Timely Closure and "Ongoing" Corrective Action

[tori2432]

Just started at a new company and reviewing management review. There is a 2 year old corrective action that is 'on-going'. I don't like seeing the 'on-going' word on any corrective action. It should have a quick end date, or shouldn't it?

 

[gpainter]

re: Timely Closure and "Ongoing" Corrective Action

Can share what the permanent CA is.

 

[cbhigdon3]

re: Timely Closure and "Ongoing" Corrective Action

A good third-party auditor from one of the major CBs would be all over this one and, depending on their strictness, might even write you up for a second finding in that the corrective action system is not effective and that there is no validation activity performed. Ongoing CAs bear the hallmarks of a previous individual (or individuals) that don't want to receive a finding from their CB, so they create a corrective action preemptively in order to demonstrate that the "organization is taking care of it" - except they never actually implement the CA just keep it open so that they don't get a finding on future audits.

Generally, 30 days out is about the limit that most of my customers want to see for the full CA/PA cycle.

 

[Ajit Basrur]

Just started at a new company and reviewing management review. There is a 2 year old corrective action that is 'on-going'. I don't like seeing the 'on-going' word on any corrective action. It should have a quick end date, or shouldn't it?

Yes, ideally we all love to see corrective actions closed in a timely manner (and complies with the procedural requirements). But certain CAs require a longer time for closure and effectiveness.

I do not mind the CA as "ongoing" provide there is some traction and not just lying dormant and unattended.

 

[Golfman25]

Having a preconceived timeline for closure of a CA just means you're looking for feel good solutions. Not every problem is the same. Some I can close in 24 hours. Some may take a year or more. The real issue is whether progress is being made and how it is progressing.

 

[Sebastian]

Every auditor has own personal corrective action/timing matrix, e.g. effect of seeing "2 years for procedure revision" definitely will bring a smile on her(his) face.

Organization strong point - documented information reviewed and updated in a very cautious manner.

Seriously, in the past I get 1 NC for poor corrective action management connected with ineffective escalation process. Auditor found I had reported to president open CAR few times, but he didn't react to it in any way.

 

[Sidney Vianna]

It should have a quick end date, or shouldn't it?

No, quickies are, for the most part, not satisfying... The time needed for the "once-and-for-all-put-to-rest" corrective action will have to be commensurate with the complexity of the issue and the nature of true corrective action. Much better to have a monitored, gradual, "slow" but sure corrective action than a fast one that just turns into a band-aid.

Generally, 30 days out is about the limit that most of my customers want to see for the full CA/PA cycle.

And, sometimes, that means that you are pretending to perform corrective action and they, your clients, are pretending to perform supplier oversight. Some problems will demand a thorough, time-consuming investigation. Some corrective actions might demand the procurement of capital equipment, something that has budgetary implications, not solvable in 30 days. As long as artificial deadlines are present, we will end up with band-aids, recurring problems.

We must not forget that, in addition to corrective action, correction and containment are also part of the process to address nonconforming products. Sometimes, containment has to be in place for a while, until true corrective action is in place.

 

[Kronos147]

What if the containment is "don't take these orders" and corrective action is "save up and buy a $xxx,xxx machine"?

How long is reasonable?

If continually reviewed (management review? corrective action process?) including evidence, then why a problem with an ongoing CA?

 

[Bev D]

I agree that CAs can't have a 'set' time frame for completion - unless you want your CAs 'pencil whipped'. As long as the actions and planned actions make sense and are actively being pursued I see nothing wrong in a 'long time' CA. This does take more work to manage as we must have a good working understanding of what the CA team is doing and why; but isn't that our job?

I have an open CA now that is nearing it's 3rd birthday. I can tell you that it has been extremely active. we implemented containment within 3 days of discovering the problem, improved the containment action 3 times in the next 6 months while pursuing an understanding of causal mechanism which led to a redesign and will require approval by a regulatory body. These things can take time to ensure an effective solution that prevents re-occurrence, but I am more than comfortable with our approach and can defend it to any auditor as our work and the data speaks for itself.

No where in the standards is a timeframe proscribed. Timeliness is a relative term. What is proscribed is that when a nonconformance is severe enough we need to determine the root cause and implement solutions that prevent re-occurrence...

 

[Mike S.]

I agree with Bev and others who say artificial time limits don't work for all situations.

Again, Pareto is alive and well. Maybe a large majority can be completed in a relatively short time frame like 30-60 days if reasonable effort is made, but a small percentage may take a long time to do a good job on, especially if the production is sporadic.

In situations where they take a long time to fully close, I still make provisions to protect the customer in the interim with containment, correction, and temporary corrective actions like 100% inspection whenever possible.