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What to do if a Corrective Action requires several extensions

#1
Does anyone know if there are any guidelines/standards addressing what to do if a corrective action requires several extensions beyond the limits defined in the company procedure?
 

Marc

Captain Nice
Staff member
Admin
#2
There have been many discussions in the forum over the years with regard to corrective actions which take longer to implement and close out than expected or within a pre-defined timeframe.

The bottom line is reality. It happens. The question is, can why be explained. Cost, as an example?

My suggestion is that you scan some of the discussions in this forum: Nonconformance and Corrective Action

And if you still have questions, come back to this discussion and give some specifics of the scenario you are involved in.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
Does anyone know if there are any guidelines/standards addressing what to do if a corrective action requires several extensions beyond the limits defined in the company procedure?
As Marc mentioned, this issue has been debated here many times. The key aspect is to understand why the corrective actions are not implemented in a timely fashion. Reasons such as;
  • Artificial short deadlines in the procedures
  • Lack of buy in by the actionees the problem is real and deserving of a systemic fix
  • People issuing the corrective action requests not having organizational authority
  • Perception of bogus nonconformities
  • Lack of involvement by top management in the system
Assuming the corrective action requests are sound and worthy of fixing, the best way to resolve chronic delinquency is to have an automatic escalation process, whereby, after failure to respond and/or implement corrective actions on the agreed upon timeframe, the reminder gets also copied to the delinquent individual’s line manager. If the escalation process does not work, that is a strong hint that your organization’s management does not give a “rodent’s derrière” about having an effective corrective action process and the organization is, very likely, highly dysfunctional.

Good luck
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#5
bottom line: stop using arbitrary deadlines and start thinking about your corrective actions. truly understand the causes, the severity of the NC and the effectiveness of the proposed solutions.
 

Mike S.

An Early 'Cover'
Trusted
#6
Sometimes customers submit SCAR requests with an "arbitrary deadline" and if no deadline is set at all for internal CARs I doubt many would ever get done.

I usually give folks 30 days as a due date for a SCAR or internal CAR and tell folks "if you need more time, send me an extension request before it goes past due, with a brief justification, and the vast majority of the time I will give you an extension". But if they wait until the due date to even begin, or fail to ask for an extension and the due date comes and goes, I consider it late.

What would you do if you were auditing a company and over half of their CARs were past-due? Ref AS9100 10.2.1.h
 
#7
Sometimes customers submit SCAR requests with an "arbitrary deadline" and if no deadline is set at all for internal CARs I doubt many would ever get done.

I usually give folks 30 days as a due date for a SCAR or internal CAR and tell folks "if you need more time, send me an extension request before it goes past due, with a brief justification, and the vast majority of the time I will give you an extension". But if they wait until the due date to even begin, or fail to ask for an extension and the due date comes and goes, I consider it late.

What would you do if you were auditing a company and over half of their CARs were past-due? Ref AS9100 10.2.1.h
Mike, and other question on the same , What do when when some action plans into the ca, were not finished on Time, do deserve to raise a NC?

Thanks
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#8
Does anyone know if there are any guidelines/standards addressing what to do if a corrective action requires several extensions beyond the limits defined in the company procedure?

Let's be honest here. Any schedule, unless it's been specifically completed prior, is an estimate. As they say 'Plans are useless but planning is essential.' Stuff happens, markets collapse, customers change, employees leave, etc etc. There are the knowns, the known unknowns and the unknown unknowns. How can anyone control the last group?

As an auditor, if the client were late on CARs I would ask "What new information did you learn about this item?" If they can answer with a real-world challenge I would consider it valid. If they dont know it could be negligence and an observation.

Here is an example of a CAR still ongoing that is hurting people. Why isnt this fixed?

Flint water crisis - Wikipedia
 
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