Boss doesn't want Nonconformances called Nonconformances in Internal Audit Reports

[imcglone]

Re: Boss doesn't want Nonconformances called Nonconformances in Internal Audit Report

Great post

I like to think, perhaps misguidedly that we can work in a cooperative manner.
Typically if during an audit I think that things need to be tightened up or the implementation of a part of the standard is not adequately implemented I will raise an Action on the auditee and advise the team lead/manager. I will agree a time frame for the auditee to complete the action, advise them that I will return to check the action has been completed after the agreed date.

On the rare occasion that the auditee has not complied and cannot give good reason for non-compliance I will then raise a formal non-conformity.
By comparison, my boss the Quality Manager and other members of the team think we should just hit them with a non-conformance there and then.
I believe and generally find that this approach is less confrontational and results in compliance.

Am I incorrect in my approach?

 

[howste]

Re: Boss doesn't want Nonconformances called Nonconformances in Internal Audit Report

I like to think, perhaps misguidedly that we can work in a cooperative manner.
Typically if during an audit I think that things need to be tightened up or the implementation of a part of the standard is not adequately implemented I will raise an Action on the auditee and advise the team lead/manager. I will agree a time frame for the auditee to complete the action, advise them that I will return to check the action has been completed after the agreed date.

On the rare occasion that the auditee has not complied and cannot give good reason for non-compliance I will then raise a formal non-conformity.
By comparison, my boss the Quality Manager and other members of the team think we should just hit them with a non-conformance there and then.
I believe and generally find that this approach is less confrontational and results in compliance.

Am I incorrect in my approach?

There's nothing wrong with cooperation. However with the approach you suggested, I believe you may end up with mostly corrections and not real corrective actions. For the example given by Piningg, the auditee may have the one past-due item calibrated, but the reason it wasn't calibrated to begin with may not be determined. Any other past-due items may not be identified, and there will probably be recurrences with this and/or other equipment.

 

[arios]

Re: Boss doesn't want Nonconformances called Nonconformances in Internal Audit Report

My experience is the exact opposite...we show the auditor the findings and CAPA's for the findings, and he essentially says "Good job, no problems." IMO, Internal auditors shoud be strongly encouraged to dig - and dig deep -

Agree.....as long as it does not become like digging their own grave

Picky internal auditors may not be the most popular in their own companies , but they are necessary.

 

[Quality-Geek]

Re: Boss doesn't want Nonconformances called Nonconformances in Internal Audit Report

I like to think, perhaps misguidedly that we can work in a cooperative manner.
Typically if during an audit I think that things need to be tightened up or the implementation of a part of the standard is not adequately implemented I will raise an Action on the auditee and advise the team lead/manager. I will agree a time frame for the auditee to complete the action, advise them that I will return to check the action has been completed after the agreed date.

On the rare occasion that the auditee has not complied and cannot give good reason for non-compliance I will then raise a formal non-conformity.
By comparison, my boss the Quality Manager and other members of the team think we should just hit them with a non-conformance there and then.
I believe and generally find that this approach is less confrontational and results in compliance.

Am I incorrect in my approach?

Can you have a documented informal approach? What if these Actions were labeled "OFI" or "Preventive" or "Request for Information" or whatever other less-scary label you want to use?? That way people still do some investigating and make the necessary corrections but aren't raising the level too high for the finding. After all, the entire corrective/preventive action process should be appropriate to the findings, regardless of where/how the findings originated.

 

[arios]

Re: Boss doesn't want Nonconformances called Nonconformances in Internal Audit Report

Can you have a documented informal approach? What if these Actions were labeled "OFI" or "Preventive" or "Request for Information" or whatever other less-scary label you want to use?? That way people still do some investigating and make the necessary corrections but aren't raising the level too high for the finding. After all, the entire corrective/preventive action process should be appropriate to the findings, regardless of where/how the findings originated.

I hope the below classification serves as a guidance:


" INTERNAL AUDIT FINDING CLASSIFICATION:
Priority 1 non-conformance (Major):

For the purposes of this audit report, a priority 1 non-conformance (or major NC) includes those findings that fulfill one or more of the following scenarios:
1. Total failure to define, document, or implement an element of the quality system.

2. The existence of situations or products which clearly do not comply with the manufacturer’s and/or customer’s specifications, the ISO XYZ standard, the Quality System regulation, and/or other relevant regulatory requirements, and which were not adequately addressed by the systems for the Control of Non-conforming product and/or the Corrective and Preventive Actions.

3. The Non-correction or inadequate correction of major deficiencies derived from previous audit(s). Also includes repeated deficiencies of same or similar non-conformities from previous audit(s).

