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Determining Adverse Effects of Corrective/Preventive Actions

#1
Per ISO 13485:2016, I am trying to incorporate a process for determination of adverse effects incurred from Corrective/Preventive Actions. I have two questions.

1) Should determination of adverse effects be documented while determining which corrective/preventive actions to take, or should it be documented after the actions are in place? Maybe both? I could see an auditor wanting me to consider and document determination of adverse effects before corrective/preventive actions are decided on, but I could also see an auditor wanting to see documented determination of adverse effects during effectiveness review when the corrective/preventive actions are already in place. Should I do both?

2) Adverse effects are always on the mind of our Quality team so I am not really worried about us forgetting to think about adverse effects when determining actions to take. Obviously though, determination of adverse effects needs documented somewhere for CAPA's. With that being said, does anyone have any suggestions or examples of a simple standard for reviewing and documenting adverse effects? I want something that won't take a lot of time to complete, but will address and provide documentation for determining adverse effects from corrective/preventive actions.
 
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Tagin

Trusted Information Resource
#2
1) Strictly speaking, it says "verifying that the action does not adversely...", which would probably indicate -after-the-fact. However, I think it should also be considered (and mentioned) as part of "planning and documenting action needed..."

2) Maybe if you can adjust your form accordingly, you could explicitly list the 3 areas related to adverse effects. E.g.
Will the planned corrective/preventative action adversely affect the medical device's:
  • Regulatory requirements
  • Safety
  • Performance
and in the verification/effectiveness:

Did the implemented corrective/preventative action adversely affect the medical device's:
  • Regulatory requirements
  • Safety
  • Performance
 

somashekar

Staff member
Super Moderator
#3
Per ISO 13485:2016, I am trying to incorporate a process for determination of adverse effects incurred from Corrective/Preventive Actions. I have two questions.

1) Should determination of adverse effects be documented while determining which corrective/preventive actions to take, or should it be documented after the actions are in place? Maybe both? I could see an auditor wanting me to consider and document determination of adverse effects before corrective/preventive actions are decided on, but I could also see an auditor wanting to see documented determination of adverse effects during effectiveness review when the corrective/preventive actions are already in place. Should I do both?

2) Adverse effects are always on the mind of our Quality team so I am not really worried about us forgetting to think about adverse effects when determining actions to take. Obviously though, determination of adverse effects needs documented somewhere for CAPA's. With that being said, does anyone have any suggestions or examples of a simple standard for reviewing and documenting adverse effects? I want something that won't take a lot of time to complete, but will address and provide documentation for determining adverse effects from corrective/preventive actions.
Are you over thinking .....perhaps yes.
When you determine the corrective action after your root cause analysis, your focus will be on eliminating the root cause. At this instance, you are required to also see outward if any adverse affects could occur due to your corrective action changes upon the safety and performance of your medical device, as well as on the meeting of the applicable regulatory requirements.
With experience and with suitable team work you will begin to evalute your corrective action concurently addressing these areas of your medical device. Its a alert here to make sure that your corrective actions are not taken in isolation without looking into the regulatory requirements, safety requirements and performance requirements of your medical device.
Do this for the purpose of your medical device safety and performance as a discipline. Involve your regulatory affairs team / lead to assess from the regulatory angle. Do not look at any situation from the auditor view point, but approch from the standards intent. You will be good.
 
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