Conflict of Interest if I audit the QC department?

[Armen]

Hello All,

I appreciate your responses to my question. Recently, I have been promoted to be the QA manager of a small medical device company. I'll be responsible QC department as well. I'd like to know if it would be a conflict of interest if I audit the QC department since I am responsible for activities at this department.
Thank you

 

[John C. Abnet]

Hello All,

I appreciate your responses to my question. Recently, I have been promoted to be the QA manager of a small medical device company. I'll be responsible QC department as well. I'd like to know if it would be a conflict of interest if I audit the QC department since I am responsible for activities at this department.
Thank you

Good day @Armen ;
Short answer: No

Searching by key words on this forum will reveal a lot of discussion on this topic. ISO 9001 7.2 requires that "you" "...are competent ..."
ISO 9.2.2 c) specifies "select auditors and conduct audits to ensure objectivity and the impartiality of the audit process".

Do these things and demonstrate the effectiveness and you are fine.

Hope this helps.
Be well.

By the way @Armen...congratulations on the promotion !

John

 

[Armen]

Thanks John,
Speaking of effectiveness, how do you know your auditing process is effective?

By the way @Armen...congratulations on the promotion !

John

Thank yoy

 

[John C. Abnet]

Thanks John,
Speaking of effectiveness, how do you know your auditing process is effective?

I can give you some possible examples but I would be curious to know what you think would be...
evidence that the internal audits are determining the effectiveness of the management system and conformance to internal and international standard requirements.

Thoughts?

 

[Armen]

QAM is also responsible for internal auditing. Basically, I am auditing my own department, unless, I request the audit be done for example by validation department.

I can give you some possible examples but I would be curious to know what you think would be...
evidence that the internal audits are determining the effectiveness of the management system and conformance to internal and international standard requirements.

Thoughts?

I don't know the answer myself, yet one possible way could be developing post-audit checklist for auditors and auditee seeking to understand what went well during the audit, areas of improvement, lessons learned, etc.

 

[mmasiddiqui]

Thanks John,
Speaking of effectiveness, how do you know your auditing process is effective?

You should find an effective way to tie your audit findings to the Quality KPIs.
If your audit score is really good but your scrap, rework data, First Pass Yield data tells a different story, then there is surely some gap in the way you are auditing or your scope of audit is wrong.

 

[John C. Abnet]

I don't know the answer myself, yet one possible way could be developing post-audit checklist for auditors and auditee seeking to understand what went well during the audit, areas of improvement, lessons learned, etc.

Good day @Armen, nothing wrong with that but not sure how that will show that the management system is effective and internal/external requirements have been met. In addition, every checksheet that is created and committed to will add an additional layer of effort and documentation that then needs sustained

Top management have ultimate responsibility for the effectiveness of the management system. (Top Management's job to assign the direction and resources to fix it...not the auditor's responsibility)
The internal audit is to simply provide information. (ISO 19011Guidelines for auditing management systems is NOT necessary for you to procure but you may find it helpful).

The results of audits are a required input into management reviews. If I were Top Management in your organization I would want to understand ..
* summaries of the type of nonconformances found
* what are the categories of repeat nonconformances if any.
* things gone right/things gone wrong (general summary) of the audit process

You can show evidence / examples of how audit non-conformance findings are being manifested into corrective actions and/or continual improvement.
One idea is to "tick"/identify the corrective action requests and/or the continuous improvement activities that were initiated as result of internal audit findings. Corrective actions should be reviewed for effectiveness. If resultant corrective actions and/ or continuous improvement activities, were effective, then your internal audits were obviously effective.

Don't overthink it.

Hope this helps.
Be well

 

[Sidney Vianna]

, how do you know your auditing process is effective?

Do you have customer complaints? Regulatory notices of violation? Product returns? Recalls?

 

[Big Jim]

Good day @Armen ;
Short answer: No

Searching by key words on this forum will reveal a lot of discussion on this topic. ISO 9001 7.2 requires that "you" "...are competent ..."
ISO 9.2.2 c) specifies "select auditors and conduct audits to ensure objectivity and the impartiality of the audit process".

Do these things and demonstrate the effectiveness and you are fine.

Hope this helps.
Be well.

I'm having a hard time understanding why so many seem to not realize that "auditors cannot audit their own work" was removed from ISO 9001:2015.

Is it possible that the writers had a reason for leaving it out?

The best guidance on this topic is probably contained in ISO 9002:2016. I suggest you read it. It provides an explanation about how to handle the "select auditors and conduct audits to ensure objectivity and the impartiality of the audit process" issues when a company determines they do need to let someone audit themselves. I suggest you read it.

I would also like to speak on the determination of objectivity and impartiality. It is my belief that it is up to the organization, not an auditor, to determine if someone can be objective and impartial. Factors likely would include the individuals character and integrity as well as company culture, topics that an outside auditor is not likely to be able to determine as well as the organization.

So the short answer would be more like: you should try to avoid it, but if necessary proceed cautiously to ensure objectivity and impartiality.

 

[outdoorsNW]

Since the OP has just been promoted, there is less potential for auditing their own work. Much to most of what will be audited is the predecessor's work.

The OP is not completely clear if this was an internal promotion from a subordinate role to manager or this was an outside hire. If this was an internal promotion, only work that the OP worked on previously has the potential to be a conflict.

If others performed the same tasks, focusing on the work of others can avoid any potential conflict. And I think the OPs prior work can be supporting evidence of things such as different interpretations of the same work instructions.

While many companies only have quality people as internal auditors, I think auditors from outside the quality department bring value both because they start with a better understanding of how some other areas work and they gain a better understanding of how a different part of the company works. We often try to assign auditors to audit areas that either create inputs to or handle outputs of the auditor's job.