Does every nonconformance require a corrective action?

Does every nonconformance require a corrective action? Such as every data entry error?

If yes, can you offer some suggestions on how to handle types like these?

If not, what is a good way to document the fact that you looked at the nonconformance and decided it was not practical to address it?

Can anyone recommend a place to go to get ideas for a good Corrective action system, that isn't frowned upon by all employees?

Thanks.

[Roger Eastin]

Wow, there is a lot of information in this forum on that question!! I would suggest that you do a search on CAs for the various responses. The basic answer, though, to your first question is no. You don't need a CA for every nonconformance, as the standard states that your decision about this should be based on the risk involved with the nonconformance. However, before I answer anymore, do a search and I think you'll find what you're looking for.

Not every "nonconformance" requires a specific corrective action, at least not with the registrars I have worked with. Consider the (potential) impact of the nonconformance on the customer and on the financial well being of your organization. If it does make sense (perhaps according to managerial judgment) take immediate action.

Where it doesn't make business sense to take immediate action trending may be used. I recommend using a "tally sheet" for capturing the less significant nonconformances and then periodically analyzing the data using some of the basic quality tools (Pareto analysis, cost/benefit analysis, root cause analysis, etc.). Then, based on this analysis, perform a corrective action to resolve what is determined to be the most pressing problem. I have found this approach to work well.

[Marc]

From: ISO 9000 Standards Discussion
Date: Thu, 7 Dec 2000 14:24:57 -0600
Subject: Re: Q: Nonconformances /Maseman/Andrews

From: eandrews

>From: "Wendy Maseman"
>
>Does every nonconformance require a corrective action? Such as
>every data entry error? If yes, can you offer some suggestions
>on how to handle them?
>
>If not, how do address the fact that you looked at the
>nonconformance and decided it was not practical to address it?
>
>Is there a web site that would help with setting up a good
>corrective action system?
>
>Any help would be welcomed.
>
>-Wendy Maseman

Wendy,

NO - every nonconformance does NOT require a corrective action. If a system is established that requires a corrective action for EVERY nonconformance, that system is soon bogged down with investigations, corrective action requests, etc. for a large number of INSIGNIFICANT happenings. Save the corrective actions for the SIGNIFICANT items. Determination of what is SIGNIFICANT is entirely up to you and your organization. It can be based on impact to product quality, safety, customer satisfaction, bottom line, undesirable trends, etc. or anything else that YOU decide. If corrective actions (and all that they entail) are reserved for REAL problems then they will get the attention and resources that they deserve.

My thoughts - hope it's helpful,

Ethan Andrews

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From: ISO 9000 Standards Discussion
Date: Thu, 7 Dec 2000 14:28:52 -0600
Subject: Re: Q: Nonconformances /Maseman/Blair

From: GrantBlair

A single data entry level would not be a nonconformance. If there are a number of data entry errors, then it is reasonable to assume there is a root cause for all the errors, for example, incomplete or confusing work instructions. Rewriting the work instructions would address the root cause, merely correcting the data errors would not. If not, how do address the fact that you looked at the nonconformance and decided it was not practical to address it?

An example that comes to mind would be to find a single error on an internal audit, e.g. a control chart with points out of control. The auditor could request in the nonconformance an examination of a additional charts to see if there was a more extensive problem. If no such pattern was found, then it would be reasonable to document this and close the NCR.

Grant Blair

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From: ISO 9000 Standards Discussion
Date: Thu, 7 Dec 2000 14:31:22 -0600
Subject: Re: Q: Nonconformances /Maseman

From: TBliven

The ISO model addresses this topic in section 4.14, allowing for corrective action appropriate to the nonconformance. It would seem prudent to expend resources where effectiveness is maximized. Isolated or sporadic errors on a manual process such as data entry are going to happen. The cost to eliminate the errors may not be in line with the value of the task.

Tom Bliven

*************************************

From: ISO 9000 Standards Discussion
Date: Thu, 7 Dec 2000 14:35:25 -0600
Subject: Re: Nonconformances /Maseman/venkatasamy

From: "venkatasamy.v"

The ISO 9001:1994 says:

"Any corrective or preventive action taken to eliminate the causes of actual or potential non conformities shall be to a degree appropriate to the magnitude of problems and commensurate with the risks encountered"

So, the idea is to "attack the vital few, and hold the trivial many". What you need is the analysis, to classify the non conformances as "Vital" or "trivial". i.e) it is not required to have a CA for every non-conformance, provided you have proper analysis (magnitude/risk).

The data entry error in a transaction processing system, may not be vital, since you can validate it subsequently and also the effect may not be significant. How ever you find these errors quite often, it could be a chronic situation which may require a CA

However in automated production centers, any data entry error will be vital, since it could lead to rejection of the output and a CA also PA may be a must.

One method I follow is to classify the nonconformance as follows:
V - vital
E - essential
D - desirable

V will qualify for a CA & PA
E will qualify for a CA

D is further indexed as Sporadic and Chronic (that means such occurrences need to be analysed over a period of time) and a chronic D will qualify for CA, and for a sporadic D, there are no CAs, (atleast immediately)

This you need to spellout in your procedure

Regards

Venkatasamy

******************************

From: ISO 9000 Standards Discussion
Date: Thu, 7 Dec 2000 14:38:42 -0600
Subject: Re: Nonconformances /Maseman/Bartschenfeld

From: "Bob Bartschenfeld"

We log every occurrence in which product was dispositioned (ie, scrapped, reworked, returned from customer). The Quality Manager assigns a responsibility to determine the root cause, if possible. If the root cause is systemic, we require a corrective action. If it appears not to be systemic, the responsible Manager may state that and the CAR is closed out. This allows us to track root causes as well as symptoms of nonconformances (we have a lot). We use an intranet database for the tracking.

Bob Bartschenfeld

[Marc]

Also see:

http://Elsmar.com/ubb/Forum1/HTML/000016.html
http://Elsmar.com/ubb/Forum1/HTML/000330.html
http://Elsmar.com/ubb/Forum2/HTML/000036.html

Edited 2 January 2002

I can't re-lookup and change every old link to posts in the old forums. Most of them *should* still be there. If you want to find the post in the New forums, if the link to the thread in the old forums works (most of them should...), look at the thread (topic) title and what forum it is in. Then back here in the New forums - go to that forum and look for the thread topic title - OR - do a Search for the key words from Title (Note - you can search entire threads or just the 'subject' or 'title' - if you look in the Forums search page you'll see the options.

Call me lazy...

You already have a number of very good answers to your question, but keep in mind that all Registrars are not created equally. Be sure to ask your Registrar the question. Although we all agree here that a single data entry error is not a nonconformance, you registrar might disagree with this - we're all unique.

If your registrar makes a big deal about it, you can get around it by stating specifically in your documentation system something to the effect that "...single data entries are not considered nonconformances..."

Jerry

------------------
Jerry Kilpatrick & Associates
Fax: 413-556-5711
jkilpatrick@ureach.com

Actually, Auditors that have been involved with describe the approach of applying C/A to every issue is found to be what many have termed a "knee jerk" reaction. I agree with the earlier comment that a tally sheet can be used for tracking Non-Conformances.