Chronic Lateness of CAPA (Corrective and Preventive Action) Responses

[Fatboy]

This may be a repeat of earlier posts and if it is I apologize. I could not find a similar thread.

Persons at my company outside of the quality department appear to have a chronic problem with late responses and going beyond the implementation due date for CAPAs. In most cases I have to remind them that they are past due (as if I didn't have enough things to do already). My point is that there seems to be a lack of urgency in following through with the CAPA's that are issued. I may have put my finger on it as there is a disclaimer in the procedure that states that a meeting will be held with the person's supervisor to discuss the overdue condition. This is a "crutch" as persons are waiting for me to contact them.

Has anyone else encountered this problem and if so how was it resolved?

 

[Jim Wynne]

This may be a repeat of earlier posts and if it is I apologize. I could not find a similar thread.

Persons at my company outside of the quality department appear to have a chronic problem with late responses and going beyond the implementation due date for CAPAs. In most cases I have to remind them that they are past due (as if I didn't have enough things to do already). My point is that there seems to be a lack of urgency in following through with the CAPA's that are issued. I may have put my finger on it as there is a disclaimer in the procedure that states that a meeting will be held with the person's supervisor to discuss the overdue condition. This is a "crutch" as persons are waiting for me to contact them.

Has anyone else encountered this problem and if so how was it resolved?

The phenomenon you describe is common, and it happens because Deming's point #1 (Create constancy of purpose...) hasn't been followed. You and the people who are expected to respond have different priorities. The respondents are doing what they need to do to keep their bosses happy, which is different from what you need to do to keep your boss happy. The solution is at a higher level. The capo di tutti capi (boss of all bosses) is the one who has to set the priorities.

 

[Craig H.]

One of the neat things about our "new" (~2 years now) software is escalations. I get one (an email telling which one and that it's due) when a CA is due, the Ops Manager gets one 3 days late, and the Plant Manager (VP of Ops) gets one 7 days out. An email from one of them to the offending party usually does the trick. No more QA Manager begging. I like it.

The nice thing about it is it is automatic. The messages are sent by the software and the only way I know about it is through the cc I get whenever one is sent.

Call it constancy of purpose, call it a 2x4 upside the head, it works for us.

 

[Sidney Vianna]

elevate & escalate

Has anyone else encountered this problem and if so how was it resolved?

Yes, this happens quite often. This might be resolved by more frequent management reviews (IF management is serious about this) since, in such reviews, you are supposed to go over the STATUS of CA/PA's. As Craig mentioned, escalation of notices to their bosses can also be very helpful. Another point, try to quantify ($) the risks of leaving a non-conforming situation unresolved. If people do not understand the inherent risks of a process/product out of "spec", they tend not to see the urgency in resolving it.

On the other hand, ask yourself if the issues don't get the attention because they are really inconsequential. If that were the case, then the problems are the CA's themselves, not the people being chronically delinquent.

 

[rose24m03]

priority level

Usually different departments have different priorities. What's urgent for QARA is not urgent for them. Root cause is usually lack of executive management enforcement to ensure actions are taken promptly to address the issues. Got that problem almost everywhere. Sadly to mention that people and organization don't take prompt actions until FDA is coming, or worse.

 

[S Roche Hendrix]

We had the same problem, but solved it fairly easily.

We created a board (matrix) that shows each department and the steps in our CAPA system(corrective action, results) and Management of Change systems (change complete,results) that have due dates. Much like a scorecard. This is on a dry erase board in the main office. Red -- past due, yellow -- due within two weeks, green -- OK We update weekly. Everyone can easily see the status.

This works only because past due gets the attention of upper management and they start asking about it. If its important to the boss its important to everyone.

S

 

[kreco]

One of the neat things about our "new" (~2 years now) software is escalations. I get one (an email telling which one and that it's due) when a CA is due, the Ops Manager gets one 3 days late, and the Plant Manager (VP of Ops) gets one 7 days out. An email from one of them to the offending party usually does the trick. No more QA Manager begging. I like it.

The nice thing about it is it is automatic. The messages are sent by the software and the only way I know about it is through the cc I get whenever one is sent.

Call it constancy of purpose, call it a 2x4 upside the head, it works for us.

What is your software and where can I get it?

 

[Craig H.]

What is your software and where can I get it?

We use QSi, from IBS. It is a comprehensive ISO 9001/QS/14001 package in a Lotus Notes environment. There is a lot to learn to use it, but IMO is worth the effort.

And, no, I do not own any stock.

 

[ralphsulser]

When I was a QE with Rockwell we had a similar software system in Lotus Notes for escalation. Cost big bucks for all 14 plants in our division, but was a great tool to get the production types off their duffs. Wish we had it here.

 

[in_cr_ove]

yes, it is a common problem.
i have also gone through the responses.
the common thread is top down approach to elicit response.
i agree.
at the same time there may be another reason of low/ sluggish response to CAPA.
if the CAPA impacts one's job directly and makes it easier, one will repond dramatically different.
majority of times, auditors have a choice of what NCR (s) to generate. i recommend that initially we must raise NCR that makes the respondents job easy, enriching. gradually degree of difficulty may be raised. i have found this method effective in involving people and to get good reponse.
top down approch is important, so is bottoms up approach.
worth trying.