Where to include other types of Nonconformities

[QAMTY]

Hi everybody.

Please share your experiences regarding how to manage non conformances of an ISO system.

Now, I follow on way but want to improve the current method.

I have a NCR format according to 8.3 control of non conformity product, but is specifically used for product, onto it we apply dispositions.

but recently I have found other issues like these:

-An operator fails to follow procedure.

- Lack of competence

-A regulatory report is not filed on time.

-People fails at filling out records, etc.

And want to start reporting these kind of issues.

Where (which format) do you think it is more recommended to raise non conformities of this type?

1 In the current format, considering it is just for product?
but adjusting it, mentioning that are included other issues, although some
of them will not have applied dispositions like if it were product?
Here a correction (disposition) will apply o maybe to be escalated to a CA.

2 To raise a CAR , mentioning the other different issues in it?
from here, a correction or full corrective action will apply.

To complement the information, As an example, in internal audits when I have findings. The finding it is fed into the CAR format (problem definition)
here, I apply just correction or carry out a full cause analysis.

I dont have a special format just for corrections,

What is practical to be followed? or do you have any other idea?

Thanks

 

[Bev D]

It's up to you of course. We can use the same electronic form for non conforming events, but we usually only do this if we are going to escalate to a corrective action. We rarely escalate, we typically just record the NC event in the aduit report and ask for immediate correction. We only escalate high risk non conforming events to CAs and these rarely come from audits. They come from our knowledge of ongoing events within the organization. Most of our CAs are product related.

 

[Avraham Harris]

We also do not use NCRs (or Product Non-conformity reports (PNRs) for quality issues requiring corrective or preventive action. For these we open a Corrective action directly, and if it results from an audit, the audit is the primary source for the issue, followed by a CAPA. So I agree completely with QAMTY and Bev D.

 

[Mark Meer]

We have a single system procedure dealing generally with anything considered a non-conformance. This covers everything from product NCs, equipment, personnel, documentation, suppliers, etc.

This is because there are similar steps involved, regardless of the NC: documentation, evaluation, notifications, actions (includes disposition in the case of physical items, or documents).

We find that this simplifies documentation, and allows for more flexible analysis.
We can use a single generic form for documenting NCs of any type (supplemented with attachments as necessary), with a field for "category" identifying the type (product, documentation, supplier...). Because all the NC forms are maintained together on an electronic system, we can quickly, for example, see in what areas there are the most identified non-conformances, or filter by type to analyze the NCs of a particular category.

Contrast this with the approach we had previously, which involved multiple system procedures, and multiple forms for each type of NC. For our purposes, this was needlessly onerous, and inefficient - which is why we have since consolidated NC documentation. Works well for us thus far...

MM.

 

[Ettore]

Good morning.
My experience told me do not to wait until the day of the audits to collect any evidence of non-conformity.
I have always spent a lot of time in the preparation of audits, particularly in the search for new evidence of non-conformity, and in this I was helped by tools such as SAP that allowed me to follow the sale of products from raw materials purchase.
How many suppliers used without first checking their reliability. How many materials used without the approval request process, and I could go on and on until evening.
All these findings were then collected and highlighted in an action plan along with those recorded on the day of check in Department.
In the last 8 years of my 27 spent in the same company to perform audits, perhaps the experience or the request of our automotive suppliers have led me to focus attention on the development of new products and related processes. So all the audits carried out by department had an action plan that followed our procedure for the development of new products and processes in line with the APQP.
To conclude I think an action plan in line with ISO TS16949 APQP or otherwise focused on processes/products out of standard is an excellent tool where reporting this type of non conformity.

 

[Randy]

I've never failed to understand the benefit of having 14 different ways to fix the same thing...Something didn't go as planned and now it has to be corrected.

Where is the cost effectiveness of having a different corecctive action process for every different problem?

Why do it one way when 14 ways can really clog the system?

 

[Mor628]

We experienced the same issue, where the root cause came down to human error. At that point, we created an ''internal NC'' that focused primarily on personnel.

However, over time maintaining this process became more difficult and we realized alot of the NC's resulted in the same corrective action; Updating the SOP and retraining staff.

So now, NC's only document all our output (product and service) and we track everything else with an Internal SOP log, where mistakes at staff level are recorded along with steps taken to prevent them. This also helps in our training and induction for new staff.