Priority 2 non-conformance (Minor):
For the purposes of this audit report, a priority 2 non-conformance includes those findings that constitute QMS deficiencies of a quantity and/or type to conclude that there is minimal probability -- in light of the relationship between quality system deficiencies observed and the particular device and manufacturing processes involved -- that the organization will produce nonconforming and/or defective finished devices or products.

Audit Observations:
For the purposes of this audit report, an observation describes an event that may require further follow-up and/or attention in order to enhance control and/or compliance. Based on its lower severity and/or incidence a correction may be sufficient to address an identified observation, however the auditee is encouraged to evaluate if the identified finding could deserve the initiation of corrective or preventive action(s) based on subsequent information gained after the audit.

Opportunities for Improvement:
For the purposes of this audit report, an opportunity for improvement constitutes a recommendation. The auditee is encouraged to consider the noted recommendations to enhance compliance, fill gaps, clarify procedures, and/or to consider public external reference materials as a benchmark to improve its own established controls and procedures."

The feedback from the cove members is welcome to improve these suggested definitions.

Thanks

 

[foiley]

Re: Boss doesn't want Nonconformances called Nonconformances in Internal Audit Report

Hi, I can see there is a lot of fruitful debate about what is essentially just a term which which is extremely subjective.

Obviously your manager has assigned a Non Conformance to a catastrophic systems failiure. In the end it is just a name. Every auditor I have ever met have different definitions around non-conformances. Even to the point of defining their own terms about classes of non-conformances...

I use a method of internal auditing where I don't call anything a Non-Conformance. I see auditing as a service, trying to assist the business as well as the compliance aspect. I define the structure within the internal audit report. I am very up front what I condiser acceptable and not acceptable. By the way I refer to a Non-Conformance as Recommendation. As in "I recommend you do something to fix this issue, so you can be compliant."

Auditing is a skill and involves negotiation. Defining non-conformances and when they are raised is part of the audit scope. I don't see there is anything wrong with your bosses request...

 

[20110525R]

Re: Boss doesn't want Nonconformances called Nonconformances in Internal Audit Report

He can call them anything he wants, as long as your procedures reflect that name. Besides, the Registrars Auditors will call them Non Conformances (can you say Corrective Action Requests) when they don't see the terminology matching your Procedures (I figure you are either ISO 9001 or AS9100). Also, when they see you have no Internal Audits with Nonconformances, they're going to dig a little deeper in your procedures and practices, I know I would as an auditor. Auditors love it when management try's to "Lipstick up a Pig".

 

[AndyN]

Re: Boss doesn't want Nonconformances called Nonconformances in Internal Audit Report

Hi, I can see there is a lot of fruitful debate about what is essentially just a term which which is extremely subjective.

Obviously your manager has assigned a Non Conformance to a catastrophic systems failiure. In the end it is just a name. Every auditor I have ever met have different definitions around non-conformances. Even to the point of defining their own terms about classes of non-conformances...

I use a method of internal auditing where I don't call anything a Non-Conformance. I see auditing as a service, trying to assist the business as well as the compliance aspect. I define the structure within the internal audit report. I am very up front what I condiser acceptable and not acceptable. By the way I refer to a Non-Conformance as Recommendation. As in "I recommend you do something to fix this issue, so you can be compliant."

Auditing is a skill and involves negotiation. Defining non-conformances and when they are raised is part of the audit scope. I don't see there is anything wrong with your bosses request...

I think you may be doing things differently than what is accepted practice by many auditors. There shouldn't be any subjectivity in it. We deal in facts. When you say you define what's acceptable, it sounds like you are defining audit criteria yourself, instead of using the organizations' QMS etc. Auditors don't call the shots, management do. Also, what's to negotiate? If you have facts and present evidence, there's no need for negotiation. Do you ever look at the effectiveness of the QMS? You won't have any problems with negotiation if you include that in your audit.

You may wish to revisit your audit methods to get better results and spend less time talking around things in your audits and spend more time bringing answers to management they can act on...

 

[horselady]

Re: Boss doesn't want Nonconformances called Nonconformances in Internal Audit Report

Section 8.2.2 states "The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process". The way we do it here is the Lead Auditor (Quality Systems Mgr), reports to the very top management and doesn't work for the Quality Manager. The Quality Manager and Quality Systems Mgr. work closely together, but occasionally butt heads and keep each other "honest". That way, the auditors (who report to the Quality Systems Mgr during audits) report their findings objectively and impartially. If the QM has a problem with what's found and/or how it was classified, it's discussed with the Quality Sys Mgr (Lead Auditor). I hope this isn't too confusing sounding, it actually works very well and ensures impartiality.

 

[Solinas]

Re: Boss doesn't want Nonconformances called Nonconformances in Internal Audit Report

Take the opportunity to rename them "Conditions Requiring Audit Proactivity." Then, run around saying in a loud voice how much CRAP you found in the area, and how much CRAP is going on.

Think of how the Powerpoints of the audit results will look!