Where are the rules for when a repeat minor nonconformance becomes a major?

[Rameshwar25]

This is another time where I don't have the text so it would be good to know what "rule book" is being referred to, what 5.11.5 in it says, and to have example(s) of what the minor nonconformances are.

Dear Marc,
Following text is is part of clause 5.11.5

" In cases where the accepted corrective action plan for a minor nonconformity is found to be not effectively implemented, a new major nonconformity shall be issued against the corrective action process (see IATF 16949, section 10.2) and the previous minor nonconformity reissued as a major nonconformity."​

​

There are two parts of this paragraph which require for two major NCs

1. a new major nonconformity shall be issued against the corrective action process.​

2. the previous minor nonconformity reissued as a major nonconformity.​

​

regards
rameshwar

 

[Marc]

Which brings to the front: The definition of "similar".

In my opinion, 5.11.5 does not address Andy's reason for starting this discussion.

 

[Rameshwar25]

No Marc,
the discussion was started with an event when auditor converted a previous year's minor NC into major next year when submitted corrective actions were not effectively implemented throughout the year. The initiator of post wanted to know the rule against which it was converted.
The answer to this situation is in clause 5.11.5 only and nowhere else.

 

[Marc]

@Rameshwar25 - What is the definition of "similar"? 5.11.5 addresses a specific identified nonconformance the corrective action for which "... isn't effectively implemented" which is an easy call to make.

 

[Rameshwar25]

I want to explain with an example.
Two vernier calipers (VC-01 and VC-02) out of 20 are found uncalibrated in an audit. Getting them calibrated is only correction. after root cause determination, corrective action should be to prevent recurrence of such situation. The corrective action will not only cover these two vernier calipers but all instruments which needs calibration.

if any other instrument, apart from these two, is found uncalibrated in next audit, it will be considered SIMILAR minor nonconformity and will be considered failure to effectively implementing the corrective actions. The previous year's NC will be converted into major.

 

[Marc]

I agree that in the isolated case you cite there is clear similarity.

 

[AndyN]

Rameshwar - great example. This happened to an organization. However, with over 400 items of equipment and ZERO impact on product quality, I fail to see how 1) it's a complete breakdown and 2) it didn't result in any non-conforming product being made or shipped.

The rule is highly suspect, IMHO.

 

[Rameshwar25]

Dear Andy, See below:
"Major nonconformity is one or more of the following:
01.The absence of or total breakdown of a system to meet an IATF 16949 requirement. A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.
02. Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose.
03. A noncompliance that judgment and experience indicate is likely either to result in the failure of the quality management system or to materially reduce its ability to ensure controlled processes and products."

Complete breakdown, as you mentioned in your post, is not only one reason. There are other reasons also. If previous year, there were two instruments found calibrated. This year, other three found uncalibrated. What does it indicate? where are we going? The entire calibration calibration is likely to fail in future. and it becomes basis for a major NC. Pl read point No. 02 and 03 above.

And above all, we are not in capacity of challenging Rulebook. Sometimes, auditor, unwillingly, raises NC because of requirement of standard and rule.

 

[Golfman25]

Rameshwar - great example. This happened to an organization. However, with over 400 items of equipment and ZERO impact on product quality, I fail to see how 1) it's a complete breakdown and 2) it didn't result in any non-conforming product being made or shipped.

The rule is highly suspect, IMHO.

The rule is BS. As the calibration examples point out, you could have a no harm, no foul situation that suddenly becomes a major. Complete nonsense. But the rule was added because of issues they where having -- typical bureaucratic response.

Consider the situation where several years ago you filled out a FEMA form "wrong" by not having a date. You made the correction, and learned your "lesson" but who knows how many other old forms might be missing a date. Welcome to two majors. It's nuts.

 

[Sidney Vianna]

The people who establish these rules don’t have to deal with the outcome and consequences of their decisions, unfortunately, and they believe that such rules will prevent soft grading of nonconformities. It seems to me that the IATF rule was copied from the IAQG Scheme, and, as I said earlier, in the aerospace sector, this rule was developed to placate regulators.

When they created the rule and submitted the draft of AS9101 for review, I was a member of the Americas Aerospace Quality Standard Committee and expressed my concern. We have threads here at The Cove about that circa 2011.

A much better rule would force lead auditors to justify in the report why similar nonconformities in consecutive audits do not represent a failure of the organization’s corrective action process. By forcing the auditor to justify their position, it would give the CB and the registrant a way out of an automatic major NC when and if the evidence and rationale justifies it. Everything is supposed to be processed via a risk-based line of thought. Why not in this case?