Guys

I just need to know how do you represent specific example for CAPA initiation to close out if you have to explain somebody in training I would really apprciated your feed back on this subject


Thanks in advance

Guys
I just need to know how do you represent specific example for CAPA initiation to close out if you have to explain somebody in training I would really apprciated your feed back on this subject
Thanks in advance

Use something from everyday life as your first example. I often use a flat tire.

Then use an example from their work area, whether real or made up.

If you look through these threads, you will find some discussions and examples:
CAPA discussion threads (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=capa),
Corrective Action discussion threads (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=corrective+action),
and
Preventive Action discussion threads (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=preventive+action).

You might also want to try a Search of the CAPA Post File Attachments (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=capa).

Also see: 8-D Problem Solving (http://elsmar.com/8D/)

NOTE: You can refine your Searches by refining the words you search on. See my 'sig'.

There are real life examples in a number of the existing threads and attached files, but if you cannot find any that will 'work' for you, come back and ask again.

Why do we say CAPA? Preventive Action comes before Corrective Action so surely it should be PACA?

We have way too many people thinking that corrective action is fixing the problem and that preventive action is stopping it from happening again. Continuing with the old-fashioned CAPA term may just stop them putting in place a genuine preventive action process.

I realize the FDA regulators have this wrong but we have not need to perpetuate the problem. Long live PACA!

Use something from everyday life as your first example. I often use a flat tire.

Then use an example from their work area, whether real or made up.

Duke

I will be glad if you could describe me about flat tire example

Thanks inadvance

Duke I will be glad if you could describe me about flat tire example Thanks inadvance

You mean you've never had one??? Lucky you. Guess after more than 30 cars (not counting rental cars) the odds are against me?

Here's just one of many I use in my root cause analysis training:

1. Tire looks somewhat deflated. Why?
1.1 Wasn’t properly inflated when installed, or
1.2 Some intentionally let air out of tire, or
1.3 Tire is leaking (it was this one). Why?
1.3.1 Valve stem is leaking, or
1.3.2 Aluminum wheel is leaking, or
1.3.3 Interface between wheel and tire is leaking, or
1.3.4 Tire has a puncture (it was this one; this is the Physical Cause to be corrected, plugging the hole in the tire or replacing tire). Why did it occur?
1.3.4.1 Someone intentionally punctured it, or
1.3.4.2 Driver ran over something hazardous (it was this one). Why?
1.3.4.2.1 Didn't see a hazard in the road, or
1.3.4.2.2 Tried to avoid rear-ending another vehicle and swerved off the road hitting a hazard, or
1.3.4.2.3 Habit of driving through the median to avoid heavy traffic (it was this one; this is the System Cause, which is the root cause; only by changing driving habits would problem not likely recur due to same cause)

You mean you've never had one??? Lucky you. Guess after more than 30 cars (not counting rental cars) the odds are against me?

Here's just one of many I use in my root cause analysis training:

1. Tire looks somewhat deflated. Why?
1.1 Wasn’t properly inflated when installed, or
1.2 Some intentionally let air out of tire, or
1.3 Tire is leaking (it was this one). Why?
1.3.1 Valve stem is leaking, or
1.3.2 Aluminum wheel is leaking, or
1.3.3 Interface between wheel and tire is leaking, or
1.3.4 Tire has a puncture (it was this one; this is the Physical Cause to be corrected, plugging the hole in the tire or replacing tire). Why did it occur?
1.3.4.1 Someone intentionally punctured it, or
1.3.4.2 Driver ran over something hazardous (it was this one). Why?
1.3.4.2.1 Didn't see a hazard in the road, or
1.3.4.2.2 Tried to avoid rear-ending another vehicle and swerved off the road hitting a hazard, or
1.3.4.2.3 Habit of driving through the median to avoid heavy traffic (it was this one; this is the System Cause, which is the root cause; only by changing driving habits would problem not likely recur due to same cause)

Thanks Duke

I just want to add one more thing How do you coordinate CAPA evaluation, investigation, and closure of consumer complaints, and ensure with full GMP compliance ?