Internal Audit Major Nonconformity or Not?

[HRMaribeth]

Hello:

I am in the midst of an internal audit within a smaller "machine shop" manufacturing company. While auditing quality and the CAR/PAR section. I asked how many CARs were written since my last internal audit (1 year ago). The answer was 18. As I reviewed these CARs, I found that all of these CARs were written by me, the auditor during our last two internal and external audits. Meaning: no one within the company has utilized the CAR/PAR system! To me... this is a system failure! ... or is it? Can it be written as a major nonconformity?? We may be improving but we have no record of it! How do you all feel about this? Would you write this as a major or minor nonconformity?

I need to open everyone's eyes and make them aware of the system we have in-place needs to be utilized.

Thank you for your thoughts on this on.. I would really appreciate your input.

 

[Reg Morrison]

In my mind, the best way to make the employees use and improve the QMS is by relating real-case problems the organization had to endure.

Are you able to identify serious customer complaints, repeat problems, returned product, loss of revenue due to quality problems, etc?

If so, you should be able to demonstrate to the organization's top management and workforce how exercising their systems and processes, including the corrective action loop should have helped them in AVOIDING some of those problems. It is imperative that corrective action is perceived as a positive thing in the real world.

Out of the 18 corrective actions, can you make a correlation how things have improved for the business? Unless people clearly understand how corrective actions help them in avoiding repeat mistakes, crisis, fires, long days, stress, etc., the WIIIFM factor has not been used effectively.

Writing another CAR, major, critical, lethal (or any other superfluous categorization) would seem counter intuitive at this time.

 

[Jim Wynne]

Hello:

I am in the midst of an internal audit within a smaller "machine shop" manufacturing company. While auditing quality and the CAR/PAR section. I asked how many CARs were written since my last internal audit (1 year ago). The answer was 18. As I reviewed these CARs, I found that all of these CARs were written by me, the auditor during our last two internal and external audits. Meaning: no one within the company has utilized the CAR/PAR system! To me... this is a system failure! ... or is it? Can it be written as a major nonconformity?? We may be improving but we have no record of it! How do you all feel about this? Would you write this as a major or minor nonconformity?

I need to open everyone's eyes and make them aware of the system we have in-place needs to be utilized.

Thank you for your thoughts on this on.. I would really appreciate your input.

You don't say what standard is involved, but I would first not classify internal audit nonconformities as major or minor. Having said that, the audit trail should lead you to investigate the number of incidents wherein someone perhaps should have opened a CA. You say that you yourself wrote 18, presumably in a 12-month period, which seems extreme. I'm not suggesting that you were wrong to do it, just that 18 seems like an awful lot if IA CARs.

You also say that your were the auditor for your last two external audits as well as the internal ones. I'm not sure how that's possible. In any event, before you can "ding" anyone for not doing something, you need to be sure that it did indeed need to be done.

 

[HRMaribeth]

You're right, I spoke too soon and not with great detail. I would ask you to read between the lines. But to clarify.... There were 18 CARs written from both last year's internal audit and the other two audits which were conducted by Perry Johnson (our ISO Registrar) and also from our API external audit. Totaling 18. (API was a *&%$$).

My debate in my head is do I consider it a lack of training, lack of putting in the effort to log into our quality system, lack of understanding the importance of it and just go ahead and let it go and talk to managers later.... OR do I acknowledge it by writing a nonconformity during this internal audit so that a root cause will be defined and management can come up with a corrective action to figure out how to start using the system? Our Registrar will be here in May to conduct a 3-year recert audit. I think it would be wise to address it now so that he sees that I've recognized it and does not wonder the same thing I am now. Hmmm?

 

[Randy]

A very long time ago when I was a young law enforcement officer I realized that I could meet the PD's requirement for "traffic contacts" by finding a "cherry patch" where ticket writing was a no brainer, no strain activity and guess what, I set records for "contacts" but actually contributed nothing to increasing motor vehicle safety.

Now in such a case as you've provided you gotta ask yourself a question "Have I found a cherry patch that results in no value?"

Auditing and the results are centered around a sample process, just because one auditor see's something and another auditor doesn't isn't really a deal unless the sample and circumstances are exactly, exactly the same.

Has every audit conducted by others been absolutely exactly the same as yours?

 

[somashekar]

You're right, I spoke too soon and not with great detail. I would ask you to read between the lines. But to clarify.... There were 18 CARs written from both last year's internal audit and the other two audits which were conducted by Perry Johnson (our ISO Registrar) and also from our API external audit. Totaling 18. (API was a *&%$$).

My debate in my head is do I consider it a lack of training, lack of putting in the effort to log into our quality system, lack of understanding the importance of it and just go ahead and let it go and talk to managers later.... OR do I acknowledge it by writing a nonconformity during this internal audit so that a root cause will be defined and management can come up with a corrective action to figure out how to start using the system? Our Registrar will be here in May to conduct a 3-year recert audit. I think it would be wise to address it now so that he sees that I've recognized it and does not wonder the same thing I am now. Hmmm?

Can you let us know if you are Internal to the company or External, just involved in performing the internal audit as a part of some consultancy...

 

[HRMaribeth]

I am an internal auditor. Company employee. Management Rep.

 

[AndyN]

I am an internal auditor. Company employee. Management Rep.

Is this the only internal audit done during the year? When you say you were auditing "quality" and "CA/PAR" are you auditing against the standard, or are you auditing a process of the business and looking at how they use CAR/PARs to help with issues?

Part of the problem may be how the audits are being planned...

 

[RoxaneB]

<snip>

I asked how many CARs were written since my last internal audit (1 year ago). The answer was 18. As I reviewed these CARs, I found that all of these CARs were written by me, the auditor during our last two internal and external audits. Meaning: no one within the company has utilized the CAR/PAR system! To me... this is a system failure! ... or is it? Can it be written as a major nonconformity?? We may be improving but we have no record of it! How do you all feel about this? Would you write this as a major or minor nonconformity?

I need to open everyone's eyes and make them aware of the system we have in-place needs to be utilized.

Thank you for your thoughts on this on.. I would really appreciate your input.

Has the CAR/PAR system been established and communicated in such a way that it is user-friendly, user-accessible, user-known, and user-believable?

User-friendly | Is it simple and easy to understand? If it's complicated, paperwork-heavy and full of jargon that they do not understand, they won't use it.

User-accessible | Is the system set up that ANYONE can initiate one? Does it require going to a supervisor first?...because that will drop your number right there potentially.

User-known | Do people believe that they are responsible for quality and can initiate reports on discrepancies? Is the process set up to capture real-time product and production issues or is it established to be more about ISO-stuff like audits?

User-believable | Is it something that folks see value in and can believe will positively impact their job and satisfaction? Do people feel they will be taken seriously?

 

[HRMaribeth]

I did not realize when posting my "question" it would have such a wide array of responses. Your points have been well taken and thank you.

My auditing partner and I have figured out our course of action on this one.

At the end of the day... you must wonder why no one writes a CAR/PAR within our company. To me this is not right. NCRs addressed weekly within our company. There are many NCRs written. We have found that all nonconformities found are issued an NCRs and the Quality Inspector is responsble for them. After rethinking, many/some of these NCRs could have been written as a CAR/PAR and issued to another person other than the quality inspector. Not only will that involve everyone in the CAR/PAR process and get them involved but it will also document to external auditors that we are addressing our nonconformities, assigning responsibility, conducting root cause analysis, assigning corrective action and verifying the effectiveness of them.

Training will be included.