Nonconformance for not closing an NC (Corrective Action)

[Randy]

Corrective action time will be stipulated in the body of the audit report and becomes a requirement that must be fulfilled and that's where the date comes from.

Perfectly acceptable and also required by the CB's Accreditation Body

Or....

The organization has a requirement it has set for action to be taken that stipulates a time frame

Right here is what is contained within our report format....

A nonconformity requiring attention was identified. This, along with other findings, is contained within subsequent sections of the report.

A minor nonconformity relates to a single identified lapse, which in itself would not indicate a breakdown in the management system's ability to effectively control the processes for which it was intended. It is necessary to investigate the underlying cause of any issue to determine corrective action. The proposed action will be reviewed for effective implementation at the next assessment.

Please submit a plan detailing the nonconformity, the cause and your proposed corrective action, with responsibilities and timescales allocated. The plan is to be submitted no later than x/x/xxxx by e-mail or fax to your assessor, referencing the report number.

If it's not done then there is a failure to fulfill a system requirement (contractural). In fact I had to notify a client not 15 minutes ago about this very subject.

 

[Sidney Vianna]

Any CB auditor would raise an NC on such issues under clause 8.2.2 that reads:

That requirement applies to corrective actions originating from internal audits. There are many other sources for triggering corrective action requests, outside internal audits, such as product and product non-conformities, customer complaints, returned product etc...

Right here is what is contained within our report format....

A nonconformity requiring attention was identified. This, along with other findings, is contained within subsequent sections of the report.

A minor nonconformity relates to a single identified lapse, which in itself would not indicate a breakdown in the management system's ability to effectively control the processes for which it was intended. It is necessary to investigate the underlying cause of any issue to determine corrective action. The proposed action will be reviewed for effective implementation at the next assessment.

Please submit a plan detailing the nonconformity, the cause and your proposed corrective action, with responsibilities and timescales allocated. The plan is to be submitted no later than x/x/xxxx by e-mail or fax to your assessor, referencing the report number.

If it's not done then there is a failure to fulfill a system requirement (contractural). In fact I had to notify a client not 15 minutes ago about this very subject.

Once again, that applies to the nonconformity management for nonconformities triggered by the BSi auditor and would not necessarily apply to internally triggered corrective action requests.

The truth is that the OP did not provide enough information for us to make a sound judgement on the adequacy of the CB auditor write up. Chronically delinquent corrective action requests is a common failure mode in the corporate world. One of the reasons why ISO 9001 mandates the assessment of corrective action status during management review.

This has been discussed, for example in the Chronic Lateness of CAPA (Corrective and Preventive Action) Responses thread. In principle a SINGLE failure to implement a corrective action within the expected timeframe should not lead not a non-conformity, IF there are sound reasons for the delay. Auditing requires sound analytical skills, assessment of the context and robustness of the system, etc... There is no one-size-fits-all scenario.

Without adequate information, we can conjecture ad nauseum here. Posters who don't take the time to provide adequate information about the scenario they would like to have assessed will never get adequate answers, for the most part. At best, educated guesses.

As always, the caliber of the answers depend on the quality of the question.

 

[vanputten]

I totally agree with Sidney. The original poster did not give us enough data. We were not told anything about a due date. All we were told is that the NC was not closed. We don't know if that NC was open within or outside of any due date.

There is no way to draw a conclusion.

 

[6-Sigma]

The standard does not require a non conformance to be closed within X days.
Please note that there is a difference between "responding" and "closing" of a non conformance (NC).

There are 2 considerations:
1) If the original non conformance was issued by the registrar then the standard requires a response to the NC within 30 days. Even here if there is discussion relevant to the NC the registrar may allow for additional days ...
a. This NC response will have a proposed implementation date
b. This NC response will have a proposed monitoring time period to determine effectiveness of the proposed corrective action
c. After the monitoring period the auditor who issued the NC will review the data for corrective action effectiveness
d. The auditor who issued the NC will determine if the NC is closed or more work needs to be done to address the NC.

2) If the original NC was issued due to a planned internal audit or due to a internal process failure or a product failure or due to a reported customer complaint then the NC is subject to the time frames determined within the QMS procedures. Questions,

a. Is there a time frame by which NC is to be closed?
b. Is there leave way to keep a NC open if it best serves all stakeholders involved?
c. Is there a defined process to close or keep open a NC?
d. Has the corrective Action related to this NC proven to be effective?
e. Has the MR given a reason why the NC is not closed?

 

[JaneB]

Without adequate information, we can conjecture ad nauseum here. Posters who don't take the time to provide adequate information about the scenario they would like to have assessed will never get adequate answers, for the most part. At best, educated guesses.

As always, the caliber of the answers depend on the quality of the question.

Right on, as usual Sidney. Totally agree.

 

[AndyN]

Hello,
Recently the auditor issues an NC to MR when his Documents and Record Control was audited. Reason for the NC was that earlier NC issues to other department was not yet closed.
1. Can such an NC be issued?
2. Are there any clause under ISO 9001:2008 stating NC's MUST be closed within x days?

Thanks
Anand

Anand. Which auditor - internal or CB auditor?

I'd be a bit concerned that any auditor would be auditing document and records controls and 'jump' to corrective actions failure! Sounds like something is contrived here. Can you give us the exact wording etc of the NC. There's nothing here to relate to ISO 9001

 

[AnandR]

Hello,
Sorry, if my question posted was not clear and did not sufficient data.

1. It was an internal Audit
2. Process audited was: Document & Record Control

NC raised was on the process: Document & Record Control. Internal auditor checked if to ensure previous NC's raised during inter audit were closed and found one NC that was raised to Marketing Dept still open. Marketing dept had mentioned the implementation date to close the date, but failed to meet the date for reasons unknown.
Hence NC was raised to MR reporting previous NC was still open.

No where we have mentione din any our process on the time lines for closing the NC.

Hope the information helps.
Anand

 

[qusys]

Hello,
Sorry, if my question posted was not clear and did not sufficient data.

1. It was an internal Audit
2. Process audited was: Document & Record Control

NC raised was on the process: Document & Record Control. Internal auditor checked if to ensure previous NC's raised during inter audit were closed and found one NC that was raised to Marketing Dept still open. Marketing dept had mentioned the implementation date to close the date, but failed to meet the date for reasons unknown.
Hence NC was raised to MR reporting previous NC was still open.

No where we have mentione din any our process on the time lines for closing the NC.

Hope the information helps.
Anand

Did you also interview the process owner/response coordinator of this action?
What is the process in place to eventually communicate a reschedule/postponing an asction related to the closure of an action coming from an internal audit?
Were the results of the internal audit an input to the Management review?
Was this issue already raised in management review?

From what you have reported the process of the internal audit does not appears to be so robust in terms of monitoring of the effective of the corrective actions closure.
If you can give more details based upon what I requested, we could have a wider scenario on this ncn.

 

[AnandR]

I was constantly following-up with process owner to close the NC and their response was they need to discuss with their seniors on the corrective action. seniors were not available most of the time as they were travelling.

Currently, there is no process or guidelines for postponment of action against an NC

This was informed in the Management Meeting and it was acknowledged that there is a delay, but seniors are required to make the decision on corrective action.

 

[qusys]

I was constantly following-up with process owner to close the NC and their response was they need to discuss with their seniors on the corrective action. seniors were not available most of the time as they were travelling.

Currently, there is no process or guidelines for postponment of action against an NC

This was informed in the Management Meeting and it was acknowledged that there is a delay, but seniors are required to make the decision on corrective action.

How much time passed from when the non conformity was raised up?