Nonconformity Caused by Human Error - How to make a Corrective Action?

clara · Mar 4, 2008

Dear all,
During the recent audit, the auditor detected that the personnel record of one of our employees was not updated the trainings taken though all the training certificates were filed as per our procedure.
The root cause is that the HR Manager really forget and the corrective proposed is retrain our HR Manager so hat he will apply well our procedure. But the auditor does not accept it.
Please advice me what I have to reply the auditor.
hank you in advance.
Clara

Stijloor · Mar 4, 2008

clara said:
Dear all,
During the recent audit, the auditor detected that the personnel record of one of our employees was not updated the trainings taken though all the training certificates were filed as per our procedure.
The root cause is that the HR Manager really forget and the corrective proposed is retrain our HR Manager so hat he will apply well our procedure. But the auditor does not accept it.
Please advice me what I have to reply the auditor.
hank you in advance.
Clara

Hello Clara,

If this is really a single isolated nonconformity, tell the auditor that you accept the NC, but because this is really a one-time occurrence, you are not going to waste your company's resources on it. This is perfectly in line and in compliance with 8.5.2. Period.

Stijloor.

eternal_atlas · Mar 4, 2008

If the finding is limited to only one case and the root cause is due to human error not due to absence of any procedure or not awareness of that procedure by the HR Manager then it is not an NCR at all.

See Auditor has the rights limited to raise an NC but not to give proposed corrective action unless the auditee asks. So, Accept if it is an NC as per her his words, but do root cause analysis and corrective action with respect o your purview since you are the process owner.

Suresh Kumar
RTW Consultant

Jen Kirley · Mar 4, 2008

Welcome to The Cove Suresh! Good first post.

I agree that retraining is not a fix for this process problem. It is a simple matter, since evidence of training existed in the file. In fact, I am interested in the fact that the registrar did not treat it as an observation because evidence of training did exist in the file.

I have a question about your training record. If you have certificates etc. as evidence of training in the file, why is it important for the HR Manager to enter data in a separate record? I can imagine the human brain's response to filing the certificates as being: "Okay, evidence of training filed. Done."

If it really is important for the separate training record to be updated, then the process could be error proofed somehow. Since people's brains don't have computer routines, training wouldn't ensure the fix will endure. I would ask the HR Manager:

1. If the separate record is really needed, and why.
2. If the separate record really is needed, is there another reasonable way to show this training has taken place?
3. If the separate record is really necessary and there is no better method, what sort of reminder would help make sure the information gets entered every time? Take the answer, try it, see if it works. If it works, go with it. This way, the problem has become part of the solution.

Let's be clear that I am not trying to overthink this. But in the face of a discovery that a procedure is not being followed, the logical course of action is to examine the procedure first to see if it is appropriate, and then to examine ways to follow it if it's really needed. As an internal auditor I advocate simplifying when possible.

Given that this is a useful problem solving exersize, I would not tell the registrar I won't waste my company's resources on it. I would just get through it, and apply the lesson learned to other discoveries.

Helmut Jilling · Mar 4, 2008

Jennifer Kirley said:
Welcome to The Cove Suresh! Good first post.

I agree that retraining is not a fix for this process problem. It is a simple matter, since evidence of training existed in the file. In fact, I am interested in the fact that the registrar did not treat it as an observation because evidence of training did exist in the file.

I have a question about your training record. If you have certificates etc. as evidence of training in the file, why is it important for the HR Manager to enter data in a separate record? I can imagine the human brain's response to filing the certificates as being: "Okay, evidence of training filed. Done."

If it really is important for the separate training record to be updated, then the process could be error proofed somehow. Since people's brains don't have computer routines, training wouldn't ensure the fix will endure. I would ask the HR Manager:

1. If the separate record is really needed, and why.
2. If the separate record really is needed, is there another reasonable way to show this training has taken place?
3. If the separate record is really necessary and there is no better method, what sort of reminder would help make sure the information gets entered every time? Take the answer, try it, see if it works. If it works, go with it. This way, the problem has become part of the solution.

Let's be clear that I am not trying to overthink this. But in the face of a discovery that a procedure is not being followed, the logical course of action is to examine the procedure first to see if it is appropriate, and then to examine ways to follow it if it's really needed. As an internal auditor I advocate simplifying when possible.

Given that this is a useful problem solving exersize, I would not tell the registrar I won't waste my company's resources on it. I would just get through it, and apply the lesson learned to other discoveries.

I agree. I think many times we make our systems too complicated. However, if the separate record is needed, then reverse the procedure to enter the information into this separate record before filing the certificate away. Reverse the order so you don't forget.

Helmut Jilling · Mar 4, 2008

eternal_atlas said:
If the finding is limited to only one case and the root cause is due to human error not due to absence of any procedure or not awareness of that procedure by the HR Manager then it is not an NCR at all.

See Auditor has the rights limited to raise an NC but not to give proposed corrective action unless the auditee asks. So, Accept if it is an NC as per her his words, but do root cause analysis and corrective action with respect o your purview since you are the process owner.

Suresh Kumar
RTW Consultant

That is too broad a statement. Being one incident only or being human error does not determine whether it is an NCR? If the process failed to do what it required, then it is an NC.

Quantity has nothing to do with whether it is an NC, only the severity.

SteelMaiden · Mar 4, 2008

Jennifer makes excellent points, as always. Our brains think a little differently than computers (or most do).

A bigger problem, as I see it, is that your system while attempting to be electronic, still relies upon filing paper copies of certificates (tests, evaluations, etc.) While I am with everyone else in "fixing" the records that the auditor found, I think I would start looking for an alternative that would allow me to keep electronic copies of all those pieces of paper that you are stuffing into a file folder within the training documentation software itself.

We will always have to have private (legal) HR files that are not for ordinary public consumption...but why not find a long term solution for your training, testing, evaluation results that allows you to pull up information from any computer you decide to load your training record software on to? (i.e. scanned copies of tests, certificates, etc., in the training software instead of in some paper file locked in HR?)

Bev D · Mar 4, 2008

Jennifer's point concerning the duplicate records is a pivotal one. It seems that all other actions are based on this.

Typically, a training record for an individual is a compliation of all things are trained to do. This is an excellent AID to the person or supervisor when assigning tasks. A matrix of all available employees and their training status is even more helpful. However, both of these are a compilation of a set of individual records.

An electronic system makes this easy.

a paper system makes this fraught with error opportunities..

Sidney Vianna · Mar 4, 2008

Helmut Jilling said:
That is too broad a statement. Being one incident only or being human error does not determine whether it is an NCR? If the process failed to do what it required, then it is an NC.

Quantity has nothing to do with whether it is an NC, only the severity.

The basic problem with that approach is: once a NC is written, corrective action is required. Root cause analysis and corrective action implementation have an associated cost. To incur unnecessary costs to "fix" robust processes is unwise.

Auditors should evaluate the impact of writing an NC. Most experienced auditors do that. Even a process operating at a six-sigma level will have 3.4 defects (NC's) per million opportunities. Should we write up every process that is less than perfect?

Caster · Mar 4, 2008

SteelMaiden said:
A bigger problem, as I see it, is that your system while attempting to be electronic, still relies upon filing paper copies of certificates (tests, evaluations, etc.) ..., I think I would start looking for an alternative that would allow me to keep electronic copies of all those pieces of paper

Steel

Our procedure says that once the paper record is entered into our electronic system, the hard copy is discarded. This has survived numerous customer and several different registrar audits. In fact it was suggested by a registrar (I know they aren't supposed to consult, but the best ones always offer up good ideas).

Nonconformity Caused by Human Error - How to make a Corrective Action?

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