How to measure CAPA (Corrective Action Preventive Action) System Performance

[Sandra Gauvin]

Chris,
I agree with you....nice post.

Sandra

 

[QA Memphis]

Great reply!....I feel that we are consistently monitoring our processes.

 

[Sardokar]

can u clarify the following areas? ( maybe by giving an example)

Source of issue
Type of issue (general category)
Quality System element
Specific processes
Cause (general category)

 

[SpongeMouse]

same as ours:

• quantity of NC
• recurrence of NC
• type of NC/complaints (product/services - depts etc)
• lenght of NC (these are usually classified due to lenght of time & classifications of NC)
• location of NC (mfg or services)
• others (ex. customer supplied matierials or internal materials)

 

[aJerry4u]

So many thanks for Chris Ford.

My Boss asked me to check the effectiveness of our CAPA system of a Pvt. Cancer Hospital in Pakistan and Answer that in a single Yes:NO. I am pretty much confused before reading this post. Now I have at least a direction to some extent. It would be great if someone please guide me how to analyze the data of customer/ patient complaints.

Major Categories include:

• Delay in Service
• Attitude & Behavior
• Management Policy
• Communication Gap
• Non-Conformance
• etc

There are almost 100 complaints a year on average,

Please note that I am a newbie to this field.

Thanks again for your help

aJerry4u

 

[Raffy]

Hi Sandra & Chris,
Thanks for sharing... I agree to both of you.
best regards,
raffy

 

[KarenKH]

Hi everyone,
I too want to say Thanks to Sandra and Chris.

 

[Sidney Vianna]

I too want to say Thanks to Sandra and Chris.

The easiest way is to use the button at the end of each post.

 

[cutievampire - 2011]

Hi Chris,
do you have any criteria that trigger CAPA in your organization?
is receiving a major complaints will trigger as a CAPA or any 2 or 3 consecutive findings during internal audit will trigger capa?
im actually determining what's the best criteria that will trgigger to have a CAPA coz we will going to implement this to our system and that everyone will be aware that we have criteria to be followed for us or any person can issue a CAPA to other party but we need to be careful as well to impose such criteria that it may misuse by other parties in organization.

i hope you get my point and hope to hear any suggestions or questions or comments. Thank you.

 

[Hunter36]

In the biotech industry, we definately measure the age of the CA and PA, since this is something that the FDA would also look at. If aging isn't watched closely, it can be shocking the amount of time that a CA or PA will linger, making it very difficult to defend to the FDA.

Sandra

I would think that regardless of industry a large amount of time for a lingering CA or PA is also reflective of a failure to comply to ISO section 6.1 Provision of Resources.

If a CA or PA remains unaddressed for a long enough period of time that would be reflective of the companies inability to provide the appropriate resources to effectively deal with these issues. Whether it be financially or man-power, a lack of resources is generally at the root cause, unless the rare occasion where NO CORRECTIVE ACTION is even conceivable, and this could reflect a potentially larger problem.

In my company we are very small, 6 people, so if there is an issue that requires corrective action we attempt to rectify the situation as fast as possible. Sometimes this is dependent upon our suppliers (sending incorrect part, inappropriate packing slips, no mfg certs, etc) and cannot be done as fast as we would like, but even in these instances the corrective actions dependence upon our supplier is documented and someone is assigned to follow up on it until it is rectified.

As for a specific time frame of a CA lingering to long, I am not experienced enough to say. But if a CA remained open in our company for more than 2 weeks for non-product issues and a month for product related issues, I would be very distraught with my co-workers!