Recurring Nonconformance - Missing Deadline for Closing a Corrective Action

C

cymsg

#1
Hi All,

I worked as an internal auditor in a certified ISO 13485 company (5 employee).
Currently there is a recurring issue in closing a corrective action due to missing deadline (a few items) after root cause investigation. The deadline was raise up to the management and manual job to be done list is created. The personnel still failed to close one of the item.

Is there a solution or plan beside having a eQMS system to prevent recurring of missing deadline to prove that the existing QMS is effective?
 
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RoxaneB

Super Moderator
Super Moderator
#3
Re: Recurring Nonconformance (missing deadline)

Hi All,

I worked as an internal auditor in a certified ISO 13485 company (5 employee).
Currently there is a recurring issue in closing a corrective action due to missing deadline (a few items) after root cause investigation. The deadline was raise up to the management and manual job to be done list is created. The personnel still failed to close one of the item.

Is there a solution or plan beside having a eQMS system to prevent recurring of missing deadline to prove that the existing QMS is effective?
Welcome to the Cove, cymsg.

A QMS - electronic or otherwise - is no guarantee of meeting a deadline. The QMS is more about having a system in place to effectively resolve the issue - in this particular situation, how was the deadline assigned? Was it based on looking at a calendar and saying "30 days sounds good"? Or was it based on the complexity of the action, while taking into consideration other activities that could be a drain on resources?

The other item to take into consideration is why the deadline was not met (and why it continues to be unmet, by the sounds of it). Is there an issue with process? Are there sufficient resources (this includes people, time, money, knowledge, etc.)? Are there regular status update meetings to keep the assigned individual (and leadership) focused and committed to completing the action? Does the person responsible not understand the activity and/or believe it has little value to correcting the original issue?

Part of resolving a nonconformance can involve root cause analysis. Same thing applies here. Understanding WHY the deadline was not met is the more relevant issue, in my opinion.
 

dsanabria

Quite Involved in Discussions
#4
Re: Recurring Nonconformance (missing deadline)

Hi All,

I worked as an internal auditor in a certified ISO 13485 company (5 employee).
Currently there is a recurring issue in closing a corrective action due to missing deadline (a few items) after root cause investigation. The deadline was raise up to the management and manual job to be done list is created. The personnel still failed to close one of the item.

Is there a solution or plan beside having a eQMS system to prevent recurring of missing deadline to prove that the existing QMS is effective?
If management is aware and doesn't get involved and provide support then your next move is to let the external auditor be aware of it - the auditor is your ally.
 

RoxaneB

Super Moderator
Super Moderator
#5
Re: Recurring Nonconformance (missing deadline)

If management is aware and doesn't get involved and provide support then your next move is to let the external auditor be aware of it - the auditor is your ally.
I'll be honest...I disagree with this approach. You do not disclose your internal issues with your external auditor, regardless of their 'ally status', especially on something that sounds non-systematic, such as a missed deadline.

If the auditor makes a note of it during his/her next visit, it the responsibility of LEADERSHIP to explain their approach. The internal auditor is not the one responsible for sustaining the QMS.
 
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D

Duke Okes

#6
Re: Recurring Nonconformance (missing deadline)

Although it may create a career risk letting the CB auditor know of significant issues that have been brought to management's attention without adequate resolution is certainly an option.
 

dsanabria

Quite Involved in Discussions
#7
Re: Recurring Nonconformance (missing deadline)

This is only one option when management give lip service to maintaining the integrity of the QMS while not supporting the internal audits.

All of the CB auditors are experienced, savvy and the issues will not return to the internal audit, they make it look like they did the discovery and will request from top management for additional information without getting anyone in trouble. That is building relationship and trust.

Note: if you do not trust your CB auditor - then all you could do is provide yourself an NCR and raise it up to a Major in which Top management needs to answer it.

Tighten up your procedures and make them accountable
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
Re: Recurring Nonconformance (missing deadline)

All of the CB auditors are experienced, savvy
What? Not all auditors are experienced, savvy, trustworthy, etc. To paint all auditors with a wide brush is risky.

There is no universal rule. Some relationships would justify the leak to the external auditor as a mean to get it resolved. But you have to have matured, collaborative people in both ends.

Some relationships between registrants and CB's are not strong enough for this approach to be advisable.

Case by case, in my experience.

As for the missing deadlines issue, many times the problem happens because of unrealistic, artificial deadlines are set. Have flexibility when setting deadlines, based on the risks associated with the nonconforming situation and the resources available at hand.
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#9
Re: Recurring Nonconformance (missing deadline)

The words "Whistle Blower" comes to my mind, and I say that with no prejudice as to good or bad. Sometimes it is appropriate and other times not. As others in the discussion have said, situations are specific scenarios thus case-by-case as to the whether to disclose or not.
 
C

cymsg

#10
Re: Recurring Nonconformance (missing deadline)

Thanks RoxaneB for the warm welcome. I'm thankful for the responses.

I agree on not revealing internal issues as external audit are not able to give advice to avoid conflict of interest.

As for setting flexible deadline, it would be responsible of management to be tracking the it (eg. frequency, severity). This can be counter effective.

I have disagree with my lead auditor on the root cause given by her that is lack of time management. My reasoning for missing deadline is due to 2 reason, lack of knowledge and time management. However, it is deem by lead auditor that sufficient time is given for a task to be completed.

I understand the importance of committing into a due date, how do you know how much time should be put into a task to deem the time spent on task is effective?
 
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