ISO9001 Major for repeat issue.

smhillman

Starting to get Involved
#1
We received a is9001 Major for clause 10.2.1 nonconformity and corrective action because of a repeat issue that failed in one of our processes. My thoughts are our containment and corrective actions should be related to how we address and or handle all CARs, not specific to that one process that failed repeatedly. Any feedback?
 
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AMIT BALLAL

Super Moderator
#2
Can you share the nonconformity statement & objective evidence details (excluding confidential information) to understand the situation better?
 

smhillman

Starting to get Involved
#3
Major Nonconformance – Nonconformance and Corrective Action

Statement of Nonconformity: The process for ensuring effective and sustained CA's is not completely effective

10.2 Nonconformity and Corrective Action
10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:

a. react to the nonconformity and, as applicable:
1. take action to control and correct it;
2. deal with the consequences;

b. evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:

Objective Evidence:

During the last audit period CAR xxx was issued, the auditor issued a Minor Nonconformity when it was noted:
“During an internal audit of the area, MO XXXX, Operation XXX "XXX" requires inspection following Standard requires operator/inspectors to be certified to the applicable standard. The operator performing the inspection was not certified.

During the last internal audit period CAR XXX, the auditor issued a Minor Nonconformity when it was noted:
“During the audit, there were several discrepancies in Maintenance records for tooling that was not maintained for some of the tooling.
 
#4
We just had a similar issue, and you are correct. It should specifically be related to the effectiveness of your corrective action process. How can you should that your process is effective and provide evidence? We created a spreadsheet for read across and rated each closed CAR within the last years for effectiveness and noted why. We called that CAR the bonus finding, since we got another one on the original minor as a major. Hope this helps.
 

AMIT BALLAL

Super Moderator
#5
IMHO, the nonconformity seems poorly worded, hence difficult to fully understand.

Based on the objective evidence recorded, I don't feel it is a nonconformity. You should have an analysis of repeated issues, but an NC should not be raised just because issues are repeated, but in absence of an analysis & action plan.
 

smhillman

Starting to get Involved
#6
IMHO, the nonconformity seems poorly worded, hence difficult to fully understand.

Based on the objective evidence recorded, I don't feel it is a nonconformity. You should have an analysis of repeated issues, but an NC should not be raised just because issues are repeated, but in absence of an analysis & action plan.
Yes, agree it is poorly written, looks like they just forgot to note that each of these two previous CARS were found to have failed again furing this audit for the same issue, but they did and he did issue separate minors for each of those two items. So this would be considered legitimate.
 

Jim Wynne

Staff member
Admin
#7
Yes, agree it is poorly written, looks like they just forgot to note that each of these two previous CARS were found to have failed again furing this audit for the same issue, but they did and he did issue separate minors for each of those two items. So this would be considered legitimate.
That NC statement is pure bafflegab. You should ask for it to be updated and clarified before doing anything else.
 

smhillman

Starting to get Involved
#8
Understand your concern and I have already addressed it accordingly, it was issued by an internal auditor. Regardless, I will answer the CAR, do you have any constructive feedback on my question?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#9
Major NCRs within AS9100 - What is the most frequent reason for Major NCRs?
AS9100D Major nonconformity due to recurrence of a NC during a subsequent CB audit.
Where are the rules for when a repeat minor nonconformance becomes a major?

When the Corrective Action Process shows to be ineffective due to multiple and repeat similar system failures, an expectation of a nonconformity against that process makes sense, but the presented write up does not make sense as the failures were not similar nor related.
 
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