing corrective action to eliminate that cause (or that cause’s effect) you are following a corrective process regardless of what you call it.

In one organization where I worked, we did as you say. Only those investigations and corrective actions requested by QA were called “corrective actions”. The actions taken to reduce or eliminate defects, failures and customer complaints were called “problem solving projects”. This was because teh QA organization at that time only issued “CARs” due to audit findings; they wanted resolution in 30 days and would drive to silly solutions to meet them. They were not expert problem solvers. Eventually we changed the QA mindset and process and all problem solving was done under an organization issued CAR. This was done to properly prioritize and resource and manage and coach teh problem solving process.

Short answer: if you are going to have a an ‘official’ corrective action process and a shadow corrective action process that is a sign of something that is wrong with your ‘official’ corrective action process.

 

[perinad]

Thank you. I asked this question for a reason, to me in medical devices CAPAs are big projects that are lasting maybe 6 months. But if I implement for example a corrective action to update a work instruction or if as a corrective action I retrain the staff, I will not open a CAPA project, going through a board etc. for those type of corrective actions, I will implement it,, verify it is implemented and that it is effective. Nothing more. This is the reason why I wanted to know a bit more about the experience of others. I am not thinking about shadow processes but a way not to overload the system where everything is a CAPA

 

[Bev D]

OK. What you describe is more like continual improvement or simple corrections. In the examples sited you have not truly done a “root cause investigation” but rather implemented a quick solution…

As a note a “corrective action” may be a short or a long term effort. They are not always ‘big’. What differentiates a corrective action from other activity is the investigation as to cause and implementing a solution that prevents the re-occurrence of the cause or the effect of the cause/problem.

By the way CAPA is a nonsensical acronym. Corrective Action and Preventive Action are two separate and distinct things as defined by the standards…