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#1 MvanEeden

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Posted 25 August 2014 - 10:34 AM

Good day,

 

Kindly give me your opinion / advice on this:

 

For customer complaints, non-conformances and audits, how can we decide when to perform a root cause analysis.  For example, an audit finding suggested that a certain area around the facility needs to be paved.  This is already on a capex plan and will be done by the end of the year.  Is it necessary to perform a root-cause analysis? 

 

Kind Regards,

Madel



#2 Mike Green

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Posted 25 August 2014 - 01:06 PM

Hi Madel

 

 Not sure why your audit identified that the area needs to be paved-so IMO.....It depends....

 

'A root cause is a cause that once removed from the problem fault sequence, prevents the final undesirable event from recurring. A causal factor is a factor that affects an event's outcome, but is not a root cause.'

 

 

If, for example, the problem identified in the audit is mud being brought into the factory on the feet of the staff -then paving the area may solve it-however if the mud is being caused by water from a cracked drain or leaking pipe- or a high water table/insufficient drainage..... it probably won't!

 

Kind Regards

 

Mike


I may sound like a complete idiot...but actually there are a couple of bits missing

#3 Charles.C

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Posted 25 August 2014 - 02:23 PM

Good day,

 

Kindly give me your opinion / advice on this:

 

For customer complaints, non-conformances and audits, how can we decide when to perform a root cause analysis.  For example, an audit finding suggested that a certain area around the facility needs to be paved.  This is already on a capex plan and will be done by the end of the year.  Is it necessary to perform a root-cause analysis? 

 

Kind Regards,

Madel

 

Dear Mvaneeden,

 

As per previous post, one wonders what caused the "needs paving" suggestion ?, eg auditor leg stuck in a hole ?

 

If  you are referring to FS audits (??), IMEX root cause analysis is more often tied to a haccp corrective action occurrence, ie a CCP defect.

 

The urgency maybe depends on a RA / auditorial consequences if neglected.

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


#4 jel

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Posted 25 August 2014 - 08:46 PM

Good day,

 

Kindly give me your opinion / advice on this:

 

For customer complaints, non-conformances and audits, how can we decide when to perform a root cause analysis.  For example, an audit finding suggested that a certain area around the facility needs to be paved.  This is already on a capex plan and will be done by the end of the year.  Is it necessary to perform a root-cause analysis? 

 

Kind Regards,

Madel

In the situation you present, to pave an area, as you mention, it's just a suggestion, and you do not need to perform a root cause analysis 
 
You must perform a root cause analysis when recurrent situations that are affecting or may affect the ability of the organization to produce safe products are presented. 
 
If a condition of noncompliance, major or less, occurs only in isolation, a correction should be applied


#5 whiskylass

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Posted 28 August 2014 - 06:36 AM

An auditor once told me that root cause should be put in place for all process and procedural fails.  Within my organisation we investigate customer complaints which inevitably come up with a root cause anyway, we do root causes for all non conformances arising from audits with the exception of GMP audits - within a GMP audit root cause is carried out if it is a procedural failure as mentioned above but if it is something as simple as a bit of proofing then this doesn't get put through the root cause procedure.

 

All auditors are different so the above may not be suitable in all cases but it seems to be working for us at the moment :smile:






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