4 replies to this topic

[Bingo67]

Can you give me an example of the information on your CAPA log? Do you have a separate on for just "correction"? My last auditor said it was best practice to have them separate? Thoughts?

[TimG]

As long as I document what the correction is, what the goal of the correction is, and what the plans are with the issue (quality will continue to monitor, Production Director to verify effectiveness after x time and stronger measures might be implemented at that time, etc.) I haven't had any negative feedback. What you can't do is put in a simple correction because it's easy and then evidence by audits/customer complaints/GMP inspections etc. that the correction was ineffective and you never escalated it to a full CAPA.

[jfrey123]

On the LOG itself, we only list the correction whether it be the minor "correction" or a full on CAPA.  The log is just the running list of all our findings, and each finding is wholly documented separately.  When we do the trend analysis of the log, the number of those minor corrections is important to consider as it can mean you should now escalate to a full CAPA. 

 

Ex:  Find an employee with ear buds, you tell them to take them out and you move on.  Happens again a month later, you do the same and get back to your real work.  6 months later you do your trend analysis and realize your team is correcting people for earbuds every dang month?  Now it's time to CAPA these fools and get stuff fixed.

[GMO]

I don't have much SQF experience but in general with CAPAs, depending on the severity of the issue, I might include an immediate correction (sometimes called a "mitigation" or "containment action", i.e. what makes it food safe now) and separately list the correction and prevention. The prevention should be addressing root cause which you've also used a recognised method to determine.

 

Whether or not you include the immediate correction separately, I would definitely list out the corrective and preventive actions separately. It's good practice to ensure you really are aiming for that so called 100 year fix or at least as close to prevention as you can.

I hate for example seeing a preventive action which includes the member of staff was "retrained" unless there was something wrong with the training in the first place and if so, why not change the training? 

 

This is not all about audits too. If you split out the CAPA you might start to see trends in the type of actions you choose for both corrective and preventive actions which could challenge you to push for more / better.

[TimG]

 

I hate for example seeing a preventive action which includes the member of staff was "retrained" unless there was something wrong with the training in the first place and if so, why not change the training? 

 

Because it's not usually the training, it's the trainee not absorbing the information or understanding the severity of it. I have had great success with "You are being given opportunity to absorb this information again because it was made evident you didn't understand it the first time you were instructed on X.XX.XXX. Do not hesitate to ask questions if you do not completely understand all information presented, as (not following X GMP, not filling out X documentation, etc) will result in disciplinary action up to possible termination."

I don't know what kind of folks you guys are getting over in the EU, but yeah..retraining is pretty essential here stateside from time to time.